Initial tranche of $20
Million extends cash runway into 1H26, subsequent tranche of
up to $52.6 Million will provide for
runway 3+ years enabling the company to reach both near-term and
long-term value inflecting readouts
NEWTOWN,
Pa., Dec. 30, 2024 /PRNewswire/ -- Traws
Pharma, Inc. (NASDAQ: TRAW) ("Traws Pharma", "Traws" or "the
Company"), a clinical-stage biopharmaceutical company developing
oral small molecule therapies for the treatment of respiratory
viral diseases including bird flu, today announced that it has
entered into definitive agreements to raise up to $72.6 million before deduction of placement
agent's fees and other estimated offering expenses. The initial
tranche of $20 million gross proceeds
will come in at closing for the issuance and sale of an aggregate
of 3,919,249.00 shares of common stock and pre-paid warrants, and
up to another $52.6 million upon
exercise of non-prepaid warrants issued with the offering if
exercised in full within 30 days of the later of the following key
data read outs: Ferret Bird Flu Data and Non-Human Primate Bird Flu
Data (both expected early-1Q25) and Phase 2A Data (expected-2H25).
The closing of the offering is expected to occur on or about
December 31, 2024, subject to the
satisfaction of customary closing conditions.
"We are appreciative of the support from new and existing
institutional investors including Perceptive Advisors, OrbiMed,
Alyeska, Torrey Pines and Ikarian Capital. This financing by high
quality investors is transformative for Traws and highlights the
meaningful potential for Tivoxavir Marboxil," said Iain D.
Dukes, MA, DPhil, Executive
Chairman of Traws Pharma and Venture Partner of OrbiMed.
Robert R. Redfield, MD, Chief
Medical Officer for Traws Pharma and former Director of the
U.S. Centers for Disease Control and Prevention (CDC) commented,
"With increasing numbers of human infections and recent reports of
severe cases, we should be alert to the rising potential for
epidemic or pandemic spread of bird flu." According to C.
David Pauza, PhD, Chief Science
Officer for Traws Pharma, Tivoxavir Marboxil has demonstrated
potent inhibition of bird flu viruses as well as drug-resistant
influenza viruses both in vitro and in vivo.
Traws Pharma will host an update call on Tivoxavir Marboxil
during the first quarter of 2025 with additional details
forthcoming.
Tungsten Advisors acted as the sole placement agent for the
offering.
This announcement is neither an offer to sell, nor a
solicitation of an offer to buy, any of these securities and shall
not constitute an offer, solicitation or sale in any state or
jurisdiction in which such offer, solicitation or sale is unlawful.
Any offer, if at all, will be made only by means of the prospectus
forming a part of the effective registration statement.
About H5N1 Bird Flu
The virus, also known as Type A H5N1 was detected for the first
time in U.S. dairy cattle in March
2024. Since then, bird flu has been confirmed in at least
866 herds in 16 states. More than 60 people in eight states have
been infected according to the U.S. Centers for Disease Control and
Prevention. Health officials confirmed in December 2024 the first known severe illness in
the U.S. caused by bird flu. The California governor declared a state of
emergency as the virus rampages through dairy cattle in that
state.
About Tivoxavir Marboxil
Seasonal influenza is estimated to represent a multi-billion
antiviral market opportunity, largely driven by global health
organizations, practice guidelines and government tenders, with
upside potential from pandemic flu outbreaks. Tivoxavir Marboxil
(also known as AV5124 or TRX-100) was designed as an inhibitor of
the highly conserved influenza protein, CAP-dependent endonuclease
(CEN). It has demonstrated potent in vitro activity against a range
of influenza strains, including the highly pathogenic avian flu, in
preclinical studies. The drug candidate's Phase 1 pharmacokinetic
(PK) profile in healthy subjects, including the ability to achieve
plasma levels that are consistently above the EC90 (as determined
in laboratory studies), for more than twenty-three days with higher
dose data to come, may enable a single dose prophylaxis regimen.
These data, combined with good overall tolerability results in
healthy subjects and prevention of lethal influenza in animal
models, supports further development of Tivoxavir Marboxil as a
one-time treatment for influenza.
About Tungsten Advisors
Tungsten Advisors (www.tungstenadv.com) is an investment banking
firm focused on strategic advisory and corporate finance for
healthcare companies. Tungsten provides transactional services
including financings (PPs/PIPEs/RDs), corporate licensing and
mergers and acquisitions (securities offered through its
Broker-Dealer, Finalis Securities LLC). Tungsten also focuses on
company incubation and makes direct investments alongside the
creation of new companies in healthcare.
Financing Disclosures
A portion of the securities to be sold in this financing have
not been registered under the Securities Act of 1933, as amended
(the "Securities Act"), or any state or other applicable
jurisdiction's securities laws and may not be offered or sold in
the United States absent
registration or an applicable exemption from the registration
requirements of the Securities Act and applicable state or other
jurisdictions' securities laws. Pursuant to the securities
purchase agreement with investors, Traws Pharma has agreed to file
a registration statement with the SEC to register the resale by the
investors of the securities sold in the private placement.
A portion of the securities are being offered by the Company
pursuant to an effective shelf registration statement on
Form S-3 (File No. 333-273081 that was declared
effective by the U.S. Securities and Exchange Commission ("SEC") on
July 11, 2023. This offering is being
made only by means of a prospectus and related prospectus
supplement. A prospectus supplement relating to and describing the
terms of the offering will be filed with the SEC and will be
available on the SEC's website at www.sec.gov. When available,
electronic copies of the prospectus supplement and the accompanying
prospectus may also be obtained from Tungsten Advisors (through its
Broker-Dealer, Finalis Securities LLC), 767 Third Ave, 29th Floor,
New York, NY 10017, by phone at
(917) 268-1097 or email at
prospectus@tungstenadv.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking
statements within the meaning of Section 27A of the Securities Act,
Section 21E of the Securities Exchange Act of 1934, as amended, and
the Private Securities Litigation Reform Act of 1995, and involve
risks and uncertainties. These statements relate to Traws Pharma
expectations regarding its products, its collaborations, its
clinical trials, planned update calls with investors, planned FDA
approvals or other development plans, the use of proceeds of the
offering, and the satisfaction of the closing conditions set forth
in the securities purchase agreement. Traws has attempted to
identify forward-looking statements by terminology including
"believes," "estimates," "anticipates," "expects," "plans,"
"intends," "may," "could," "might," "will," "should,"
"approximately" or other words that convey uncertainty of future
events or outcomes. Although Traws believes that the expectations
reflected in such forward-looking statements are reasonable as of
the date made, expectations may prove to have been materially
different from the results expressed or implied by such
forward-looking statements. These statements are only predictions
and involve known and unknown risks, uncertainties, and other
factors, including Traws' ability to continue as a going concern,
the need for additional financing, risks associated with market
conditions, the success and timing of Traws' clinical trials
and regulatory approval of protocols, the closing of this offering,
the use of proceeds of this offering, market and other conditions
and those discussed under the heading "Risk Factors" in Traws
Pharma's most recent Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q filed with the SEC. Any forward-looking
statements contained in this release speak only as of its date.
Traws undertakes no obligation to update any forward-looking
statements contained in this release to reflect events or
circumstances occurring after its date or to reflect the occurrence
of unanticipated events.
General Contact
Mark Guerin
267-759-3680
ir@trawspharma.com
http://www.trawspharma.com/contact/
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SOURCE Traws Pharma, Inc.
