—Award from Highly Competitive Initiative Will Enable Ancilia to Advance Its Lead Program through IND Filing for Its First Clinical Trial—

—Ancilia Also Awarded $274,000 NIH STTR Grant to Expand Its Platform to Diseases of the Gastrointestinal Tract—

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NEW YORK, NY, October 23, 2024

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Ancilia Biosciences, Inc., (Ancilia Bio), a biotechnology company harnessing the natural power of CRISPR to create bacterial therapies and products with immunity against destructive viruses, today announced that it has been selected to receive a $3 million award over two years from the Sprint for Women’s Health of the Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS). This effort was designed to address critical unmet challenges in women’s health, champion transformative innovations and tackle health conditions that primarily affect women, generated an unprecedented worldwide response.

Ancilia’s winning Sprint for Women’s Health proposal, Enabling a New Class of Bacterial Therapies for Vaginal Health, applies the company’s unique technologies to develop a safer and more effective treatment for bacterial vaginosis (BV), a common but undertreated health condition that affects 3.5 million women in the U.S. each year. BV is associated with impaired fertility, pelvic inflammatory disease, preterm labor and sexually transmitted diseases. Ancilia’s solution, a novel bacterial therapy that is immune to predatory viruses and restores the vaginal microbiome to its naturally healthy state, has demonstrated proof of concept in preclinical studies. The award will enable the company to complete preclinical testing and advance its lead therapeutic candidate through Investigational New Drug (IND) submission for a first-in-human clinical trial.

Co-founder and chief executive officer Alexandra Sakatos, PhD, noted, “Our conviction that Ancilia’s unique approach has great potential to improve the treatment of challenging diseases is further confirmed by this prestigious award, which followed a highly competitive review process that selected just 23 winners from the more than 1,700 proposals received from 45 states, the District of Columbia, and 34 countries. We are honored to be among the recipients and thrilled that this non-dilutive funding will prepare us to begin clinical trials. We also were recently awarded a grant by the NIH that will help fund expansion of our platform technologies into gastrointestinal diseases, a prime target for bacteria-based therapeutics. These recent successes position us well to advance our programs and prepare for our next financing round.”

Despite evidence that therapeutics based on beneficial bacteria can potentially transform the treatment of many diseases, efforts to develop them have often failed. Ancilia believes a key reason is that the therapeutic bacteria are being targeted by predatory viruses, known as bacteriophages, that are present in the microbiome of patients. Ancilia is harnessing nature’s first immune system, known as CRISPR, to immunize beneficial bacteria against these viruses and increase their chances of therapeutic success. While best known for its role in human genome editing, CRISPR actually evolved in bacteria to protect them from destructive viruses.  Ancilia is the first company harnessing this natural function of CRISPR to develop improved bacteria-based therapies for diseases with high unmet need. Its platform uses novel computational tools to identify and characterize destructive viruses and then leverages CRISPR to “immunize” beneficial bacteria against these viruses.

The ARPA-H Sprint for Women’s Health is conducted in collaboration with the Investor Catalyst Hub of ARPANET-H, the agency’s nationwide health innovation network that connects people, innovators and institutions to accelerate better health outcomes for everyone. Ancilia will work with an ARPA-H Program Manager and the Investor Catalyst Hub over two years to develop their proposed solution, receiving milestone-based payments aligned to research activities and performance objectives.

Ancilia Advisor Caroline Mitchell, MD, MPH, a clinician who is Director of the Vulvovaginal Disorders Program at Massachusetts General Hospital and an Associate Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, noted, “Clinically, when I see people with recurrent symptoms due to a disrupted vaginal microbiome, my options for treatment are the same as we were using 40 years ago, and they don’t work well.  The need for novel, breakthrough therapies in this area is widely acknowledged and long overdue. Ancilia’s innovative approach intersects with my lab’s focus on how vaginal microbes influence reproductive health and disease, as well as the design of new treatments to address these disorders. We are encouraged that the ARPA-H Sprint for Women’s Health initiative is supporting Ancilia’s important work.”

Ancilia also announced that Jacques Ravel, PhD, has been named a Scientific Advisor to the company. Dr. Ravel is the Acting Director at the Institute for Genome Sciences and a Professor of Microbiology and Immunology at the University of Maryland School of Medicine. Dr. Ravel is an expert in microbial genetics and is well-known for his pioneering work in mapping and exploring the critical role of the vaginal microbiome in women’s health.

Separately, Ancilia announced that it has been awarded a $274,000 grant under the Small Business Technology Transfer (STTR) program of the NIH that will enable the company to expand its technology platforms to address diseases of the gastrointestinal tract, facilitating Ancilia’s goal of developing novel live bacterial products for a range of diseases and applications. The company has now raised approximately $8 million in total dilutive and non-dilutive funding.

Ancilia’s newly awarded STTR grant is supported by the National Institute Of Diabetes And Digestive And Kidney Diseases of the NIH under Award Number R41DK141344.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

See today’s White House statement on the Sprint for Women’s Health awards at: https://www.whitehouse.gov/briefing-room/statements-releases/2024/10/23/fact-sheet-biden-harris-administration-announces-110-million-in-awards-from-arpa-hs-sprint-for-womens-health-to-accelerate-new-discoveries-and-innovation/.

A video on the awards can be viewed at https://arpa-h.gov/engage-and-transition/sprint.

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About Ancilia

Ancilia Biosciences is developing live bacterial products for human health and other applications. The company aims to overcome a major obstacle to the success of these products—the failure to address the role of predatory bacterial viruses in limiting their effectiveness. The company’s proprietary enabling technologies identify and characterize these viruses and leverage the natural function of CRISPR to produce a new class of live biotherapeutics and other microbial products with immunity to key viral pathogens. Ancilia’s founders and advisors include scientific leaders across CRISPR and the virome. The company’s core technologies are based on the pioneering work of co-founder Dr. Rodolphe Barrangou, who established this natural function of CRISPR in bacteria and filed the first-ever CRISPR patent in 2004, and co-founder and chief technology officer David Paez-Espino, PhD, who has published more than 20 high impact papers in virology and bioinformatics and holds multiple patents in the field. Ancilia has obtained both issued and pending patents for its technologies. The company is headquartered in New York City. For more information, visit anciliabio.com.

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Contacts:

Ancilia Corporate:

Alexandra Sakatos, PhD                        

Chief Executive Officer

info@ancilia.com

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Ancilia Media:

Barbara Lindheim

BLL Partners for Ancilia

blindheim@bllbiopartners.com‍

(917) 355-9234

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