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Pharmather Holdings Ltd
Symbol PHRM
Shares Issued 91,019,065
Close 2026-10-05 C$ 0.065
Market Cap C$ 5,916,239
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Pharmather talks CraftMake plans, rebrands Personaliz3D

2026-10-05 18:03 ET - News Release

Mr. Fabio Chianelli reports

PHARMATHER OUTLINES CORPORATE STRATEGY AND UPCOMING MILESTONES; LAUNCHES NEW CORPORATE WEBSITE AND REBRANDS PERSONALIZ3D AS M3DICINES

Pharmather Holdings Ltd. today outlined its corporate strategy and upcoming milestones, following its Oct. 1, 2026, announcement that it is now the exclusive North American distributor of Craft Health Pte. Ltd.'s CraftMake pharmaceutical 3-D printing platform. Pharmather has also launched its new corporate website and rebranded its Personaliz3D platform as M3dicines.

Strategy at a glance

Mass manufacturing is built to make millions of identical tablets. Pharmaceutical 3-D printing makes it economical to produce the exact dose a specific patient needs, in small batches, close to where it is needed.

Pharmather's strategy rests on two pillars that share one platform:

  • The company advances proprietary products and builds out the placement network: 503A, rare and ultrarare disease, psychedelic and discontinued-medicine products, and a national emergency preparedness network.
  • It opens the platform to partners: CraftMake distribution, formulation licensing, white-label products, CDMO (contract development and manufacturing organization) services, research collaborations and government readiness contracts.

Pharmather owns its formulations, data and regulatory filings, and runs an asset-light model with Craft Health (hardware), PD Labs (U.S. 503A compounding and R&D (research and development)) and GMP (good manufacturing practice) contract manufacturer (FDA-track (U.S. Food and Drug Administration) products and CDMO services).

One platform, four business lines, M3dicines is the platform for the four business lines. CraftMake placements build the installed base, the pipeline creates proprietary value, the national emergency network adds preparedness capacity and partnering earns service revenue.

CraftMake commercial plan:

  • Launch: initial orders in Q4 (fourth quarter) 2026, with the first placements at PD Labs, a national 503A compounding pharmacy and Pharmather's U.S. Center of Excellence, and at a GMP contract manufacturer;
  • Scale: up to 50 placements targeted over the next 12 months across pharmacies, telehealth companies, CDMOs, hospitals, and research and government sites, out of an estimated 10,000-plus potential sites in North America;
  • Recurring revenue: each placement designed to generate system revenue plus recurring software, consumables and service revenue, and can become a node in the national emergency network. As the network grows, each new site adds potential demand for formulations, products and services, so partnering and revenue opportunities compound.

Product pipeline

Pharmather focuses on products where 3-D printing creates a real advantage: a precise dose, several medicines in one unit or a small batch that mass manufacturing cannot make economically. Its pipeline spans five areas:

  • 503A personalized products: first launches, planned for Q4 2026, include Rx wellness products such as NAD+ and glutathione and 503A-eligible peptides such as sermorelin and PT-141, printed as chewables, dissolvable tablets and multilayer combinations. A ketamine dissolvable tablet for telehealth is planned for Q1 (first quarter) 2027. More peptides may follow once the FDA completes the required rulemaking. In July, 2026, its pharmacy compounding advisory committee recommended adding six to the 503A bulks list, including BPC-157, KPV and TB-500, and it is scheduled to review five more, including GHK-Cu and LL-37, before the end of February, 2027;
  • FDA rare pediatric disease program: a 3-D-printed dissolvable tablet of a never-approved active ingredient for a serious rare pediatric disease with no FDA-approved treatment (compound and indication undisclosed for competitive reasons). Pharmather plans to apply for orphan drug and rare pediatric disease designations in October, 2026, and will announce the applications once filed, followed by a pre-IND (investigational new drug) meeting in Q1 2027 and an NDA (non-disclosure agreement) submission in Q4 2028. Approval could bring seven years of orphan exclusivity and a priority review voucher that the company could sell; such vouchers have recently sold for $100-million (U.S.) to $155-million (U.S.);
  • FDA ultrarare disease program: About 95 per cent of the roughly 10,000 known rare diseases have no FDA-approved treatment, according to the U.S. National Institutes of Health. Many are ultrarare, commonly defined as affecting fewer than one in 50,000 people (roughly 7,000 or fewer in the United States). Their small, often weight-based dose needs are too few for a production line but well suited to 3-D printing. Pharmather is evaluating ultrarare diseases where a precisely dosed printed product could become the first approved therapy, using the same regulatory approach as its lead program. The FDA's 2025 rare disease evidence principles allow approval based on one adequate and well-controlled study plus confirmatory evidence for certain genetic diseases affecting fewer than 1,000 U.S. patients;
  • Psychedelic medicines for clinical trials and special access: Psilocybin and MDMA are already available to eligible patients through Health Canada's special access program and Australia's authorized prescriber scheme, and a 2026 U.S. executive order directs the FDA and the Drug Enforcement Administration (DEA) to create a right-to-try pathway for investigational psychedelic drugs. Trials and access programs need small GMP batches in several strengths, plus matching placebos for trials. Pharmather intends to become a reliable supplier of precisely dosed, 3-D-printed psychedelic medicines to researchers, trial sponsors and access programs, working with licensed GMP partners and building on its ketamine experience;
  • Discontinued medicines: Many medicines are discontinued because demand is too small to justify a production line, not because they stopped working, leaving patients without supply. 3D printing makes these small volumes economical again. Pharmather plans to bring back discontinued medicines with continuing patient need, either through FDA abbreviated pathways that reference the original approval (once the FDA confirms the product was not withdrawn for safety or effectiveness reasons) or through 503A compounding where permitted. Pharmather has already taken a product through FDA approval with its ketamine ANDA.

