We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Diffusion Pharmaceuticals Inc | NASDAQ:DFFN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 4.40 | 4.48 | 4.50 | 0 | 01:00:00 |
“We believe this is an exciting time for Diffusion Pharmaceuticals. The data we have obtained over the last year from our TCOM and COVID-19 studies have enhanced our understanding of TSC dosing and its mechanism of action, which we feel provides support for the broad potential use of TSC as a treatment for conditions complicated by hypoxia. As the next step in our efforts to realize TSC’s broad potential, we have chosen to target the treatment of hypoxic solid tumors as a first indication,” said Robert Cobuzzi, Jr. Ph.D., President and CEO of Diffusion. Dr. Cobuzzi continued, “We believe targeting hypoxic solid tumors is right for TSC given the significant unmet medical need, the compelling preclinical and clinical data accumulated to date, and the current, intravenous formulation of TSC. As a prelude to launching the first clinical study in the program, we plan to obtain input from the U.S. Food and Drug Administration (“FDA”) on its design in early 2022, and our study start date will be dependent upon FDA feedback and the availability of clinical drug supply. In the meantime, we will continue to execute on the final two Oxygenation Trials. On that, I am happy to say we plan to dose the first subject in the Altitude Trial within the next couple weeks, and in parallel we are working to initiate the ILD-DLCO Trial.”
TSC Development Plans for 2021 and 2022
The Oxygenation Trials
In June 2021, Diffusion reported a positive trend in oxygenation from its Phase 1b TCOM Trial evaluating the effect of TSC versus placebo on peripheral tissue oxygenation in healthy normal volunteers using transcutaneous oxygen measurements. The data obtained from the TCOM Trial have been used to guide dose selection in the Company’s two additional Oxygenation Trials–the Altitude Trial and the ILD-DLCO Trial.
The Company believes these Oxygenation Trials remain integral to the overall development plan for TSC, as they are intended to provide further information regarding TSC’s mechanism of action and dose-response characteristics, as well as to support what the Company believes is the broad therapeutic potential of TSC to treat a variety of conditions complicated by hypoxia. More specifically, the Altitude Trial is designed to provide information on TSC’s effects on oxygen consumption, and the ILD-DLCO Trial is designed to evaluate the effects of TSC on the uptake of oxygen through the lungs.
Using TSC to Treat Hypoxic Solid Tumors
While the Company intends to continue developing data to support TSC’s broad potential uses, it has 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.
“Solid tumors comprise approximately 90% of all adult cancers, and according to the American Cancer Society, roughly 1.9 million new cancer cases will be diagnosed in the U.S. alone during 2021. Hypoxia is a common complicating factor in nearly all solid tumors, directly contributing to treatment resistance and metastatic potential. Tumor hypoxia has been studied for decades and continues to be an area of unmet need that negatively influences treatment outcomes independent of modality,” said Chris Galloway, M.D., Chief Medical Officer of Diffusion. Dr. Galloway went on to state, “We believe TSC’s unique mechanism of action along with its safety profile has the potential to improve treatment success of solid tumors coincident with standard of care therapy. Diffusion has existing pre-clinical and clinical evidence of TSC’s potential positive effects in solid tumors, and now further informative exposure-response data from recently completed studies like the Oxygenation Trials and our COVID-19 trial. Building upon this we are actively working to design a targeted development plan in multiple solid tumor types and plan to submit a briefing document to the FDA in early 2022. In parallel, data from the upcoming Altitude and ILD-DLCO Trials will be used to refine and enhance our understanding of TSC’s dose and effects that conceivably translate into a multitude of oncology and non-oncology indications.”
3Q21 Financial Results
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. For more information, please visit us at www.diffusionpharma.com.
