Endogena Therapeutics, Inc.

SAN FRANCISCO and TORONTO and ZÜRICH, Switzerland, May 04, 2023 (GLOBE NEWSWIRE) -- Endogena Therapeutics Inc., a clinical-stage biotech company, is pleased to announce that it has completed patient enrollment ahead of schedule in its Phase 1/2a trial of EA-2353 for the treatment of retinitis pigmentosa (RP). With the dose-escalation stage completed in April, the ongoing trial is now in the expansion cohort stage. The trial (NCT05392751) is examining the safety, tolerability, and preliminary efficacy of intravitreal EA-2353, a first-in-class small molecule that selectively activates endogenous retinal stem and progenitor cells to potentially preserve and restore visual function. The trial has enrolled 14 patients with RP due to any pathologic genetic mutation and is being conducted across five US sites. The first patient started treatment in July 2022 and topline interim data is anticipated in early 2024. Matthias Steger, PhD, MBA, CEO of Endogena Therapeutics: “Getting this far in a remarkably short time is testament to the outstanding execution of our clinical team in collaboration with InFocus Clinical Research. There’s a tremendous enthusiasm surrounding our trial and completing enrollment ahead of schedule has only been possible thanks to the invaluable contribution of the patients, their families, the investigators and their study staff. We are all driven by the hope of finding a treatment for this rare and devastating disease.” About EA-2353 EA-2353 is a first-in-class small molecule that selectively activates endogenous retinal stem and progenitor cells, which differentiate into photoreceptors and can potentially preserve and restore visual function. This gene-independent treatment approach has significant advantages in RP, which has multiple genetic causes. EA-2353 was granted Orphan Drug Designation by the US FDA in May 2021, and Fast Track Designation in February 2023. See our YouTube channel for a video explaining how EA-2353 works. For more information on the clinical trials, please visit www.clinicaltrials.gov (Reference: NCT05392751) About retinitis pigmentosa (RP) RP is a serious and debilitating condition. It consists of a group of inherited diseases causing slow and progressive retinal degeneration and loss of vision, for which there is currently no treatment for most patients. It is a leading cause of inherited blindness, with an estimated 1.5 million people worldwide presently affected. About Endogena Endogena Therapeutics Inc. is a clinical-stage biotech company that discovers and develops first-in-class endogenous regenerative medicines to repair and regenerate tissues and organs. Its approach has the potential to change the way degenerative conditions related to aging and genetic disorders are treated. The concept is based on the selective regulation of endogenous adult stem- and progenitor-cells for controlled tissue repair by small molecules. Endogena’s most advanced programs target degenerative diseases of the eye, including retinitis pigmentosa and geographic atrophy (secondary to age-related macular degeneration). Endogena is registered in San Francisco, USA, with a head office in Zürich, Switzerland, and a research facility at JLABS in Toronto, Canada. See our YouTube channel for a video explaining how endogenous regenerative medicine works. For more information, please visit www.endogena.com Follow us on LinkedIn For media enquiries, please contact: Free Range Communications – peter.sandbach@freerangecommunications.com +41 79 500 9824 Charles Consultants – sue@charles-consultants.com+44 7968 726585 Investor Contact: info@endogena.com

KYIV, Ukraine--(BUSINESS WIRE)-- Enamine Ltd., a provider of drug discovery services empowered with the world’s largest collections of building blocks, fragments, and screening compounds, gave an update of its long-standing research collaboration with Endogena Therapeutics AG, a clinical-stage biotech company focused on the development of endogenous regenerative medicines. This press release features multimedia. View the full release here: Enamine provides Endogena with its integrated capability in medicinal chemistry to support Endogena’s small molecule drug discovery programs in the fields of hit finding, hit-to-lead and lead optimization. The companies have been collaborating under a Full Time Equivalent (FTE) model since 2019. The two discovery partners have been continuing their research collaboration to date, their research relationship not being impacted by the war in Ukraine. This collaboration extension, along with many others and new ones established by Enamine since February 24, 2022, already under the conflict, is a systematic positive trend experienced by the company, that demonstrates the support of its customers and the trust they have in receiving high-quality service backed up by the unparalleled number of diverse building blocks available at Enamine. Sven Weiler, Vice President of Medicinal Chemistry at Endogena, commented: “The interaction with colleagues from Enamine has been a smooth one from the start. In addition to the FTE model, it is great to have access to their huge compound collection and be able to flexibly use Enamine’s capacity to its full potential. We value the output and responsiveness of the Enamine team, helping us to achieve our demanding milestones. It is stunning to see how well Enamine has been able to keep pace after February 2022.” Michael Bossert, Head of Strategic Alliances at Enamine, added: “After 13 months of the war in the country, we are especially pleased to announce our collaboration with Endogena, a long-lasting partner we have been serving during those several years with extensive medicinal chemistry and SAR efforts”. About Enamine Ltd. Established in Kyiv in 1991, Enamine is a leading global designer and largest producer of building blocks (285,000+), fragments (172,000+) and screening libraries (3M+ compounds). Enamine provides expertise in advanced organic synthesis, library synthesis, and medicinal chemistry. In 2011 Enamine established a pre-clinical service unit including ADME, in-vivo PK studies and High Throughput Screening under the brand name “Bienta”, allowing the company to tackle since that time fully integrated or à-la-carte research programs. About Endogena AG Endogena Therapeutics Inc. is a clinical-stage biotech company that discovers and develops first-in-class endogenous regenerative medicines to repair and regenerate tissues and organs. Its approach has the potential to change the way degenerative conditions related to aging and genetic disorders are treated. The concept is based on selective regulation of endogenous adult stem- and progenitor cells for controlled tissue repair by small molecules. Endogena’s most advanced programs target degenerative diseases of the eye, including retinitis pigmentosa and geographic atrophy secondary to AMD. Endogena is registered in San Francisco, USA, with a Head office in Zürich, Switzerland, and holds a research facility at JLABS in Toronto, Canada. View source version on businesswire.com: Contacts Enamine Ltd. Michael Bossert m.bossert@enamine.net Endogena Therapeutics info@endogena.com Source: Enamine Ltd. and Endogena Therapeutics AG View this news release online at:

