Filed Pursuant to Rule 424(b)(3)
Registration No. 333-269090
PROSPECTUS
CELCUITY
INC.
24,347,754
SHARES OF COMMON STOCK BY THE SELLING STOCKHOLDERS
This
prospectus relates to the resale, from time to time, of up to an aggregate of 24,347,754 shares of common stock, par value $0.001 per
share, of Celcuity Inc. (“Celcuity,” “we,” “us,” or the “Company”) by the selling stockholders
named in this prospectus, including their respective donees, pledgees, transferees, assignees or other successors-in-interest.
On
May 15, 2022, we entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with the selling stockholders
for a private placement of shares of our common stock, shares of our Series A Convertible Preferred Stock, par value $0.001 per share
(the “Series A Preferred Stock”) and warrants that were initially exercisable for shares of Series A Preferred Stock (the
“Warrants”). The Warrants were subsequently adjusted to be exercisable for shares of our common stock following satisfaction
of a condition that the Company amend its Certificate of Incorporation to increase the aggregate authorized number of shares of capital
stock and the number of shares of common stock such that the Company has available, and has reserved, such number of its duly authorized
but unissued shares of common stock as shall be sufficient to effect the conversion of all shares of Series A Preferred Stock then outstanding
or available for issuance upon the exercise of the Warrants.
The
transactions contemplated by the Securities Purchase Agreement closed on December 9, 2022. The number of shares of common stock offered
for sale by the selling stockholders consists of (i) 6,182,574 shares of common stock purchased by the selling stockholders under the
Securities Purchase Agreement, (ii) 11,208,730 shares of common stock issuable upon conversion of the Series A Preferred Stock and (iii)
6,956,450 shares of common stock issuable upon exercise of the Warrants.
We
are not selling any shares of our common stock under this prospectus and will not receive any proceeds from sales of the shares offering
by the selling stockholders, although we will incur expenses in connection with the offering. The registration of the resale of the shares
of common stock covered by this prospectus does not necessarily mean that any of the shares will be offered or sold by the selling stockholders.
The timing and amount of any sales are within the sole discretion of the selling stockholders.
The
shares of common stock offered under this prospectus may be sold by the selling stockholders through public or private transactions,
at prevailing market prices or at privately negotiated prices. For more information on the times and manner in which the selling stockholders
may sell the shares of common stock under this prospectus, please see the section entitled “Plan of Distribution,” beginning
on page 14 of this prospectus.
Our
common stock is traded on The Nasdaq Capital Market under the symbol “CELC.” On January 5, 2023, the closing
price of our common stock was $10.92.
Investing
in our securities involves risks. See “Risk Factors” on page 8. You should carefully read this prospectus, the documents
incorporated herein, and the applicable prospectus supplement before making any investment decision.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed
upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The
date of this prospectus is January 12, 2023.
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus is a part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (“SEC”),
under the Securities Act of 1933, as amended (“Securities Act”). Under this registration process, the selling stockholders
named in this prospectus may offer or sell shares of our common stock in one or more offerings from time to time. Each time the selling
stockholders named in this prospectus (or in any supplement to this prospectus) sells shares of our common stock under the registration
statement of which this prospectus is a part, such selling stockholders must provide a copy of this prospectus and any applicable prospectus
supplement, to a potential purchaser, as required by law (including by compliance with Rule 172 under the Securities Act).
In
certain circumstances we may provide a prospectus supplement that may add, update or change information contained in this prospectus.
Any statement that we make in this prospectus will be modified or superseded by any inconsistent statement made by us in a prospectus
supplement. You should read both this prospectus and any prospectus supplement, including all documents incorporated herein or therein
by reference, together with additional information described under “Where You Can Find More Information” beginning on page
20 of this prospectus and “Incorporation of Certain Documents by Reference” beginning on page 20 of this prospectus.
Neither
we, nor the selling stockholders, have authorized any other person to provide you with different information. If anyone provides you
with different or inconsistent information, you should not rely on it. Neither we nor any of the selling stockholders will make an offer
to sell our common stock in any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing
in this prospectus and any prospectus supplement is accurate as of the date on its respective cover, and that any information incorporated
by reference is accurate only as of the date of the document incorporated by reference, unless we indicate otherwise. Our business, financial
condition, results of operations and prospects may have changed since those dates.
Unless
otherwise indicated, information contained in or incorporated by reference into this prospectus concerning our industry and the markets
in which we operate, including our general expectations and market position, market opportunity and market share, is based on information
from our own management estimates and research, as well as from industry and general publications and research, surveys and studies conducted
by third parties. Management estimates are derived from publicly available information, our knowledge of our industry and assumptions
based on such information and knowledge, which we believe to be reasonable. In addition, assumptions and estimates of our and our industry’s
future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, see “Risk Factors”
beginning on page 8 of this prospectus. These and other factors could cause our future performance to differ materially from our assumptions
and estimates. See “Cautionary Note Regarding Forward-Looking Statements” beginning on page 9 of this prospectus.
Unless
the context otherwise requires, “CELC,” the “Company,” “we,” “us,” “our”
and similar names refer to Celcuity Inc, and the term “common stock” refers to our common stock, par value $0.001 per share.
The phrase “this prospectus” refers to this prospectus and any applicable prospectus supplement unless the context otherwise
requires.
PROSPECTUS
SUMMARY
This
summary highlights certain information about us, this offering and selected information contained in this prospectus. This summary is
not complete and does not contain all of the information that you should consider before deciding whether to invest in our common stock.
For a more complete understanding of the Company and this offering, we encourage you to read and consider the more detailed information
included or incorporated by reference in this prospectus, including risk factors, see “Risk Factors” beginning on page 8
of this prospectus, and our most recent consolidated financial statements and related notes.
Company
Overview
We
are a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications.
Our lead therapeutic candidate is gedatolisib, a pan-PI3K/mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are
highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. We initiated
VIKTORIA-1, a Phase 3 study evaluating gedatolisib in patients with HR+/HER2- advanced breast cancer in 2022. On December 7, 2022, the
first patient in the trial was dosed. In addition, we continue to develop our CELsignia companion diagnostic platform which is uniquely
able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies.
Gedatolisib
is a potent, well-tolerated, small molecule reversible dual inhibitor, administered intravenously, that selectively targets all class
I isoforms of PI3K and mammalian target of rapamycin (mTOR). In April 2021, we obtained exclusive global development and commercialization
rights to gedatolisib under a license agreement with Pfizer, Inc. We believe gedatolisib’s unique mechanism of action, differentiated
chemical structure, favorable pharmacokinetic properties, and intravenous formulation offer distinct advantages over currently approved
and investigational therapies that target PI3K or mTOR alone or together.
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Overcomes
limitations of therapies that only inhibit a single class I PI3K isoform or only one mTOR kinase complex |
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Gedatolisib
is a pan-class I isoform PI3K and mTOR inhibitor with low nanomolar potency for the p110α, p110β, p110γ, and p110δ
isoforms and mTORC1 and mTORC2 complexes. Each PI3K isoform and mTOR complex is known to preferentially affect different signal transduction
events that involve tumor cell survival, depending upon the aberrations associated with the linked pathway. When a therapy only inhibits
a single class I isoform (e.g., alpelisib, a PI3K-α inhibitor) or only one mTOR kinase complex (e.g., everolimus, an mTORC1
inhibitor), numerous feedforward and feedback loops between the PI3K isoforms and mTOR complexes cross-activates the uninhibited
sub-units. This, in turn, induces compensatory resistance that reduces the efficacy of isoform specific PI3K or single mTOR kinase
complex inhibitors. Inhibiting all four PI3K isoforms and both mTOR complexes, as gedatolisib does, thus prevents the confounding
effect of isoform interaction that may occur with isoform-specific PI3K inhibitors and the confounding interaction between PI3K isoforms
and mTOR. |
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Better
tolerated by patients than oral PI3K and mTOR drugs |
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Gedatolisib
is administered intravenously (IV) on a four-week cycle of three weeks-on, one week-off, in contrast to the orally administered pan-PI3K
or dual PI3K/mTOR inhibitors that are no longer being clinically developed. Oral pan-PI3K or PI3K/mTOR inhibitors have repeatably
been found to induce significant side effects that were not well tolerated by patients. This typically leads to a high proportion
of patients requiring dose reductions or treatment discontinuation. The challenging toxicity profile of these drug candidates ultimately
played a significant role in the decisions to halt their development, despite showing promising efficacy. By contrast, gedatolisib
stabilizes at lower concentration levels in plasma compared to orally administered PI3K inhibitors, resulting in less toxicity, while
maintaining concentrations sufficient to inhibit PI3K/mTOR signaling. |
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Isoform-specific
PI3K inhibitors administered orally were developed to reduce toxicities in patients. While the range of toxicities associated with
isoform-specific inhibitors is narrower than oral pan-PI3K or PI3K/mTOR inhibitors, administering them orally on a continuous basis
still leads to challenging toxicities. The experience with an FDA approved oral p110-α specific inhibitor, Piqray, illustrates
the challenge. In its Phase 3 pivotal trial Piqray was found to induce a Grade 3 or 4 adverse event (AE) related to hyperglycemia
in 39% of patients evaluated. In addition, 26% of patients discontinued alpelisib due to treatment related adverse events. By contrast,
in the 103-patient dose expansion portion of the Phase 1b clinical trial with gedatolisib, only 7% of patients experienced Grade
3 or 4 hyperglycemia and less than 10% discontinued treatment. |
As
of September 30, 2022, 492 patients with solid tumors have received gedatolisib in eight clinical trials sponsored by Pfizer. Of the
492 patients, 129 were treated with gedatolisib as a single agent in three clinical trials. The remaining 363 patients received gedatolisib
in combination with other anti-cancer agents in five clinical trials. Additional patients received gedatolisib in combination with other
anti-cancer agents in nine investigator sponsored clinical trials.
