As filed with the Securities and Exchange Commission
on September 24, 2024
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Seelos Therapeutics, Inc.
(Exact name of registrant as specified in its
charter)
Nevada |
2834 |
87-0449967 |
(State or other jurisdiction of
incorporation or organization) |
(Primary Standard Industrial
Classification Code Number) |
(I.R.S. Employer
Identification Number) |
Seelos Therapeutics, Inc.
300 Park Avenue, 2nd Floor
New York, NY 10022
(646) 293-2100
(Address, including zip code, and telephone
number,
including area code, of registrant’s principal
executive offices)
Raj Mehra, Ph.D.
President, Chief Executive Officer and Chairman of the Board of Directors
Seelos Therapeutics, Inc.
300 Park Avenue, 2nd Floor
New York, NY 10022
(646) 293-2100
(Name, address, including zip code, and telephone
number, including area code, of agent for service)
Copies to:
Ron Ben-Bassat, Esq.
Eric Victorson, Esq.
Sullivan & Worcester
LLP
1251 Avenue of the Americas
New York, NY 10020
(212)-660-5003
Approximate
date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration
statement.
If any of the securities being
registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box. x
If this Form is
filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement number of the earlier effective registration statement for the same
offering. ¨
If this Form is a post-effective
amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. ¨
If this Form is a post-effective
amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. ¨
Indicate by check mark whether
the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging
growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting
company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
¨ |
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Non-accelerated filer |
x |
Smaller reporting company |
x |
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Emerging growth company |
¨ |
If an emerging growth company,
indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ¨
The Registrant hereby amends
this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further
amendment that specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and
Exchange Commission, acting pursuant to said Section 8(a), may determine.
The information in this prospectus is not complete and
may be changed. The Placement Agent may not sell these securities until the registration statement filed with the Securities and
Exchange Commission is effective. This prospectus is not an offer to sell these securities, and the Placement Agent is not soliciting
offers to buy these securities, in any state where the offer or sale of these securities is not permitted.
Preliminary Prospectus |
Subject to Completion |
Dated September 24, 2024 |
Up
to Shares of Common Stock
Pre-Funded
Warrants to Purchase up to Shares of Common Stock
Common
Warrants to Purchase up to Shares of Common Stock
We
are offering on a reasonable best efforts basis up to shares of our common
stock, par value $0.001 per share (“common stock”), together with common warrants to purchase up to shares
of our common stock (the “Common Warrants”), based on an assumed combined public offering price of $
per share and accompanying Common Warrant (the last reported sale price of our common stock on The Nasdaq Capital Market on
, 2024). Each Common Warrant will be exercisable for one share of our common stock and have an assumed exercise price of $ per share (or
100% of the assumed offering price per share and accompanying Common Warrant). Each Common Warrant will be exercisable beginning on the
effective date of stockholder approval of the issuance of the shares upon exercise of the Common Warrants (the “Warrant Stockholder
Approval”), provided however, if the Pricing Conditions (as defined below) are met, the Warrant
Stockholder Approval will not be required, and the Common Warrants will be exercisable upon issuance (the “Initial Exercise Date”).
The Common Warrants will expire five years from the Initial Exercise Date or the Warrant Stockholder Approval, as applicable. The shares
of common stock and Common Warrants will be issued separately and will be immediately separable upon issuance but will be purchased together
in this offering. This prospectus also relates to the shares of common stock issuable upon exercise of the Common Warrants sold in this
offering. As used herein “Pricing Conditions” means that the combined public offering price per share and accompanying common
warrants is such that the Warrant Stockholder Approval is not required under the rules of The Nasdaq Stock Market LLC (“Nasdaq”)
because either (i) the offering is an at-the-market offering under Nasdaq rules and such price equals or exceeds the sum of (a) the applicable
“Minimum Price” per share under Nasdaq Rule 5635(d) plus (b) $0.125 per whole share of common stock underlying the common
warrants or (ii) the offering is a discounted offering where the pricing and discount (including attributing a value of $0.125 per whole
share underlying the common warrants) meet the pricing requirements under Nasdaq’s rules.
We
are also offering pre-funded warrants (the “Pre-Funded Warrants” and together with the Common Warrants, the “Warrants”)
to purchase up to shares of common stock to those investors whose purchase
of shares of common stock in this offering would result in the purchaser, together with its affiliates and certain related parties, beneficially
owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation
of this offering, in lieu of shares of common stock that would result in beneficial ownership in excess of 4.99% (or, at the election
of the purchaser, 9.99%) of our outstanding common stock. Each Pre-Funded warrant is exercisable for one share of common stock and has
an exercise price of $0.0001 per share. The combined purchase price per Pre-Funded warrant and accompanying Common Warrants is equal
to $ , which is equal to the combined purchase price per share of common stock and accompanying Common Warrants less
$0.0001. Each Pre-Funded Warrant will be exercisable immediately upon issuance and may be exercised at any time until exercised in full.
The Pre-Funded Warrants and Common Warrants will be issued separately and will be immediately separable upon issuance but will be purchased
together in this offering. For each Pre-Funded Warrant we sell, the number of shares of common stock we are offering will be decreased
on a one-for-one basis. This prospectus also relates to the shares of common stock issuable upon exercise of the Pre-Funded Warrants
sold in this offering.
We
refer to the common stock and Warrants to be sold in this offering collectively as the “securities.”
These
securities are being sold in this offering to certain purchasers under a securities purchase agreement dated ,
2024 between us and such purchasers. The securities are expected to be issued in a single closing and the combined public offering price
per share of common stock or Pre-Funded Warrant and accompanying Common Warrants will be fixed for the duration of this offering.
We will deliver all securities to be issued in connection with this offering delivery versus payment or receipt versus payment, as the
case may be, upon receipt of investor funds received by us.
Our
common stock is listed on Nasdaq under the symbol “SEEL.” On September 23, 2024 the last reported sale price of our
common stock on Nasdaq was $0.19 per share. The actual number of securities, the combined offering price per share of common stock or
Pre-Funded Warrant and accompanying Common Warrant and the exercise price per share of common stock for the accompanying Common Warrants
will be as determined between us, the placement agent and the investors in this offering based on market conditions at the time of pricing.
Therefore, the recent market price used throughout this prospectus may not be indicative of the actual public offering price for the
securities, which may be substantially lower than the assumed price used in this prospectus. There is no established public trading market
for the Warrants and we do not expect a market to develop. In addition, we do not intend to apply for a listing of the Warrants on any
national securities exchange or other trading system.
We
have engaged __ to act as our sole placement agent (the “Placement Agent”) in connection with this offering. The Placement
Agent has agreed to use its reasonable best efforts to arrange for the sale of the securities offered by this prospectus. The Placement
Agent is not purchasing or selling any of the securities we are offering and the Placement agent is not required to arrange the purchase
or sale of any specific number of securities or dollar amount. We have agreed to compensate the Placement Agent as set forth in the table
below, which assumes that we sell all of the securities offered by this prospectus. Because there is no minimum number of securities
or minimum aggregate amount of proceeds for this offering to close, we may sell fewer than all of the securities offered hereby, and
investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to pursue the
business goals outlined in this prospectus. Because there is no escrow account and there is no minimum offering amount, investors could
be in a position where they have invested in our company, but we are unable to fulfill our objectives due to a lack of interest in this
offering. Also, any proceeds from the sale of securities offered by us will be available for our immediate use, despite uncertainty about
whether we would be able to use such funds to effectively implement our business plan. This offering will end no later than ,
2024, except that the shares of common stock underlying the Warrants will be offered on a continuous basis pursuant to Rule 415
under the Securities Act of 1933, as amended (the “Securities Act”).
You
should read this prospectus, together with additional information described under the headings “Incorporation of Certain Information
by Reference” and “Where You Can Find More Information,” carefully before you invest in any of our securities.
We
are a “smaller reporting company” as defined in Rule 12b-2 of the Exchange Act and have elected to take advantage of
certain of the scaled disclosure available for smaller reporting companies in this prospectus as well as our filings under the Exchange
Act.
Unless
otherwise noted, all historical share and per share information and historical financial information included in this prospectus have
been adjusted to reflect the reverse stock split of 1-for-8 effected on May 16, 2024.
Investing
in our securities involves a high degree of risk. See the section entitled “Risk Factors” beginning on page 17 of this
prospectus for a discussion of risks that should be considered in connection with an investment in our securities.
Neither
the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the
accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.
| |
Per
Share and
accompanying
Common Warrant
| |
Per
Pre-Funded
Warrant and
accompanying
Common Warrant
| |
Total | |
Public offering price | |
$ |
| |
$ |
| |
$ | | |
Placement
Agent fees(1) | |
$ |
| |
$ |
| |
$ | | |
Proceeds
to us, before expenses(2) | |
$ |
| |
$ |
| |
$ | | |
(1) |
We have agreed to pay the
Placement Agent a cash fee equal to % of the aggregate proceeds of this offering and to reimburse
the Placement Agent for certain of its offering-related expenses. See “Plan of Distribution” beginning on page 34
of this prospectus for a description of the compensation to be received by the Placement Agent. |
(2) |
The amount of the proceeds
to us presented in this table does not give effect to any exercise of the Warrants. |
Delivery of the shares
of common stock and Warrants is expected to be made on or about , 2024, subject
to satisfaction of customary closing conditions.
Sole
Placement Agent
__
The date of this prospectus is ,
2024.
TABLE OF CONTENTS
We incorporate by reference
important information into this prospectus. You may obtain the information incorporated by reference without charge by following the
instructions under the section of this prospectus entitled “Where You Can Find More Information”. You should carefully read
this prospectus as well as additional information described under the section of this prospectus entitled “Incorporation of Certain
Information by Reference,” before deciding to invest in our Securities.
Unless the context otherwise
requires, the terms “Seelos,” “we,” “us” and “our” in this prospectus refer to Seelos
Therapeutics, Inc., and “this offering” refers to the offering contemplated in this prospectus.
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-1 that we filed with the Securities and Exchange Commission (“SEC”)
to register the securities offered hereby under the Securities Act. We may also file a prospectus supplement or post-effective amendment
to the registration statement of which this prospectus forms a part that may contain material information relating to these offerings.
We incorporate by reference important information into this prospectus. You may obtain the information incorporated by reference without
charge by following the instructions under “Where You Can Find More Information.” You should carefully read this prospectus
as well as additional information described under “Incorporation of Certain Information by Reference,” before deciding to
invest in our securities.
We
have not, and the Placement Agent has not, authorized anyone to provide any information or to make any representations other than those
contained in this prospectus or in any free writing prospectuses prepared by or on behalf of us or to which we have referred you. We
take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This
prospectus is an offer to sell only the securities offered hereby, and only under circumstances and in jurisdictions where it is lawful
to do so. The information contained in this prospectus or in any applicable free writing prospectus is current only as of its date, regardless
of its time of delivery or any sale of our securities. Our business, financial condition, results of operations and prospects may have
changed since that date.
For
investors outside the United States: We have not, and the Placement Agent has not, done anything that would permit this offering or possession
or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons
outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating
to, the offering of the securities and the distribution of this prospectus outside the United States.
This
prospectus and the information incorporated by reference into this prospectus may contain references to trademarks belonging to other
entities. Solely for convenience, trademarks and trade names referred to in this prospectus and the information incorporated by reference
into this prospectus, including logos, artwork, and other visual displays, may appear without the ® or TM symbols. We do not intend
our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of
us by, any other company.
No
dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus.
You must not rely on any unauthorized information or representations. This prospectus is an offer to sell only the securities offered
hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is
current only as of its date.
This
prospectus contains estimates and other statistical data made by independent parties and by us relating to market size and growth and
other data about our industry. We obtained the industry and market data in this prospectus from our own research as well as from industry
and general publications, surveys and studies conducted by third parties. This data involves a number of assumptions and limitations
and contains projections and estimates of the future performance of the industries in which we operate that are subject to a high degree
of uncertainty. We caution you not to give undue weight to such projections, assumptions and estimates.
DISCLOSURE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus and the documents incorporated
by reference in this prospectus may contain “forward-looking statements” by us within the meaning of Section 27A of
the Securities Act and Section 21E of the Exchange Act, including, without limitation, statements as to expectations, beliefs and
strategies regarding the future. These statements involve known and unknown risks, uncertainties and other important factors that may
cause our actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking statements. These forward-looking statements rely on a number of assumptions concerning future
events and include statements relating to:
| · | the
potential impact to our business, financial condition and employees, including disruptions
to our clinical trials, preclinical studies, supply chain and operations; |
| · | risks
and uncertainties associated with our actual and proposed research and development activities,
including our clinical trials and preclinical studies; |
| · | the
timing or likelihood of regulatory filings and approvals or of alternative regulatory pathways
for our product candidates; |
| · | the
potential market opportunities for commercializing our product candidates; |
| · | our
expectations regarding the potential market size and the size of the patient populations
for our product candidates, if approved for commercial use, and our ability to serve such
markets; |
| · | estimates
of our expenses, future revenue, capital requirements and our needs for additional financing; |
| · | our
ability to continue as a going concern; |
| · | our
ability to maintain the listing of our common stock on the Nasdaq Capital Market; |
| · | our
ability to develop, acquire and advance our product candidates into, and successfully complete,
clinical trials and preclinical studies and obtain regulatory approvals; |
| · | the
implementation of our business model and strategic plans for our business and product candidates; |
| · | the
initiation, cost, timing, progress and results of future and current preclinical studies
and clinical trials, and our research and development programs; |
| · | the
terms of future licensing arrangements, and whether we can enter into such arrangements at
all; |
| · | timing
and receipt or payments of licensing and milestone revenues or payments, if any; |
| · | the
scope of protection we are able to establish and maintain for intellectual property rights
covering our product candidates and our ability to operate our business without infringing
the intellectual property rights of others; |
| · | regulatory
developments in the United States and foreign countries; |
| · | the
performance of our third-party suppliers and manufacturers; |
| · | our
ability to maintain and establish collaborations or obtain additional funding; |
| · | the
success of competing therapies that are currently or may become available; |
| · | our
financial performance; and |
| · | developments
and projections relating to our competitors and our industry. |
Any forward-looking statements should be considered
in light of these factors. Words such as “anticipates,” “believes,” “forecasts,” “potential,”
“goal,” “contemplates,” “expects,” “intends,” “plans,” “projects,”
“hopes,” “seeks,” “estimates,” “strategy,” “continues,” “ongoing,”
“opportunity,” “could,” “would,” “should,” “likely,” “will,”
“may,” “can,” “designed to,” “future,” “foreseeable future” and similar expressions
and variations, and negatives of these words, identify forward-looking statements. These forward-looking statements are based on the
expectations, estimates, projections, beliefs and assumptions of our management based on information currently available to management,
all of which are subject to change. These forward-looking statements are not guarantees of future performance and are subject to risks
and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-looking statements.
Many of the important factors that will determine these results and values are beyond our ability to control or predict. You are cautioned
not to put undue reliance on any forward-looking statements. Except as otherwise required by law, we do not assume any obligation to
update any forward-looking statements.
In evaluating an investment in shares of our
securities, you should carefully consider the discussion of risks and uncertainties described under the heading “Risk Factors”
contained in this prospectus, and under similar headings in other documents, including in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2023, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2024 and in our other filings with the SEC, that are incorporated by reference
in this prospectus. You should carefully read this prospectus together with the information incorporated by reference in this prospectus
as described under the headings “Where You Can Find More Information” and “Incorporation of Certain Information by
Reference” completely and with the understanding that our actual future results may be materially different from what we expect.
All subsequent written and oral forward-looking
statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by our cautionary statements.
The forward-looking statements included or incorporated by reference herein are made only as of the date of this prospectus (or as of
the date of any such document incorporated by reference). We do not intend, and undertake no obligation, to update these forward-looking
statements, except as required by law.
PROSPECTUS SUMMARY
This
summary highlights selected information contained elsewhere in, or incorporated by reference into, this prospectus. This summary is not
complete and may not contain all of the information that is important to you and that you should consider before deciding whether or
not to invest in our securities. For a more complete understanding of Seelos and this offering, you should carefully read this prospectus,
including any information incorporated by reference into this prospectus, in its entirety. Before you decide whether to
purchase our securities, you should read this entire prospectus carefully, including the risks of investing in our securities discussed
under the section of this prospectus entitled “Risk Factors” and similar headings in the other documents that are incorporated
by reference into this prospectus. You should also carefully read the information incorporated by reference into this prospectus, including
our financial statements, and the exhibits to the registration statement of which this prospectus is a part.
The Company
Overview
We are a clinical-stage biopharmaceutical company
focused on achieving efficient development of products that address significant unmet needs in Central Nervous System (“CNS”)
disorders and other rare disorders.
Our business model is to advance multiple late-stage
therapeutic candidates with proven mechanisms of action that address large markets with unmet medical needs and for which there is a
strong economic and scientific rationale for development.
Our product development pipeline is as follows:
Product |
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Indication |
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Development
Phase |
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Development
Status |
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SLS-002
Intranasal
Racemic
Ketamine |
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Acute Suicidal Ideation
and Behavior (“ASIB”) in Major Depressive Disorder (“MDD”) |
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Phase II |
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Completed open-label patient enrollment and
announced the initial topline data from Part 1 of the proof-of-concept (“PoC”) study on May 17, 2021;
enrollment of Part 2 of a Phase II study
closed in June 2023; topline data for Part 2 announced on September 20, 2023 |
|
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SLS-005
IV Trehalose |
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Amyotrophic Lateral Sclerosis
(“ALS”) |
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Phase II/III |
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Completed enrollment of
final participants in February 2023 in the registrational study; topline data announced on March 19, 2024 |
|
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Spinocerebellar
Ataxia (“SCA”) |
|
Phase
IIb/III |
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Announced
dosing of the first participant in the registrational study in October 2022; enrollment of additional patients temporarily paused
on March 29, 2023 |
|
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Huntington’s Disease
(“HD”) and Alzheimer’s Disease (“AD”) |
|
Phase II |
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Obtaining biomarker activity |
|
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SLS-004
Gene Therapy |
|
Parkinson’s Disease (“PD”)
|
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Pre-IND |
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Preclinical in vivo studies ongoing; announced
partial results from a study demonstrating downregulation of α-synuclein in December 2022;
currently analyzing data while temporarily
pausing additional spend |
|
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SLS-007
Peptide Inhibitor |
|
PD |
|
Pre-IND |
|
Preclinical study completed
and analysis of the results ongoing; next steps for development of this program will be decided in concert with SLS-004 results and
readouts, as both target the same pathway upstream; temporarily pausing additional spend |
|
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SLS-009 |
|
HD,
AD, ALS |
|
Pre-IND |
|
Preclinical
in vivo studies ongoing |
Lead Programs
Our lead programs are currently SLS-002 for the
potential treatment of ASIB in adults with MDD and SLS-005 for the potential treatment of ALS and SCA. SLS-005 for the potential treatment
of Sanfilippo Syndrome currently requires additional natural history data, which is being considered.
SLS-002 is
intranasal racemic ketamine with two investigational new drug applications (“INDs”). The lead program is focused on the treatment
of ASIB in MDD. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical
studies involving approximately 500 subjects. SLS-002 is being developed to address an unmet need for an efficacious drug to treat suicidality
in the United States. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to
contribute to an increased risk of suicidal thoughts in some circumstances, and if and when they are effective, it often takes weeks
for the full therapeutic effect to be manifested. We believe there is a large opportunity in the United States and European markets for
products in this space. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were
approximately 1.48 million visits to emergency rooms for suicidal ideation or suicide attempts in 2017 in the United States alone.
Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for depression and suicidality.
The clinical development program for SLS-002
includes two parallel healthy volunteer studies (Phase I). We announced interim data from our Phase I study of SLS-002 during
the quarterly period ended March 31, 2020. As a result, in March 2020, we completed a Type C meeting with the U.S. Food and
Drug Administration (the “FDA”) and received guidance to conduct a Phase II PoC study of SLS-002 for ASIB in adults
with MDD, to support the further clinical development of this product candidate, together with nonclinical data under development.
As a result of the Type C meeting and the Fast
Track designation for SLS-002 for the treatment of ASIB in patients with MDD, we believe we are well positioned to pursue the FDA’s
expedited programs for drug development and review.
On June 23, 2020, we announced the final
safety data from our Phase I pharmacokinetics/pharmacodynamics study of intranasal racemic ketamine (SLS-002) as well as the planned
design of a Phase II double blind, placebo-controlled PoC study for ASIB in subjects with MDD. We initiated this PoC study in two
parts: Part 1 was an open-label study of 17 subjects, and was followed by Part 2, which is a double blind, placebo-controlled
study of approximately 175 subjects. On January 15, 2021, we announced dosing of the first subjects in Part 1 of the PoC study.
