Mr. Fabio Chianelli reports

PHARMATHER LAUNCHES PERSONALIZ3D PEPTIDES(TM) TO ADVANCE PERSONALIZED PEPTIDE CARE FOLLOWING POSITIVE FDA ADVISORY COMMITTEE RECOMMENDATIONS

Pharmather Holdings Ltd. has launched Personaliz3D Peptides, a new division focused on developing and commercializing personalized peptide products and protocols using 3-D printing and artificial intelligence (AI) technologies.

Patients and health care providers are increasingly seeking peptide therapies tailored to individual treatment goals. However, traditional peptide compounding is often limited to fixed doses, injectable or liquid formulations, and fragmented access through separate prescribers, pharmacies and technology providers, with additional variability in quality standards and limited access to verified GMP-compliant (good manufacturing practice) manufacturing controls.

Pharmather established Personaliz3D Peptides to help address these limitations.

The division intends to create an integrated personalized peptide ecosystem that leverages 3-D printing and artificial intelligence alongside physician oversight, telemedicine, qualified compounding pharmacies, proprietary formulations and precise dosing to enable more advanced and individualized treatment design, including alternative delivery formats. Potential formats may include gummies, oral films, tablets, gels, chews, suppositories and patches.

The launch follows last week's positive votes by the U.S. Food and Drug Administration's (FDA) pharmacy compounding advisory committee (PCAC), which recommended that BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax be included on the Section 503A bulks list.

Pharmather believes the PCAC recommendations represent an important potential step toward establishing a responsible regulatory framework for the development, compounding and clinical evaluation of personalized peptide medicines in the United States.

"Patients and health care providers should not have to rely on a one-size-fits-all approach when individual treatment needs can differ significantly," said Fabio Chianelli, chairman and chief executive officer of Pharmather. "Personaliz3D Peptides is being built to make personalized peptide care more precise, convenient, connected and manufactured under strict quality and GMP-aligned standards. By bringing together physician oversight, telemedicine, qualified pharmacies with the support of 3-D printing and artificial intelligence, we intend to develop customized doses, proprietary protocols, combination formulations and alternative delivery formats within one integrated personalized peptides ecosystem."

The problem: peptide care remains fragmented

Interest in peptides continues to grow among patients, health care providers, pharmacies and researchers. Yet the current peptide care experience can be difficult to navigate.

Patients may encounter limited dosage options, inconvenient administration methods, concerns around peptide quality and consistency, and little ability to personalize a formulation to their individual requirements or access standardized GMP-manufactured finished product alternatives. Health care providers and pharmacies may also lack access to integrated technology, validated formulations and scalable systems for producing more customized peptide products.

Pharmather believes personalized pharmaceutical manufacturing may provide a better path forward.

Rather than requiring every patient to receive the same product in the same dose and format, a 3-D printing system may allow qualified providers to produce formulations based on specific dosing, combination and release-profile requirements, while also enabling quality assurance through GMP production standards and certificates of analysis.

Artificial intelligence may further support the development and optimization of formulations, protocols and patient-specific treatment pathways.

The guide: Pharmather's personalized medicine platform

Pharmather intends to use its pharmaceutical development experience, 3-D printing systems and AI-assisted capabilities to help physicians and pharmacies deliver more personalized peptide solutions.

Personaliz3D Peptides is designed to bring these capabilities together with strategic 503A pharmacy, physician, health care and technology partnerships.

"Our role is to provide the tools, formulations, protocols and partnerships that may help qualified health care providers offer more individualized peptide solutions," continued Mr. Chianelli.

"We intend to simplify a fragmented process and build a platform through which patients can be assessed by a physician, prescribed an appropriate personalized solution and connected with a qualified pharmacy capable of preparing the prescribed product."

The plan: connect, personalize and deliver

Pharmather intends to build the Personaliz3D Peptides ecosystem through a clear three-part strategy:

1. Connect

The company plans to establish a focused personalized peptide telemedicine platform, which is currently under development.

