{"success":true,"data":{"pressRelease":{"id":"35535","rtpr_id":"nPn28kJ3da","ticker":"VBIO","exchange":"NASDAQ","all_tickers":["VBIO"],"title":"VALION BIO REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS","author":"PR Newswire","published_at":"2026-05-14T20:05:00.060Z","article_body":"VALION BIO REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS\n\nPR Newswire\n\nSAN ANTONIO, May 14, 2026\n\nFirst Reporting Quarter as Valion Bio Marked by Continued Advancement of the\nEntolimod Platform, Broader Government Engagement, and Continued Integration\nof Velocity Bioworks\n\nConference Call to be Held Today at 1:30 PM PT / 4:30 PM ET\n\nSAN ANTONIO , May 14, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic\nHealth Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics\ncompany, today reported financial results for the three months ended March 31,\n2026 — the company's first full reporting quarter under its new corporate\nidentity — and provided a business update on the continued advancement of\nits Entolimod platform, ongoing engagement with U.S. government agencies, and\ncontinued integration of wholly owned manufacturing subsidiary Velocity\nBioworks.\n\n(https://mma.prnewswire.com/media/2972189/Valion_Logo_Logo.html)\n\nFirst Quarter 2026 Highlights and Subsequent Events\n\n * Completed corporate transformation, including the change of the company's\nlegal name from Tivic Health Systems, Inc. to Valion Bio, Inc. and the change\nof the company's Nasdaq listing symbol from TIVC to VBIO, consolidating the\ncompany's identity as a focused clinical-stage immunotherapeutics platform.\n \n * Advanced engagement with U.S. government agencies, including BARDA, the\nNational Institute of Allergy and Infectious Diseases (NIAID), and the\nDepartment of War, regarding the development, procurement, and stockpiling of\nEntolimod as a medical countermeasure for Acute Radiation Syndrome (ARS).\n \n * Continued integration of Velocity Bioworks, the company's wholly owned\ncontract development and manufacturing organization (CDMO) subsidiary acquired\nin December 2025, with operational workstreams advancing across both internal\npipeline manufacturing support and third-party CDMO business development.\n \n * Reinforced regulatory pathway for Entolimod under the FDA's Animal Rule,\nsupported by the program's Fast Track and Orphan Drug designations and the\npreviously demonstrated 200-fold manufacturing scale-up at 50-liter\nfermentation, equivalent to approximately 1.3 million human doses.\n \n * Continued advancement of Entolasta, the company's next-generation TLR5\nagonist, designed to support broader therapeutic applications including\noncology supportive care, longevity, and immunosenescence.\n \n * Maintained domestic biologics manufacturing footprint through Velocity\nBioworks' San Antonio, Texas operations, addressing both the company's\ninternal pipeline manufacturing requirements and a structurally underserved\nPhase I and Phase II domestic biologics manufacturing market.\nThe first quarter of 2026 was, by design, a quarter of execution rather than\nannouncement: the first full quarter operating with Velocity Bioworks\nintegrated, the first quarter following the previously demonstrated 200-fold\nmanufacturing scale-up, and the first quarter under the Valion Bio identity.\nThe transition follows the divestiture and discontinuation of the legacy\nconsumer bioelectronics business completed in 2025 and consolidates the\ncompany's focus on the development and potential commercialization of its TLR5\nplatform.\n\n\"The transition to Valion Bio is more than a change of name and ticker. It\nreflects the institutional identity we have built — a clinical-stage\nimmunotherapeutics company anchored by a differentiated TLR5 platform, an\nin-house biologics manufacturing capability through Velocity Bioworks, and\nincreasing visibility within the federal agencies responsible for national\nmedical countermeasure preparedness,\" said Michael K. Handley, Chief Executive\nOfficer of Valion Bio. \"Each of those pillars advanced through the first\nquarter, and we believe the company enters the balance of 2026 with sharper\nfocus, deeper engagement, and broader optionality than at any point in our\nhistory.\"\n\nGovernment engagement broadened across multiple agencies during the quarter.\nBuilding on the previously disclosed non-clinical evaluation agreement with\nNIAID, Valion Bio further advanced Entolimod toward potential procurement and\nstockpiling under the FDA's Animal Rule pathway. Engagement with BARDA, the\nDepartment of War, and additional federal stakeholders progressed in scope and\ndepth over the same period. Entolimod's profile — dual gastrointestinal and\nhematopoietic protection, repeat-dose tolerability supported by a\ndeletion-variant design that reduces immunogenicity, Fast Track and Orphan\nDrug designations, and a domestic manufacturing footprint — represents a\nmeaningful point of differentiation from currently fielded countermeasures,\nand one that aligns with both Strategic National Stockpile modernization\npriorities and allied-government preparedness initiatives.