On March 5, 2021, we announced the completion of open-label enrollment of subjects in Part 1 of the PoC study. On May 17,
2021, we announced positive topline data from Part 1 of the PoC study, the open-label cohort, of our study of SLS-002 (intranasal
racemic ketamine), demonstrating a significant treatment effect and a well-tolerated safety profile for ASIB in patients with MDD. This
study enrolled 17 subjects diagnosed with MDD requiring psychiatric hospitalization due to significant risk of suicide with a baseline
score of ≥ 28 points on the Montgomery-Åsberg Depression Rating Scale (“MADRS”), a score of 5 or 6 on MADRS Item-10,
a score of ≥ 15 points on the Sheehan-Suicidality Tracking Scale (S-STS) and a history of previous suicide attempt(s), as confirmed
on the Columbia Suicide Severity Rating Scale (C-SSRS) with a history of at least one actual attempt, or if the attempt was interrupted
or aborted, is judged to have been serious in intent. SLS-002 demonstrated a 76.5% response rate (response meaning 50% reduction from
baseline) in the primary endpoint on MADRS 24 hours after first dose, with a mean reduction in total score from 39.4 to 14.5 points.
On July 6, 2021, we announced dosing of
the first subject in Part 2 of the Phase II study. Based on feedback from a Type C meeting with the FDA in June 2021,
we increased the subjects in Part 2 to increase the sample size and power to support a potential marketing application. On June 20,
2023, we announced the close of enrollment of this study and released the topline results on September 20, 2023.
SLS-005
is IV trehalose, a protein stabilizer that crosses the blood-brain barrier and activates autophagy and the lysosomal pathway.
Based on preclinical and in vitro studies, there is a sound scientific rationale for developing trehalose for the treatment of
ALS, SCA and other indications such as Sanfilippo Syndrome. Trehalose is a low molecular weight disaccharide (0.342 kDa) that protects
against pathological processes in cells. It has been shown to penetrate muscle and cross the blood-brain barrier. In animal models of
several diseases associated with abnormal cellular protein aggregation, it has been shown to reduce pathological aggregation of misfolded
proteins as well as to activate autophagy pathways through the activation of Transcription Factor EB (“TFEB”), a key factor
in lysosomal and autophagy gene expression. Activation of TFEB is an emerging therapeutic target for a number of diseases with pathologic
accumulation of storage material.
Trehalose 90.5 mg/mL IV solution has demonstrated
promising clinical potential in prior Phase II clinical development for oculopharyngeal muscular dystrophy (“OPMD”)
and spinocerebellar ataxia type 3 (“SCA3”), also known as Machado Joseph disease, with no significant safety signals to date
and encouraging efficacy results. Pathological accumulation of protein aggregates within cells, whether in the CNS or in muscle, and
eventually leads to loss of function and ultimately cell death. Prior preclinical studies indicate that this platform has the potential
to prevent mutant protein aggregation in other devastating PolyA/PolyQ diseases.
We own three U.S. patents for parenteral administration
of trehalose for patients with OPMD and SCA3, all of which are expected to expire in 2034. In addition, Orphan Drug Designation (“ODD”)
for OPMD and SCA3 has been secured in the United States and in the European Union (“EU”). In February 2019, we assumed
a collaborative agreement, turned subsequently into a research grant, with Team Sanfilippo Foundation (“TSF”), a nonprofit
medical research foundation founded by parents of children with Sanfilippo Syndrome. On April 30, 2020, we were granted ODD for
SLS-005 in Sanfilippo Syndrome from the FDA. SLS-005 was previously granted ODD from the FDA and European Medicines Agency (the “EMA”)
for SCA3 and OPMD as well as Fast Track designation for OPMD. On August 25, 2020, we were issued U.S. patent number 10,751,353 titled
“COMPOSITIONS AND METHODS FOR TREATING AN AGGREGATION DISEASE OR DISORDER” which relates to trehalose (SLS-005). The issued
patent covers the method of use for trehalose (SLS-005) formulation for treating a disease or disorder selected from any one of the following:
spinal and bulbar muscular atrophy, dentatombral-pallidoluysian atrophy, Pick’s disease, corticobasal degeneration, progressive
supranuclear palsy, frontotemporal dementia or parkinsonism linked to chromosome 17. On May 15, 2020, we were granted Rare Pediatric
Disease Designation (“RPDD”) for SLS-005 in Sanfilippo Syndrome from the FDA. RPDD is an incentive program created under
the Federal Food, Drug, and Cosmetic Act to encourage the development of new therapies for the prevention and treatment of certain rare
pediatric diseases. On May 27, 2021, we announced that we were granted ODD for SLS-005 in ALS from the EMA. In December 2020,
we announced the selection of SLS-005 for the Healey ALS platform trial led by Harvard Medical School, Massachusetts. The Healey ALS
platform trial is designed to study multiple potential treatments for ALS simultaneously. The platform trial model aims to greatly accelerate
the study access, reduce costs and shorten development timelines. On February 28, 2022, we announced the dosing of the first participants
in the Healey ALS platform trial. On March 19, 2024 we announced topline results. In November 2021, we announced the FDA acceptance
of an IND and grant of Fast Track designation for SLS-005 for the treatment of SCA. In July 2022, we also announced dosing of the
first patient in an open-label basket study in Australia for the treatment of patients with ALS, SCA, and Huntington’s disease
(“HD”). In October 2022, we also announced the dosing of the first participant in the registrational Phase II/III
study for the treatment of SCA. In March 2023, we announced that in order to focus the majority of our resources on the Phase II
study of SLS-002 (intranasal racemic ketamine) for ASIB in adults with MDD and the fully enrolled Phase II/III study of SLS-005
in ALS, we have temporarily paused additional enrollment of patients in the SLS-005-302 study in SCA. Patients already enrolled will
continue in the study and data will continue to be collected in order to make decisions for resuming enrollment in the future. This temporary
pause has been implemented as a business decision due to financial considerations, and is not based on any data related to safety or
therapeutic effects.
Additionally, we are developing several preclinical
programs, most of which have well-defined mechanisms of action, including SLS-004, licensed from Duke University, and SLS-007, licensed
from The Regents of the University of California, for the potential treatment of PD.
Strategy and Ongoing Programs
SLS-002:
The clinical development program for SLS-002 includes two parallel healthy volunteer studies (Phase I). Following these Phase I studies,
we completed a Type C meeting with the FDA in March 2020 and received guidance to conduct a Phase II PoC study of SLS-002 for ASIB
in adults with MDD. We released topline data for Part 1 of our open-label study on May 17, 2021. We initiated enrollment in
Part 2 of the Phase II study on July 6, 2021, closed enrollment in June 2023, and released the topline data results in
the third quarter of 2023.
We retained Canaccord Genuity to assist in our
ongoing review of potential partnerships, collaborations, and business development opportunities. On the merits of our unique ketamine
expertise with SLS-002 in suicidality and our inclusion in a government sponsored PTSD study, we are currently exploring a potential
collaboration in the mental health space to increase shareholder value. Additionally, we have been evaluating the use of SLS-002 in indications
beyond ASIB and PTSD including but not limited to MDD and adjunctive MDD.
SLS-005: We
completed enrollment in February 2023 for a clinical study in ALS and began enrollment for a clinical study in SCA in October 2022.
In December 2020, we announced the selection of SLS-005 for the Healey ALS platform trial led by Harvard Medical School, Massachusetts.
The Healey ALS platform trial is designed to study multiple potential treatments for ALS simultaneously. The platform trial model aims
to greatly accelerate the study access, reduce costs, and shorten development timelines. On February 28, 2022, we announced dosing
of the first participants in the Healey ALS platform trial. In February 2023, we announced the completion of enrollment of the study
and released the topline data results on March 19, 2024.
In November 2021, we announced the FDA acceptance
of an IND and grant of Fast Track designation for SLS-005 for the treatment of SCA. In July 2022, we announced dosing of the first
patient in an open-label basket study in Australia for the treatment of patients with ALS, SCA, and HD. In October 2022, we also
announced the dosing of the first participant in the registrational Phase II/III study for the treatment of SCA.
During 2022, we received regulatory approval
in Australia to commence a study pursuing the collection of certain biomarker data in patients with AD.
We are also continuing to consider trials in
Sanfilippo Syndrome and are seeking more natural history data based on the guidance from regulatory agencies.
In March 2023, we announced that in order
to focus the majority of our resources on the ongoing Phase II study of SLS-002 (intranasal racemic ketamine) for ASIB in patients with
MDD and the fully enrolled Phase II/III study of SLS-005 in ALS, we have temporarily paused additional enrollment of patients in the
SLS-005-302 study in SCA. Patients already enrolled will continue in the study and data will continue to be collected in order to make
decisions for resuming enrollment in the future. This temporary pause has been implemented as a business decision due to financial considerations,
and is not based on any data related to safety or therapeutic effects.
SLS-004 is
an all-in-one lentiviral vector, targeted for gene editing through DNA methylation within intron 1 of the synuclein alpha (“SNCA”)
gene that expresses alpha-synuclein (“α-synuclein”) protein. SLS-004, when delivered to dopaminergic neurons derived
from human-induced pluripotent stem cells of a PD patient, modified the expression on α-synuclein and exhibited reversal of the
disease-related cellular-phenotype characteristics of the neurons. The role of mutated SNCA in PD pathogenesis and the need to maintain
the normal physiological levels of α-synuclein protein emphasize the yet unmet need to develop new therapeutic strategies, such
as SLS-004, targeting the regulatory mechanism of α-synuclein expression. On May 28, 2020, we announced the initiation of
a preclinical study of SLS-004 in PD through an all-in-one lentiviral vector targeting the SNCA gene. We are constructing a bimodular
viral system harboring an endogenous α-synuclein transgene and inducible regulated repressive CRISPR/dCas9-unit to achieve suppression
of PD-related pathologies. On July 7, 2021, we announced positive in vivo data demonstrating down-regulation of SNCA mRNA and protein
expression under this study. In December 2022, we announced in vivo data demonstrating that a single dose of SLS-004 was successful
in reversing some of the key hallmarks of PD in a humanized mouse model. These findings observed in an in vivo humanized PD model validate
and extend prior findings from in vitro data using SLS-004. SLS-004 demonstrated therapeutically desirable change in SNCA expression
that led to reversing the key hallmarks of PD in the model towards normal physiological levels, indicating disease modifying effect of
single dose administration of SLS-004, a CRISPR/dCas-9 based gene therapy for PD. We have halted any further investment in this program
until additional funding is received.
SLS-007 is
a rationally designed peptide-based approach, targeting the nonamyloid component core (“NACore”) of α-synuclein to
inhibit the protein from aggregation. Recent in vitro and cell culture research has shown that SLS-007 has the ability to stop the propagation
and seeding of α-synuclein aggregates. We will evaluate the potential for in vivo delivery of SLS-007 in a PD transgenic mice model.
The goal will be to establish in vivo pharmacokinetics/pharmacodynamics and target engagement parameters of SLS-007, a family of anti-α-synuclein
peptidic inhibitors. On June 25, 2020, we announced the initiation of a preclinical study of SLS-007 in PD delivered through an
adeno-associated viral (“AAV”) vector targeting the non-amyloid component core of α-synuclein. We have initiated an
in vivo preclinical study of SLS-007 in rodents to assess the ability of two specific novel peptides, S62 and S71, delivered via AAV1/2
vector, to protect dopaminergic function in the AAV A53T overexpression mice model of PD. Production of AAV1/2 vectors encoding each
of the two novel peptides incorporating hemagglutinin tags has already been completed. The results are currently being analyzed and the
next steps for development of this program will be decided in concert with SLS-004 results and readouts, as both target the same pathway
upstream.
SLS-009
is our first internally created program, which follows the mechanism of action known as PROTACs (protein-targeting chimeric
molecules), which uses the body’s own natural process of autophagy and lysosomal degradation to clear out mutant and misfolded
proteins in the body. SLS-009 induces autophagy and enhances lysosomal clearance by augmenting existing endogenous cellular degradation
pathways to remove only the mutant and neurotoxic proteins.
We intend to become a leading biopharmaceutical
company focused on neurological and psychiatric disorders, including orphan indications. Our business strategy includes:
| · | advancing
SLS-002 in ASIB in MDD and post-traumatic stress disorder; |
| · | advancing
SLS-004 in PD; |
| · | advancing
SLS-005 in ALS, SCA, HD and Sanfilippo Syndrome; |
| · | advancing
new formulations of SLS-005 in neurological diseases; and |
| · | acquiring
synergistic assets in the CNS therapy space through licensing and partnerships. |
We also have two legacy product candidates: a
product candidate in the United States for the treatment of erectile dysfunction, which we in-licensed from Warner Chilcott Company, Inc.,
now a subsidiary of Allergan plc; and a product candidate which has completed a Phase IIa clinical trial for the treatment of Raynaud’s
Phenomenon, secondary to scleroderma, for which we own worldwide rights.
Nasdaq Delisting Notice
On April 30, 2024, we received written notice
(the “Bid Notice”) from Nasdaq indicating that, for the last thirty consecutive business days, the bid price for our common
stock had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing
Rule 5550(a)(2) (“Rule 5550(a)(2)”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been
provided an initial period of 180 calendar days, or until October 28, 2024, to regain compliance. The Bid Notice states that the
Nasdaq staff will provide written confirmation that we have achieved compliance with Rule 5550(a)(2) if at any time before
October 28, 2024, the bid price of our common stock closes at $1.00 per share or more for a minimum of ten consecutive business
days.
If we do not regain compliance with Rule 5550(a)(2) by
October 28, 2024, we may be eligible for an additional 180 calendar day compliance period. To qualify, we would be required to meet
the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital
Market, with the exception of the bid price requirement, and would need to provide written notice to Nasdaq of our intention to cure
the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. However, if it appears to the Nasdaq
staff that we will not be able to cure the deficiency, or if we are otherwise not eligible, Nasdaq would notify us that our securities
will be subject to delisting.
On
November 2, 2023, we received written notice (the “Initial Notice”) from Nasdaq indicating that, for the last thirty-two
consecutive business days, the market value of the Company’s listed securities has been below the minimum requirement of $35 million
for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2) (“Rule 5550(b)(2)”).
In accordance with Nasdaq Listing Rule 5810(c)(3)(C), we were provided a period of 180 calendar days, or until April 30, 2024,
to regain compliance. The Initial Notice stated that the Nasdaq staff will provide written notification that the Company has achieved
compliance with Rule 5550(b)(2) if at any time before April 30, 2024, the market value of the Company’s common stock
closes at $35 million or more for a minimum of ten consecutive business days.
Additionally, on May 1, 2024, we received written
notice (the “Delist Notice” and, together with the Bid Notice and the Initial Notice, the “Notices”) from Nasdaq
indicating that, based upon our continued non-compliance with Rule 5550(b)(2), the Nasdaq staff has determined to delist our common stock
from the Nasdaq Capital Market effective May 10, 2024 unless we timely requested an appeal of this determination before the Nasdaq Hearings
Panel (the “Panel”) by May 8, 2024. We timely requested a hearing before the Panel, which had the effect of staying the suspension
of our common stock pending the Panel’s decision. During the pendency of any requested hearing before the Panel, our common stock
will remain listed and trading on Nasdaq.
In response to our request following a hearing
before the Panel, on July 25, 2024, we received written notification (the “Extension Notice”) from the Panel notifying us
that the Panel had granted our request for an additional period, during which the Company will remain listed on Nasdaq, to regain compliance
with Rule 5550(b)(2) and demonstrate continued compliance with Rule 5550(a)(2). Pursuant to the Extension Notice, the Panel granted the
Company an additional period until August 30, 2024 to regain compliance with Rule 5550(b)(2) and until September 30, 2024 to regain compliance
with Rule 5550(a)(2). The extension is subject to certain conditions specified by the Panel in the Extension Notice.
We are diligently working to evidence compliance
with all applicable requirements for continued listing on the Nasdaq Capital Market and we expect to submit a plan to that effect to
the Panel as part of the hearing process; however, there can be no assurance the Panel will grant any request for continued listing or
that we will be able to regain compliance with the applicable listing criteria within the period of time that may be granted by the Panel.
The Notices have no immediate effect on the listing
or trading of our common stock and the common stock will continue to trade on the Nasdaq Capital Market under the symbol “SEEL.”
We intend to monitor the bid price and market
value of our common stock and consider available options if our common stock does not trade at a level likely to result in us regaining
compliance with Nasdaq’s minimum bid price rule by October 28, 2024 and the minimum market value of listed securities rule, which
may include, among other options, effectuating a reverse stock split. There can be no assurance that we will be able to regain compliance
with Nasdaq’s minimum bid price rule or Nasdaq’s minimum market value of listed securities rule or that we will otherwise
be in compliance with the other listing standards for the Nasdaq Capital Market.
Recent Developments
Announcement of Strategic Focus on Mental Health and Appointment
of Richard Pascoe as Chairman of the Board
On April 29, 2024, we announced our strategic
focus on mental health initiatives and that Richard Pascoe has been appointed as the Chairman of the Board of Directors to lead the ongoing
strategic process and business development discussions and negotiations. Mr. Pascoe has served as member of our Board of Directors
since 2019.
Amendment No. 6 to Convertible Promissory Note
On November 23, 2021, we entered into a
Securities Purchase Agreement (the “Purchase Agreement”) with Lind Global Asset Management V, LLC (“Lind”) pursuant
to which, among other things, on November 23, 2021, we issued and sold to Lind, in a private placement transaction, in exchange
for the payment by Lind of $20.0 million, (i) a convertible promissory note (the “Note”) in an aggregate principal amount
of $22.0 million, which bore no interest until the first anniversary of the issuance of the 2021 Note and thereafter bore interest at
a rate of 5% per annum until October 1, 2023 when the 2021 Note began to bear interest at an annual rate of 12% per annum, and is
set to mature on November 23, 2024, and (ii) 2,229 shares of common stock.
Effective May 1, 2024, we and Lind entered
into an Amendment No. 6 to Convertible Promissory Note (“Amendment No. 6”), which amended the convertible promissory
note we previously issued to Lind on November 23, 2021. Pursuant to Amendment No. 6, we and Lind agreed, among other things,
that: (A) we shall not be required to maintain any minimum balance of cash or cash equivalents with one or more financial institutions
prior to May 31, 2024, and that we shall thereafter be required to maintain an aggregate minimum balance equal to 50% of the then
outstanding principal amount under the note or more in cash or cash equivalents with one or more financial institutions; (B) that
all payments of accrued interest and monthly payments of the outstanding principal amount payable by us under the note in shares of common
stock shall be reduced from ninety percent (90%) to eighty-five percent (85%) of the average of the five lowest daily volume weighted
average price of common stock during the 20 trading days prior to each respective payment date; (C) Lind will, through May 31,
2024, forebear from exercising any right to assert or claim that a Material Adverse Effect (as defined in the note) has occurred as a
result of any event, occurrence, fact, condition or change that occurred on or prior to May 1, 2024.
Amendment No. 7 to Convertible Promissory Note
Effective June 1, 2024, we and Lind entered
into an Amendment No. 7 to Convertible Promissory Note (“Amendment No. 7”), which amended the convertible promissory
note we previously issued to Lind on November 23, 2021 (as amended, the “Amended Note”). Pursuant to Amendment No. 7,
we and Lind agreed, among other things, that: (A) we shall not be required to maintain any minimum balance of cash or cash equivalents
with one or more financial institutions prior to July 31, 2024, and that we shall thereafter be required to maintain an aggregate
minimum balance equal to 50% of the then outstanding principal amount under the Note or more in cash or cash equivalents with one or
more financial institutions; and (B) Lind will, through July 31, 2024, forebear from exercising any right to assert or claim
that a Material Adverse Effect (as defined in the Note) has occurred as a result of any event, occurrence, fact, condition or change
that occurred on or prior to June 1, 2024.
Amendment No. 8 to Convertible Promissory
Note
Effective July 16, 2024, we and Lind entered
into an Amendment No. 8 to Convertible Promissory Note (“Amendment No. 8”), which amended the Note. Pursuant to
Amendment No. 8, we and Lind agreed, among other things, that: (A) we shall not be required to maintain any minimum balance
of cash or cash equivalents with one or more financial institutions prior to October 31, 2024, and that we shall thereafter be required
to maintain an aggregate minimum balance equal to 50% of the then outstanding principal amount under the Note or more in cash or cash
equivalents with one or more financial institutions; (B) Lind will, through October 31, 2024, forebear from exercising any
right to assert or claim that a Material Adverse Effect (as defined in the Note) has occurred as a result of any event, occurrence, fact,
condition or change that occurred on or prior to July 16, 2024; and (C) we shall use our reasonable best efforts to seek, at
a special or annual meeting of our stockholders, to be scheduled to be held no later than October 31, 2024, instead of July 31,
2024, stockholder approval as contemplated by Nasdaq Listing Rule 5635(d) to issue any shares in connection with the repayment
or conversion of any portion of the March 2024 principal increase amount of the Note.
Lind Agreement
On August 30, 2024,
we entered into an agreement with Lind (the “Lind Agreement”). The Lind Agreement relates to the Purchase Agreement. The
Lind Agreement provides that, upon the consummation of a Fundamental Transaction (as defined in the Lind Agreement), Lind shall convert
the outstanding balance of the Note into shares of common stock, at a conversion price per share of common stock to be agreed upon by
the parties at the time of conversion. The conversion is intended to enable us to comply with the continued listing standard set forth
in Rule 5550(b)(1) of the Nasdaq Capital Market listing requirements relating to our stockholders’ equity.
The
conversion of the Note as set forth in the Lind Agreement is subject to our continued listing on Nasdaq and compliance with all applicable
laws and regulations, including any shareholder voting requirements under Nasdaq rules. The Lind Agreement further ensures that no conversion
shall result in Lind exceeding the ownership cap set forth in the original Note.