National emergency and medical countermeasures

Emergency stockpiles hold finished medicines in fixed, mostly adult strengths, and the U.S. is building a reserve of raw drug ingredients that must be made into doses when needed. Pharmather's national emergency preparedness node network is built on a simple idea: stockpile the inputs, not the pills. Validated digital recipes, held under one quality system, are released in an emergency to qualified CraftMake sites, such as pharmacies, hospitals, CDMOs and government facilities, to print doses where and when they are needed. In peacetime, the same printers do commercial work and governments would pay readiness fees to keep the network ready.

Pharmather is evaluating the approximately 26 critical drugs prioritized for the U.S. Strategic Active Pharmaceutical Ingredients Reserve, managed by the U.S. Administration for Strategic Preparedness and Response (ASPR) under a 2025 executive order, to determine which can be developed as validated 3-D-printed formulations so that stockpiled ingredients can be printed into ready-to-use doses, including for children, during an emergency.

Over the next 12 months, Pharmather plans to complete a demonstration and pursue readiness contracts with U.S. and Canadian agencies, including ASPR and Defence Research and Development Canada (DRDC).

Partnering opportunities

Partners can work with Pharmather through M3dicines in six ways: placing CraftMake(TM) systems; licensing M3dicines formulations; white-label products for telehealth, wellness and consumer-health brands; CDMO services, including clinical trial supply; research collaborations; and national emergency readiness.

Strategic assets

Pharmather's strategic assets outside its 3-D printing business offer potential non-dilutive value. Its FDA-approved ketamine, ANDA, sold in December, 2025, could generate more than $25-million (U.S.) over time, subject to commercial performance, with payments expected to begin in Q1 2027. Pharmather intends to license, sell, partner or spin out its other strategic assets: KetaVault, a ketamine microneedle patch, the KetaMist collaboration and its 49-per-cent interest in Sairiyo Therapeutics Inc.

Upcoming milestones:

  • Q4 2026: initial CraftMake orders; first proprietary 503A product launches; initial white-label and CDMO agreements; orphan drug and rare pediatric disease designation applications;
  • Q1 2027: ketamine dissolvable tablet launch for telehealth; first ketamine ANDA payments expected; pre-IND meeting with the FDA on the rare pediatric program;
  • Next 12 months: up to 50 CraftMake placements; telehealth partnerships and further white-label and CDMO agreements; national emergency demonstration and readiness-contract discussions;
  • 2027 to 2028: M3dicines formulation licences; government readiness contracts; an expanded product portfolio, including ultrarare disease, psychedelic and discontinued medicine programs, and additional peptides as FDA rulemaking allows;
  • Q4 2028: rare pediatric NDA submission (target);
  • Beyond: first FDA approval of a Pharmather-printed medicine; potential priority review voucher.

New corporate website and M3dicines brand

Pharmather's new corporate website outlines the company's strategy, pipeline, partnering opportunities and investor information, including its corporate presentation.

M3dicines, a name that says what the platform makes, replaces Personaliz3D. At the M3dicines website, customers and partners can learn about CraftMake and Pharmather's services.

Management commentary

"Today, we are setting out how we plan to turn our exclusive North American rights to CraftMake into a scalable business," said Fabio Chianelli, chairman and chief executive officer of Pharmather. "We are advancing proprietary products, and we plan to grow a network of placements and open our platform to partners. Each printer we place is designed to generate recurring revenue and add a node to a network that can support our commercial partners and help in a national emergency. We expect the model to reinforce itself, as each placement brings formulations, data and partners that can lead to the next. Over the next 12 months, we plan to place our first systems, launch our first products and apply for designations in our rare pediatric program. From there, we plan to expand into other ultrarare diseases and bring back discontinued medicines that are no longer made at scale, working toward our goals of growing commercial sales and recurring revenue and achieving an FDA approval of a Pharmather-printed medicine."

About Pharmather Holdings Ltd.

Pharmather Holdings is a specialty pharmaceutical company advancing 3-D-printed medicines. Through its M3dicines platform and its exclusive North American distribution of Craft Health's CraftMake system, Pharmather develops proprietary personalized products, including peptides, ketamine, treatments for rare and ultrarare diseases, discontinued medicines and medical countermeasures, and plans to supply psychedelic medicines for clinical trials and special access programs. It also offers CDMO services, white-label products and formulation licensing to pharmaceutical, biotechnology, telehealth, wellness and consumer-health companies, and partners with pharmacies and academic and government organizations.

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