Emtora Clinical Data to be Highlighted in Podium Presentation at Prestigious 2024 Digestive Disease Week Annual Meeting

Results of Multicenter Phase 2 Trial in Familial Adenomatous Polyposis to be Presented

Grant-Funded Registrational Trial Set to Commence Early Next Year

Emtora Biosciences, Inc., a privately-held, San Antonio-based biotechnology company developing a novel reformulated version of a previously-approved drug today announced the acceptance of an abstract for oral presentation at the upcoming Digestive Disease Week (“DDW”) Annual Meeting. DDW is the world’s premier meeting for physicians, researchers, and industry in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery, which will take place in Washington D.C. May 18-21, 2024.

Dr. Carol Burke, MD, Principal Investigator, will present the 6 month primary endpoint data of a multi-center Phase 2 trial of Emtora’s eRapa^TM in patients with Familial Adenomatous Polyposis (or “FAP”), a genetic disease characterized by the proliferation of precancerous polyps in the gastrointestinal tract, see https://clinicaltrials.gov/ct2/show/NCT04230499.

FAP is an incurable systemic disease for which no approved chemo-preventive agent exists. mTOR, a ubiquitous biological pathway, is over-expressed in FAP polyps. eRapa^TM is a safe, predictable and potent mTOR inhibitor with a unique formulation designed for chronic use.

“eRapa^TM has the potential to reduce the progression of FAP polyps and thereby may delay, or even eliminate in some cases, the need for surgical intervention, which is associated with a devastating impact on quality of life in FAP patients. We look forward to sharing the 6 month safety and efficacy data in our Phase 2 trial of eRapa^TM in FAP at DDW and to the initiation of a registrational trial in FAP in the first quarter of next year,” said Dr. George Peoples, MD, Chief Medical Officer of Emtora Biosciences.

Emtora’s Phase 2 trial of eRapa^TM in FAP was funded by an earlier product development grant (DP190069) from the Cancer Prevention and Research Institute of Texas (“CPRIT”) totaling $3,000,000. The Company previously announced its receipt of a new product development award (DP220053) from CPRIT that will provide nearly $17,000,000 in non-dilutive funding to complete further clinical and product development of eRapa^TM, including the execution of a multicenter, randomized, placebo-controlled, Phase 3 registrational trial of eRapa^TM in the lead indication of FAP. Dr. Carol Burke will serve as the Global Principal Investigator for the trial, which is set to commence later this year. Additional details regarding the DDW presentation are provided below.

Presentation: PHASE IIA TRIAL OF ENCAPSULATED RAPAMYCIN (ERAPA) IN PATIENTS WITH FAMILIAL ADENOMATOUS POLYPOSIS TO REDUCE INTESTINAL POLYP BURDEN: 6 MONTH INTERIM RESULTS

Session: Chemoprevention for GI Cancers: Drugs and/or Bugs

Session Type: Research Forum

Abstract Number: 4041480

Embargo Date: 21-May-2024

Embargo Time: 12:01 a.m. EST



Presentation Date: 21-May-2024

Start Time: 2:00 PM EST

End Time: 2:15 PM EST

Location: 146AB

Presenter: Carol Burke, MD, Director of Hereditary Polyposis in the Sanford R. Weiss MD Center for Colorectal Neoplasia in the Digestive Disease Institute at Cleveland Clinic

About DDW

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

About Emtora Biosciences

Emtora Biosciences is a clinical stage biopharmaceutical company headquartered in San Antonio, Texas. The company is developing eRapa^TM, an encapsulated formulation of the previously approved rapamycin, for the treatment of rare genetic diseases and cancer. Emtora’s lead indication is Familial Adenomatous Polyposis. The ubiquitous mTOR protein, involved in multiple signaling pathways, is overexpressed in FAP polyps. eRapa^TM is a potent mTOR inhibitor believed to provide several significant advantages over rapamycin including: targeted delivery to the site of active disease (in addition to systemic exposure); reduced toxicity and improved tolerability; consistent pharmacokinetics (potentially eliminating the need for drug level monitoring) and improved bioavailability. eRapa^TM was originally developed at University of Texas Health San Antonio and is currently the subject of two ongoing and grant-funded Phase 2 trials. For more information, please visit www.emtorabio.com.

About the Cancer Prevention and Research Institute of Texas

CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention. To date, the agency has awarded more than $3 billion in grants to Texas research institutions and organizations through its academic research, prevention, and product development research programs. CPRIT has also recruited 306 distinguished researchers to Texas, supported the establishment, expansion, or relocation of 62 companies to Texas, and supported 9.4 million prevention services reaching all 254 counties in Texas. Learn more at https://cprit.texas.gov.

Forward-Looking Statements

We make no assurances as to any forward-looking statements in this press release. Actual results could differ materially. We will not update or supplement any forward-looking statements. You should not rely on any forward-looking statements.

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