Press Release

Diffusion Pharmaceuticals Regains Compliance with Nasdaq Capital Market Minimum Equity Rule

Company Release - 11/20/2017 8:00 AM ET

CHARLOTTESVILLE, Va., Nov. 20, 2017 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (Nasdaq:DFFN) (“Diffusion” or “the Company”), is a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients using the novel small molecule trans sodium crocetinate (TSC) in conjunction with standard radiation and chemotherapy. The Company today announced that it has received notice from Nasdaq stating that the Company complies with the Nasdaq Capital Market Listing Rules requiring minimum stockholders’ equity of $2.5 million.  Based on stockholders’ equity of $6.4 million listed in Diffusion Pharmaceuticals’ September 30, 2017 Form 10-Q, Nasdaq Staff has determined that the Company complies with the Rule and the matter is closed.  Additionally, as a result of the previously announced charter amendment allowing the common stock purchase warrants issued with the Series A Convertible Preferred Stock to be classified, for accounting purposes, as permanent equity rather than as a liability, the Company should not be subject to potential further warrant liabilities and non-cash charges that could affect stockholders’ equity.

David Kalergis, Chairman and Chief Executive Officer of Diffusion Pharmaceuticals, stated, “We are pleased to put this issue behind us.  This development permits additional financial flexibility as we advance our programs, particularly as we gear up to begin enrollment in our Phase 3 study in non-operable glioblastoma multiforme with TSC before the end of the year.”

About Diffusion Pharmaceuticals Inc.

Diffusion Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients by improving the effectiveness of current standard-of-care treatments including radiation therapy and chemotherapy. Diffusion is developing its lead product candidate, trans sodium crocetinate, for use in the many cancers where tumor hypoxia (oxygen deprivation) is known to diminish the effectiveness of SOC treatments. TSC targets the cancer's hypoxic micro-environment, re-oxygenating treatment-resistant tissue and making the cancer cells more vulnerable to the therapeutic effects of SOC treatments without the apparent occurrence of any serious side effects.

A Phase 2 clinical program was completed in the second quarter of 2015 and evaluated 59 patients with newly diagnosed glioblastoma multiforme, a type of brain cancer. This open-label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC combined with SOC, including a 37% improvement in overall survival compared with the control group at two years.  A particularly strong efficacy signal was seen in the subset of inoperable patients where survival of TSC-treated patients at two years was nearly four-fold higher compared with the controls. Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in preclinical and clinical studies.  Diffusion believes the therapeutic potential of TSC is not limited to specific tumors, thereby making it potentially useful to improve SOC treatments of other life-threatening cancers.  Additional studies under consideration include Phase 2 trials in pancreatic cancer and brain metastases, with study initiation subject to receipt of additional funding or collaborative partnering. The Company also believes that TSC has potential application in other indications involving hypoxia, such as stroke, neurodegenerative diseases and emergency medicine, and is considering ways to further investigate these areas.

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 protocol review, satisfying Nasdaq continued listing standards 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; Nasdaq’s acceptance of the warrant reclassification to enable satisfaction of its continued listing standards; the company's need for and ability to obtain additional financing; and 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.

Contacts:
David Kalergis, CEO
Diffusion Pharmaceuticals Inc.
(434) 220-0718
dkalergis@diffusionpharma.com
or
LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com

Source: Diffusion Pharmaceuticals Inc.