Current Report · Items 7.01, 9.01 · 8-K
Traws Pharma, Inc.
TRAWNASDAQEQUITYCurrent
Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On June 12, 2026, Traws Pharma, Inc. (the “Company”) issued a press release (the “Press Release”) announcing that the planned test of tivoxavir marboxil in a Phase 2a human influenza challenge study has been deferred due to a negative review of the program by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency.…
Filed Jun 12, 2026Accepted Jun 12, 2026, 5:25 PM EDTCIK 1130598Accession 0001104659-26-073593
Company context
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.
Current securities
Historical securities (2)
Disclosure sections
Items 7.01, 9.01Select an item to read the extracted section. The as-filed document remains the primary evidence.
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On June 12, 2026, Traws Pharma,
Inc. (the “Company”) issued a press release (the “Press Release”) announcing that the planned test of tivoxavir
marboxil in a Phase 2a human influenza challenge study has been deferred due to a negative review of the program by the United Kingdom’s
Medicines and Healthcare Products Regulatory Agency. A copy of the Press Release is attached as Exhibit 99.1 to this Current Report on
Form 8-K (this “Current Report”) and is incorporated by reference into this Item 7.01.
The information included in this
Current Report under this Item 7.01 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for the purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or the Securities
Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
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 reasonable 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 June 12, 2026.
104 Cover Page Interactive Data File (embedded
within the inline XBRL Document)
Filed exhibits (1)
EX-99.1 (by filename) tm2617872d1_ex99-1.htmEX-99.1
2
tm2617872d1_ex99-1.htm
EXHIBIT 99.1
Exhibit 99.1
Traws Pharma
Provides Regulatory Update on Influenza Program
NEWTOWN, PA -
June 12, 2026 - (GLOBENEWSWIRE) Traws Pharma, Inc. (NASDAQ: TRAW, the Company), a clinical-stage biopharmaceutical
company developing novel therapies for critical global viral threats, today announced that the planned test of tivoxavir marboxil (TXM)
in a Phase 2a human influenza challenge study has been deferred due to a negative review of the program by the United Kingdom’s
Medicines and Healthcare Products Regulatory Agency (MHRA).
“Tivoxavir marboxil demonstrated potent
efficacy in three animal models of highly pathogenic avian influenza and a pharmacokinetic profile consistent with its use for bird flu
treatment and prevention,” said C. David Pauza, PhD Chief Science Officer for Traws Pharma, “The product candidate
retains potential for emergency use in a bird flu outbreak and for prevention in high-risk populations.” The Company has a portfolio
of back-up influenza antiviral compounds and is actively advancing candidates with TXM's long-duration pharmacokinetic and antiviral profile
and devoid of any mutagenic potential.
“Influenza, in…
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