EIP Pharma Inc. (EIP Pharma), a privately held clinical-stage company focused on developing treatments for neurodegenerative diseases, and Diffusion Pharmaceuticals Inc. (Diffusion or Diffusion Pharmaceuticals) (NASDAQ: DFFN), today announced that the companies have entered into a definitive merger agreement for an all-stock transaction forming a publicly traded, combined company that will focus on the advancement of EIP Pharma’s pioneering pipeline of oral stress kinase inhibitors, including its lead drug candidate neflamapimod, which is currently being developed for the treatment of dementia with Lewy bodies (DLB).
“With this proposed merger, we are creating a leading company focused on developing treatments for neurodegenerative diseases, beginning first with neflamapimod for the treatment of dementia with Lewy bodies, the second most common type of dementia after Alzheimer’s disease, and for which there are currently no approved treatments,” said John Alam, MD, Chief Executive Officer of EIP Pharma. “We believe neflamapimod is poised to be the first to market disease-modifying drug therapy for DLB, with the potential to reverse and possibly slow the progression of synaptic dysfunction that contributes to the hallmark neurological decline associated with this devastating disease. The combined company will leverage an experienced drug development and leadership team, and we expect it to be well capitalized to advance neflamapimod through to Phase 2b clinical data.”
“This transaction is the result of a thorough strategic review process led by Diffusion’s board of directors and executive team initiated in 2022 to identify and negotiate the most compelling, value-enhancing transaction for Diffusion stockholders. From this, EIP Pharma’s clinical programs, management team and corporate strategy stood out amongst the many bids we received,” said Robert J. Cobuzzi, Jr., Ph.D., Chief Executive Officer of Diffusion Pharmaceuticals. “We believe this proposed merger is opportunistic and exciting for our shareholders, as EIP has built a robust pipeline of highly needed CNS therapeutic candidates, and we are highly confident in the capabilities of John and his team to support the leadership of the combined company. Taken together, we are thrilled at the prospect of combining our resources and expertise to join EIP’s unwavering commitment to treat patients with neurodegenerative diseases.”
Upcoming Anticipated Catalysts/Milestones
EIP Pharma has several anticipated catalysts and development milestones for neflamapimod through to the end of 2024, including:
- Presentation of Phase 2a clinical data in an oral presentation at the upcoming AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders, being held March 28 – April 1, 2023, in Gothenburg, Sweden.
- Initiate Phase 2b clinical study evaluating neflamapimod in patients with DLB during the second quarter of 2023.
- Closing of the merger with Diffusion in mid-2023.
- Publication of additional results from the Phase 2a clinical study in DLB in a peer-reviewed medical journal in the second half of 2023.
- Completion of enrollment into the Phase 2b clinical study in DLB in the first half of 2024.
- Reporting of data from placebo-controlled portion of the Phase 2b DLB study during the second half of 2024.
EIP Pharma was recently awarded a $21 million grant from the National Institutes of Health’s National Institute on Aging (NIA) that will fully fund development costs associated with the planned Phase 2b study. The NIA grant funds will be disbursed over the course of the study as costs are incurred.