05/10/2021 | Press release | Distributed by Public on 05/10/2021 05:06
CHARLOTTESVILLE, Va., May 10, 2021 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ('Diffusion' or the 'Company'), an innovative biopharmaceutical company developing novel therapies that enhance the body's ability to deliver oxygen to areas where it is needed most, today announced financial results for the first quarter of 2021 and provided a business update.
During the first quarter, Diffusion continued to focus on progressing the development of its novel oxygen enhancing therapeutic, trans sodium crocetinate (TSC). The company's balance sheet also was fortified through a $34.5 million equity raise.
1Q21 Business and Operational Highlights
1Q21 Financial Results
'We met the key milestones we set for ourselves for the first quarter of 2021, including completing and announcing topline safety and tolerability results for the COVID-19 Trial, completing enrollment and treatment of the subjects in the first of the Oxygenation Trials, the TCOM study, and execution of a significant capital raise that we believe will enable us to obtain the data required to demonstrate the clinical value of TSC. For the remainder of 2021, we are focused on the design and execution of the remaining two Oxygenation Trials, which are the foundation of our redefined TSC development strategy announced in November of 2020,' said Robert Cobuzzi, Jr., Ph.D., President and CEO of Diffusion.
Near-term Clinical Strategy
Data from the TCOM Trial is anticipated to be available later in the second quarter of 2021 and will be used to guide dose selection for the two additional Oxygenation Trials the Company plans to initiate and complete in the second half of 2021, both of which will be funded with cash-on-hand.
Diffusion anticipates topline results from each study will be available within two months of their respective completion. The Company believes positive data from any one or more of the three Oxygenation Trials, if obtained, would provide evidence of a definitive effect of TSC on oxygenation. If such positive data are obtained, the Company expects to announce in the fourth quarter of 2021 up to two hypoxia-related indications in which TSC would be studied as part of its clinical development strategy aimed at supporting regulatory approval and commercialization. Diffusion intends to initiate clinical studies in the identified indications during the first quarter of 2022.
About Diffusion Pharmaceuticals Inc.
Diffusion Pharmaceuticals Inc. is an innovative 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. In addition to TSC, Diffusion's product candidate DFN-529, a novel, allosteric PI3K/Akt/mTOR Pathway inhibitor, is in early-stage development. 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 anticipated cash runway, its near-term strategic priorities, and anticipated timelines for the initiation, completion, and announcement of data from the Company's ongoing and planned Oxygenation Trials. 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 ongoing and planned studies evaluating TSC; 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
Investors:
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA/Miriam Weber Miller
(212) 375-2664 / (212) 375-2694
[email protected] / [email protected]
Media:
Kate Barrette
RooneyPartners
(212) 223-0561
[email protected]