Anticipated peptide reclassification could expand the addressable market for PharmaTher’s PharmaPatch™ product strategy and PatchPrint™ manufacturing platform, strengthening its position in next-generation peptide delivery
Toronto, Ontario--(Newsfile Corp. - April 16, 2026) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) ("PharmaTher" or the "Company"), a specialty pharmaceutical company focused on microneedle patch technologies and peptide-enabled product opportunities, today expressed support for recent U.S. initiatives led by U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and the U.S. Food and Drug Administration (FDA) to revisit the regulatory treatment of select therapeutic peptides.
"We applaud Secretary Kennedy and the FDA for advancing a science-based, patient-centered review of the peptide compounding framework and for supporting a more practical, medically supervised pathway for selected therapeutic peptides," said Fabio Chianelli, Chief Executive Officer of PharmaTher. "We believe this evolving policy direction could be highly value-accretive for PharmaTher, as it directly aligns with the peptide-focused strategy we have built around PharmaPatch™ and PatchPrint™. A clearer and more accessible regulatory path for peptides would be constructive for patients, prescribers and innovators, while strengthening the commercial relevance of our peptide delivery, formulation and manufacturing capabilities. As the regulatory landscape evolves, we believe PharmaTher is strategically ahead of the shift and well positioned to expand its peptide-focused opportunities."
PharmaTher believes the current U.S. policy review, including the FDA's planned July 23-24, 2026 meeting of the Pharmacy Compounding Advisory Committee and related public comment process, could represent an important catalyst for the Company's peptide-focused strategy. According to the FDA's notice, the Committee is scheduled to review BPC-157-related, KPV-related, TB-500-related and MOTs-C-related bulk drug substances on July 23 for possible inclusion on the Section 503A Bulks List. PharmaTher believes this is directly relevant to its previously announced peptide strategy, as BPC-157, KPV and TB-500 are already among the peptide candidates it has identified for evaluation under PharmaPatch™. If the regulatory pathway for certain peptides becomes more accessible, the Company believes it could expand the commercial opportunity for PharmaPatch™ and strengthen the strategic relevance of PatchPrint™, its microneedle patch manufacturing platform.
Why This Matters for PharmaPatch™
PharmaTher previously announced that it is evaluating select therapeutic peptides for its PharmaPatch™ microneedle patch platform, including BPC-157, GHK-Cu, TB-500, KPV and potential combinations of those peptides. Importantly, three of the peptide categories now listed on the FDA's July 23 agenda - BPC-157, KPV and TB-500 - are already part of PharmaTher's previously disclosed peptide roadmap.
The Company believes this overlap strengthens the relevance of its PharmaPatch™ strategy at a time when the U.S. regulatory framework for certain peptides may be shifting. If access to these peptides broadens through lawful, medically supervised channels, PharmaTher believes a microneedle patch format could offer a differentiated delivery option focused on convenience, needle-free administration, patient adherence and future product flexibility.
Why PatchPrint™ Could Benefit
PharmaTher also believes the proposed policy shift could strengthen the commercial case for PatchPrint™, the Company's proprietary automated tabletop microneedle patch manufacturing platform. Introduced in March 2026, PatchPrint™ is intended to support both PharmaTher's own PharmaPatch™ pipeline and third-party opportunities across pharmaceutical companies, hospitals, pharmacies, including 503A compounding pharmacies, and other partner settings.
If peptide compounding and related medical use cases expand in the United States, PharmaTher believes PatchPrint™ could become increasingly relevant as a scalable platform for developing and manufacturing peptide-based microneedle patch products. The Company further believes PatchPrint™ could be particularly attractive to 503A pharmacy compounders as a potential customer segment, given its compact footprint, programmable manufacturing approach and potential to support differentiated peptide patch formulations in pharmacy environments, subject to applicable regulatory requirements.
Figure 1. Prototype rendering of PatchPrint™, PharmaTher's automated tabletop microneedle patch production platform designed for end-to-end manufacturing.
To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/11479/292817_ab27a69c1477db56_001full.jpg
Adds Support to PharmaTher's Peptide IP Strategy
On April 13, 2026, PharmaTher announced the filing of U.S. provisional patent application No. 64/034,315, titled Stabilized Peptide Compositions for Microneedle and Transdermal Delivery. The patent filing is intended to strengthen the Company's peptide formulation capabilities for PharmaPatch™ while complementing PatchPrint™ as part of its broader commercialization strategy.
The application includes formulation approaches designed to help protect peptides during manufacturing, drying, storage and use, and includes embodiments involving BPC-157, GHK-Cu, TB-500 and KPV, as well as multi-peptide combinations. PharmaTher believes this formulation layer could become increasingly important as peptide product opportunities continue to grow.
