OrganaBio and RxMP Therapeutics Announce Manufacturing Partnership to Advance RMP-402 Hemostatic Drug Product

MIAMI & SANTA FE, Calif.--(BUSINESS WIRE)--OrganaBio, LLC ("OrganaBio"), a vertically integrated blood and cell products and services company delivering end-to-end solutions for cell and gene therapy developers, and RxMP Therapeutics, Inc. ("RxMP"), a late pre-clinical development stage therapeutics company developing novel therapies for the rapid control of severe hemorrhage, today announced a manufacturing partnership under which OrganaBio will serve as RxMP's contract manufacturing partner for the cGMP production of its lead product candidate, RMP-402.

Under the agreement, OrganaBio will support the technology transfer, qualification, and cGMP production of RMP-402, leveraging its integrated manufacturing infrastructure and quality management systems to advance the drug product through key development milestones. The collaboration brings together OrganaBio's capabilities in cGMP manufacturing, quality assurance, and analytical development with RxMP's proprietary hemostatic platform technology.

RMP-402 is a first-in-class hemostatic therapeutic composed of manufactured allogeneic red cell membrane particles (RMPs) — analogs of particles that circulate naturally in human blood. These RMPs are designed to rapidly stop bleeding when administered intravenously without increasing the risk of off-target clotting. RMP-402 is being developed for use in both civilian and military settings, addressing a global trauma and surgical bleeding market estimated at $12 billion dollars annually, where uncontrolled bleeding remains a leading cause of morbidity and preventable death. In 2025, RxMP reached consensus with the U.S. Food and Drug Administration ("FDA") on its proposed GMP manufacturing process for RMP-402 and entered into a Cooperative Research and Development Agreement ("CRADA") with the U.S. Department of Defense's Institute of Surgical Research to further validate the product's therapeutic potential for the treatment of combat casualties.

"OrganaBio was built to be the kind of partner that therapeutics companies need: responsive, rigorous, and deeply invested in our clients' success," said Justin Irizarry, Chief Executive Officer of OrganaBio. "We are honored that RxMP has entrusted us with the manufacturing of RMP-402. This is a product that has the potential to fundamentally change how clinicians manage life-threatening bleeding events, and we take that responsibility seriously. Our team is energized by the opportunity to apply our cGMP manufacturing capabilities and quality-first approach to help bring this therapy closer to the patients who need it most."

"Selecting the right manufacturing partner is one of the most consequential decisions a company at our stage can make, and we are confident that OrganaBio's combination of blood-products expertise and cGMP manufacturing under one quality system makes them the right partner for RxMP," said Shawna Khouri, Chief Operating Officer of RxMP Therapeutics. "Uncontrolled bleeding remains an area of critically high unmet need, and the urgency of the problem demands that we move with both speed and precision. With OrganaBio now established as our manufacturing partner, our team can sharpen its focus on advancing our regulatory strategy, completing the remaining IND-enabling studies, and deepening our collaboration with the Department of Defense, all while having full confidence that the manufacturing of RMP-402 is in capable and committed hands. This partnership is a critical enabler for RxMP as we work to bring a first-in-class hemostatic therapeutic to the patients, surgeons, and warfighters who need it most."

The partnership underscores the continued momentum of both companies as they work to address significant unmet medical needs. OrganaBio continues to expand its manufacturing and services capabilities from its Miami headquarters, while RxMP advances a robust development program for RMP-402 with strong support from both federal partners and private investors.

About OrganaBio

OrganaBio, LLC is a vertically integrated blood and cell products and services company headquartered in Miami, Florida. Through its wholly owned, FDA-registered subsidiaries, OrganaBio operates proprietary supply chains for ethically sourced human tissues and blood-derived cellular products, and delivers a comprehensive suite of cGMP manufacturing, analytical development, quality assurance, and regulatory support services. By combining upstream sourcing with downstream manufacturing and development expertise under a single quality framework, OrganaBio enables cell and gene therapy developers to accelerate the translation of novel therapeutics from bench to bedside. For more information, visit www.organabio.com.

About RxMP Therapeutics

RxMP Therapeutics, Inc. is a therapeutics company in late stage pre-clinical development advancing novel therapies for the rapid control of severe hemorrhage. Its lead product candidate, RMP-402, is a first-in-class hemostatic therapeutic inspired by naturally occurring red blood cell membrane particles and is designed to rapidly stop bleeding without increasing the risk of off-target clotting. RMP-402 is being developed for use in both civilian and military settings, addressing a global trauma and surgical bleeding market estimated at up to 12 billion dollars annually, where uncontrolled bleeding remains a leading cause of morbidity and preventable death. For more information, visit www.rxmpt.com.

This press release contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those expressed or implied in any forward-looking statements.

Contacts

OrganaBio: Dr. Carlos Carballosa, Ph.D. | carlos@organabio.com

RxMP Therapeutics: Cliff Mastricola | cliffm@rxmpt.com

RxMP Therapeutics Announces Opening of $2 Million Bridge Financing Round

RxMP Therapeutics is announcing the opening of a $2 million bridge financing round to support the next phase of development for its lead hemostatic platform. The round already has over $1.2M committed, led by a $750,000 investment from the Wallace H. Coulter Foundation, the company’s largest shareholder and long-time partner. This strong early support, including additional investment in this round by insiders, underscores continued confidence in RxMP’s mission and progress toward delivering a life-saving hemorrhage control solution.

