エドガーで原本を確認する
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): March 21, 2025
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 8.01 | Other Events |
On March 21, 2025, Traws Pharma, Inc. (the “Company”) issued a press release announcing data presented in a poster (the “Poster”), titled “Tivoxavir marboxil, an Influenza Inhibitor Targeting Cap-dependent Endonuclease: Results from a Phase I Trial Demonstrating Safety, Tolerability and Pharmacokinetics and Demonstrating Protection Against H5N1 Bird Flu in a Rodent Challenge Model,” presented at the International Conference on Antiviral Research (ICAR 2025) on March 20, 2025. The Poster highlights positive data supporting the potential for the Company’s investigational one-dose influenza therapy, tivoxavir marboxil, for treatment of H5N1 avian influenza. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”), and is incorporated herein by reference.
Additionally, a copy of the Poster is furnished as Exhibit 99.2 to this Current Report, and is incorporated herein by reference.
Forward-Looking Statements
This Current Report, including Exhibits 99.1 and 99.2, 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 Exhibits 99.1 and 99.2, 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 March 21, 2025. | |
| 99.2 | Poster Presentation, dated March 20, 2025. | |
| 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: March 21, 2025 | TRAWS PHARMA, INC. | |
| By: | /s/ Werner Cautreels | |
| Werner Cautreels | ||
| Chief Executive Officer | ||
Exhibit 99.1
Traws Pharma’s Bird Flu Drug Candidate, Tivoxavir Marboxil, Presented at ICAR
| · | Poster underscores Tivoxavir Marboxil’s
potential for the treatment of bird flu, supported by 100% survival in a rodent challenge model, potent suppression of resistant viruses
and Phase 1 data |
| · | Full dataset to be highlighted during Investor Call on March 31, 2025 at 10:00 AM ET |
NEWTOWN, PA, March 21, 2025 (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 announced that positive data supporting the potential for tivoxavir marboxil (TXM) as a bird flu treatment was presented yesterday in a poster at the International Society for Antiviral Research (ICAR 2025), being held in Las Vegas, Nevada.
C. David Pauza, PhD, Chief Science Officer of Traws Pharma commented, “Bird flu has emerged as a potential threat to human health. Extensive spread in poultry and dairy farms have increased the exposure risk for agricultural workers. We believe an effective antiviral agent for bird flu needs to potently suppress native and resistant viruses and provide protection against mortality and viral disease, with good overall tolerability and ease of use. The positive data presented at ICAR, from laboratory, preclinical and Phase 1 studies, reinforce our view that TXM meets that target profile and has the potential to be a potent, effective and safe treatment for bird flu, with broad applicability to seasonal flu. Looking ahead, we plan to meet with the FDA to align on next steps, including the potential for an accelerated path to approval.”
“We were pleased to have the opportunity to share the promising TXM results in bird flu with the international antiviral community during the poster session at ICAR. We look forward to updating investors on Traws’ antiviral programs during a virtual event on Monday, March 31, 2025 at 10:00 AM ET, said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma.
Tivoxavir Marboxil Poster
Poster Title: Tivoxavir marboxil, an Influenza Inhibitor Targeting Cap-dependent Endonuclease: Results from a Phase I Trial Demonstrating Safety, Tolerability and Pharmacokinetics and Demonstrating Protection Against H5N1 Bird Flu in a Rodent Challenge Model
Poster Date: March 20, 2025
Data in the poster support potential use of single dose treatment of TXM in bird flu:
| · | Potent Preclincial Suppression of Resistant Virus: Laboratory studies showed that TXM potently suppressed influenza A, B and C viruses and baloxavir resistant flu viruses, with sub-nanomolar potency against H5N1/influenza A virus. |
| · | Potent Antiviral Activity in Preclinical Challenge Model: Results from a rodent challenge model showed that 100% of mice treated with TXM survived, with no virus-induced weight loss and significant reductions in lung viremia, whereas all untreated animals succumbed by study day 6. These data are consistent with previously reported ferret data. |
| · | Phase 1 data show potential for single treatment to maintain target drug levels: Results in healthy volunteers showed that a single dose of TXM maintained plasma blood levels at EC90 for ~3 weeks, with good overall tolerability. The study incorporated a wide dose range in anticipation that bird flu would be more virulent and hard to treat. |
About ICAR
The International Conference on Antiviral Research (ICAR, https://www.isar-icar.com/ICAR2025) is international organization dedicated to bringing together scientists and clinicians from multiple disciplines to discuss the latest advances and breakthroughs in antiviral research.