\n\nIntegration of Velocity Bioworks advanced on multiple fronts during the\nquarter. The San Antonio facility continued to support internal Entolimod\nmanufacturing capability while active business development discussions with\nthird-party biotech sponsors progressed in parallel. Velocity addresses a\nstructurally underserved domestic Phase I and Phase II biologics manufacturing\nmarket and is expected to function both as a cost and timeline accelerant for\nValion Bio's internal pipeline and, increasingly, as a stand-alone source of\nrevenue and operating leverage.\n\n\"Beyond Entolimod's role in radiation defense, the most significant commercial\nopportunity in front of us is oncology supportive care,\" Mr. Handley\ncontinued. \"Neutropenia and related conditions affect a meaningful proportion\nof patients undergoing chemotherapy and radiation therapy, and the mechanistic\nprofile of Entolimod — together with the broader applicability of our\nsecond-generation molecule, Entolasta — positions us to address that market\nwith a differentiated entry. Velocity Bioworks accelerates our path on both\nfronts: it compresses our internal development timelines, structurally lowers\nour manufacturing cost base, and creates a stand-alone CDMO revenue stream\nserving the broader biotech industry. The first quarter was a quarter of\nexecution, and we are building.\"\n\nPipeline development advanced across both molecules during the quarter.\nEntolimod continued progressing toward potential approval under the FDA's\nAnimal Rule, with regulatory and clinical development workstreams positioned\nto support both medical countermeasure and oncology supportive care\napplications, including neutropenia. Entolasta, the company's next-generation\nTLR5 agonist, continued to advance as a strategic platform extension —\nengineered to support broader therapeutic applications including longevity,\nimmunosenescence, and additional oncology supportive care indications, areas\nwhere the underlying TLR5 mechanism is mechanistically suited and the\naddressable markets are substantial.\n\nFinancial Results for the Three Months Ended March 31, 2026\n\nOperating expenses for the three months ended March 31, 2026 were $5.6\nmillion, compared with $1.4 million for the three months ended March 31, 2025.\nThe year-over-year change reflects the inclusion of Velocity Bioworks\noperating costs following the December 2025 acquisition, continued advancement\nof the Entolimod regulatory and development program, and one-time costs\nassociated with the corporate rebrand and Nasdaq symbol change.\n\nNet loss for the three months ended March 31, 2026 was $6.2 million, or $2.23\nper share, compared with a net loss of $1.5 million, or $2.52 per share, for\nthe three months ended March 31, 2025. Cash and cash equivalents at March 31,\n2026 totaled $7.2 million, compared with $12.6 million at December 31, 2025.\nThe company continues to evaluate capital alternatives to support continued\nexecution against pipeline, regulatory, and manufacturing milestones.\n\nConference Call and Webcast Information\n\nValion Bio will host a conference call and webcast today, Thursday, May 14,\n2026, at 1:30 PM PT / 4:30 PM ET to discuss the company's first quarter 2026\nfinancial results and provide a business update. The webcast may be accessed\nat https://www.webcaster5.com/Webcast/Page/2865/54024\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4689299-1&h=1117102827&u=https%3A%2F%2Fwww.webcaster5.com%2FWebcast%2FPage%2F2865%2F54024&a=https%3A%2F%2Fwww.webcaster5.com%2FWebcast%2FPage%2F2865%2F54024)\n. Participants may access the call by dialing 888-506-0062 (U.S. toll-free) or\n973-528-0011 (international), with participant access code 118764. A replay of\nthe webcast will be available on the Investors section of the company's\nwebsite following the conclusion of the event.\n\nAbout Entolimod for Acute Radiation Syndrome\n\nEntolimod (CBLB502) is a recombinant deletion variant of Salmonella FliC\nflagellin engineered to activate TLR5 selectively. Upon engagement, Entolimod\ntriggers NF-κB-dependent signaling to stimulate G-CSF, PI3K, and IL-6\nproduction, promote multi-tissue cytoprotection, and inhibit apoptosis in\nradiosensitive hematopoietic and gastrointestinal tissues. The compound has\ndemonstrated survival benefit as both a radioprotectant and a radiomitigant in\ncontrolled non-human primate studies under the FDA's Animal Rule.\n\nAbout Valion Bio, Inc.\n\nValion Bio, Inc. (Nasdaq: VBIO), the new corporate identity of Tivic Health\nSystems, Inc., is developing biologics that activate innate immune pathways\nfor cytoprotection and modulate immune responses in conditions driven by\nradiation, disease, and immune dysregulation. The Company's lead candidate,\nEntolimod for acute radiation syndrome (ARS), has been extensively studied and\nhas demonstrated survival benefits and improved tissue recovery in animal\nmodels under the FDA's Animal Rule. Entolimod is a novel Toll-like receptor 5\n(TLR5) agonist that activates NF-κB signaling pathways to protect cells from\ndamage and stimulate immune responses. Entolimod for ARS has received Fast\nTrack and Orphan Drug designations from the U.S. Food and Drug Administration.