Mr. Fabio Chianelli reports

PHARMATHER LAUNCHES M3DICINES NATIONAL NETWORK PROGRAM TO PROVIDE 3D-PRINTED MEDICINES FOR RARE DISEASES, DISCONTINUED MEDICINES, DRUG SHORTAGES AND NATIONAL EMERGENCIES

Pharmather Holdings Ltd. has launched the M3dicines National network program. The program will build a national network of qualified sites that make personalized medicines on CraftMake pharmaceutical 3-D printers, supported by Pharmather's M3dicines platform.

The network starts with United States 503A compounding pharmacies and is designed to expand to hospitals, contract development and manufacturing organizations (CDMOs) and government facilities. Illustrative map of the M3dicines Network. Pharmather releases validated digital recipes to qualified nodes, which print the doses needed locally. Node locations are illustrative, and nodes require site qualification.

Each qualified site, or node, can produce Pharmather products, licensed formulations, partner programs and research supply and, in time, medical countermeasures for national emergencies.

Program highlights

• National network launched. Open U.S. 503A compounding pharmacies, hospitals, CDMOs, 503B outsourcing facilities, research institutions and government sites.
• Medicines ready to print. Network Partners get validated M3dicines formulations, co-developed products for telehealth and other channels, and training and qualification support.
• Focused on unmet medical needs. Personalized doses, rare and ultrarare diseases, discontinued medicines, drug shortages, clinical and research supply, and emergency preparedness.

Why 3-D-printed medicines matter

Conventional pharmaceutical manufacturing pays off only at hundreds of thousands to millions of identical units, which leaves many patients poorly served:

• Personalized doses. Many personalized prescriptions through U.S. telehealth are available only as injections or in a few fixed strengths.
• Children and rare diseases. Children with rare diseases are often dosed from adult tablets cut at home, and about 95 per cent of the roughly 10,000 known rare diseases have no Food and Drug Administration-approved treatment, according to the U.S. National Institutes of Health.
• Discontinued medicines. Many medicines are discontinued not because they stopped working, but because demand became too small for a production line.
• Drug shortages. Many medicines are made in central plants, often overseas, far from the patients who need them.
• Clinical and research supply. Trials often need many strengths in batches of a few hundred units.
• National emergencies. Stockpiles hold limited quantities of finished medicines in a few standard strengths and forms, so supplies can run short in a large-scale emergency and may not meet every patient's needs.

Pharmaceutical 3-D printing changes the economics. With CraftMake printers and the M3dicines platform, one validated formulation can print any dose and combine several medicines and release profiles in one unit. Printing at room temperature, without heat or UV curing, opens the door to peptides and other heat-sensitive medicines. Every dose has a digital batch record and can be made where patients are.

How the M3dicines network works

The network runs on one set of validated formulations and quality standards:

1. Validate. Pharmather and its development partners, including Craft Health, develop, and validate M3dicines formulations and the digital recipes for each dose.
2. Qualify. Each network partner installs a CraftMake system and completes qualification and training with Pharmather's support.
3. Produce. Qualified sites print medicines for individual patients, Pharmather products, partner programs, and research and clinical supply.
4. Stay ready. Qualified sites can become nodes in Pharmather's planned national emergency preparedness node network.

Pharmather is the exclusive North American distributor of Craft Health's CraftMake systems, CraftControl software, CraftBlends materials and service, and works with Craft Health to develop M3dicines formulations using CraftBlends.

A pharmaceutical network powered by 3-D printers

Pharmather's model is built on the network, not on selling as many printers as possible. Over time, each productive node can create value through:

• Product offerings of validated M3dicines formulations for 503A compounding pharmacies;
• White-label and CDMO programs for telehealth, consumer-health, pharmaceutical and biotech partners;
• Consumables, software and service for every system in the network;
• Research collaborations and clinical supply with pharma, universities and government;
• Government readiness contracts, if awarded.

The network may become more valuable as it grows. A validated formulation can run at every qualified node, so each new node extends the reach of every product, adds capacity for partners and adds surge capacity for national emergencies.

Commercial work in peacetime. Countermeasures in an emergency.

Any CraftMake system in the M3dicines Network can be qualified as a node in Pharmather's planned national emergency preparedness node network. The idea is to stockpile the inputs, not the pills. In normal times, nodes do commercial work. In an emergency, Pharmather would release validated digital recipes, and qualified nodes would print the doses needed locally, in the quantities, strengths and forms patients need.

Under a 2025 U.S. executive order, the Strategic Active Pharmaceutical Ingredients Reserve will stock ingredients for about 26 critical drugs rather than finished doses, and the U.S. Administration for Strategic Preparedness and Response (ASPR) is piloting point-of-need drug manufacturing. Pharmather plans to demonstrate the node network within the next 12 months and will pursue readiness contracts with ASPR and Defence Research and Development Canada (DRDC). The network is designed to complement national stockpiles, not replace them.

Management commentary

"Mass manufacturing was built to make the same medicine millions of times. The M3dicines network is built to make the right medicine for one patient, close to where that patient is," said Fabio Chianelli, founder, chairman and chief executive officer of Pharmather. "The printer gets us into the pharmacy. Our products, our formulations and the network create the value. Every productive node expands what we can make and who we can reach, from a child who needs a dose no factory makes to a country that needs medicines quickly in an emergency. We are building a national medicines network powered by CraftMake pharmaceutical 3-D printers, and we believe it can make Pharmather a leader in 3-D-printed medicines."

About Pharmather Holdings Ltd.

Pharmather Holdings is a specialty pharmaceutical company advancing 3-D-printed medicines. Through its M3dicines platform, Pharmather develops validated formulations that print any dose, release profile or combination in one unit on CraftMake pharmaceutical 3-D printers, for which it is the exclusive North American distributor. Pharmather's pipeline includes personalized 503A products, including peptides and ketamine; Food and Drug Administration rare and ultrarare disease programs; psychedelic medicines for clinical trials and special access programs; discontinued medicines; medicines in short supply; and medical countermeasures.

Pharmather also offers CDMO services, white-label products, and formulation licensing to pharmaceutical, biotechnology, telehealth, wellness and consumer-health companies, and works with pharmacies, academic institutions and government organizations.

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