aibioTraws Pharma sets at-the-market sales limit at $7,427,749 under baby shelf cap
Tickers TRAW
Traws Pharma raised its at-the-market limit to $7,427,749 under the baby shelf cap, after selling 42,100 shares for about $122,210. The float that sets the cap uses an $8.29 high close, while the stock closed at $1.96 on April 4, 2025.
Key facts
- Company
- Traws Pharma, Inc. (NASDAQ: TRAW)
- News type
- Financings
- Primary source
- Traws Pharma, Inc. 424B5 (2025-04-07)
The program
Traws Pharma, Inc. entered an at-the-market program with Citizens JMP Securities, LLC on March 10, 2025. The 8-K filed that day says the agreement allows sales of up to $50,000,000, subject to limits. The April 7, 2025 prospectus supplement sets the current cap at $7,427,749. The stock trades on the Nasdaq Capital Market as TRAW.
So far, the company has sold 42,100 shares under the program for aggregate gross proceeds of about $122,210. The new limit is in addition to that amount.
The baby shelf cap
Under the rule the company cites, a company with a public float below $75 million may not sell more than one-third of its public float in any 12-month period through a shelf registration. Traws put its public float at approximately $31,960,763, based on 3,855,339 non-affiliate shares at $8.29, the highest closing price in the prior 60 days. In the prior 12 calendar months it sold $3,225,839 of securities under the same rule.
The float is calculated on that high closing price, from February 6, 2025, not the latest one. On April 4, 2025, the stock closed at $1.96 a share on the Nasdaq Capital Market.
What the company does
Traws describes itself as a company developing novel antiviral agents against difficult-to-treat or resistant virus strains. Before the merger, its focus was cancer. On April 1, 2024, it completed a merger with Trawsfynydd Therapeutics, Inc., a private company developing antivirals for influenza, COVID and other infections. The company was then named Onconova Therapeutics, Inc.
It now has four clinical programs. Tivoxavir marboxil is an oral, small molecule cap-dependent endonuclease inhibitor, which the company intends to develop as a single oral dose for bird flu and seasonal influenza. Ratutrelvir inhibits the main protease of the virus that causes COVID-19. Narazaciclib, also called ON 123300, is a multi-targeted kinase inhibitor for solid tumors and hematological malignancies. Rigosertib is for various cancers, alone or in combination.
The first-in-human study
The first-in-human study of tivoxavir marboxil, designated AV5124 in an earlier study, ran from May to September 2023 in Russia. The study sponsor was Pharmasyntez, JSC. The company says it has the right to use the data outside Russia and the Eurasian Economic Community countries.
It was a single ascending dose study of 28 healthy males aged 18 to 45, in four dose cohorts receiving 20, 40, 80 or 120 mg, or placebo. The company says one subject given a single 40 mg dose had two adverse events: mild hyperglycemia, believed probably related to the drug, and a serious adverse event of severe iron deficiency anemia from erosive gastritis, which it considers unlikely to be related. It was run in healthy volunteers, so it says little about efficacy.
Traws then ran a Phase 1 study in Australia, with four cohorts of eight participants each, six on drug and two on placebo. Its doses were 80, 120, 240 and 480 mg, taken once by mouth. The company reports topline data showing good overall tolerability and a pharmacokinetic profile it says supports a one-time influenza treatment. Sixteen adverse events were recorded, three of them possibly related to the study drug, and all of those were mild headaches. The study's primary endpoint was safety and tolerability, not effectiveness.
Counsel and next steps
Citizens JMP Securities, LLC acts as sales agent and/or principal under the agreement. The 8-K attaches a legal opinion from Snell & Wilmer L.L.P. on the shares, and was signed by Iain Dukes, the interim Chief Executive Officer. Neither document states the commission rate, the company's cash balance or net loss, or how it will use the proceeds.
The company says it plans to meet the FDA in the first half of 2025 about a path forward for tivoxavir marboxil, including guidance on accelerated approval under the "Animal Rule" for H5N1 bird flu. That rule allows approval where a controlled human trial would be unethical or infeasible. The company's bird flu evidence so far comes from preclinical studies in mice, ferrets and nonhuman primates.