A
Phase 1b trial (B2151009) evaluating patients with HR+/HER2- metastatic breast cancer was initiated in 2016 and subsequently enrolled
138 patients. Nine patients from this study continue to receive study treatment, as of September 30, 2022, each of whom have received
study treatment for more than three years. The B2151009 clinical trial was an open label, multiple arm Phase 1b study that evaluated
gedatolisib in combination with palbociclib (CDK4/6 inhibitor) and fulvestrant or letrozole in patients with HR+/HER2- advanced breast
cancer. Thirty-five patients were enrolled in two dose escalation arms to evaluate the safety and tolerability and to determine the maximum
tolerated dose (MTD) of gedatolisib when used in combination with the standard doses of palbociclib and endocrine therapy (letrozole
or fulvestrant). The MTD was determined to be 180 mg administered intravenously once weekly. A total of 103 patients were subsequently
enrolled in one of four expansion arms (A, B, C, D).
High
objective overall response rates (ORR) were observed in all four expansion arms and were comparable in each arm for PIK3CA WT and PIK3CA
MT patients. In treatment-naïve patients (Arm A), ORR was 85%. In patients who received prior hormonal therapy alone or in combination
with a CDK4/6 inhibitor (Arms B, C, and D), ORR ranged from 36% to 77%. Each arm achieved its primary endpoint target, which was reporting
higher ORR in the study arm than ORR from either the PALOMA-2 (ORR=55%) study that evaluated palbociclib plus letrozole for Arm A or
the PALOMA-3 study (ORR=25%) that evaluated palbociclib plus fulvestrant for Arms B, C, and D. For all enrolled patients, a clinical
benefit rate (CBR) of ≥79% was observed. Median progression-free survival (PFS) was 12.9 months for patients who received a prior
CDK4/6 inhibitor and were treated in the study with the Phase 3 dosing schedule (Arm D).
Gedatolisib
combined with palbociclib and endocrine therapy demonstrated a favorable safety profile with manageable toxicity. The majority of treatment
emergent adverse events were Grade 1 and 2. The most frequently observed adverse events included stomatitis/mucosal inflammation, the
majority of which were Grade 1 and 2. The most common Grade 4 AEs were neutropenia and neutrophil count decrease, which were assessed
as related to treatment with palbociclib. No grade 5 events were reported in this study.
We
activated VIKTORIA-1, a Phase 3, open-label, randomized clinical trial to evaluate the efficacy and safety of two regimens in adults
with HR+/HER2- advanced breast cancer whose disease has progressed after prior CDK4/6 therapy in combination with an aromatase inhibitor:
1) gedatolisib in combination with palbociclib and fulvestrant; and 2) gedatolisib in combination with fulvestrant. Two hundred clinical
sites in North America, Europe, South America, Asia, and Australia have been selected to participate in the study. The first clinical
site was activated in the third quarter of 2022. The first dosage of a patient in the trial occurred on December 7, 2022.
The
clinical trial will enable separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility criteria and
are PIK3CA WT will be randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm A), gedatolisib
and fulvestrant (Arm B), or fulvestrant (Arm C). Subjects who meet eligibility criteria and are PIK3CA MT will be randomly assigned (3:3:1)
to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D), alpelisib and fulvestrant (Arm E), or gedatolisib and
fulvestrant (Arm F).
Our
proprietary CELsignia diagnostic platform is the only commercially ready technology we are aware of that uses a patient’s living
tumor cells to identify the specific abnormal cellular process driving a patient’s cancer and the targeted therapy that best treats
it. This enables us to identify patients whose tumors may respond to a targeted therapy, even though they lack a previously associated
molecular mutation. By identifying cancer patients whose tumors lack an associated genetic mutation but have abnormal cellular activity
a matching targeted therapeutic is designed to inhibit, CELsignia CDx can expand the markets for a number of already approved targeted
therapies. Our current CDx identifies breast and ovarian cancer patients whose tumors have cancer drivers potentially responsive to treatment
with human epidermal growth factor receptor 2-negative (HER2), mesenchymal-epithelial transition factor (c-MET), or phosphatidylinositol
3-kinases (PI3K) targeted therapeutics. While U.S. Food and Drug Administration (“FDA”) approval or clearance is not currently
required for CELsignia tests offered as a stand-alone laboratory developed test, if we are partnered with a drug company to launch a
CELsignia test as a companion diagnostic for a new drug indication, we would be required to obtain premarket approval, or PMA, in conjunction
with the pharmaceutical company seeking a new drug approval for the matching therapy.
We
are supporting the advancement of new potential indications for four different targeted therapies, controlled by other pharmaceutical
companies, that would rely on a CELsignia CDx to select patients. Five Phase 2 trials are underway to evaluate the efficacy and safety
of these therapies in CELsignia selected patients. These patients are not currently eligible to receive these drugs and are not identifiable
with a molecular test.
Supporting
the development of a potential first-in-class targeted therapy for breast cancer, like gedatolisib, with our CELsignia platform is a
natural extension of our strategy to use our CELsignia CDx to enable new indications for other companies’ targeted therapies. By
combining companion diagnostics designed to enable proprietary new drug indications with targeted therapies that treat signaling dysregulation
our CDx identifies, we believe we are uniquely positioned to improve the standard-of-care for many early and late-stage breast cancer
patients. Our goal is to play a key role in the multiple treatment approaches required to treat breast cancer patients at various stages
of their disease. With each program, we are:
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Leveraging
the proprietary insights CELsignia provides into live patient tumor cell function; |
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Using
a CELsignia CDx to identify new patients likely to respond to the paired targeted therapy; |
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Developing
a new targeted therapeutic option for breast cancer patients; and |
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Maximizing
the probability of getting regulatory approval to market the targeted therapy indication. |
Recent
Highlights
Below
is a summary of certain recent highlights with respect to the Company:
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Granted
Breakthrough Therapy Designation for gedatolisib with respect to HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy; |
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Initiated
and dosed the first patient in our VIKTORIA-1, a Phase 3 study evaluating gedatolisib in patients with HR+/HER2- advanced breast
cancer in 2022; |
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Completed
a private placement resulting in gross proceeds to the Company of approximately $100 million, before deducting placement agent fees
and other estimated offering expenses payable by the Company, as further described below in “The PIPE Offering”; and |
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Received
funding of an additional $20 million term loan for a total of $35 million in term loans drawn from our $75 million debt financing
arrangement with an affiliate of Innovatus Capital Partners. |
The
PIPE Offering
On
May 15, 2022, we entered into the Securities Purchase Agreement with the selling stockholders pursuant to which we conducted a private
placement of securities, resulting in gross proceeds to the Company, before deducting placement agent fees and other estimated offering
expenses payable by the Company, of approximately $100 million (the “PIPE Offering”). The closing of the PIPE Offering occurred
on December 9, 2022 (the “Closing Date”) following satisfaction of a primary closing condition—the first dosing of
a patient enrolled in our Phase 3 clinical study (VIKTORIA-1) at a clinical site located in the United States. The Company intends to
use the net proceeds from the PIPE Offering to advance clinical development of gedatolisib, including its Phase 3 clinical study (VIKTORIA-1),
and for general corporate purposes.
Securities
Purchase Agreement
Under
the terms of the securities purchase agreement, the selling stockholders purchased from the Company: (i) 6,182,574 shares of common stock
at a purchase price of $5.75 per share, (ii) 1,120,873 shares of Series A Preferred Stock at a purchase price of $57.50 per share, and
(iii) Warrants to purchase 695,645 shares of Series A Preferred Stock, with an exercise price of $80.50 per share, or $8.05 per share
on an as converted to common stock basis, a 40% premium to the price paid by the selling
stockholders for the initial shares of common stock purchased under the Securities Purchase Agreement.
On
September 1, 2022, the Company amended its Certificate of Incorporation to increase the aggregate authorized number of shares of capital
stock and the number of shares of common stock such that the company has available, and has reserved, such number of its duly authorized
but unissued shares of common stock as shall be sufficient to effect the conversion of all shares of Series A Preferred Stock then outstanding
or available for issuance upon the exercise of the Warrants (the “Authorized Share Increase”). Following the Authorized Share
Increase, and notice to the selling stockholders, the Warrants were adjusted to become exercisable for an aggregate of 6,956,450 shares
of common stock with an exercise price of $8.05 per share.
Each
share of Series A Preferred Stock is convertible into ten (10) shares of common stock. For a summary of the rights and preferences of
the Series A Preferred Stock, see “Description of Capital Stock – Preferred Stock” beginning on page 15 of this prospectus.
Each
Warrant issued on the Closing Date is immediately exercisable and will remain exercisable until the earlier of (i) five years from the
date of issuance and (ii) seventy-five (75) days after the Company announces (x) whether the progression-free survival (“PFS”)
of gedatolisib in combination with Palbociclib and fulvestrant (Arm A) to fulvestrant (Arm C) in the Phase 3 study met its primary endpoint
target, (y) whether the PFS of gedatolisib in combination with fulvestrant (Arm B) to fulvestrant (Arm C) in the Phase 3 study met its
primary endpoint target, and (z) the associated hazard ratios and median PFS values for each of Arm A, Arm B, and Arm C.
