Edesa News Archive

TORONTO, Dec. 13, 2024 (GLOBE NEWSWIRE) — 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 fiscal year ended September 30, 2024 and provided an update on its business.

During the fiscal year, the company pivoted the in-house development of its anti-TLR4 drug candidate, EB05 (paridiprubart), to a U.S. government-funded study investigating novel threat-agnostic host-directed therapeutics in patients with Acute Respiratory Distress Syndrome (ARDS). Given this opportunity, Edesa is also amending a development and drug manufacturing project for the same asset that is supported by the Government of Canada. The company said that the goal is to maximize synergies between the two government-funded projects. For its anti-CXCL10 program, Edesa intends to manufacture EB06 and submit related data to the U.S. Food and Drug Administration as part of an investigational new drug (IND) application. The manufacturing of clinical-grade drug batches and initiation of the patient enrollment is subject to funding. Edesa anticipates topline results for this Phase 2 study could be available within as few as 12 to 18 months following regulatory clearance in the U.S. The study is currently approved in Canada.

“This year, Edesa maintained its momentum despite the headwinds in the drug development sector, and we once again validated our TLR4 technology with a third competitive government award,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “I have maintained my strategic support financially and I believe that our team can continue to advance and expand our development pipeline and partnerships.”

Edesa’s Chief Financial Officer Stephen Lemieux reported that financial results for the fiscal year benefited from prudent use of working capital and effective financial management, including a more than 20% decrease in operating expenses. “Following the end of the fiscal year, we strengthened our balance sheet, and with two governments now funding the advancement of our anti-TLR4 technology, we have improved our position for future financing, potential strategic arrangements as well as other opportunities to advance our pipeline.”

Financial Results for the Fiscal Year Ended September 30, 2024

Total operating expenses decreased by $2.2 million to $7.0 million for the year ended September 30, 2024 compared to $9.2 million for the prior year:

• Research and development expenses decreased by $1.9 million to $2.9 million for the year ended September 30, 2024 compared to $4.8 million for the prior year primarily due to decreased external research expenses related to the company’s completed dermatitis study and a reduction in labor costs and noncash share-based compensation, which were partially offset by an increase in expenses related to manufacturing of paridiprubart.
• General and administrative expenses decreased by $0.3 million to $4.1 million for year ended September 30, 2024 compared to $4.4 million for the prior year primarily due to a decrease in noncash share-based compensation, which was partially offset by an increase salaries and related costs.

Total other income was unchanged at $0.8 million for the years ended September 30, 2024 and September 30, 2023 as a $0.1 million increase in reimbursement funding from the Canadian government’s Strategic Innovation Fund was offset by a $0.1 million decrease in interest income.

For the year ended September 30, 2024, Edesa reported a net loss of $6.2 million, or $1.93 per common share, compared to a net loss of $8.4 million, or $2.93 per common share, for the year ended September 30, 2023.

Working Capital

At September 30, 2024, Edesa had cash and cash equivalents of $1.0 million and negative working capital of $0.2 million. Subsequent to the fiscal year end, the company received $1.5 million in gross proceeds under a securities purchase agreement with an entity affiliated with Edesa’s Chief Executive Officer and Founder, and $0.6 million in net proceeds, after deducting sales agent commissions, from common shares sold under an at-the-market offering program.

Calendar

Edesa management plans to participate in one-on-one meetings during JP Morgan week, which begins on January 13, 2025, in San Francisco, California. 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. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. In addition to EB05, Edesa is preparing an investigational new drug application (IND) in the United States for EB07 (paridiprubart) to conduct a future Phase 2 study in patients with pulmonary fibrosis. Sign up for news alerts. Connect with us on X and LinkedIn.

