Diffusion Pharmaceuticals Reports Q2 Financial Results and Provides Business Update
August 11 2021 - 7:32AM
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 second quarter of
2021 and provided a business update.
“We met our key milestones for the first half of 2021,
completing and announcing topline results from our COVID-19 Trial
and the first of our Oxygenation Trials. Our development plan
remains on track. With the positive outcomes of the COVID-19 and
TCOM studies, as well as our significant capital raise in the first
quarter, we believe we have the data and the financial capacity to
execute our clinical development strategy for TSC through Phase 2b.
For the remainder of 2021, we are focused on the design and
execution of the remaining two Oxygenation Trials to further our
understanding of TSC’s mechanism of action and potential, as well
as the further development of our regulatory and commercial
strategy for TSC,” said Robert Cobuzzi, Jr. Ph.D., President and
CEO of Diffusion.
TSC Q2 Development Update
- In May 2021,
Diffusion reported final results from its Phase 1b trial (the
“COVID-19 Trial”) of trans sodium crocetinate (“TSC”) in
hospitalized COVID-19 patients. Although the study was not designed
or powered to evaluate efficacy, the study’s external safety
monitoring committee observed that patients receiving the 1.5 mg/kg
dose of TSC had improved outcomes in secondary and exploratory
endpoints compared to those receiving lower doses. The final
results were consistent with topline results previously announced
in February 2021, indicating that TSC was safe and well-tolerated
when administered on a more frequent dosing regimen than previously
tested in a clinical trial setting.
- In June 2021, the Company reported a
positive trend in oxygenation from its Phase 1b trial (the “TCOM
Trial”) evaluating TSC using transcutaneous oxygen monitoring
(“TCOM”). The TCOM Trial was designed to evaluate the effect of TSC
versus placebo on peripheral tissue oxygenation in healthy normal
volunteers. Topline results based upon analyses of primary endpoint
data indicated, as compared to placebo, a positive dose-response
trend in TCOM readings after TSC administration that persisted
through the measurement period with no evidence of
hyperoxygenation. TSC was also safe and well-tolerated at all doses
tested.
TSC Development Plans for 2021 and 2022
The positive trend observed in the TCOM Trial is being used to
guide dose selection in the additional Oxygenation Trials planned
for the latter part of 2021 – the Altitude Trial, followed by the
ILD-DLCO Trial.
- Altitude Trial (formerly
known as the Induced Hypoxia Trial): This
trial will be a double-blind, randomized, placebo-controlled study
which will evaluate the effects of TSC on maximal oxygen
consumption, or VO2, and partial pressure of blood oxygen, or PaO2,
in normal healthy volunteers subjected to incremental levels of
physical exertion while exposed to hypoxic and hypobaric conditions
(i.e., simulated altitude). The study is designed to evaluate the
effect of TSC versus placebo on maximal oxygen consumption and
partial pressure of blood oxygen. Diffusion anticipates initiating
and completing the Altitude Trial in the fourth quarter of 2021,
with topline results available within one to two months of study
completion.
- ILD - DLCO
Trial: This trial will be a double-blind,
randomized, placebo-controlled study which will evaluate the
effects of TSC on the diffusion of carbon monoxide through the
lungs (“DLCO”) in patients with previously diagnosed interstitial
lung disease (“ILD”) who have a baseline DLCO test result that is
abnormal. DLCO will act as a surrogate measure of oxygen transfer
efficiency, or uptake, from the alveoli of the lungs, through the
plasma, and onto hemoglobin within red blood cells. The study will
be statistically powered to evaluate the difference in effect of
TSC versus placebo on improvement in DLCO as well as in a standard
six-minute walk test. Diffusion now anticipates initiating the
ILD-DLCO Trial in the late fourth quarter of 2021 and completing
the trial in the first quarter of 2022, with topline results
available within one to two months of study completion.
Diffusion expects to announce in the fourth quarter of 2021 the
initial indication in which TSC will be studied to support the
planned pathway for regulatory approval and to initiate a
controlled, clinical outcome study evaluating TSC in the chosen
indication during the first half of 2022, funded with
cash-on-hand.
Operating and Leadership Team Developments
During the second quarter, Diffusion enhanced its operating team
with the addition of new employees in the areas of administration,
quality assurance, clinical operations, and finance. In addition,
in connection with the Diffusion’s annual meeting of stockholders
in June 2021, Jane H. Hollingsworth was elected as the new chair of
the Company’s board of directors and Diana Lanchoney, M.D. and Eric
Francois were newly elected to the board of directors. The Company
believes these organizational additions have already had a
significant, positive impact on its ability to develop, implement
and execute on its corporate strategy and development plans, and
position the Company well to build shareholder value through its
next stage of growth.
2Q21 Financial Results
- Research and development expenses in the second quarter were
$2.0 million compared to expenses of $2.2 million in the prior year
period. The decrease was attributable to the wind-down of the
Company’s clinical trial evaluating TSC in glioblastoma multiforme
brain cancer and its COVID-19 Trial completed in February 2021.
These decreases were offset by increased headcount and costs
related to the TCOM Trial.
- General and administrative expenses were $1.8 million during
the second quarter of 2021 versus $1.5 million in the comparable
quarter last year. The increase compared to the prior year period
was primarily attributable to increased salaries, wages,
stock-based compensation, and professional fees related to
increased headcount and costs associated with the separation of
former employees that will not recur in future years.
- As of June 30, 2021, Diffusion had cash and cash equivalents of
approximately $43.3 million as compared to $18.5 million as of
December 31, 2020.
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 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, the impact of organizational changes
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; 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.
ContactsInvestors: Tiberend
Strategic Advisors, Inc. Maureen McEnroe, CFA/ Lisa
Shermmcenroe@tiberend.com / lsher@tiberend.com
Media: Kate
BarretteRooneyPartners Kbarrette@rooneypartners.com
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