The total committed funding is expected to
provide sufficient capital to fund Talphera through a potential FDA
approval of Niyad™, targeted for the first half of 2025
$16 million of
total equity committed with $6
million upfront and $10
million upon the announcement of positive NEPHRO
registration trial data
Existing investors, Nantahala Capital and
Rosalind Advisors, committed the total equity capital priced
at-the-market as defined by Nasdaq rules
$8 million of
non-dilutive capital received from XOMA Royalty from the partial
monetization of DSUVIA royalties and milestones
Upon XOMA Royalty receiving a specified
return, Talphera and XOMA Royalty will share in certain royalties
and milestones earned from the sales of DSUVIA
Abhinav Jain
from Nantahala Capital Management will join the Talphera Board at
closing of the equity offering
SAN
MATEO, Calif., Jan. 18,
2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq:
TLPH), (Talphera), a specialty pharmaceutical company focused on
the development and commercialization of innovative therapies for
use in medically supervised settings, today announced a total of
$26 million of committed capital
including $8 million from a partial
monetization of DSUVIA royalties and milestones, $6 million of equity issued at a first closing,
$10 million of committed capital upon
the announcement of positive NEPHRO registration trial data, and an
additional $2 million if Talphera
stock trades above a specified price following the NEPHRO
registration trial announcement.
"The combination of the non-dilutive and equity financing
transactions is expected to secure our funding through a potential
FDA approval of Niyad targeted for the first half of 2025," said
Vince Angotti, Talphera Chief
Executive Officer. "The strong support from Nantahala and
Rosalind demonstrated by the capital committed further enforces our
belief in Niyad's market potential and the significance of the
recent corporate rebranding to Talphera. We are eager to
demonstrate through our pivotal study why Niyad has received
Breakthrough Designation from the FDA, and potentially introduce a
much-anticipated new alternative to healthcare providers,"
continued Angotti. "Finally, being able to secure a
non-dilutive royalty capital solution from XOMA to focus our
resources on Niyad while still being able to participate in the
DSUVIA royalty and milestone stream is an ideal transaction for
Talphera. While we continue to believe in DSUVIA's long-term
potential in the hands of Alora, our priority has shifted to
advancing our lead program, Niyad, with the execution of the NEPHRO
registration trial and the expected Niyad PMA submission later this
year."
The equity offering and commitment
The equity issuance transaction with Nantahala Capital and
Rosalind Advisors totals $18 million,
with (a) $6 million at the first
closing, (b) $10 million at the
second closing upon Talphera announcing the achievement of the
NEPHRO registration trial's primary endpoint and a statistically
significant secondary endpoint of mean post-filter activated
clotting time (ACT) composed of measurements made in the first 72
hours (the "Pivotal Trial Milestone"), and (c) an additional $2
million should Talphera stock trade at a price of at least $0.92
per share for 5 days after the announcement of the NEPHRO
registration trial data (the "Price Milestone"). At closing,
expected on January 19, 2024, Abhinav Jain of Nantahala Capital
Management will join Talphera's Board of Directors, further
strengthening Talphera's Board.
Talphera will issue 7,792,208 pre-funded warrants in lieu of
shares to purchase common stock at a price of $0.769 per share at the first closing of the
transaction. The warrants will have an exercise price of
$0.001 per share, for a total
purchase price per share of common stock of $0.77. Talphera expects to issue 12,987,013
pre-funded warrants in lieu of common stock at a price of
$0.769 per share at a second closing
upon the achievement of the Pivotal Trial Milestone, and 2,597,403
pre-funded warrants in lieu of common stock at a price of
$0.769 per share upon the achievement
of the Price Milestone. See below for further details about
the equity offering.
In addition, Talphera will amend certain Series A common stock
warrants to purchase up to 2,941,178 shares of common stock and
certain Series B common stock warrants to purchase up to 2,941,178
shares of common stock previously issued to Nantahala and Rosalind
in July 2023, to lower the exercise
price of such warrants to $0.77 per
share. The total additional capital available to the Company
should all outstanding Series A and Series B common stock warrants
be exercised is $14.4 million.
The royalty financing transaction
Talphera has completed a partial monetization of its DSUVIA
royalties and milestones with XOMA for $8
million. Upon XOMA achieving a specified return,
Talphera and XOMA will share equally in the royalties earned on
DSUVIA sales to the Department of Defense, and all milestones
earned. This transaction was closed on January 12, 2024. The previous sale of
DSUVIA to Alora generates a 15% royalty on commercial sales of
DSUVIA, 75% royalties on sales of DSUVIA to the Department of
Defense and up to $116.5 million in
sales-based milestones.
Corporate updates
Talphera expects the committed funding to provide sufficient
capital to fund Talphera through a potential approval of Niyad,
targeted in the first half of 2025. Talphera expects the
top-line data read-out of its NEPHRO registration trial in the
third quarter of 2024, with an expected pre-market approval (PMA)
application submitted before the end of 2024. Talphera
preliminary cash balance at the end of 2023 totaled approximately
$9.4 million. Cash operating
expenses, or selling, general and administrative, and research and
development expenses, excluding stock-based compensation, is
expected to be in the range of $21
million to $23 million in
2024, which includes the initiation and expected completion of the
NEPHRO registration trial during the year.
The offer and sale of the securities described above are being
offered and sold in a private placement under Section 4(a)(2) of
the Securities Act of 1933, as amended (the "Act"), and Regulation
D promulgated thereunder, and have not been registered under the
Act, or applicable state securities laws. Accordingly, such
securities may not be offered or sold in the United States except pursuant to an
effective registration statement or an applicable exemption from
the registration requirements of the Act and such applicable state
securities laws.
