STRM.BIO Secures $16.4M to Advance Non-Viral Gene Delivery System

CAMBRIDGE, MA – January 07, 2026 – Cambridge-based biotech firm STRM.BIO has announced a significant financial boost totaling $16.4 million, aimed at advancing its pioneering non-viral gene delivery platform. The funding, comprised of an $8 million Series Seed 2 financing round and a recent $8.4 million contract from the Advanced Research Projects Agency for Health (ARPA-H), signals strong investor and government confidence in a technology that could reshape the landscape of gene therapy.

The new financing was led by Recordati, a global pharmaceutical group with a deep focus on rare diseases. It was supported by continued participation from existing investors Boehringer Ingelheim Venture Fund and Delos Capital, along with new funding from Blue Bay Capital Fund. This infusion of capital is set to propel the company’s novel delivery system toward clinical trials, with an initial focus on rare blood disorders like Fanconi anemia and next-generation in vivo CAR-T therapies.

A New Paradigm in Gene Delivery

For years, the promise of gene therapy has been tempered by the challenge of delivery. Traditional methods often rely on viral vectors—modified viruses used as vehicles to carry genetic material into cells. While effective, they can carry risks, including triggering immune responses that prevent repeat dosing and, in rare cases, causing unintended genetic mutations. Alternative non-viral methods, such as lipid nanoparticles (LNPs) made famous by COVID-19 vaccines, have shown great promise but often struggle with targeting, tending to accumulate in the liver rather than reaching specific tissues in need.

STRM.BIO aims to overcome these hurdles with its proprietary megakaryocyte-derived vesicle (MV) platform. Megakaryocytes are large cells found in bone marrow responsible for producing platelets. The company has harnessed vesicles derived from these cells to create a natural, non-viral delivery system with an innate ability to home in on the bone marrow. This specificity allows for the precise delivery of therapeutic payloads directly to hematopoietic stem cells, the very factory of the body's blood and immune systems.

The platform's advantages are multi-faceted. By being cell-derived and non-viral, it offers a potentially superior safety profile. Crucially, preclinical data suggests the MVs are "immune privileged," meaning they do not provoke a strong immune reaction. This could allow for multiple doses over time, a critical feature for managing chronic genetic conditions that is often impossible with viral vectors. Furthermore, the MV platform boasts a large and versatile cargo capacity, capable of carrying complex genetic instructions via plasmid DNA, messenger RNA, or proteins, opening the door to a wide range of therapeutic applications from gene editing to immune cell engineering.

Targeting Unmet Needs in Rare Disease

The company's initial focus is Fanconi anemia, a devastating and rare inherited disease that causes progressive bone marrow failure and a high risk of cancer. For many patients, the only curative option is a hematopoietic stem cell transplant (HSCT), a high-risk procedure that requires a matched donor and involves aggressive chemotherapy, carrying significant potential for life-threatening complications.

STRM.BIO's technology offers a new ray of hope. The goal is to perform an in vivo gene therapy, where the corrective gene is delivered directly into the patient’s body, targeting the bone marrow stem cells without the need to first remove them. This approach could eliminate the need for a donor and the harsh conditioning regimens associated with traditional HSCT, potentially providing a safer and more accessible cure for patients.

"We believe our platform is transformative for hematological diseases and the field of non-viral gene delivery," said Michael Luther, Ph.D., MBA, CEO of STRM.BIO, in the company's announcement. "Now, with the backing that includes two leading pharma investors, we are well-positioned to validate our platform and pipeline focus for in vivo modification of bone marrow cells with an initial focus on Fanconi anemia... with the potential to expand into other rare diseases."

Beyond Fanconi anemia, the platform's ability to engineer immune cells directly within the body holds immense potential for in vivo CAR-T therapies. This could revolutionize cancer treatment by creating cancer-fighting T-cells inside the patient, bypassing the complex, expensive, and time-consuming ex vivo process currently used.

Strategic Backing Signals Major Confidence

The composition of the investor syndicate speaks volumes about the perceived potential of STRM.BIO's technology. The lead investor, Recordati, has built a formidable presence in the rare disease market. Their investment aligns perfectly with a corporate strategy focused on acquiring and developing innovative therapies for underserved patient populations. For Recordati, backing a platform like STRM.BIO’s represents a strategic move into the next generation of genetic medicine.

The continued participation of the Boehringer Ingelheim Venture Fund (BIVF) is equally significant. BIVF has a stated interest in advanced gene therapy delivery platforms, particularly those capable of targeting hematopoietic stem cells. Their ongoing support underscores a deep-seated belief in the unique technical advantages of the MV platform and its potential to unlock new therapies for conditions like sickle cell anemia, another area of interest for the fund. This dual backing from major pharmaceutical players provides not just capital, but also invaluable strategic validation.

Government and Industry Validation

Further bolstering STRM.BIO's position is the recent $8.4 million contract from ARPA-H. Established to fund high-risk, high-reward biomedical research, an ARPA-H award is one of the most significant external endorsements a biotech company can receive. The funding comes from the agency's "Engineering of Immune Cells Inside the Body (EMBODY)" program, which aims to develop technologies that can program a patient's own cells to fight disease.

This award places STRM.BIO's technology at the center of a national health priority to create more accessible and adaptable genetic medicines. As the prime awardee, STRM.BIO will lead a collaboration with key partners, including Ginkgo Bioworks, to accelerate the development of its in vivo CAR-T therapeutic pipeline. The ARPA-H contract, combined with the new private financing, provides a powerful one-two punch of validation from both the market and the scientific establishment.

With this robust financial and strategic support, STRM.BIO is poised to accelerate its platform validation and move its lead programs toward the clinic. The proceeds from the financing will be instrumental in reaching key developmental milestones and supporting a future Series A funding round, moving this promising technology one step closer to potentially transforming the lives of patients with rare and serious diseases.