Announcement • Jul 22
Valion Bio Entolimod Dossier Accepted for Formal Review Under Ukraine Regulatory Equivalence Pathway Valion Bio, Inc. had its regulatory dossier for Entolimod—a medical countermeasure for Acute Radiation Syndrome (ARS)—accepted for formal review under Ukraine's Regulatory Equivalence Pathway, following the Ministry's earlier request that the Company submit the application. Government acceptance initiates formal regulatory review of Entolimod under Ukraine's Regulatory Equivalency pathway, with a potential review expected in as few as 45- to 60-days. The acceptance initiates the Ministry's scientific and regulatory evaluation and represents the first allied-nation regulatory review of Entolimod. Ukraine operates a facilitated "recognition" registration pathway for biological products that is based on the regulatory reviews of select foreign authorities, including the U.S. Food and Drug Administration ("FDA"). Accordingly, the Company anticipates that the MoH review may rely on the FDA's current review status and documentation for Entolimod, which the Company believes could allow the technical review to be completed in as little as 45 days — with actual timing dependent on the Ministry's questions and its operational circumstances. Entolimod is being developed in the United States under the FDA's Animal Rule for Acute Radiation Syndrome and has received FDA Fast Track and Orphan Drug designations. Entolimod's development has been supported by engagements with U.S. government agencies, including BARDA, NIAID, DTRA, and the Department of War. The Ukraine submission extends that foundation toward allied-nation consideration, without diverting resources from the Company's domestic program. Through its wholly owned CDMO, Velocity Bioworks, Valion Bio has demonstrated a 200-fold manufacturing scale-up of Entolimod at 50-liter fermentation — a scale with the potential to produce approximately 1,300,000 human doses, meeting purity and potency specifications — and is prepared to supply Entolimod at the volumes national-stockpile and allied-nation programs require. Entolimod represents a paradigm shift in the treatment of Acute Radiation Syndrome. Growth-factor therapies currently held in the U.S. Strategic National Stockpile — such as Neupogen (filgrastim) and Neulasta (pegfilgrastim), both G-CSF agents, and Leukine (sargramostim), a GM-CSF agent — are effective at stimulating the recovery of white blood cells after depletion, but they do not address the lethal damage caused to the gastrointestinal ("GI") tract at higher radiation doses. As a selective TLR5 agonist, Entolimod activates the NF-?B signaling pathway, through a cascade of cell signaling pathways, actively preventing programmed cell death (apoptosis) in both bone marrow and GI epithelial tissues. This dual-system protection offers a comprehensive survival benefit that currently approved G-CSF therapies cannot provide, positioning Entolimod as a unique and essential candidate for national defense and emergency response. The Company's lead candidate, Entolimod for acute radiation syndrome (ARS), has been extensively studied and has demonstrated survival benefits and improved tissue recovery in animal models under the FDA's Animal Rule, which allows the Agency to approve new drugs and biological products based on animal efficacy studies when human clinical trials are unethical or not feasible, such as in the case of internal radioactive contamination. Entolimod is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-?B signaling pathways to protect cells from damage and stimulate immune responses. Entolimod for ARS has received Fast Track and Orphan Drug designations from the FDA. Announcement • Jul 19
Valion Bio, Inc. has filed a Follow-on Equity Offering. Valion Bio, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 29,411,764
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 29,411,764
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 29,411,764 New Risk • May 17
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$11m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 1.7% per year over the past 5 years. Shareholders have been substantially diluted in the past year (257% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.76m market cap). 