Forward-Looking StatementsThis 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, anticipated timelines for the initiation, completion, and announcement of data from the Company’s planned Oxygenation Trials and hypoxic solid tumor program, the relevance and significance of any such data, 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 optimal doses and dosing regimens of TSC in connection with the potential treatment of any particular disease or indication, including solid tumors complicated by hypoxia; 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
Investors:Tiberend Strategic Advisors, Inc.Maureen McEnroe, CFA/ Lisa Shermmcenroe@tiberend.com/ lsher@tiberend.com
Media:Kate BarretteRooneyPartnersKbarrette@rooneyco.com
DIFFUSION PHARMACEUTICALS, INC.UNAUDITED CONDENSED STATEMENTS OF OPERATIONS(in thousands, except share and per share amounts)
Three Months ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 2,105,815 | $ | 3,137,553 | $ | 6,994,866 | $ | 6,845,203 | ||||||||
In-process research and development impairment charge | 8,639,000 | — | 8,639,000 | — | ||||||||||||
General and administrative | 1,930,082 | 2,112,375 | 5,510,365 | 4,964,440 | ||||||||||||
Depreciation | 19,100 | 24,192 | 67,302 | 78,233 | ||||||||||||
Loss from operations | 12,693,997 | 5,274,120 | 21,211,533 | 11,887,876 | ||||||||||||
Other income: | ||||||||||||||||
Interest income | (50,710 | ) | (29,233 | ) | (146,354 | ) | (89,246 | ) | ||||||||
Loss from operations before income tax benefit | (12,643,287 | ) | (5,244,887 | ) | (21,065,179 | ) | (11,798,630 | ) | ||||||||
Income tax benefit | (443,893 | ) | (805,676 | ) | (443,893 | ) | (1,675,381 | ) | ||||||||
Net loss | $ | (12,199,394 | ) | $ | (4,439,211 | ) | $ | (20,621,286 | ) | $ | (10,123,249 | ) | ||||
Deemed dividend arising from warrant exchange | — | — | — | (1,950,378 | ) | |||||||||||
Net loss attributable to common stockholders | $ | (12,199,394 | ) | $ | (4,439,211 | ) | $ | (20,621,286 | ) | $ | (12,073,627 | ) | ||||
Per share information: | ||||||||||||||||
Net loss per share of common stock, basic and diluted | $ | (0.12 | ) | $ | (0.07 | ) | $ | (0.21 | ) | $ | (0.24 | ) | ||||
Weighted average shares outstanding, basic and diluted | 101,903,979 | 64,011,342 | 98,810,420 | 50,216,239 |
DIFFUSION PHARMACEUTICALS, INC.CONDENSED BALANCE SHEETS(in thousands, except share and par value amounts)
September 30, 2021 | December 31, 2020 | |||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 40,335,045 | $ | 18,515,595 | ||
Prepaid expenses, deposits and other current assets | 380,097 | 260,825 | ||||
Total current assets | 40,715,142 | 18,776,420 | ||||
Property and equipment, net | 81,896 | 149,198 | ||||
Intangible asset | — | 8,639,000 | ||||
Right of use asset | 67,886 | 149,162 | ||||
Other assets | 15,579 | 15,771 | ||||
Total assets | $ | 40,880,503 | $ | 27,729,551 | ||
Liabilities and Stockholders’ Equity | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 678,036 | $ | 545,844 | ||
Accrued expenses and other current liabilities | 2,002,981 | 1,776,470 | ||||
Current operating lease liability | 67,886 | 113,469 | ||||
Total current liabilities | 2,748,903 | 2,435,783 | ||||
Deferred income taxes | — | 443,893 | ||||
Noncurrent operating lease liability | — | 35,693 | ||||
Total liabilities | 2,748,903 | 2,915,369 | ||||
Stockholders’ Equity: | ||||||
Common stock, $0.001 par value: | ||||||
1,000,000,000 shares authorized; 101,903,979 and 64,015,441 issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 101,904 | 64,016 | ||||
Additional paid-in capital | 164,560,366 | 130,659,550 | ||||
Accumulated deficit | (126,530,670 | ) | (105,909,384 | ) | ||
Total stockholders' equity | 38,131,600 | 24,814,182 | ||||
Total liabilities and stockholders' equity | $ | 40,880,503 | $ | 27,729,551 |
1 Year Diffusion Pharmaceuticals Chart |
1 Month Diffusion Pharmaceuticals Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions