Form 8-K

8-K — Traws Pharma, Inc.

Accession: 0001104659-26-061771

Filed: 2026-05-15

Period: 2026-05-15

CIK: 0001130598

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — tm2614707d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2614707d1_ex99-1.htm)

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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):

May 15, 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 ¨

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 May 15, 2026, Traws Pharma, Inc. (the “Company”)

issued a press release (the “Earnings Release”) announcing its financial results for the quarter ended March 31, 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 May 15, 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: May 15, 2026

TRAWS PHARMA, INC.

By:

/s/ Charles

Parker

Charles Parker

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2614707d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Traws Pharma

Provides Business Highlights and Reports Q1 2026 Financial Results

Private financing of up to $60M offering of

common stock (with $10M upfront) and milestone-based warrants expected to support operations into Q1 2027

Tivoxavir marboxil advancing towards a human

influenza challenge trial as a once-monthly prophylactic agent

Advancing clinical candidates for the treatment

of hantavirus infections

NEWTOWN, PA, May 15, 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 provided recent business

highlights and reported financial results for the quarter ended March 31, 2026. The highlights include updates on the Company's lead program,

tivoxavir marboxil (TXM), in development for influenza prophylaxis, and its hantavirus drug development efforts.

“Q1 2026 was a period of meaningful progress

for Traws. The recently announced private financing of up to $60 million in gross proceeds provides us with a clear runway into Q1 2027

and supports our ability to execute on our key programs. We are advancing TXM toward a human challenge trial as a once-monthly prophylactic

agent against seasonal influenza, which is scheduled to be initiated in Q2 2026. Separately, we will be actively engaging with the FDA

to resolve the clinical hold and enable initiation of global studies by year end,” commented Iain Dukes, MA, DPhil, Chief

Executive Officer of Traws Pharma. “Our pipeline now also includes a potential antiviral therapy for hantavirus. The recent

outbreak1 brought new attention to a disease with no approved treatments.”

Recent Highlights and Anticipated Milestones:

$60 Million Private Financing

On April 15, 2026, TRAW announced an up to $60

million private investment in a public equity (PIPE) financing, including $10 million in gross proceeds at closing, with up to approximately

$50 million of additional potential gross proceeds from milestone-based and three-year warrants. As described in the Company’s 8K

issued on April 15, 2026, the financing consists of the sale of 5,982,919 shares of common stock (or pre-funded warrants in lieu thereof)

at a purchase price of $1.6730 per share.

The upfront gross proceeds and milestone-based

warrants, along with the current cash and cash equivalents, are estimated to provide sufficient resources to fund company operations into

Q1 2027 including completion of a human challenge trial to evaluate TXM as a once-monthly prophylactic agent for influenza prevention.

Investigational Programs:

Tivoxavir Marboxil (TXM, influenza):

Intended Indication and Market Potential: Potential

as a best-in-class once-monthly prophylactic for seasonal flu and potential inclusion in pandemic preparedness initiatives,2,3 all-together,

estimated to be a multi-billion-dollar opportunity.

Next Steps:

· Completion of Phase

1 Bridging Study – The ongoing Phase 1 Bridging Study, conducted under an open IND in Australia, is intended to evaluate if

the compressed tablet formulation provides 28-days of coverage.

· MHRA Approval and Initiation

of Challenge trial – Following completion of the Phase 1 Bridging Study and receipt of MHRA approval, TRAW will conduct

a single-dose influenza virus challenge trial of TXM 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 – 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, with the goal of resolving the hold and enabling initiation of global clinical studies

by year end.

Hantavirus Program:

Intended Indication and Market Potential: Hantavirus,

a rodent-borne negative-strand RNA virus that typically results in a 30-50% fatality rate when transmitted to humans and which has been

implicated as the cause of several cruise ship fatalities and serious illnesses in recent days1.

Next Steps: Traws plans to move rapidly

to advance a clinical candidate for hantavirus treatment.

Financial Results:

Cash and cash equivalents: As of March

31, 2026, the Company had cash and cash equivalents of approximately $3.1 million, compared to approximately $3.8 million as of December

31, 2025, excluding gross proceeds of up to approximately $60 million for a PIPE financing and milestone-based and three-year warrants

which the Company completed on April 15, 2026. Based on current plans, the Company believes that its current cash balance, including net

proceeds from the offering and milestone-based warrants, is sufficient to support planned expenses, including completion of the Challenge

Study, into Q1 2027.

Revenue for the quarter ended March 31,

2026, was $0.0 million, compared to $0.06 million for the comparable period in 2025.

Research and development (R&D) expense

for the quarter ended March 31, 2026, totaled $4.9 million, compared to $2.5 million for the comparable period in 2025. This increase

of $2.4 million primarily relates to an increase in expenses related to completion of antiviral clinical trial milestones.

