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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
August 14, 2026
Traws
Pharma, Inc.
(Exact name of Registrant as specified in its
charter)
| Delaware |
|
001-36020 |
|
22-3627252 |
(State or Other Jurisdiction
of Incorporation or Organization) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
12 Penns Trail
Newtown, PA 18940 |
| (267)
759-3680 |
(Address,
Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
Not Applicable
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
| Common
stock, par value $.01 per share |
TRAW |
The
Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item
2.02 Results of Operations and Financial Condition.
The information provided below in “Item
7.01 - Regulation FD Disclosure” of this Current Report on Form 8-K (this “Current Report”) regarding the Earnings
Release is incorporated by reference into this Item 2.02.
Item 7.01 Regulation FD Disclosure.
On August 14, 2026, Traws Pharma, Inc.
(the “Company”) issued a press release (the “Earnings Release”) announcing its financial results for the quarter
ended June 30, 2026, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Current
Report”) and incorporated herein by reference.
The information set forth under
Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject
to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated
by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference
language in any such filing, except as expressly set forth by specific reference in such a filing. This Current Report will not be deemed
an admission as to the materiality of any information in this Current Report that is required to be disclosed solely by Regulation FD.
Forward-Looking Statements
This Current Report, including
Exhibit 99.1, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the
terms “anticipates,” “expects,” “estimates,” “believes,” “will” and similar
expressions, as they relate to the Company or its management, are intended to identify such forward-looking statements.
Forward-looking statements in
this Current Report, including Exhibit 99.1, or hereafter, including in other publicly available documents filed with the Securities
and Exchange Commission, reports to the stockholders of the Company and other publicly available statements issued or released by the
Company involve known and unknown risks, uncertainties and other factors which could cause the Company’s actual results, performance
(financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed
or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current
conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such
other documents filed with the Securities and Exchange Commission, each of which could adversely affect the Company’s business and
the accuracy of the forward-looking statements contained herein.
Item 9.01 Financial
Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release, dated August 14,
2026 |
| 104 |
|
Cover Page Interactive Data File (embedded within the inline XBRL Document) |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
| Date: August 14, 2026 |
TRAWS PHARMA, INC. |
| |
|
|
| |
By: |
/s/ Charles Parker |
| |
|
Charles Parker |
| |
|
Chief Financial Officer |
Exhibit 99.1
Traws Pharma
Reports Q2 2026 Financial Results and Provides Business Highlights
| · | Advancing
tivoxavir marboxil toward MHRA resubmission in Q3 2026 with a revised toxicology package,
supporting initiation of the Phase 2a human influenza Challenge study |
| · | Completed
the April 2026 private placement and received shareholder approval of the Series B
and Series C tranches, enabling access to up to $50 million in potential additional financing,
subject to achievement of program milestones and investor participation |
NEWTOWN, PA, August 14,
2026 (GLOBE NEWSWIRE) – Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”),
a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral
diseases, today reported financial results and provided recent business highlights for the quarter ended June 30, 2026, including
updates on its lead clinical programs and April 2026 financing.
"Following
the MHRA's review, we are moving quickly to generate the revised toxicology package the agency identified, and we expect to resubmit
by the end of the third quarter of this year. Our conviction in tivoxavir marboxil’s potential as a prophylactic agent for
seasonal influenza is unchanged. We look forward to progressing the program towards the initiation of the Phase 2a human influenza
Challenge pending MHRA approval," commented Iain Dukes, MA, DPhil, Chief Executive Officer of Traws Pharma.
"As we approach
respiratory virus season, seasonal influenza remains a significant public health threat, particularly for vulnerable populations such
as the elderly and immunocompromised," commented Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma. "Tivoxavir
marboxil has the potential to provide an important new option for influenza prophylaxis in these vulnerable populations."
Recent Highlights
and Anticipated Milestones:
Investigational
Programs:
Tivoxavir marboxil
(TXM, influenza)
Intended Indication
and Market Potential: Potential as a best-in-class oral prophylactic for seasonal flu and potential inclusion in pandemic
preparedness initiatives, all-together, estimated to be a multi-billion-dollar opportunity1.
