CHARLOTTESVILLE, Va., Jan. 03, 2019 (GLOBE NEWSWIRE) — Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it’s needed most, today announced it received notice from NASDAQ staff that the Company has regained compliance with Listing Rule 5550(a)(2) and will remain listed on the NASDAQ stock market. The news came as a result of the closing bid price of Diffusion’s stock remaining above $1.00 per share between December 14 and December 28, 2018.
This latest news follows a number of exciting recent developments, including FDA approval of a Phase 2 on-ambulance clinical trial for the treatment of stroke using the Company’s lead drug, Trans Sodium Crocetinate (TSC) and the U.S. Patent Office awarding the Company a patent for the use of TSC in conjunction with Tissue Plasminogen Activator (tPA), which remains the only FDA-approved therapeutic stroke treatment.
“We believe remaining on the NASDAQ Capital Market will play a critical role in delivering results to investors while allowing our Company to continue to pursue the scientific progress needed to fight some of medicine’s most significant and deadly challenges,” said David Kalergis, Chairman and CEO of Diffusion. “As we look to the new year, we are excited by the opportunity to build on our recent success and bring real 21st Century advancements to problems that have remained unsolved by generations of medical professionals, and which continue to impact patients and their families.”
Over the past quarter, Diffusion has also appointed a new Chief Financial Officer, executed a reverse stock split of its shares of common stock at a ratio of 1-for-15 as part of their NASDAQ Compliance Plan, and sent executive leadership to present at internationally-recognized events such as the BIO Investor Forum and the Annual Meeting for the Society of NeuroOncology.
About Diffusion Pharmaceuticals Inc.
Diffusion Pharmaceuticals Inc. is an innovative biotechnology company developing new treatments that improve the body’s ability to bring oxygen to the areas where it’s needed most —offering new hope for the treatment of life-threatening medical conditions.
Diffusion’s lead drug, Trans Sodium Crocetinate (TSC), was originally developed in conjunction with the Office of Naval Research, which was seeking a way to treat hemorrhagic shock caused by massive blood loss on the battlefield.
Evolutions in research have led to Diffusion’s focus today: Fueling Life by taking on some of medicine’s most intractable and difficult-to-treat diseases, including stroke and GBM brain cancer. In each of these diseases, hypoxia – when essential tissue in your body is deprived of oxygen – has proved to be a significant obstacle for medical providers and the target for TSC’s novel mechanism.
In 2018, the Company began enrolling patients in its Phase 3 INTACT program, using TSC to target inoperable GBM brain cancer. Its on-ambulance Phase 2 acute stroke protocol was granted FDA clearance to proceed in September 2018. Additional pre-clinical data supports the potential use of TSC as a treatment for other conditions where hypoxia plays a major role, such as myocardial infarction, respiratory diseases such as COPD, peripheral artery disease, and neurodegenerative conditions such as Alzheimer’s and Parkinson’s.
In addition, RES-529, the Company’s PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes, is in the preclinical testing phase for GBM.
Diffusion is headquartered in Charlottesville, Virginia—an emerging hub of advancement in the life science and biopharmaceutical industries and is led by CEO David Kalergis, a 30-year industry veteran and company co-founder.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the company’s plans, objectives, expectations and intentions with respect to future operations and products, the potential of the company’s technology and product candidates, the anticipated timing of future clinical trials, and other statements that are not historical in nature, particularly those that utilize terminology such as “would,” “will,” “plans,” “possibility,” “potential,” “future,” “expects,” “anticipates,” “believes,” “intends,” “continue,” “expects,” other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause the company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include: general business and economic conditions; the company’s need for and ability to obtain additional financing or partnering arrangement; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; and the various risk factors (many of which are beyond Diffusion’s control) as described under the heading “Risk Factors” in Diffusion’s filings with the United States Securities and Exchange Commission. All forward-looking statements in this news release speak only as of the date of this news release and are based on management’s current beliefs and expectations. Diffusion undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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