Reduction in Force
On April 30, 2024, we announced a reduction
in its workforce that affected approximately 33% of our current employees (the “RIF”), along with a reduction in working
hours and related compensation for all of our remaining employees. This decision relates to our recent announcement of our strategic
focus on our mental health initiatives and serves to reduce ongoing operating expenses not related to such initiatives and extend our
cash runway. Total annualized cost savings from the RIF are estimated at approximately $0.8 million and total annualized cost savings
from the reduction in working hours are estimated at approximately $1.6 million. The RIF was substantially completed on April 30,
2024.
We expect to recognize approximately $50,000
in total charges for related benefits for employees whose employment was terminated pursuant to the RIF. These are one-time termination
benefits and are cash charges. The estimates of costs and expenses that we expect to incur in connection with the RIF are subject to
a number of assumptions and actual results may differ materially from those estimates. We may also incur other charges or cash expenditures
not currently contemplated due to events that may occur as a result of, or associated with, the RIF.
Reverse Stock Split
On May 15, 2024, we filed a Certificate
of Change with the Secretary of State of the State of Nevada to (i) effect a 1-for-8 reverse stock split (the “Reverse Stock
Split”) of our issued and outstanding shares of common stock, effective at 12:01 a.m. Eastern Time, on May 16, 2024,
and (ii) decrease the number of total authorized shares of our common stock from 400,000,000 shares to 50,000,000 shares (the “Authorized
Share Decrease”). Our common stock began trading on a Reverse Stock Split-adjusted basis on the Nasdaq Capital Market at the opening
of the market on May 16, 2024. Unless specifically provided otherwise herein, the share and per share information in this prospectus
gives effect to the Reverse Stock Split and the Authorized Share Decrease.
May 2024 Offering
On May 16, 2024, we entered into a securities
purchase agreement with certain institutional investors pursuant to which we agreed to issue
and sell 380,968 shares of common stock and pre-funded warrants to purchase up to 81,239 shares of common stock in a registered direct
offering. In a concurrent private placement, we also agreed to issue and sell to the investors, warrants to purchase up to 924,414 shares
of common stock. The combined purchase price for one share and accompanying common warrant to purchase two shares of common stock for
each share purchased was $2.46. The combined purchase price for one pre-funded warrant to purchase one share of common stock and accompanying
common warrant to purchase two shares of common stock for each share of common stock issuable upon exercise of a purchased pre-funded
warrant was $2.459.
The
pre-funded warrants have an exercise price of $0.001 per share of common stock and were exercisable immediately upon issuance.
Each holder of a pre-funded warrant will not have the right to exercise any portion of its pre-funded warrant if the holder, together
with its affiliates, would beneficially own more than 4.99% (or, at the election of the purchaser, 9.99%) of the number of shares of
common stock outstanding immediately after giving effect to such exercise (the “Warrant Beneficial Ownership Limitation”);
provided, however, that upon 61 days’ prior notice to the Company, the holder may increase the Warrant Beneficial Ownership Limitation,
but not to above 9.99%. The exercise price and number of shares of common stock issuable upon the exercise of the pre-funded warrants
will be subject to adjustment in the event of any stock dividend, stock split, reverse stock split, recapitalization, reorganization
or similar transaction, as described in the pre-funded warrants. The holders may exercise the pre-funded warrants by means of a “cashless
exercise.”
The
common warrants have an exercise price of $2.21 per share of common stock, were exercisable immediately upon issuance and expire
five years following the original issuance date. Each holder of a common warrant will not have the right to exercise any portion of its
common warrant if the holder, together with its affiliates, would beneficially own more than the Warrant Beneficial Ownership Limitation;
provided, however, that upon 61 days’ prior notice to us, the holder may increase the Warrant Beneficial Ownership Limitation,
but not to above 9.99%. The exercise price and number of shares of common stock issuable upon the exercise of the common warrant will
be subject to adjustment in the event of any stock dividend, stock split, reverse stock split, recapitalization, reorganization or similar
transaction, as described in the common warrant. If at any time after the six month anniversary of the date of issuance, a registration
statement covering the resale of the shares of common stock issuable upon exercise of the common warrants is not available for the issuance,
then the holders may exercise the common warrants by means of a “cashless exercise.” The common warrant s are not and will
not be listed for trading on any national securities exchange or other nationally recognized trading system.
On May 16, 2024, we also entered into a
placement agent agreement with Roth Capital Partners, LLC (“Roth”), pursuant to which Roth acted as placement agent for the
offering and we agreed to pay Roth an aggregate fee equal to 7.0% of the aggregate gross proceeds received by us from the sale of the
securities in the offering. The placement agent agreement included indemnity and other customary provisions for transactions of this
nature. We also agreed to reimburse Roth for up to $50,000 for Roth’s legal fees and expenses.
We also agreed, pursuant to the securities purchase
agreement, to file a registration statement on Form S-1 by June 15, 2024 to provide for the resale of the shares. We filed
the registration statement on June 14, 2024 and it became effective as of June 25, 2024.
The closing of the offering occurred on May 21,
2024.
July 2024 Offering
On
July 11, 2024, we entered into an inducement offer letter agreement (the “Inducement Letter”) with certain accredited
investors, who at the time of execution of the Inducement Letter, were holders of warrants to purchase up to an aggregate of 939,739
shares of common stock, originally issued to such investors on December 1, 2023, with an exercise price of $10.56 per share
of common stock and a termination date of December 1, 2028, and January 30, 2024, with an exercise price of $8.40 per share
of common stock and a termination date of January 30, 2029.
Pursuant
to the Inducement Letter, the investors agreed to exercise for cash their existing warrants at an exercise price of $0.61 per share of
common stock in consideration for the Company’s agreement to issue, in a private placement, new warrants to purchase up
to an aggregate of 1,879,478 shares of common stock at an exercise price of $0.61 per share. We received aggregate gross proceeds of
approximately $573,240 from the exercise of such existing warrants by the investors, before deducting placement agent fees and other
offering expenses payable by us.
We engaged H.C. Wainwright & Co., LLC
(“H.C. Wainwright”) to act as our exclusive placement agent in connection with the offering and agreed to pay H.C. Wainwright
a cash fee equal to 7.5% of the aggregate gross proceeds received from the investors’ exercise of their existing warrants, as well
as a management fee equal to 1.0% of the gross proceeds from the exercise of the existing warrants. We also agreed to issue to H.C. Wainwright
or its designees warrants to purchase up to 65,782 shares of common stock (representing 7.0% of the existing warrants being exercised),
which have the same terms as the new warrants except the placement agent warrants have an exercise price equal to $0.7625 per share (125%
of the exercise price of the existing warrants). In addition, we agreed to reimburse H.C. Wainwright for their expenses in connection
with the exercise of the existing warrants and the issuance of the new warrants of: (i) $30,000 for fees and expenses of H.C. Wainwright’s
counsel, and (ii) $15,950 for their clearing costs.
The closing of the offering occurred on July 12, 2024.
We agreed to hold an annual or special meeting
of stockholders on or prior to the date that is ninety (90) days following July 12, 2024 for the purpose of obtaining such approval
as may be required by the applicable rules and regulations of Nasdaq (or any successor entity) from the stockholders of the Company
with respect to issuance of all of the new warrants and the shares upon the exercise thereof. If we do not obtain stockholder approval
at the first meeting, we agreed to call a meeting every ninety (90) days thereafter to seek stockholder approval until the earlier of
the date on which stockholder approval is obtained or the new warrants are no longer outstanding.
We also agreed, pursuant to the Inducement Letter,
to file a registration statement on Form S-3 providing for the resale of the shares issued or issuable upon the exercise of the
new warrants. We filed the registration statement on August 16, 2024 and it became effective as of August 23, 2024.
In addition, pursuant to the Inducement Letter,
we agreed not to issue any shares of common stock or common stock equivalents or to file any other registration statement with the SEC
(in each case, subject to certain exceptions) until fifteen (15) days after July 12, 2024. We also agreed not to effect or agree
to effect any Variable Rate Transaction (as defined in the Inducement Letter) until six (6) months after July 12, 2024 (subject
to certain exceptions).
The
conversion of the Note as set forth in the Agreement is subject to our continued listing on Nasdaq and compliance with all applicable
laws and regulations, including any shareholder voting requirements under Nasdaq rules. The Agreement further ensures that no conversion
shall result in Lind exceeding the ownership cap set forth in the original Note.
Agreement with U.S. Army Medical Materiel
Development Activity
On August 16, 2024, we entered into an agreement
with the U.S. Army Medical Materiel Development Activity (“USAMMDA”) to supply SLS-002 (intranasal racemic ketamine) for
the U.S. Department of Defense's (“DOD”) Military and Veterans Adaptive Platform Clinical Trial to evaluate its potential
for treatment of post-traumatic stress disorder (PTSD).
Dosing of the SLS-002 cohort is expected to commence
prior to the end of 2024 and it is the only ketamine-based therapy selected for inclusion in this study. The trial is funded by the DOD’s
Defense Health Agency and led by USAMMDA’s Warfighter Readiness, Performance, and Brain Health Project Management Office.
Corporate Information
Our principal executive offices are located at
300 Park Avenue, 2nd Floor, New York, NY 10022, and our telephone number is (646) 293-2100. Our website is located at www.seelostherapeutics.com.
Any information contained on, or that can be accessed through, our website is not incorporated by reference into, nor is it in any way
part of, this prospectus and should not be relied upon in connection with making any decision with respect to an investment in our securities.
We are required to file annual, quarterly and current reports, proxy statements and other information with the SEC. You may obtain any
of the documents filed by us with the SEC at no cost from the SEC’s website at www.sec.gov.
We are a “smaller reporting company”
as defined in Rule 12b-2 of the Exchange Act, and have elected to take advantage of certain of the scaled disclosure available for
smaller reporting companies in this prospectus as well as our filings under the Exchange Act.
The Offering
Common
Stock we are offering |
|
Up
to shares of common stock based on an assumed combined public offering price of $ per
share of common stock and accompanying Common Warrant, which is equal to the last sale price of our common stock as reported by Nasdaq
on , 2024. |
Pre-Funded
Warrants we are offering |
|
We
are also offering Pre-Funded Warrants to purchase up to shares of common stock in
lieu of shares of common stock to any purchaser whose purchase of shares of common stock in this offering would otherwise result
in such purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the purchaser’s
election, 9.99%) of our outstanding common stock immediately following the consummation of this offering. Each Pre-Funded Warrant
will be exercisable for one share of common stock, will have an exercise price of $0.0001 per share, will be immediately exercisable,
and may be exercised at any time until exercised in full. This prospectus also relates to the offering of the shares of common stock
issuable upon exercise of the Pre-Funded Warrants. |
Common Warrants
we are offering |
|
We
are also offering Common Warrants to purchase up to shares of common stock. Each Common
Warrant will be exercisable beginning on the effective date of the Warrant Stockholder Approval, provided however, if the Pricing
Conditions are met, the Warrant Stockholder Approval will not be required and the Common Warrant will be exercisable on the Initial
Exercise Date. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the Common Warrants.
|
Common Stock
outstanding immediately before this offering |
|
shares
|
Common Stock
outstanding immediately after this offering |
|
shares,
assuming no sale of any Pre-Funded Warrants and assuming none of the Common Warrants issued in this offering are exercised. |
Use of proceeds |
|
We
estimate that the net proceeds from this offering will be approximately $ million, based on an
assumed combined public offering price of $ per share, which is the closing price of our common
stock as reported on Nasdaq on , 2024, after deducting the Placement Agent
fees and estimated offering expenses payable by us. We intend to use the proceeds from this offering primarily for general
corporate purposes, to advance the development of our product candidates and to make periodic principal and interest payments under,
or to repay a portion of, the Note. See “Use of Proceeds.” |
Reasonable
best efforts offering |
|
We
have agreed to offer and sell the securities offered hereby to the purchasers through the Placement Agent. The Placement Agent is
not required to buy or sell any specific number or dollar amount of the securities offered hereby, but will use its reasonable best
efforts to solicit offers to purchase the securities offered by this prospectus. See “Plan of Distribution” on
page 34 of this prospectus. |
Risk Factors |
|
An
investment in our securities involves a high degree of risk. See “Risk Factors” beginning on page 17 of this prospectus
and the other information included and incorporated by reference in this prospectus for a discussion of the risk factors you should
carefully consider before deciding to invest in our securities. |
Nasdaq listing symbol |
|
Our common stock is listed
on Nasdaq under the symbol “SEEL”. There is no established trading market for the Common Warrants or the Pre-Funded Warrants
and we do not expect a market to develop. In addition, we do not intend to apply for the listing of the Warrants on any national
securities exchange or other trading market. Without an active trading market, the liquidity of the Common Warrants and Pre-Funded
Warrants will be limited. |
The
number of shares of common stock to be outstanding after this is based on shares
outstanding as of , 2024, and excludes:
| · | shares
of common stock underlying outstanding warrants at a weighted average exercise price of $
per share; |
| · | shares
of common stock underlying outstanding options issued under our Amended and Restated 2012
Stock Long Term Incentive Plan (the "2012 Plan") with a weighted average exercise
price of $ per share; |
| · | shares
of common stock underlying outstanding options issued under our 2019 Inducement Plan (the
"2019 Inducement Plan") with a weighted average exercise price of $ per share; |
| · | shares
of common stock available for future issuance under the 2012 Plan; |
| · | shares
of common stock available for future issuance under the 2019 Inducement Plan; and |
| · | the
shares of common stock issuable upon exercise of the Pre-Funded Warrants and the Common Warrants
issued in this offering. |
Except
as otherwise indicated, the information in this prospectus assumes no exercise of options or exercise of Warrants or sale of Pre-Funded
Warrants in this offering.
The
information discussed above is illustrative only and will adjust based on the actual public offering price and other terms of this offering
determined at pricing.
RISK FACTORS
Investing in our Securities involves a high
degree of risk. Before making an investment decision, you should carefully consider the risks described under “Risk Factors”
in our most recent Annual Report on Form 10-K, and the updates in our Quarterly Reports on Form 10-Q, together with all of
the other information appearing in or incorporated by reference into this prospectus before deciding whether to purchase any of the Securities
being offered. Our business, financial condition or results of operations could be materially adversely affected by any of these risks.
The trading price of shares of our common stock could decline due to any of these risks, and you may lose all or part of your investment.
Risks Related to the Company
Our debt agreement contains restrictive
and financial covenants that may limit our operating flexibility and the failure to comply with such covenants could cause our outstanding
debt to become immediately payable.
On November 23, 2021, we issued and sold
the outstanding convertible promissory note in an initial aggregate principal amount of $22.0 million (the “Note”) to Lind.
The Note, as amended, contains certain restrictive covenants and event of default provisions, including restrictions on certain sales
or other dispositions of company assets, restrictions on entering into certain variable-rate transactions and a covenant requiring us
to maintain an aggregate minimum balance equal to 50% of the then outstanding principal amount under the Note or more in cash and cash
equivalents commencing on July 31, 2024. As of September 18, 2024, the outstanding principal amount of the Note was approximately
$10.8 million and our cash and cash equivalents as of June 30, 2024 were approximately $0.5 million. Based on our current operating
plan and our cash balance as of June 30, 2024, and even after giving effect to the receipt of proceeds from the Offering, we do
not expect to be able to maintain the minimum cash balance required to satisfy this covenant if we do not raise additional financing.
In the event we fail to meet the minimum cash balance as required under the Note, and if we are unable to cure such default within fifteen
business days from its occurrence or otherwise obtain a waiver from Lind or amend the terms of the Note, we would trigger a default under
the Note. If we are not able to comply or regain compliance with any of the covenants in, or otherwise fail to make cash payments or
trigger a default under, the Note, Lind could declare the Note immediately due and payable, which would require us to pay 120% of the
outstanding principal amount of the Note and would have a material adverse effect on our liquidity, financial condition, operating results,
business and prospects, and could cause the price of our common stock to decline. In addition, since the borrowings under the Note are
secured by a first priority lien on our assets, Lind would be able to foreclose on our assets if we do not cure any default or pay any
amounts due and payable under the Note. In addition, upon an Event of Default (as defined in the Note), Lind shall have the right to
convert the then outstanding principal amount of the Note into shares of our common stock at the lower of (x) the then-current conversion
price (which is currently $1,440.00 per share, subject to adjustment in certain circumstances as described in the Note) and (y) 85%
of the average of the five lowest daily volume weighted average price of our common stock during the 20 trading days prior to the delivery
by Lind of a notice of conversion.
Risks Related to this Offering and Owning Our Securities
If we fail to comply with the continued listing requirements
of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital
markets could be negatively impacted.
We must continue to satisfy the Nasdaq Capital
Market’s continued listing requirements, including, among other things, a minimum closing bid price requirement of $1.00 per share
for 30 consecutive business days. If a company fails for 30 consecutive business days to meet the $1.00 minimum closing bid price requirement,
Nasdaq will send a deficiency notice to the company, advising that it has been afforded a “compliance period” of 180 calendar
days to regain compliance with the applicable requirements.
A delisting of our common stock from the Nasdaq
Capital Market could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price
of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable
to us, or at all, and may result in the potential loss of confidence by investors and employees.
On April 30, 2024, we received the Bid Notice
from Nasdaq indicating that, for the last thirty consecutive business days, the bid price for our common stock had closed below the minimum
$1.00 per share requirement for continued listing on the Nasdaq Capital Market under Rule 5550(a)(2). In accordance with Nasdaq
Listing Rule 5810(c)(3)(A), we have been provided an initial period of 180 calendar days, or until October 28, 2024, to regain
compliance. The Bid Notice states that the Nasdaq staff will provide written confirmation that the Company has achieved compliance with
Rule 5550(a)(2) if at any time before October 28, 2024, the bid price of the Company’s common stock closes at $1.00
per share or more for a minimum of ten consecutive business days.
On November 2, 2023, we received a written notice
from Nasdaq indicating that, for the last thirty-two consecutive business days, the market value of our listed securities has been below
the minimum requirement of $35 million for continued listing on the Nasdaq Capital Market under Rule 5550(b)(2). In accordance with Nasdaq
Listing Rule 5810(c)(3)(C), we were provided a period of 180 calendar days, or until April 30, 2024, to regain compliance. The Initial
Notice stated that the Nasdaq staff will provide written notification that we have achieved compliance with Rule 5550(b)(2) if at any
time before April 30, 2024, the market value of our common stock closes at $35 million or more for a minimum of ten consecutive business
days.
On May 1, 2024, we received written notice from
Nasdaq indicating that, based upon our continued non-compliance with Rule 5550(b)(2), the Nasdaq staff has determined to delist our common
stock from the Nasdaq Capital market effective May 10, 2024 unless we timely request an appeal of this determination before the Panel
by May 8, 2024. We timely requested a hearing before the Panel, which had the effect of staying the suspension of the Company’s
common stock pending the Panel’s final written decision. During the pendency of our hearing before the Panel, our common stock will
remain listed and trading on Nasdaq.
In response to our request following a hearing
before the Panel, on July 25, 2024, we received written notification from the Panel notifying us that the Panel had granted our
request for an additional period, during which the Company will remain listed on Nasdaq, to regain compliance with Rule 5550(b)(2)
and demonstrate continued compliance with Rule 5550(a)(2). Pursuant to the Extension Notice, the Panel granted the Company an additional
period until August 30, 2024 to regain compliance with Rule 5550(b)(2) and until September 30, 2024 to regain compliance
with Rule 5550(a)(2). The extension is subject to certain conditions specified by the Panel in the Notice.
On May 15, 2024, we filed a Certificate
of Change (the “Certificate of Change”) with the Secretary of State of the State of Nevada to (i) effect a 1-for-8 Reverse
Stock Split of our issued and outstanding shares of common stock, effective at 12:01 a.m. Eastern Time, on May 16, 2024, and
(ii) decrease the number of total authorized shares of our common stock from 400,000,000 shares to 50,000,000 shares. The Reverse
Stock Split was intended, among other reasons, to allow us to achieve the requisite increase in the market price of our common stock
to be in compliance with the minimum bid price of Nasdaq. However, there can be no assurance that the price of our common stock will
stay above the minimum requirements for the time period required by Nasdaq in order to regain compliance with the rule.
In addition, we have previously received similar
notices from Nasdaq that our bid price of our common stock had closed below the minimum $1.00 per share requirement for continued listing
on the Nasdaq Capital Market under Rule 5550(a)(2), and that the market value of our listed securities has been below the minimum
requirements of $35 million for continued listing on the Nasdaq Capital Market under Rule 5550(b)(2). Even though we previously
regained compliance with the Nasdaq Capital Market’s minimum closing bid price requirement, and minimum market value of listed
securities requirement, there is no guarantee that we will remain in compliance with such listing requirements or other listing requirements
in the future. Any failure to maintain compliance with continued listing requirements of the Nasdaq Capital Market could result in delisting
of our common stock from the Nasdaq Capital Market and negatively impact our company and holders of our common stock, including by reducing
the willingness of investors to hold our common stock because of the resulting decreased price, liquidity and trading of our common stock,
limited availability of price quotations and reduced news and analyst coverage. Delisting may adversely impact the perception of our
financial condition, cause reputational harm with investors, our employees and parties conducting business with us and limit our access
to debt and equity financing.