\nValion Bio is also advancing Entolasta, a next-generation TLR5 agonist\ndesigned for potential broader therapeutic applications, including oncology\nsupportive care. Valion Bio's wholly owned subsidiary, Velocity Bioworks, is a\nfull-service contract development and manufacturing organization (CDMO) that\nprovides biomanufacturing services to third-party biotech companies. Valion\nBio also leverages Velocity Bioworks' manufacturing capabilities to advance\nits own drug pipeline with the expected benefits of lower costs, accelerated\nmanufacturing outcomes, and supply chain security. For more information, visit\nwww.valionbio.com (http://www.valionbio.com) .\n\nForward-Looking Statements\n\nThis press release may contain \"forward-looking statements\" that are subject\nto substantial risks and uncertainties. All statements, other than statements\nof historical fact, contained in this press release are forward-looking\nstatements. Forward-looking statements contained in this press release may be\nidentified by the use of words such as \"anticipate,\" \"believe,\" \"contemplate,\"\n\"could,\" \"estimate,\" \"expect,\" \"intend,\" \"seek,\" \"may,\" \"might,\" \"plan,\"\n\"potential,\" \"predict,\" \"project,\" \"target,\" \"aim,\" \"should,\" \"will,\" \"would,\"\nor the negative of these words or other similar expressions, although not all\nforward-looking statements contain these words. Forward-looking statements are\nbased on Valion Bio, Inc.'s current expectations and are subject to inherent\nuncertainties, risks, and assumptions that are difficult to predict. Further,\ncertain forward-looking statements are based on assumptions as to future\nevents that may not prove to be accurate, including as a result of the\ncompany's interactions with and guidance from the FDA and other regulatory\nauthorities; the continued interest of BARDA and other U.S. government\nagencies in Entolimod™; the ability of the company to achieve the expected\nbenefits from the acquisition of development and manufacturing assets within\nexpected time frames or at all; changes to the company's relationship with its\npartners; failure to obtain FDA or similar clearances or approvals and\nnoncompliance with FDA or similar regulations, including related to the Animal\nRule; the company's future development of Entolimod or Entolasta; changes to\nthe company's business strategy; timing and success of pre-clinical and\nclinical trials and study results; regulatory requirements and pathways for\napproval; the company's ability to successfully commercialize its product\ncandidates in the future; changes in the markets and industries in which the\ncompany does business; consummation of any strategic transactions; the\ncompany's need for, and ability to secure when needed, additional working\ncapital; the company's ability to maintain its Nasdaq listing; and changes in\ntariffs, inflation, legal, regulatory, political and economic risks.\nAccordingly, you are cautioned not to place undue reliance on such\nforward-looking statements. For a discussion of risks and uncertainties\nrelevant to the company, and other important factors, see Valion Bio's filings\nwith the SEC, including, its Annual Report on Form 10-K for the year ended\nDecember 31, 2025, filed with the SEC on March 30, 2026, under the heading\n\"Risk Factors\", as well as the company's subsequent filings with the SEC.\nForward-looking statements contained in this press release are made as of this\ndate, and the company undertakes no duty to update such information except as\nrequired by applicable law.\n\nInvestor and Media Contact:\nRich Cockrell\nCG Capital\nvbio@cg.capital (mailto:vbio@cg.capital)\nwww.cg.capital\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4689299-1&h=2152865240&u=https%3A%2F%2Fwww.cg.capital%2F&a=www.cg.capital)\n Valion Bio, Inc. (formerly known as Tivic Health Systems, Inc.)\n\nCondensed Consolidated Balance Sheets\n\n(in thousands, except share and per share data)\n\n March 31, 2026 December 31,\n 2025\n (Unaudited) (Audited)\n ASSETS\n Cash and cash equivalents $ 7,215 $ 12,645\n Other current assets 1,437 361\n TOTAL CURRENT ASSETS 8,652 13,006\n PROPERTY AND EQUIPMENT, NET 12,644 12,641\n ROU ASSETS 10,086 —\n GOODWILL 3,457 3,457\n OTHER NON-CURRENT ASSETS 3,376 2,503\n TOTAL ASSETS $ 38,215 $ 31,607\n\n LIABILITIES, TEMPORARY EQUITY AND STOCKHOLDERS' EQUITY\n Accounts payable and accrued expenses $ 2,119 $ 640\n Operating lease liabilities, current $ 492 $ —\n Other current liabilities $ 4 $ 6\n TOTAL CURRENT LIABILITIES 2,615 646\n DEBT, NET 6,899 6,454\n OPERATING LEASE LIABILITIES 9,643 —\n OTHER NON-CURRENT LIABILITIES 510 340\n TOTAL NON-CURRENT LIABILITIES 17,052 6,794\n TEMPORARY EQUITY 7,486 7,370\n STOCKHOLDERS' EQUITY\n Common stock 2 2\n Additional paid in capital 70,094 69,392\n Accumulated deficit (59,034) (52,597)\n TOTAL STOCKHOLDERS' EQUITY 11,062 16,797\n TOTAL LIABILITIES, TEMPORARY EQUITY AND STOCKHOLDERS' EQUITY $ 38,215 $ 31,607\n\n \n Valion Bio, Inc. (formerly known as Tivic Health Systems, Inc.)