SAN FRANCISCO and TORONTO and ZÜRICH, Switzerland, April 05, 2023 (GLOBE NEWSWIRE) -- Endogena Therapeutics Inc., a clinical-stage biotech company focused on the development of endogenous regenerative medicines, announced today that the dose-escalation stage of its phase 1/2a study of EA-2353 in retinitis pigmentosa (RP) has been successfully completed. No clinically relevant or dose-limiting adverse events were identified after repeated intravitreal injections. Given the positive safety and tolerability profile, the study will now enroll patients into the expansion cohort, using the highest dose evaluated in the study to explore the potential efficacy of the compound. The phase 1/2a study is conducted in collaboration with Endogena’s Lead Investigator, Mark Pennesi, MD, Ph.D., Professor of Ophthalmology at the Casey Eye Institute in Oregon, USA, to examine the safety, tolerability and preliminary efficacy of EA-2353 administered by intravitreal injection in patients with RP (ClinicalTrials.gov identifier: NCT05392751). A total of 14 patients with RP due to any pathologic genetic mutation are being recruited across up to six sites in the USA. The first patient was dosed in July 2022 and 9 patients have been treated to date during the dose escalation phase.EA-2353 takes a novel, small-molecule approach and selectively activates endogenous retinal stem and progenitor cells, which differentiate into photoreceptors and can potentially preserve or restore visual function. This gene-independent treatment approach has significant advantages in RP, which has multiple genetic causes. EA-2353 was granted Orphan Drug Designation by the US FDA in May 2021, and Fast Track Designation in February 2023.RP is a serious and debilitating condition. It consists of a group of inherited diseases causing slow and progressive retinal degeneration and loss of vision, for which there is currently no treatment for most patients. It is a leading cause of inherited blindness, with an estimated 1.5 million people worldwide presently affected.Matthias Steger, Ph.D., MBA, CEO of Endogena, said: “We are edging closer to a treatment for this devastating condition, and I’m very encouraged by the safety and tolerability profile in this dose escalation stage. We have the best people working tirelessly to bring this novel treatment to the patients who need it as fast as possible.”Endogena’s artificial intelligence-driven drug discovery platform, combined with cutting-edge knowledge of molecular pathways that regulate retinal stem cells and retinal pigment epithelial cells, provides a potential new treatment paradigm to tackle degenerative conditions related to aging and genetic disorders. Beyond EA-2353, other products in Endogena’s pipeline include treatment for dry age-related macular degeneration (AMD), which is approaching IND-enabling studies, and earlier programs in idiopathic pulmonary fibrosis (IPF) and hematopoietic recovery. About Endogena Endogena Therapeutics Inc. is a clinical-stage biotech company that discovers and develops first-in-class endogenous regenerative medicines to repair and regenerate tissues and organs. Its approach has the potential to change the way degenerative conditions related to aging and genetic disorders are treated. The concept is based on the selective regulation of endogenous adult stem- and progenitor cells for controlled tissue repair by small molecules. Endogena’s most advanced programs target degenerative diseases of the eye, including retinitis pigmentosa and geographic atrophy (secondary to AMD). Endogena is registered in San Francisco, USA, with a head office in Zürich, Switzerland, and a research facility at JLABS in Toronto, Canada. For more information, please visit www.endogena.com Follow us on LinkedIn See our YouTube channel for a video explaining how EA-2353 works. For more information on the clinical trials, please visit www.clinicaltrials.gov (Reference: NCT05392751). For media enquiries, please contact: Free Range Communications – peter.sandbach@freerangecommunications.com +41 79 500 9824 Charles Consultants – sue@charles-consultants.com+44 7968 726585