Under
the terms of the Series A Preferred Stock and the Warrants, the Company may not effect the conversion of Series A Preferred stock into
common stock, or the exercise of any such Warrant, and a holder will not be entitled to request the conversion of shares of Series A
Preferred Stock or exercise any portion of any Warrant, if, upon giving effect to such conversion or exercise, the aggregate number of
shares of common stock (assuming the conversion of the Series A Preferred Stock into common stock with respect to the Warrants) beneficially
owned by the holder (together with any affiliates, any other person acting as a group together with the holder or any of the holder’s
affiliates, and any other persons whose beneficial ownership of common stock would or could be aggregated with the holder’s for
purposes of Section 13(d) or Section 16 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) would exceed
9.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise, as such percentage ownership
is calculated in accordance with Section 13(d) of the Exchange Act and the applicable regulations of the SEC (the “Beneficial Ownership
Limitation”). A holder may reset the Beneficial Ownership Limitation percentage to a higher percentage (not to exceed 19.9%), effective
61 days after written notice to the Company, or a lower percentage, effective immediately upon written notice to the Company. Any such
increase or decrease will apply only to that holder and not to any other holder of Series A Preferred Stock or Warrants.
Brian
Sullivan, the Company’s Chief Executive Officer, participated in the PIPE Offering. Except for Mr. Sullivan, there are no material
relationships between the Company and any of the selling stockholders other than in respect of the PIPE Offering. Jeffries LLC acted
as placement agent for the PIPE Offering.
The
Securities Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing,
indemnification obligations of the Company, other obligations of the parties and termination provisions. The descriptions of the Securities
Purchase Agreement in this prospectus do not purport to be complete and are qualified in their entirety by reference to the full text
of the Securities Purchase Agreement, a copy of which is filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed
with the SEC on May 18, 2022.
Registration
Rights Agreement
In
connection with the PIPE Offering, the Company entered into a registration rights agreement (the “Registration Rights Agreement”)
with the selling stockholders, pursuant to which the Company agreed to register for resale (i) the common stock, (ii) the shares of common
stock then issued or issuable upon conversion of the Series A Preferred Stock (assuming on such date the shares of Series A Preferred
Stock are convertible in full without regard to any conversion limitations in the Certificate of Designations), and (iii) the common
stock then issued or issuable upon exercise of the Warrants (assuming the Warrants are exercisable in full without regard to any exercise
limitations therein) (collectively, the “Registrable Securities”).
Under
the Registration Rights Agreement, the Company agreed to file the registration statement to which this prospectus relates
covering the resale by the selling stockholders of the Registrable Securities no later than 30 days following (i) the Closing Date and
(ii) the date the Company obtains the necessary stockholder approval to effect the Authorized Share Increase. The Company agreed to use
commercially reasonable efforts to cause the registration statement to which this prospectus relates to become effective
and to keep such registration statement effective until such time as there are no longer Registrable Securities held by the selling
stockholders. The Company has also agreed to be responsible for all fees and expenses incurred in connection with the registration
of the Registrable Securities.
In
the event (i) the registration statement to which this prospectus relates had not been filed within the time period specified
above, (ii) the registration statement to which this prospectus relates, as may be amended, had not been declared effective (A)
by February 7, 2023 (the 60th day after the Closing Date) (or, in the event of a review by the SEC, March 9, 2023 (the
90th day after the Closing Date)) or (B) within ten business days following the date the Company was notified by the
SEC that the registration statement will not be reviewed or is no longer subject to further review and comments, or (iii) after such
registration statement was declared effective by the SEC, sales cannot be made pursuant to such registration statement for
any reason (including without limitation by reason of a stop order, or the Company’s failure to update such registration statement),
but excluding any Allowed Delay (as defined in the Registration Rights Agreement) or, if the registration statement would have instead
been on Form S-1, for a period of twenty (20) days following the date on which the Company files a post-effective amendment to incorporate
the Company’s Annual Report on Form 10-K, then the Company agreed to make pro rata payments to each holder as liquidated damages
in an amount equal to 1.0% of the aggregate amount invested by each such holder in the Registrable Securities then held by the holder
per 30-day period or pro rata for any portion thereof for each such month during which such event continues, provided that the maximum
aggregate amounts payable as liquidated damages shall not exceed 5.0% of the aggregate amount invested by each such holder in the Registrable
Securities then held by the holder.
The
Company has granted the selling stockholders customary indemnification rights in connection with the registration statement, including
for liabilities arising under the Securities Act. The selling stockholders have also granted the Company customary indemnification rights
in connection with the registration statement. The representations, warranties and covenants contained in the Warrants, the Securities
Purchase Agreement and the Registration Rights Agreement were made solely for the benefit of the parties thereto and may be subject to
limitations agreed upon by the contracting parties.
The
descriptions of the Registration Rights Agreement in this prospectus do not purport to be complete and are qualified in their entirety
by reference to the full text of the Registration Rights Agreement, a copy of which is filed as Exhibit 10.2 to the Company’s Current
Report on Form 8-K filed with the SEC on May 18, 2022.
The
Offering
| Common
stock outstanding prior to this offering: |
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21,667,250
shares of common stock, which includes 6,182,574 shares of common stock issued in the PIPE Offering that are Registrable Securities
and are being registered for sale pursuant to the registration statement to which this prospectus relates. |
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| Common
stock to be offered by the selling stockholders: |
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Up
to 24,347,754 shares of common stock (assuming conversion of all outstanding shares of Series A Preferred Stock and exercise of all
outstanding Warrants). |
| Common
stock to be outstanding after the offering: |
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39,832,430
shares of common stock, assuming that: |
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Celcuity
issues 11,208,730 shares of its common stock upon conversion of the Series A Preferred Stock sold pursuant to the Securities Purchase
Agreement; and |
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Celcuity
issues 6,956,450 shares its common stock upon the exercise of the Warrants sold pursuant to the Securities Purchase Agreement. |
| Offering
price per share: |
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The
selling stockholders identified in this prospectus may sell all or a portion of the shares being offered pursuant to this prospectus
at fixed prices and prevailing market prices at the time of sale, at varying prices or at negotiated prices. |
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| Use
of proceeds: |
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We
will not receive any proceeds from the sale of shares in this offering. See “Use of Proceeds” beginning on page 10 of
this prospectus. |
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| Risk
factors: |
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Investing
in our common stock involves a high degree of risk, and the purchasers of our common stock may lose all or part of their investment.
Before deciding to invest in our securities, please carefully read the section entitled “Risk Factors” beginning on page
8 of this prospectus. |
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| Stock
exchange listing: |
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Our
common stock is listed on The Nasdaq Capital Market under the symbol “CELC”. |
Additional
Information
Our
principal executive office is located at 16305 36th Avenue North, Suite 100, Minneapolis, Minnesota. Our telephone number is (763) 392-0123,
and our website is www.celcuity.com. The information contained on or accessible through our website is not incorporated by reference
into, and should not be considered part of, this prospectus supplement, the accompanying prospectus or the information incorporated herein
by reference.
Change
of Emerging Growth Company Status
As
of January 1, 2023, we are no longer an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act
of 2012, or the JOBS Act. We were previously an “emerging growth company” through December 31, 2022, which was the end of
the first five fiscal years after we completed our initial public offering.
RISK
FACTORS
Investing
in our securities involves risk. You should consider the risks, uncertainties and assumptions discussed under the heading “Risk
Factors” in our Quarterly Report on Form 10-Q for the period ended September 30, 2022, filed on November 10, 2022 with the Securities
and Exchange Commission (“SEC”), which is incorporated herein by reference, and may be amended, supplemented or superseded
from time to time by other reports we file with the SEC in the future. The risks and uncertainties we have described are not the only
ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our operations.
If any of these risks were to occur, our business, financial condition, and results of operations could be severely harmed. This could
cause the trading price of our common stock to decline, and you could lose all or part of your investment.
FORWARD-LOOKING
STATEMENTS
This
prospectus and the documents incorporated herein by reference contain forward-looking statements and information within the meaning of
Section 27A of the Securities Act of 1933, as amended, or the “Securities Act”, and Section 21E of the Securities Exchange
Act of 1934, as amended, or the “Exchange Act”, which are subject to the safe harbor created by those sections. These forward-looking
statements and information regarding us, our business prospects and our results of operations are subject to certain risks and uncertainties
that could cause our actual business, prospects and results of operations to differ materially from those that may be anticipated by
such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described
under “Risk Factors” herein and in our other filings with the SEC. You should not place undue reliance on these forward-looking
statements. You should assume that the information contained in or incorporated by reference in this prospectus is accurate only as of
the date on the front cover of this prospectus or as of the date of the documents incorporated by reference herein or therein, as applicable.
We expressly disclaim any intent or obligation to update or revise any forward-looking statements, whether as a result of new information,
future events or otherwise. You are urged to carefully review and consider the various disclosures made by us in this prospectus and
the documents incorporated herein by reference and in our other reports filed with the SEC that advise interested parties of the risks
and uncertainties that may affect our business.
