Forward-looking statements

This website contains “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking information is often, but not always, identified by words such as “plans”, “expects”, “intends”, “targets”, “anticipates”, “estimates”, “potential”, “may”, “could”, “will” and similar expressions.

What it covers

Forward-looking information on this website includes, but is not limited to, statements regarding: PharmaTher Holdings Ltd.’s (“PharmaTher” or the “Company”) corporate strategy and business model; the M3DICINES™ brand and the Company’s websites; the commercial plan for CraftMake™, including the timing of initial orders, the target of up to 50 placements over the next 12 months, the estimated number of potential placement sites and the expectation that placements will generate recurring revenue; the development, launch timing and commercialization of the Company’s 503A products, including Rx wellness, peptide and ketamine products; the potential compounding of additional peptides following FDA rulemaking; the Company’s FDA rare pediatric disease program, including planned designation applications, a pre-IND meeting, clinical development, the timing of an NDA submission, potential approval, orphan exclusivity and potential eligibility for, and the value of, a priority review voucher; the evaluation and potential development of products for ultra-rare diseases; plans to supply psychedelic medicines for clinical trials and special access programs; plans to identify and reintroduce discontinued medicines; national emergency and medical countermeasures initiatives, including the evaluation of drugs identified for the Strategic Active Pharmaceutical Ingredients Reserve, a planned demonstration, the node network and potential readiness contracts; partnering opportunities, including CDMO services, white-label products, formulation licensing and research collaborations; the timing and amount of payments from the sale of the Company’s ketamine ANDA; the potential licensing, sale, partnering or spin-out of the Company’s strategic assets; and the Company’s upcoming milestones and catalysts.

Assumptions

Forward-looking information is based on management’s current expectations, estimates and assumptions, including that: Craft Health will supply CraftMake™ systems, software, materials and support on a timely basis; PD Labs, the Company’s GMP manufacturing partners and its other partners will perform as expected; the Company will maintain its exclusive distribution rights; the Company will obtain financing on acceptable terms to fund its plans; there will be demand for pharmaceutical 3D printing and for the Company’s products and services; the Company and its partners will be able to develop, validate and produce formulations to the required quality standards; the regulatory framework for pharmacy compounding, including for peptides, will develop as expected; the Company and its partners will obtain the required regulatory designations, approvals, licences and registrations, including for controlled substances; special access, expanded access and Right to Try pathways for psychedelic medicines will remain available or be established as expected; the FDA will confirm that discontinued medicines selected by the Company were not withdrawn for safety or effectiveness reasons; the purchaser of the Company’s ketamine ANDA will commercialize the product as expected; government agencies will fund and procure distributed manufacturing and readiness capabilities; and the Company will be able to enter into agreements with pharmacies, telehealth companies, contract manufacturers, government agencies and other partners.

Risks

Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from those expressed or implied. These include, but are not limited to: the Company’s limited operating history in pharmaceutical 3D printing; dependence on Craft Health as the sole supplier of CraftMake™ systems, software and materials, and on PD Labs, GMP manufacturing partners and other partners; the risk that the Company does not meet the conditions required to maintain exclusivity or that its distribution agreement is terminated or not renewed; the ability to obtain financing when needed and on acceptable terms; market acceptance of CraftMake™ and of the Company’s products and services; competition; changes in the laws and regulations governing pharmacy compounding, outsourcing facilities, controlled substances, dietary supplements and natural health products in the United States, Canada and other jurisdictions, including the outcome of FDA rulemaking on the Section 503A bulks list; changes to, or the failure to establish, special access, expanded access and Right to Try pathways for psychedelic medicines; the risks inherent in drug development, including that designations may not be granted, clinical studies may not succeed and regulatory approval may not be obtained; the risk that the FDA does not accept a reduced evidence package for an ultra-rare disease product, or does not confirm that a discontinued medicine was withdrawn for reasons other than safety or effectiveness; the risk that a priority review voucher is not awarded, including because the rare pediatric disease priority review voucher program is currently authorized only through September 30, 2029, or that a voucher cannot be sold on attractive terms; the absence of a finalized FDA framework for distributed manufacturing and the uncertainty of government funding and procurement for medical countermeasures; the commercial performance of the purchaser of the Company’s ketamine ANDA; the ability to license, sell, partner or spin out strategic assets on acceptable terms; product quality and product liability risks; the ability to protect intellectual property and brands; tariffs, trade restrictions, import requirements and currency fluctuations; the ability to attract and retain key personnel; general economic and market conditions; and the other risk factors described in the Company’s public filings available on SEDAR+.

Regulatory and third-party information

Compounded drugs are not approved by the FDA. 503A products are patient-specific prescriptions prepared by licensed pharmacies, and 503A eligibility is confirmed for each product before launch. Certain peptides, including BPC-157, may not be compounded under Section 503A of the Federal Food, Drug, and Cosmetic Act unless and until the FDA completes the applicable rulemaking. Ketamine is a controlled substance, and its compounding, manufacture and distribution require registrations with the DEA. Psilocybin and MDMA are Schedule I controlled substances in the United States and are controlled in Canada and other jurisdictions; they are not approved for any medical use by the FDA, and their manufacture, supply and use require licences and authorizations from the DEA, Health Canada and other regulators. The Company’s product candidates are at an early stage of development, and timelines are internal estimates.

Market sizes are third-party estimates of total markets, not PharmaTher revenue. Reported priority review voucher sale prices are taken from public disclosures by the companies involved, and rare disease statistics are from the U.S. National Institutes of Health; this third-party information has not been independently verified by the Company. The award and value of a voucher are not assured. The number of potential placement sites and the placement target are management estimates.

Statements regarding PharmaTher’s products, pipeline and business plans are made solely by PharmaTher. Craft Health and PD Labs have not independently verified, and make no representation regarding, such statements. CraftMake™, CraftControl™ and CraftBlends™ are trademarks of Craft Health Pte. Ltd. All other trademarks are the property of their respective owners.

No obligation to update

Readers are cautioned not to place undue reliance on forward-looking information. Forward-looking information on this website speaks only as of the date it was published or, for news releases, presentations and other dated materials, as of the date of that material. Except as required by applicable securities laws, PharmaTher undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.

Last updated: October 2026.