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Diffusion Pharmaceuticals Inc. (DFFN) is a clinical-stage biopharmaceutical company dedicated to enhancing the efficacy of standard-of-care therapies for life-threatening, treatment-resistant solid cancerous tumors. The company's flagship product, Trans Sodium Crocetinate (TSC), focuses on re-oxygenating the hypoxic (oxygen-deprived) microenvironment of tumors, thereby improving the effectiveness of conventional treatments like radiation and chemotherapy.
TSC has earned the Orphan Drug Designation from the FDA for its application in several cancers where tumor hypoxia undermines current therapeutic strategies. This innovative drug targets the hypoxic areas within tumors, making the cancer cells more susceptible to established treatments without adding harmful side effects.
Diffusion Pharmaceuticals is preparing to embark on a pivotal Phase 3 trial in glioblastoma (GBM), a particularly aggressive form of brain cancer, by 2016. Additionally, the company has plans for Phase 2/3 trials in pancreatic cancer and brain metastases, reflecting the broad applicability of TSC's unique mechanism of action across various tumor types.
Financially, Diffusion Pharmaceuticals is strategically positioning itself with strong partnerships and an innovative pipeline, aiming to make significant strides in cancer treatment. The company's ongoing projects and achievements underscore its commitment to revolutionizing oncological care by leveraging TSC's potential to safely and effectively re-oxygenate diverse tumor tissues.
Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) has announced topline data from a Phase 1b trial studying its therapy, trans sodium crocetinate (TSC), in COVID-19 patients with hypoxemia. The trial found no dose-limiting toxicities or serious adverse events across cohorts receiving doses from 0.25 to 1.5 mg/kg. The study assessed TSC's safety and tolerability with ongoing evaluation of secondary endpoints, including improvements in blood oxygen levels. Future studies are planned to further explore TSC's efficacy in enhancing oxygen delivery and transfer.
Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) announced an increased public offering of 29,268,294 shares at $1.025 each, raising approximately $30 million. The underwriter, H.C. Wainwright & Co., has a 30-day option for an additional 4,390,244 shares. Proceeds will fund research for its lead candidate, TSC, and other clinical trials. The offering is part of a 'shelf' registration statement effective since October 2020, with shares available via a prospectus. Closing is expected around February 17, 2021, pending customary conditions.
Diffusion Pharmaceuticals (NASDAQ: DFFN) has secured an underwriting agreement with H.C. Wainwright & Co. for the purchase of 9,756,098 shares at $1.025 each, aiming to raise approximately $10 million. The offering is anticipated to close around February 17, 2021, pending customary conditions. Additionally, the underwriter possesses a 30-day option to acquire 1,463,414 extra shares at the public price. The proceeds will fund research and development for the company’s lead product candidate, TSC, and support general corporate initiatives.
Diffusion Pharmaceuticals (Nasdaq: DFFN) announced its participation in the H.C. Wainwright BioConnect 2021 Conference from January 11-14, 2021. During this event, the company will provide insights into its innovative therapies aimed at enhancing oxygen delivery to tissues. Participants can access recorded presentations and presentation materials on the investor relations section of the company's website. Diffusion’s lead product, trans sodium crocetinate, addresses hypoxia in various medical conditions, while its other candidate, DFN-529, is a novel inhibitor in early-stage development.
Diffusion Pharmaceuticals (DFFN) announced its Q3 2020 results, ending with $21.9 million in cash. The company is advancing its lead product candidate, trans sodium crocetinate (TSC), for COVID-19 patients, having initiated a Phase 1b clinical trial. The trial aims to evaluate TSC's safety and tolerability with a dosing regimen of every six hours for up to 15 days. R&D expenses rose to $3.1 million due to COVID-19 trial initiation, while G&A expenses increased to $2.1 million. The company expects topline data from the trial by the end of Q1 2021.
Diffusion Pharmaceuticals Inc. (DFFN) has appointed Dr. Christopher D. Galloway as Chief Medical Officer, effective immediately. Dr. Galloway, with over 20 years in clinical development, will lead ongoing clinical trials for Trans Sodium Crocetinate (TSC) in COVID-19 patients and expand its use in other hypoxia-related conditions. The company has also approved stock options for Dr. Galloway as part of his inducement grant. TSC aims to enhance oxygen delivery in medical conditions where oxygen deficiency is critical, including COVID-19 and glioblastoma.
Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) announced the appointment of William Elder, J.D., as general counsel and corporate secretary, effective immediately. Elder's extensive background includes roles as CEO of a fantasy sports company and corporate associate at Dechert LLP, focusing on securities laws and corporate governance. He expressed optimism about Diffusion's lead product candidate, trans sodium crocetinate (TSC), particularly its potential in treating hypoxia related to COVID-19. The Board approved a grant of stock options to Elder totaling 70,000 shares at an exercise price of $0.82.
Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) has appointed Dr. Robert J. Cobuzzi Jr. as President and CEO, effective immediately. He succeeds David G. Kalergis, who remains as Chairman. Dr. Cobuzzi brings over 25 years of pharmaceutical experience, previously holding senior roles at Endo International. The company focuses on developing trans sodium crocetinate (TSC) for life-threatening conditions related to oxygen delivery. Kalergis praised Cobuzzi's expertise in driving product development, while Cobuzzi expressed excitement in leading Diffusion's growth and addressing unmet medical needs.
Diffusion Pharmaceuticals (Nasdaq: DFFN) announced the appointment of Jane H. Hollingsworth to its board of directors, expanding the board to seven. She brings over 25 years of leadership experience in life sciences, co-founding Militia Hill Ventures and serving in executive roles at several biopharmaceutical companies. Additionally, the company received full regulatory approval from Romania to enroll patients in a 24-participant clinical trial for COVID-19 treatment, highlighting its ongoing commitment to addressing critical health issues.
Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) announced on June 1, 2020, that it has regained compliance with the Nasdaq minimum bid price requirement. The company received notice from Nasdaq stating that it maintained a closing bid price above $1.00 for ten consecutive trading days, achieving a closing bid price of $1.27 on May 28, 2020. Although the company is still considering a reverse stock split, it does not anticipate implementing it at this time unless there's a significant change in the market price.
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