Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) (“Diffusion” or the
“Company”), a biopharmaceutical company developing novel therapies
that may enhance the body’s ability to deliver oxygen to areas
where it is needed most, today announced financial results for the
quarter ended June 30, 2022, and provided a business update.
Development Updates
Aligned with FDA on Innovative Trial Design in
Glioblastoma Multiforme (“GBM”) Patients: In July 2022,
Diffusion announced that it had aligned with the U.S. Food and Drug
Administration (“FDA”) on the design of an open-label,
dose-escalation, Phase 2 safety and efficacy study of its lead
product candidate, trans sodium crocetinate (“TSC”), administered
with standard of care to patients newly diagnosed with glioblastoma
multiforme. The trial, which has been designated
Study 200-208, has been designed to incorporate an innovative
use of positron emission tomography (“PET”) to map hypoxia within
the tumor. The use of PET is designed to allow the Company to
directly quantify the effects of TSC on tumor hypoxia, and thereby
test TSC’s ability to enhance oxygen within the tumor
microenvironment. These initial imaging readouts are expected to be
available within one year of study initiation, thereby providing
objective surrogate data readouts significantly faster than
historical clinical trials in patients with GBM. The Company
expects to initiate the trial by the end of 2022 with the first
patient dosed in the first quarter of 2023.
Reported Positive Results from Altitude Trial:
In June 2022, positive results were reported from the Company’s
Altitude Trial. The data suggested that a higher dose of TSC (2.5
mg/kg dose) decreased blood acidity (lower lactate accumulation)
and enhanced metabolic recovery at 10 minutes after completion of
exercise under the stressful conditions of simulated high altitude
and exercise. Additionally, positive changes were observed in blood
markers of oxygen utilization, indicating that TSC may enhance
oxygen availability at the cellular level, reinforcing Diffusion’s
belief in the therapeutic potential of TSC.
“During the second quarter of 2022, we maintained significant
momentum across our clinical and corporate programs achieving
clinical and operational milestones we believe will help build
Diffusion’s long-term success. Specifically, we were pleased to
report positive results from our Altitude Trial, which we believe
support our plans for further development of TSC to treat hypoxic
solid tumors like GBM,” commented Robert Cobuzzi, Jr., Ph.D.,
President and Chief Executive Officer of Diffusion. “Additionally,
we are very pleased to have reached alignment with the FDA on an
innovative GBM Trial design, and our team is already working to
initiate the trial. We believe TSC has the potential to enhance the
effectiveness of available treatment of this devastating
disease.”
Business Updates
Appointed Raven Jaeger, M.S., as Chief Regulatory
Officer: In May 2022, Diffusion appointed Ms. Raven Jaeger
as the Company’s Chief Regulatory Officer. Ms. Jaeger will, among
other things, oversee the development and implementation of
regulatory and related strategies to support the development and
commercialization of Diffusion’s product development
candidates.
Ended Quarter with $28.5 Million in Cash, Cash
Equivalents and Marketable Securities with Expected Cash Runway
into First Quarter of 2024
Research and development expenses in the second quarter of 2022
were $2.1 million, compared to $2.0 million in the prior year
period. There was a decrease in costs associated with clinical
trials and drug manufacturing, offset by an increase in salaries
and wages and stock-based compensation related to increased
headcount.General and administrative expenses were $2.1 million
during the second quarter of 2022 versus $1.8 million in the
comparable quarter last year. The increase reflects a rise in
professional fees related to the reverse stock split that occurred
in April 2022, as well as increased salary expenses related to
additional headcount.As of June 30, 2022, Diffusion had $28.5
million in cash, cash equivalents, and marketable securities, which
the Company currently expects will enable it to fund its operating
expenses and capital expenditure requirements into the first
quarter of 2024, without giving effect to any business development
activities the Company may undertake.
About Diffusion Pharmaceuticals Inc.Diffusion
Pharmaceuticals Inc. is a biopharmaceutical company developing
novel therapies to enhance the body’s ability to deliver oxygen to
areas where it is needed most. Diffusion’s lead product candidate,
TSC, is being investigated 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 like
GBM. 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: the potential therapeutic value of TSC in
cancer and non-cancer indications; anticipated timelines for the
initiation, completion, and announcement of data from Study
200-208; the Company’s ongoing and planned clinical trials; the
Company’s near-term strategic priorities with respect to the
development of TSC and otherwise; and the Company’s anticipated
cash runway. 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 risks and uncertainties include, among other things,
those related to: the novelty of the Company’s Oxygenation Trials’
design and endpoints, the relevance of trends observed in those
studies to any indication, including hypoxic solid tumors, and the
therapeutic value of TSC; the optimal doses and dosing regimens of
TSC in connection with the potential treatment of any particular
disease or indication; the Company’s ability to design, initiate,
enroll, execute, and complete its ongoing and planned studies
evaluating TSC, including Study 200-208; 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
global supply chain disruptions on the Company’s drug product
manufacturing capabilities, clinical development program, and
associated timelines; the Company’s ability to identify, evaluate
and execute potential business development transactional
opportunities, if any; the Company’s ability to protect and expand
its intellectual property portfolio; general economic, political,
business, industry, and market conditions, including the ongoing
COVID-19 pandemic, inflationary pressures, and geopolitical
conflicts; 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.