About Tivoxavir Marboxil
Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. Consistent, positive preclinical data from three species indicate that a single-dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of tivoxavir marboxil as a treatment for bird flu.
Source information: 1. TRAW data on file; 2. Mostafa, A., Barre, R.S., Allue-Guardia, A., et al. (2025) Emerging Microbes and Infections, https://doi.org/10.1080/22221751.2024.2447614
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. We strive to advance novel investigational antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health. Our product candidates are intended to be safe, with simple dosing regimen. We seek to utilize accelerated clinical trial strategies with a commitment to patients who are especially vulnerable.
The Company’s two antiviral programs are investigational oral small molecules targeting bird flu and seasonal influenza, and COVID-19. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a COVID treatment, targeting the Main protease (Mpro or 3CL protease), without the need for co-administration of ritonavir.
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, benefits, effectiveness, safety, and the regulatory plans for tivoxavir marboxil. 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 success and timing of Traws’ clinical trials, collaborations, market conditions, regulatory requirements and pathways for approval, the extent of the spread and threat of the bird flu, 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:
Nora Brennan
Traws Pharma, Inc.
nbrennan@trawspharma.com
www.trawspharma.com
Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com
Exhibit 99.2
|
Tivoxavir marboxil, an Influenza Inhibitor Targeting Cap-dependent Endonuclease: Results from a Phase I Trial Demonstrating Safety, Tolerability and Pharmacokinetics and Demonstrating Protection Against H5N1 Bird Flu in a Rodent Challenge Model Ekaterina Dokukina1 , Viktoriya Moskovich1 , Boris Rogovoy1 , Ruben Karapetian2 , Alexander Ivaschenko2 , Robert R. Redfield3 , Iain D. Dukes3 , Nikolay Savchuk3 , Werner Cautreels3 , and C. David Pauza3 1 Viriom, Inc. Rockville, MD, 2 Chem Div, San Diego, CA, 3 Traws Pharma, Inc., Rockville, MD Tivoxavir marboxil (TXM) is a prodrug inhibitor of the Influenza virus cap-dependent endonuclease (CEN), which is encoded by the viral RNA segment 3 (Acidic polymerase). Due to its critical role in virus replication and very high level of sequence conservation across virus strains, CEN inhibition has become an important strategy for treatment and prevention of seasonal or pandemic influenza. In laboratory testing, the TXM metabolite TXA demonstrated an effective concentration 50% (EC50) in the picomolar range for a variety of Influenza A isolates and was up to 10-times more potent than Baloxavir (BXA), for inhibiting the BXA-resistant I38T variant of H1N1 or H3N2 A/Influenza. TXA also demonstrated picomolar EC50 against multiple highly pathogenic avian influenza H5N1 strains circulating in nature during 2022-2023. Oral dosing with TXM protected 100% of mice from a lethal, intranasal challenge with H5N1 (A/Texas/37/2024), a virus isolated from a dairy worker who was infected through contact with dairy cattle. The TXM Phase I clinical study evaluated 3 dose levels, single dose, in healthy volunteers. Pharmacokinetic studies of the highest dose level showed plasma drug levels at or above the predicted therapeutic window for ~25 days after a single dose. The laboratory and clinical findings for TXM support further development of this compound for treatment of seasonal or pandemic influenza and the pharmacokinetic data support additional studies on TXM as a potential treatment or prophylactic agent for H5N1 bird flu. The viral replication complex binds and cleaves host mRNA leaving the 5’ cap. Sequences in the 3’ end of viral genomic RNA (-strand) are complementary to the remaining fragment of host mRNA and serve to prime +strand RNA synthesis. Cap-dependent endonuclease inhibitors (CENI) prevent cleavage of host mRNA, reduce viral + strand synthesis and block genomic RNA replication. Adapted from Dou, et al., 2018. Front. Immunol. 