\n\nCondensed Consolidated Statements of Operations\n\n(in thousands, except share and per share data)\n\n Three Months Ended March 31,\n 2026 2025\n OPERATING EXPENSES\n Research and development $ 1,854 $ 335\n Selling, general and administrative 3,780 1,042\n TOTAL OPERATING EXPENSES 5,634 1,377\n NET OPERATING LOSS (5,634) (1,377)\n OTHER INCOME (EXPENSE), NET (591) 4\n NET LOSS BEFORE DISCONTINUED OPERATIONS (6,225) (1,373)\n INCOME (LOSS ) FROM DISCONTINUED OPERATIONS 23 (129)\n NET LOSS $ (6,202) $ (1,502)\n NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED $ (2.23) $ (2.52)\n WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED 2,883,650 569,368\n\n \n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/valion-bio-reports-first-quarter-2026-financial-results-302772859.html\n(https://www.prnewswire.com/news-releases/valion-bio-reports-first-quarter-2026-financial-results-302772859.html)\n\nSOURCE Valion Bio, Inc.\n\n\n\nPhoto: \nhttps://mma.prnewswire.com/media/2972189/Valion_Logo_Logo.jpg\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPn28kJ3da","title":"VALION BIO REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS","author":"PR Newswire","ticker":"VBIO","created":"2026-05-14T20:05:00.060Z","tickers":["VBIO"],"exchange":"NASDAQ","article_body":"VALION BIO REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS\n\nPR Newswire\n\nSAN ANTONIO, May 14, 2026\n\nFirst Reporting Quarter as Valion Bio Marked by Continued Advancement of the\nEntolimod Platform, Broader Government Engagement, and Continued Integration\nof Velocity Bioworks\n\nConference Call to be Held Today at 1:30 PM PT / 4:30 PM ET\n\nSAN ANTONIO , May 14, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic\nHealth Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics\ncompany, today reported financial results for the three months ended March 31,\n2026 — the company's first full reporting quarter under its new corporate\nidentity — and provided a business update on the continued advancement of\nits Entolimod platform, ongoing engagement with U.S. government agencies, and\ncontinued integration of wholly owned manufacturing subsidiary Velocity\nBioworks.\n\n(https://mma.prnewswire.com/media/2972189/Valion_Logo_Logo.html)\n\nFirst Quarter 2026 Highlights and Subsequent Events\n\n * Completed corporate transformation, including the change of the company's\nlegal name from Tivic Health Systems, Inc. to Valion Bio, Inc. and the change\nof the company's Nasdaq listing symbol from TIVC to VBIO, consolidating the\ncompany's identity as a focused clinical-stage immunotherapeutics platform.\n \n * Advanced engagement with U.S. government agencies, including BARDA, the\nNational Institute of Allergy and Infectious Diseases (NIAID), and the\nDepartment of War, regarding the development, procurement, and stockpiling of\nEntolimod as a medical countermeasure for Acute Radiation Syndrome (ARS).\n \n * Continued integration of Velocity Bioworks, the company's wholly owned\ncontract development and manufacturing organization (CDMO) subsidiary acquired\nin December 2025, with operational workstreams advancing across both internal\npipeline manufacturing support and third-party CDMO business development.\n \n * Reinforced regulatory pathway for Entolimod under the FDA's Animal Rule,\nsupported by the program's Fast Track and Orphan Drug designations and the\npreviously demonstrated 200-fold manufacturing scale-up at 50-liter\nfermentation, equivalent to approximately 1.3 million human doses.\n \n * Continued advancement of Entolasta, the company's next-generation TLR5\nagonist, designed to support broader therapeutic applications including\noncology supportive care, longevity, and immunosenescence.\n \n * Maintained domestic biologics manufacturing footprint through Velocity\nBioworks' San Antonio, Texas operations, addressing both the company's\ninternal pipeline manufacturing requirements and a structurally underserved\nPhase I and Phase II domestic biologics manufacturing market.\nThe first quarter of 2026 was, by design, a quarter of execution rather than\nannouncement: the first full quarter operating with Velocity Bioworks\nintegrated, the first quarter following the previously demonstrated 200-fold\nmanufacturing scale-up, and the first quarter under the Valion Bio identity.\nThe transition follows the divestiture and discontinuation of the legacy\nconsumer bioelectronics business completed in 2025 and consolidates the\ncompany's focus on the development and potential commercialization of its TLR5\nplatform.