All
statements, other than statements of historical facts, contained in this prospectus and the documents incorporated herein by reference,
including statements regarding our plans, objectives and expectations for our business, operations and financial performance and condition,
are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “might,” “target,” “ongoing,” “plan,” “potential,” “predict,”
“project,” “should,” “will,” “would,” or the negative of these terms or other comparable
terminology, although not all forward-looking statements contain these words. Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause our results, performance or achievements to be materially different from the information
expressed or implied by the forward-looking statements in this prospectus and the documents incorporated herein by reference. Additionally,
our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures
or investments that we may make. Forward-looking statements may include, among other things, statements relating to:
| |
● |
our
clinical trial plans and the estimated timelines and costs for such trials; |
| |
● |
our
expectations with respect to the development, validation, required approvals, costs and timelines of gedatolisib and our CELsignia
tests; |
| |
● |
our
expectations with respect to the potential efficacy of gedatolisib in various patient types alone or in combination with other treatments; |
| |
● |
our
expectations regarding the timeline of patient enrollment and results from clinical trials, including our existing Phase 3 VIKTORIA-1
clinical trial for gedatolisib; |
| |
● |
our
beliefs related to the potential benefits resulting from Breakthrough Therapy designation for gedatolisib; |
| |
● |
our
beliefs related to the perceived advantages of our CELsignia tests compared to traditional molecular or other diagnostic tests; |
| |
● |
our
plans with respect to research and development and related expenses for the foreseeable future; |
| |
● |
the
future payments that may be owed to Pfizer under our license agreement with them; |
| |
● |
our
expectations regarding partnering with pharmaceutical companies and other third parties; |
| |
● |
our
expectations regarding revenue from sales of CELsignia tests and revenue from milestone or other payment sources; |
| |
● |
our
expectations regarding business development activities, including companion diagnostic related activities with pharmaceutical companies; |
| |
● |
our
expectations as to the use of proceeds from the PIPE Offering; |
| |
● |
our
expectations with respect to accessing our current debt facility or any other debt facility or other capital source in the future; |
| |
● |
our
beliefs regarding the adequacy of our cash on hand to fund our research and development expenses, capital expenditures, working capital,
sales and marketing expenses, and other general corporate expenses, as well as the increased costs associated with being a public
company; and |
| |
● |
our
expectations regarding the impact that the COVID-19 pandemic and related economic effects will have on our business and results of
operations. |
These
statements involve known and unknown risks, uncertainties and other factors that may cause our results or our industry’s actual
results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these
forward-looking statements. Certain risks, uncertainties and other factors include, but are not limited to, our limited operating history;
the potential impact of COVID-19 and any resurgence thereof on our business and clinical study activities; our potential inability to
develop, validate and commercialize gedatolisib on a timely basis or at all; the uncertainties and costs associated with clinical studies
and with developing and commercializing biopharmaceuticals; the complexity and difficulty of demonstrating the safety and sufficient
magnitude of benefit to support regulatory approval of gedatolisib and other products we may develop; challenges we may face in developing
and maintaining relationships with pharmaceutical company partners; the complexity and timeline for development of our CELsignia tests;
the uncertainty regarding market acceptance of our products and services by physicians, patients, third-party payors and others in the
medical community, uncertainty with respect to the size of market opportunities available to us; uncertainty regarding the pricing of
drug products and molecular and other diagnostic products and services that compete or may compete with us; uncertainty with insurance
coverage and reimbursement for our products and services; difficulties we may face in managing growth, such as hiring and retaining key
personnel; changes in government regulations; and obtaining and maintaining intellectual property protection for our technology and time
and expense associated with defending third-party claims of intellectual property infringement, investigations or litigation threatened
or initiated against us. See “Risk Factors” beginning on page 8 of this prospectus
for additional risks, uncertainties and other factors applicable to the Company.
USE
OF PROCEEDS
We
are filing the registration statement, of which this prospectus is a part, to permit the selling stockholders described in the section
entitled “Selling Stockholders,” beginning on page 11 of this prospectus, to resell shares of our common stock. We are not
selling any securities under this prospectus and will not receive any proceeds from the sale of shares by the selling stockholders. However,
we received proceeds from our initial sale of shares of common stock, shares of Series A Preferred Stock and Warrants to the selling
stockholders pursuant to the PIPE Offering. Additionally, we may receive proceeds from the exercise of Warrants to purchase 6,956,450
shares of common stock issued under the Securities Purchase Agreement and held by the selling stockholders. The Warrants have an exercise
price of $8.05 per share. We plan to use the net proceeds from the PIPE Offering to advance clinical development of gedatolisib, including
our Phase 3 clinical study (VIKTORIA-1), and for general corporate purposes.
SELLING
STOCKHOLDERS
The
common stock being offered by the selling stockholders consists of the following securities purchased by the selling stockholders under
the Securities Purchase Agreement: (i) 6,182,574 shares of common stock, (ii) 11,208,730 shares of common stock issuable upon conversion
of the Series A Preferred Stock and (iii) 6,956,450 shares of common stock issuable upon exercise of the Warrants at an initial exercise
price of $8.05 per share. We are registering these shares of common stock in order to permit the selling stockholders to offer for resale
from time to time the shares of common stock acquired under the Securities Purchase Agreement and the shares of common stock issuable
upon conversion of the Series A Preferred Stock and upon the exercise of the Warrants. For more information regarding the issuances to
the selling stockholders of shares of common stock, shares of Series A Preferred Stock and the Warrants under the Securities Purchase
Agreement, see “Prospectus Summary—The PIPE Offering” above. When we refer to the “selling stockholders”
in this prospectus, or, if required, a post-effective amendment to the registration statement of which this prospectus is a part, we
mean the selling stockholders, as well as any of their respective pledgees, assignees and successors-in-interest. The selling stockholders
may sell all, some or none of the shares of common stock subject to this prospectus. See “Plan of Distribution” below as
it may be supplemented and amended from time to time.
Under
the terms of the Series A Preferred Stock and the Warrants, the Company may not effect the conversion of the Series A Preferred Stock
into common stock, or the exercise of any such Warrant, and a selling stockholder will not be entitled to request the conversion of shares
of Series A Preferred Stock or exercise any portion of any Warrant, if, upon giving effect to such conversion or exercise, the aggregate
number of shares of common stock beneficially owned by the selling stockholder (together with its affiliates, any other persons acting
as a group together with the selling stockholder or any of the selling stockholder’s affiliates, and any other persons whose beneficial
ownership of common stock would or could be aggregated with the holder’s for purposes of Section 13(d) or Section 16 of the Exchange
Act) would exceed the Beneficial Ownership Limitation, which is 9.99% of the number of shares of common stock outstanding immediately
after giving effect to any conversion or exercise, as such percentage ownership is calculated in accordance with Section 13(d) of the
Exchange Act and the applicable regulations of the SEC. A selling stockholder may reset the Beneficial Ownership Limitation percentage
to a higher percentage (not to exceed 19.9%), effective 61 days after written notice to the Company, or a lower percentage, effective
immediately upon written notice to the Company. Any such increase or decrease will apply only to that selling stockholder and not to
any other holder of Series A Preferred Stock or Warrants.
Brian
Sullivan, our Chairman and Chief Executive Officer, participated in the PIPE Offering and is a selling stockholder hereunder. Except
for the PIPE Offering and ownership of common stock, the selling stockholders, other than Mr. Sullivan, have not had any material relationship
within the past three years with Celcuity or any of its affiliates. For purposes of the table below,
the Beneficial Ownership Limitation is not applied with respect to Mr. Sullivan as he is an affiliate of the Company and his beneficial
ownership already exceeded the Beneficial Ownership Limitation both prior to and after the purchase of common stock and Warrants under
the PIPE Offering.
The
information in the table below with respect to the selling stockholders has been obtained from the selling stockholders and sets forth,
to our knowledge, information concerning the beneficial ownership of shares of our common stock by the selling stockholders. Beneficial
ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to our common stock.
Generally, a person “beneficially owns” shares of our common stock if the person has or shares with others the right to vote
those shares or to dispose of them, or if the person has the right to acquire voting or disposition rights with respect to such shares
within 60 days. In computing the number of shares of our common stock beneficially owned by each selling stockholder and the percentage
ownership of each selling stockholder, we excluded (except with respect to Mr. Sullivan) any shares for which the Series A Preferred
Stock and Warrants held by a selling stockholder that may not be converted or exercised, respectively, due to the Beneficial Ownership
Limitations because such shares may not be acquired by such selling stockholders within 60 days of December 30, 2022. The inclusion
of any shares in this table does not constitute an admission of beneficial ownership by the selling stockholders.
| | |
Shares of Common Stock Beneficially Owned Prior to Offering | | |
Maximum Number of Shares of Common Stock to be Sold Pursuant to this | | |
Number of Shares of Common Stock Owned After Offering | |
| Name of Selling Stockholder | |
Number | | |
Percentage | | |
Prospectus(1) | | |
Number | | |
Percentage | |
| Entities associated with Venrock Entities(2) | |
| 2,171,126 | | |
| 9.99 | % | |
| 6,086,906 | | |
| - | | |
| - | |
| Entities associated with Soleus Entities(3) | |
| 2,299,538 | | |
| 9.99 | % | |
| 6,086,946 | | |
| 232,073 | | |
| 1 | % |
| Growth Equity Opportunities 18 VGE, LLC(4) | |
| 2,266,063 | | |
| 9.99 | % | |
| 4,869,561 | | |
| - | | |
| - | |
| RA Capital Healthcare Fund, L.P.(5) | |
| 2,249,415 | | |
| 9.99 | % | |
| 4,504,351 | | |
| - | | |
| - | |
| Commodore Capital Master LP(6) | |
| 2,252,691 | | |
| 9.99 | % | |
| 2,434,781 | | |
| 920,464 | | |
| 4.3 | % |
| Brian F. Sullivan(7) | |
| 3,459,384 | | |
| 15.99 | % | |
| 365,209 | | |
| 3,094,175 | | |
| 14.3 | % |
| (1) |
The
number of shares of our common stock in the column “Maximum Number of Shares of Common Stock to be Sold Pursuant to this Prospectus”
represents all of the shares of our common stock that the selling stockholders may offer and sell from time to time under this prospectus
without giving effect to the Beneficial Ownership Limitation described above. |
| |
|
| (2) |
Shares
held by Venrock Healthcare Capital Partners EG, L.P. (“VHCP EG”), Venrock Healthcare
Capital Partners III, L.P. (“VHCP III”), and VHCP Co-Investment Holdings III,
LLC (“VHCP III Co”), which we refer to collectively as the Venrock Entities,
consist of: (i) 1,496,508 shares of our common stock, 159,392 shares of our Series A Preferred
Stock convertible into 1,593,920 shares of our common stock and Warrants to purchase 1,236,140
shares of common stock, in each case held by VHCP EG, (ii) 553,506 shares of our common stock,
58,954 shares of our Series A Preferred Stock convertible into 589,540 shares of our common
stock and Warrants to purchase 457,200 shares of our common stock, in each case held
by VHCP III and (iii) 55,372 shares of our common stock, 5,898 shares of our Series A Preferred
Stock convertible into 58,980 shares of our common stock and Warrants to purchase 45,740
shares of our common stock, in each case held by VHCP III Co.