9:1581. Adapted from: Mostafa, et al. (2025) Replication kinetics, pathogenicity and virus-induced cellular responses of cattle-origin influenza A(H5N1) isolates from Texas, United States, Emerging Microbes and Infections, 14:1 2447614, DOI: 10.1080/22221751.2024.2447614 Tivoxavir marboxil inhibits the cap-independent endonuclease of influenza and suppresses replication of baloxavir-resistant viruses. Tivoxavir marboxil was well-tolerated up to a single dose of 480 mg in a Phase I clinical trial with healthy adult participants Tivoxavir (dose equivalent to 240 mg in humans) protected 100% of mice from lethal infection with the human isolate A/Texas/37/2024 (H5N1) The cap-dependent endonuclease coding region in PA is highly conserved among H5N1 viruses from multiple species 5 Strain Designation Tivoxavir (TRX101) H5N1 viruses EC50 (nM) A/chicken/Idaho/22-011347-004/2022 0.40 A/Canada_goose/Wyoming/22-011671-001/2022 0.52 A/Red_Shoulder_Hawk/Minnesota/22-012000-004/2022 0.43 A/dolphin/Florida/22-025319-002/2022 0.34 A/black_vulture/Florida/22-012333-001/2022 - c30 0.41 Reference A(H3N2) Viruses A/Louisiana/50/2017 (Wt) 1.21 A/Louisiana/49/2017 (PA-138M) 10.28 Subtype/Lineage A(H1N1)pdm2009 A(H3N2) A/Illinois/37/2018 I38L 6.23 ± 1.05 (1) 13.71 ± 1.33 (7.70) A/Illinois/08/2018 I38T 22.26 ± 4.45 (11.97) 73.9 ± 14.31 (41.52) 36.33 ± 9.86 (19.53) 86.69 ± 19.18 (48.14) A/Illinois/08/2018 I38S 8.46 ± 3.62 (10.85) 11.94 ± 3.47 (12.44) A/Louisiana/50/2017 I38M 8.24 ± 1.73 (24.24 0 33.61 ± 7.61 (80.14) A/Yokohama/133/2018 I38T Source: Adapted from Chesnokov, A., et al. 2024. Antimicrob. Agents Chemother. 68: e0172723 Source: United States Centers for Disease Control and Prevention, Atlanta, Georgia 26.78 ± 4.62 (41.2) 81.41 ± 16.25 (92.51) A/Bangladesh/3007/2017 I38T Virus PA Mutation TXA BXA Mean EC50 +SD, nM (fold-change) Tivoxavir marboxil Tivoxavir exhibits sub-nanomolar potency against A/H5N1 circulating in nature during 2022-2023 Bovine to human transmission resulted in 9 amino acid changes across 5 influenza genome segments, that are associated with increased replication in mammalian cells Day 3 Lung Virus Titers (TCID 50) Animal 31 32 33 34 35 46 47 48 49 50 Virus titer - TCID 50/gram of tissue BLLQ-below lower limit of quantitation (2.2x10³ TCID 50/gram) Group Virus Titer 7x108 Vehicle TXM Day 1 dose of 50 mg/kg 1.3x107 1.3x108 8.2x108 1.2x107 BLLQ BLLQ BLLQ BLLQ BLLQ Cohort 1 (80 mg fasted) Sentinels Active (1); Placebo (1) Main Group Active (5); Placebo (1) Cohort 2 (120 mg fasted) Sentinels Active (1); Placebo (1) Main Group Active (5); Placebo (1) Cohort 3 (240 mg fasted) Sentinels Active (1); Placebo (1) Main Group Active (5); Placebo (1) Cohort 4 (480 mg fasted) Sentinels Active (1); Placebo (1) Main Group Active (5); Placebo (1) Virus challenge stock: H5N1 (A/Texas/37/2024) Stock titer: 1.47x109 TCID 50/mL Intranasal challenge: 7.34x100 TCID 50/dose Oral treatment - TXM given 0 and 12 hours after virus inoculation (total 50 mg/kg) 15 animals per group - 5 animals per group sacrificed on D3 for determination of virus titer in lungs Phase I Clinical Trial Schema for Oral Tivoxavir Marboxil in Healthy Adults: Safety, Tolerability and Pharmacokinetics 20 days Pharmacokinetics of Tivoxavir in Healthy . PB2 PB1 PA PA-X NA NS1 E E L K K I R N S R Q 40 E K v I K M G E L LEGEND: Amino acids in red are substitutions found in the human isolate A/Texas/37/2024 (H5N1) Amino acids in blue are amino acids found in the corresponding bovine isolate: A/bovine/Texas/24-029328-02/2024 (H5N1) 3 4 2 1 6 71 142 219 497 142 392 362 627 631 |
