Traws Pharma Reports First Quarter 2024 Financial Results and Provides Business Update
Traws Pharma announced its Q1 2024 financial results and provided a business update, highlighting significant developments. The company completed the acquisition of Trawsfynydd and raised $14 million in private placement financing.
Key pipeline advancements include the initiation of first-in-human dosing for their COVID-19 product candidate and completion of the last dose escalation cohort for their CDK4+ inhibitor, narazaciclib. They plan to advance their influenza treatment and ritonavir-free COVID-19 protease inhibitor into expanded Phase 1 and Phase 2 studies in H2 2024.
First quarter financials show cash and equivalents at $16.4 million, a slight decrease from $20.8 million at the end of 2023. Revenue remained consistent at $56,000. G&A expenses rose to $3.4 million due to acquisition-related costs, while R&D expenses decreased to $1.9 million. The net loss narrowed to $5.0 million from $5.8 million in Q1 2023.
- Completed $14 million capital raise.
- Initiated first-in-human dosing for COVID-19 product candidate.
- Completed last dose escalation cohort for narazaciclib.
- Plans to initiate Phase 2 studies for influenza and COVID-19 treatments in H2 2024.
- Revenue for Q1 2024 remained steady at $56,000.
- Reduced net loss from $5.8 million in Q1 2023 to $5.0 million in Q1 2024.
- Cash and cash equivalents decreased from $20.8 million in December 2023 to $16.4 million in March 2024.
- General and administrative expenses increased to $3.4 million from $2.1 million in Q1 2023.
- Research and development expenses decreased from $4.1 million in Q1 2023 to $1.9 million in Q1 2024.
- Net loss of $5.0 million in Q1 2024 indicates ongoing financial challenges.
Insights
From a financial perspective, Traws Pharma has demonstrated notable developments, yet there are both positive and negative aspects to consider. The $14 million capital raise presents a significant positive move, providing necessary funds to continue clinical trials and operations, especially given their current $16.4 million cash position. However, the company's burn rate is concerning. Cash decreased from $20.8 million to $16.4 million in one quarter and with the current expenses, the new funds could run out by Q4 2024.
The company's G&A expenses increased substantially to $3.4 million from $2.1 million year-over-year, driven mainly by acquisition-related costs. Meanwhile, R&D expenses decreased to $1.9 million from $4.1 million, reflecting reduced manufacturing and development costs for narazaciclib. While this might seem positive, it could raise concerns about the pace of R&D.
Overall, the net loss decreased slightly to $5.0 million from $5.8 million, but the revenue remained flat at
Traws Pharma's pipeline reveals significant progress, with three promising candidates: TRX100 for influenza, TRX01 for COVID-19 and narazaciclib for oncology. The initiation of first-in-human dosing for TRX01 is crucial, given its potential as a ritonavir-free option, which might offer a safer alternative by reducing drug-drug interactions. Additionally, TRX100 has shown excellent preclinical data and its phase 1 results support the potential for a once-daily dosage, which could enhance patient compliance.
Narazaciclib's advancement is also notable, particularly due to its activity across multiple tumor types and reduced side effects compared to existing drugs like palbociclib. However, with phase 2 yet to begin for both TRX100 and TRX01 and narazaciclib still in early stages, investors should temper expectations. The pipeline is promising, but commercialization is still distant and the success of these trials remains a critical factor.
The completion of Trawsfynydd acquisition and the $14 million raise indicate a strategic move to bolster Traws Pharma's capabilities and market positioning. The acquisition could bring in synergies and potential cost savings, but the lack of immediate financial benefits might be a concern. Additionally, the company's emphasis on respiratory viral diseases and oncology aligns with growing market needs, potentially leveraging the increased focus on COVID-19 and cancer treatments.
However, the relatively low revenue and high expenses underline potential risks. The company must show progress in clinical milestones and eventual commercialization to justify continued investor confidence. Market competition, particularly in the highly competitive pharmaceutical sector, also needs to be considered as many players are developing similar treatments.
Completed acquisition of Trawsfynydd and concurrent
Excellent pipeline progress, led by candidates for COVID 19, influenza, and oncology programs
Poised to initiate Phase 2 studies 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 clinical stage biopharmaceutical company developing oral small molecules for respiratory viral diseases and cancer, today announced financial results for the first quarter of 2024, and provided a business update.
“2024 has already been a transformative year for Traws Pharma to advance our portfolio of novel treatments for serious respiratory infections and oncology programs. We completed the acquisition of Trawsfynydd and concluded a concurrent
“Based on the preclinical profile and early clinical data from our infectious disease candidates and narazaciclib, I am optimistic about the outlook for Traws’ portfolio and look forward to updating our investors with our progress through the year,” concluded Dr. Cautreels.