\n\n\"The transition to Valion Bio is more than a change of name and ticker. It\nreflects the institutional identity we have built — a clinical-stage\nimmunotherapeutics company anchored by a differentiated TLR5 platform, an\nin-house biologics manufacturing capability through Velocity Bioworks, and\nincreasing visibility within the federal agencies responsible for national\nmedical countermeasure preparedness,\" said Michael K. Handley, Chief Executive\nOfficer of Valion Bio. \"Each of those pillars advanced through the first\nquarter, and we believe the company enters the balance of 2026 with sharper\nfocus, deeper engagement, and broader optionality than at any point in our\nhistory.\"\n\nGovernment engagement broadened across multiple agencies during the quarter.\nBuilding on the previously disclosed non-clinical evaluation agreement with\nNIAID, Valion Bio further advanced Entolimod toward potential procurement and\nstockpiling under the FDA's Animal Rule pathway. Engagement with BARDA, the\nDepartment of War, and additional federal stakeholders progressed in scope and\ndepth over the same period. Entolimod's profile — dual gastrointestinal and\nhematopoietic protection, repeat-dose tolerability supported by a\ndeletion-variant design that reduces immunogenicity, Fast Track and Orphan\nDrug designations, and a domestic manufacturing footprint — represents a\nmeaningful point of differentiation from currently fielded countermeasures,\nand one that aligns with both Strategic National Stockpile modernization\npriorities and allied-government preparedness initiatives.\n\nIntegration of Velocity Bioworks advanced on multiple fronts during the\nquarter. The San Antonio facility continued to support internal Entolimod\nmanufacturing capability while active business development discussions with\nthird-party biotech sponsors progressed in parallel. Velocity addresses a\nstructurally underserved domestic Phase I and Phase II biologics manufacturing\nmarket and is expected to function both as a cost and timeline accelerant for\nValion Bio's internal pipeline and, increasingly, as a stand-alone source of\nrevenue and operating leverage.\n\n\"Beyond Entolimod's role in radiation defense, the most significant commercial\nopportunity in front of us is oncology supportive care,\" Mr. Handley\ncontinued. \"Neutropenia and related conditions affect a meaningful proportion\nof patients undergoing chemotherapy and radiation therapy, and the mechanistic\nprofile of Entolimod — together with the broader applicability of our\nsecond-generation molecule, Entolasta — positions us to address that market\nwith a differentiated entry. Velocity Bioworks accelerates our path on both\nfronts: it compresses our internal development timelines, structurally lowers\nour manufacturing cost base, and creates a stand-alone CDMO revenue stream\nserving the broader biotech industry. The first quarter was a quarter of\nexecution, and we are building.\"\n\nPipeline development advanced across both molecules during the quarter.\nEntolimod continued progressing toward potential approval under the FDA's\nAnimal Rule, with regulatory and clinical development workstreams positioned\nto support both medical countermeasure and oncology supportive care\napplications, including neutropenia. Entolasta, the company's next-generation\nTLR5 agonist, continued to advance as a strategic platform extension —\nengineered to support broader therapeutic applications including longevity,\nimmunosenescence, and additional oncology supportive care indications, areas\nwhere the underlying TLR5 mechanism is mechanistically suited and the\naddressable markets are substantial.\n\nFinancial Results for the Three Months Ended March 31, 2026\n\nOperating expenses for the three months ended March 31, 2026 were $5.6\nmillion, compared with $1.4 million for the three months ended March 31, 2025.\nThe year-over-year change reflects the inclusion of Velocity Bioworks\noperating costs following the December 2025 acquisition, continued advancement\nof the Entolimod regulatory and development program, and one-time costs\nassociated with the corporate rebrand and Nasdaq symbol change.\n\nNet loss for the three months ended March 31, 2026 was $6.2 million, or $2.23\nper share, compared with a net loss of $1.5 million, or $2.52 per share, for\nthe three months ended March 31, 2025. Cash and cash equivalents at March 31,\n2026 totaled $7.2 million, compared with $12.6 million at December 31, 2025.\nThe company continues to evaluate capital alternatives to support continued\nexecution against pipeline, regulatory, and manufacturing milestones.