We
have broad discretion in how we use the proceeds of this offering and may not use these proceeds effectively, which could affect our
results of operations and cause our common stock to decline.
We will
have considerable discretion in the application of the net proceeds of this offering. We intend to use the net proceeds from this offering
primarily for general corporate purposes, to advance the development of our product candidates and to make periodic principal and interest
payments under, or to repay a portion of, the Note. Investors will be relying upon management’s judgment with only limited information
about our specific intentions for the use of the net proceeds of this offering. We may use the net proceeds for purposes that do not
yield a significant return or any return at all for our stockholders. In addition, pending their use, we may invest the net proceeds
from this offering in a manner that does not produce income or that loses value.
We
will require substantial funding, which may not be available to us on acceptable terms, or at all, and, if not so available, may require
us to delay, limit, reduce or cease our operations.
We expect to expend substantial funds in
research and development, including preclinical studies and clinical trials of our product candidates, and to manufacture and market
any product candidates in the event they are approved for commercial sale. We also may need additional funding to develop or acquire
complementary companies, technologies and assets, as well as for working capital requirements and other operating and general corporate
purposes. Moreover, our planned increases in staffing will dramatically increase our costs in the near and long-term.
However, our spending on current and future
research and development programs and product candidates for specific indications may not yield any commercially viable products. Due
to our limited financial and managerial resources, we must focus on a limited number of research programs and product candidates and
on specific indications. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable
market opportunities.
Because the successful development of our
product candidates is uncertain, we are unable to precisely estimate the actual funds we will require to develop and potentially commercialize
them. In addition, we may not be able to generate sufficient revenue, even if we are able to commercialize any of our product candidates,
to become profitable.
We may
seek additional funding through a combination of equity offerings, debt financings, government or other third-party funding, commercialization,
marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. Additional funding
may not be available to us on acceptable terms or at all. In addition, the terms of any financing may adversely affect the holdings or
the rights of our stockholders.
If we
are unable to obtain funding on a timely basis, we may be required to significantly curtail one or more of our research or development
programs. We also could be required to seek funds through arrangements with collaborative partners or otherwise that may require us to
relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us.
Purchasers
in this offering will experience immediate and substantial dilution in net tangible book value.
The
public offering price per share of common stock and related Common Warrant and the public offering price of each Pre-Funded Warrant and
related Common Warrant will be substantially higher than the pro forma as adjusted net tangible book value per share of our common stock
after giving effect to this offering. Assuming the sale of shares of our common stock and accompanying Common Warrants to purchase up
to shares of common stock at an assumed combined public offering price of $ per share, the closing sale price per share of our common
stock on Nasdaq on , 2024, assuming no sale of any Pre-Funded Warrants in this offering, no exercise of the Warrants being offered in
this offering and after deducting the Placement Agent fees and commissions and estimated offering expenses payable by us, you will incur
immediate dilution in pro forma as adjusted net tangible book value of approximately $ per share. As a result of the dilution to investors
purchasing securities in this offering, investors may receive significantly less than the purchase price paid in this offering, if anything,
in the event of the liquidation of our company. See the section entitled “Dilution” below for
a more detailed discussion of the dilution you will incur if you participate in this offering. To the extent shares are issued under
outstanding options and Warrants at exercise prices lower than the public offering price of our common stock in this offering, you will
incur further dilution.
Your
ownership may be diluted if additional capital stock is issued to raise capital, to finance acquisitions or in connection with strategic
transactions.
We intend to seek to
raise additional funds for our operations, to finance acquisitions or to develop strategic relationships by issuing equity or convertible
debt securities in addition to the securities issued in this offering, which would reduce the percentage ownership of our existing stockholders.
Future issuances of common or preferred stock would reduce your influence over matters on which stockholders vote and would be dilutive
to earnings per share. In addition, any newly issued preferred stock could have rights, preferences and privileges senior to those of
the common stock. Those rights, preferences and privileges could include, among other things, the establishment of dividends that must
be paid prior to declaring or paying dividends or other distributions to holders of our common stock or providing for preferential liquidation
rights. These rights, preferences and privileges could negatively affect the rights of holders of our common stock, and the right to convert
such preferred stock into shares of our common stock at a rate or price that would have a dilutive effect on the outstanding shares of
our common stock.
There
is no public market for the Warrants being offered in this offering.
There
is no established public trading market for the Warrants being offered in this offering, and we do not expect a market to develop. In
addition, we do not intend to apply to list the Warrants on any securities exchange or nationally recognized trading system, including
Nasdaq. Without an active market, the liquidity of the Warrants will be limited.
If
we are required to obtain Warrant Stockholder Approval, until we are able to receive such approval, the Common Warrants will not be exercisable,
and if we are unable to obtain such approval the Common Warrants will have no value.
If we
are required to obtain Warrant Stockholder Approval, the Common Warrants will not be exercisable until, and unless, we obtain the Warrant
Stockholder Approval from our stockholders. While we intend to promptly seek stockholder approval, if required, there is no guarantee
that the Warrant Stockholder Approval will ever be obtained. If we are unable to obtain the Warrant Stockholder Approval, the Common Warrants
will have no value. In addition, we will incur substantial cost, and management will devote substantial time and attention, in attempting
to obtain the Warrant Stockholder Approval.
Holders
of our Warrants will have no rights as a common stockholder until they acquire our common stock.
Until
holders of our Warrants acquire shares of our common stock upon exercise of such warrants, the holders will have no rights with respect
to shares of our common stock issuable upon exercise of such Warrants. Upon exercise of the Warrants, holders will be entitled to exercise
the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.
If
we do not maintain a current and effective prospectus relating to the common stock issuable upon exercise of the Common Warrants and pre-funded
warrants, public holders will only be able to exercise such Common Warrants and pre-funded warrants on a “cashless basis.”
If we
do not maintain a current and effective prospectus relating to the shares of common stock issuable upon exercise of the Common Warrants
and pre-funded warrants at the time that holders wish to exercise such warrants, they will only be able to exercise them on a “cashless
basis,” and under no circumstances would we be required to make any cash payments or net cash settle such warrants to the holders.
As a result, the number of shares of common stock that holders will receive upon exercise of the warrants will be fewer than it would
have been had such holders exercised their warrants for cash. We will do our best efforts to maintain a current and effective prospectus
relating to the shares of common stock issuable upon exercise of such warrants until the expiration of such warrants. However, we cannot
assure you that we will be able to do so. If we are unable to do so, the potential “upside” of the holder’s investment
in our company may be reduced.
The
Common Warrants and Pre-Funded Warrants are speculative in nature.
The Common
Warrants and pre-funded warrants offered hereby do not confer any rights of common stock ownership on their holders, such as voting rights
or the right to receive dividends, but rather merely represent the right to acquire shares of common stock at a fixed price. Specifically,
commencing on the date of issuance, holders of the pre-funded warrants may acquire the common stock issuable upon exercise of such warrants
at an exercise price of $0.0001 per share and holders of the Common Warrants may acquire the common stock issuable upon exercise of such
warrants at an exercise price per share equal to the public offering price of shares of common stock in this offering. Moreover, following
this offering, the market value of the pre-funded warrants and Common Warrants will be uncertain and there can be no assurance that the
market value of such warrants will equal or exceed their public offering price. There can be no assurance that the market price of the
common stock will ever equal or exceed the exercise price of the Common Warrants, and consequently, whether it will ever be profitable
for holders of the Common Warrants to exercise the Common Warrants.
This
is a “best efforts” offering. No minimum amount of securities is required to be sold, and we may not raise the amount of
capital we believe is required for our business plans, including our near-term business plans.
The
Placement Agent has agreed to use its reasonable best efforts to solicit offers to purchase the securities in this offering. The Placement
Agent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar
amount of the securities. There is no required minimum number of securities that must be sold as a condition to completion of this offering.
Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, Placement
Agent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth above.
We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and
investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to support our
continued operations, including our near-term continued operations. Thus, we may not raise the amount of capital we believe is required
for our operations and may need to raise additional funds to complete such short-term operations. Such additional fundraises may not
be available or available on terms acceptable to us.
If
our stock price fluctuates after the offering, you could lose a significant part of your investment.
The
market price of our common stock could be subject to wide fluctuations in response to, among other things, the risk factors described
in this prospectus, and other factors beyond our control, such as fluctuations in the valuation of companies perceived by investors to
be comparable to us. Furthermore, the stock markets have experienced price and volume fluctuations that have affected and continue to
affect the market prices of equity securities of many companies. These fluctuations often have been unrelated or disproportionate to
the operating performance of those companies. These broad market and industry fluctuations, as well as general economic, political, and
market conditions, such as recessions, interest rate changes or international currency fluctuations, may negatively affect the market
price of our common stock. In the past, many companies that have experienced volatility in the market price of their stock have been
subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities litigation against
us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously
harm our business.
This offering may cause
the trading price of our common stock to decrease.
The
price per share, together with the number of shares of common stock we issue if this offering is completed, may result in an immediate
decrease in the market price of our common stock. This decrease may continue after the completion of this offering.
We have never paid
dividends on our capital stock, and we do not anticipate paying dividends in the foreseeable future.
We have
never paid dividends on any of our capital stock and currently intend to retain any future earnings to fund the growth of our business.
We may also enter into credit agreements or other borrowing arrangements in the future that will restrict our ability to declare or pay
cash dividends on our common stock. Any determination to pay dividends in the future will be at the discretion of our board of directors
and will depend on our financial condition, operating results, capital requirements, general business conditions and other factors that
our board of directors may deem relevant. As a result, capital appreciation, if any, of the securities will be the sole source of gain,
if any, for the foreseeable future.
USE OF PROCEEDS
We estimate
that the net proceeds from the offering will be approximately $ million, assuming we complete the maximum offering pursuant to this prospectus,
after deducting the Placement Agent fees and estimated offering expenses payable by us, and excluding the proceeds, if any, from the
exercise of the Common Warrants. However, because this is a “best efforts” offering and there is no minimum offering amount
required as a condition to the closing of this offering, the actual offering amount, the Placement Agent fees and net proceeds to us
are not presently determinable and may be substantially less than the maximum amounts set forth on the cover page of this prospectus.
As a result, we may receive significantly less in net proceeds.
Based on the assumed offering price set forth above,
we estimate that our net proceeds from the sale of 75%, 50%, and 25% of the securities offered in this offering would be approximately
$ million, $ million, and $ million, respectively, after deducting the estimated Placement Agent fees and estimated offering expenses
payable by us, and assuming no issuance of any Pre-Funded Warrants and assuming no exercise of the Common Warrants. The combined public
offering price per share (or Pre-Funded Warrant) and Common Warrants will be fixed for the duration of this offering.
We intend to use the
net proceeds from this offering for general corporate purposes, to advance the development of our product candidates and to make periodic
principal and interest payments under, or to repay a portion of, the Note, with an aggregate principal balance of $10.8 million as of
September 18, 2024 and bearing an interest rate of 12% per annum.
As of
the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to us from this offering.
Accordingly, our management will have broad discretion in the application of these proceeds. Net offering proceeds not immediately applied
to the uses summarized above will be invested in short-term investments such as money market funds, commercial paper, U.S. treasury bills
and similar securities investments pending their use.
CAPITALIZATION
The following table sets
forth our cash and cash equivalents and capitalization as of June 30, 2024:
|
· |
on an actual basis; |
|
|
|
|
· |
on
a pro forma basis to give effect to the issuance of (i) 6,073,761 shares to pay $1.3 million of principal and $317,000 of interest
under the Note as of September 20, 2024, and (ii) 939,739 shares under the Warrant Inducement transaction in July 2024
for $449,000; |
|
|
|
|
· |
on a pro forma as adjusted basis to give further effect to the issuance
and sale of shares of our common stock and accompanying Warrants in this
offering at an assumed offering price of $ per share, which was the closing
price of our common stock as reported on Nasdaq on , 2024, after deducting
the Placement Agent fees and estimated offering expenses payable by us, and assuming no sale of Pre-Funded Warrants and no exercise
of Warrants. |
Our
capitalization following the closing of this offering will be adjusted based on the actual public offering price and other terms of this
offering determined at pricing. You should read this table in conjunction with “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and our financial statements and related notes included in our Quarterly Report on Form 10-Q
for the quarter ended June 30, 2024, which are incorporated by reference into this prospectus.
| |
Actual | | |
Pro Forma | | |
Pro Forma
As Adjusted | |
| |
(amounts in thousands) | |
Cash
and cash equivalents | |
$ | 294 | | |
$ | 449 | | |
$ | | |
Notes
Payable | |
| 10,110 | (1) | |
| 1,288 | | |
| | |
Stockholders’
equity (deficit): | |
| | | |
| | | |
| | |
Common stock,
par value $0.001 per share: 50,000,000 shares authorized as of June 30, 2024; 3,322,045 shares issued and outstanding as of
June 30, 2024; 10,335,545 shares issued and outstanding pro forma; [___] shares issued and outstanding pro forma as
adjusted; | |
| 3 | | |
| 7 | | |
| | |
Additional paid-in capital | |
| 225,444 | | |
| 1,730 | | |
| | |
Accumulated
deficit | |
| (253,580 | ) | |
| 0 | | |
| | |
| |
| | | |
| | | |
| | |
Total
stockholders’ equity (deficit) | |
| (28,133 | ) | |
| 1,737 | | |
| | |
| |
| | | |
| | | |
| | |
Total
capitalization | |
$ | (17,729 | ) | |
$ | 3,474 | | |
$ | | |
| (1) | Represents the fair value of the Note of $10.1 million, provided,
however that the aggregate principal amount outstanding under the Note as of June 30,
2024 was $11.95 million. |
A $0.25
increase or decrease in the assumed public offering price of $ per share,
which was the closing price of our common stock as reported on Nasdaq on ,
2024, would increase or decrease, respectively, our pro forma as adjusted cash and cash equivalents, additional paid-in capital, total
stockholders’ equity, and total capitalization by approximately $ ,
assuming the number of securities offered by us, as set forth on the cover page of this prospectus, remains the same, assuming no
sale of any Pre-Funded Warrants and no exercise of Warrants, and after deducting underwriting discounts and commissions and estimated
offering expenses payable by us. We may also increase or decrease the number of securities to be issued in this offering. An increase
or decrease of 1,000,000 in the number of shares of common stock and common warrants offered by us would increase or decrease, respectively,
our pro forma as adjusted cash and cash equivalents, additional paid-in capital, total stockholders’ equity, and total capitalization
by $ , assuming that the assumed public offering price remains the same,
assuming no sale of any pre-funded warrants and no exercise of warrants, and after deducting estimated Placement Agent fees and
estimated offering expenses payable by us. The information discussed above is illustrative only and will be adjusted based on the actual
public offering price and other terms of this offering as determined between us, the Placement Agent, and the investors at pricing.
Dilution
If you
invest in our securities in this offering, your interest will be diluted immediately to the extent of the difference between the public
offering price paid by the purchasers of the shares of common stock (and Pre-Funded Warrants) and related Common Warrants sold in this
offering and the as adjusted net tangible book value per shares of common stock after this offering.
As of
June 30, 2024, our as reported net tangible book value was $(28.1) million, or $(8.47) per share of common stock or $(2.60) per share
of common stock reflecting the issuance of 939,739 shares of common stock resulting from the exercise of previously issued Pre-Funded
Warrants subsequent to June 30, 2024 and 6,073,761 shares of common stock to pay $1.3 million of principal and $317,000 of interest under
the Note as of September 20, 2024.
Net tangible
book value per share represents our total tangible assets, less our total liabilities, divided by the number of outstanding shares of
our common stock. Dilution represents the difference between the amount per share paid by purchasers in this offering and the as adjusted
net tangible book value per share of common stock after the offering.
After giving effect to the sale of shares of common
stock and accompanying Common Warrants in this offering at an assumed offering price of $ per share, which was the closing price of our
common stock as reported on Nasdaq on , 2024, and after deducting Placement Agent fees and estimated offering expenses payable by us,
but without adjusting for any other change in our net tangible book value subsequent to June 30, 2024, our pro-forma as adjusted net tangible
book value would have been $[___] per share. This represents an immediate increase in net tangible book value on a pro-forma basis of
$[___] per share to our existing stockholders and immediate dilution of $[___] per share to new investors purchasing securities at the
proposed public offering price. The dilution figures assume no sale of Pre-Funded Warrants, which, if sold, would reduce the number of
shares of common stock that we are offering on a one-for-one basis, and excludes the proceeds, if any, from the exercise of any Common
Warrants issued in this offering. The following table illustrates the dilution in net tangible book value per share to new investors as
of June 30, 2024:
Assumed public offering price
per share and accompanying Common Warrants | |
| | | $ |
|
|
Historical net tangible book value per
share at June 30, 2024 | |
$ | (8.47 | ) |
|
|
|
Increase in net tangible book value per
share to the existing stockholders on a pro-forma basis attributable to ––this offering. | |
$ | | |
|
|
|
Pro-forma net tangible book value per share
after this offering | |
| | | $ |
|
|
Dilution in net tangible book value per
share to new investors on a pro-forma basis | |
| | | $ |
|
|
Each
$0.25 increase (decrease) in the assumed public offering price of $ per share,
would increase (decrease) our pro-forma as adjusted net tangible book value per share to existing investors by $ ,
and would increase (decrease) dilution per share to new investors in this offering by $
, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after
deducting the estimated Placement Agent fees and estimated offering expenses payable by us. We may also increase or decrease the number
of securities to be issued in this offering. Each increase (decrease) of 1,000,000 shares offered by us would increase (decrease)
our as adjusted net tangible book value per share by $ and the dilution per
share to new investors purchasing securities in this offering by $
assuming that the assumed public offering price remains the same, and after deducting Placement Agent fees and estimated offering expenses
payable by us. The information discussed above is illustrative only and will be adjusted based on the actual public offering price and
other terms of this offering as determined between us and the Placement Agent at pricing.
The
number of shares of common stock to be outstanding after this offering is based on 3,322,045 shares outstanding as of June 30, 2024
and excludes:
| · | shares
of common stock underlying outstanding warrants at a weighted average exercise price of $
per share; |
| · | shares
of common stock underlying outstanding options issued under our Amended and Restated 2012
Stock Long Term Incentive Plan (the "2012 Plan") with a weighted average exercise
price of $ per share; |
| · | shares
of common stock underlying outstanding options issued under our 2019 Inducement Plan (the
"2019 Inducement Plan") with a weighted average exercise price of $ per share; |
| · | shares
of common stock available for future issuance under the 2012 Plan; |
| · | shares
of common stock available for future issuance under the 2019 Inducement Plan; and |
| · | the
shares of common stock issuable upon exercise of the Pre-Funded Warrants and the Common Warrants
issued in this offering. |
The
discussion and table above assume no exercise of the Warrants. To the extent that the Warrants are exercised, you may
experience further dilution. In addition, we may choose to raise additional capital due to market conditions or strategic
considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional
capital is raised through the sale of equity or convertible debt securities, the issuance of these securities could result in
further dilution to our stockholders.
DESCRIPTION OF CAPITAL
STOCK
The
following description of our capital stock is not complete and may not contain all the information you should consider before investing
in our capital stock. This description is summarized from, and qualified in its entirety by reference to, our Amended and Restated Articles
of Incorporation, as amended, which have been publicly filed with the SEC. See “Where You Can Find More Information.”
Our
authorized capital stock consists of:
| · | 50,000,000
shares of common stock, $0.001 par value; and |
| · | 10,000,000
shares of preferred stock, $0.001 par value. |
Common Stock
Voting
Rights. Holders of common stock are entitled to one vote per share for the election of directors and on all
other matters that require stockholder approval. Holders of common stock do not have any cumulative voting rights.
Liquidation
Rights. Subject to any preferential rights of any outstanding preferred stock, in the event of the Company’s
liquidation, dissolution or winding up, holders of common stock are entitled to share ratably in the assets remaining after payment of
liabilities and the liquidation preferences of any outstanding preferred stock.
No
Preemptive or Redemption Rights. Shares of common stock do not carry any redemption rights or any preemptive
or preferential rights enabling a holder to subscribe for, or receive shares of, any class of common stock or any other securities convertible
into common stock.
Dividend
Rights. Holders of common stock shall be entitled to receive dividends if, as and when declared by our board
of directors in accordance with applicable law.
Anti-Takeover
Provisions. See the below section titled “Anti-Takeover Effects of Nevada Law and Provisions of our
Articles of Incorporation and Bylaws”.
Dividends
We
have never paid cash dividends on shares of common stock. Moreover, we do not anticipate paying periodic cash dividends on shares
of common stock for the foreseeable future. Any future determination about the payment of dividends will be made at the discretion of
our board of directors and will depend upon its earnings, if any, capital requirements, operating and financial conditions and on such
other factors as our board of directors deems relevant.
Preferred Stock
We currently have no outstanding shares of preferred
stock. Under our Amended and Restated Articles of Incorporation, as amended, our board of directors has the authority, without further
action by stockholders, to designate one or more series of preferred stock and to fix the voting powers, designations, preferences, limitations,
restrictions and relative rights granted to or imposed upon the preferred stock, including dividend rights, conversion rights, voting
rights, rights and terms of redemption, liquidation preference and sinking fund terms. Any or all of these may be preferential to or
greater than the rights of the common stock. Of our authorized preferred stock, 1,000,000 shares have been designated as Series A
Junior Participating Preferred Stock, 800 shares have been designated as Series B 8% Cumulative Convertible Preferred Stock, and
600 shares have been designated as Series C 6% Cumulative Convertible Preferred Stock.