ContactsInvestors: Tiberend
Strategic Advisors, Inc. Daniel Kontoh-Boateng/Jonathan
Nugentdboateng@tiberend.comjnugent@tiberend.com
Media: Kate
BarretteRooneyPartners Kbarrette@rooneypartners.com
Diffusion Pharmaceuticals Inc. |
Balance Sheets |
|
|
June 30, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
5,965,726 |
|
|
$ |
37,313,558 |
|
Marketable securities |
|
22,574,681 |
|
|
|
— |
|
Prepaid expenses, deposits and other current assets |
|
643,618 |
|
|
|
510,015 |
|
Total current assets |
|
29,184,025 |
|
|
|
37,823,573 |
|
Other assets |
|
— |
|
|
|
15,578 |
|
Total assets |
$ |
29,184,025 |
|
|
$ |
37,839,151 |
|
Liabilities and Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
846,032 |
|
|
$ |
947,495 |
|
Accrued expenses and other current liabilities |
|
1,668,990 |
|
|
|
1,980,189 |
|
Total current liabilities |
|
2,515,022 |
|
|
|
2,927,684 |
|
Stockholders’ Equity: |
|
|
|
Common stock, $0.001 par value: 1,000,000,000 shares authorized;
2,038,914 and 2,038,185 shares issued and outstanding at June 30,
2022 and December 31, 2021, respectively |
|
2,038 |
|
|
|
2,038 |
|
Additional paid-in capital |
|
165,475,801 |
|
|
|
164,914,540 |
|
Accumulated other comprehensive loss |
|
(86,583 |
) |
|
|
— |
|
Accumulated deficit |
|
(138,722,253 |
) |
|
|
(130,005,111 |
) |
Total stockholders' equity |
|
26,669,003 |
|
|
|
34,911,467 |
|
Total liabilities and stockholders' equity |
$ |
29,184,025 |
|
|
$ |
37,839,151 |
|
|
|
|
|
Diffusion Pharmaceuticals Inc. |
Statement of Operations |
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,108,553 |
|
|
$ |
1,972,673 |
|
|
|
$ |
4,534,451 |
|
|
$ |
4,889,051 |
|
General and administrative |
|
|
2,137,326 |
|
|
|
1,836,773 |
|
|
|
|
4,265,878 |
|
|
|
3,580,283 |
|
Depreciation |
|
|
— |
|
|
|
23,755 |
|
|
|
|
— |
|
|
|
48,202 |
|
Loss from operations |
|
|
4,245,879 |
|
|
|
3,833,201 |
|
|
|
|
8,800,329 |
|
|
|
8,517,536 |
|
Interest income |
|
|
(55,378 |
) |
|
|
(55,228 |
) |
|
|
|
(83,187 |
) |
|
|
(95,644 |
) |
Net loss |
|
$ |
(4,190,501 |
) |
|
$ |
(3,777,973 |
) |
|
|
$ |
(8,717,142 |
) |
|
$ |
(8,421,892 |
) |
Per share information: |
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
$ |
(2.06 |
) |
|
$ |
(1.85 |
) |
|
|
$ |
(4.28 |
) |
|
$ |
(4.54 |
) |
Weighted average shares outstanding, basic and diluted |
|
|
2,038,727 |
|
|
|
2,037,978 |
|
|
|
|
2,038,529 |
|
|
|
1,854,161 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,190,501 |
) |
|
$ |
(3,777,973 |
) |
|
|
$ |
(8,717,142 |
) |
|
$ |
(8,421,892 |
) |
Unrealized loss on marketable securities |
|
|
(36,925 |
) |
|
|
- |
|
|
|
|
(86,583 |
) |
|
|
- |
|
Comprehensive loss: |
|
$ |
(4,227,426 |
) |
|
$ |
(3,777,973 |
) |
|
|
$ |
(8,803,725 |
) |
|
$ |
(8,421,892 |
) |
|
|
|
|
|
|
|
|
|
|
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