Next Steps:
Updated Preclinical Data Package to Support
MHRA Resubmission — Following feedback from the MHRA on the Company's planned Phase 2a human influenza Challenge study, Traws
is preparing an updated toxicology data package. The Company expects to resubmit this package at the end of the third quarter of 2026.
If accepted by the MHRA, the study is planned to be conducted in healthy volunteers at hVIVO, a global leader in the conduct of human
Challenge studies for infectious diseases and respiratory viruses, in the UK.
Efforts Ongoing to Resolve the Clinical Hold
— The U.S. Food and Drug Administration (FDA) placed the U.S. IND for TXM on clinical hold due to concerns with the toxicology data
package. The Company is preparing a comprehensive response to address the FDA's concerns, with the goal of resolving the hold and advancing
the program in the US by the end of 2026.
Emerging Viral
Threats: Platform Breadth
Beyond its lead
influenza and COVID-19 programs, Traws' platform has generated early leads with potential applicability to other emerging viral threats,
including hantavirus, Ebola virus disease, and Lassa fever, reflecting the breadth of the Company's antiviral capabilities.
Financing Update:
In April 2026,
the Company completed a financing that delivered $10.0 million in upfront proceeds and provides the potential to raise up to an additional
$50.0 million through three tranches of warrants, each structured to align capital with key clinical and regulatory milestones:
| · | Series A
warrant ($10.0 million): exercisable upon MHRA approval of the Company's planned human influenza
Challenge study. |
| · | Series B
warrant ($10.0 million): approved by shareholders and exercisable upon announcement of data
from the Challenge study. |
| · | Series C
warrant (up to $30.0 million): approved by shareholders. |
On July 8,
2026, the Company's shareholders approved the Series B and Series C tranches, satisfying a necessary condition for the milestone-based
financing structure established in the April 2026 private placement. Access to capital under these tranches remains subject to achievement
of the applicable program milestones, the sequential exercise of the earlier tranches, and investor participation. The Series A
tranche is exercisable upon MHRA approval of the Company's planned Phase 2a human influenza Challenge study, while the Series B
warrant is positioned to become exercisable upon announcement of data from the Challenge study. Together with the Series A warrant,
this structure gives Traws Pharma the potential to access up to $50.0 million in additional capital as it advances its influenza program,
reinforcing the Company's financial position and its ability to drive its pipeline toward key value-creating milestones.
Financial Results:
Cash and cash
equivalents: As of June 30, 2026, the Company had cash and cash equivalents of $5.0 million, compared to $3.8 million as of
December 31, 2025. The increase primarily reflects proceeds from the Company's April 2026 private placement and sales under
its at-the-market (ATM) equity program, partially offset by cash used in operations.
The Company believes that its existing cash and
cash equivalents, together with anticipated proceeds from its at-the-market equity program, will be sufficient to fund planned operations
into the first quarter of 2027. However, based on current projections, the Company may not have sufficient cash and cash equivalents to
support its operations subsequent to the first quarter of 2027, and may require additional financing.
Revenue:
The Company recognized no revenue for the three months ended June 30, 2026, compared to $2.7 million for the same period in 2025.
For the six months ended June 30, 2026, the Company recognized no revenue, compared to $2.8 million for the same period in 2025.
The decrease in both periods was primarily attributable to non-recurring deferred revenue recognized in the second quarter of 2025 in
connection with the mutual termination of a licensing agreement related to the Company's legacy oncology program.
Research and
Development (R&D) Expenses: R&D expenses were $1.1 million for the three months ended June 30, 2026, compared to $2.3
million for the same period in 2025. The decrease of $1.2 million was primarily attributable to lower spending on the Company's tivoxavir
marboxil program. For the six months ended June 30, 2026, R&D expenses were $6.0 million, compared to $4.8 million for the same
period in 2025. The increase of $1.2 million was primarily attributable to ongoing development activities for ratutrelvir and tivoxavir
marboxil, including completion of the Phase 2a clinical trial for ratutrelvir and initiation of a bridging study for tivoxavir marboxil
in March 2026.
General and
Administrative (G&A) Expenses: G&A expenses were $3.5 million for the three months ended June 30, 2026, compared to
$1.7 million for the same period in 2025. The increase of $1.8 million was primarily attributable to higher professional and consulting
fees and non-cash stock-based compensation expense. For the six months ended June 30, 2026, G&A expenses were $5.5 million,
compared to $4.4 million for the same period in 2025.