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 including A and B strains
- First Phase 1 study demonstrated safety and tolerability in healthy volunteers with pharmacokinetics and pharmacodynamics (PK/PD) data to support the potential use of a single oral dose for treatment or prophylaxis
- We plan to initiate Phase 1 dose extension to evaluate one additional, higher dose prior to the initiation of Phase 2 studies in H2 2024. Topline data from the Phase 2 study are expected 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), effective against the original, delta, and omicron variants of SARS-CoV-2, that does not require co-administration with ritonavir, reducing the risk of drug-drug interactions. Preclinical data support once-daily dosing for 10days which could overcome viral rebound seen with other agents.
- We are in the process of conducting a Phase 1 first-in-human single ascending dose/multiple ascending dose (SAD/MAD) study in normal volunteers. The second dosing cohort is underway and topline data are expected H2 2024. A Phase 2 study is also planned to begin in H2 2024 in patients with moderate to severe COVID19. Topline data are expected H1 2025
Narazaciclib: CDK 4+ to treat solid tumors: Phase 1/2
- Available preclinical and clinical data suggest that narazaciclib is active in numerous tumor types, inhibiting CDK 2/4/6, CSF1R and ARK 5/NUAK1. Preclinical studies also showed reduced neutropenia, as compared to palbociclib, and inhibition of palbociclib resistant cancer cells.
- A dose escalation study to define the recommended Phase 2 dose (RP2D) recently enrolled the last cohort. A review of the clinical and PK/PD data is underway. We intend to utilize these data to define the clinical strategy, including selection of a lead indication and next steps in its development.
First Quarter 2024 Financial Results
Cash and cash equivalents as of March 31, 2024, were
In April 2024, the Company raised gross proceeds of
The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations into the fourth quarter of 2024.
Revenue was fifty-six thousand dollars for the first quarter of 2024, consistent with the same period in 2023.
General and administrative (G&A) expenses were
Research and development (R&D) expenses were
Net loss for the first quarter of 2024 was
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 an oral inhibitor of the SARS-CoV-2 Mpro (3CL protease), ratutrelvir, and tivoxavir marboxil, a new oral antiviral drug candidate for influenza which targets the influenza cap-dependent endonuclease and has shown activity in cell-based assays against drug resistant viruses as well as against avian flu.
In the cancer program, Traws is developing the novel, proprietary multi-kinase CDK4-plus inhibitor narazaciclib potentially for 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 delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need or that are specifically vulnerable, we build solutions for important medical challenges, aiming to alleviate the burden of viral infections and cancer.
Forward-Looking Statements
Some of the 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, and involve risks and uncertainties including statements regarding the Phase 1 study of ratutrelvir in Australia and its design, timing and potential results and the timing of a planned Phase 2 study. Traws has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “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 the success and timing of Traws’ clinical trials, collaborations, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the Securities and Exchange Commission. 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.
Traws Pharma, Inc. Contact:
Mark Guerin
Traws Pharma, Inc.
267-759-3680
www.trawspharma.com
Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com
| Traws Pharma, Inc. | |||||||
| Condensed Consolidated Balance Sheets | |||||||
| March 31, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Assets | (unaudited) | ||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 16,390,000 | $ | 20,821,000 | |||
| Receivables | 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 and equipment, net | 18,000 | 22,000 | |||||
| Other non-current assets | 1,000 | 1,000 | |||||
| Total assets | $ | 18,172,000 | $ | 22,683,000 | |||
| Liabilities and stockholders’ 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 revenue, non-current | 2,735,000 | 2,791,000 | |||||
| Total liabilities | 12,157,000 | 12,011,000 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Preferred stock, | — | — | |||||
| Common stock, | 211,000 | 210,000 | |||||
| Additional paid in capital | 493,448,000 | 493,116,000 | |||||
| Accumulated deficit | (487,614,000 | ) | (482,631,000 | ) | |||
| Accumulated other comprehensive loss | (30,000 | ) | (23,000 | ) | |||
| Total stockholders’ equity | 6,015,000 | 10,672,000 | |||||
| Total liabilities and stockholders’ equity | $ | 18,172,000 | $ | 22,683,000 | |||
| Traws Pharma, Inc. | |||||||
| Condensed Consolidated Statements of Operations | |||||||
| Three Months Ended March 31, | |||||||
| 2024 | 2023 | ||||||
| Revenue | $ | 56,000 | $ | 56,000 | |||
| Operating expenses: | |||||||
| General and administrative | 3,356,000 | 2,113,000 | |||||
| Research and development | 1,912,000 | 4,080,000 | |||||
| Total operating expenses | 5,268,000 | 6,193,000 | |||||
| Loss from operations | (5,212,000 | ) | (6,137,000 | ) | |||
| Other income, net | 229,000 | 362,000 | |||||
| Net loss | $ | (4,983,000 | ) | $ | (5,775,000 | ) | |
| Net loss per share, basic and diluted | $ | (0.24 | ) | $ | (0.28 | ) | |
| Basic and diluted weighted average shares outstanding | 20,803,746 | 20,960,171 | |||||
FAQ
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