The
ability of the Venrock Entities to convert their Series A Preferred Stock and exercise of their Warrants is subject to the Beneficial
Ownership Limitation as described above. The shares reported under “Shares of Common Stock Beneficially Owned Prior to Offering”
consist of 2,105,386 shares of our common stock and 65,740 shares of common stock issuable to the Venrock Entities upon conversion
of their Series A Preferred Stock or exercise of their Warrants. The shares reported under “Shares of Common Stock Beneficially
Owned Prior to Offering” do not include the remaining 3,915,780 shares of common stock issuable to the Venrock Entities upon
conversion of their Series A Preferred Stock and exercise of their Warrants due to the application of the applicable Beneficial Ownership
Limitation. VHCP Management III, LLC (“VHCPM III”) is the sole general partner of VHCP III and the sole manager of VHCP
Co. VHCP Management EG, LLC (“VHCPM EG”) is the sole general partner of VHCP EG. Dr. Bong Koh and Nimish Shah are the
voting members of VHCPM III and VHCPM EG. Dr. Koh, Mr. Shah, VHCPM III and VHCPM EG disclaim beneficial ownership over all shares
held by VHCP III, VHCP III Co, and VHCP EG, except to the extent of their respective indirect pecuniary interests therein. The address
of the entities and individuals listed above is 7 Bryant Park, 23rd Floor, New York, NY 10018. |
| |
|
| (3) |
Shares
held by Soleus Private Equity Fund II, L.P. (“Soleus PE”) and Soleus Capital
Master Fund, L.P. (“Soleus Cap MF”), which we refer to collectively as the Soleus
Entities, consist of: (i) 343,832 shares of our common stock, 174,313 shares of our Series
A Preferred Stock convertible into 1,743,130 shares of our common stock and Warrants to purchase
834,780 shares of our common stock, in each case held by Soleus PE and (ii) 604,557
shares of our common stock (including 372,484 shares of common stock purchased under the
Securities Purchase Agreement and 232,073 shares of common stock acquired prior to the PIPE
Offering), 188,838 shares of our Series A Preferred Stock convertible into 1,888,380
shares of our common stock and Warrants to purchase 904,340 shares of our common stock, in
each case held by Soleus Cap MF.
The
ability of the Soleus Entities to convert their Series A Preferred Stock and exercise of their Warrants is subject to the Beneficial
Ownership Limitation as described above. The shares reported under “Shares of Common Stock Beneficially Owned Prior to Offering”
consist of 948,349 shares of our common stock and 1,351,149 shares of common stock issuable to the Soleus Entities upon conversion
of their Series A Preferred Stock or exercise of their Warrants. The shares reported under “Shares of Common Stock Beneficially
Owned Prior to Offering” do not include the remaining 4,161,541 shares of common stock issuable to the Soleus Entities upon
conversion of their Series A Preferred Stock and exercise of their Warrants due to the application of the Beneficial Ownership Limitation.
Soleus Private Equity GP II, LLC (“Soleus GP”) is the sole general partner of Soleus PE and Soleus PE GP II, LLC. (“Soleus
PE GP”) is the sole manager of Soleus GP. Soleus Capital, LLC (“Soleus Cap”) is the sole general partner of Soleus
Cap MF and Soleus Capital Group, LLC (“Soleus CG”) is the sole managing member of Soleus Cap. Mr. Guy Levy is the sole
manager of Soleus PE GP and sole managing member of Soleus CG. Mr. Levy, Soleus GP, Soleus PE GP, Soleus Cap and Soleus CG disclaim
beneficial ownership over all shares held by Soleus PE and Soleus Cap MF, except to the extent of their respective indirect pecuniary
interests therein. The address of the entities and individual listed above is 104 Field Point Road, 2nd Floor, Greenwich, CT 06830. |
| (4) |
Shares
held by Growth Equity Opportunities 18 VGE, LLC (“GEO”) consist of 1,250,001 shares of our common stock, 222,826 shares
of our Series A Preferred Stock convertible into 2,228,260 shares of our common stock and Warrants to purchase 1,391,300 shares of
our common stock. The ability of the selling stockholder to convert its Series A Preferred Stock and exercise of their Warrants is
subject to the Beneficial Ownership Limitation as described above. The shares reported under “Shares of Common Stock Beneficially
Owned Prior to Offering” consist of 1,250,001 shares of our common stock and 1,016,062 shares of common stock issuable to the
selling stockholder upon conversion of its Series A Preferred Stock or exercise of its Warrants. The shares reported under “Shares
of Common Stock Beneficially Owned Prior to Offering” do not include the remaining 2,603,498 shares of common stock issuable
to the selling stockholder upon conversion of its Series A Preferred Stock and exercise of its Warrants due to the application of
the Beneficial Ownership Limitation. NEA 18 Venture Growth Equity, L.P. (“NEA 18 VGE”) is the sole member of GEO. NEA
Partners 18 VGE, L.P. (“NEA Partners 18 VGE”) is the sole general partner of NEA 18 VGE; and NEA 18 VGE GP, LLC (“NEA
18 VGE LLC”) is the sole general partner of NEA Partners 18 VGE. The managers (collectively, the “Managers”) of
NEA 18 VGE LLC are Ali Behbahani (“Behbahani”), Carmen Chang (“Chang”), Anthony A. Florence, Jr. (“Florence”),
Liza Landsman (“Landsman”), Mohamad H. Makhzoumi (“Makhzoumi”), Edward T. Mathers (“Mathers”),
Scott D. Sandell (“Sandell”), Peter W. Sonsini (“Sonsini”), Paul Walker (“Walker”) and Rick Yang
(“Yang”). NEA 18 VGE, NEA Partners 18 VGE, NEA 18 VGE LLC and each of the Managers expressly disclaim beneficial ownership
over all shares held by GEO, except to the extent of their respective indirect pecuniary interests therein. The address of entities
listed above and Sandell is New Enterprise Associates, 1954 Greenspring Drive, Suite 600, Timonium, MD 21093. The address of Behbahani
and Mathers is New Enterprise Associates, 5425 Wisconsin Avenue, Suite 800, Chevy Chase, MD 20815. The address of Chang, Makhzoumi,
Sonsini, Walker and Yang is New Enterprise Associates, 2855 Sand Hill Road, Menlo Park, California 94025. The address of Florence
and Landsman is New Enterprise Associates, 104 5th Avenue, 19th Floor, New York, NY 10001. |
| (5) |
Shares
held by RA Capital Healthcare Fund, L.P. (“RACHF”) consist of 1,400,001 shares of our common stock, 181,739 shares of
our Series A Preferred Stock convertible into 1,817,390 shares of our common stock and Warrants to purchase 1,286,960 shares of our
common stock. The ability of the selling stockholder to convert its Series A Preferred Stock and exercise of their Warrants is subject
to the Beneficial Ownership Limitation as described above. The shares reported under “Shares of Common Stock Beneficially Owned
Prior to Offering” consist of 1,400,001 shares of our common stock and 849,414 shares of our common stock issuable to the selling
stockholder upon conversion of its Series A Preferred Stock or exercise of its Warrants. The shares reported under “Shares
of Common Stock Beneficially Owned Prior to Offering” do not include the remaining 2,254,936 shares of our common stock issuable
to the selling stockholder upon conversion of its Series A Preferred Stock and exercise of its Warrants due to the application of
the Beneficial Ownership Limitation. RA Capital Management, L.P. is the investment manager for RACHF. The general partner of RA Capital
Management, L.P. is RA Capital Management GP, LLC, of which Peter Kolchinsky and Rajeev Shah are the managing members. Each of Mr.
Kolchinsky and Mr. Shah may be deemed to have voting and investment power over the shares held by RACHF. Mr. Kolchinsky and Mr. Shah
disclaim beneficial ownership of such shares, except to the extent of any pecuniary interest therein. The address of the entities
and persons listed above is 200 Berkeley Street, 18th Floor, Boston, Massachusetts 02116. |
| |
|
| (6) |
Shares
held by Commodore Capital Master LP (“Commodore Master”) consist of 1,370,465 shares of our common stock (including
450,001 shares of common stock purchased under the Securities Purchase Agreement and 920,464 shares of common stock acquired prior
to the PIPE Offering), 128,913 shares of our Series A Preferred Stock convertible into 1,289,130 shares of our common stock and
Warrants to purchase 695,650 shares of our common stock. The ability of the selling stockholder to convert its Series A Preferred
Stock and exercise its Warrants is subject to the Beneficial Ownership Limitation as described above. The shares reported under “Shares
of Common Stock Beneficially Owned Prior to Offering” consist of 1,370,465 shares of our common stock and 882,226 shares of
our common stock issuable to the selling stockholder upon conversion of its Series A Preferred Stock or exercise of its Warrants.
