Full Press Release Details
Reports Q2 2024 Financial Results,
Provides Recent Business Highlights
Merger with Trawsfynydd Therapeutics, Inc
("Trawsfynydd") and concurrent private placement of $14 million (cash runway to support planned operations through year end),
with recently achieved clinical milestones, put Traws on track to achieve key readouts for the clinical pipeline in H2 2024 and beyond
NEWTOWN, PA, August 15, 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 outlined recent business highlights and reported
unaudited financial results for the second quarter ended June 30, 2024. The Company intends to host a conference call and live webcast
on Thursday, August 15, 2024 at 8:00 AM ET.
last several months have been transformational for Traws Pharma, with strategic and product development progress and an increase in capital,"
said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. "Completion of the merger agreement that created Traws
Pharma expanded our investor base to include recognized healthcare investors, Orbimed and Torrey Pines, while broadening our portfolio
to include compounds that we believe have best-in-class potential for influenza (flu), including bird flu, and COVID-19. In addition, ISTs
are enhancing our multi-kinase inhibitors for cancer, narazaciclib and rigosertib."
"We expect the antiviral
program to advance over the next 6+ months as we complete preparations to report Phase 1 results and initiate Phase 2 studies in flu and
COVID-19. Preclinical data and topline data from SAD studies from our influenza candidate, tivoxavir marboxil, suggest that it
has the potential to achieve our target product profile as a single dose treatment that is active against pandemic-potential viruses as
well as oseltamivir and baloxavir resistant viruses," continued Dr. Cautreels. "In addition, clinical-trial enabling
studies for our COVID-19 candidate, ratutrelvir, suggest that it has the potential to be effective without the requirement for
co-administration of a CYP-inhibitor, and active against virus strains that may be resistant to other approved agents such as nirmatrelvir.
In the coming months, we look forward to completing the Phase 1 studies, finalizing the dosing plan and initiating the Phase 2 program
for both tivoxavir marboxil and ratutrelvir. We believe these data could pave the way for key readouts in 2025."
marboxil -- Targets the influenza cap-dependent endonuclease, which is highly conserved across flu strains, including avian
flu. The compound is intended to be administered as a single dose per treatment
- Targets Mpro (3CL protease). The compound does not require combination
use of a CYP-inhibitor such as ritonavir
- our multi-kinase inhibitor, including CKD4+, with potential for use in multiple solid tumors
- our multi-kinase inhibitor targeting cell cycle proteins including PLK-1, with potential
for use in the ultra-rare disease, advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa
(RDEB-associated SCC, RDEB)
Traws financial results for the
quarter ended June 30, 2024 represent the first post-transaction quarterly report of the combined company. The financial results
for the comparable period in 2023 represent a consolidated summary of the combined entity. For simplicity, the explanatory statements
below provide a high-level summary of expenses for the quarter ended June 30, 2024.
cash equivalents and short-term investments: As of June 30, 2024, the Company had cash, cash equivalents, and short-term
investments of approximately $16.9 million, compared to cash, cash equivalents, and short-term investments of approximately $20.8 million
at December 31, 2023. The company believes its cash balance is adequate to support planned operations through year end 2024.
in-process R&D related to our transaction early in the second quarter resulted in a non-cash charge of $117.5 million.
and development (R&D) expense for the three months ended June 30, 2024, totaled $4.0 million, compared to $2.5 million
for the comparable period in 2023. Q2 2024 R&D expenses mainly reflect the cost of the Phase 1 SAD/MAD COVID-19 study, the Phase 1
extension study in flu, completion of the narazaciclib Phase 1/2 dose escalation study, regulatory expenses to support planned upcoming
studies, and expenses related to stock-based compensation and restructuring costs related to the recent transaction.
and administrative (G&A) expense for the three months ended June 30, 2024, totaled $2.0 million compared to $2.2 million
for the comparable period in 2023. Q2 2024 G&A expenses include stock-based compensation and restructuring costs related to the merger.
loss: The net loss for the three months ended June 30, 2024 was $123.1 million, or $4.87 per basic and diluted common
share, which reflects a non-cash charge of $117.5 million related to in-process R&D from Onconova's April 2024 acquisition
of Trawsfynydd. This compares with a net loss of $4.3 million, or $0.20 per basic and diluted common share, for the same period in 2023.
Conference Call and Webcast
Pharma will host a conference call and webcast today, August 15, 2024, at 8:00 AM ET to discuss recent business progress and second
quarter financial results. To access the call, please dial: 1 (877) 407-0789 (United States) or 1 (201) 689-8562 (International) and
reference the conference ID "13748066". To access the webcast, please click: Traws Pharma Corporate
Update Call. The live and archived webcast can also be accessed by visiting the "Corporate
Events & Presentations" tab of the Events and Presentations section of the Investor
Relations page. A replay of the webcast will be archived for 90 days.