Other operating income for the three
and six months ended June 30, 2026, consists of the removal of a legacy accrued research and development obligation carried on the Company's
balance sheet of $1.4 million, which was initially recognized in a prior reporting period. During the second quarter of 2026, in connection
with a review of its legacy accrued balances, the Company determined that the obligation is no longer subject to enforcement and that
no future outflow of economic benefits is expected. Because the amount was originally recorded as research and development expense, its
removal is presented within operating expenses rather than as non-operating income.
Net Loss:
Net loss for the three months ended June 30, 2026, was $3.0 million, or $0.16 per basic and diluted common share, compared to a
net loss of $0.9 million, or $0.11 per basic and diluted common share, for the same period in 2025. Net loss for the six months ended
June 30, 2026, was $10.2 million, or $0.64 per basic and diluted common share, compared to net income of $20.6 million, or $2.02
per basic and $1.95 per diluted common share, for the same period in 2025. Net income for the six months ended June 30, 2025 included
a $26.7 million non-cash gain from the change in fair value of warrant liabilities.
Shares Outstanding:
Traws had 15,368,277 shares of common stock outstanding as of August 13, 2026.
About Tivoxavir
Marboxil
Tivoxavir marboxil
(TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose prophylactic
agent for seasonal influenza and treatment of pandemic/bird flu. It has shown potent in vitro activity against a range of influenza strains
in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical
data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza
represents an estimated multi-billion-dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines
and government tenders and inclusion in drug stock piling initiatives1,2, with upside potential from potential pandemic flu
outbreaks including H5N1 bird flu.
Source information
Third-party products
mentioned herein are the trademarks of their respective owners.
About Traws
Pharma, Inc.
Traws Pharma is a clinical-stage biopharmaceutical
company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates
antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases.
The Company is advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat
or resistant virus strains that threaten human health including seasonal influenza and H5N1 bird flu, negative-strand RNA viruses including
Hantavirus, Ebola Virus Disease, Lassa Fever and COVID-19/Long COVID.
For more information,
please visit www.trawspharma.com and follow us on LinkedIn.
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 Company, its business and product candidates, including the potential opportunity, market size, benefits,
effectiveness, safety, and the clinical and regulatory plans for tivoxavir marboxil, as well as plans for its legacy programs. The Company
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
outcome of Traws’ IND filing with the FDA for tivoxavir marboxil, including the current FDA clinical hold; the success and timing
of Traws’ clinical trials; the potential for tivoxavir marboxil to gain market acceptance, if and when regulatory approval is obtained,
or to become the new standard of care; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations;
market conditions; regulatory requirements and pathways for approval; the extent of the spread and threat of the bird flu; seasonal flu;
the Company’s cash projections; Traws’ ability to raise additional capital when needed; and those discussed under the heading
“Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (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, except
to the extent required by law.
Traws Pharma
Contact:
Charles Parker
Traws Pharma, Inc.
cparker@trawspharma.com
www.trawspharma.com
Investor
Contact:
John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.com
Traws Pharma, Inc.