The Company has agreed to file a registration statement under
the Act with the Securities and Exchange Commission (the "SEC"),
covering the resale of the shares of common stock to be issued in
the private placement and the shares of common stock underlying the
pre-funded warrants no later than 15 days following the closing
date, and to use reasonable best efforts to have the registration
statement declared effective as promptly as practical thereafter,
and in any event no later than 90 days following the closing date
in the event of a "full review" by the SEC.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy any of the securities described
herein, nor shall there be any sale of these securities in any
state or other jurisdiction in which such an offer, solicitation or
sale would be unlawful prior to registration or qualification under
the securities laws of any such state or other jurisdiction.
About Talphera, Inc.
Talphera, Inc. is a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for use in medically
supervised settings. Talphera's lead product candidate, Niyad™ is a
lyophilized formulation of nafamostat and is currently being
studied under an investigational device exemption, or IDE, as an
anticoagulant for the extracorporeal circuit, and has received
Breakthrough Device Designation status from the FDA. Talphera is
also developing two pre-filled syringes in-licensed from its
partner Aguettant: Fedsyra™, a pre-filled ephedrine syringe, and
PFS-02, a pre-filled phenylephrine syringe. This release is
intended for investors only. For additional information about
Talphera, please visit www.talphera.com.
About Nafamostat
Nafamostat is a broad spectrum,
synthetic serine protease inhibitor with anticoagulant,
anti-inflammatory and potential anti-viral activities. Niyad™ is a
lyophilized formulation of nafamostat and is currently being
studied under an investigational device exemption (IDE), as an
anticoagulant for the extracorporeal circuit, and has received
Breakthrough Device Designation Status from the FDA. LTX-608 is a
proprietary nafamostat formulation for direct IV infusion that may
be investigated and developed for the treatment of acute
respiratory distress syndrome (ARDS), disseminated intravascular
coagulation (DIC), acute pancreatitis and COVID, amongst other
potential targets.
Forward-looking statements
This press release contains
forward-looking statements based upon Talphera's current
expectations. These and any other forward-looking statements are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by the use of forward-looking terminology such as
"potential," "potentially," "believe," "expect," "anticipate,"
"may," "will," "if," "enable," "should," "seek," "approximately,"
"intends," "intended," "plans," "planned," "planning," "targeted,"
"estimates," "sufficient," "benefits," or the negative of these
words or other comparable terminology, and include Talphera's
statements regarding a potential FDA approval of Niyad
targeted for the first half of 2025; Talphera's expectation of the
top-line data read out of its NEPHRO registration trial in the
third quarter of 2024, with an expected PMA application submitted
before the end of 2024; Talphera's expectation that the committed
funding will provide sufficient capital to fund Talphera through a
potential approval of Niyad, targeted in the first half of 2025;
and Talphera's expected cash operating expenses for 2024. The
discussion of strategy, plans or intentions may also include
forward-looking statements, which are predictions, projections and
other statements about future events that are based on current
expectations and assumptions. These forward-looking statements
involve risks and uncertainties that could cause actual results to
differ materially from those projected, anticipated or implied by
such statements, including: (i) risks relating to Talphera's
product development activities and ongoing commercial business
operations; (ii) risks related to the ability of Talphera and its
business partners to implement development plans, launch plans,
forecasts and other business expectations; (iii) risks related to
unexpected variations in market growth and demand for Talphera 's
commercial and developmental products and technologies; (iv) risks
related to Talphera 's liquidity and its ability to maintain
capital resources sufficient to conduct the required clinical
studies; (v) Talphera 's ability to retain its listing on the
Nasdaq exchange; and (vi) risks relating to Talphera's ability to
obtain regulatory approvals for its developmental product
candidates. Although it is not possible to predict or identify all
such risks and uncertainties, they may include, but are not limited
to, those described under the caption "Risk Factors" and elsewhere
in Talphera 's annual, quarterly and current reports (i.e., Form
10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC
and any subsequent public filings. You are cautioned not to place
undue reliance on any such forward-looking statements, which speak
only as of the date such statements were first made. To the degree
financial information is included in this press release, it is in
summary form only and must be considered in the context of the full
details provided in Talphera 's most recent annual, quarterly or
current report as filed or furnished with the SEC. Talphera 's SEC
reports are available at www.talphera.com under the "Investors"
tab. Except to the extent required by law, Talphera undertakes no
obligation to publicly release the result of any revisions to these
forward-looking statements to reflect new information, events or
circumstances after the date hereof, or to reflect the occurrence
of unanticipated events.
Non-GAAP Financial Measures
Estimated cash operating
expenses for 2024 is a forward-looking non-GAAP financial
measure. Talphera does not provide a reconciliation for
non-GAAP estimates on a forward-looking basis where it is unable to
provide a meaningful calculation or estimate of reconciling items
and the information is not available without unreasonable effort.
This is due to the inherent difficulty of forecasting the timing or
amount non-cash stock-based compensation and other items that would
impact the most directly comparable forward-looking U.S. GAAP
financial measure that have not yet occurred and cannot be
reasonably estimated. Forward-looking non-GAAP financial measures
provided without the most directly comparable U.S. GAAP financial
measures may vary materially from the corresponding U.S. GAAP
financial measures.
Preliminary Financial Information
Talphera's estimate
of its cash as of December 31, 2023
is based on management's preliminary, unaudited analysis of
Talphera's financial results as of and for year ended December 31, 2023, and is subject to change as a
result of the completion of the Company's standard financial and
operating closing procedures and customary audit procedures.
The Company's independent registered accounting firm has not
audited the preliminary financial data discussed in this press
release. As a result, the preliminary cash estimate
constitutes forward-looking information and is subject to risks and
uncertainties, including possible adjustments. Accordingly,
investors should not place undue reliance on this preliminary
financial data.
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SOURCE Talphera, Inc.