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 two potentially best-in-class oral small molecules in Phase 1 studies: tivoxavir marboxil, a novel oral antiviral drug
candidate for influenza and avian flu, targeting the influenza cap-dependent endonuclease, and ratutrelvir, targeting Mpro (3CL protease).
In the cancer program, Traws is developing the
novel, proprietary multi-kinase CDK4-plus inhibitor narazaciclib, with potential for refractory endometrial cancer and potentially other
solid tumor cancers, and rigosertib, multi-kinase inhibitor targeting cell cycle proteins including PLK-1, with potential for use in advanced
squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC, RDEB).
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 aim to build solutions for important medical challenges and 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 Traws Pharma, its respective businesses, the merger agreement with Trawsfynydd Therapeutics, Inc. and concurrent private
placement and the use of proceeds from such financing and the Company's financing strategies, as well as statements regarding the
milestones, preclinical studies and clinical studies for its four product candidates, tivoxavir marboxil for influenza including avian
flu, ratutrelvir for COVID-19, and narazaciclib and rigosertib for cancer, related to the design, timing and potential results and the
timing of next steps. 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, merger integration, 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
Traws Pharma Contact:
Consolidated Balance Sheets
| June 30, | December 31, | |||||||
| 2024 (unaudited) | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,886,000 | $ | 20,821,000 | ||||
| Receivables | 18,000 | 18,000 | ||||||
| Prepaid expenses and other current assets | 1,767,000 | 1,821,000 | ||||||
| Total current assets | 18,671,000 | 22,660,000 | ||||||
| Property and equipment, net | 14,000 | 22,000 | ||||||
| Other non-current assets | 1,000 | 1,000 | ||||||
| Total assets | $ | 18,686,000 | $ | 22,683,000 | ||||
| Liabilities, redeemable convertible preferred stock and stockholders' (deficit) equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,174,000 | $ | 5,619,000 | ||||
| Accrued expenses and other current liabilities | 3,509,000 | 3,375,000 | ||||||
| Deferred revenue | 227,000 | 226,000 | ||||||
| Total current liabilities | 9,910,000 | 9,220,000 | ||||||
| Deferred revenue, non-current | 2,677,000 | 2,791,000 | ||||||
| Total liabilities | 12,587,000 | 12,011,000 | ||||||
| Commitments and contingencies | ||||||||
| Series C redeemable convertible preferred stock; $0.01 par value, 5,000,000 shares authorized; 12,472 and zero shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 111,619,000 | - | ||||||
| Stockholders' (deficit) equity: | ||||||||
| Common stock, $0.01 par value, 125,000,000 shares authorized, 25,306,509 and 21,003,409 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 253,000 | 210,000 | ||||||
| Additional paid in capital | 505,017,000 | 493,116,000 | ||||||
| Accumulated deficit | (610,757,000 | ) | (482,631,000 | ) | ||||
| Accumulated other comprehensive loss | (33,000 | ) | (23,000 | ) | ||||
| Total stockholders' (deficit) equity | (105,520,000 | ) | 10,672,000 | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders' (deficit) equity | $ | 18,686,000 | $ | 22,683,000 |
Condensed Consolidated Statements of Operations
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue | $ | 57,000 | $ | 57,000 | $ | 113,000 | $ | 113,000 | ||||||||
| Operating expenses: | ||||||||||||||||
| Acquired in-process research and development | 117,464,000 | - | 117,464,000 | - | ||||||||||||
| Research and development | 3,964,000 | 2,456,000 | 5,876,000 | 6,536,000 | ||||||||||||
| General and administrative | 1,977,000 | 2,211,000 | 5,333,000 | 4,324,000 | ||||||||||||
| Total operating expenses | 123,405,000 | 4,667,000 | 128,673,000 | 10,860,000 | ||||||||||||
| Loss from operations | (123,348,000 | ) | (4,610,000 | ) | (128,560,000 | ) | (10,747,000 | ) | ||||||||
| Other income, net | 205,000 | 360,000 | 434,000 | 722,000 | ||||||||||||
| Net loss | $ | (123,143,000 | ) | $ | (4,250,000 | ) | $ | (128,126,000 | ) | $ | (10,025,000 | ) | ||||
| Net loss per share, basic and diluted | $ | (4.87 | ) | $ | (0.20 | ) | $ | (5.53 | ) | $ | (0.48 | ) | ||||
| Basic and diluted weighted average shares outstanding | 25,310,774 | 20,979,766 | 23,177,117 | 20,970,022 |