Condensed Consolidated
Balance Sheets (unaudited)
| | |
June 30, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 5,016,000 | | |
$ | 3,820,000 | |
| Tax incentive and other receivables | |
| 3,454,000 | | |
| 3,794,000 | |
| Prepaid expenses and other assets | |
| 553,000 | | |
| 365,000 | |
| Total current assets | |
| 9,023,000 | | |
| 7,979,000 | |
| Property and equipment, net | |
| 5,000 | | |
| 7,000 | |
| Intangible assets, net | |
| 2,441,000 | | |
| 2,527,000 | |
| Other assets | |
| 1,000 | | |
| 104,000 | |
| Total assets | |
$ | 11,470,000 | | |
$ | 10,617,000 | |
| Liabilities and stockholders’ equity (deficit) | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 6,334,000 | | |
$ | 5,653,000 | |
| Accrued expenses and other liabilities | |
| 3,401,000 | | |
| 5,493,000 | |
| Total current liabilities | |
| 9,735,000 | | |
| 11,146,000 | |
| Warrant liabilities | |
| 44,000 | | |
| 100,000 | |
| Total liabilities | |
| 9,779,000 | | |
| 11,246,000 | |
| | |
| | | |
| | |
| Commitments and contingencies (Note 5) | |
| | | |
| | |
| | |
| | | |
| | |
| Stockholders’ deficit: | |
| | | |
| | |
| Series C Preferred stock, $0.01 par value, 5,000,000 shares authorized, 7,440 shares issued and 6,737 shares outstanding at June 30, 2026 and December 31, 2025 | |
| — | | |
| — | |
| Common stock, $0.01 par value, 250,000,000 shares authorized, 15,264,812 and 9,067,774 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively | |
| 152,000 | | |
| 90,000 | |
| Additional paid-in capital | |
| 651,689,000 | | |
| 639,259,000 | |
| Accumulated deficit | |
| (650,145,000 | ) | |
| (639,984,000 | ) |
| Accumulated other comprehensive (loss) income | |
| (5,000 | ) | |
| 6,000 | |
| Total stockholders’ equity (deficit) | |
| 1,691,000 | | |
| (629,000 | ) |
| Total liabilities and stockholders’ equity (deficit) | |
$ | 11,470,000 | | |
$ | 10,617,000 | |
Traws Pharma, Inc.
Condensed Consolidated
Statements of Operations (unaudited)
| | |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Revenue | |
$ | — | | |
$ | 2,733,000 | | |
$ | — | | |
$ | 2,790,000 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 1,101,000 | | |
| 2,291,000 | | |
| 6,013,000 | | |
| 4,797,000 | |
| General and administrative | |
| 3,479,000 | | |
| 1,691,000 | | |
| 5,513,000 | | |
| 4,445,000 | |
| Other operating income | |
| (1,405,000 | ) | |
| — | | |
| (1,405,000 | ) | |
| — | |
| Total operating expenses | |
| 3,175,000 | | |
| 3,982,000 | | |
| 10,121,000 | | |
| 9,242,000 | |
| Loss from operations | |
| (3,175,000 | ) | |
| (1,249,000 | ) | |
| (10,121,000 | ) | |
| (6,452,000 | ) |
| Change in fair value of warrant liability | |
| 215,000 | | |
| 146,000 | | |
| 56,000 | | |
| 26,659,000 | |
| Other (loss) income, net | |
| (94,000 | ) | |
| 188,000 | | |
| (96,000 | ) | |
| 368,000 | |
| Net (loss) income | |
$ | (3,054,000 | ) | |
$ | (915,000 | ) | |
$ | (10,161,000 | ) | |
$ | 20,575,000 | |
| Net (loss) income attributable to common stockholders, basic and diluted | |
$ | (2,611,000 | ) | |
$ | (625,000 | ) | |
$ | (8,446,000 | ) | |
$ | 14,860,000 | |
| Weighted-average shares of common stock outstanding, basic | |
| 15,864,041 | | |
| 5,820,903 | | |
| 13,266,763 | | |
| 7,359,825 | |
| Net (loss) income per share of common stock, basic | |
$ | (0.16 | ) | |
$ | (0.11 | ) | |
$ | (0.64 | ) | |
$ | 2.02 | |
| Weighted-average shares of common stock outstanding, diluted | |
| 15,864,041 | | |
| 5,820,903 | | |
| 13,266,763 | | |
| 7,614,325 | |
| Net (loss) income per share of common stock, diluted | |
$ | (0.16 | ) | |
$ | (0.11 | ) | |
$ | (0.64 | ) | |
$ | 1.95 | |
| Net (loss) income attributable to Series C Preferred stockholders, basic and diluted | |
$ | (443,000 | ) | |
$ | (290,000 | ) | |
$ | (1,715,000 | ) | |
$ | 5,715,000 | |
| Weighted-average shares of Series C Preferred outstanding, basic and diluted | |
| 6,737 | | |
| 6,759 | | |
| 6,737 | | |
| 7,077 | |
| Net (loss) income per share of Series C Preferred, basic and diluted | |
$ | (65.76 | ) | |
$ | (42.91 | ) | |
$ | (254.56 | ) | |
$ | 807.55 | |