Completed acquisition of Trawsfynydd and concurrently closed $14 million in capital raising
Exciting progress in pipeline led by candidates in COVID-19, influenza and oncology programs
Our influenza candidate and
Ritonavir-free Novel Coronavirus Infection 19 Protease Inhibitor
NEWTOWN, Pa., May 16, 2024 (Globe Newswire) — Traws Pharma, Inc. (“Traws” or “ Traws Pharma'') announced its financial results today. Provided first quarter 2024 financial and business updates.
“2024 is a transformational year for Traws Pharma as we advance our portfolio of new therapies and oncology programs for serious respiratory infections. In addition, the Company has initiated first human doses of its COVID 19 product candidate, including the completion of the first cohort dosing group. “We have completed the last dose escalation cohort of our inhibitor, nalazaciclib.” Dr. Werner Cautrells, Chief Executive Officer of Trouz Pharma. “We will make further meaningful progress in the second half of 2024 by expanding our Phase 1 dose escalation studies and commencing Phase 2 development of our influenza treatment and ritonavir-free protease inhibitor for COVID-19. I believe we can.”
“Based on the preclinical profile and early clinical data of our infectious disease drug candidate and narazaciclib, I am optimistic about the outlook for Traws’ portfolio and look forward to reporting to investors on our progress this year. ” Dr. Courtrelles concluded.
Traws unique portfolio highlights:
TRX100 (tivoxavir marboxil): Cap-dependent endonuclease inhibitor against influenza: Phase 1
-
It targets the influenza cap-dependent endonuclease and is a potent inhibitor of influenza virus replication, including A and B strains.
-
Initial Phase 1 study demonstrates safety and tolerability in healthy volunteers with pharmacokinetic and pharmacodynamic (PK/PD) data supporting the feasibility of single oral administration for treatment or prevention It was done.
-
The Company plans to initiate a Phase 1 dose extension to evaluate one additional higher dose before commencing a Phase 2 study in the second half of 2024. Topline data from the Phase 2 study is expected to be released in the first half of 2025.
TRX01 (Latoutrel building): Ritonavir-free Mpro protease inhibitor against COVID19: Phase 1
-
A potent oral inhibitor of SARS-CoV-2 Mpro (3CL protease). It is effective against the original, delta, and micron variants of SARS-CoV-2, does not require coadministration with ritonavir, and reduces the risk of drug-drug interactions. . Preclinical data support once-daily dosing for 10 days, which may overcome viral rebound seen with other drugs.
-
We are conducting a Phase 1 initial human single ascending dose/multiple ascending dose (SAD/MAD) study in normal volunteers. A second dosing cohort is underway, with topline data expected in the second half of 2024. A Phase 2 trial in patients with moderate to severe COVID-19 infection is also expected to begin in the second half of 2024.Topline data expected in 1H 2025
Narazaclib: CDK 4+ to treat solid tumors: Phase 1/2
-
Available preclinical and clinical data suggest that narazaciclib is active in many tumor types and inhibits CDK 2/4/6, CSF1R, and ARK 5/NUAK1. Preclinical studies also showed reduced neutropenia and inhibition of palbociclib-resistant cancer cells compared to palbociclib.
-
A dose escalation study to define the recommended phase 2 dose (RP2D) recently enrolled its final cohort. Review of clinical and PK/PD data is ongoing. We plan to utilize these data to develop our clinical strategy, including selection of lead indications and next steps in their development.
Financial results for the first quarter of 2024
Cash and cash equivalents at December 31, 2023 were $20.8 million compared to $16.4 million at March 31, 2024.
In April 2024, the Company realized gross proceeds of $14 million from the sale of common stock and preferred stock to TPAV, LLC, an affiliate of Torrey Pines, and OrbiMed Private Investment VIII, LP, an affiliate of OrbiMed Advisors. I have procured it.
The Company believes that its cash and cash equivalents will be sufficient to fund its ongoing clinical trials and business operations through the fourth quarter of 2024.
Revenue for the first quarter of 2024 was $56,000, consistent with the same period in 2023.
General and administrative (G&A) expenses for the first quarter of 2024 were $3.4 million, compared to $2.1 million for the same period in 2023. The increase in general and administrative expenses is due to an increase in legal and professional fees related to his acquisition of Trawsfynydd on April 1, 2023. 2024 was partially offset by lower bonus accruals, lower insurance premiums, conference fees and public company expenses.
Research and development (R&D) expenses were $1.9 million in the first quarter of 2024, compared to $4.1 million in the same period in 2023. This decrease was primarily due to lower costs associated with manufacturing the narazaciclib drug substance and drug product, as well as fewer clinical trials. Reduction in personnel costs due to reductions in development costs, consulting costs, and bonuses.
Net loss for the first quarter of 2024 was $5.0 million, or $0.24 per share, based on a weighted average number of shares outstanding of 20.8 million. By comparison, net loss for the same period in 2023 was $5.8 million, or $0.28 per share, based on a weighted average of 20.8 million shares. Number of shares outstanding.
About Traws Pharma, Inc.