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’s ability to pivot the in-house development of its anti-TLR4 drug candidate; the company’s plans to amend its contribution agreement with the Government of Canada; the company’s goal to maximize synergies between two government-funded projects; Edesa plans to manufacture EB06 and submit related data to the FDA as part of an IND application; the company’s plans to manufacture clinical-grade drug and initiate patient enrollment; the company’s plans to finance clinical and manufacturing activities; the company’s estimate that topline results for its Phase 2 vitiligo study could be available within as few as 12 to 18 months following regulatory clearance; the company’s belief that in 2024 it maintained its momentum despite the headwinds in the drug development sector and once again validated its TLR4 technology with a third competitive government award; the company’s belief that its team can continue to advance and expand its development pipeline and partnerships; the company’s belief that its fiscal year financial results benefited from prudent use of working capital and effective financial management; the company’s belief that with two governments funding the advancement of its anti-TLR4 technology, it has improved its position for future financing, potential strategic arrangements and alternatives as well as other opportunities to 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.

• This Phase 2 clinical study will evaluate paridiprubart (EB05) in hospitalized patients with acute respiratory distress syndrome (ARDS) due to a variety of causes.
• This BARDA-funded project is expected to complement Edesa’s ongoing drug development activities in COVID-19 ARDS.
• Paridiprubart was selected following a competitive review process of multiple host-directed therapeutic candidates.

TORONTO, ON / ACCESSWIRE / June 24, 2024 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics (HDTs) for immuno-inflammatory diseases, announced today that its first-in-class drug candidate has been selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for evaluation in a U.S. government-funded clinical study.

Edesa’s drug paridiprubart represents a new class of HDTs that are designed to modulate the body’s own immune response when confronted with known or unknown public health threats such as pandemic influenza, COVID-19, other emerging infectious diseases, and chemical, biological, radiological, and nuclear incidents. Importantly, HDTs are agnostic to the causal agent and can be stockpiled preemptively to respond to public health emergencies and biodefense.

“HDTs have the potential to become key countermeasures for both critical care medicine as well as pandemic preparedness and biodefense, and we are pleased to be part of public-private efforts to speed the development of novel therapeutics that are threat-agnostic and can be rapidly deployed to protect civilian and military populations,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech.

The BARDA-funded Phase 2 platform trial will be a randomized, double-blinded, placebo-controlled, multi-center U.S. clinical trial to investigate three novel threat-agnostic host-directed therapeutics, including paridiprubart, in hospitalized adult patients with ARDS. The BARDA study of paridiprubart is expected to build on the success of a Phase 2 clinical study that the company completed during the COVID-19 pandemic which demonstrated that paridiprubart reduced mortality by 84% among critically ill ARDS patients. A parallel study using an in vitro model also demonstrated that paridiprubart inhibits a key mediator of inflammatory responses from influenza and other pathogens. A separate Edesa-sponsored Phase 3 study of paridiprubart in patients with ARDS due to SARS-CoV-2 infection is currently ongoing in Canada and the U.S.

Dr. Nijhawan said that the data from the BARDA-run study, which includes an exploratory biomarker study, could provide additional support and insight for expanding the utility of paridiprubart. “We expect this parallel study to inform our development, regulatory, and commercialization plans. Our ultimate goal is to label paridiprubart as a standard-of-care drug therapy for all-cause ARDS,” he said.

The BARDA-funded study will be managed under a BARDA contract with PPD Development, LP, a clinical research business of Thermo Fisher Scientific, Inc. For the paridiprubart cohort of the study, patients will be randomized one-to-one to either paridiprubart plus Standard of Care (SOC) or to a placebo plus SOC control arm. Edesa will provide drug products to the study as well as technical support. Additional details regarding this trial can be found on the BARDA website.

About ARDS

Acute Respiratory Distress Syndrome manifests in some patients as an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few recommended treatments other than supplemental oxygen and mechanical ventilation, and mortality rates are high. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury, and other causes. Prior to the pandemic, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Paridiprubart

Paridiprubart is a first-in-class human monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. This host-directed therapeutic candidate inhibits toll-like receptor 4 (TLR4), a key immune signaling receptor that has been shown to be activated both by viruses, like SARS-CoV-2, SARS-CoV-1, and influenza, as well as in the pathogenesis of chronic autoimmune diseases.

About Edesa’s Phase 3 Clinical Study

Edesa’s Phase 3 study of paridiprubart is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of paridiprubart in critical-care patients. The current protocol will recruit ARDS subjects hospitalized with SARS-CoV-2 infections who are on invasive mechanical ventilation, both with and without additional organ support. The primary endpoint of the trial is the mortality rate at 28 days.