The shares reported under “Shares of Common Stock Beneficially Owned Prior to Offering” do not include the remaining
1,102,554 shares of our common stock issuable to the selling stockholder upon conversion of its Series A Preferred Stock and exercise
of its Warrants due to the application of the Beneficial Ownership Limitation. Commodore Capital LP (the “Firm”) is the
investment manager to Commodore Master. Messrs. Michael Kramarz and Robert Egen Atkinson are the managing partners of the Firm. The
address of the entities and persons listed above is 767 Fifth Avenue, FL 12, New York, NY 10153 |
| |
|
| (7) |
Shares
held by Mr. Sullivan consist of 3,016,643 shares of our common stock, Warrants to purchase 104,340 shares of our common stock, and
options to purchase 338,401 shares of our common stock. Mr. Sullivan is the Chief Executive Officer of the Company and is a member
of the Company’s board of directors. The share numbers and percentages reported in the table for Mr. Sullivan do no not include
application of the Beneficial Ownership Limit. Stock options included in the reported numbers for Mr. Sullivan include those that
are currently vested or will vest within 60 days of December 30, 2022. Mr. Sullivan’s address is 16305 36th Avenue North,
Suite 100, Minneapolis, MN 55446. |
PLAN
OF DISTRIBUTION
Each
selling stockholder (the “Selling Stockholders”) of the securities and any of their pledgees, assignees and successors-in-interest
may, from time to time, sell any or all of their securities covered hereby on The Nasdaq Capital Market or any other stock exchange,
market or trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices.
A Selling Stockholder may use any one or more of the following methods when selling securities:
| ● |
ordinary
brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| ● |
block
trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block
as principal to facilitate the transaction; |
| ● |
purchases
by a broker-dealer as principal and resale by the broker-dealer for its account; |
| ● |
an
exchange distribution in accordance with the rules of the applicable exchange; |
| ● |
privately
negotiated transactions; |
| ● |
settlement
of short sales entered into after the effective date of the registration statement of which this prospectus is a part; |
| ● |
in
transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such securities at a stipulated
price per security; |
| ● |
through
the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
| ● |
a
combination of any such methods of sale; or |
| ● |
any
other method permitted pursuant to applicable law. |
The
Selling Stockholders may also sell securities under Rule 144 or any other exemption from registration under the Securities Act of 1933,
as amended (the “Securities Act”), if available, rather than under this prospectus.
Broker-dealers
engaged by the Selling Stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions
or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser)
in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction not in
excess of a customary brokerage commission in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or
markdown in compliance with FINRA IM 2121.01.
In
connection with the sale of the securities or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers
or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they
assume. The Selling Stockholders may also sell securities short and deliver these securities to close out their short positions, or loan
or pledge the securities to broker-dealers that in turn may sell these securities. The Selling Stockholders may also enter into option
or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the
delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer
or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The
Selling Stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters”
within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers
or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts
under the Securities Act. Each Selling Stockholder has informed the Company that it does not have any written or oral agreement or understanding,
directly or indirectly, with any person to distribute the securities.
The
Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the securities; provided,
however, that each Selling Stockholder will pay all underwriting discounts and selling commissions, if any, and any related legal
expenses incurred by it. The Company has agreed to indemnify the Selling Stockholders against certain losses, claims, damages and liabilities,
including liabilities under the Securities Act. The Company may be indemnified by the Selling Stockholders against civil liabilities,
including liabilities under the Securities Act, that may arise from any written information furnished to the Company by the Selling Stockholders
specifically for use in this prospectus in accordance with the related Registration Rights Agreement, or the Company may be entitled
to contribution.
We
agreed to keep the registration to which this prospectus relates effective until such time as there are no longer Registrable Securities
held by the selling stockholders. The resale securities
will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition,
in certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the
applicable state or an exemption from the registration or qualification requirement is available and is complied with.
Under
applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously
engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M,
prior to the commencement of the distribution. In addition, the Selling Stockholders will be subject to applicable provisions of the
Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the
common stock by the Selling Stockholders or any other person. We will make copies of this prospectus available to the Selling Stockholders
and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including
by compliance with Rule 172 under the Securities Act).
DESCRIPTION
OF CAPITAL STOCK
The
following summary of the terms of our capital stock is subject to and qualified in its entirety by reference to our certificate of incorporation,
as amended, and bylaws, copies of which are on file with the SEC as exhibits to previous SEC filings. Please refer to “Where You
Can Find More Information” below for directions on obtaining these documents.
As
of December 30, 2022, we were authorized to issue 65,000,000 shares of common stock, $0.001 par value per share, and 2,500,000
shares of preferred stock, $0.001 par value per share. As of December 30, 2022, we had 21,667,250 shares of common stock outstanding,
1,120,873 shares of Series A Preferred Stock outstanding and Warrants to purchase 6,956,450 shares of common stock outstanding.
Common
Stock
Voting
Rights
Each
holder of common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders.
Dividend
Rights
Holders
of our common stock are entitled to receive ratably any dividends that our board of directors may declare out of funds legally available
for that purpose.
Rights
and Preferences
Holders
of our common stock have no preemptive, conversion, subscription or other rights, and there are no redemption or sinking fund provisions
applicable to our common stock.
Right
to Liquidation Distributions
Upon
our liquidation, dissolution or winding-up, the assets legally available for distribution to our stockholders would be distributable
ratably among the holders of our common stock and any participating preferred stock outstanding at that time, subject to prior satisfaction
of all outstanding debt and liabilities and the preferential rights of and the payment of liquidation preferences, if any, on any outstanding
shares of preferred stock, including the liquidation preference of our Series A Preferred Stock.
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Continental Stock Transfer & Trust Company. The transfer agent and registrar’s
address is One State Street Plaza, 30th Floor, New York, NY 10004.
The
Nasdaq Capital Market
Our
common stock is listed for quotation on The Nasdaq Capital Market under the symbol “CELC”.
Preferred
Stock
Our
board or directors is authorized, without action by the stockholders, to designate and issue up to an aggregate of 2,500,000 shares of
preferred stock in one or more series. Our board of directors is authorized to designate the rights, preferences and privileges of the
shares of each series and any of its qualifications, limitations or restrictions. Our board of directors is able to 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 common
stock. The issuance of preferred stock, while providing flexibility in connection with possible future financings and acquisitions and
other corporate purposes could, under certain circumstances, have the effect of restricting dividends on our common stock, diluting the
voting power of our common stock, impairing the liquidation rights of our common stock, or delaying, deferring or preventing a change
in control of the Company, which might harm the market price of our common stock. See also “Anti-Takeover Effect of Delaware Law
and Certain Charter and Bylaw Provisions” below.
On
May 16, 2022, in connection with the PIPE Offering, the Company filed a Certificate of Designations (the “Certificate of Designations”)
with the Secretary of State of the State of Delaware, designating 1,850,000 shares out of the authorized but unissued shares of its preferred
stock as Series A Convertible Preferred Stock. The following is a summary of the principal terms of the Series A Preferred Stock:
Dividend
Rights
Holders
of Series A Preferred Stock shall be entitled to receive dividends or distributions on shares of Series A Preferred Stock equal (on an
as-if-converted-to-common stock basis) to and in the same form as dividends or distributions actually paid on shares of the common stock
when, as and if such dividends or distributions are paid on shares of the common stock. No other dividends or distributions shall be
paid on shares of Series A Preferred Stock.
Right
to Liquidation Distributions
In
the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, the holders of shares of Series A Preferred
Stock then outstanding shall be entitled to be paid out of the assets of the Company available for distribution to its stockholders,
and in the event of a Deemed Liquidation Event (as defined in the Certificate of Designations) the holders of shares of Series A Preferred
Stock then outstanding shall be entitled to be paid out of the consideration payable to stockholders in such Deemed Liquidation Event
or out of the Available Proceeds (as defined in the Certificate of Designations), as applicable, before any payment shall be made to
the holders of common stock by reason of their ownership thereof, an amount per share equal to the greater of (i) the Series A Original
Issue Price (as defined in the Certificate of Designations), plus any dividends declared but unpaid thereon, or (ii) such amount per
share as would have been payable had all shares of Series A Preferred Stock been converted into common stock pursuant to the Certificate
of Designations immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event (the “Series A Liquidation
Amount”).
Voting
Rights
The
Series A Preferred Stock is non-voting stock and does not entitle the holder thereof to vote on any matter submitted to the stockholders
of the Company for their action or consideration, except as otherwise provided by the General Corporation Law of the State of Delaware
or the other provisions of the Certificate of Incorporation or the Certificate of Designations.
As
long as any shares of Series A Preferred Stock are outstanding, the Company may not, without the approval of the holders of a majority
of the outstanding shares of Series A Preferred Stock, take the following actions: (i) amend, alter or repeal any provision of the Certificate
of Incorporation, the Certificate of Designations or Bylaws of the Company in a manner that adversely affects the powers, preferences
or rights of the Series A Preferred Stock; (ii) create, or authorize the creation of, or issue or obligate itself to issue shares of,
any additional class or series of capital stock unless the same ranks junior to the Series A Preferred Stock with respect to the distribution
of assets on the liquidation, dissolution or winding up of the Company, the payment of dividends and rights of redemption, or increase
the authorized number of shares of Series A Preferred Stock or increase the authorized number of shares of any additional class or series
of capital stock of the Company unless the same ranks junior to the Series A Preferred Stock with respect to the distribution of assets
on the liquidation, dissolution or winding up of the Company, the payment of dividends and rights of redemption; (iii) (A) reclassify,
alter or amend any existing security of the Company that is pari passu with the Series A Preferred Stock in respect of the distribution
of assets on the liquidation, dissolution or winding up of the Company, the payment of dividends or rights of redemption, if such reclassification,
alteration or amendment would render such other security senior to the Series A Preferred Stock in respect of any such right, preference,
or privilege or (B) reclassify, alter or amend any existing security of the Company that is junior to the Series A Preferred Stock in
respect of the distribution of assets on the liquidation, dissolution or winding up of the Company, the payment of dividends or rights
of redemption, if such reclassification, alteration or amendment would render such other security senior to or pari passu with the Series
A Preferred Stock in respect of any such right, preference or privilege; or (iv) purchase or redeem (or permit any subsidiary to purchase
or redeem) or pay or declare any dividend or make any distribution on, any shares of capital stock of the Company (with exceptions for
dividends on the common stock solely in the form of additional shares of common stock and repurchases from former service providers in
connection with the cessation of such services).
