Completed acquisition of Trawsfynydd and concurrent $14 million Capital Raise
Excellent pipeline progress, led by candidates for COVID 19, influenza, and oncology applications
Poised to provoke Phase 2 research in H2 2024 for our influenza candidate and ritonavir-free COVID 19 protease inhibitor
NEWTOWN, Pa., May 16, 2024 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (Traws or Traws Pharma), a medical stage biopharmaceutical firm creating oral small molecules for respiratory viral ailments and most cancers, at this time introduced monetary outcomes for the primary quarter of 2024, and offered a enterprise replace.
2024 has already been a transformative 12 months for Traws Pharma to advance our portfolio of novel remedies for severe respiratory infections and oncology applications. We accomplished the acquisition of Trawsfynydd and concluded a concurrent $14 million non-public placement financing. In addition, we initiated first-in-human dosing for our COVID 19 product candidate, together with completion of the primary cohort dosing group. Furthermore, we accomplished the final dose escalation cohort for our CDK4+ inhibitor, narazaciclib, acknowledged Werner Cautreels, Ph.D., Chief Executive Officer of Traws Pharma. We consider that we’re poised to make much more significant progress within the second half of 2024, as we advance our influenza therapy and ritonavir-free protease inhibitor for COVID 19 into expanded Phase 1 dose escalation research and start Phase 2 improvement.
Based on the preclinical profile and early medical information from our infectious illness candidates and narazaciclib, I’m optimistic in regards to the outlook for Traws’ portfolio and stay up for updating our buyers with our progress by the 12 months, concluded Dr. Cautreels.
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Traws Proprietary Portfolio Highlights:
TRX100 (tivoxavir marboxil): a cap-dependent endonuclease inhibitor for influenza: Phase 1
- Targets the cap-dependent endonuclease of influenza and is a potent inhibitor of influenza virus replication together with A and B strains
- First Phase 1 examine demonstrated security and tolerability in wholesome volunteers with pharmacokinetics and pharmacodynamics (PK/PD) information to help the potential use of a single oral dose for therapy or prophylaxis
- We plan to provoke Phase 1 dose extension to guage one further, greater dose previous to the initiation of Phase 2 research in H2 2024. Topline information from the Phase 2 examine are anticipated in H1 2025
TRX01 (ratutrelvir): a ritonavir-free Mpro protease inhibitor for COVID19: Phase 1
- Potent oral inhibitor of SARS-CoV-2 Mpro (3CL protease), efficient towards the unique, delta, and omicron variants of SARS-CoV-2, that doesn’t require co-administration with ritonavir, lowering the chance of drug-drug interactions. Preclinical information help once-daily dosing for 10days which may overcome viral rebound seen with different brokers.
- We are within the strategy of conducting a Phase 1 first-in-human single ascending dose/a number of ascending dose (SAD/MAD) examine in regular volunteers. The second dosing cohort is underway and topline information are anticipated H2 2024. A Phase 2 examine can be deliberate to start in H2 2024 in sufferers with average to extreme COVID19. Topline information are anticipated H1 2025
Narazaciclib: CDK 4+ to deal with strong tumors: Phase 1/2
- Available preclinical and medical information counsel that narazaciclib is energetic in quite a few tumor sorts, inhibiting CDK 2/4/6, CSF1R and ARK 5/NUAK1. Preclinical research additionally confirmed lowered neutropenia, as in comparison with palbociclib, and inhibition of palbociclib resistant most cancers cells.
- A dose escalation examine to outline the advisable Phase 2 dose (RP2D) just lately enrolled the final cohort. A assessment of the medical and PK/PD information is underway. We intend to make the most of these information to outline the medical technique, together with collection of a lead indication and subsequent steps in its improvement.
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First Quarter 2024 Financial Results
Cash and money equivalents as of March 31, 2024, had been $16.4 million, in contrast with $20.8 million as of December 31, 2023.
In April 2024, the Company raised gross proceeds of $14 million from the sale of widespread and most well-liked inventory to TPAV, LLC, an affiliate of Torrey Pines, and OrbiMed Private Investments VIII, LP, an affiliate of OrbiMed Advisors.
The Company believes that its money and money equivalents will likely be adequate to fund ongoing medical trials and enterprise operations into the fourth quarter of 2024.
Revenue was fifty-six thousand {dollars} for the primary quarter of 2024, according to the identical interval in 2023.
General and administrative (G&A) bills had been $3.4 million for the primary quarter of 2024, in contrast with $2.1 million for a similar interval in 2023. The enhance in G&A bills was attributable to greater authorized {and professional} charges associated to the Trawsfynydd acquisition on April 1, 2024, partially offset by decrease bonus accrual in addition to decrease insurance coverage, assembly, and public firm bills.
Research and improvement (R&D) bills had been $1.9 million for the primary quarter of 2024, in contrast with $4.1 million for a similar interval in 2023. The lower was primarily attributable to decrease prices associated to narazaciclib drug substance and drug product manufacturing, a discount in medical improvement and consulting prices and decrease personnel bills resulting from decrease bonus accrual.
Net loss for the primary quarter of 2024 was $5.0 million, or $0.24 per share on 20.8 million weighted common shares excellent, in contrast with a web lack of $5.8 million, or $0.28 per share for a similar interval in 2023, primarily based on 20.8 million weighted common shares excellent.
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About Traws Pharma, Inc.