The platform is intended to connect eligible patients with qualified health care providers who can assess individual needs, determine whether peptide therapy may be appropriate and provide continuing medical oversight.

2. Personalize

Pharmather plans to use 3-D printing and AI-assisted technologies to develop proprietary peptide formulations, protocols and dosage formats that may be utilized by qualified peptide providers, including 503A compounding pharmacies, as well as physicians, clinics and other licensed health care practitioners involved in personalized peptide care.

Potential personalization capabilities may include:

• Patient-specific dosing;
• Precise microdosing;
• Combination peptide formulations;
• Immediate, delayed or sustained-release profiles;
• Alternative formats such as tablets, oral films, gels, chews, gummies, suppositories and patches.

3. Deliver

The company intends to establish relationships with qualified 503A compounding pharmacies, physicians, clinics, hospitals, researchers, technology providers and pharmaceutical companies.

These partners may support the compliant development, preparation and delivery of personalized peptide solutions while retaining responsibility for their respective professional, regulatory, manufacturing and patient care obligations.

The desired outcome: a scalable personalized peptide ecosystem

The objective is to create an integrated ecosystem through which:

• Patients may gain access to more convenient and individualized peptide options;
• Physicians may prescribe doses, combinations and delivery formats based on patient-specific needs;
• Pharmacies may access proprietary formulations, technologies, training and operating support;
• Researchers and pharmaceutical companies may develop and evaluate new peptide products and protocols.

The division's initial priorities are expected to include:

• Establishing the telemedicine platform;
• Developing proprietary peptide formulations and protocols;
• Creating alternative and non-invasive dosage formats;
• Advancing precise dosing and combination product capabilities;
• Establishing collaborations with 503A compounding pharmacies and health care providers;
• Developing training, certification and onboarding programs;
• Integrating pharmacy, physician and patient data;
• Pursuing intellectual property relating to production methods, formulations, protocols, software and personalized medicine technologies.

Commercialization strategy

Pharmather intends to pursue a partnership-driven commercialization model designed to support independent health care providers and pharmacies while building multiple potential revenue channels and intellectual property opportunities across the platform.

The Personaliz3D Peptides commercialization model may generate revenue from:

• Personalized peptide solutions offered through the telemedicine platform;
• 3-D printing systems, equipment placements and related services;
• Telemedicine and pharmacy platform participation arrangements;
• Licensing of proprietary formulations, protocols, software and AI-assisted tools;
• Consumables and pharmaceutical manufacturing materials;
• Formulation development and small-batch manufacturing services;
• Training, certification and onboarding programs;
• Sales, royalties and milestone payments from proprietary or partnered products.

Pharmather believes this model may allow independent pharmacies and health care providers to participate in a broader personalized peptide platform while maintaining responsibility for their own professional, regulatory and patient care obligations.

The company is currently establishing an integrated network of qualified pharmacy, health care, technology and supply partners designed to support product development, GMP-compliant manufacturing, data integration and the future delivery of personalized peptide solutions.

The PCAC recommendation is advisory and non-binding and does not constitute FDA approval or authorize compounding under Section 503A. Compounded drugs are not FDA-approved or evaluated by the FDA for safety, effectiveness or quality. Any related activities by Pharmather or its partners will be subject to applicable laws and regulatory requirements.

About Personaliz3D Peptides

Personaliz3D Peptides is focused on developing and commercializing personalized peptide solutions using 3-D printing, artificial intelligence and pharmaceutical development technologies.

The division intends to create an integrated personalized peptide ecosystem connecting patients, physicians and qualified pharmacies.

Personaliz3D Peptides plans to develop customized doses, combination formulations, alternative delivery formats, proprietary protocols, software, intellectual property and commercial partnerships.

About Pharmather Holdings Ltd.

Pharmather Holdings is a specialty pharmaceutical company focused on personalized medicines, specifically peptides and psychedelics.

We seek Safe Harbor.