Conversion
Rights
Subject
to the Beneficial Ownership Limitation described below, each share of Series A Preferred Stock shall be convertible, at the option of
the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder thereof, into
such number of fully paid and non-assessable shares of common stock as is determined by multiplying one share of Series A Preferred Stock
by the Series A Conversion Rate in effect at the time of conversion. The “Series A Conversion Rate” shall initially be ten
(10) shares of Common Stock for each share of Series A Preferred Stock. The Series A Conversion Rate shall be subject to adjustment as
provided in the Certificate of Designation.
Under
the terms of the Certificate of Designations, the Company may not effect the conversion of Series A Preferred Stock into common stock,
and a holder will not be entitled to request the conversion of shares of Series A Preferred Stock, if, upon giving effect to such conversion,
the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates, any other persons acting
as a group together with the holder or any of the holder’s affiliates, and any other persons whose beneficial ownership of common
stock would or could be aggregated with the holder’s for purposes of Section 13(d) or Section 16 of the Securities Exchange Act
of 1934, as amended) would exceed the Beneficial Ownership Limitation, which is 9.99% of the number of shares of common stock outstanding
immediately after giving effect to the conversion, as such percentage ownership is calculated in accordance with Section 13(d) of the
Exchange Act and the applicable regulations of the Securities and Exchange Commission. A holder may reset the Beneficial Ownership Limitation
percentage to a higher percentage (not to exceed 19.9%), effective 61 days after written notice to the Company, or a lower percentage,
effective immediately upon written notice to the Company. Any such increase or decrease will apply only to that holder and not to any
other holder of Series A Preferred Stock.
The
Series A Preferred Stock does not have, or is subject to, any preemptive or similar rights.
Warrants
Under
the Securities Purchase Agreement, dated May 15, 2022 by and among the Company and the selling stockholders, the Company issued Warrants
to purchase 695,645 shares of Series A Preferred Stock, each Warrant having an exercise price of $85.50 per share, or $8.05 per share
on an as converted to common stock basis, a 40% premium to the price paid by the selling
stockholders for the initial shares of common stock purchased under the Securities Purchase Agreement.
On
September 1, 2022, the Company amended its Certificate of Incorporation to increase the aggregate authorized number of shares of capital
stock and the number of shares of common stock such that the company has available, and has reserved, such number of its duly authorized
but unissued shares of common stock as shall be sufficient to effect the conversion of all shares of Series A Preferred Stock then outstanding
or available for issuance upon the exercise of the Warrants. Following this Authorized Share Increase, and notice to the selling stockholders,
the Warrants became exercisable for an aggregate 6,956,450 shares of common stock with an exercise price per share adjusted of $8.05.
Each
Warrant, when issued, is immediately exercisable and will remain exercisable until the earlier of (i) five years from the date of issuance
and (ii) seventy-five (75) days after the Company announces (x) whether the progression-free survival (“PFS”) of gedatolisib
in combination with Palbociclib and fulvestrant (Arm A) to fulvestrant (Arm C) in the Phase 3 study met its primary endpoint target,
(y) whether the PFS of gedatolisib in combination with fulvestrant (Arm B) to fulvestrant (Arm C) in the Phase 3 study met its primary
endpoint target, and (z) the associated hazard ratios and median PFS values for each of Arm A, Arm B, and Arm C.
Under
the terms of the Warrants, the Company may not effect the exercise of any such Warrant, and a holder will not be entitled to request
the exercise any portion of any Warrant, if, upon giving effect to such exercise, the aggregate number of shares of common stock beneficially
owned by the holder (together with its affiliates, any other persons acting as a group together with the holder or any of the holder’s
affiliates, and any other persons whose beneficial ownership of common stock would or could be aggregated with the holder’s for
purposes of Section 13(d) or Section 16 of the Securities Exchange Act of 1934, as amended) would exceed the Beneficial Ownership Limitation
as described in the “Preferred Stock—Conversion Rights” section above. A holder may reset the Beneficial Ownership
Limitation percentage to a higher percentage (not to exceed 19.9%), effective 61 days after written notice to the Company, or a lower
percentage, effective immediately upon written notice to the Company. Any such increase or decrease will apply only to that holder and
not to any other holder of Warrants.
Registration
Rights Agreement
In
connection with the PIPE Offering, the Company entered into the Registration Rights Agreement with the selling stockholders, pursuant
to which the Company agreed to register for resale the Registrable Securities, which include: (i) the common stock, (ii) the shares of
common stock then issued or issuable upon conversion of the Series A Preferred Stock (assuming on such date the shares of Series A Preferred
Stock are convertible in full without regard to any conversion limitations in the Certificate of Designations), and (iii) the common
stock then issued or issuable upon exercise of the Warrants (assuming the Warrants are exercisable in full without regard to any exercise
limitations therein). Under the Registration Rights Agreement, the Company agreed to file the registration statement to which
this prospectus relates covering the resale by the selling stockholders of the Registrable Securities no later than 30 days following
(i) the Closing Date and (ii) the date the Company obtains the necessary stockholder approval to effect the Authorized Share Increase.
The Company agreed to use commercially reasonable efforts to cause the registration statement to which this prospectus relates
to become effective and to keep such registration statement effective until such time as there are no longer Registrable Securities
held by the selling stockholders. The Company has also agreed to be responsible for all fees and expenses incurred in connection
with the registration of the Registrable Securities.
In
the event (i) the registration statement to which this prospectus relates had not been filed within the time period specified
above, (ii) the registration statement to which this prospectus relates, as may be amended, had not been declared
effective (A) by February 7, 2023 (the 60th day after the Closing Date) (or, in the event of a review by the SEC, March 9, 2023 (the
90th day after the Closing Date)) or (B) within ten business days following the date the Company was notified by the SEC that
the registration statement will not be reviewed or is no longer subject to further review and comments, or (iii) after such registration
statement was declared effective by the SEC, sales cannot be made pursuant to such registration statement for any reason (including
without limitation by reason of a stop order, or the Company’s failure to update such registration statement), but excluding any
Allowed Delay (as defined in the Registration Rights Agreement) or, if the registration statement would have instead been on Form S-1,
for a period of twenty (20) days following the date on which the Company files a post-effective amendment to incorporate the Company’s
Annual Report on Form 10-K, then the Company agreed to make pro rata payments to each holder as liquidated damages in an amount equal
to 1.0% of the aggregate amount invested by each such holder in the Registrable Securities then held by the holder per 30-day period
or pro rata for any portion thereof for each such month during which such event continues, provided that the maximum aggregate amounts
payable as liquidated damages shall not exceed 5.0% of the aggregate amount invested by each such holder in the Registrable Securities
then held by the holder.
The
Company has granted the selling stockholders customary indemnification rights in connection with the registration statement to which
this prospectus relates, including for liabilities arising under the Securities Act. The selling stockholders have also granted the
Company customary indemnification rights in connection with the registration statement. The representations, warranties and covenants
contained in the Warrants, the Securities Purchase Agreement and the Registration Rights Agreement were made solely for the benefit of
the parties thereto and may be subject to limitations agreed upon by the contracting parties.
Anti-Takeover
Effect of Delaware Law and Certain Charter and Bylaw Provisions
Our
certificate of incorporation, as amended, and bylaws contain provisions that could have the effect of discouraging potential acquisition
proposals or tender offers or delaying or preventing a change of control of our Company. A summary of these provisions is as follows:
| ● | Board
of directors vacancies. Our bylaws authorize only our board of directors to fill
vacant directorships, including newly created seats. In addition, the number of directors
constituting our board of directors will be permitted to be set only by a resolution adopted
by our board of directors. These provisions would prevent a stockholder from increasing the
size of our board of directors and then gaining control of our board of directors by filling
the resulting vacancies with its own nominees. This makes it more difficult to change the
composition of our board of directors but promotes continuity of management. |
| | | |
| ● | Advance
notice requirements for stockholder proposals and director nominations. Our bylaws
provide advance notice procedures for stockholders seeking to bring business before our annual
meeting of stockholders or to nominate candidates for election as directors at our annual
meeting of stockholders. Our bylaws also specify certain requirements regarding the form
and content of a stockholder’s notice. These provisions might preclude our stockholders
from bringing matters before our annual meeting of stockholders or from making nominations
for directors at our annual meeting of stockholders if the proper procedures are not followed.
