Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage
biopharmaceutical company focused on developing host-directed
therapeutics for immuno-inflammatory diseases, today reported
financial results for the three and nine months ended June 30, 2024
and provided an update on its business.
During the quarter, the company’s anti-TLR4 drug candidate, EB05
(paridiprubart), was selected by the U.S. Department of Health and
Human Services for use in a U.S. government-funded platform study
investigating novel threat-agnostic host-directed therapeutics in
patients with Acute Respiratory Distress Syndrome (ARDS). Edesa is
providing drug product for the trial as well as technical support
at its own expense. In addition, the company reported today that it
plans to continue utilizing its internal resources to advance its
vitiligo and pulmonary fibrosis programs, including preparations to
file an Investigational New Drug application with the U.S. Food and
Drug Administration for a Phase 2 study of its anti-CXCL10
technology in moderate-to-severe vitiligo patients.
“We believe the fully funded government ARDS clinical study has
the potential to open significant new value-creation opportunities
for Edesa,” said Par Nijhawan, MD, Chief Executive Officer of Edesa
Biotech. “This commitment to our TLR4 technology positions us to
increase investment and operational focus on our other
programs.”
Edesa's Chief Financial Officer Stephen Lemieux reported that
financial results for the three and nine months ended June 30, 2024
were in line with management’s expectations. "Our fiscal quarter
and nine-month results demonstrate our commitment to prudent use of
working capital and effective financial management, while we
strategically advance our pipeline. We believe this steady
performance enhances our position for future financing and other
opportunities to support the advancement of our clinical programs,”
he said.
Financial Results for the Three Months Ended June 30,
2024
Total operating expenses decreased by $0.2 million to $1.9
million for the three months ended June 30, 2024 compared to $2.1
million for the same period last year.
- Research and development expenses decreased by $0.1 million to
$0.9 million for the three months ended June 30, 2024 compared to
$1.0 million for the same period last year primarily due to
decreased external research expenses related to the company’s
ongoing Phase 3 ARDS study and its completed dermatitis study,
which were partially offset by an increase in expenses related to
manufacturing of the company’s investigational drug,
paridiprubart.
- General and administrative expenses were unchanged at $1.0
million for the three months ended June 30, 2024 and June 30,
2023.
Total other income increased by $185,000 to $264,000 for the
three months ended June 30, 2024 compared to $79,000 for the same
period last year primarily due to an increase in reimbursement
funding from the Canadian government's Strategic Innovation
Fund.
For the quarter ended June 30, 2024, Edesa reported a net loss
of $1.7 million, or $0.52 per common share, compared to a net loss
of $2.0 million, or $0.68 per common share, for the quarter ended
June 30, 2023.
Financial Results for the Nine Months Ended June 30,
2024
Total operating expenses decreased by $0.9 million to $6.0
million for the nine months ended June 30, 2024 compared to $6.9
million for the same period last year:
- Research and development expenses decreased by $1.0 million to
$2.8 million for the nine months ended June 30, 2024 compared to
$3.8 million for the same period last year primarily due to
decreased external research expenses related to the company’s
completed dermatitis study and a reduction in noncash share-based
compensation and labor costs, which were partially offset by an
increase in expenses for the company’s ongoing ARDS study and
expenses related to manufacturing of paridiprubart.
- General and administrative expenses increased by $0.2 million
to $3.2 million for the nine months ended June 30, 2024 compared to
$3.0 million for the same period last year primarily due to
increased fees for professional services, which were partially
offset by a decrease in non-cash share-based compensation.
Total other income increased by $0.6 million to $0.8 million for
the nine months ended June 30, 2024 compared to $0.2 million for
the same period last year primarily due to an increase in
reimbursement funding from the Canadian government's Strategic
Innovation Fund.
For the nine months ended June 30, 2024, Edesa reported a net
loss of $5.2 million, or $1.64 per common share, compared to a net
loss of $6.7 million, or $2.37 per common share, for the nine
months ended June 30, 2023.
Working Capital
At June 30, 2024, Edesa had cash and cash equivalents of $2.0
million and working capital of $0.7 million. Subsequent to the
quarter end, the company received $0.3 million in reimbursement
funding from the Canadian government's Strategic Innovation Fund.