Our board of directors may authorize the issuance
of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of shares
of common stock. The issuance of preferred stock, while providing flexibility in connection with possible acquisitions and other corporate
purposes, could, among other things, have the effect of delaying, deferring or preventing a change in control of our company and may
adversely affect the market price of the common stock and the voting and other rights of the holders of shares of common stock.
Our board of directors may specify the following
characteristics of any preferred stock:
| · | the
designation and stated value, if any, of the class or series of preferred stock; |
| · | the
number of shares of the class or series of preferred stock offered, and the liquidation preference,
if any, per share; |
| · | the
dividend rate(s), period(s) or payment date(s) or method(s) of calculation,
if any, applicable to the class or series of preferred stock; |
| · | whether
dividends, if any, are cumulative or non-cumulative and, if cumulative, the date from which
dividends on the class or series of preferred stock will accumulate; |
| · | the
provisions for a sinking fund, if any, for the class or series of preferred stock; |
| · | the
provision for redemption, if applicable, of the class or series of preferred stock; |
| · | the
terms and conditions, if applicable, upon which the class or series of preferred stock will
be convertible into common stock, including the conversion price or manner of calculation
and conversion period; |
| · | voting
rights, if any, of the class or series of preferred stock; |
| · | the
relative ranking and preferences of the class or series of preferred stock as to dividend
rights and rights, if any, upon the liquidation, dissolution or winding up of our affairs; |
| · | any
limitations on issuance of any class or series of preferred stock ranking senior to or on
a parity with the class or series of preferred stock as to dividend rights and rights, if
any, upon liquidation, dissolution or winding up of our affairs; and |
| · | any
other specific terms, preferences, rights, limitations or restrictions of the class or series
of preferred stock. |
Outstanding Warrants
As of ,
2024, in addition to the Warrants we are registering hereunder, we had outstanding warrants to purchase 3,002,011 shares of common stock,
with a weighted-average exercise price of approximately $8.33 per share were outstanding, as follows:
| · | warrants
to purchase an aggregate of three (3) shares of common stock with an exercise price
of $92,880.00 per share, all of which are currently exercisable (subject to certain beneficial
ownership limitations) and expire on October 17, 2024, all of which shall be automatically
exercised on a “cashless” basis upon expiration if the fair market value of the
common stock is greater than the exercise price of the warrants on the expiration date of
the warrants; |
| · | warrants
to purchase an aggregate of three (3) shares of common stock with an exercise price
of $118,080 per share, all of which are currently exercisable and expire on July 23,
2025, all of which shall be automatically exercised on a “cashless” basis upon
expiration if the fair market value of the common stock is greater than the exercise price
of the warrants on the expiration date of the warrants; |
| · | warrants
to purchase an aggregate of 4,204 shares of common stock with an exercise price of $201.60
per share, all of which are currently exercisable (subject to certain beneficial ownership
limitations) and expire on March 9, 2026; |
| · | warrants
to purchase an aggregate of 111,459 shares of common stock with an exercise price of $144.00
per share, all of which is currently exercisable (subject to certain beneficial ownership
limitations) and expire on September 14, 2028; |
| · | warrants
to purchase an aggregate of 16,668 shares of common stock with an exercise price of $254.40
per share, all of which is currently exercisable (subject to certain beneficial ownership
limitations) and expire on November 20, 2028; |
| · | warrants
to purchase an aggregate of 924,414 shares of common stock with an exercise price of $2.21
per share, all of which are currently exercisable (subject to certain beneficial ownership
limitations) and expire on May 21, 2029; |
| · | warrants
to purchase an aggregate of 939,739 shares of common stock with an exercise price of $0.61
per share, all of which are exercisable on or after the date of Stockholder Approval (as
defined in the warrant) and have a term of exercise of eighteen (18) months following the
date of Stockholder Approval; |
| · | warrants
to purchase an aggregate of 939,739 shares of common stock with an exercise price of $0.61
per share, all of which are exercisable on or after the date of Stockholder Approval (as
defined in the warrant) and have a term of exercise of five (5) years following the
date of Stockholder Approval; and |
| · | warrants
to purchase up to 65,782 shares of common stock with an exercise price of $0.7625 per share,
all of which are exercisable on or after the date of Stockholder Approval (as defined in
the warrant) and have a term of exercise of five (5) years following the date of Stockholder
Approval. |
All of the outstanding warrants contain provisions
for the adjustment of the exercise price in the event of stock dividends, stock splits or similar transactions. In addition, certain
of the warrants contain a “cashless exercise” feature that allows the holders thereof to exercise the warrants without a
cash payment to us under certain circumstances. Certain of the warrants also contain provisions that provide certain rights to warrant
holders in the event of a fundamental transaction, including a merger or consolidation with or into another entity, such as:
| · | the
right to receive the same amount and kind of consideration paid to the holders of common
stock in the fundamental transaction; |
| · | the
right to require us or a successor entity to purchase the unexercised portion of certain
warrants at the warrant’s respective fair value using the Black Scholes option pricing
formula; or |
| · | the
right to require us or a successor entity to redeem the unexercised portion of certain warrants
for the same consideration paid to holders of common stock in the fundamental transaction
at the warrant’s respective fair value using the Black Scholes option pricing formula. |
Convertible Promissory Note
As
of September 18, 2024, we had one outstanding convertible promissory note in an aggregate principal outstanding amount of approximately
$10.8 million, which was issued on November 23, 2021, is convertible by the holder thereof into up to approximately 7,406 shares
of common stock any time and matures on November 23, 2024.
The
Note provides that, commencing on the nine (9) month anniversary of the date of issuance of the Note, the holder of the Note may
convert any portion of the then-outstanding principal amount into shares of common stock at a price per share of $1,440.00 subject
to adjustment for stock splits, reverse stock splits, stock dividends and similar transactions. Beginning on November 23, 2022,
the Note began amortizing in twenty-four (24) monthly installments equal to the quotient of (i) the then-outstanding principal amount
of the Note, divided by (ii) the number of months remaining until the maturity date of the Note. All amortization payments shall
be payable, at our sole option, in cash, shares of common stock or a combination of both. In addition, commencing on the last business
day of the first month following November 23, 2022, we must pay, on a monthly basis, all interest that has accrued and remains unpaid
on the then-outstanding principal amount of the Note. Any portion of an amortization payment or interest payment that is paid in shares
of common stock shall be priced at 90% of the average of the five (5) lowest daily volume weighted average prices of the common
stock during the twenty (20) trading days prior to the date of issuance of the shares.
Anti-Takeover Effects of Nevada Law and
Provisions of our Amended and Restated Articles of Incorporation, as amended, and Amended and Restated Bylaws, as amended
Certain
provisions of Nevada law and our Amended and Restated Articles of Incorporation,
as amended, and Amended and Restated Bylaws, as amended, could make the following more difficult:
| · | acquisition
of us by means of a tender offer; |
| · | acquisition
of us by means of a proxy contest or otherwise; or |
| · | removal
of our incumbent officers and directors. |
These
provisions, summarized below, could have the effect of discouraging certain types of coercive takeover practices and inadequate
takeover bids. These provisions may also encourage persons seeking to acquire control of
us to first negotiate with our board of directors.
Classified
Board. Our Amended and Restated Articles of Incorporation, as amended, provide that our board of directors
is to be divided into three classes, as nearly equal in number as possible, with directors in each class serving three-year terms. This
provision may have the effect of delaying or discouraging an acquisition of us or a change in our management.
Filling
Vacancies. Our Amended and Restated Articles of Incorporation, as amended, provide that newly created directorships
resulting from any increase in the authorized number of directors or any vacancies in the our board of directors resulting from death,
resignation, retirement, disqualification, removal from office or other cause shall, unless otherwise provided by law or resolution of
our board of directors, be filled only by a majority of the directors then in office, though less than a quorum. The directors so chosen
shall hold office for a term expiring at the annual meeting of stockholders at which the term of office of the class to which they have
been chosen expires.
Removal. The
Nevada Revised Statutes (“NRS”) provide that any director may be removed from our board of directors by the vote or written
consent of stockholders representing not less than two-thirds of the voting power of the issued and outstanding shares entitled to vote.
Requirements
for Advance Notification of Stockholder Nominations and Proposals. Our Amended and Restated Bylaws, as amended,
establish advance notice procedures with respect to stockholder proposals and the nomination of candidates for election as directors,
other than nominations made by or at the direction of the board of directors.
Special
Meetings of the Stockholders. Our Amended and Restated Bylaws, as amended, provide that special meetings
of the stockholders may be called by our chair of our board of directors or our President, or by our board of directors acting pursuant
to a resolution adopted by the total number of authorized directors, whether or not there exist any vacancies in previously authorized
directorships.
No
Cumulative Voting. Our Amended and Restated Articles of Incorporation, as amended, and Amended and Restated
Bylaws, as amended, do not provide for cumulative voting in the election of directors.
Undesignated
Preferred Stock. The authorization of undesignated preferred stock in our Amended and Restated Articles of
Incorporation, as amended, makes it possible for our board of directors to issue preferred stock with voting or other rights or preferences
that could impede the success of any attempt to change control of our company. These and other provisions may have the effect of deferring
hostile takeovers or delaying changes in control or management of our company.
Amendment
of Charter Provisions. The amendment of any of the above provisions set forth in our Amended and
Restated Articles of Incorporation, as amended, except for the provision making it possible for our board of directors to issue
undesignated preferred stock, would require approval by a stockholder vote by the holders of at least 66 2/3% of the voting power
of all the then-outstanding shares of our capital stock entitled to vote generally in the election of directors.
In addition, the NRS contain provisions governing
the acquisition of a controlling interest in certain Nevada corporations. Nevada’s “acquisition of controlling interest”
statutes (NRS 78.378 through 78.3793, inclusive) contain provisions governing the acquisition of a controlling interest in certain Nevada
corporations. These “control share” laws provide generally that any person that acquires a “controlling interest”
in certain Nevada corporations may be denied voting rights, unless a majority of the disinterested stockholders of the corporation elects
to restore such voting rights. These laws will apply to us as of a particular date if we were to have 200 or more stockholders of record
(at least 100 of whom have addresses in Nevada appearing on our stock ledger at all times during the 90 days immediately preceding
that date) and do business in the State of Nevada directly or through an affiliated corporation, unless our articles of incorporation
or bylaws in effect on the tenth day after the acquisition of a controlling interest provide otherwise. These laws provide that a person
acquires a “controlling interest” whenever a person acquires shares of a subject corporation that, but for the application
of these provisions of the NRS, would enable that person to exercise (1) one-fifth or more, but less than one-third, (2) one-third
or more, but less than a majority or (3) a majority or more, of all of the voting power of the corporation in the election of directors.
Once an acquirer crosses one of these thresholds, shares which it acquired in the transaction taking it over the threshold and within
the 90 days immediately preceding the date when the acquiring person acquired or offered to acquire a controlling interest become
“control shares” to which the voting restrictions described above apply. These laws may have a chilling effect on certain
transactions if our Amended and Restated Articles of Incorporation, as amended, or Amended and Restated Bylaws, as amended, are not amended
to provide that these provisions do not apply to us or to an acquisition of a controlling interest, or if our disinterested stockholders
do not confer voting rights in the control shares.
Nevada’s “combinations with interested
stockholders” statutes (NRS 78.411 through 78.444, inclusive) provide that specified types of business “combinations”
between certain Nevada corporations and any person deemed to be an “interested stockholder” of the corporation are prohibited
for two years after such person first becomes an “interested stockholder” unless the corporation’s board of directors
approves the combination (or the transaction by which such person becomes an “interested stockholder”) in advance, or unless
the combination is approved by the board of directors and sixty percent of the corporation’s voting power not beneficially
owned by the interested stockholder, its affiliates and associates. Furthermore, in the absence of prior approval certain restrictions
may apply even after such two-year period. For purposes of these statutes, an “interested stockholder” is any person who
is (1) the beneficial owner, directly or indirectly, of 10% or more of the voting power of the outstanding voting shares of the
corporation, or (2) an affiliate or associate of the corporation and at any time within the two previous years was the beneficial
owner, directly or indirectly, of 10% or more of the voting power of the then-outstanding shares of the corporation. The definition of
the term “combination” is sufficiently broad to cover most significant transactions between a corporation and an “interested
stockholder”. These laws generally apply to Nevada corporations with 200 or more stockholders of record. However, a Nevada corporation
may elect in its articles of incorporation not to be governed by these particular laws, but if such election is not made in the corporation’s
original articles of incorporation, the amendment (1) must be approved by the affirmative vote of the holders of stock representing
a majority of the outstanding voting power of the corporation not beneficially owned by interested stockholders or their affiliates and
associates, and (2) is not effective until 18 months after the vote approving the amendment and does not apply to any combination
with a person who first became an interested stockholder on or before the effective date of the amendment. We have not made such an election
in our original articles of incorporation or in our Amended and Restated Articles of Incorporation, as amended, and we have not amended
our Amended and Restated Articles of Incorporation to so elect.
Further, NRS 78.139 also provides that directors
may resist a change or potential change in control of the corporation if the board of directors determines that the change or potential
change is opposed to or not in the best interest of the corporation upon consideration of any relevant facts, circumstances, contingencies
or constituencies pursuant to NRS 78.138(4).
Transfer Agent and Registrar
The
transfer agent and registrar for our common stock is EQ Shareowner
Services. The transfer agent and registrar’s address is 1110 Centre Pointe Curve,
Suite 101, Mendota Heights, MN 55120.
Listing
Our
common stock is listed on the Nasdaq Capital Market under
the symbol “SEEL”.
Description
of PRE-FUNDED WARRANTS
The
following summary of certain terms and provisions of the Pre-Funded Warrants that are being offered hereby is not complete and is subject
to, and qualified in its entirety by, the provisions of the Pre-Funded Warrant, the form of which is filed as an exhibit to the registration
statement of which this prospectus forms a part.
Form.
The Pre-Funded Warrants will be issued to the investors as individual warrant agreements. You should review the form of Pre-Funded Warrant,
filed as an exhibit to the registration statement of which this prospectus forms a part, for a complete description of the terms and conditions
applicable to the Pre-Funded Warrants.
Exercisability.
The Pre-Funded Warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise
notice accompanied by payment in full in immediately available funds for the number of shares of our common stock purchased upon such
exercise (except in the case of a cashless exercise as described below). A holder (together with its affiliates) may not exercise any
portion of the Pre-Funded Warrant to the extent that the holder would own more than 4.99% (or, at the election of the holder, 9.99%) of
the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us,
the holder may increase the amount of ownership of outstanding stock after exercising the holder’s Pre-Funded Warrants up to 9.99%
of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership
is determined in accordance with the terms of the Pre-Funded Warrants. Purchasers of Pre-Funded Warrants in this offering may also elect
prior to the issuance of the Pre-Funded Warrants to have the initial exercise limitation set at 9.99% of our outstanding common stock.
No fractional shares of common stock will be issued in connection with the exercise of a Pre-Funded Warrant. In lieu of fractional shares,
we will pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price.
Duration
and Exercise Price. The exercise price per whole share of our common stock purchasable upon the exercise of the Pre-Funded Warrants
is $0.0001 per share of common stock. The Pre-Funded Warrants will be immediately exercisable and may be exercised at any time until the
Pre-Funded Warrants are exercised in full. The exercise price of the Pre-Funded Warrants is subject to appropriate adjustment in the event
of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our common
stock and also upon any distributions of assets, including cash, stock or other property to our stockholders.
Cashless
Exercise. If, at any time after the holder’s purchase of Pre-Funded Warrants, such holder exercises its Pre-Funded Warrants
and a registration statement registering the issuance of the shares of common stock underlying the Pre-Funded Warrants under the Securities
Act is not then effective or available (or a prospectus is not available for the resale of shares of common stock underlying the Pre-Funded
Warrants), then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate
exercise price, the holder shall instead receive upon such exercise (either in whole or in part) only the net number of shares of common
stock determined according to a formula set forth in the Pre-Funded Warrants. Notwithstanding anything to the contrary, in the event we
do not have or maintain an effective registration statement, there are no circumstances that would require us to make any cash payments
or net cash settle the Pre-Funded Warrants to the holders.
Transferability.
Subject to applicable laws, the Pre-Funded Warrants may be offered for sale, sold, transferred or assigned at the option of the holder
upon surrender of the Pre-Funded Warrant to us together with the appropriate instruments of transfer.
Exchange
Listing. We do not plan on applying to list the Pre-Funded Warrants on Nasdaq, any other national securities exchange or any other
nationally recognized trading system.
Fundamental
Transactions. In the event of a fundamental transaction, as described in the Pre-Funded Warrants and generally including any reorganization,
recapitalization or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties
or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding common stock,
or any person or group becoming the beneficial owner of 50% of the voting power represented by our outstanding common stock, the holders
of the Pre-Funded Warrants will be entitled to receive upon exercise of the Pre-Funded Warrants the kind and amount of securities, cash
or other property that the holders would have received had they exercised the Pre-Funded Warrants immediately prior to such fundamental
transaction.
Rights
as a Stockholder. Except by virtue of such holder’s ownership of shares of our common stock, the holder of a Pre-Funded
Warrant does not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder exercises
the Pre-Funded Warrant.
Description
of COMMON WARRANTS
The
following summary of certain terms and provisions of Common Warrants that are being offered hereby is not complete and is subject to,
and qualified in its entirety by, the provisions of the common warrant, the form of which is filed as an exhibit to the registration statement
of which this prospectus forms a part.
Form.
The Common Warrants will be issued to the investors as individual warrant agreements. You should review the form of Common warrant, filed
as an exhibit to the registration statement of which this prospectus forms a part, for a complete description of the terms and conditions
applicable to the Common Warrants.
Exercisability.
The Common Warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise
notice accompanied by payment in full in immediately available funds for the number of shares of our common stock purchased upon such
exercise (except in the case of a cashless exercise as described below). A holder (together with its affiliates) may not exercise any
portion of the Common warrant to the extent that the holder would own more than 4.99% (or, at the election of the holder, 9.99%) of the
outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the
holder may increase the amount of ownership of outstanding stock after exercising the holder’s Common Warrants up to 9.99% of the
number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined
in accordance with the terms of the Common Warrants. Purchasers of Common Warrants in this offering may also elect prior to the issuance
of the Common Warrants to have the initial exercise limitation set at 9.99% of our outstanding common stock. No fractional shares of common
stock will be issued in connection with the exercise of a Common warrant. In lieu of fractional shares, we will pay the holder an amount
in cash equal to the fractional amount multiplied by the exercise price.
Duration
and Exercise Price. The Common Warrants will be exercisable beginning on the effective date of the Warrant Stockholder Approval,
provided however, if the Pricing Conditions are met, the Warrant Stockholder Approval will not be required and the Common Warrants will
be exercisable on the Initial Exercise Date. The Common Warrants will expire five years from the Initial Exercise Date or the Warrant
Stockholder Approval, as applicable. The exercise price per whole share of our common stock purchasable upon the exercise of the Common
Warrants would be $ per share of common stock (or 100% of the assumed offering price per share and accompanying Common Warrants). The
exercise price of the Common Warrants is subject to appropriate adjustment in the event of certain stock dividends and distributions,
stock splits, stock combinations, reclassifications or similar events affecting our common stock and also upon any distributions of assets,
including cash, stock or other property to our stockholders.
Cashless
Exercise. If, at any time after the holder’s purchase of Common Warrants, such holder exercises its Common Warrants and
a registration statement registering the issuance of the shares of common stock underlying the Common Warrants under the Securities Act
is not then effective or available (or a prospectus is not available for the resale of shares of common stock underlying the Common Warrants),
then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise
price, the holder shall instead receive upon such exercise (either in whole or in part) only the net number of shares of common stock
determined according to a formula set forth in the Common Warrants. Notwithstanding anything to the contrary, in the event we do not have
or maintain an effective registration statement, there are no circumstances that would require us to make any cash payments or net cash
settle the Common Warrants to the holders.
Transferability.
Subject to applicable laws, the Common Warrants may be offered for sale, sold, transferred or assigned at the option of the holder upon
surrender of the Common Warrant to us together with the appropriate instruments of transfer.
Exchange
Listing. We do not plan on applying to list the Common Warrants on Nasdaq, any other national securities exchange or any other
nationally recognized trading system.
Fundamental
Transactions. In the event of a fundamental transaction, as described in the Common warrants and generally including any
reorganization, recapitalization or reclassification of our common stock, the sale, transfer or other disposition of all or substantially
all of our properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding
common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by our outstanding common stock,
the holders of the Common warrants will be entitled to receive upon exercise of the Common warrants the kind and amount of securities,
cash or other property that the holders would have received had they exercised the Common warrants immediately prior to such fundamental
transaction. In the case of certain fundamental transactions affecting us, a holder of Common warrants, upon exercise of such warrants
after such fundamental transaction, will have the right to receive, in lieu of shares of our common stock, the same amount and kind of
securities, cash or property that such holder would have been entitled to receive upon the occurrence of the fundamental transaction,
had the Common warrants been exercised immediately prior to such fundamental transaction. In lieu of such consideration, a holder of
Common warrants may instead elect to receive a cash payment based upon the Black-Scholes value of their Common warrants.
