Sarcomatrix Therapeutics Provides Business Update: Board Expanded, Regulatory and Manufacturing Partners Engaged Across Two Rare Neuromuscular Programs

Two programs, one patient population

Sarcomatrix is building a focused portfolio for muscular dystrophies that remain without disease-modifying therapy for most patients.

S-969, the company’s lead program, is an orally administered small molecule in preclinical development for Duchenne and Becker muscular dystrophy (DMD/BMD) and for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). The program is mutation-agnostic in design, addressing muscle degeneration itself rather than a single genetic defect, which is the population that gene-directed approaches leave unserved.

LAM-111, recombinant human laminin-111, is wholly owned by Sarcomatrix and holds confirmed Orphan Drug Designation (ODD) in both the United States and the European Union. Laminin-111 has been studied as a replacement for a structural protein of the muscle basement membrane, and the asset gives Sarcomatrix a second, mechanistically distinct shot at the same patient community.

Progress since the last update

Chemistry, Manufacturing and Controls (CMC). The company has selected the sulfate salt form for S-969 following salt and polymorph screening, and has contracted drug substance and drug product manufacturing partners to produce material for toxicology and first-in-human (FIH) supply.

Nonclinical and regulatory. Sarcomatrix has engaged Duck Flats Pharma to conduct an integrated review across regulatory, nonclinical, CMC, and first-in-human strategy for both S-969 and LAM-111, with the objective of a single coherent development plan before pivotal toxicology begins. The two-species Good Laboratory Practice (GLP) toxicology package is the rate-limiting activity on the path to a clinical trial application, and provider selection is the company’s immediate priority. Pre-IND meeting strategy is under development.

Clinical planning. A single ascending dose and multiple ascending dose (SAD/MAD) Phase 1 study in healthy adults is being scoped. The company is evaluating conduct in Australia to access the 43.5% refundable research and development tax incentive, which would return a meaningful share of Phase 1 spend to the balance sheet and extend runway per dollar raised.

Intellectual property. Sarcomatrix has engaged PatentVest for patent intelligence and prosecution support, including provisional filings covering salt and polymorph forms of S-969.

Governance. The board has added two independent directors, Brian Cain and Bill Ashton, restoring a three-director quorum and establishing independent oversight of a company that operates with a deliberately small full-time footprint and a senior consulting bench.

Management commentary

“Our work over the next year is straightforward to describe and demanding to execute: put S-969 in front of regulators with a toxicology, manufacturing, and clinical package that holds up to scrutiny,” said David Craig, Co-Founder, President, and Chief Executive Officer of Sarcomatrix Therapeutics. “We have chosen to spend our capital on the studies that create value and to buy senior expertise by the engagement rather than by the headcount. Adding independent directors and seasoned external partners this quarter is part of the same discipline. Families living with these diseases do not need optimism from us. They need a program that survives the next review.”

Capital formation

Sarcomatrix is conducting a Regulation Crowdfunding offering through the KoreConX platform, with Andes Capital Group LLC serving as broker-dealer of record and KoreTransfer USA LLC as transfer agent. Offering terms, financial statements, and risk factors are available in the company’s Form C filed with the U.S. Securities and Exchange Commission (SEC) and on the offering page at www.sarcomatrix.com/invest

A concurrent private placement under Rule 506(c) of Regulation D is open to verified accredited investors. Interested accredited investors may contact ir@sarcomatrix.com or 775-525-1795. Data room access is granted by request.

About Sarcomatrix Therapeutics Corporation

Sarcomatrix Therapeutics Corporation is a preclinical-stage biopharmaceutical company based at the University of Nevada, Reno Innevation Center, 450 Sinclair Street, Reno, NV 89501. The company is developing S-969, an oral small molecule for Duchenne, Becker, and limb-girdle muscular dystrophy, and LAM-111, a recombinant human laminin-111 with United States and European Union Orphan Drug Designation. Learn more at www.sarcomatrix.com.

Investor and media contact

Investor Relations Sarcomatrix Therapeutics Corporation ir@sarcomatrix.com 775-525-1795

Forward-looking statements

This release contains forward-looking statements, including statements about planned nonclinical studies, manufacturing activities, regulatory interactions, clinical trial design and location, intellectual property filings, and financing activities. These statements reflect current expectations and are subject to risks and uncertainties, including the availability of capital, the results of nonclinical and clinical studies, the timing and outcome of regulatory reviews, the performance of third-party vendors, and the availability of tax incentives and designations. S-969 and LAM-111 are investigational and have not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. No conclusions regarding safety or efficacy in humans should be drawn from preclinical work. Actual results may differ materially. Sarcomatrix undertakes no obligation to update these statements except as required by law.

Offering disclosure

This communication is for informational purposes and is not an offer to sell or a solicitation of an offer to buy any security. Any offer is made only through the company’s official offering materials. Investing in a Regulation Crowdfunding offering involves substantial risk, including the risk of losing the entire investment, illiquidity, and dilution. Prospective investors should read the Form C, including the risk factors, in full before investing. Securities offered under Rule 506(c) of Regulation D are available only to investors whose accredited status has been verified.