On May 9, 2024 Coya Therapeutics, Inc. (Nasdaq: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, reported a corporate update and announces its financial results for the quarter ended March 31, 2024 (Press release, Coya Therapeutics, MAY 9, 2024, View Source [SID1234643046]).

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Recent Corporate Highlights

Announced successful pre-IND and Type C meetings with FDA in January 2024 to advance the development of COYA 302 for the treatment of ALS; IND expected to be filed in 2Q24 followed by initiation of Ph. 2 trial with COYA 302 in ALS
Expanded pipeline of COYA 302 in January 2024 beyond ALS to also include Frontotemporal Dementia (FTD), with an IND planned in 2H24, and Parkinson’s disease (PD), with animal data to be released in 2H24
Expanded patent estate surrounding next-generation immune modulatory biologics in February 2024 through a license from the University of Nebraska Medical Center to cover multiple LD IL-2 combinations, including those with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Expanded pipeline of COYA 302 in February 2024 to include AD; COYA 302 to now be explored in four neurodegenerative diseases (ALS, PD, FTD, and AD) – Coya to leverage data from the Ph. 2 LD IL-2 study in AD to inform on strategy and next steps for COYA 302 in AD
Presented data in March 2024 on immune system and Regulatory T Cell (Treg) contribution in Frontotemporal Dementia (FTD) patients at the AD/PD 2024 Conference
Presented novel biomarker data in March 2024 documenting serum levels of a biomarker (4-HNE) that strongly correlate with rate of progression and survival in patients with ALS at the Society of Neuroimmune Pharmacology conference. Coya has filed intellectual property on multiple uses of 4-HNE in ALS
Presented updated biomarker data in late April 2024 at the 2nd Annual Johnson Center Symposium that showed 4-HNE levels were predictive of survival in ALS patients and are elevated at diagnosis in bulbar vs. limb onset ALS
"During the first quarter of 2024, we expanded our clinical pipeline with our lead asset COYA 302 beyond the initial indication of ALS and into FTD, Parkinson’s, and Alzheimer’s diseases," stated Howard Berman, Ph.D., Coya’s Chief Executive Officer. "Based on our work to date, we believe the dual mechanism of action from COYA 302, a combination of our proprietary low-dose IL-2 and CTLA4-Ig, holds immense potential in treating such neurodegenerative diseases that have complex immune pathways. The combination effect of restoring Tregs via low-dose IL-2 and inhibiting other inflammatory cell types via CTLA4-Ig could be a significant breakthrough therapeutic approach, much like the growing acceptance of combination therapy in treating cancer or viral diseases. Many patients, families, and caregivers are looking for meaningful new therapies for these neurodegenerative diseases.

"We expect to report clinical progress from a number of initiatives over the balance of 2024 with COYA 302, our ‘pipeline in a product.’ In ALS, our lead indication, we expect to file the IND for COYA 302 in 2Q24 and subsequently initiate the Ph. 2 trial. Over the last two months, we have presented encouraging data in patients with ALS that strongly correlates the biomarker 4-HNE with the rate of progression and survival in patients with ALS. We are in discussions with the FDA about the inclusion of 4-HNE in the expected Ph. 2 trial. Additionally, clinical data from the previously completed investigator-initiated trial in patients with ALS is also anticipated in the second quarter.

"In Alzheimer’s disease, data from the Ph. 2 investigator-initiated trial involving COYA 301, or low-dose IL-2 alone, is expected in the summer of 2024. Given our previously announced decision to move forward in Alzheimer’s with COYA 302, data from this trial will help guide us in the subsequent trial design of COYA 302 in AD. Obviously, Alzheimer’s disease is a huge unmet need, so we eagerly anticipate results from the Ph. 2 trial of COYA 301.

"In 2H24, we expect to file the IND in FTD and subsequently initiate a Ph. 2 trial thereafter. Data shared in March 2024 at the AD/PD 2024 Conference in Lisbon highlighted the reduction in Treg suppressive function and the simultaneous elevated inflammatory environment in patients with FTD. This data in FTD is consistent with Treg dysfunction and increased inflammatory levels in other progressive and neurodegenerative diseases and supports the multi-pathway combination approach of COYA 302.

"The potential therapeutic applications with COYA 302 in neurodegenerative diseases are vast. Dr. Reddy’s Laboratories was granted an exclusive license in December 2023 for COYA 302 in ALS patients in the U.S., Canada, the EU, and the U.K. We continue to have discussions about additional commercial partnerships and license opportunities for COYA 302 in other indications outside of ALS, including FTD, Parkinson’s and Alzheimer’s diseases. Our cash and cash equivalents balance of $36.0 million provides us a runway into 2026, so we can be patient with any future commercial negotiations in order to maximize shareholder value. I look forward to sharing additional corporate, clinical, and regulatory progress as warranted," concluded Berman.

Unaudited Financial Results

As of March 31, 2024, Coya had cash and cash equivalents of $36.0 million.

Research and development (R&D) expenses were $3.1 million for the three months ended March 31, 2024, compared to $1.2 million for the three months ended March 31, 2023. The change was primarily due to a $1.7 million increase in our preclinical expenses and a $0.2 million increase in internal research and development expenses.

General and administrative expenses were $2.4 million for the three months ended March 31, 2024 and $1.7 million for the three months ended March 31, 2023, a change of approximately $0.7 million. The increase was primarily due to an increase in personnel related expenses and consulting fees as we continue to expand our operations to support our research and development efforts.

Net loss was $5.1 million for the three months ended March 31, 2024, compared to net loss of $2.7 million for the three months ended March 31, 2023.