\n\nConference Call and Webcast Information\n\nValion Bio will host a conference call and webcast today, Thursday, May 14,\n2026, at 1:30 PM PT / 4:30 PM ET to discuss the company's first quarter 2026\nfinancial results and provide a business update. The webcast may be accessed\nat https://www.webcaster5.com/Webcast/Page/2865/54024\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4689299-1&h=1117102827&u=https%3A%2F%2Fwww.webcaster5.com%2FWebcast%2FPage%2F2865%2F54024&a=https%3A%2F%2Fwww.webcaster5.com%2FWebcast%2FPage%2F2865%2F54024)\n. Participants may access the call by dialing 888-506-0062 (U.S. toll-free) or\n973-528-0011 (international), with participant access code 118764. A replay of\nthe webcast will be available on the Investors section of the company's\nwebsite following the conclusion of the event.\n\nAbout Entolimod for Acute Radiation Syndrome\n\nEntolimod (CBLB502) is a recombinant deletion variant of Salmonella FliC\nflagellin engineered to activate TLR5 selectively. Upon engagement, Entolimod\ntriggers NF-κB-dependent signaling to stimulate G-CSF, PI3K, and IL-6\nproduction, promote multi-tissue cytoprotection, and inhibit apoptosis in\nradiosensitive hematopoietic and gastrointestinal tissues. The compound has\ndemonstrated survival benefit as both a radioprotectant and a radiomitigant in\ncontrolled non-human primate studies under the FDA's Animal Rule.\n\nAbout Valion Bio, Inc.\n\nValion Bio, Inc. (Nasdaq: VBIO), the new corporate identity of Tivic Health\nSystems, Inc., is developing biologics that activate innate immune pathways\nfor cytoprotection and modulate immune responses in conditions driven by\nradiation, disease, and immune dysregulation. The Company's lead candidate,\nEntolimod for acute radiation syndrome (ARS), has been extensively studied and\nhas demonstrated survival benefits and improved tissue recovery in animal\nmodels under the FDA's Animal Rule. Entolimod is a novel Toll-like receptor 5\n(TLR5) agonist that activates NF-κB signaling pathways to protect cells from\ndamage and stimulate immune responses. Entolimod for ARS has received Fast\nTrack and Orphan Drug designations from the U.S. Food and Drug Administration.\nValion Bio is also advancing Entolasta, a next-generation TLR5 agonist\ndesigned for potential broader therapeutic applications, including oncology\nsupportive care. Valion Bio's wholly owned subsidiary, Velocity Bioworks, is a\nfull-service contract development and manufacturing organization (CDMO) that\nprovides biomanufacturing services to third-party biotech companies. Valion\nBio also leverages Velocity Bioworks' manufacturing capabilities to advance\nits own drug pipeline with the expected benefits of lower costs, accelerated\nmanufacturing outcomes, and supply chain security. For more information, visit\nwww.valionbio.com (http://www.valionbio.com) .\n\nForward-Looking Statements\n\nThis press release may contain \"forward-looking statements\" that are subject\nto substantial risks and uncertainties. All statements, other than statements\nof historical fact, contained in this press release are forward-looking\nstatements. Forward-looking statements contained in this press release may be\nidentified by the use of words such as \"anticipate,\" \"believe,\" \"contemplate,\"\n\"could,\" \"estimate,\" \"expect,\" \"intend,\" \"seek,\" \"may,\" \"might,\" \"plan,\"\n\"potential,\" \"predict,\" \"project,\" \"target,\" \"aim,\" \"should,\" \"will,\" \"would,\"\nor the negative of these words or other similar expressions, although not all\nforward-looking statements contain these words. Forward-looking statements are\nbased on Valion Bio, Inc.'s current expectations and are subject to inherent\nuncertainties, risks, and assumptions that are difficult to predict. Further,\ncertain forward-looking statements are based on assumptions as to future\nevents that may not prove to be accurate, including as a result of the\ncompany's interactions with and guidance from the FDA and other regulatory\nauthorities; the continued interest of BARDA and other U.S. government\nagencies in Entolimod™; the ability of the company to achieve the expected\nbenefits from the acquisition of development and manufacturing assets within\nexpected time frames or at all; changes to the company's relationship with its\npartners; failure to obtain FDA or similar clearances or approvals and\nnoncompliance with FDA or similar regulations, including related to the Animal\nRule; the company's future development of Entolimod or Entolasta; changes to\nthe company's business strategy; timing and success of pre-clinical and\nclinical trials and study results; regulatory requirements and pathways for\napproval; the company's ability to successfully commercialize its product\ncandidates in the future; changes in the markets and industries in which the\ncompany does business; consummation of any strategic transactions; the\ncompany's need for, and ability to secure when needed, additional working\ncapital; the company's ability to maintain its Nasdaq listing; and changes in\ntariffs, inflation, legal, regulatory, political and economic risks.\nAccordingly, you are cautioned not to place undue reliance on such\nforward-looking statements. For a discussion of risks and uncertainties\nrelevant to the company, and other important factors, see Valion Bio's filings\nwith the SEC, including, its Annual Report on Form 10-K for the year ended\nDecember 31, 2025, filed with the SEC on March 30, 2026, under the heading\n\"Risk Factors\", as well as the company's subsequent filings with the SEC.