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). Announcement • May 11
Valion Bio, Inc. to Report Q1, 2026 Results on May 14, 2026 Valion Bio, Inc. announced that they will report Q1, 2026 results After-Market on May 14, 2026 Announcement • May 07
Valion Bio, Inc. Receives First FDA -Precedent Study Protocol from NIAID for Entolimod Valion Bio, Inc. (Nasdaq: VBIO) (formerly Tivic Health Systems, Inc.), a clinical-stage immunotherapeutics company developing Entolimod™ for Acute Radiation Syndrome (ARS) and oncology supportive care, announced it has received the first study protocol under its previously announced non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health. Under the agreement — valued at up to $7 million — NIAID will fully fund the in vivo studies required to support the Company's Biologics License Application (BLA) for Entolimod™ under the FDA's Animal Rule pathway, with the agency further committed to co-navigate the FDA submission process alongside Valion Bio upon favorable study outcomes. The protocol provided to Valion Bio is identical to a study design previously used and accepted by the FDA in support of a prior ARS medical countermeasure approval. This regulatory precedent meaningfully de-risks the design phase of the Company's BLA-enabling work, as the agency has already accepted the structure as evidentiary under the Animal Rule. The studies will be conducted at the Armed Forces Radiobiology Research Institute (AFRRI), the U.S. government's primary radiological research facility for ARS countermeasure evaluation, with NIAID serving as the contracting and funding agency. The first study under the protocol is a Partial-Body Irradiation Gastrointestinal Acute Radiation Syndrome (PBI-GI-ARS) pilot designed specifically to evaluate Entolimod's ability to preserve gastrointestinal tissue — including intestinal crypt cells and endothelial cells — following radiation exposure. No countermeasure currently approved by the FDA or held in the U.S. Strategic National Stockpile has demonstrated GI-tract preservation under this protocol. In real-world radiation exposure scenarios — including dirty-bomb events, nuclear reactor incidents, partial detonations, and special-operations exposures involving directional radiation sources — partial-body irradiation is the predominant injury pattern. Bone marrow is often partially shielded; the GI tract typically is not. GI failure can result in death within 24–48 hours due to loss of nutrient and water absorption, irrespective of hematopoietic function. A positive signal in this pilot would position Entolimod™ as the only medical countermeasure capable of demonstrating both hematopoietic and gastrointestinal protection — addressing the full lethal radiation injury cascade currently uncovered by stockpiled agents including Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Leukine® (sargramostim). The NIAID-funded program covers all in vivo testing remaining on the critical path to BLA filing, including bridging studies designed to confirm that Entolimod™ manufactured at Velocity Bioworks, Valion Bio's wholly owned CDMO subsidiary in San Antonio, is equivalent to drug material previously evaluated. Entolimod™ has been administered in 42 non-human primate studies and to approximately 300 human subjects, with over $140 million invested in the program to date, including approximately $35.6 million in prior U.S. government funding. Entolimod™ has received FDA Fast Track and Orphan Drug designations for ARS and is being developed under the Animal Rule pathway, which permits approval based on animal efficacy data when human efficacy trials are not feasible or ethical. Its mechanism — TLR5 agonism driving NF-?B-mediated cytokine induction in parallel with PI3K/AKT anti-apoptotic signaling — is differentiated from currently stockpiled G-CSF agents in that it is designed to protect both hematopoietic and gastrointestinal tissues across the full lethal-dose range of radiation exposure. The NIAID-funded program covers all in vivo testing remaining on the critical path to BLA filing, including bridging studies designed to confirm that Entolimod™ manufactured at Velocity Bioworks, Valion Bio's wholly owned CDMO subsidiary in San Antonio, is equivalent to drug material previously evaluated. Entolimod™ has been administered in 42 non-human primate studies and to approximately 300 human subjects, with over $140 million invested in the program to date, including approximately $35.6 million in prior U.S. government funding. 