To date, the company has not drawn any funds under a $10.0 million
revolving credit agreement with the company’s founder and chief
executive officer.
Calendar
Edesa management plans to participate in the Canaccord 44th
Annual Growth Conference being held August 13-15, 2024 in Boston,
Mass; the H.C. Wainwright 26th Annual Global Investment Conference
being held September 9-11, 2024 in New York, NY and the Dermatology
Drug Development Summit being held November 12-14, 2024 in Boston,
Mass. Attendees interested in meeting with management can request
meetings through the conference organizers or by contacting Edesa
directly at investors@edesabiotech.com.
About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage
biopharmaceutical company developing innovative ways to treat
inflammatory and immune-related diseases. The company’s most
advanced drug candidate is EB05 (paridiprubart), a monoclonal
antibody developed for acute and chronic disease indications that
involve dysregulated innate immune responses. Edesa is currently
evaluating EB05 in a Phase 3 study as a potential treatment for
Acute Respiratory Distress Syndrome (ARDS), a life-threatening form
of respiratory failure. EB05 has also been included in a U.S.
government funded platform study of host directed therapeutics. In
addition, the company has received Canadian regulatory approval to
conduct a Phase 2 trial its EB06 (anti-CXCL10) monoclonal antibody
as a treatment for vitiligo, a life-altering autoimmune disease
that causes skin to lose its color in patches. In addition, Edesa
is developing an sPLA2 inhibitor, EB01 (1.0% daniluromer cream), as
a topical treatment for chronic Allergic Contact Dermatitis (ACD),
a common occupational skin condition. Sign up for news alerts.
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Edesa Forward-Looking Statements
This press release may contain forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. Forward-looking statements may be identified by the use of
words such as "anticipate," "believe," "plan," "estimate,"
"expect," "intend," "may," "will," "would," "could," "should,"
"might," "potential," or "continue" and variations or similar
expressions, including statements related to: Edesa plans to
provide drug product and technical support for a U.S. funded ARDS
study; the company’s plans to continue using internal resources to
advance its vitiligo and pulmonary fibrosis programs, including
preparations to file an Investigational New Drug application with
the U.S. Food and Drug Administration for a Phase 2 study of its
anti-CXCL10 technology in moderate-to-severe vitiligo patients; the
company’s belief that the fully funded government ARDS study opens
significant new value-creation opportunities for Edesa,; the
company’s belief that it is now in a position to redeploy its
resources for its anti-inflammatory TLR4 technology and other
programs; the company’s plans to potentially place increased
operational focus on vitiligo and pulmonary fibrosis areas and its
belief that is significant unmet medical need and increasing
industry interest in these indications; the company’s belief that
its third fiscal quarter and nine month results demonstrate its
commitment to prudent use of working capital and effective
financial management; the company’s belief that its steady
performance enhances its position for future financing and other
opportunities to support the advancement of our clinical programs;
the company’s plans to strategically advance its pipeline; and the
company's timing and plans regarding its clinical studies in
general. Readers should not unduly rely on these forward-looking
statements, which are not a guarantee of future performance. There
can be no assurance that forward-looking statements will prove to
be accurate, as all such forward-looking statements involve known
and unknown risks, uncertainties and other factors which may cause
actual results or future events to differ materially from the
forward-looking statements. Such risks include: the ability of
Edesa to obtain regulatory approval for or successfully
commercialize any of its product candidates, the risk that access
to sufficient capital to fund Edesa's operations may not be
available or may be available on terms that are not commercially
favorable to Edesa, the risk that Edesa's product candidates may
not be effective against the diseases tested in its clinical
trials, the risk that Edesa fails to comply with the terms of
license agreements with third parties and as a result loses the
right to use key intellectual property in its business, Edesa's
ability to protect its intellectual property, the timing and
success of submission, acceptance and approval of regulatory
filings, and the impacts of public health crises. Many of these
factors that will determine actual results are beyond the company's
ability to control or predict. For a discussion of further risks
and uncertainties related to Edesa's business, please refer to
Edesa's public company reports filed with the U.S. Securities and
Exchange Commission and the British Columbia Securities Commission.
All forward-looking statements are made as of the date hereof and
are subject to change. Except as required by law, Edesa assumes no
obligation to update such statements.
