Valion Bio, Inc. Common Stock (NASDAQ:VBIO) reported a wider first-quarter loss as the newly renamed company absorbed the operating costs of its Velocity Bioworks biomanufacturing subsidiary and continued shifting from its prior consumer device business into clinical-stage biopharmaceutical development.
Chief Executive Officer Michael K. Handley said the company’s transition from Tivic Health Systems to Valion Bio became effective April 28, with shares now trading under the ticker VBIO. He said the change “formalizes” the company’s new focus on entolimod, a TLR5 agonist being developed for oncology supportive care and as a medical countermeasure for acute radiation syndrome, as well as Velocity Bioworks, its domestic biomanufacturing business.
Government Engagement Advances Entolimod Program
Handley highlighted several recent government-related developments for entolimod. On March 26, Valion Bio signed a non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases, or NIAID, targeting gastrointestinal acute radiation syndrome. On May 5, the company announced it had received what Handley called the first FDA precedent gastrointestinal study protocol from NIAID for entolimod.
According to Handley, NIAID will fully fund the BLA-enabling in vivo programs and support the FDA submission process. He said the arrangement moves the Animal Rule pathway “from a company-funded development effort to a federally funded, federally supported program.”
Handley also said Valion Bio briefed senior leadership at the U.S. Department of War on April 28 regarding entolimod for acute radiation syndrome. He said the company emphasized the product candidate’s potential differentiation, including simultaneous bone marrow and gastrointestinal protection and efficacy when administered up to a day after exposure. The company also presented its oral transmucosal program to the Department of War on May 7, describing it as a potential needle-free formulation for mass casualty and warfighter scenarios.
Internationally, Valion Bio said it received a request for information from Ukraine’s Ministry of Health regarding the potential inclusion of entolimod in national stockpile reserves as a medical countermeasure for acute radiation syndrome.
Oncology Supportive Care Remains Long-Term Focus
While Handley described acute radiation syndrome as a potential non-dilutive path to first revenue through government procurement, he said the company’s intended long-term primary value driver is oncology supportive care, particularly neutropenia and gastrointestinal toxicity associated with myelosuppressive chemoradiation therapy.
Valion Bio expects to initiate physician-sponsored studies for neutropenia in the second half of 2026. Handley said six institutional sites have shown interest, and the data from those studies are expected to support a later Phase IIB program.
The company is also planning development work for Entolasta, a second-generation molecule intended to reduce antibody formation that can limit longer-term use of entolimod. Handley said the company expects to advance Entolasta through IND-enabling studies during 2026 and 2027.
Velocity Bioworks Drives Cost Increase, Near-Term Revenue Focus
Handley said Velocity Bioworks represents Valion Bio’s “most immediate revenue opportunity.” The company recently held a formal grand opening for its San Antonio, Texas, facility, which Handley said is staffed with about 45 scientists, engineers and operators.
He said the company completed a 200-fold manufacturing scale-up of entolimod at a 50-liter fermentation bioreactor, meeting purity and potency specifications. Valion Bio plans to offer services including bioprocess development, GMP manufacturing, analytical method development, fill and finish, and regulatory and quality support.
Handley said Velocity Bioworks is operationally active for non-GMP activity and is producing revenue, while the company continues customer development efforts for third-party contract development and manufacturing organization, or CDMO, work. He cautioned that CDMO sales cycles are long, with customers often planning manufacturing capacity 12 to 18 months in advance.
First-Quarter Financial Results
Chief Financial Officer Lisa Wolf said total operating expenses were $5.6 million for the three months ended March 31, 2026, up from $1.4 million in the prior-year quarter. She said the increase reflected the addition of Velocity Bioworks, continued advancement of entolimod and Entolasta, and the build-out of regulatory, manufacturing and corporate functions.
- Research and development expense: $1.9 million, compared with $0.3 million a year earlier.
- Selling, general and administrative expense: $3.8 million, compared with $1 million in the first quarter of 2025.
- Net loss: $6.2 million, compared with a net loss of $1.5 million a year earlier.
- Net loss per share: $2.23, compared with $2.52 in the prior-year period.
- Cash and cash equivalents: $7.2 million at March 31, 2026, compared with $12.6 million at Dec. 31, 2025.
Wolf said approximately $1 million of the R&D increase and $1.7 million of the SG&A increase came from the Velocity Bioworks operating footprint. SG&A also included about $0.4 million of executive severance. Other expense, net, was $0.6 million, primarily tied to interest expense and amortization related to a $16.3 million convertible note payable.
The company’s discontinued ClearUP consumer device business generated income of approximately $23,000 in the quarter, reflecting residual sales during the first two months of the year before the Shopify storefront was closed.
2026 Milestones
Handley outlined several expected milestones for the remainder of 2026, including initiation of physician-sponsored neutropenia studies in the second half, entolimod GMP manufacturing validation in the third quarter, and a targeted completion of that validation by year-end. He also said the company expects Entolasta manufacturing and entolimod pre-BLA meeting activities in the fourth quarter.
Valion Bio also plans to continue NIAID-funded BLA-enabling testing for gastrointestinal radiation syndrome and pursue Velocity Bioworks third-party customer engagement. Handley said the company is “actively evaluating financial opportunities” to support execution of its strategic plan and will provide disclosures as required.
Handley said future investor engagement will change beginning with the second-quarter call, when the company intends to host a live management question-and-answer session and use a presentation to support its remarks.
About Valion Bio, Inc. Common Stock (NASDAQ:VBIO)
Tivic Health Systems is a commercial-stage medical technology company that develops and markets non-drug, neuromodulation-based therapies for nasal and sinus health. The company’s solutions are designed to alleviate sinus pain, pressure and congestion through gentle microcurrent and vibration stimulation. By targeting the underlying nerve pathways in the nasal passages, Tivic Health aims to provide an alternative to over-the-counter and prescription medications without introducing systemic side effects.
The flagship product, ClearUP™ Sinus Pain Relief, is an FDA-cleared, hand-held device intended for home use.
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