General and administrative (G&A) expense

for the quarter ended March 31, 2026, totaled $2.0 million, compared to $2.8 million for the comparable period in 2025. This decrease

of $0.7 million was primarily attributable to a decrease in professional and consulting fees.

Change in fair value of warrant liability

for the quarter ended March 31, 2026, was an expense of $0.2 million, compared to other income of $26.5 million for the comparable period

in 2025. The change for the three months ended March 31, 2025 is primarily attributable to remeasurement of the warrant liability upon

amendment and partial exercise of the Pre-Funded Warrants and Series A Warrants, and the fair value of remaining Series A Warrants as

of March 31, 2025.

Net Income (loss): The net loss for the

quarter ended March 31, 2026 was $7.1 million, or a net loss of $0.53 per basic and diluted common share. This compares to net income

of $21.5 million, or net income of $2.17 per basic and $2.09 per diluted common share, for the quarter ended March 31, 2025.

Shares Outstanding: Traws had 15,150,669

shares of common stock outstanding as of May 12, 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 initiatives 2,3, with upside potential from potential pandemic flu outbreaks

including H5N1 bird flu.

Source information

1. Wall Street Journal. (2026,

May 7). The 33-day 'Atlantic Odyssey' that turned into a hantavirus nightmare. The Wall Street

Journal. https://www.wsj.com/world/the-33-day-atlantic-odyssey-that-turned-into-a-hantavirus-nightmare-ae8c7f48

2. Per link

3. Traws data on file

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.

We are 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

and COVID-19/Long COVID. Lead program, tivoxavir marboxil, is in development as a once-monthly oral prophylactic agent for influenza prevention,

with additional potential as a single-dose therapy for seasonal flu or H5N1 bird flu, targeting the influenza cap-dependent endonuclease

(CEN).

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 and ratutrelvir, 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; Traws’ ability to identify and advance potential clinical candidates for the treatment of hantavirus

infections, the potential efficacy of ratutrelvir for the treatment of COVID-19, including the potential to reduce the risk of COVID rebound

and Long COVID; the potential for tivoxavir marboxil and ratutrelvir 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 ongoing need for improved therapy to reduce the frequency of clinical

rebound and the concomitant risk for Long COVID; the extent of the spread and threat of pandemic flu including H5N1 bird 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)

March 31,

December 31,

2026

2025

Assets

Current assets:

Cash and cash equivalents

$ 3,133,000

$ 3,820,000

Tax incentive and other receivables

1,687,000

3,794,000

Prepaid expenses and other assets

845,000

365,000

Total current assets

5,665,000

7,979,000

Property and equipment, net

6,000

7,000

Intangible assets, net

2,484,000

2,527,000

Other assets

1,000

104,000

Total assets

$ 8,156,000

$ 10,617,000

Liabilities and stockholders’ deficit

Current liabilities:

Accounts payable

$ 7,665,000

$ 5,653,000

Accrued expenses and other liabilities

5,543,000

5,493,000

Total current liabilities

13,208,000

11,146,000

Warrant liabilities

259,000

100,000

Total liabilities

13,467,000

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 March 31, 2026 and December 31, 2025

—

Common stock, $0.01 par value, 250,000,000 shares authorized, 10,162,587 and 9,067,774 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

101,000

90,000

Additional paid-in capital

641,681,000

639,259,000

Accumulated deficit

(647,091,000 )

(639,984,000 )

Accumulated other comprehensive (loss) income

(2,000 )

6,000

Total stockholders’ deficit

(5,311,000 )

(629,000 )

Total liabilities and stockholders’ deficit

$ 8,156,000

$ 10,617,000

Traws Pharma, Inc.

Condensed Consolidated Statements of Operations

(unaudited)

Three Months Ended March 31,

2026

2025

Revenue

$ —

$ 57,000

Operating expenses:

Research and development

4,912,000

2,506,000

General and administrative

2,034,000

2,754,000

Total operating expenses

6,946,000

5,260,000

Loss from operations

(6,946,000 )

(5,203,000 )

Change in fair value of warrant liability

(159,000 )

26,513,000

Other income, net

(2,000 )

180,000

Net (loss) income

$ (7,107,000 )

$ 21,490,000

Net (loss) income attributable to common stockholders, basic and diluted

$ (5,692,000 )

$ 15,083,000

Weighted-average shares of common stock outstanding, basic

10,640,625

6,965,927

Net (loss) income per share of common stock, basic

$ (0.53 )

$ 2.17

Weighted-average shares of common stock outstanding, diluted

10,640,625

7,215,125

Net (loss) income per share of common stock, diluted

$ (0.53 )

$ 2.09

Net (loss) income attributable to Series C Preferred stockholders, basic and diluted

$ (1,415,000 )

$ 6,407,000

Weighted-average shares of Series C Preferred outstanding, basic and diluted

6,737

7,398

Net (loss) income per share of Series C Preferred, basic and diluted

$ (210.03 )

$ 866.04

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dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

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dei_

Data Type:

xbrli:booleanItemType

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duration