Traws Pharma is a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes oral inhibitors of SARS-CoV-2 Mpro (3CL protease), lattrevir, and tivoxavir marboxil. Tivoxavir marboxil is a new oral antiviral drug candidate for influenza that targets the influenza cap-dependent endonuclease and has shown activity within cells. Based assays for drug-resistant viruses and avian influenza.
In its oncology program, Traws is developing a novel, proprietary multi-kinase CDK4 plus inhibitor, narazaciclib, with the potential to target refractory endometrial cancer and other solid tumor cancers. Narazaciclib targets pathways involved in the development of resistance to CDK inhibitors.
Traws Pharma is committed to using cutting-edge drug development techniques to deliver novel compounds that address unmet medical needs. We build solutions to important healthcare challenges, with a focus on product safety and addressing patients in need or particularly vulnerable populations, with the aim of reducing the burden of viral infections and cancer. I am.
Forward-looking statements
Certain statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. , risks and uncertainties, including statements regarding the Phase 1 trial of lattrevir in Australia and its design, timing and potential results, and the timing of the planned Phase 2 trial. Traws does not intend to make forward-looking statements with forward-looking statements that include, but are not limited to, forward-looking statements that include ”, “may”, “will”, and other terms. “,” “should,” “tentative,” “encourage,” “approximately,” or other words that convey uncertainty of future events or results. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made; It could turn out to be very different. These statements are only predictions and are subject to known and unknown risks, uncertainties, and the success and timing of Traws' clinical trials, collaborations, market conditions, and the heading “Risk Factors” in Traws' filings with securities firms. and other factors, including those discussed in. and the Exchange Committee. The forward-looking statements contained in this release speak only as of the date hereof. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after the date of this release or to reflect the occurrence of unanticipated events.
Traws Pharma, Inc. Contact:
Mark Guerin
Trauz Pharma Co., Ltd.
267-759-3680
www.trawspharma.com
Investor contact information:
bruce muckle
Lifecy Advisors LLC
646-889-1200
bmackle@lifesciadvisors.com
Trauz Pharma Co., Ltd. |
|||||||
Condensed Consolidated Balance Sheet |
|||||||
March 31st |
December 31 |
||||||
2024 |
2023 |
||||||
assets |
(Unaudited) |
||||||
Current assets: |
|||||||
cash and cash equivalents |
$ |
16,390,000 |
$ |
20,821,000 |
|||
accounts receivable |
18,000 |
18,000 |
|||||
Prepaid expenses and other current assets |
1,745,000 |
1,821,000 |
|||||
Total current assets |
18,153,000 |
22,660,000 |
|||||
Property, plant and equipment, net |
18,000 |
22,000 |
|||||
Other non-current assets |
1,000 |
1,000 |
|||||
Total assets |
$ |
18,172,000 |
$ |
22,683,000 |
|||
Debt and equity |
|||||||
Current Liabilities: |
|||||||
accounts payable |
$ |
6,568,000 |
$ |
5,619,000 |
|||
Accrued expenses and other current liabilities |
2,628,000 |
3,375,000 |
|||||
deferred revenue |
226,000 |
226,000 |
|||||
Total current liabilities |
9,422,000 |
9,220,000 |
|||||
Deferred income, non-current |
2,735,000 |
2,791,000 |
|||||
Total debt |
12,157,000 |
12,011,000 |
|||||
promises and contingencies |
|||||||
Shareholders' equity: |
|||||||
Preferred stock, $0.01 par value, 5,000,000 shares authorized, no shares issued and outstanding as of March 31, 2024 and December 31, 2023. |
— |
— |
|||||
Common stock, $0.01 par value, 125,000,000 authorized shares, 21,085,935 shares and 21,003,409 shares outstanding as of March 31, 2024 and December 31, 2023, respectively. |
211,000 |
210,000 |
|||||
Additional paid-in capital |
493,448,000 |
493,116,000 |
|||||
cumulative deficit |
(487,614,000 |
) |
(482,631,000 |
) |
|||
Accumulated other comprehensive loss |
(30,000 |
) |
(23,000 |
) |
|||
Total shareholders' equity |
6,015,000 |
10,672,000 |
|||||
Total debt and equity |
$ |
18,172,000 |
$ |
22,683,000 |
|||
Trauz Pharma Co., Ltd. |
|||||||
Condensed consolidated income statement |
|||||||
3 months ending March 31st |
|||||||
2024 |
2023 |
||||||
revenue |
$ |
56,000 |
$ |
56,000 |
|||
Operating expenses: |
|||||||
General and administration |
3,356,000 |
2,113,000 |
|||||
Research and Development |
1,912,000 |
4,080,000 |
|||||
total operating expenses |
5,268,000 |
6,193,000 |
|||||
operating loss |
(5,212,000 |
) |
(6,137,000 |
) |
|||
Other income, net |
229,000 |
362,000 |
|||||
net loss |
$ |
(4,983,000 |
) |
$ |
(5,775,000 |
) |
|
Basic and diluted net loss per share |
$ |
(0.24 |
) |
$ |
(0.28 |
) |
|
Basic and diluted weighted average number of shares outstanding |
20,803,746 |
20,960,171 |
|||||