Rights
as a Stockholder. Except by virtue of such holder’s ownership of shares of our common stock, the holder of a Common
warrant does not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder exercises
the Common warrant.
PLAN OF DISTRIBUTION
has
agreed to act as our sole Placement Agent in connection with this offering subject to the terms and conditions of the placement agent
agreement dated , 2024. The Placement Agent is not purchasing or selling any of the securities offered by this prospectus, nor is it
required to arrange the purchase or sale of any specific number or dollar amount of securities, but has agreed to use its reasonable
best efforts to arrange for the sale of all of the securities offered hereby. We will enter into a securities purchase agreement (the
“purchase agreement”) directly with the investors who purchase our securities in this offering, at the investors’ option.
Investors who do not enter into the purchase agreement shall rely solely on this prospectus in connection with the purchase of our securities
in this offering.
We expect
this offering to be completed not later than two business days following the commencement of the offering and we will deliver the securities
being issued to each investor upon receipt of such investor’s funds for the purchase of the securities offered pursuant to this
prospectus and we will deliver all securities to be issued in connection with this offering delivery versus payment (DVP)/receipt versus
payment (RVP) upon receipt of investor funds received by us. We expect to deliver the securities being offered pursuant to this prospectus
on or about , 2024.
We have
agreed to indemnify the Placement Agent against specified liabilities, including liabilities under the Securities Act, and to contribute
to payments the Placement Agent may be required to make in respect thereof.
Placement
Agent Fees, Commissions and Expenses
This
offering is being conducted on a reasonable best efforts basis and the Placement Agent has no obligation to buy any of the securities
from us or to arrange for the purchase or sale of any specific number or dollar amount of securities. Upon the closing of this offering,
we will pay the Placement Agent a cash transaction fee equal to __% of the aggregate gross cash proceeds to us from the sale of the securities
in the offering. In addition, we will reimburse the Placement Agent for up to $ for the Placement Agent’s legal fees and up to
$ of the aggregate gross proceeds of the offering for certain reasonable non-accountable fees and expenses.
The
following table shows the public offering price, Placement Agent fees and proceeds, before expenses, to us, assuming the sale of all
the shares of common stock we are offering and no exercise of any warrants.
| |
Per
Share
and
Accompanying
Common
Warrants
| |
Per
Pre-Funded
Warrant and
Accompanying
Common Warrants
| |
| Total | |
Public offering price | |
$ |
| |
$ |
| |
$ | | |
Placement Agent fees | |
$ |
| |
$ |
| |
$ | | |
Proceeds, before expenses, to us | |
$ |
| |
$ |
| |
$ | | |
We estimate
that the total expenses of the offering payable by us, excluding the total Placement Agent fees, will be approximately $ .
Lock-Up Agreements
Our
directors and executive officers have entered into lock-up agreements. Under these agreements, these individuals have agreed,
subject to specified exceptions, not to sell or transfer any shares of common stock or securities convertible into, or exchangeable or
exercisable for, our shares of common stock during a period ending 90 days after the closing of this offering, without first obtaining
the written consent of the Placement Agent. Specifically, these individuals have agreed, in part, not to:
| · | sell,
offer, contract or grant any option to sell (including any short sale), pledge, transfer,
establish an open “put equivalent position” within the meaning of Rule 16a-l(h) under
the Securities Exchange Act of 1934, as amended; |
| · | enter
into any swap or other arrangement that transfers to another, in whole or in part, any of
the economic consequences of ownership of our securities, whether any such transaction is
to be settled by delivery of our shares of common stock, in cash or otherwise; |
| · | make
any demand for or exercise any right with respect to the registration of any of our securities; |
| · | publicly
disclose the intention to make any offer, sale, pledge or disposition, or to enter into any
transaction, swap, hedge; |
| · | or
other arrangement relating to any of our securities. |
Notwithstanding
these limitations, these shares of common stock may be transferred under limited circumstances, including, without limitation, by gift,
will or intestate succession.
In addition,
we have agreed that, subject to certain exceptions, we will not (i) conduct any issuances of our common stock for a period of 45
days following closing of this offering or (ii) enter into a variable rate transaction (as defined in the purchase agreement) for
a period of 90 days following closing of this offering; provided that following the closing date of this offering we will be permitted
to enter into an agreement in connection with an “at the market” offering under Rule 415(a)(4) under the Securities
Act and make sales thereunder.
Regulation M
The
Placement Agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissions
received by it and any profit realized on the resale of the shares sold by it while acting as principal might be deemed to be underwriting
discounts or commissions under the Securities Act. As an underwriter, the Placement Agent would be required to comply with the requirements
of the Securities Act and the Exchange Act, including, without limitation, Rule 415(a)(4) under the Securities Act and Rule 10b-5 and
Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of shares by the Placement
Agent acting as principal. Under these rules and regulations, the Placement Agent:
| · | may
not engage in any stabilization activity in connection with our securities; and |
| · | may
not bid for or purchase any of our securities or attempt to induce any person to purchase
any of our securities, other than as permitted under the Exchange Act, until it has completed
its participation in the distribution. |
Listing
Our
common stock is listed on Nasdaq under the symbol “SEEL”. There is no established public market for the warrants, and we
do not expect a market to develop. In addition, we do not intend to apply for listing of the warrants on any national securities exchange.
Discretionary
Accounts
The
Placement Agent does not intend to confirm sales of the securities offered hereby to any accounts over which they have discretionary
authority.
LEGAL MATTERS
The
validity of the shares of common stock offered by this prospectus will be passed upon for us by Brownstein Hyatt Farber Schreck,
LLP, Las Vegas, Nevada. The validity of the Warrants offered by this prospectus will be passed upon for us by Sullivan &
Worcester LLP, New York, New York. The Placement Agent is being represented by ___, in connection with this offering.
EXPERTS
The consolidated financial statements of Seelos
Therapeutics, Inc. as of December 31, 2023 and 2022, and for each of the years in the two-year period ended December 31,
2023, have been incorporated by reference herein in reliance upon the report of KPMG LLP, independent registered public accounting firm,
incorporated by reference herein, and upon the authority of said firm as experts in accounting and auditing. The audit report covering
the December 31, 2023 consolidated financial statements contains an explanatory paragraph that states that Seelos Therapeutics, Inc.’s
recurring losses from operations and net capital deficiency raises substantial doubt about the entity’s ability to continue as
a going concern. The financial statements do not include any adjustments that might result from the outcome of that uncertainty.
WHERE YOU CAN FIND MORE
INFORMATION
We
have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the securities being offered
by this prospectus. This prospectus, which constitutes a part of the registration statement, does not contain all of the information
in the registration statement of which this prospectus is a part and the exhibits to such registration statement. For further information
with respect to us and the securities offered by this prospectus, we refer you to the registration statement of which this prospectus
is a part and the exhibits to such registration statement. Statements contained in this prospectus as to the contents of any contract
or any other document are not necessarily complete. If a contract or document has been filed as an exhibit to the registration statement,
please see the copy of the contract or document that has been filed. Each statement in this prospectus relating to a contract or document
filed as an exhibit is qualified in all respects by the filed exhibit.
The
SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers,
like us, that file electronically with the SEC. The SEC’s Internet site can be found at http://www.sec.gov. You may also
request a copy of these filings, at no cost, by writing us at 300 Park Avenue, 2nd Floor, New York, New York 10022 or telephoning us
at (646) 293-2100.
We
are subject to the information and reporting requirements of the Exchange Act and, in accordance with this law, file periodic
reports, proxy statements and other information with the SEC. These periodic reports, proxy statements and other information are available
at the website of the SEC referred to above. We also maintain a website at https://seelostherapeutics.com. You may access these
materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. Information
contained on our website is not a part of this prospectus and the inclusion of our website address in this prospectus is an inactive
textual reference only.
DISCLOSURE OF COMMISSION
POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers, and persons controlling
us pursuant to the provisions described in Item 14 of the registration statement of which this prospectus is a part or otherwise, we
have been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and
is therefore unenforceable. In the event that a claim for indemnification against such liabilities (other than our payment of expenses
incurred or paid by our directors, officers, or controlling persons in the successful defense of any action, suit, or proceeding) is
asserted by our directors, officers, or controlling persons in connection with the Securities being registered, we will, unless in the
opinion of our counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by us is against public policy as expressed in the Securities Act and will be governed by the final
adjudication of the issue.
INCORPORATION OF CERTAIN
INFORMATION BY REFERENCE
The
SEC allows us to incorporate by reference the information and reports we file with it, which means that we can disclose important information
to you by referring you to these documents. The information incorporated by reference is an important part of this prospectus.
We are incorporating by reference the documents listed below, which we have already filed with the SEC:
|
(a) |
Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the SEC on March 6, 2024; |
|
(b) |
Our
Annual Report on Form 10-K/A for the fiscal year ended December 31, 2023, as filed with the SEC on April 29, 2024; |
|
(c) |
Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the SEC on May 14, 2024 |
|
(d) |
Our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the SEC on August 14, 2024 |
|
(e) |
The
information specifically incorporated by reference into our Annual Report on Form 10-K for
the fiscal year ended December 31,
2023 from
our Definitive
Proxy Statement on Schedule 14A, as filed with the SEC on April 12, 2023; |
|
(f) |
Our Current Reports on
Form 8-K filed with the SEC on (i) March 19,
2024, (ii) March 28,2024,
(iii) May 3,
2024, (iv) May 14,
2024, (v) May 16,
2024, (vi) May 21,
2024, (vii) June 5,
2024, (viii) July 12,
2024, (ix) July 16,
2024, (x) July 26,
2024, (xi) August 8,
2024, (xii) September 3,
2024, and (xiii) September 24, 2024; and |
|
(g) |
The description of our
common stock set forth in our Registration Statement on Form 8-A (File No. 000-22245), filed with the SEC on April 10,
2000, including any amendments or reports filed for the purpose of updating such description, including the description
of our common stock included as Exhibit 4.12
to our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 6, 2024. |
We also incorporate by reference any future filings
(other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are related
to such items unless such Form 8-K expressly provides to the contrary) made with the SEC pursuant to Sections 13(a), 13(c), 14 or
15(d) of the Exchange Act, including those made after the date of the initial filing of the registration statement of which this
prospectus is a part and prior to effectiveness of such registration statement, until we file a post-effective amendment that indicates
the termination of the offering of the securities made by this prospectus and such future filings will become a part of this prospectus
from the respective dates that such documents are filed with the SEC. Any statement contained herein or in a document incorporated or
deemed to be incorporated by reference herein shall be deemed to be modified or superseded for purposes hereof to the extent that a statement
contained herein or in any other subsequently filed document which is also incorporated or deemed to be incorporated herein modifies
or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded,
to constitute a part of this prospectus.
Documents
incorporated by reference are available from us, without charge. You may obtain documents incorporated by reference in this prospectus
by requesting them in writing or by telephone at the following address:
Seelos Therapeutics, Inc.
300 Park Avenue, 2nd Floor
New York, New York 10022
Telephone: (646) 293-2100
You also may access these filings on our Internet
site at https://seelostherapeutics.com. Our web site and the information contained on that site, or connected to that site,
are not incorporated into this prospectus or the registration statement of which this prospectus is a part.
This
prospectus is part of a registration statement we filed with the SEC. We have incorporated exhibits into the registration statement
of which this prospectus is a part. You should read the exhibits carefully for provisions that may be important to you.
Neither
we nor the Placement Agent has authorized anyone to provide any information or to make any representations other than those
contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We
take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you.
This prospectus is an offer to sell only the securities offered hereby, but only under the circumstances and in the
jurisdictions where it is lawful to do so. The information contained in this prospectus or in any applicable free writing prospectus
is current only as of its date, regardless of its time of delivery or any sale of our Securities. Our business, financial condition,
results of operations and prospects may have changed since that date. We are not making an offer of these securities in any
jurisdiction where such offer is not permitted.
Up
to Shares of Common Stock
Pre-Funded
Warrants to Purchase up to Shares of Common Stock
Common
Warrants to Purchase up to Shares of Common Stock
Sole
Placement Agent
___
PROSPECTUS
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. |
Other Expenses of Issuance and
Distribution |
The
following table sets forth the costs and expenses, other than underwriting discounts and commissions, payable by Seelos Therapeutics, Inc.
(the “Registrant”), in connection with the sale and distribution of the securities being registered. All amounts are estimated
except the Securities and Exchange Commission (the “SEC”) registration fee.
Item |
|
Amount |
|
SEC registration fee |
|
$ |
1771.20 |
|
Legal fees and expenses |
|
$ |
* |
|
Accounting fees and expenses |
|
$ |
* |
|
Printing, transfer agent fees and miscellaneous expenses |
|
$ |
* |
|
Total |
|
$ |
* |
|
* To be provided by amendment
Item 14. |
Indemnification of Directors
and Officers |
The Registrant’s officers and directors
are indemnified under Nevada law, the Registrant’s Amended and Restated Articles of Incorporation, as amended, and its Amended
and Restated Bylaws, as amended, against certain liabilities. The Registrant’s Amended and Restated Articles of Incorporation,
as amended, require the Registrant to indemnify its directors and officers to the fullest extent permitted by the laws of the State of
Nevada in effect from time to time.
Pursuant to its Amended and Restated Articles
of Incorporation, as amended, none of the Registrant’s directors or officers shall be personally liable to the Registrant or its
stockholders for damages for breach of fiduciary duty as a director or officer, except for (1) acts or omissions which involve intentional
misconduct, fraud or a knowing violation of law, or (2) the payment of dividends in violation of the applicable statutes of Nevada.
Further, the Registrant’s Amended and Restated Articles of Incorporation, as amended, provide that if Nevada law is amended to
authorize corporate action further eliminating or limiting the personal liability of directors or officers, the liability of a director
or officer of the Registrant shall be eliminated or limited to the fullest extent permitted by Nevada law, as so amended from time to
time. However, Nevada Revised Statutes 78.138 currently provides that, except as otherwise provided in the Nevada Revised Statutes, a
director or officer shall not be individually liable to the Registrant or its stockholders or creditors for any damages as a result of
any act or failure to act in his or her capacity as a director or officer unless it is proven that (i) the presumption established
by Nevada Revised Statutes 78.138(3) has been rebutted, (ii) the director’s or officer’s acts or omissions constituted
a breach of his or her fiduciary duties as a director or officer, and (iii) such breach involved intentional misconduct, fraud or
a knowing violation of the law.
Pursuant to the Registrant’s Amended and
Restated Articles of Incorporation, as amended, it shall indemnify and hold harmless any person who was or is a party or is threatened
to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative,
by reason of the fact that he or she is or was or has agreed to become a director or officer of the Registrant or is serving at the Registrant’s
request as a director or officer of another entity or enterprise or by reason of actions alleged to have been taken or omitted in such
capacity or in any other capacity while serving as a director or officer, to the fullest extent permitted by applicable law, against
all loss, liability and expenses, including attorneys’ fees, costs, damages, judgments, fines, amounts paid in settlement, and
ERISA excise taxes or penalties, actually and reasonably incurred by or on behalf of such person in connection with such action, suit
or proceeding, including any appeal. This right to indemnification shall continue for any person who has ceased to be a director or officer
and shall inure to the benefit of his or her heirs, next of kin, executors, administrators and legal representatives.
The Registrant’s Amended and Restated Articles
of Incorporation, as amended, also provide that it shall pay the expenses of directors and officers incurred as a party to any threatened,
pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, as they are incurred and in
advance of the final disposition of the action, suit or proceeding, but, if applicable law so requires, only upon receipt by the Registrant
of an undertaking from the director or officer to repay the advanced amounts in the event it is ultimately determined by a final decision,
order or decree of a court of competent jurisdiction that the director or officer is not entitled to be indemnified for such expenses.
The Registrant’s Amended and Restated Bylaws,
as amended, provide that the Registrant shall indemnify and hold harmless, to the fullest extent permitted by the laws of the State of
Nevada, each director or officer of the Registrant who was or is a party to, or is threatened to be made a party to, or is otherwise
involved in, any threatened, pending, or completed action, suit or proceeding (whether civil, criminal, administrative or investigative,
and including, without limitation, an action, suit or proceeding by or in the right of the Registrant), by reason of the fact that he
or she is or was a director or officer of the Registrant or is or was serving in any capacity at the request of the Registrant as a director,
officer, employee, agent, partner, member, manager or fiduciary of, or in any other capacity for, another corporation or any partnership,
joint venture, limited liability company, trust or other enterprise. Such indemnification shall be against all expense, liability and
loss (including, without limitation, attorneys’ fees, judgments, fines, taxes, penalties and amounts paid or to be paid in settlement)
reasonably incurred or suffered by such director or officer in connection with any such action, suit or proceeding; provided that such
director or officer either is not liable pursuant to Nevada Revised Statutes 78.138 or acted in good faith and in a manner he or she
reasonably believed to be in or not opposed to the best interests of the Registrant, and with respect to any such action, suit or proceeding
that is criminal in nature, had no reasonable cause to believe that his or her conduct was unlawful. No such indemnification shall be
made to or on behalf of any such director or officer if a final adjudication establishes that his or her acts or omissions involved intentional
misconduct, fraud or a knowing violation of law and was material to the cause of action, or for any expenses of such director or officer
incurred in his or her capacity as a stockholder. The Amended and Restated Bylaws, as amended, also require that the expenses of such
directors and officers must be paid by the Registrant (or through insurance maintained, or other financial arrangements made, by the
Registrant) as such expenses are incurred and in advance of the final disposition of such action, suit or proceeding, upon receipt of
an undertaking by or on behalf of such director or officer to repay the amount if it is ultimately determined by a court of competent
jurisdiction that he or she is not entitled to be indemnified by the Registrant. Any indemnification of directors and officers under
the Amended and Restated Bylaws, as amended, shall inure to the benefit of their respective heirs, executors and administrators.
Section 78.7502 of the Nevada Revised Statutes
permits a corporation to indemnify, pursuant to that statutory provision, a present or former director, officer, employee or agent of
the corporation, or of another entity or enterprise (including as a manager of a limited liability company), for which such person is
or was serving in such capacity at the request of the corporation, who was or is a party or is threatened to be made a party to any threatened,
pending or completed action, suit or proceeding, except an action by or in the right of the corporation, against expenses, including
attorneys’ fees, judgments, fines and amounts paid in settlement actually and reasonably incurred in connection therewith, arising
by reason of such person’s service in such capacity if such person (i) is not liable pursuant to Section 78.138 of the
Nevada Revised Statutes, or (ii) acted in good faith and in a manner which he or she reasonably believed to be in or not opposed
to the best interests of the corporation and, with respect to a criminal action or proceeding, had no reasonable cause to believe his
or her conduct was unlawful. In the case of actions brought by or in the right of the corporation, however, no indemnification pursuant
to Section 78.7502 of the Nevada Revised Statutes may be made for any claim, issue or matter as to which such person has been adjudged
by a court of competent jurisdiction, after exhaustion of all appeals therefrom, to be liable to the corporation or for amounts paid
in settlement to the corporation, unless and only to the extent that the court in which the action or suit was brought or other court
of competent jurisdiction determines upon application that in view of all the circumstances of the case, such person is fairly and reasonably
entitled to indemnity for such expenses as the court deems proper.
Any discretionary indemnification pursuant to
Section 78.7502 of the Nevada Revised Statutes, unless ordered by a court or advanced to a director or officer by the corporation
in accordance with the Nevada Revised Statutes, may be made by a corporation only as authorized in each specific case upon a determination
that indemnification of the director, officer, employee or agent is proper in the circumstances. Such determination must be made (1) by
the stockholders, (2) by the board of directors by majority vote of a quorum consisting of directors who were not parties to the
action, suit or proceeding, (3) if a majority vote of a quorum consisting of directors who were not parties to the action, suit
or proceeding so orders, by independent legal counsel in a written opinion, or (4) if a quorum consisting of directors who were
not parties to the action, suit or proceeding cannot be obtained, by independent legal counsel in a written opinion.
Section 78.751 of the Nevada Revised Statutes
further provides that indemnification pursuant to Section 78.7502 of the Nevada Revised Statutes does not exclude any other rights
to which a person seeking indemnification or advancement of expenses may be entitled under the Registrant’s Amended and Restated
Articles of Incorporation, as amended, or any bylaw, agreement, vote of stockholders or disinterested directors or otherwise, for either
an action in the person’s official capacity or an action in another capacity while holding office, except that indemnification,
unless ordered by a court pursuant to Section 78.7502 of the Nevada Revised Statutes or for the advancement of expenses, may not
be made to or on behalf of any director or officer finally adjudged by a court of competent jurisdiction, after exhaustion of any appeals,
to be liable for intentional misconduct, fraud or a knowing violation of law, and such misconduct, fraud or violation was material to
the cause of action.
The Registrant maintains a general liability
insurance policy that covers certain liabilities of directors and officers of the Registrant arising out of claims based on acts or omissions
in their capacities as directors or officers.
See also the undertakings set out in response to Item 17 herein.