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 paridiprubart (EB05), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. Edesa is currently evaluating paridiprubart (EB05) in a Phase 3 study as a potential treatment for ARDS, a life-threatening form of respiratory failure. In addition, Edesa is developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic allergic contact dermatitis (ACD), a common occupational skin condition. The company has also received regulatory approval to conduct a Phase 2 trial of its EB06 monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. Edesa is also planning to file an investigational new drug application for a future Phase 2 study of paridiprubart (EB05) for pulmonary fibrosis. Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn.

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: the company’s belief that the BARDA study could provide additional support and insight for expanding the utility of EB05; the company’s expectation that the BARDA study will inform Edesa’s development, regulatory and commercialization plans; the company’s goal of labeling EB05 as a standard-of-care drug therapy for all-cause ARDS; 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, such as Covid-19. 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.

TORONTO, ON / ACCESSWIRE / May 10, 2024 / 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 six months ended March 31, 2024 and provided an update on its business.

During the quarter, the company expanded site selection activities for a Phase 3 study of its ARDS (Acute Respiratory Distress Syndrome) drug candidate, EB05 (paridiprubart). Edesa previously secured up to C$23 million from the Canadian government toward the development of EB05, a portion of which is conditionally repayable. The company also intends to evaluate EB05, an anti-TLR4 monoclonal antibody, separately in a broader ARDS population and plans to file an investigational new drug application (IND) for a Phase 2 study in pulmonary fibrosis.

“We are positioning our anti-TLR4 respiratory technology for both acute and chronic conditions,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “With governments now focusing on host-directed therapeutics as part of their pandemic preparedness and biodefense plans, and strong scientific rationale for evaluating EB05 in both ARDS and chronic lung fibrosis, we believe we can significantly expand the medical opportunities for this promising antibody as well as enhance its attractiveness for commercial development and partnering.”

For its medical dermatology technologies, Edesa reported that it plans to seek regulatory approval in the U.S for a Phase 2 study of its anti-CXCL10 monoclonal antibody in patients with moderate-to-severe nonsegmental vitiligo, common autoimmune disorder that causes skin to lose its color in patches. The protocol has been approved previously in Canada. The company also intends to seek strategic arrangements to further develop and/or monetize its EB01 asset, following favorable Phase 2b results of 1.0% EB01 cream.

Edesa’s Chief Financial Officer Stephen Lemieux reported that financial results for the three and six months ended March 31, 2024 reflected consistent operational efficiency and prudent management of working capital. He noted that during the quarter the company deployed additional resources to its current Phase 3 ARDS study and has engaged a new clinical research organization with increased analytical and recruitment capabilities.

“With government funding in place, we believe we are in a stronger position to efficiently manage our Phase 3 ARDS study, while remaining opportunistic to ramp up our development activities in vitiligo and pulmonary fibrosis,” he said. “We have continued to demonstrate our ability to execute on our plans, and we are working towards a rich set of milestones over the next 12 to 24 months.”

Financial Results for the Three Months Ended March 31, 2024

Total operating expenses decreased by $0.2 million to $2.2 million for the three months ended March 31, 2024 compared to $2.4 million for the same period last year.

• Research and development expenses decreased by $0.3 million to $1.2 million for the three months ended March 31, 2024 compared to $1.5 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, which was partially offset by an increase in expenses for the company’s ongoing ARDS study.
• General and administrative expenses increased by $0.1 million to $1.0 million for the three months ended March 31, 2024 compared to $0.9 million for the same period last year primarily due to increased fees for professional services, which was partially offset by a decrease in noncash share-based compensation.

Total other income increased by $283,000 to $360,000 for the three months ended March 31, 2024 compared to $77,000 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 March 31, 2024, Edesa reported a net loss of $1.9 million, or $0.58 per common share, compared to a net loss of $2.3 million, or $0.82 per common share, for the quarter ended March 31, 2023.