These provisions may also discourage or deter a potential acquirer from conducting a solicitation
of proxies to elect the acquirer’s own slate of directors or otherwise attempting to
obtain control of the Company. |
| | | |
| ● | No
cumulative voting. The Delaware General Corporation Law, or DGCL, provides that stockholders
are not entitled to the right to cumulate votes in the election of directors unless a corporation’s
certificate of incorporation provides otherwise. Our certificate of incorporation, as amended,
does not provide for cumulative voting. |
| | | |
| ● | Stockholder
action; special meetings of stockholders. Our certificate of incorporation, as amended,
provides that our stockholders may not take action by written consent, but may only take
action at annual or special meetings of our stockholders. As a result, a holder controlling
a majority of our capital stock would not be able to amend our bylaws or remove directors
without holding a meeting of our stockholders called in accordance with our bylaws. Further,
our bylaws provide that special meetings of our stockholders may be called only by a majority
of our board of directors, the chairperson of our board of directors, or our Chief Executive
Officer, thus prohibiting a stockholder from calling a special meeting. These provisions
might delay the ability of our stockholders to force consideration of a proposal or for stockholders
controlling a majority of our capital stock to take any action, including the removal of
directors. |
| | | |
| ● | Issuance
of undesignated preferred stock. As of the date of this prospectus, we have 650,000
shares of undesignated preferred stock. Subject to certain limitations and approval requirements
with respect to our Series A Preferred Stock as described in “Preferred Stock –
Voting Rights” above, our board of directors has the authority, without further action
by the stockholders, to issue this preferred stock with rights and preferences, including
voting rights, designated from time to time by our board of directors. The existence of authorized
but unissued shares of preferred stock would enable our board of directors to render more
difficult or to discourage an attempt to obtain control of us by means of a merger, tender
offer, proxy contest or other means. |
| | | |
| ● | Amendment
of charter and bylaw provisions. The affirmative vote of stockholders representing
at least two-thirds of the voting power of all then-outstanding capital stock, and in certain
instances, the vote of the holders of a majority of the then-outstanding Series A Preferred
Stock, is required to amend, alter or repeal certain provisions of our certificate of incorporation,
as amended, including the provision noted above regarding stockholders not being able to
act by written consent. Subject to certain limitations and approval requirements with respect
to our Series A Preferred Stock as described in “Preferred Stock – Voting Rights”
above, a majority of our board of directors has authority to adopt, amend or repeal provisions
of our bylaws. Stockholders also have the authority to adopt, amend or repeal provisions
of our bylaws, but only with the affirmative vote of stockholders representing at least two-thirds
of the voting power of all then-outstanding capital stock and in certain instances, the vote
of the holders of a majority of the then-outstanding Series A Preferred Stock. |
We
are subject to the provisions of Section 203 of the DGCL, an anti-takeover law. In general, Section 203 prohibits a publicly held Delaware
corporation from engaging in a “business combination” with an “interested stockholder” for a period of three
years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved
in a prescribed manner. For purposes of Section 203, a “business combination” includes a merger, asset sale or other transaction
resulting in a financial benefit to the interested stockholder, and an “interested stockholder” is a person who owns 15%
or more of the voting stock of a corporation, or any affiliate or associate of a corporation who, within three years prior, did own 15%
or more of the voting stock of that corporation.
Indemnification
of Directors and Officers
Section
102(b)(7) of the DGCL provides that a Delaware corporation, in its certificate of incorporation, may limit the personal liability of
a director to the corporation or its stockholders for monetary damages for breach of fiduciary duties as a director, except for liability
for any:
| ● | transaction
from which the director derived an improper personal benefit; |
| | | |
| ● | act
or omission not in good faith or that involved intentional misconduct or a knowing violation
of law; |
| | | |
| ● | unlawful
payment of dividends or redemption of shares; or |
| | | |
| ● | breach
of the director’s duty of loyalty to the corporation or its stockholders. |
Section
145(a) of the DGCL provides, in general, that a Delaware corporation may indemnify 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
(other than an action by or in the right of the corporation) because that person is or was a director, officer, employee or agent of
the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation
or other enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement
actually and reasonably incurred by the person in connection with such action, so long as the person acted in good faith and in a manner
he or she reasonably believed was in or not opposed to the corporation’s best interests, and, with respect to any criminal action
or proceeding, had no reasonable cause to believe his or her conduct was unlawful.
Section
145(b) of the DGCL provides, in general, that a Delaware corporation may indemnify any person who was or is a party, or is threatened
to be made a party, to any threatened, pending or completed action or suit by or in the right of the corporation to obtain a judgment
in its favor because the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request
of the corporation as a director, officer, employee or agent of another corporation or other enterprise. The indemnity may include expenses
(including attorneys’ fees) actually and reasonably incurred by the person in connection with the defense or settlement of such
action, so long as the person acted in good faith and in a manner the person reasonably believed was in or not opposed to the corporation’s
best interests, except that no indemnification shall be permitted without judicial approval if a court has determined that the person
is to be liable to the corporation with respect to such claim. Section 145(c) of the DGCL provides that, if a present or former director
or officer has been successful in defense of any action referred to in Sections 145(a) and (b) of the DGCL, the corporation must indemnify
such officer or director against the expenses (including attorneys’ fees) he or she actually and reasonably incurred in connection
with such action.
Section
145(g) of the DGCL provides, in general, that a corporation may purchase and maintain insurance on behalf of any person who is or was
a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer,
employee or agent of another corporation or other enterprise against any liability asserted against and incurred by such person, in any
such capacity, or arising out of his or her status as such, whether or not the corporation could indemnify the person against such liability
under Section 145 of the DGCL.
Our
certificate of incorporation, as amended, and our bylaws provide for the limitation of liability and indemnification of our directors
and officers to the fullest extent permitted under the DGCL.
We
have also entered into separate indemnification agreements with our directors and officers in addition to the indemnification provided
for in our certificate of incorporation, as amended, and our bylaws. These indemnification agreements provide, among other things, that
we will indemnify our directors and officers for certain expenses, including damages, judgments, fines, penalties, settlements and costs
and attorneys’ fees and disbursements, incurred by a director or officer in any claim, action or proceeding arising in his or her
capacity as a director or officer of the Company or in connection with service at our request for another corporation or entity. The
indemnification agreements also provide for procedures that will apply in the event that a director or officer makes a claim for indemnification.
We
also maintain a directors’ and officers’ insurance policy pursuant to which our directors and officers are insured against
liability for actions taken in their capacities as directors and officers.
SEC
Position on Indemnification for Securities Act Liabilities
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted for directors, officers or persons controlling our
Company, we understand that it is the SEC’s opinion that such indemnification is against public policy as expressed in the Securities
Act and therefore is unenforceable.
WHERE
YOU CAN FIND MORE INFORMATION
We
have filed a registration statement on Form S-3 with the SEC for the securities we are offering by this prospectus. This prospectus does
not include all of the information contained in the registration statement. You should refer to the registration statement and its exhibits
for additional information.
We
are required to file annual and quarterly reports, special reports, proxy statements, and other information with the SEC. We make these
documents publicly available, free of charge, on our website at www.celcuity.com as soon as reasonably practicable after filing such
documents with the SEC. Please note, however, that information on our website is not, and should
not be deemed to be, a part of this prospectus. You can read our SEC filings, including the registration statement, on the SEC’s
website at http://www.sec.gov.
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
The
SEC allows us to “incorporate by reference” into this prospectus the information we file with it, which means that we can
disclose important information to you by referring you to those documents. The information incorporated by reference is considered to
be part of this prospectus, and information in documents that we file later with the SEC will automatically update and supersede information
in this prospectus. We incorporate by reference into this prospectus the documents listed below and any future filings made by us with
the SEC under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act until we close this offering, including all filings made after the
date of the initial registration statement and prior to the effectiveness of the registration statement. We hereby incorporate by reference
the following documents:
| ● | Our
Annual Report on Form 10-K for the year ended December 31, 2021, filed on March 23, 2022; |
| ● | Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed on May 16, 2022,
our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed on August 12,
2022, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed
on November 10, 2022; |
| ● | Our
Current Reports on Form 8-K or Form 8-K/A (excluding any reports or portions thereof that
are deemed to be furnished and not filed) filed on May 16, 2022, May 18, 2022, May 19, 2022,
July 29, 2022, August 11, 2022, September 1, 2022, September 14, 2022, November 9, 2022,
November 10, 2022, and December 23, 2022; |
| ● | Our
definitive Proxy Statement filed on April 11, 2022 and our definitive Proxy Statement filed
on July 19, 2022; and |
| ● | The
description of our common stock contained in our registration statement on Form 8-A filed
September 15, 2017, under the Securities Act, including any amendment or report filed for
the purpose of updating such description. |
You
may request a copy of these filings, at no cost, by writing or telephoning us at the following address:
Celcuity
Inc.
16305
36th Avenue N., Suite 100
Minneapolis,
MN 55446
Attention:
Investor Relations
Phone:
(763) 392-0123
Copies
of these filings are also available, without charge, through the “Investors” section of our website (www.celcuity.com) as
soon as reasonably practicable after they are filed electronically with the SEC. Please note, however,
that information on our website is not, and should not be deemed to be, a part of this prospectus.
LEGAL
MATTERS
The
validity of the issuance of the securities offered hereby will be passed upon for us by Fredrikson & Byron, P.A., Minneapolis, Minnesota.
EXPERTS
The
audited financial statements incorporated by reference in this prospectus and elsewhere in the registration statement have been so incorporated
by reference in reliance upon the report of Boulay PLLP, our independent registered public accountants, upon the authority of said firm
as experts in accounting and auditing.
PROSPECTUS
CELCUITY
INC.
24,347,754
SHARES OF COMMON STOCK
January 12, 2023
We
have not authorized any dealer, salesperson or other person to give any information or represent anything not contained in this prospectus.
You must not rely on any unauthorized information. If anyone provides you with different or inconsistent information, you should not
rely on it. This prospectus does not offer to sell any shares in any jurisdiction where it is unlawful. Neither the delivery of this
prospectus, nor any sale made hereunder, shall create any implication that the information in this prospectus is correct after the date
hereof.
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