Mr. Marcello Leone reports

VANTA COMMENDS U.S. FDA ADVISORY COMMITTEE VOTE RECOMMENDING INCLUSION OF SIX PEPTIDE SUBSTANCES ON FDA'S 503A BULKS LIST, INCLUDING BPC-157, TB-500 AND MOTS-C

Vanta Holdings Inc. has commended the recent vote by the U.S. Food and Drug Administration pharmacy compounding advisory committee, held on July 23 and July 24, 2026, recommending that six peptide substances, namely BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax, be included on the FDA's 503A bulks list.

The committee's recommendation follows a multiday public meeting during which scientific, medical and stakeholder submissions relating to the nominated peptide substances were reviewed. The committee's recommendations are advisory in nature, and the FDA retains final authority regarding whether any substance is ultimately included on the FDA's 503A bulks list.

The FDA's 503A bulks list identifies bulk drug substances that may be used by licensed 503A compounding pharmacies in preparing customized medications for individual patients pursuant to a valid prescription, subject to applicable statutory and regulatory requirements. Inclusion of a substance on the 503A bulks list does not constitute FDA approval of a drug product or therapy. Rather, it may provide a regulatory pathway for licensed 503A compounding pharmacies to compound medications containing eligible bulk drug substances in accordance with applicable U.S. laws and regulations.

The committee's recommendation follows Vanta's previously announced strategic initiatives supporting its planned entry into the U.S. peptide market. As disclosed in its news release dated May 28, 2026, the company's indirect wholly owned subsidiary, Vanta Amino Sciences Inc., entered into a master service, commercialization and strategic operations agreement with an arm's-length strategic operating partner to support the development of Vanta's contemplated United States-focused peptide platform. Pursuant to the agreement, the strategic peptide operating partner provides strategic operating services and infrastructure co-ordination, including the co-ordination of FDA-registered 503A and 503B compounding pharmacy relationships, peptide manufacturing and fulfilment capabilities, compliant payment processing infrastructure, and telehealth-enabled commercialization support.

As previously disclosed, through its existing commercial and operational relationships, the strategic peptide operating partner has entered into a memorandum of understanding and related commercial framework arrangements with certain third party FDA-registered 503A and 503B compounding pharmacy providers relating to peptide manufacturing, prescription fulfilment, related supply chain infrastructure, compliant payment processing infrastructure, and certain other commercialization and operational infrastructure counterparties. These arrangements are intended to support the negotiation and execution of definitive commercial agreements as the company's contemplated U.S. peptide platform advances toward commercialization.

"The committee's recommendation is part of the FDA's ongoing review process for nominated peptide substances," said Marcello Leone, chief executive officer of Vanta. "As previously announced, we have been establishing the operational infrastructure supporting our planned entry into the U.S. peptide market through our strategic peptide operating partner. We remain focused on executing that strategy while continuing to monitor developments in the FDA's review process and will provide updates regarding our U.S. peptide initiatives, as appropriate."

Vanta's U.S. peptide strategy

As previously disclosed, Vanta is developing a contemplated United States-focused peptide platform designed to integrate telehealth-enabled patient acquisition, physician consultation and prescription authorization workflows, FDA-registered compounding pharmacy fulfilment, compliant payment processing infrastructure, and subscription-based commercialization initiatives. Future commercialization activities are intended to be conducted through licensed health care providers and pharmacy partners, and will remain subject to applicable laws, regulatory requirements, pharmacy compliance standards and the execution of definitive commercial agreements, where required.

The company's broader U.S. strategy contemplates integrating its planned peptide platform with its existing consumer health science portfolio, including nutraceutical and premium functional hydration products, as part of an integrated longevity-focused platform.

As of the date of this news release, the company has not commenced the commercial sale of peptide therapies in the United States. The company currently estimates that approximately $850,000 of initial capital will be required to support the contemplated commercial launch and early-stage scaling of its proposed U.S. peptide platform. These expenditures are expected to include inventory and fulfilment infrastructure, telehealth and clinician network on-boarding, commercialization and patient acquisition initiatives, operational infrastructure, regulatory and compliance activities, and general working capital.

The proposed U.S. peptide platform remains subject to a number of risks and uncertainties, including, without limitation, the availability of financing, the negotiation and execution of definitive commercial agreements where required, applicable regulatory and compliance requirements, continued access to third party operational infrastructure, and the company's ability to execute its operational, commercialization and growth strategy. There can be no assurance that the proposed U.S. peptide platform will be commercialized on the timeline anticipated by the company or at all.

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