Contact:Gary KoppenjanEdesa Biotech, Inc. (289)
800-9600investors@edesabiotech.com
Condensed Interim Consolidated Statements of
Operations |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
June 30, 2024 |
|
June 30, 2023 |
|
June 30, 2024 |
|
June 30, 2023 |
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
897,305 |
|
|
|
1,025,622 |
|
|
$ |
2,778,100 |
|
|
$ |
3,841,150 |
|
General and administrative |
|
|
1,035,140 |
|
|
|
1,038,587 |
|
|
|
3,232,248 |
|
|
|
3,011,945 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(1,932,445 |
) |
|
|
(2,064,209 |
) |
|
|
(6,010,348 |
) |
|
|
(6,853,095 |
) |
|
|
|
|
|
|
|
|
|
Other Income (Loss): |
|
|
|
|
|
|
|
|
Reimbursement grant income |
|
|
236,226 |
|
|
|
- |
|
|
|
661,062 |
|
|
|
- |
|
Other income (loss) |
|
|
28,007 |
|
|
|
79,303 |
|
|
|
142,092 |
|
|
|
199,823 |
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
- |
|
|
|
- |
|
|
|
800 |
|
|
|
800 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(1,668,212 |
) |
|
|
(1,984,906 |
) |
|
|
(5,207,994 |
) |
|
|
(6,654,072 |
) |
|
|
|
|
|
|
|
|
|
Exchange differences on translation |
|
|
1,612 |
|
|
|
39,839 |
|
|
|
(10,143 |
) |
|
|
23,415 |
|
|
|
|
|
|
|
|
|
|
Net comprehensive loss |
|
$ |
(1,666,600 |
) |
|
$ |
(1,945,067 |
) |
|
$ |
(5,218,137 |
) |
|
$ |
(6,630,657 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
3,221,806 |
|
|
|
2,930,681 |
|
|
|
3,180,647 |
|
|
|
2,802,793 |
|
|
|
|
|
|
|
|
|
|
Loss per common share - basic and diluted |
|
$ |
(0.52 |
) |
|
$ |
(0.68 |
) |
|
$ |
(1.64 |
) |
|
$ |
(2.37 |
) |
|
|
|
|
|
Condensed Interim Consolidated Balance Sheets |
(Unaudited) |
|
|
|
|
|
|
|
June 30, 2024 |
|
September 30, 2023 |
|
|
|
|
|
Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
2,040,884 |
|
|
$ |
5,361,397 |
|
Other current assets |
|
|
1,005,750 |
|
|
|
1,075,455 |
|
Non-current assets |
|
|
2,181,088 |
|
|
|
2,453,585 |
|
|
|
|
|
|
Total Assets |
|
$ |
5,227,722 |
|
|
$ |
8,890,437 |
|
|
|
|
|
|
Liabilities and shareholders' equity: |
|
|
|
|
Current liabilities |
|
$ |
2,360,627 |
|
|
$ |
1,821,864 |
|
Non-current liabilities |
|
|
- |
|
|
|
19,773 |
|
Shareholders' equity |
|
|
2,867,095 |
|
|
|
7,048,800 |
|
|
|
|
|
|
Total liabilities and shareholders' equity |
|
$ |
5,227,722 |
|
|
$ |
8,890,437 |
|
Condensed Interim Consolidated Statements of Cash
Flows |
(Unaudited) |
|
|
|
|
|
|
|
Nine Months Ended |
|
|
June 30, 2024 |
|
June 30, 2023 |
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
Net loss |
|
$ |
(5,207,994 |
) |
|
$ |
(6,654,072 |
) |
Adjustments for non-cash items |
|
|
570,636 |
|
|
|
866,881 |
|
Change in working capital items |
|
|
714,192 |
|
|
|
618,730 |
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(3,923,166 |
) |
|
|
(5,168,461 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
623,466 |
|
|
|
4,417,646 |
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
(20,813 |
) |
|
|
117,066 |
|
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
(3,320,513 |
) |
|
|
(633,749 |
) |
Cash and cash equivalents, beginning of year |
|
|
5,361,397 |
|
|
|
7,090,919 |
|
|
|
|
|
|
Cash and cash equivalents, end of year |
|
$ |
2,040,884 |
|
|
$ |
6,457,170 |
|