Coya expands pipeline for COYA 302, adding Alzheimer’s Disease

Coya Therapeutics releases the following letter to stockholders from its Chief Executive Officer and Chairman, Dr. Howard Berman. Just over two months ago we announced our partnership with Dr. Reddy’s Laboratories for COYA 302 in Amyotrophic Lateral Sclerosis ALS , our lead product candidate in our lead indication. This pivotal collaboration is worth up to $733M plus low-to-mid teens product royalties to us. We have already received $7.5M as an upfront payment tranche from that transaction and expect to receive an additional $8.4M tranche in 2024 following the IND filing and first patient dosed in the Ph. 2 ALS trial. Our team continues to see strong value in COYA 302, as exhibited by our announcement in January 2024 that we were expanding the potential indications for that product candidate to include Frontotemporal Dementia FTD and Parkinson’s disease PD as additional indications. FTD and PD are two neurodegenerative diseases that share common inflammatory disease pathways with ALS, and we believe COYA 302 can target these multiple pathways by restoring dysfunctional regulatory T cells , reducing oxidative stress, and inhibiting toxic neuroinflammation. Today, we announce that we are further expanding the pipeline for COYA 302, adding Alzheimer’s disease AD to its growing list of indications expected to be validated in the clinic. We recognize the historical challenges faced by pharma companies looking to address the massive problem that AD is posing to patients, families, and the healthcare system. Yet, researchers have shown that ALS, FTD, PD, and AD share common features, including neuroinflammation and catastrophic neuronal loss that leads to cognitive or motor dysfunction through the complex interplay of the body’s immune system and dysfunctional anti-inflammatory Tregs. We believe the traditional “one disease – one target – one drug” approach might not be the most appropriate framework for neurodegenerative disorders, and may be partly responsible for the lack of available and truly effective treatments …With our current cash balance at the end of 2023, along with the initial $7.5M upfront payment received from Dr. Reddy’s in early January 2024, we believe we have at least a two-year cash runway to support our operations. We anticipate milestones in 2024 that could deliver additional shareholder value, including, but are not limited to, 1) the publication of additional data from the COYA 302 investigator initiated trial in ALS patients and biomarker data that is positively correlated to survival and rate of decline in ALS patients, 2) the filing of INDs for COYA 302 in ALS and FTD, and 3) topline data from the Ph. 2 investigator-initiated trial with COYA 301 in AD that we expect will support the development of COYA 302 in that same indication.