\nForward-looking statements contained in this press release are made as of this\ndate, and the company undertakes no duty to update such information except as\nrequired by applicable law.\n\nInvestor and Media Contact:\nRich Cockrell\nCG Capital\nvbio@cg.capital (mailto:vbio@cg.capital)\nwww.cg.capital\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4689299-1&h=2152865240&u=https%3A%2F%2Fwww.cg.capital%2F&a=www.cg.capital)\n Valion Bio, Inc. (formerly known as Tivic Health Systems, Inc.)\n\nCondensed Consolidated Balance Sheets\n\n(in thousands, except share and per share data)\n\n March 31, 2026 December 31,\n 2025\n (Unaudited) (Audited)\n ASSETS\n Cash and cash equivalents $ 7,215 $ 12,645\n Other current assets 1,437 361\n TOTAL CURRENT ASSETS 8,652 13,006\n PROPERTY AND EQUIPMENT, NET 12,644 12,641\n ROU ASSETS 10,086 —\n GOODWILL 3,457 3,457\n OTHER NON-CURRENT ASSETS 3,376 2,503\n TOTAL ASSETS $ 38,215 $ 31,607\n\n LIABILITIES, TEMPORARY EQUITY AND STOCKHOLDERS' EQUITY\n Accounts payable and accrued expenses $ 2,119 $ 640\n Operating lease liabilities, current $ 492 $ —\n Other current liabilities $ 4 $ 6\n TOTAL CURRENT LIABILITIES 2,615 646\n DEBT, NET 6,899 6,454\n OPERATING LEASE LIABILITIES 9,643 —\n OTHER NON-CURRENT LIABILITIES 510 340\n TOTAL NON-CURRENT LIABILITIES 17,052 6,794\n TEMPORARY EQUITY 7,486 7,370\n STOCKHOLDERS' EQUITY\n Common stock 2 2\n Additional paid in capital 70,094 69,392\n Accumulated deficit (59,034) (52,597)\n TOTAL STOCKHOLDERS' EQUITY 11,062 16,797\n TOTAL LIABILITIES, TEMPORARY EQUITY AND STOCKHOLDERS' EQUITY $ 38,215 $ 31,607\n\n \n Valion Bio, Inc. (formerly known as Tivic Health Systems, Inc.)\n\nCondensed Consolidated Statements of Operations\n\n(in thousands, except share and per share data)\n\n Three Months Ended March 31,\n 2026 2025\n OPERATING EXPENSES\n Research and development $ 1,854 $ 335\n Selling, general and administrative 3,780 1,042\n TOTAL OPERATING EXPENSES 5,634 1,377\n NET OPERATING LOSS (5,634) (1,377)\n OTHER INCOME (EXPENSE), NET (591) 4\n NET LOSS BEFORE DISCONTINUED OPERATIONS (6,225) (1,373)\n INCOME (LOSS ) FROM DISCONTINUED OPERATIONS 23 (129)\n NET LOSS $ (6,202) $ (1,502)\n NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED $ (2.23) $ (2.52)\n WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED 2,883,650 569,368\n\n \n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/valion-bio-reports-first-quarter-2026-financial-results-302772859.html\n(https://www.prnewswire.com/news-releases/valion-bio-reports-first-quarter-2026-financial-results-302772859.html)\n\nSOURCE Valion Bio, Inc.\n\n\n\nPhoto: \nhttps://mma.prnewswire.com/media/2972189/Valion_Logo_Logo.jpg\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-05-14T20:05:00.138728997Z","server_sent_at_ms":1778789100138},"received_at":"2026-05-14T20:05:00.316Z","source_url":"https://www.prnewswire.com/news-releases/valion-bio-reports-first-quarter-2026-financial-results-302772859.html"},"analysis":{"id":"24983","press_release_id":"35535","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Cash balance ($7.2M) is low relative to quarterly burn rate (~$6.2M net loss), implying limited runway without additional financing","Operating expenses quadrupled YoY due to acquisition integration and rebranding","Company explicitly states it is 'evaluating capital alternatives', signaling potential near-term dilution or debt issuance"],"eventType":"earnings","narrative":"Valion Bio reported Q1 2026 results with a net loss of $6.2 million ($2.23 per share), widening from a $1.5 million loss in the prior year quarter. The increase in losses is attributed to the integration of its newly acquired subsidiary, Velocity Bioworks, and one-time costs associated with its corporate rebranding from Tivic Health Systems.\n\nOperating expenses rose to $5.6 million from $1.4 million year-over-year, driven by higher R&D and SG&A costs. The company ended the quarter with $7.2 million in cash, down from $12.6 million at year-end, and stated it is evaluating capital alternatives to support future pipeline and manufacturing milestones.\n\nOperationally, Valion highlighted continued engagement with U.S. government agencies (BARDA, NIAID) regarding its lead asset Entolimod for Acute Radiation Syndrome. It also noted progress in integrating Velocity Bioworks to support both internal manufacturing and third-party CDMO business development.","sentiment":"neutral","agentHooks":{"shouldPost":false,"suggestedAngle":"Q1 results show widened losses and low cash runway; watch for capital raise announcement."