Item 15. |
Recent Sales of Unregistered
Securities. |
Since
September 1, 2021, the Registrant has issued the following securities that were not registered under the Securities Act of
1933, as amended (the “Securities Act”) (all share amounts have been retrospectively adjusted to reflect a 30-for-1 reverse
stock split that was effected on November 28, 2023):
(1) On
November 24, 2021, the Registrant issued 85,676 shares of common stock to iX Biopharma Europe Limited (“iX Biopharma”)
as partial consideration pursuant that certain exclusive license agreement, dated as of November 24, 2021.
The
shares of common stock were offered and sold to iX Biopharma in a transaction exempt from registration under the Securities Act
in reliance on Section 4(a)(2) thereof and Rule 506(b) of Regulation D thereunder. iX Biopharma represented that
it was an “accredited investor,” as defined in Regulation D, and was acquiring the shares of common stock for investment
only and not with a view towards, or for resale in connection with, the public sale or distribution thereof.
(2) On
November 23, 2021, the Registrant issued and sold to Lind Global Asset Management V, LLC (“Lind”) in, a
private placement, in exchange for the payment by Lind of $20,000,000, (a) the Note and (b) 17,826 shares of common stock.
The
shares of common stock were offered and sold or will be offered and sold, as applicable, to Lind on November 23, 2021 in
a transaction exempt from registration under the Securities Act in reliance on Section 4(a)(2) thereof and Rule 506(b) of
Regulation D thereunder. Lind represented that it was an “accredited investor,” as defined in Regulation D, and was acquiring
the Securities for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof.
(3) On
April 11, 2022, the Registrant issued 16,667 shares of common stock to Phoenixus AG f/k/a Vyera Pharmaceuticals AG (“Vyera”)
pursuant to an amendment to that certain Asset Purchase Agreement by and between the Regitrant and Vyera, dated March 6, 2018 (as
amended by a first amendment thereto entered into on May 18, 2018, a second amendment thereto entered into on December 31,
2018, a third amendment thereto entered into on October 15, 2019 and a fourth amendment thereto entered into on February 15,
2021) as partial consideration. The Registrant also agreed to issue to Vyera on or before July 11, 2022 an additional 16,667 shares
of common stock and issue to Vyera on or before January 11, 2023 an additional number of shares of common stock equal to $1,000,000
divided by the volume weighted average closing price of the common stock for the ten consecutive trading days ending on the fifth trading
day prior to the applicable date of issuance of the shares of common stock.
The
shares of common stock were offered and issued, or would be issued, to Vyera in transactions exempt from registration, in reliance
on Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation D thereunder.
(4) On
August 30, 2022, the Registrant entered into a consulting agreement with an advisory firm, pursuant to which the advisory firm agreed
to provide the Registrant with certain management consulting, business and advisory services. As partial consideration for the services,
the Registrant issued the advisory firm 3,334 unregistered shares of common stock on August 30, 2022.
The
issuance of the shares of common stock was not registered under the Securities Act in reliance upon the exemption from registration
provided by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated by the SEC, and in reliance
on similar exemptions under applicable state laws. Appropriate legends were affixed to the shares of common stock. The advisory firm
had adequate access, through employment, business or other relationships, to information about the Company. In connection with the foregoing
issuance, the advisory firm represented to the us that it was an accredited investor and was acquiring the shares of common stock for
investment purposes only and not with a view to, or for sale in connection with, any distribution thereof and that it could bear the
risks of the investments and could hold the securities for an indefinite period of time. In connection with the foregoing issuance, the
advisory firm received written disclosures that the securities had not been registered under the Securities Act and that any resale must
be made pursuant to a registration statement or an available exemption from the registration requirements of the Securities Act. The
shares are deemed restricted securities for purposes of the Securities Act. There were no underwriters employed in connection with this
transaction.
(5) On
June 1, 2022, the Registrant entered into a consulting agreement with an advisory firm, pursuant to which the advisory firm agreed
to provide the Registrant with certain management consulting, business and advisory services. As partial consideration for the services,
the Registrant issued the advisory firm 3,334 unregistered shares of common stock on June 1, 2022.
The
issuance of the shares of common stock was not registered under the Securities Act in reliance upon the exemption from registration
provided by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated by the SEC, and in reliance
on similar exemptions under applicable state laws.
Appropriate
legends were affixed to the shares of common stock. The advisory firm had adequate access, through employment, business or other
relationships, to information about the Registrant. In connection with the foregoing issuance, the advisory firm represented to the Registrant
that it was an accredited investor and was acquiring the shares of common stock for investment purposes only and not with a view to,
or for sale in connection with, any distribution thereof and that it could bear the risks of the investments and could hold the securities
for an indefinite period of time. In connection with the foregoing issuance, the advisory firm received written disclosures that the
securities had not been registered under the Securities Act and that any resale must be made pursuant to a registration statement or
an available exemption from the registration requirements of the Securities Act. The shares of common stock are deemed restricted securities
for purposes of the Securities Act. There were no underwriters employed in connection with this transaction.
(6) On
February 9, 2023, the Registrant entered into a consulting agreement with an advisory firm, pursuant to which the advisory firm
agreed to provide the Registrant with certain management consulting, business and advisory services. As partial consideration for the
services, the Registrant issued the advisory firm 1,667 unregistered shares of common stock on February 9, 2023.
The
issuance of the shares of common stock was not registered under the Securities Act in reliance upon the exemption from registration
provided by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated by the SEC, and in reliance
on similar exemptions under applicable state laws.
Appropriate
legends were affixed to the shares of commons stock. The advisory firm had adequate access, through employment, business or other relationships,
to information about the Registrant. In connection with the foregoing issuance, the advisory firm represented to us that it was an accredited
investor and was acquiring the shares of common stock for investment purposes only and not with a view to, or for sale in connection
with, any distribution thereof and that it could bear the risks of the investments and could hold the securities for an indefinite period
of time. In connection with the foregoing issuance, the advisory firm received written disclosures that the securities had not been registered
under the Securities Act and that any resale must be made pursuant to a registration statement or an available exemption from the registration
requirements of the Securities Act. The shares of common stock are deemed restricted securities for purposes of the Securities Act. There
were no underwriters employed in connection with this transaction.
(7) On
May 19, 2023, the Registrant issued to Lind 33,334 shares of common stock (the “May Consideration Shares”)
as consideration for entering into that certain Amendment No. 3 to the Note (“Amendment No. 3”).
The May Consideration Shares were offered
and sold to Lind in a transaction exempt from registration in reliance on Section 4(a)(2) of the Securities Act and Rule 506(b) of
Regulation D thereunder. Lind represented that it was an “accredited investor,” as defined in Regulation D, and was acquiring
the applicable securities for investment only and not with a view towards, or for resale in connection with, the public sale or distribution
thereof.
(8) On
May 19, 2023, the Registrant issued common stock warrants to purchase up to an aggregate of 133,334 shares of common stock
(the “May Warrants”) as consideration to certain purchasers who entered into that certain Amendment No. 1 (the
“Purchase Agreement Amendment”) to that certain Securities Purchase Agreement, dated as of March 14, 2023 (the “Securities
Purchase Agreement”), pursuant to which the purchasers agreed to, among other things, waive certain restrictions on issuing and
registering shares of common stock contained within the Securities Purchase Agreement to permit the Registrant to make the certain payments
of accrued interest and monthly payments of the outstanding principal amount payable by the Company pursuant to the Note for the months
of May, June, July, August and September 2023 in a combination of cash and shares of common stock as contemplated in Amendment
No. 3 and to issue the May Consideration Shares to the Lind.
The exercise price of the May Warrants is
$31.80 per share, subject to adjustment as provided therein, and the May Warrants will be exercisable beginning on the six
month anniversary of the issuance date and will expire on the date that is five and a half years following the original issuance date.
The
May Warrants and the shares of common stock issuable upon exercise of the May Warrants were offered and sold to the
Purchasers in a transaction exempt from registration in reliance on Section 4(a)(2) of the Securities Act and Rule 506(b) of
Regulation D thereunder. Each Purchaser represented that it was an “accredited investor,” as defined in Regulation D, and
was acquiring the applicable securities for investment only and not with a view towards, or for resale in connection with, the public
sale or distribution thereof.
(9) Between
January 23, 2023 and September 20, 2024, the Registrant issued the following shares of common stock to Lind to satisfy
principal and interest payments under the Note:
(a) 6,221
shares of common stock on January 23, 2023 to satisfy principal payments at a repayment share price of $147.36 per share,
(b) 516
shares of common stock on January 31, 2023 to satisfy interest payments at a repayment share price of $161.12 per share,
(c) 5,968
shares of common stock on February 23, 2023 to satisfy principal payments thereunder at a repayment share price of $153.60
per share,
(d) 488
shares of common stock on February 28, 2023 to satisfy interest payments thereunder at a repayment share price of $152.14
per share,
(e) 2,833
shares of common stock on May 23, 2023 to satisfy principal payments thereunder at a repayment share price of $146.88 per
share,
(f) 419
shares of common stock on May 31, 2023 to satisfy interest payments thereunder at a repayment share price of $172.27 per
share,
(g) 2,143
shares of common stock on June 23, 2023 to satisfy principal payments thereunder at a repayment share price of $194.15 per
share,
(h) 343
shares of common stock on June 30, 2023 to satisfy interest payments thereunder at a repayment share price of $200.85 per
share,
(i) 1,650
shares of common stock on July 24, 2023 to satisfy principal payments thereunder at a repayment share price of $252.23 per
share,
(j) 255
shares of common stock on August 1, 2023 to satisfy interest payments thereunder at a repayment share price of $261.98 per
share,
(k) 1,680
shares of common stock on August 23, 2023 to satisfy principal payments thereunder at a repayment share price of $247.67
per share,
(l) 270
shares of common stock on August 31, 2023 to satisfy interest payments thereunder at a repayment share price of $231.60 per
share,
(m) 7,821
shares of common stock on October 5, 2023 to satisfy principal payments thereunder at a repayment share price of $35.28 per
share,
(n) 21,520
shares of common stock on November 9, 2023 to satisfy principal payments thereunder at a repayment share price of $35.52
per share,
(o) 4,801
shares of common stock on November 9, 2023 to satisfy interest payments thereunder at a repayment share price of $35.52 per
share,
(p) 60,216
shares of common stock on January 12, 2024 to satisfy principal and interest payments thereunder at a repayment share price
of $9.63 per share,
(q) 112,410
shares of common stock on February 15, 2024 to satisfy principal payments thereunder at a repayment share price of $5.56
per share,
(r) 84,135
shares of common stock on March 25, 2024 to satisfy principal payments thereunder at a repayment share price of $3.74 per
share,
(s) 85,366
shares of common stock on April 10, 2024 to satisfy principal and interest payments thereunder at a repayment share price
of $3.61 per share,
(t) 83,742
shares of common stock on April 23, 2024 to satisfy principal and interest payments thereunder at a repayment share price
of $2.45 per share,
(u) 96,939
shares of common stock on May 3, 2024 to satisfy principal and interest payments thereunder at a repayment share price of
$1.96 per share,
(v) 53,648
shares of common stock on May 14, 2024 to satisfy principal and interest payments thereunder at a repayment share price of
$1.86 per share,
(w) 125,709
shares of common stock on May 28, 2024 to satisfy principal and interest payments thereunder at a repayment share price of
$1.23 per share,
(x) 126,213
shares of common stock on June 4, 2024 to satisfy principal and interest payments thereunder at a repayment share price of
$1.03 per share, and
(y) 126,666
shares of common stock on June 13, 2024 to satisfy principal and interest payments thereunder at a repayment share price
of $0.900 per share.
(z) 127,364
shares of common stock on June 20, 2024 to satisfy principal and interest payments thereunder at a repayment share price
of $0.793 per share.
(aa)
127,009 shares of common stock on June 25, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.622 per share.
(ab)
126,908 shares of common stock on July 1, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.524 per share.
(ac)
127,236 shares of common stock on July 3, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.503 per share.
(ad)
127,083 shares of common stock on July 9, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.480 per share.
(ae)
382,217 shares of common stock on July 10, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.480 per share.
(af)
181,434 shares of common stock on July 16, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.474 per share.
(ag)
181,415 shares of common stock on July 22, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.452 per share.
(ah)
181,705 shares of common stock on July 25, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.434 per share.
(ai)
142,144 shares of common stock on July 29, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.401 per share.
(aj)
142,241 shares of common stock on August 1, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.401 per share.
(ak)
142,736 shares of common stock on August 5, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.296 per share.
(al)
142,292 shares of common stock on August 7, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.253 per share.
(am)
140,888 shares of common stock on August 9, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.225 per share.
(an)
141,203 shares of common stock on August 13, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.216 per share.
(ao)
297,142 shares of common stock on August 15, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.210 per share.
(ap)
296,904 shares of common stock on August 16, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.210 per share.
(aq)
297,238 shares of common stock on August 20, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.210 per share.
(ar)
297,238 shares of common stock on August 22, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.210 per share.
(as)
338,095 shares of common stock on August 30, 2024 to satisfy principal and interest payments thereunder at a repayment share
price of $0.210 per share.
(as)
347,826 shares of common stock on September 4, 2024 to satisfy principal and interest payments thereunder at a repayment
share price of $0.207 per share.
(at)
346,733 shares of common stock on September 6, 2024 to satisfy principal and interest payments thereunder at a repayment
share price of $0.199 per share.
(au)
345,744 shares of common stock on September 10, 2024 to satisfy principal and interest payments thereunder at a repayment
share price of $0.188 per share.
(av)
344,252 shares of common stock on September 12, 2024 to satisfy principal and interest payments thereunder at a repayment
share price of $0.174 per share.
(aw)
347,305 shares of common stock on September 17, 2024 to satisfy principal and interest payments thereunder at a repayment
share price of $0.167 per share.
(ax)
347,590 shares of common stock on September 18, 2024 to satisfy principal and interest payments thereunder at a repayment
share price of $0.166 per share.
(ay) 348,192 shares
of Common Stock on September 20, 2024 to satisfy principal and interest payments thereunder at a repayment share price of $0.166
per share.
These shares were issued in transactions exempt
from registration under the Securities Act, in reliance on Section 4(a)(2) thereof and Rule 506(b) of Regulation
D thereunder.
(10) On
January 30, 2024, the Registrant issued warrants to purchase up to 425,532 shares of common stock in a private placement to certain
institutional investors. Pursuant to a securities purchase agreement, dated as of January 26, 2024, by and among the Registrant
and certain institutional investors (the “January 2024 SPA”), the Registrant also issued and sold an aggregate of 425,532
shares of common stock in a registered direct offering, where the shares were offered by the Registrant pursuant to its shelf registration
statement on Form S-3 filed with the SEC on December 18, 2023. Pursuant to the January 2024 SPA, the combined purchase
price for one share and one warrant to purchase one share of common stock in the registered offering and concurrent private placement
was $9.40. The Registrant received total gross proceeds of approximately $4.0 million, before deducting the placement agent’s fees
of approximately $0.3 million. The warrants have an exercise price of $8.40 per share of common stock, are currently exercisable and
will expire five and a half years following the date of issuance. A.G.P./Alliance Global Partners acted as the Registrant’s placement
agent for the offering.
(11) On
May 16, 2024, the Registrant issued warrants to purchase up to 924,414 shares of common stock in a private placement to certain
institutional investors. Pursuant to a securities purchase agreement, dated May 16, 2024, by and among the Registrant and certain
institution investors (the “May 2024 SPA”), the Registrant also issued and sold an aggregate of 380,968 shares of common
stock and pre-funded warrants to purchase up to 81,239 shares of common stock in a registered direct offering, where the shares were
offered by the Registrant pursuant to its shelf registration statement on Form S-3 filed with the SEC on December 18, 2023.
Pursuant to the May 2024 SPA, the combined purchase price for one Share and accompanying Common Warrants to purchase two shares
of common stock for each Share purchased was $2.46, and the combined purchase price for one Pre-Funded Warrant to purchase one share
of common stock and accompanying Common Warrants to purchase two shares of common stock for each share of common stock issuable upon
exercise of a purchased Pre-Funded Warrant was $2.459. The Registrant received total gross proceeds of approximately $1.1 million, before
deducting the placement agent fees and estimated offering expenses payable by the Registrant. The warrants have an exercise price of
$2.21 per share of common stock, are currently exercisable and will expire five years following the date of issuance. Roth Capital Partners,
LLC acted as the Registrant’s placement agent for the offering.
The
warrants and the shares of common stock issuable upon exercise of the warrants were offered and sold to purchasers in a transaction
exempt from registration in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act
and Rule 506(b) of Regulation D promulgated by the SEC.
Appropriate legends were affixed to the warrants
issued in the transaction.
All purchasers of the warrants in the above transaction
exempt from registration pursuant to Section 4(a)(2) of the Securities Act represented to the Registrant that they were accredited
investors and were acquiring the shares for investment purposes only and not with a view to, or for sale in connection with, any distribution
thereof and that they could bear the risks of the investment and could hold the securities for an indefinite period of time. The purchasers
received written disclosures that the securities had not been registered under the Securities Act and that any resale must be made pursuant
to a registration statement or an available exemption from the registration requirements of the Securities Act.
The warrants are deemed restricted securities
for purposes of the Securities Act. There were no underwriters employed in connection with the above transaction.
Item 16. |
Exhibits and Financial Statement
Schedules. |
(a) Exhibits
EXHIBITS
NO. |
DESCRIPTION |
|
|
2.1+ |
Agreement
and Plan of Merger and Reorganization, dated July 30, 2018, by and among the Company, Arch Merger Sub, Inc. and Seelos
Therapeutics, Inc. (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K
filed with the Securities and Exchange Commission on July 30, 2018). |
|
|
2.2 |
Amendment
No. 1 Agreement and Plan of Merger and Reorganization, dated October 16, 2018, by and among the Company, Arch Merger Sub, Inc.
and Seelos Therapeutics, Inc. (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on
Form 8-K filed with the Securities and Exchange Commission on October 17, 2018). |
|
|
2.3 |
Amendment
No. 2 Agreement and Plan of Merger and Reorganization, dated December 14, 2018, by and among the Company, Arch Merger Sub, Inc.
and Seelos Therapeutics, Inc. (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on
Form 8-K filed with the Securities and Exchange Commission on December 14, 2018). |
|
|
2.4 |
Amendment
No. 3 Agreement and Plan of Merger and Reorganization, dated January 16, 2019, by and among the Company, Arch Merger Sub, Inc.
