MAIPL THERAPEUTICS, INC. FORMS STRATEGIC ALLIANCE WITH ENDOSURE, INC. TO FACILITATE FIRST‑IN‑HUMAN TRIAL OF NOVEL NON‑HORMONAL ENDOMETRIOSIS THERAPY

SCARSDALE, N.Y., May 20, 2025 /PRNewswire/ -- Maipl Therapeutics, Inc. ("Maipl"), a biopharmaceutical company focused on first‑in‑class, non‑hormonal therapies for women's health, today announced a strategic alliance with Endosure, Inc., the developer of the ENDOSURE TEST—the only Tier-1 non‑invasive, 30-minute and highly accurate diagnostic with rapid results capable of diagnosing or excluding the presence of endometriosis in any anatomical location. The collaboration will leverage the ENDOSURE TEST to expedite Maipl's clinical studies of MA-4604, a potent and selective antagonist of the Prostaglandin‑F2α receptor (FP), with the goals of accelerating patient identification, enrollment and pharmacodynamic assessment.

"Our alliance with Endosure allows us to leap‑frog two of the greatest hurdles in endometriosis drug development—timely and accurate diagnosis and objective measurement of treatment effect," said Dr. Yong Yue, Chief Executive Officer of Maipl Therapeutics, Inc. "By incorporating the ENDOSURE TEST into the MA‑4604 development program, we have the potential to recruit the right patients faster, monitor response in near‑real time, and ultimately bring a much‑needed, non‑hormonal option to millions of women suffering from this debilitating disease."

Endometriosis is a systemic, chronic disorder marked by ectopic endometrial tissue and severe pain. It affects at least one in ten women of reproductive age—nearly 200 million worldwide—and imposes a staggering US $69.8 billion annual economic burden in the United States alone.¹ Delays in diagnosis average eight to ten years, permitting disease progression that often leads to infertility, organ damage and diminished quality of life.

MA‑4604: Non-hormonal, Oral, First‑in‑Class FP Antagonist

• Mechanism: Highly potent, selective blockade of Prostaglandin-F2α Receptor (FP), a key driver of endometriosis‑associated menstrual pain resulting from dysregulated smooth muscle contractions and inflammation.
• Preclinical results: Demonstrated robust reduction of uterine contractions, lesion burden, and pain response in validated animal models.
• Clinical plan: Phase 1 study is expected to begin in 2Q 2026

ENDOSURE™ Test: Transforming Diagnosis and Trial Efficiency

• Modality: Non‑invasive EKG-like myoelectrical assay completed in approximately 30 minutes.
• Accuracy: >99% sensitivity and >95 % specificity, independent of anatomical location.
• Utility in trials: Has the potential to enable non-invasive patient identification and serve as a quantitative pharmacodynamic biomarker of post- treatment disease activity.

"The combination of a Tier‑1 diagnostic with a truly innovative, non‑hormonal therapeutic candidate could redefine the standard of care in endometriosis," added Carlos Babini, Chief Executive Officer of Endosure, Inc. "We are thrilled that our technology will help Maipl expedite patient recruitment as well as objectively measure the impact of MA‑4604."

The alliance will initially focus on incorporating the ENDOSURE TEST into the clinical development program for MA-4604 including use in the upcoming phase 1b study in patients with endometriosis to demonstrate target engagement and assist in dose selection for Phase 2.  The test also has the potential to expedite enrollment in future clinical trials compared to previous trials that required definitive diagnosis by laparoscopic surgery which prolonged recruitment.

About Maipl Therapeutics, Inc.

Maipl Therapeutics is a privately held biopharmaceutical company headquartered in Scarsdale, New York. The company is pioneering non‑hormonal treatments for women's health disorders, with an initial focus on endometriosis. Maipl's lead candidate, MA‑4604, is positioned to be the first FP receptor antagonist to enter human trials. For more information, visit www.maipltx.com/.

About Endosure, Inc.

Endosure, Inc. is a diagnostic company dedicated to transforming the detection and management of endometriosis. The ENDOSURE TEST—the world's first rapid, non‑invasive test capable of detecting endometriosis systemically—is commercially available in select markets and the company plans to submit for 510K approval in the United States soon.  Importantly, the Prostaglandin-F2α neurotransmitter plays a significant role in the test's diagnostic process. Learn more at www.endosure.com.

Forward‑Looking Statements

This press release contains forward‑looking statements, including but not limited to statements regarding the anticipated benefits of the alliance, planned clinical studies and the potential of MA‑4604. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Maipl undertakes no obligation to update any forward‑looking statements.

¹ *Soliman et al., American Journal of Obstetrics & Gynecology, 2020.

MAIPL THERAPEUTICS, INC. SELECTS THE ENDOSURE TEST TO FACILITATE THE Development of novel oral PGF2alpha receptor (FP) antagonist for the treatment of endometriosis

SOURCE Maipl Therapeutics, Inc.