Financial Results for the Six Months Ended March 31, 2024

Total operating expenses decreased by $0.7 million to $4.1 million for the six months ended March 31, 2024 compared to $4.8 million for the same period last year:

• Research and development expenses decreased by $0.9 million to $1.9 million for the six months ended March 31, 2024 compared to $2.8 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, which was partially offset by an increase in expenses for the company’s ongoing ARDS study.
• General and administrative expenses increased by $0.2 million to $2.2 million for the six months ended March 31, 2024 compared to $2.0 million for the same period last year primarily due to increased fees for professional services, which was partially offset by a decrease in non-cash share-based compensation.

Total other income decreased by $0.4 million to $0.5 million for the six months ended March 31, 2024 compared to $0.1 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 six months ended March 31, 2024, Edesa reported a net loss of $3.5 million, or $1.12 per common share, compared to a net loss of $4.7 million, or $1.70 per common share, for the six months ended March 31, 2023.

Working Capital

At March 31, 2024, Edesa had cash and cash equivalents of $2.8 million and working capital of $2.1 million. Subsequent to the quarter end, the company received $0.7 million in reimbursement funding the Canadian government’s Strategic Innovation Fund.

Calendar

Edesa management plans to participate in the RBC Capital Markets Global Healthcare Conference on May 14-15, 2024 in New York, NY, and the BIO International Convention being held June 5-8, 2023 in San Diego, Calif. 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. The company has also received 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. Connect with us on X (Twitter) and LinkedIn.

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: the Company’s intention to evaluate EB05 in a broader ARDS population as well as file an investigational new drug application for a Phase 2 study in pulmonary fibrosis; the Company’s plans to position its anti-TLR4 respiratory technology for both acute and chronic conditions; the Company’s belief that it can significantly expand the medical opportunities for paridiprubart, as well as increase its attractiveness for partnering and commercial development; the Company’s plans to seek regulatory approval in the U.S for a Phase 2 study of its anti-CXCL10 monoclonal antibody in vitiligo patients; the Company’s intention to seek strategic arrangements to further develop and/or monetize its EB01 asset; the Company’s belief that its financial results reflect consistent operational efficiency and prudent management of working capital; the Company’s belief that its new clinical research organization has increased analytical and recruitment capabilities; the Company’s belief that with government funding in place, it is in a stronger position to efficiently manage its Phase 3 ARDS study, while remaining opportunistic to ramp up its development activities in vitiligo and pulmonary fibrosis; the Company’s belief that it has continued to demonstrate its ability to execute on its plans and that it is working towards a rich set of milestones over the next 12 to 24 months; 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.

Condensed Interim Consolidated Statements of Operations
(Unaudited)

Condensed Interim Consolidated Balance Sheets
(Unaudited)

Condensed Interim Consolidated Statements of Cash Flows
(Unaudited)

View the original press release on accesswire.com

TORONTO, ON / ACCESSWIRE / April 11, 2024 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that the company will participate in the 2024 Bloom Burton & Co. Healthcare Investor Conference scheduled for April 16-17, 2024 in Toronto, Ontario.

Edesa’s Chief Executive Officer Par Nijhawan, MD, is scheduled to present on Wednesday, April 17 at 11:00 am ET. To meet with Edesa management during the conference, please utilize the conference’s online portal or contact the company directly at investors@edesabiotech.com.

About Edesa Biotech
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. Edesa is also planning to file an investigational new drug application for a future Phase 2 study of paridiprubart for pulmonary fibrosis. For its dermatology assets, the company has received regulatory approval to conduct a Phase 2 trial of 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 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn.

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. 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.

View the original press release on accesswire.com

TORONTO, ON / ACCESSWIRE / April 2, 2024 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that Edesa management plans to participate in the following upcoming investor conferences:

• Mintz Conference, Toronto, Canada, April 15, 2024
• LSX World Congress, London, UK, April 29-30, 2024, with showcase presentation at 4:30 pm GMT on April 29, 2024
• RBC Capital Markets Global Healthcare Conference, New York, NY, May 14-15, 2024

To schedule a meeting with Edesa during the conference, please contact conference organizers or the company directly at investors@edesabiotech.com.

