Mr. Pratap Sandhu reports

THE PRECISION PEPTIDE COMPANY'S NEEDLE-FREE FIRST STRATEGY ALREADY IN PLACE AS HHS DRAFT POLICY RECOGNIZES NON-INJECTABLE ROUTES FOR LEADING PEPTIDES

The Precision Peptide Company Inc. has commented on the "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances," published by the U.S. Department of Health and Human Services (HHS) in the federal register on Oct. 30, 2026, under docket No. HHS-OASH-2026-0496, and its potential relevance to the company's U.S. prescription platform and needle-free delivery strategy.

BPC-157, the peptide the company takes its ticker symbol from, heads the policy's list.

Highlights:

• Federal path for BPC-157: HHS has published a draft enforcement discretion policy concerning a potential interim 503A compounding path for six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500;
• Needle-free routes recognized: oral and topical forms for BPC-157 and KPV and intranasal use for Semax now sit alongside injection in federal policy;
• Built for the company's model: the policy runs through 503A compounding, a similar U.S. pathway behind the company's 16-therapy prescription formulary announced on Oct. 29, 2026;
• A higher bar for the category: FDA-registered (U.S. Food and Drug Administration) sourcing, lot-level certificates of analysis, single-ingredient products and adverse event reporting to FDA;
• Needle-free first, every format available: the company offers needle-free patches, oral and topical formulations and clinician-prescribed therapies under one brand.

About the policy

The policy describes an interim approach to enforcement discretion while the FDA develops the list of bulk drug substances that may be used in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act (the 503A bulks list). It follows the July, 2026, meeting of FDA's pharmacy compounding advisory committee, which voted to recommend the same six peptides for the 503A bulks list. HHS stated that the policy is intended to expand and improve patient access while FDA reviews these substances, while appropriately protecting patient safety.

Under the policy, HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding products from the six peptides, provided defined conditions are met. These include a single active pharmaceutical ingredient per product, bulk drug substance from an FDA-registered manufacturer operating under current good manufacturing practice, a valid lot-level certificate of analysis, a valid patient-specific prescription, and reporting of serious adverse events and product quality issues to FDA.

The policy also sets out the routes of administration recognized for each peptide. BPC-157 is recognized for subcutaneous, intramuscular, oral and topical forms; KPV for oral and topical forms; Semax for intranasal use; and Epitalon, MOTS-c and TB-500 for injectable forms.

This summary is not exhaustive and should be read together with the full text of the policy.

Relevance to the company

The company has a compounding agreement with a U.S.-based 503A sterile compounding pharmacy (see news release dated June 2, 2026), supported by its prescription and telehealth infrastructure (see news releases dated June 9, 2026, and July 7, 2026). On Oct. 29, 2026, the company announced that its U.S. telehealth formulary had grown to 16 prescription therapies across seven therapy areas, with every prescription issued by a U.S.-licensed clinician and compounded in the United States.

Needle-free routes recognized: The policy lists three of the six peptides are recognized for non-injectable routes, including BPC-157 in oral and topical forms. Needle-free delivery has been the company's focus from the start, and it now offers needle-free patches, oral and topical formulations, and clinician-prescribed therapies under one brand.

A higher bar for the category: The policy's requirements for verified sourcing, lot-level testing and safety reporting reflect the standards the company applies across its U.S.-compounded prescription formulary.

The company is evaluating, with its 503A compounding partner, how the policy may apply to its prescription formulary.

Pratap Sandhu, chief executive officer of The Precision Peptide Company, commented: "Last week, we announced 16 prescription therapies, all compounded in the United States. HHS has now set out a framework for six widely used peptides, led by BPC-157, concerning the U.S. 503A pathway, with verified sourcing, lot-level testing and safety reporting built in. Just as important, it recognizes oral, topical and intranasal routes alongside injection. Needle-free first, every format available, has been our approach from day one."

About The Precision Peptide Company Inc.

The Precision Peptide Company is a publicly traded wellness company building a next-generation platform for high-quality peptide formulations. By combining scientific formulation and innovative delivery technologies, the company creates products at the intersection of biotechnology and scalable consumer wellness. Products are manufactured in an approved U.S. facility and distributed across North America.

Important information

The policy is a draft. It is not binding on HHS or the public and may be revised or withdrawn, including if a safety signal or product quality issue arises. It applies only to compounded drug products prepared under Section 503A and does not constitute FDA approval of any peptide. Whether any of the six peptides is added to the 503A bulks list will be determined through future FDA rulemaking.

The prescription therapies referred to in this news release are compounded medications. Compounded medications are not FDA-approved and have not been evaluated by the FDA for safety, effectiveness or quality. They are not equivalent to or substitutes for any FDA-approved product. They are available only by prescription from a licensed clinician following a clinical review and may not be appropriate for all individuals. Availability of individual therapies is subject to applicable law and pharmacy supply. Nothing in this news release constitutes medical advice.

We seek Safe Harbor.