A More Complete Peptide Strategy
PharmaTher believes the proposed peptide policy shift, if implemented as described, could materially strengthen the commercial opportunity for its peptide-focused strategy. With PharmaPatch™ as its peptide product platform, PatchPrint™ as its manufacturing platform, and a growing peptide formulation IP portfolio, the Company believes it is building an integrated position in next-generation peptide delivery.
PharmaTher believes this positions the Company to pursue multiple future growth opportunities, including proprietary product development, strategic collaborations, compounding-related opportunities and partner-facing platform deployments.
"This is more than a regulatory headline for PharmaTher. We view it as a potential external catalyst that supports the peptide-focused strategy we have been building," added Mr. Chianelli. "PharmaPatch™ provides product opportunity, our peptide patent work strengthens our formulation foundation, and PatchPrint™ adds a manufacturing platform. Together, we believe these elements position PharmaTher with a more integrated platform for its next phase of peptide-focused growth."
The Company notes that the FDA process remains ongoing and there can be no assurance as to the outcome, timing or scope of any regulatory change. However, PharmaTher believes the current policy direction is encouraging and supports continued execution of its peptide-focused strategy.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty pharmaceutical company focused on developing, acquiring, and commercializing pharmaceutical products and enabling technologies. The Company is advancing microneedle patch solutions through its PharmaPatch™ product strategy and PatchPrint™ manufacturing platform, with opportunities across therapeutics, peptides and other high-value applications. For more information, visit PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.comWebsite: www.pharmather.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws, including, but not limited to, statements regarding: potential regulatory developments relating to therapeutic peptides in the United States; the timing, scope and outcome of any FDA advisory committee review, related regulatory process or potential policy change; the possible implications of any such developments for the Company's business, strategy or market opportunities; the development, positioning and potential commercialization of PharmaPatch™ and PatchPrint™; the scope, utility or potential commercial significance of the Company's intellectual property; and the Company's ability to pursue or realize product, partnership, compounding-related or platform deployment opportunities. Forward-looking statements are based on management's current expectations, assumptions and beliefs as of the date of this news release and are subject to a number of known and unknown risks, uncertainties and other factors, many of which are beyond the Company's control, that could cause actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These factors include, among others, risks relating to regulatory review and decision-making, changes in applicable laws or policies, the uncertainty of commercial development, the ability of the Company to execute its business plans, obtain or maintain intellectual property protection, secure partnerships or other opportunities, and general market, financing, scientific and economic conditions. There can be no assurance that any forward-looking statements will prove to be accurate, and readers are cautioned not to place undue reliance on such statements. Except as required by applicable law, PharmaTher undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. Except as required by applicable law, PharmaTher undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Additional risk factors are described in the Company's MD&A for the three and six months ended November 30, 2025, dated January 29, 2026, available on SEDAR+.
This news release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/292817
"We applaud Secretary Kennedy and the FDA for advancing a science-based, patient-centered review of the peptide compounding framework and for supporting a more practical, medically supervised pathway for selected therapeutic peptides," said Fabio Chianelli, Chief Executive Officer of PharmaTher. "We believe this evolving policy direction could be highly value-accretive for PharmaTher, as it directly aligns with the peptide-focused strategy we have built around PharmaPatch™ and PatchPrint™. A clearer and more accessible regulatory path for peptides would be constructive for patients, prescribers and innovators, while strengthening the commercial relevance of our peptide delivery, formulation and manufacturing capabilities. As the regulatory landscape evolves, we believe PharmaTher is strategically ahead of the shift and well positioned to expand its peptide-focused opportunities."
PharmaTher believes the current U.S. policy review, including the FDA's planned July 23-24, 2026 meeting of the Pharmacy Compounding Advisory Committee and related public comment process, could represent an important catalyst for the Company's peptide-focused strategy. According to the FDA's notice, the Committee is scheduled to review BPC-157-related, KPV-related, TB-500-related and MOTs-C-related bulk drug substances on July 23 for possible inclusion on the Section 503A Bulks List. PharmaTher believes this is directly relevant to its previously announced peptide strategy, as BPC-157, KPV and TB-500 are already among the peptide candidates it has identified for evaluation under PharmaPatch™. If the regulatory pathway for certain peptides becomes more accessible, the Company believes it could expand the commercial opportunity for PharmaPatch™ and strengthen the strategic relevance of PatchPrint™, its microneedle patch manufacturing platform.
Why This Matters for PharmaPatch™
PharmaTher previously announced that it is evaluating select therapeutic peptides for its PharmaPatch™ microneedle patch platform, including BPC-157, GHK-Cu, TB-500, KPV and potential combinations of those peptides. Importantly, three of the peptide categories now listed on the FDA's July 23 agenda - BPC-157, KPV and TB-500 - are already part of PharmaTher's previously disclosed peptide roadmap.
