With FDA Alignment and a positive Phase 2 clinical trial for its Next Generation TKI, Ashvattha Therapeutics prepares for a Phase 2b/3 trial

Montgomery brings decades of experience in Life Sciences Corporate Development, M&A, and Capital Formation

Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company developing a nanomedicine therapeutic that traverses the blood-retinal barrier in areas of inflammation selectively targeting and reprogramming activated cells in the retina, today announced the appointment of George Montgomery as Executive Chairman, effective immediately. Mr. Montgomery brings over three decades of experience as an investor (private equity and venture capital), a start-up entrepreneur, CFO, board member and investment banker.

The appointment follows positive topline results from Ashvattha's 40-week Phase 2 clinical trial of migaldendranib, a subcutaneously administered tyrosine kinase inhibitor nanomedicine, in diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). The data demonstrated that migaldendranib was safe and well-tolerated with no treatment-related ocular or systemic serious adverse events. The study showed improvements in efficacy outcomes and a marked reduction in the need for supplemental intravitreal anti-VEGF injections, with an 83.4% (6-fold) reduction in nAMD patients and a 78.6% (4.7-fold) reduction in DME patients. Notably, migaldendranib demonstrated a bilateral treatment effect in both study and fellow eyes, supporting advancement into pivotal development.

Ashvattha has also received strong support from the FDA for its clinical development program for migaldendranib – endorsing its expedited roadmap to potential approval. Importantly, the FDA agreed with the company’s Phase 2b/3 protocol, including the 12 month primary efficacy endpoint and statistical analysis strategy, and has accepted Ashvattha’s plan to conduct two studies under the same protocol, streamlining the program. Based on this guidance, Ashvattha is preparing to launch its Phase 2b/3 global trial.

“After serving on the Ashvattha Board for the past several years, I look forward to taking a more active role in working with Jeff Cleland and the leadership team at Ashvattha at this exciting inflection point for the Company,” said George Montgomery, Executive Chairman. “I believe that we have developed an important, innovative product that can make a significant difference for patients affected by neovascular age-related macular degeneration (Wet AMD) and diabetic macular edema (DME).”

About George Montgomery

Mr. Montgomery currently serves as Chairman of Alira Health, CFO of NEUVOGEN, and a Senior Advisor and Member of the Health Care Advisory Committee of Symbiotic Capital. He also serves on the Board of the Jackson Laboratory and as a member of the Yale Cancer Center Advisory Board.

Over his career, he has worked on numerous M&A, partnering and licensing transactions in life sciences, and raised public and private equity and debt. Prior to his current roles, he was a partner at Gurnet Point Capital, a large global PE and VC fund, and was also partner at WestRiver Group, where he co-led the health care investment team. In banking, he was a managing director at JPMorgan H&Q and Cowen after starting his career at CSFB.

About Migaldendranib

Migaldendranib (MGB) is a novel first-in-class tyrosine kinase inhibitor nanomedicine in clinical development for the treatment of DME and nAMD. Administered subcutaneously, MGB has a differentiated mechanism of action that crosses the blood-retinal barrier in regions of inflammation and selectively normalizes VEGF expression in activated macrophages, microglia, and retinal pigment epithelial cells in the retina. Phase 2 clinical results demonstrate that subcutaneous MGB is safe and well-tolerated across multiple doses, with the potential for convenient once-monthly at-home administration that could significantly reduce intravitreal injection burden for patients, including those with bilateral disease.

About Ashvattha Therapeutics

Ashvattha Therapeutics is advancing a new class of clinical-stage nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells only in regions of inflammation. Our targeted nanomedicine approach seeks to redefine precision medicine, empowering a new standard of care in ophthalmology. Ashvattha Therapeutics was founded by Kannan Rangaramanujam, Sujatha Kannan, and Jeff Cleland and incubated by Natural Capital. For more information, visit: www.avttx.com.

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