Traws Pharma is a medical stage biopharmaceutical firm creating oral small molecule therapies for the therapy of respiratory viral ailments and most cancers. The viral respiratory illness program contains an oral inhibitor of the SARS-CoV-2 Mpro (3CL protease), ratutrelvir, and tivoxavir marboxil, a brand new oral antiviral drug candidate for influenza which targets the influenza cap-dependent endonuclease and has proven exercise in cell-based assays towards drug resistant viruses in addition to towards avian flu.
In the most cancers program, Traws is creating the novel, proprietary multi-kinase CDK4-plus inhibitor narazaciclib probably for refractory endometrial most cancers and different strong tumor cancers. Narazaciclib targets pathways concerned within the improvement of resistance to CDK inhibitors.
Traws Pharma is dedicated to delivering novel compounds for unmet medical wants utilizing state-of-the-art drug improvement expertise. With a give attention to product security and a dedication to sufferers in want or which are particularly weak, we construct options for vital medical challenges, aiming to alleviate the burden of viral infections and most cancers.
Forward-Looking Statements
Some of the statements on this launch are forward-looking statements inside the which means 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, and contain dangers and uncertainties together with statements concerning the Phase 1 examine of ratutrelvir in Australia and its design, timing and potential outcomes and the timing of a deliberate Phase 2 examine. Traws has tried to establish forward-looking statements by terminology together with believes, estimates, anticipates, expects, plans, intends, could, may, would possibly, will, ought to, preliminary, encouraging, roughly or different phrases that convey uncertainty of future occasions or outcomes. Although Traws believes that the expectations mirrored in such forward-looking statements are affordable as of the date made, expectations could show to have been materially completely different from the outcomes expressed or implied by such ahead trying statements. These statements are solely predictions and contain identified and unknown dangers, uncertainties, and different components, together with the success and timing of Traws’ medical trials, collaborations, market situations and people mentioned below the heading Risk Factors in Traws’ filings with the Securities and Exchange Commission. Any forward-looking statements contained on this launch communicate solely as of its date. Traws undertakes no obligation to replace any forward-looking statements contained on this launch to mirror occasions or circumstances occurring after its date or to mirror the prevalence of unanticipated occasions.
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Traws Pharma, Inc. Contact:Mark GuerinTraws Pharma, Inc.267-759-3680www.trawspharma.com
Investor Contact:Bruce Mackle LifeSci Advisors, LLC646-889-1200bmackle@lifesciadvisors.com
| Traws Pharma, Inc. | |||||||
| Condensed Consolidated Balance Sheets | |||||||
| March 31, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Assets | (unaudited) | ||||||
| Current belongings: | |||||||
| Cash and money equivalents | $ | 16,390,000 | $ | 20,821,000 | |||
| Receivables | 18,000 | 18,000 | |||||
| Prepaid bills and different present belongings | 1,745,000 | 1,821,000 | |||||
| Total present belongings | 18,153,000 | 22,660,000 | |||||
| Property and gear, web | 18,000 | 22,000 | |||||
| Other non-current belongings | 1,000 | 1,000 | |||||
| Total belongings | $ | 18,172,000 | $ | 22,683,000 | |||
| Liabilities and stockholders’ fairness | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 6,568,000 | $ | 5,619,000 | |||
| Accrued bills and different present liabilities | 2,628,000 | 3,375,000 | |||||
| Deferred income | 226,000 | 226,000 | |||||
| Total present liabilities | 9,422,000 | 9,220,000 | |||||
| Deferred income, non-current | 2,735,000 | 2,791,000 | |||||
| Total liabilities | 12,157,000 | 12,011,000 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ fairness: | |||||||
| Preferred inventory, $0.01 par worth, 5,000,000 shares licensed, none issued and excellent at March 31, 2024 and December 31, 2023 | ” | ” | |||||
| Common inventory, $0.01 par worth, 125,000,000 shares licensed, 21,085,935 and 21,003,409 shares issued and excellent at March 31, 2024 and December 31, 2023, respectively | 211,000 | 210,000 | |||||
| Additional paid in capital | 493,448,000 | 493,116,000 | |||||
| Accumulated deficit | (487,614,000 | ) | (482,631,000 | ) | |||
| Accumulated different complete loss | (30,000 | ) | (23,000 | ) | |||
| Total stockholders’ fairness | 6,015,000 | 10,672,000 | |||||
| Total liabilities and stockholders’ fairness | $ | 18,172,000 | $ | 22,683,000 | |||
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| Traws Pharma, Inc. | |||||||
| Condensed Consolidated Statements of Operations | |||||||
| Three Months Ended March 31, | |||||||
| 2024 | 2023 | ||||||
| Revenue | $ | 56,000 | $ | 56,000 | |||
| Operating bills: | |||||||
| General and administrative | 3,356,000 | 2,113,000 | |||||
| Research and improvement | 1,912,000 | 4,080,000 | |||||
| Total working bills | 5,268,000 | 6,193,000 | |||||
| Loss from operations | (5,212,000 | ) | (6,137,000 | ) | |||
| Other revenue, web | 229,000 | 362,000 | |||||
| Net loss | $ | (4,983,000 | ) | $ | (5,775,000 | ) | |
| Net loss per share, fundamental and diluted | $ | (0.24 | ) | $ | (0.28 | ) | |
| Basic and diluted weighted common shares excellent | 20,803,746 | 20,960,171 | |||||
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