Zetagen Therapeutics Awarded $2 Million USD Grant from the National Cancer Institute (NCI) for Phase 2 Study of ZetaMet™ for Treatment of Metastatic Bone Cancers

• NCI Grant will be used for Phase 2 development of ZetaMet, a first-of-its kind molecular pathway designed to suspend cancer, inhibit pain, and regenerate bone

• The Company is developing ZetaMet for patients living with metastatic bone lesions and other osteologic conditions

• First human clinical trial for metastatic bone lesions in breast cancer patients targeted to begin in early 2022

SYRACUSE, N.Y.–(BUSINESS WIRE)–#Bone–Zetagen Therapeutics, Inc., a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, today announced it has received a two year, $2 million USD grant from the National Cancer Institute of the National Institutes of Health (NIH). The grant will be used for the Phase 2 clinical and commercial development of its ZetaMet™ technology. ZetaMet is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

“This support from the NCI marks a key milestone and will facilitate the continued development of ZetaMet for the use in treating metastasis in bone,” said Bryan S. Margulies, PhD,chief scientific officer of Zetagen Therapeutics. “Preclinical trials have successfully demonstrated ZetaMet’s ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration. If these results hold true in the next phase of study, ZetaMet could offer an entirely new treatment for patients living with certain late-stage cancers where present therapies do not offer desired results.”

ZetaMet works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as “osteoblasts”, and inhibits cells associated with bone degradation called “osteoclasts”.

Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called “lytic lesions.” Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.¹

“We know there are hundreds of thousands of patients living with late-stage cancers which involve painful, debilitating metastatic bone lesions,” said Joe C. Loy, CEO of Zetagen Therapeutics. “This recognition from the NCI further reinforces our commitment to developing breakthrough therapies that will make a tangible difference in quality of life as they battle these devastating diseases.”

Earlier this year, ZetaMet received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The first human clinical trial using ZetaMet in Stage 4 breast cancer patients is being targeted for early 2022.

About Zetagen Therapeutics

Founded in 2015, Zetagen is a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions. Our multi-patented, ZetaMet™ technology is a first-of-its kind molecular pathway designed to suspend cancer, inhibit pain, and regenerate bone. Zetagen exclusively-licensed the platform technology from the State University of New York in 2016. This novel therapy, a drug-eluting implant technology, has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022. In addition to ZetaMet™, the Company’s pipeline includes other oncologic treatments for Skeletal Related Events (SREs), i.e., ZetaMet Flowable™ and ancillary osteologic treatments including, ZetaFuse™, ZetaSet™, ZetaDent™ and ZetaBase™. To learn more, visit www.zetagen.com

Forward-Looking Statements

This press release contains certain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

Source: Zetagen Therapeutics, Inc.

^{_________________________________________}

¹ Li S, Peng Y, Weinhandl ED, et al. Estimated number of prevalent cases of metastatic bone disease in the US adult population. Clin Epidemiol. 2012;4:87-93. doi:10.2147/CLEP.S28339

Contacts

Investor Inquiries:
Zetagen Therapeutics, Inc.

Email: [email protected]

Media Inquiries:

McDougall Communications on Behalf of Zetagen Therapeutics, Inc.

Elizabeth Harness, Senior Consultant, [email protected] Phone: +1-585-435-7379

Dan Smith, Senior Counselor, [email protected] Phone: +1-585-434-2154