About Edesa Biotech

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. Edesa is also planning to file an investigational new drug application for a future Phase 2 study of paridiprubart for pulmonary fibrosis. For its dermatology assets, the company has received regulatory approval to conduct a Phase 2 trial of 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 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn.

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. 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.

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TORONTO, ON / ACCESSWIRE / March 21, 2024 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that the company will participate in a Fireside Chat and host one-on-one meetings at the H.C. Wainwright Autoimmune & Inflammatory Disease Virtual Conference on March 28, 2024.

The Fireside Chat discussion between Edesa’s Chief Executive Officer Par Nijhawan, MD, and an H.C. Wainwright analyst will be made available on March 28, 2024 at approximately 7:00 am ET to registered attendees. To schedule a meeting with Edesa during the conference, please contact your H.C. Wainwright representative or the company directly at investors@edesabiotech.com.

About Edesa Biotech

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. Edesa is also planning to file an investigational new drug application for a future Phase 2 study of paridiprubart for pulmonary fibrosis. For its dermatology assets, the company has received regulatory approval to conduct a Phase 2 trial of 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 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn.

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. 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.

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TORONTO, ON / ACCESSWIRE / March 7, 2024 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that company management will participate in the Barclays 26^th Annual Global Healthcare Conference, which is being held in Miami, Florida, from March 12-14, 2024.

Attendees interested in meeting with Edesa can request meetings through conference organizers or by contacting the company at investors@edesabiotech.com.

About Edesa Biotech

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. Edesa is also planning to file an investigational new drug application for a future Phase 2 study of paridiprubart for pulmonary fibrosis. For its dermatology assets, the company has received regulatory approval to conduct a Phase 2 trial of 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 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn.

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. 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 Koppenjan
Edesa Biotech, Inc.
(289) 800-9600
investors@edesabiotech.com

SOURCE: Edesa Biotech, Inc.

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TORONTO, ON / ACCESSWIRE / March 4, 2024 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that the company plans to participate in the American Contact Dermatitis Society Annual Meeting on March 7, 2024 and the American Academy of Dermatology Annual Meeting from March 8-12, 2024 in San Diego, California.

Attendees interested in meeting with Edesa can request meetings by contacting the company at investors@edesabiotech.com.

About Edesa Biotech

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. Edesa is also planning to file an investigational new drug application for a future Phase 2 study of paridiprubart for pulmonary fibrosis. For its dermatology assets, the company has received regulatory approval to conduct a Phase 2 trial of 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 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn.

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. 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.

View the original press release on accesswire.com

TORONTO, ON / ACCESSWIRE / February 9, 2024 / 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 months ended December 31, 2023 and provided an update on its business.

During the first fiscal quarter, the company secured funding of up to C$23 million from the Canadian government toward the development of Edesa’s ARDS (Acute Respiratory Distress Syndrome) drug candidate, EB05 (paridiprubart), a portion of which is conditionally repayable. Canadian regulators also approved the company’s proposal to harmonize clinical trial designs in the U.S. and Canada for the current Phase 3 trial of EB05. Edesa intends to evaluate paridiprubart in a broader ARDS population as well as file an investigational new drug application (IND) for a Phase 2 study in pulmonary fibrosis. The company is planning for a Phase 2 study of its anti-CXCL10 monoclonal antibody in moderate-to-severe nonsegmental vitiligo patients.

“We believe that the positive momentum that Edesa demonstrated at the beginning of the year puts us on a solid path to advance our respiratory and dermatology assets, including strategic discussions with potential commercialization and licensing partners,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “Engagements with regulatory agencies have also been productive, and Edesa is on track with key regulatory submissions, including clearance of INDs for our vitiligo and fibrosis projects.”

Edesa’s Chief Financial Officer Stephen Lemieux reported that the company continues to benefit from the flexibility of its business model as it advances its clinical programs. “With our government funding and access to capital, we have extended our cash runway, with the option to ramp up our development activities in vitiligo and pulmonary fibrosis through potential partnerships, non-dilutive programs, direct investments in projects and other financings,” he said.