},"keyFigures":{"revenue":0,"customDimensions":{"net_loss":6202000,"sga_expenses":3780000,"r_and_d_expenses":1854000,"operating_expenses":5634000,"weighted_avg_shares":2883650,"cash_and_equivalents":7215000}},"quotedText":"The transition to Valion Bio is more than a change of name and ticker. It reflects the institutional identity we have built — a clinical-stage immunotherapeutics company anchored by a differentiated TLR5 platform, an in-house biologics manufacturing capability through Velocity Bioworks, and increasing visibility within the federal agencies responsible for national medical countermeasure preparedness","namedEntities":{"people":[{"name":"Michael K. Handley","role":"Chief Executive Officer"},{"name":"Rich Cockrell","role":"Investor and Media Contact"}],"products":["Entolimod","Entolasta"],"companies":[{"name":"Valion Bio, Inc.","ticker":"VBIO","relationship":"filer"},{"name":"Tivic Health Systems, Inc.","relationship":"former name"},{"name":"Velocity Bioworks","relationship":"subsidiary"},{"name":"BARDA","relationship":"government agency"},{"name":"National Institute of Allergy and Infectious Diseases","relationship":"government agency"},{"name":"Department of War","relationship":"government agency"},{"name":"CG Capital","relationship":"investor relations"}],"dollarAmounts":[{"amount":"$5.6 million","context":"Q1 2026 operating expenses"},{"amount":"$1.4 million","context":"Q1 2025 operating expenses"},{"amount":"$6.2 million","context":"Q1 2026 net loss"},{"amount":"$1.5 million","context":"Q1 2025 net loss"},{"amount":"$7.2 million","context":"Cash and cash equivalents at March 31, 2026"},{"amount":"$12.6 million","context":"Cash and cash equivalents at December 31, 2025"}]},"materialImpact":{"score":2,"reasoning":"Routine quarterly financial results for a clinical-stage biotech with no revenue. The net loss widened significantly ($6.2M vs $1.5M YoY) due to the integration of the Velocity Bioworks acquisition and rebranding costs. Cash burn is elevated relative to the small cash balance ($7.2M), implying a near-term need for capital, but no specific offering or dilution event is announced in this release."},"tickerRelevance":{"others":[],"primary":"VBIO"},"globalImportance":15,"audienceRelevance":10,"eventTypeSecondary":["operations_update"],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"routine-earnings","sectorWeight":"biotech","householdBrandBoost":0,"marketCapAdjustment":"low","retailFavoriteBoost":0}},"event_type":"earnings","event_type_secondary":["operations_update"],"sentiment":"neutral","material_impact_score":2,"narrative":"Valion Bio reported Q1 2026 results with a net loss of $6.2 million ($2.23 per share), widening from a $1.5 million loss in the prior year quarter. The increase in losses is attributed to the integration of its newly acquired subsidiary, Velocity Bioworks, and one-time costs associated with its corporate rebranding from Tivic Health Systems.\n\nOperating expenses rose to $5.6 million from $1.4 million year-over-year, driven by higher R&D and SG&A costs. The company ended the quarter with $7.2 million in cash, down from $12.6 million at year-end, and stated it is evaluating capital alternatives to support future pipeline and manufacturing milestones.\n\nOperationally, Valion highlighted continued engagement with U.S. government agencies (BARDA, NIAID) regarding its lead asset Entolimod for Acute Radiation Syndrome. It also noted progress in integrating Velocity Bioworks to support both internal manufacturing and third-party CDMO business development.","key_figures":{"revenue":0,"customDimensions":{"net_loss":6202000,"sga_expenses":3780000,"r_and_d_expenses":1854000,"operating_expenses":5634000,"weighted_avg_shares":2883650,"cash_and_equivalents":7215000}},"named_entities":{"people":[{"name":"Michael K. Handley","role":"Chief Executive Officer"},{"name":"Rich Cockrell","role":"Investor and Media Contact"}],"products":["Entolimod","Entolasta"],"companies":[{"name":"Valion Bio, Inc.","ticker":"VBIO","relationship":"filer"},{"name":"Tivic Health Systems, Inc.","relationship":"former name"},{"name":"Velocity Bioworks","relationship":"subsidiary"},{"name":"BARDA","relationship":"government agency"},{"name":"National Institute of Allergy and Infectious Diseases","relationship":"government agency"},{"name":"Department of War","relationship":"government agency"},{"name":"CG Capital","relationship":"investor relations"}],"dollarAmounts":[{"amount":"$5.6 million","context":"Q1 2026 operating expenses"},{"amount":"$1.4 million","context":"Q1 2025 operating expenses"},{"amount":"$6.2 million","context":"Q1 2026 net loss"},{"amount":"$1.5 million","context":"Q1 2025 net loss"},{"amount":"$7.2 million","context":"Cash and cash equivalents at March 31, 2026"},{"amount":"$12.6 million","context":"Cash and cash equivalents at December 31, 2025"}]},"model_name":"qwen3_6_27b_awq","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-05-14T20:06:08.611Z","global_importance":15,"audience_relevance":10,"importance_components":{"tickerTier":"small-cap","eventGravity":"routine-earnings","sectorWeight":"biotech","householdBrandBoost":0,"marketCapAdjustment":"low","retailFavoriteBoost":0}},"durationMs":66189,"modelName":"george-droid-qwen-72b"}}