Diffusion Pharmaceuticals Inc. - DFFN STOCK NEWS

EIP Pharma and Diffusion Pharmaceuticals (DFFN) have announced a definitive merger agreement to form a publicly traded company focused on late-stage clinical development of neflamapimod for treating dementia with Lewy bodies. This all-stock transaction has the unanimous support of both boards and is expected to close in mid-2023. EIP Pharma will initiate a Phase 2b study in 2Q 2023, partially funded by a $21 million grant from the National Institute on Aging. After the merger, EIP Pharma’s stakeholders will own approximately 77.25% of the combined company, which will be renamed CervoMed and trade under the new ticker CRVO.

Diffusion Pharmaceuticals (NASDAQ: DFFN) has announced an agreement with LifeSci Special Opportunities, which owns approximately 4.8% of its shares. Under this agreement, LifeSci will withdraw its director nominations and support Diffusion’s nominees for the upcoming Annual Meeting. If a strategic transaction is not finalized by July 1, 2023, Diffusion will appoint a director from LifeSci's recommendations. This settlement allows Diffusion to focus on its strategic review process to enhance stockholder value.

Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) has notified stockholders about its ongoing strategic review process aimed at maximizing shareholder value. The company received bids from over 15 interested parties. Meanwhile, LifeSci Capital has mounted a proxy contest for board control, which Diffusion’s board regards as self-serving and potentially harmful to shareholders. LifeSci’s past performance in SPAC transactions has led to significant losses, totaling over $1.3 billion. Diffusion encourages stockholders to support its board nominees at the upcoming Annual Meeting on December 30, 2022.

Diffusion Pharmaceuticals (NASDAQ: DFFN) reported its financial results for Q3 2022, ending with $25.9 million in cash and equivalents, sufficient to fund operations into Q1 2024. The company is evaluating strategic opportunities to enhance shareholder value, including potential transactions involving its key asset, trans sodium crocetinate (TSC). A Phase 2 trial for glioblastoma treatment is planned, aligning with FDA guidance, focusing on safety and efficacy with initial data expected within a year.

Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) is engaged in an active strategic review process to enhance stockholder value, including potential sale or merger opportunities. The Board rejected an unsolicited offer deemed inadequate from a LifeSci Capital affiliate. LifeSci has initiated a proxy contest, aiming to replace existing Board members, which Diffusion's Board believes could undermine their strategic review efforts. The 2022 Annual Meeting of Stockholders is set for December 30, 2022, allowing for more time to address these matters.

Diffusion Pharmaceuticals (NASDAQ: DFFN) has initiated a comprehensive review of strategic opportunities aimed at enhancing shareholder value. This includes potential transactions to optimize the use of its lead product, trans sodium crocetinate (TSC). The Board has expanded its evaluation to include options like joint ventures, licensing, or divesting proprietary technologies. Financial advisor Canaccord Genuity LLC and legal counsel Dechert LLP have been retained to assist in this process. While TSC shows promising effects on oxygenation in clinical trials, there is no set timeline for this review or guarantee of any transactions.

Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) reported significant progress in its clinical trials and financial standing as of June 30, 2022. The company aligned with the FDA on the design of a Phase 2 GBM trial for its lead product candidate, trans sodium crocetinate (TSC), set to begin by 2022's end. Positive results from the Altitude Trial highlight TSC's potential in enhancing oxygen availability. Ending the quarter with $28.5 million in cash, Diffusion anticipates a sustainable cash runway into Q1 2024, supporting ongoing operational needs.

Diffusion Pharmaceuticals announced FDA alignment on a Phase 2 trial for trans sodium crocetinate (TSC) in newly diagnosed glioblastoma multiforme (GBM) patients. The study, expected to begin by the end of 2022, will evaluate TSC's impact on tumor oxygenation using advanced PET imaging techniques. GBM, affecting around 13,000 patients annually in the U.S., has limited effective treatments. This trial aims to assess TSC's safety and efficacy alongside standard care, with initial results expected within a year.

Diffusion Pharmaceuticals (NASDAQ:DFFN) announced positive findings from its Altitude Trial, evaluating the oxygen-enhancing effects of TSC. At a 2.5 mg/kg dose, significant improvements in pH and lactate levels were recorded, suggesting enhanced metabolic recovery post-exercise under hypoxic conditions. All subjects tolerated TSC well, with no serious adverse events reported. The promising results support further development of TSC to treat hypoxic conditions, particularly in solid tumors. The company plans to initiate a Phase 2 Hypoxic Tumor Trial in late 2022.