Diffusion Pharmaceuticals Announces Issuance of U.S. Patent 11,185,523

Claims Related to Use of TSC with Radiotherapy and Chemotherapy for Treatment of Cancer

CHARLOTTESVILLE, Va., Dec. 01, 2021 (GLOBE NEWSWIRE) -- *Diffusion Pharmaceuticals Inc**. (NASDAQ: DFFN)* (“Diffusion” or the “Company”), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, today announced that it has been granted United States Patent No. 11,185,523, “Use of Bipolar Trans Carotenoids With Chemotherapy and Radiotherapy for Treatment of Cancer,” by the United States Patent and Trademark Office. This patent includes new claims related to methods of treating cancerous tumors by administering the Company’s lead product candidate, trans sodium crocetinate (“TSC”), in combination with radiation therapy and chemotherapy."We believe the issuance of this patent represents another important step in our development of TSC and provides us with additional intellectual property protection to support the design and execution of our recently announced clinical program to support the use of intravenously administered TSC as a treatment for hypoxic solid tumors," said Robert J. Cobuzzi, Jr., Ph.D., President and Chief Executive Office of Diffusion.

*About Diffusion Pharmaceuticals Inc.*

Diffusion Pharmaceuticals Inc. is a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most. Diffusion’s lead product candidate, TSC, is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions, including hypoxic solid tumors. In November 2021, based on the preclinical and clinical data accumulated to date and the significant unmet medical need, Diffusion announced that its near-term focus will be the design and execution of a clinical program to support the use of intravenously administered TSC as a treatment for hypoxic solid tumors. For more information, please visit us at www.diffusionpharma.com.

*Forward-Looking Statements *

This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s near-term strategic priorities and the potential therapeutic value of TSC. The Company may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although the Company believes that it has a reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, the Company’s actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risk and uncertainties include, among other things, those related to: the Company’s ability to design, initiate, enroll, execute, and complete its planned studies evaluating TSC; the likelihood and timing of regulatory approval of TSC, if any, for the treatment of solid tumors complicated by hypoxia or any other indication, or the nature of any feedback the Company may receive from the U.S. Food and Drug Administration or other regulatory bodies; the impact of supply chain and other supplier issues on the Company’s clinical development program and associated timelines; the Company’s ability to protect and expand its intellectual property portfolio; the Company’s ability to maintain compliance with the continued listing standards of Nasdaq; general economic, political, business, industry, and market conditions, including the ongoing COVID-19 pandemic; and the other factors discussed under the heading “Risk Factors” in the Company’s filings most recent Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified) and, except as required by applicable law, rule, or regulation, the Company undertakes no obligation to update any such statements after the date hereof.

*Contacts:*
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA/ Lisa Sher
mmcenroe@tiberend.com/ lsher@tiberend.com

*Media Contact:*
Kate Barrette
RooneyPartners
Kbarrette@rooneypartners.com