Daniluromer

TORONTO, Aug. 09, 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 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. 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: 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

1.0% Formulation Reached Primary Endpoint with Statistical Significance Full Analysis Identified Additional Efficacy Signals TORONTO, ON / ACCESSWIRE / November 20, 2023 / Edesa Biotech, Inc., (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced favorable final results from a Phase 2b dose-ranging clinical study of the company's drug candidate, EB01 (daniluromer), as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD). Edesa reported that final data confirmed previous topline findings that 1.0% EB01 cream demonstrated statistically significant improvement over placebo. For the primary endpoint, patients with 1.0% EB01-treated lesions demonstrated a 60% average improvement in symptoms from baseline at day 29 on the Contact Dermatitis Severity Index (CDSI) versus 40% for placebo/vehicle (p=0.027). For the ISGA secondary efficacy endpoint, 53% of patients with 1.0% EB01-treated lesions achieved a score of "clear" or "almost clear" with at least a 2-point improvement from baseline after treatment at day 29 (p=0.048). Only 29% of patients in the placebo group reached the same endpoint. For other dose formulations, no material changes to previously reported topline efficacy results were identified. No serious treatment-related adverse events were reported across all dose formulations. In addition, analysis of the full dataset demonstrated that patients receiving 1.0% EB01 (daniluromer) experienced improvement across each component symptom of the CDSI score, including redness (50% reduction for EB01 vs. 35.4% placebo; p=0.17), pruritis/itching (60.5% reduction for EB01 vs. 41.3% placebo; p=0.06), fissures (63.1% reduction for EB01 vs. 44.3% placebo; p=0.02), scaling (58.3% reduction for EB01 vs. 42.9% placebo; p=0.36), and dryness (62.9% reduction for EB01 vs. 35.9% placebo; p=0.02). The final data also demonstrated that the Body Surface Area (BSA) of 1.0% EB01-treated lesions was reduced by 42.1% on average at day 29 compared to a 8.8% reduction for placebo/vehicle (p=0.054). "We are thrilled to announce the positive final clinical study results for 1.0% EB01 cream, which not only confirm our previous data but also provided important new insights into the efficacy of our first-in-class drug candidate," said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. "This significant milestone puts us in position to advance potential partnership discussions and ultimately brings us one step closer to delivering potentially life-changing solutions to patients with moderate to severe, chronic allergic contact dermatitis." About the Phase 2b Study Edesa's double-blind, placebo-controlled Phase 2b trial evaluated the safety and efficacy of EB01 (daniluromer) in approximately 200 subjects, who were treated for 28 days with either EB01 cream (2.0%, 1.0% or 0.2%) or a placebo/vehicle cream. The primary efficacy outcome measurement was the mean percent improvement in symptoms from baseline at day 29 on the Contact Dermatitis Severity Index (CDSI). A key secondary efficacy measurement was the success rate of subjects achieving a score of "clear" or "almost clear" with at least a 2-point improvement from baseline after treatment at day 29 on the Investigator's Static Global Assessment (ISGA) scale. About Daniluromer Daniluromer is a first-in-class, non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors - at the inception of inflammation rather than after inflammation has occurred - Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 (topical daniluromer) has demonstrated efficacy for the treatment of ACD in two previous clinical trials, and has demonstrated anti-inflammatory activity in a variety of in vitro and in vivo preclinical pharmacology models. About Allergic Contact Dermatitis Contact dermatitis, which can be either irritant contact dermatitis or ACD (sometimes called allergic contact eczema), is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually in the U.S. as a result of lost work, reduced productivity, medical care and disability payments. The condition is caused by an allergen interacting with skin, usually on the hands and face. Inflammation can vary from irritation and redness to open sores, and in many chronic cases, the causative allergen is unknown or difficult to avoid. Approximately 3,000 substances are recognized as contact allergens. 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. 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 investigational new drug application for a future Phase 2 study of paridiprubart for systemic sclerosis (scleroderma), an autoimmune rheumatic disorder that causes fibrosis, (scarring/hardening) of skin and internal organs such as the lungs, heart and kidneys. 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 determination that the final Phase 2b study data not only confirmed previous topline data but also provided important new insights into the efficacy of its first-in-class drug candidate; the company's belief that the final study report and data represent a significant milestone; the company's belief that final Phase 2b data puts the company in position to advance potential partnership discussions and ultimately brings Edesa one step closer to delivering potentially life-changing solutions to patients with moderate to severe, chronic allergic contact dermatitis; 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 Koppenjan Edesa Biotech, Inc. (289) 800-9600 investors@edesabiotech.com SOURCE: Edesa Biotech View source version on accesswire.com: