BioHealth Innovation Weekly for March 18, 2025

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March 18, 2025

The Economic Power of NIH Grants: Why Sustained Investment Matters

The National Institutes of Health (NIH) is vital in driving scientific discovery and economic growth across the United States. Recent reports from United for Medical Research (UMR) and Forbes highlight just how impactful NIH funding has been—generating $94.58 billion in economic activity in FY2024 alone and supporting more than 407,000 jobs nationwide. For every $1 invested, NIH research funding returns $2.56 in economic impact.

For the BioHealth Capital Region (BHCR)—home to NIH, the FDA, and a growing network of research institutions and life sciences companies—this funding is critical. NIH grants fuel the work of startups, researchers, and small businesses developing groundbreaking technologies in biotech, AI-driven drug discovery, personalized medicine, and advanced therapeutics. Without sustained investment, the entire innovation ecosystem is at risk, impacting job creation, commercialization efforts, and, ultimately, patient outcomes.

Motivity Secures $27M Investment to Scale ABA Tech with NIH Entrepreneur in Residence Support

HONOLULU, HI, Mar. 12, 2025 – Motivity, a leading provider of clinical SaaS solutions for Applied Behavior Analysis (ABA) providers who treat children with autism, today announced a $27 million investment from Five Elms Capital, a leading software investment firm. The funding will enable Motivity to accelerate product innovation, expand its team, and strengthen support for ABA providers worldwide.

Since its founding in 2012, Motivity’s mission has been to empower ABA clinicians with cutting-edge technology that strengthens clinical effectiveness and improves outcomes. To date, the company has secured $11 million in Small Business Innovative Research (SBIR) grants used to develop next-generation solutions, including AI-driven workflows, analytics for clinical decision support, and caregiver engagement tools. Today, Motivity serves over 550 organizations across seven countries, enhancing the delivery of high-quality, data-driven care.

IonQ Raises Over $372 Million Via At-the-Market Equity Offering Program

COLLEGE PARK, Md.--(BUSINESS WIRE)-- IonQ, Inc. (NYSE: IONQ), a leader in the quantum computing and quantum networking industries, today announced that under its “at-the-market” equity offering program (the “ATM Program”) it has sold a total of 16,038,460 shares of its common stock for an aggregate amount of approximately $372.6 million, netting aggregate proceeds of approximately $360 million.

The Company has determined that it has raised a sufficient amount under the program to meet its currently anticipated capital needs. The Company also determined that given overall recent market disruptions, the trading prices for its shares, and the overhang from having an ATM Program in effect, the ATM Program should be terminated. The Company has therefore terminated the ATM Program today and a prospectus supplement will be filed under Rule 424(c) reflecting such termination.

Emergent BioSolutions and Rocketvax Announce Investment Agreement and Pursuit of a Strategic Relationship for Next-Generation Product Candidates

GAITHERSBURG, Md. and BASEL, Switzerland, March 12, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS), a leading public health company that delivers protective and life-saving solutions to communities across the world, and Rocketvax Ltd, one of Switzerland’s next-generation vaccine companies and a member of the Swiss Rockets Ltd family of companies, today announced entry into an agreement for Emergent’s strategic financial investment into Swiss Rockets Ltd, the parent company of Rocketvax Ltd, to support research, infrastructure development, and the expansion of Swiss Rockets’ innovative biotechnology portfolio. This endeavor underscores Emergent’s commitment to supporting Swiss Rockets’ broader mission of pioneering breakthrough medical technologies.

CEL-SCI’s Head and Neck Cancer Study Clears FDA Review, Eyes Commercialization Partners

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced it received comments from the U.S. Food and Drug Administration (FDA) on the confirmatory Registration Study’s Statistical Analysis Plan (SAP) submitted in December of 2024 for the study of Multikine* (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer. The FDA stated no response to their comments were required from CEL-SCI and that the agency presently has no comments on the confirmatory study protocol, which was submitted for FDA review contemporaneously with the SAP in December 2024.