and Seelos Therapeutics, Inc. (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on
Form 8-K filed with the Securities and Exchange Commission on January 16, 2019). |
|
|
2.5+ |
Asset
Purchase Agreement, dated February 15, 2019, by and between the Company and Bioblast Pharma Ltd. (incorporated herein by reference
to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 19,
2019). |
|
|
3.1 |
Amended
and Restated Articles of Incorporation of the Company (incorporated herein by reference to Exhibit 2.1 to the Company’s
Registration Statement on Form 10-SB filed with the Securities and Exchange Commission on March 14, 1997). |
|
|
3.2 |
Certificate
of Amendment to Articles of Incorporation of the Company, dated June 22, 2000 (incorporated herein by reference to Exhibit 3.2
to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2003). |
3.3 |
Certificate
of Amendment to Articles of Incorporation of the Company, dated June 14, 2005 (incorporated herein by reference to Exhibit 3.4
to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2006). |
|
|
3.4 |
Certificate
of Amendment to Amended and Restated Articles of Incorporation of the Company, dated March 3, 2010 (incorporated herein by reference
to Exhibit 3.6 to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31,
2010). |
|
|
3.5 |
Certificate
of Correction to Certificate of Amendment to Amended and Restated Articles of Incorporation of the Company, dated March 3, 2010
(incorporated herein by reference to Exhibit 3.7 to the Company’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission on March 31, 2010). |
|
|
3.6 |
Certificate
of Designation for Series D Junior-Participating Cumulative Preferred Stock (incorporated herein by reference to Exhibit 3.1
to the Company’s Current Report on Form 8-A filed with the Securities and Exchange Commission on March 24, 2011). |
|
|
3.7 |
Certificate
of Change filed with the Nevada Secretary of State (incorporated herein by reference to Exhibit 3.1 to the Company’s Current
Report on Form 8-K filed with the Securities and Exchange Commission on June 17, 2010). |
|
|
3.8 |
Certificate
of Amendment to Amended and Restated Articles of Incorporation of the Company, dated September 10, 2010 (incorporated herein
by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission
on September 10, 2010). |
|
|
3.9 |
Certificate
of Withdrawal of Series D Junior Participating Cumulative Preferred Stock, dated May 15, 2013 (incorporated herein by reference
to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 16,
2013). |
|
|
3.10 |
Certificate
of Change filed with the Nevada Secretary of State (incorporated herein by reference to Exhibit 3.1 to the Company’s Current
Report on Form 8-K filed with the Securities and Exchange Commission on October 25, 2016). |
|
|
3.11 |
Certificate
of Amendment filed with the Nevada Secretary of State (incorporated herein by reference to Exhibit 3.10 to the Company’s
Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 2, 2017). |
|
|
3.12 |
Certificate
of Amendment filed with the Nevada Secretary of State (incorporated herein by reference to Exhibit 3.12 to the Company’s
Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2018). |
|
|
3.13 |
Certificate
of Amendment related to the Share Increase Amendment, filed January 23, 2019 (incorporated herein by reference to Exhibit 3.1
to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 24, 2019
at 8:05 Eastern Time). |
|
|
3.14 |
Certificate
of Amendment related to the Name Change, filed January 23, 2019 (incorporated herein by reference to Exhibit 3.2 to the
Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 24, 2019 at 8:05
Eastern Time). |
|
|
3.15 |
Certificate
of Correction to Certificate of Amended and Restated Articles of Incorporation of the Company, dated March 25, 2020 (incorporated
herein by reference to Exhibit 3.16 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on May 7, 2020) |
3.16 |
Certificate
of Amendment to the Amended and Restated Articles of Incorporation of the Company, filed May 18, 2020 (incorporated herein by
reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission
on May 19, 2020). |
|
|
3.17 |
Certificate
of Correction to Certificate of Amended and Restated Articles of Incorporation of the Company, filed May 20, 2020 (incorporated
herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange
Commission on May 21, 2020). |
|
|
3.18 |
Certificate
of Amendment to the Amended and Restated Articles of Incorporation of the Company, filed May 21, 2021 (incorporated herein by
reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission
on May 21, 2021). |
|
|
3.19 |
Certificate
of Amendment to the Amended and Restated Articles of Incorporation of the Company, filed May 18, 2023 (incorporated herein by
reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission
on May 19, 2023). |
|
|
3.20 |
Certificate
of Change filed with the Secretary of State of the State of Nevada (incorporated herein by reference to Exhibit 3.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on November 28, 2023). |
|
|
3.21 |
Certificate
of Change filed with the Secretary of State of the State of Nevada (incorporated herein by reference to Exhibit 3.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on May 16, 2024). |
|
|
3.22 |
Certificate
of Amendment to the Amended and Restated Articles of Incorporation of the Company, filed January 10, 2024 (incorporated by reference
to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 10,
2024). |
|
|
3.23 |
Amended
and Restated Bylaws, effective as of March 23, 2023 (incorporated herein by reference to Exhibit 3.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on March 24, 2023). |
|
|
4.1 |
Form of
Common Stock Certificate (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K
filed with the Securities and Exchange Commission on March 24, 2011). |
|
|
4.2 |
Form of
Warrant issued to the lenders under the Loan and Security Agreement, dated as of October 17, 2014, by and among the Company,
NexMed (U.S.A.), Inc., NexMed Holdings, Inc. and Apricus Pharmaceuticals USA, Inc., as borrowers, Oxford Finance LLC,
as collateral agent, and the lenders party thereto from time to time including Oxford Finance LLC and Silicon Valley Bank (incorporated
herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange
Commission on October 20, 2014). |
|
|
4.3 |
Form of
Wainwright Warrant (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed
with the Securities and Exchange Commission on September 21, 2018). |
|
|
4.4 |
Form of
Investor Warrants (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed
with the Securities and Exchange Commission on October 17, 2018). |
4.5 |
Form of
Series A Warrant, issued to investors on January 31, 2019 (incorporated herein by reference to Exhibit 4.1 to the
Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 6, 2019). |
|
|
4.6 |
Form of
Warrant, issued to investors on September 9, 2020 (incorporated herein by reference to Exhibit 4.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on September 9, 2020). |
|
|
4.7 |
Form of
Convertible Promissory Note due November 23, 2024 (incorporated herein by reference to Exhibit 4.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission at 7:27 a.m. Eastern Time on November 24,
2021). |
|
|
4.8 |
Amendment
to Convertible Promissory Note, by and between Seelos Therapeutics, Inc. and Lind Global Asset Management V, LLC, dated
December 10, 2021 (incorporated by reference to Exhibit 4.22 to the Company’s Form 10-K filed with the Securities
and Exchange Commission on March 4, 2022). |
|
|
4.9 |
Amendment
No. 2 to Convertible Promissory Note, by and between Seelos Therapeutics, Inc. and Lind Global Asset Management
V, LLC, dated February 8, 2023 (incorporated herein by reference to Exhibit 4.14 to the Company’s Annual Report on
Form 10-K filed with the Securities and Exchange Commission on March 10, 2023). |
|
|
4.10 |
Amendment
No. 3 to Convertible Promissory Note, by and between Seelos Therapeutics, Inc. and Lind Global Asset Management V, LLC,
dated May 19, 2023 (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K
filed with the Securities and Exchange Commission on May 19, 2023). |
|
|
4.11 |
Amendment
No. 4 to Convertible Promissory Note and Amendment to Letter Agreement, by and between Seelos Therapeutics, Inc. and Lind
Global Asset Management V, LLC, effective September 30, 2023 (incorporated herein by reference to Exhibit 4.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on October 2, 2023). |
|
|
4.12 |
Amendment
No. 5 to Convertible Promissory Note, by and between Seelos Therapeutics, Inc. and Lind Global Asset Management V, LLC,
effective March 27, 2024 (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K
filed with the Securities and Exchange Commission on March 28, 2024). |
|
|
4.13 |
Amendment
No. 6 to Convertible Promissory Note, by and between Seelos Therapeutics, Inc. and Lind Global Asset Management V, LLC,
effective May 1, 2024 (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K
filed with the Securities and Exchange Commission on May 3, 2024). |
4.14 |
Amendment
No. 7 to Convertible Promissory Note, by and between Seelos Therapeutics, Inc. and Lind Global Asset Management V, LLC,
effective June 1, 2024 (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K
filed with the Securities and Exchange Commission on June 5, 2024). |
|
|
4.15 |
Amendment
No. 8 to Convertible Promissory Note, by and between Seelos Therapeutics, Inc. and Lind Global Asset Management V, LLC,
effective July 16, 2024 (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K
filed with the Securities and Exchange Commission on July 16, 2024). |
|
|
4.16 |
Form of
Common Stock Warrant, dated March 14, 2023 (incorporated herein by reference to Exhibit 4.2 to the Company’s Current
Report on Form 8-K filed with the Securities and Exchange Commission on March 14, 2023). |
|
|
4.17 |
Form of
Common Stock Warrant, dated May 19, 2023 (incorporated herein by reference to Exhibit 4.2 to the Company’s Current
Report on Form 8-K filed with the Securities and Exchange Commission on May 19, 2023). |
|
|
4.18 |
Form of
Common Stock Warrant, dated December 1, 2023 (incorporated herein by reference to Exhibit 4.2 to the Company’s Current
Report on Form 8-K filed with the Securities and Exchange Commission on November 30, 2023). |
|
|
4.19 |
Form of
Common Warrant (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K
filed with the Securities and Exchange Commission on January 30, 2024). |
|
|
4.20 |
Form of
Common Stock Warrant, dated May 21, 2024 (incorporated herein by reference to Exhibit 4.2 to the Company’s Current
Report on Form 8-K filed with the Securities and Exchange Commission on May 21, 2024). |
|
|
4.21 |
Form of
Common Stock Warrant, dated July 12, 2024 (incorporated herein by reference to Exhibit 4.1 to the Company’s Current
Report on Form 8-K filed with the Securities and Exchange Commission on July 12, 2024). |
|
|
4.22 |
Form of
Placement Agent Warrant, dated July 12, 2024 (incorporated herein by reference to Exhibit 4.2 to the Company’s Current
Report on Form 8-K filed with the Securities and Exchange Commission on July 12, 2024). |
|
|
4.23< |
Form of
Pre-Funded Warrant |
|
|
4.24< |
Form of
Common Warrant |
|
|
5.1< |
Opinion
of Brownstein Hyatt Farber Schreck, LLP. |
|
|
5.2< |
Opinion
of Sullivan & Worcester LLP. |
|
|
10.1 |
Form of
CVR Agreement (incorporated by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on July 30, 2018). |
|
|
10.2 |
Form of
Indemnification Agreement for the Company’s Directors and Officers (incorporated by reference
to Exhibit 10.32 of the Company’s Registration Statement on Form S-4 filed on August 31, 2018). |
|
|
10.3† |
License
Agreement, dated September 21, 2016, by and among Seelos Therapeutics, Inc., Ligand Pharmaceuticals Incorporated, Neurogen
Corporation and CyDex Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.33
of the Company’s Registration Statement on Form S-4 filed on August 31, 2018). |
|
|
10.4 |
Amendment
to License Agreement, dated as of February 8, 2019, by and among Ligand Pharmaceuticals Incorporated, Neurogen Corporation,
CyDex Pharmaceuticals, Inc., and Seelos Corporation (incorporated herein by reference to Exhibit 10.30 to the Company’s
Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 17, 2020). |
|
|
10.5 |
Indemnity
Agreement, dated July 8, 2016, by and between Seelos Therapeutics, Inc. and Raj Mehra, Ph.D. (incorporated
by reference to Exhibit 10.36 of the Company’s Registration Statement on Form S-4 filed on August 31, 2018). |
|
|
10.6# |
Seelos
Therapeutics, Inc. 2016 Equity Incentive Plan (incorporated by reference to Exhibit 10.39
of the Company’s Registration Statement on Form S-4 filed on August 31, 2018). |
10.7# |
Form of
Option Agreement under the Seelos Therapeutics, Inc. 2016 Equity Incentive Plan (incorporated
by reference to Exhibit 10.40 of the Company’s Registration Statement on Form S-4 filed on August 31, 2018). |
|
|
10.8#* |
Non-Employee
Director Compensation Policy. |
|
|
10.9# |
Seelos
Therapeutics, Inc. 2019 Inducement Plan (incorporated herein by reference to Exhibit 10.1 to the Company’s Current
Report on Form 8-K filed with the Securities and Exchange Commission on August 14, 2019). |
|
|
10.10# |
Form of
Stock Option Agreement under the Seelos Therapeutics, Inc. 2019 Inducement Plan (incorporated herein by reference to Exhibit 4.3
to the Company’s Registration Statement on Form S-8 filed with the Securities and Exchange Commission on August 15,
2019). |
|
|
10.11^ |
Amended
and Restated Exclusive License Agreement, dated August 29, 2019, by and between Seelos Therapeutics, Inc. and Stuart Weg,
MD. (incorporated herein by reference to Exhibit 10.7 to the Company’s Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on November 7, 2019). |
|
|
10.12# |
Seelos
Therapeutics, Inc. Amended and Restated 2012 Stock Long Term Incentive Plan, effective May 15, 2020 (incorporated herein
by reference to Appendix B to the Registrant’s Definitive Proxy Statement filed with the Securities and Exchange Commission
on April 13, 2020). |
|
|
10.13# |
Form of
Stock Option Grant Notice and Stock Option Agreement under the Company’s 2012 Stock Long Term Incentive Plan (incorporated
herein by reference to Exhibit 10.1 to the Company’s Form 10-Q filed with the Securities and Exchange Commission
on August 11, 2014). |
|
|
10.14# |
Seelos
Therapeutics, Inc. 2020 Employee Stock Purchase Plan (incorporated herein by reference to Appendix A to the Registrant’s
Definitive Proxy Statement filed with the Securities and Exchange Commission on April 13, 2020). |
|
|
10.15^ |
Securities
Purchase Agreement, dated as of November 23, 2021, by and between Seelos Therapeutics, Inc. and Lind Global Asset Management
V, LLC. (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission at 7:27 a.m. Eastern Time on November 24, 2021). |
|
|
10.16 |
Security
Agreement, dated as of November 23, 2021, by and between Seelos Therapeutics, Inc. and Lind Global Asset Management V,
LLC. (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the
Securities and Exchange Commission at 7:27 a.m. Eastern Time on November 24, 2021). |
|
|
10.17 |
Agreement
dated August 30, 2024 by and between Seelos Therapeutics, Inc. and Lind Global Asset Management V, LLC. (incorporated herein
by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission
at 7:27 a.m. Eastern Time on September 3, 2024). |
|
|
10.18^** |
License
Agreement, dated as of November 24, 2021, by and between Seelos Therapeutics, Inc. and iX Biopharma Europe Limited (incorporated
herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange
Commission at 8:20 a.m. Eastern Time on November 24, 2021). |
|
|
10.19# |
Amended
and Restated Employment Agreement by and between Seelos Therapeutics, Inc. and Raj Mehra, Ph.D., dated as of January 10,
2022 (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the
Securities and Exchange Commission on January 10, 2022). |
10.20^ |
Form of
Securities Purchase Agreement, dated March 10, 2023 (incorporated herein by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on March 14, 2023). |
|
|
10.21^ |
Form of
Amendment No. 1 to Securities Purchase Agreement, by and between Seelos Therapeutics, Inc. and each purchaser identified
on the signature pages thereto, dated May 19, 2023 (incorporated herein by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on May 19, 2023). |
|
|
10.22^ |
Form of
Securities Purchase Agreement, dated September 21, 2023 (incorporated herein by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on September 25, 2023). |
|
|
10.23 |
Letter
Agreement, dated September 21, 2023, by and between Seelos Therapeutics, Inc. and Lind Global Asset Management V, LLC (incorporated
herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange
Commission on September 25, 2023). |
|
|
10.24^ |
Form of
Securities Purchase Agreement, dated January 26, 2024 (incorporated herein by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on January 30, 2024). |
|
|
10.25 |
Form of
Securities Purchase Agreement, dated May 16, 2024 (incorporated herein by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on May 21, 2024). |
|
|
10.26 |
Placement
Agent Agreement, dated January 26, 2024 (incorporated herein by reference to Exhibit 10.2 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on January 30, 2024). |
|
|
10.27 |
Placement
Agent Agreement, dated May 16, 2024 (incorporated herein by reference to Exhibit 10.2 to the Company’s Current
Report on Form 8-K filed with the Securities and Exchange Commission on May 21, 2024). |
|
|
10.28 |
Form of
Inducement Letter Agreement, dated July 11, 2024 (incorporated herein by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on July 11, 2024). |
|
|
10.29< |
Form of
Securities Purchase Agreement |
|
|
10.30< |
Form of
Placement Agency Agreement |
|
|
21.1 |
Subsidiaries
(incorporated herein by reference to Exhibit 21.1 to the Company’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission on March 28, 2019). |
|
|
23.1* |
Consent
of KPMG, LLP, independent registered public accounting firm. |
|
|
23.2< |
Consent
of Brownstein Hyatt Farber Schreck, LLP (included in Exhibit 5.1). |
|
|
23.3< |
Consent
of Sullivan & Worcester LLP (included in Exhibit 5.2). |
|
|
24.1* |
Power
of Attorney. |
|
|
107* |
Filing Fee Table. |
| + | All
schedules and exhibits to the agreement have been omitted pursuant to Item 601(b)(2) of
Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the Securities
Exchange Commission upon request. |
| † | Confidential treatment
has been granted for portions of this exhibit. Those portions have been omitted and filed separately
with the Securities and Exchange Commission. |
| < | To be filed by Amendment. |
| # | Management compensatory plan or arrangement |
| ^ | Non-material schedules
and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company
hereby undertakes to furnish supplemental copies of any of the omitted schedules and exhibits
upon request by the Securities and Exchange Commission. |
| ** | Certain identified information has been
omitted pursuant to Item 601(b)(10) of Regulation S-K because such information is both
(i) not material and (ii) is of the type that the Company treats as private or
confidential. The Company hereby undertakes to furnish supplemental copies of the unredacted
exhibit upon request by the Securities and Exchange Commission. |
(b) Financial Statement Schedules
All
financial statement schedules are omitted because they are not applicable, the required information is not present in amounts sufficient
to require submission of such schedules or the information is included in the Registrant’s financial statements or notes thereto.
The
undersigned Registrant hereby undertakes:
(1) To file, during
any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i) To include
any prospectus required by Section 10(a)(3) of the Securities Act;
(ii) To reflect
in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range
may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in
volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration
Fee” table in the effective registration statement.
(iii) To include
any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material
change to such information in the registration statement;
Provided,
however, that:
Paragraphs (1)(i),
(1)(ii) and (1)(iii) of this section do not apply if the information required to be included in a post-effective amendment
by those paragraphs is contained in reports filed with or furnished to the SEC by the Registrant pursuant to section 13 or section 15(d) of
the Exchange Act that are incorporated by reference in the registration statement.
(2) That, for the purpose
of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
(3) To remove from registration
by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(4) That,
for the purpose of determining liability under the Securities Act to any purchaser, each prospectus filed pursuant to Rule 424(b) as
part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than
prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the
date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is
part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement
or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first
use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement
or made in any such document immediately prior to such date of first use.
(5) That, for purposes
of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to section 13(a) or
section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant
to section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be a new
registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to
be the initial bona fide offering thereof.
(6) Insofar as indemnification
for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant
to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against
public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person
of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled
by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on
its behalf by the undersigned, thereunto duly authorized, in the City of New York, State of New York, on September 24, 2024.
|
SEELOS THERAPEUTICS, INC. |
|
|
|
By: |
/s/
Raj Mehra, Ph.D. |
|
|
Raj Mehra, Ph.D. |
|
|
President and Chief
Executive Officer |
POWER OF ATTORNEY
Know
All Persons By These Presents, that each person whose signature appears below constitutes and appoints Raj Mehra, Ph.D. and
Michael Golembiewski, and each or any one of them, his or her true and lawful attorney-in-fact and agent, with full power of substitution
and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments
(including post-effective amendments) to this Registration Statement and any other Registration Statement filed pursuant to the provisions
of Rule 462 under the Securities Act of 1933, as amended, and to file the same, with all exhibits thereto, and other documents in
connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority
to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and
purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or his
substitutes or substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities
and on the dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ Raj Mehra, Ph.D |
|
President, Chief Executive Officer, Chairman of the Board and Interim Chief Financial
Officer |
|
September 24, 2024 |
Raj Mehra, Ph.D. |
|
(Principal Executive Officer) |
|
|
|
|
|
|
|
/s/ Michael Golembiewski |
|
Chief Financial Officer |
|
September 24, 2024 |
Michael Golembiewski |
|
(Principal Financial and Accounting Officer) |
|
|
|
|
|
|
|
/s/ Margaret Dalesandro, Ph.D. |
|
Director |
|
September 24, 2024 |
Margaret Dalesandro, Ph.D. |
|
|
|
|
|
|
|
|
|
/s/ Brian Lian, Ph.D. |
|
Director |
|
September 24, 2024 |
Brian Lian, Ph.D. |
|
|
|
|
|
|
|
|
|
/s/ Richard W. Pascoe |
|
Director |
|
September 24, 2024 |
Richard W. Pascoe |
|
|
|
|
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We consent to the use of our report dated March 6, 2024,
with respect to the consolidated financial statements of Seelos Therapeutics, Inc., incorporated herein by reference, and to the
reference to our firm under the heading "Experts" in the prospectus.
/s/ KPMG, LLP
Short Hills, New Jersey
September 24, 2024
Exhibit 107
Calculation of Filing Fee Table
Form S-1
(Form Type)
Seelos Therapeutics, Inc.
(Exact Name of Registrant as Specified in its Charter)
Table 1: Newly Registered Securities
Security Type |
|
Security Class Title |
|
Fee
Calculation
Rule |
|
|
Amount
Registered |
|
|
Proposed
Maximum
Offering
Price Per
Share |
|
|
Maximum
Aggregate
Offering
Price(1) |
|
|
Fee Rate |
|
|
Amount of
Registration
Fee |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
Common stock, par value $0.001 per share(2) |
|
457(o) |
|
|
|
|
|
|
|
|
$ |
6,000,000 |
|
|
$ |
0.00014760 |
|
|
$ |
885.6 |
|
Equity |
|
Pre-Funded Warrants to purchase shares of common stock(3) |
|
457(g) |
|
|
– |
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– (4) |
|
Equity |
|
Common stock underlying the Pre-Funded Warrants(2)(3) |
|
457(o) |
|
|
– |
|
|
– |
|
|
|
(3) |
|
|
$ |
0.00014760 |
|
|
|
– (3) |
|
Equity |
|
Common Warrants to purchase shares of common stock |
|
457(g) |
|
|
– |
|
|
– |
|
|
|
- |
|
|
|
– |
|
|
|
– (4) |
|
Equity |
|
Common Stock underlying the Common Warrants to purchase Common stock(2) |
|
457(o) |
|
|
– |
|
|
– |
|
|
$ |
6,000,000 |
|
|
$ |
0.00014760 |
|
|
$ |
885.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Offering Amounts |
|
|
|
|
|
$ |
12,000,000 |
|
|
|
|
|
|
$ |
1,771.2 |
|
Total Fees Previously Paid |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
- |
|
Total Fee Offsets |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
– |
|
Net Fee Due |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,771.2 |
|
(1) |
Estimated solely for the purpose of calculating the amount of the registration fee in accordance with Rule 457(o) under the Securities Act of 1933 (the “Securities Act”). |
|
|
(2) |
Pursuant to Rule 416 under the Securities Act, the securities registered hereby also include an indeterminate number of additional securities as may from time to time become issuable by reason of stock splits, stock dividends, recapitalizations, or other similar transactions. |
|
|
(3) |
The proposed maximum aggregate offering price of the common stock will be reduced on a dollar-for-dollar basis based on the offering price of any pre-funded warrants issued in the offering, and the proposed maximum aggregate offering price of the pre-funded warrants to be issued in the offering will be reduced on a dollar-for-dollar basis based on the offering price of any common stock issued in the offering. Accordingly, the proposed maximum aggregate offering price of the common stock and pre-funded warrants (including the common stock issuable upon exercise of the pre-funded warrants), if any, is $6,000,000. |
|
|
(4) |
No separate registration fee is payable pursuant to Rule 457(g) under the Securities Act. |
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