Mr. Lemieux reported that Edesa is evaluating potential partnerships and funding opportunities to complete a future Phase 3 study of its dermatitis drug candidate, EB01 (1.0% daniluromer cream), following favorable Phase 2b results reported during the first fiscal quarter. “We believe that Allergic Contact Dermatitis represents a large untapped growth market for the dermatology sector. We believe our first-in-class drug candidate offers a potential new treatment paradigm for this market and we are looking forward to advancing program one step closer to commercialization.”

Financial Results for the Three Months Ended December 31, 2023

Total operating expenses decreased by $0.5 million to $1.9 million for the three months ended December 31, 2023 compared to $2.4 million for the same period last year.

Research and development expenses decreased by $0.7 million to $0.7 million for the three months ended December 31, 2023 compared to $1.4 million for the same period last year primarily due to decreased external research expenses related to the company’s EB01 study, which was completed during the current period, while expenses for the company’s ongoing EB05 clinical study remained relatively unchanged from the prior period.

General and administrative expenses increased by $0.1 million to $1.1 million for the three months ended December 31, 2023 compared to $1.0 million for the same period last year primarily due to increased fees for professional services and noncash share-based compensation.

Total other income increased by $136,000 to $179,000 for the three months ended December 31, 2023 compared to $43,000 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 December 31, 2023, Edesa reported a net loss of $1.7 million, or $0.54 per common share, compared to a net loss of $2.3 million, or $0.89 per common share, for the quarter ended December 31, 2022.

Working Capital

At December 31, 2023, Edesa had cash and cash equivalents of $4.3 million and working capital of $3.4 million.

Calendar

Edesa management plans to participate in the American Contact Dermatitis Society Annual Meeting on March 7, 2024, the American Academy of Dermatology Annual Meeting from March 8-12, 2024 and BIO Europe Spring 2024 from March 18-20, 2024. 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. The company has also received 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. Connect with us on X (Twitter) and LinkedIn.

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: the company’s plans to evaluate paridiprubart in a broader ARDS population as well as file an IND for a Phase 2 study in pulmonary fibrosis; the company’s plans for a Phase 2 study of its anti-CXCL10 monoclonal antibody in moderate-to-severe nonsegmental vitiligo patients; the company’s belief that the positive momentum that Edesa demonstrated at the beginning of the year puts it on a solid path to advance its respiratory and dermatology assets, including strategic discussions with potential commercialization and licensing partners; the company’s belief that engagements with regulatory agencies have been productive, and the Edesa is on track with key regulatory submissions, including clearance of INDs for our vitiligo and fibrosis projects; the company belief that it has continued access to capital and government funding, it has extended its cash runway, and has the option to ramp up its development activities in vitiligo and pulmonary fibrosis through potential partnerships, non-dilutive programs, direct investments in projects and other financings; the company’s ongoing plans to evaluate potential partnerships and funding opportunities to complete a future Phase 3 study of EB01; the company’s belief that ACD represents a large untapped growth market for the dermatology sector; the company’s belief that EB01 is a first-in-class drug candidate that offers a potential new treatment paradigm for the dermatology market, and its plans to advance its EB01 development program one step closer to commercialization; 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.

Condensed Interim Consolidated Statements of Operations
(Unaudited)

Condensed Interim Consolidated Balance Sheets
(Unaudited)

Condensed Interim Consolidated Statements of Cash Flows
(Unaudited)

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TORONTO, ON / ACCESSWIRE / January 4, 2024 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that company management plans to participate in the 2024 Dermatology Summit on January 7, 2024 as well as in one-on-one meetings alongside the J.P. Morgan 42nd Annual Healthcare Conference from January 8-11, 2024 in San Fransico, California.

Attendees interested in meeting with management can request meetings by contacting Edesa at investors@edesabiotech.com.

About Edesa Biotech

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. The company has also received regulatory approval to conduct a Phase 2 trial of 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 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. Edesa is also planning to file an investigational new drug application for a future Phase 2 study of paridiprubart for fibrotic diseases such as systemic sclerosis. Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn.

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. 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.

View the original press release on accesswire.com