CEL-SCI’s 73,000 square foot Multikine manufacturing facility presently has the capacity to produce over 12,000 Multikine treatments per year. Over $200 million has been invested in the facility and the development and validation of its proprietary biologic manufacturing processes.

Gain Therapeutics Doses First Participant in Phase 1b Clinical Trial of GT-02287 in Parkinson’s Disease

BETHESDA, Md., March 14, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the dosing of the first participant with Parkinson’s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company’s lead allosteric small molecule in development for the treatment of PD with or without a GBA1 mutation.

“Initiation of dosing in our Phase 1b clinical trial represents an important step in the clinical development of GT-02287 and in Gain’s mission to deliver a disease-modifying therapy to people with Parkinson’s disease. We look forward to continued enrollment and anticipate an interim analysis from the towards the end of 2Q 2025,” said Gene Mack, President and CEO of Gain Therapeutics.

GeneDx Enhances the Power of its Interpretation Platform with Artificial Intelligence (AI) Powered Gene Ranker to Enable Faster and More Efficient Clinical Analysis

GAITHERSBURG, Md.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced Multiscore, an advanced AI-powered decision support tool designed to revolutionize genetic analysis by improving diagnostic efficiency, streamlining workflows, and enhancing clinical insights. Multiscore is embedded into GeneDx’s interpretation platform as a decision support tool to help clinical geneticists focus on the most relevant genes during their clinical analysis. GeneDx will present the AI-powered decision support tool at ACMG, in a session: Multiscore, a Gene Ranker Powered by Artificial Intelligence and Real-World Clinical Data, Shows High Sensitivity in 10,000 Exomes and Genomes which received one of the limited spots in an industry-specific platform session.

WBJ: This Md. biotech wants to get a cancer treatment to patients. It just tapped an industry outsider as co-CEO

By Sara Gilgore – Staff Reporter, Washington Business Journal -Mar 12, 2025 - Gaithersburg’s Shuttle Pharmaceuticals Holdings Inc. (NASDAQ: SHPH) has brought in a new executive to spearhead the biotech’s business activity, freeing up its longtime leader, a cancer doctor and physician administrator, to focus on research and development.

The company’s co-founder and chief executive, Dr. Anatoly Dritschilo, is now one of two co-CEOs, and will oversee the clinical trials and scientific work required to get its lead candidate for an aggressive brain cancer to patients. And Christopher Cooper, a former oil and gas industry exec who also leads a telecommunications company, has joined Shuttle as the other co-CEO on an interim basis. He will focus on the business activity and raising money through the capital markets, the firm said Wednesday.

Rockville's Cellphire Therapeutics CLPH-511 Fast Track Designation Granted

Rockville, Md. (March 11, 2025) – Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation allogeneic, platelet-derived, cellular therapeutics, is excited to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CLPH-511 (Frozen Activated Platelets) Injectable Suspension for the treatment of acute hemorrhage as an alternative to conventional platelets when not available or in short supply.

Syngene Acquires its First Manufacturing Facility in Baltimore

BANGALORE, India, March 10, 2025 /PRNewswire/ -- Syngene International Limited ('Syngene'), a global contract research, development, and manufacturing organization (CRDMO), today announced the acquisition of its first biologics site in the USA – fitted with multiple monoclonal antibody (mAbs) manufacturing lines.

The state-of-the-art biologics facility, acquired by Syngene USA Inc., a wholly owned subsidiary of Syngene, from Emergent Manufacturing Operations Baltimore, LLC (a subsidiary of Emergent BioSolutions Inc.), will expand Syngene's growing global biologics footprint to better serve its customers across both human and animal health market segments. The new site will increase Syngene's total single-use bioreactor capacity to 50,000L for large molecule discovery, development, and manufacturing services. Additionally, it will provide Syngene's customers with continuity of supply from its four development and manufacturing facilities located in India and North America, offering services ranging from cell line development, process optimization and both clinical and commercial supply.