The Company believes this overlap strengthens the relevance of its PharmaPatch™ strategy at a time when the U.S. regulatory framework for certain peptides may be shifting. If access to these peptides broadens through lawful, medically supervised channels, PharmaTher believes a microneedle patch format could offer a differentiated delivery option focused on convenience, needle-free administration, patient adherence and future product flexibility.
Why PatchPrint™ Could Benefit
PharmaTher also believes the proposed policy shift could strengthen the commercial case for PatchPrint™, the Company's proprietary automated tabletop microneedle patch manufacturing platform. Introduced in March 2026, PatchPrint™ is intended to support both PharmaTher's own PharmaPatch™ pipeline and third-party opportunities across pharmaceutical companies, hospitals, pharmacies, including 503A compounding pharmacies, and other partner settings.
If peptide compounding and related medical use cases expand in the United States, PharmaTher believes PatchPrint™ could become increasingly relevant as a scalable platform for developing and manufacturing peptide-based microneedle patch products. The Company further believes PatchPrint™ could be particularly attractive to 503A pharmacy compounders as a potential customer segment, given its compact footprint, programmable manufacturing approach and potential to support differentiated peptide patch formulations in pharmacy environments, subject to applicable regulatory requirements.
Figure 1. Prototype rendering of PatchPrint™, PharmaTher's automated tabletop microneedle patch production platform designed for end-to-end manufacturing.
To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/11479/292817_ab27a69c1477db56_001full.jpg
Adds Support to PharmaTher's Peptide IP Strategy
On April 13, 2026, PharmaTher announced the filing of U.S. provisional patent application No. 64/034,315, titled Stabilized Peptide Compositions for Microneedle and Transdermal Delivery. The patent filing is intended to strengthen the Company's peptide formulation capabilities for PharmaPatch™ while complementing PatchPrint™ as part of its broader commercialization strategy.
The application includes formulation approaches designed to help protect peptides during manufacturing, drying, storage and use, and includes embodiments involving BPC-157, GHK-Cu, TB-500 and KPV, as well as multi-peptide combinations. PharmaTher believes this formulation layer could become increasingly important as peptide product opportunities continue to grow.
A More Complete Peptide Strategy
PharmaTher believes the proposed peptide policy shift, if implemented as described, could materially strengthen the commercial opportunity for its peptide-focused strategy. With PharmaPatch™ as its peptide product platform, PatchPrint™ as its manufacturing platform, and a growing peptide formulation IP portfolio, the Company believes it is building an integrated position in next-generation peptide delivery.
PharmaTher believes this positions the Company to pursue multiple future growth opportunities, including proprietary product development, strategic collaborations, compounding-related opportunities and partner-facing platform deployments.
"This is more than a regulatory headline for PharmaTher. We view it as a potential external catalyst that supports the peptide-focused strategy we have been building," added Mr. Chianelli. "PharmaPatch™ provides product opportunity, our peptide patent work strengthens our formulation foundation, and PatchPrint™ adds a manufacturing platform. Together, we believe these elements position PharmaTher with a more integrated platform for its next phase of peptide-focused growth."
The Company notes that the FDA process remains ongoing and there can be no assurance as to the outcome, timing or scope of any regulatory change. However, PharmaTher believes the current policy direction is encouraging and supports continued execution of its peptide-focused strategy.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty pharmaceutical company focused on developing, acquiring, and commercializing pharmaceutical products and enabling technologies. The Company is advancing microneedle patch solutions through its PharmaPatch™ product strategy and PatchPrint™ manufacturing platform, with opportunities across therapeutics, peptides and other high-value applications. For more information, visit PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.comWebsite: www.pharmather.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws, including, but not limited to, statements regarding: potential regulatory developments relating to therapeutic peptides in the United States; the timing, scope and outcome of any FDA advisory committee review, related regulatory process or potential policy change; the possible implications of any such developments for the Company's business, strategy or market opportunities; the development, positioning and potential commercialization of PharmaPatch™ and PatchPrint™; the scope, utility or potential commercial significance of the Company's intellectual property; and the Company's ability to pursue or realize product, partnership, compounding-related or platform deployment opportunities. Forward-looking statements are based on management's current expectations, assumptions and beliefs as of the date of this news release and are subject to a number of known and unknown risks, uncertainties and other factors, many of which are beyond the Company's control, that could cause actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These factors include, among others, risks relating to regulatory review and decision-making, changes in applicable laws or policies, the uncertainty of commercial development, the ability of the Company to execute its business plans, obtain or maintain intellectual property protection, secure partnerships or other opportunities, and general market, financing, scientific and economic conditions. There can be no assurance that any forward-looking statements will prove to be accurate, and readers are cautioned not to place undue reliance on such statements. Except as required by applicable law, PharmaTher undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. Except as required by applicable law, PharmaTher undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Additional risk factors are described in the Company's MD&A for the three and six months ended November 30, 2025, dated January 29, 2026, available on SEDAR+.
This news release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/292817