Over the past year, RxMP has made significant traction across both manufacturing and regulatory milestones. The company has advanced its GMP manufacturing plans and strengthened its regulatory pathway, while continuing to refine its strategy for early commercialization opportunities. This includes exploration of potential Emergency Use Authorization (EUA) pathways in collaboration with the Department of Defense, reflecting the urgent and mission-critical need for effective hemorrhage control technologies in military and emergency settings.

Proceeds from the bridge round will be used to support GMP manufacturing required for remaining IND-enabling animal studies and the planned Phase I clinical trial. With this financing, RxMP aims to maintain development momentum, de-risk upcoming regulatory milestones, and position the company for subsequent clinical and commercialization phases.

RxMP Therapeutics is a pre-clinical biotechnology company developing novel therapies for the rapid control of severe hemorrhage. Its lead product candidate, RMP-402, is a first-in-class hemostatic therapeutic derived from a naturally occurring red blood cell byproduct and is designed to rapidly stop bleeding without increasing the risk of thrombosis. RMP-402 is being developed for use in both civilian and military settings, addressing a global trauma and surgical bleeding market estimated to exceed several billion dollars annually, where uncontrolled bleeding remains a leading cause of preventable death.

RxMP Therapeutics Provides Corporate Update

Enters Into Research & Development Agreement with Department of Defense’s Institute of Surgical Research
Reaches Consensus with FDA on GMP Allogeneic Manufacturing Process of RMP-402
Appoints Shawna Khouri as Chief Operating Officer

Seattle, Washington, June 9, 2025 - RxMP Therapeutics, Inc. (“RxMP” or the “Company”), a privately-held company developing innovative therapies to prevent and treat hemorrhage and excessive bleeding, is pleased to provide a corporate update, including a research and development agreement with the U.S. Department of Defense (“DoD”) and the appointment of Shawna Khouri as the Company’s Chief Operating Officer.

Cooperative Research and Development Agreement

In March 2025, RxMP entered into a Cooperative Research and Development Agreement (“CRADA”) with the Institute of Surgical Research (“ISR”), a subordinate federal laboratory of the Defense Health Agency within the DoD.

Under the terms of the CRADA, RxMP will provide its lead product candidate, RMP-402, red cell-derived lyophilized microparticles and related information (collectively, the “Research Materials”) to the ISR. The ISR will validate the effects of the Research Materials alone or as a component in a product in promoting coagulation function in large animal preclinical models of polytrauma hemorrhage and shock.

Consensus with FDA on GMP Manufacturing Process

Earlier this year, RxMP had a Type C meeting to present to the FDA, at their request, our finalized GMP manufacturing process prior to further IND-enabling studies. The outcome of the meeting resulted in agreement that RxMP may proceed with its proposed GMP manufacturing process of allogeneic RxMP-402.

Shawna Khouri, Chief Operating Officer

In May 2025, Shawna Khouri was appointed as Chief Operating Officer of RxMP. In this role, Ms. Khouri spearheads the Company’s operational strategy for its innovative injectable drug platform focused on hemostasis. Prior to RxMP, Ms. Khouri was the Director for Health and Innovation Initiatives at Tulsa Innovation Labs (“TIL”), the technology and innovation ecosystem arm of the George Kaiser Family Foundation. At TIL, Ms. Khouri played a key role in the organization's programmatic and funding strategies, establishing the operational framework for managing more than $100 million in federal and philanthropic initiatives, including the EDA Build Back Better and Tech Hubs programs. For more information on Ms. Khouri’s background, please visit www.rxmpt.com.

"I could not be more excited about our achievements in the last few months especially achieving concurrence with FDA on our allogenic GMP manufacturing process that permits large scale manufacturing in the future, which has important implications for our lead product,” commented Dr. Rifat Pamukcu, President and Chief Executive Officer of RxMP Therapeutics. "We are also excited to partner with the ISR to develop our hemorrhage and bleeding therapies. The CRADA will allow us to benefit from the additional outside expertise that the ISR brings in this cooperative agreement to further collaborative research and development, with a goal of producing transformative and marketable products that potentially benefit both civilian public health and our military personnel. We are equally enthusiastic about having Shawna Khouri join RxMP as Chief Operating Officer. We are confident that Shawna’s appointment has strengthened our leadership team as a result of her financial background and as a biomedical engineer, complementary expertise that will enhance the scale-up of our unique GMP manufacturing process. We look forward to her skilled management of the growth of our business operations.”

About RxMP Therapeutics, Inc.

RxMP Therapeutics is a pharmaceutical company focused on developing proprietary drugs for the management of excessive bleeding. The Company aims to develop and commercialize RMP-HPE, (red cell-derived microparticles produced by high-pressure extrusion), as a new hemostatic agent for the treatment or prevention of excessive bleeding. The Company’s first product candidate, RMP-402, is a hemostatic agent derived from red blood cells, designed to prevent and treat excessive bleeding by enhancing platelet function and coagulation without causing off-target clotting. For more information, please visit www.rxmpt.com.

Contact

Cliff Mastricola
RxMP Therapeutics
16236 San Dieguito Road, Suite 2-10
P.O. Box 8071
Rancho Santa Fe, California 92067
Email: cliffm@rxmpt.com
Phone: (858) 456-7300