CervoMed Inc., a clinical-stage company formed through a merger with EIP Pharma, is focused on advancing the oral stress kinase inhibitor neflamapimod for treating dementia with Lewy bodies and brain degenerative diseases. The merger resulted in shares trading under “CRVO” on Nasdaq. CervoMed is well-funded through Phase 2b clinical data expected in H2 2024. The CEO, John Alam, emphasized neflamapimod’s potential to address cognitive and motor decline. Anticipated milestones include Phase 2b study data reporting, enrollment completion, and presentation at CTAD conference. The 16-week, double-blind study is funded by a $21 million NIA grant.
CervoMed will be focused on advancing oral stress kinase inhibitor neflamapimod for the treatment of dementia with Lewy bodies and other degenerative diseases of the brain
CervoMed has a cash runway through Phase 2b clinical data which is expected during 2H 2024
BOSTON, Aug. 16, 2023 /PRNewswire/ — CervoMed Inc. (formerly known as Diffusion Pharmaceuticals Inc.) (NASDAQ: CRVO), now a clinical-stage company focused on developing treatments for degenerative diseases of the brain, today announced the closing of its previously announced merger with EIP Pharma Inc. The combined company will operate under the name CervoMed Inc., and its shares will commence trading on a 1-for-1.5 reverse split adjusted basis on August 17, 2023, on the Nasdaq Capital Market under the ticker symbol “CRVO”. CervoMed’s focus will be on advancing its lead drug candidate neflamapimod, an oral stress kinase inhibitor, which is currently being developed for the treatment of dementia with Lewy bodies (DLB) and other degenerative diseases of the brain.
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“This merger with Diffusion, launch of CervoMed and entry into the public market is a transformative event that will accelerate the advancement of neflamapimod, first, and over the coming year, for the treatment of DLB, and later in Alzheimer’s disease and stroke recovery,” said John Alam, MD, Chief Executive Officer of CervoMed. “We are excited about the potential for neflamapimod to be the first-to-market disease-modifying drug therapy for DLB, with the potential to reverse and slow the progression of synaptic dysfunction that contributes to the typical cognitive and motor function decline associated with this devastating disease. Now that our Phase 2b DLB study, named RewinD-LB is underway, we anticipate completing enrollment during the first half of next year and reporting data from the placebo-controlled portion of the study during the second half of next year. We are well-funded through these catalysts and believe we are well-positioned to achieve our goal of creating new medicines for the brain.”
“I am pleased by the close of this merger and the value I believe it will bring to Diffusion shareholders thanks to CervoMed’s encouraging CNS pipeline. I would particularly like to thank our executive team and board of directors for their significant efforts throughout the process leading to the closing of this merger,” said Robert J. Cobuzzi, Jr., Ph.D., former Chief Executive Officer of Diffusion Pharmaceuticals and Chief Operating Officer of CervoMed. “I look forward to the opportunity to serve CervoMed in my new role as COO, contributing to the Company’s efforts in our mission of bringing new medicines to patients living with degenerative diseases of the brain.”
Upcoming Anticipated Catalysts/Milestones
The Company has several anticipated catalysts and development milestones for neflamapimod through the end of 2024, including:
Publication of additional results from the Phase 2a clinical study in DLB in a peer-reviewed medical journal in the second half of 2023
Oral presentation of the RewinD-LB Phase 2b clinical study design at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in October 2023
Completion of enrollment into the RewinD-LB Phase 2b clinical study in DLB in the first half of 2024
Reporting of data from placebo-controlled portion of RewinD-LB during the second half of 2024
As announced on August 14, 2023, by EIP Pharma, following first-patient dosing, the RewinD-LB study is a randomized, 16-week double-blind, placebo-controlled phase 2b clinical trial of oral 40mg neflamapimod, three-times-per-day, in 160 patients with prodromal DLB or mild dementia due to DLB. Patients with Alzheimer’s disease-related co-pathology, assessed by a blood biomarker, will be excluded. All patients completing the placebo-controlled main study will receive an additional 32 weeks of neflamapimod on an open-label basis.
EIP Pharma was previously awarded a $21 million grant from the National Institutes of Health’s National Institute on Aging (NIA) which will fully fund development costs associated with the ongoing Phase 2b DLB study. The NIA grant funds will be disbursed over the course of the study as costs are incurred.
Transaction Details
In connection with the closing of the merger, Diffusion Pharmaceuticals enacted a 1-for-1.5 reverse stock split of its common stock. Following the reverse stock split and closing of the merger, there will be approximately 5.7 million shares of the combined company’s common stock outstanding, with prior EIP Pharma shareholders owning approximately 77.95% and prior Diffusion Pharmaceuticals shareholders owning 22.05%. CervoMed, Inc. will trade on the Nasdaq Capital Market under a new ticker symbol, “CRVO”.
The management team of EIP Pharma has become the management team of the CervoMed, led by John Alam, MD, as Chief Executive Officer and President. In addition, Robert J. Cobuzzi, Jr., PhD, the former Chief Executive Officer of Diffusion Pharmaceuticals, will serve as the Chief Operating Officer of CervoMed. The board of directors is comprised of seven directors including Dr. Alam, Sylvie Grégoire, PharmD, who will serve as Chair, Jeff Poulton, Chief Financial Officer at Alnylam, who will serve chair of the audit committee, and Diffusion Pharmaceuticals’ former Chair of the board of directors, Jane Hollingsworth, JD.
EIP Pharma Inc. is now a wholly owned subsidiary of CervoMed.
Canaccord Genuity served as financial advisor and Dechert LLP provided legal counsel to Diffusion Pharmaceuticals. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. provided legal counsel to EIP Pharma.
Source: BioSpace