(Investorideas.com Newswire) a go-to platform for big investing ideas, including  biotech stocks issues a news and trading alert for Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases. The stock makes the Nasdaq top gainer list on news today, currently trading at $1.5300, up 0.6310 on over 38 Million shares as of this report. The stock has a morning  high of $1.60. Edesa Biotech announced today p ...

Core Insights - Edesa Biotech, Inc. announced positive results from a Phase 3 study of paridiprubart, demonstrating a significant reduction in 28-day mortality across a broad patient population [1][2][3] Study Results - The study involved 278 patients, including 104 requiring invasive mechanical ventilation (IMV) and 174 non-IMV patients, showing a 27% relative reduction in mortality from 33% to 24% (p<0.001) [2][3] - In a subgroup of 174 non-IMV patients, paridiprubart reduced mortality from 23% to 15%, a 35% relative reduction (p<0.05) [4] - Exploratory analyses indicated consistent mortality reductions in patients with serious comorbidities, with overall adverse events being low and similar between treatment groups [5] Patent and Regulatory Developments - Edesa has filed provisional patent applications for paridiprubart's use in treating sepsis, acute kidney injury, and pneumonia, with core patents extending into the 2030s [6] - The company is advancing regulatory discussions and exploring strategic collaborations to accelerate development and broaden access [8] Future Studies and Presentations - Paridiprubart is being evaluated in a separate U.S. government-funded study with enrollment ongoing for approximately 200 subjects [9] - Edesa has been selected for an oral presentation at the ATS 2026 conference to share additional findings from the Phase 3 study [12] Mechanism and Background - Paridiprubart is a first-in-class anti-TLR4 antibody designed to modulate the immune response in various critical conditions, including ARDS, which has high mortality rates and limited treatment options [19][20] - ARDS accounts for 10% of ICU admissions globally, representing over 3 million patients annually [20] Company Overview - Edesa Biotech focuses on developing innovative treatments for inflammatory and immune-related diseases, with a clinical pipeline that includes both medical dermatology and respiratory therapeutic areas [21]

Financial Performance - Net loss was $2.2 million, or $0.28 per common share, for the three months ended December 31, 2025, compared to a net loss of $1.6 million, or $0.48 per common share for the same period in 2024[98]. - Total operating expenses increased by $0.4 million to $2.3 million for the three months ended December 31, 2025, compared to $1.9 million for the same period last year[95]. - The company had an accumulated deficit of $68.2 million and working capital of $12.0 million, including $12.1 million in cash and cash equivalents as of December 31, 2025[110]. - The company expects to continue incurring substantial operating losses as it develops product candidates and seeks marketing approval[111]. Cash Flow - Net cash used in operating activities was $2.1 million for the three months ended December 31, 2025, compared to $1.5 million for the same period in 2024[101]. - Net cash provided by financing activities was $3.4 million for the three months ended December 31, 2025, compared to $2.1 million for the same period in 2024[114]. - Cash and cash equivalents at the end of the quarter were $12.1 million, compared to $10.8 million as of September 30, 2025[101]. Research and Development - Research and development (R&D) expenses increased by $0.1 million to $1.1 million for the three months ended December 31, 2025, primarily due to increased expenses for manufacturing-related activities[95]. - R&D expenses increased to $1.1 million for the three months ended December 31, 2025, compared to $1.0 million for the same period in 2024, primarily due to manufacturing-related activities[116]. - EB05, a drug candidate for Acute Respiratory Distress Syndrome, met primary and secondary endpoints in a Phase 3 clinical study, showing clinically meaningful improvement in survival and recovery[92]. - EB06, an anti-CXCL10 monoclonal antibody candidate, is in discussions for a Phase 2 proof of concept study in patients with moderate-to-severe nonsegmental vitiligo, with enrollment anticipated by midyear 2026[90]. - The company is pursuing additional uses for paridiprubart in chronic diseases and is eligible for reimbursement of certain development expenses from the Government of Canada[92]. Financing Activities - The company sold 1,177,568 common shares for net proceeds of approximately $3.4 million under the At The Market Offering Agreement during the three months ended December 31, 2025[93]. - The company sold an aggregate of 834 Series B-1 Preferred Shares and 3,468,746 common shares for gross proceeds of approximately $15.0 million in a private placement[102]. - The company filed a shelf registration statement allowing for the offer and sale of up to $150.0 million of securities, effective September 9, 2025[103]. - The company plans to seek additional financing through equity sales, government grants, and potential strategic transactions to fund operations and product development[111]. Administrative Expenses - General and administrative (G&A) expenses increased by $0.3 million to $1.2 million for the three months ended December 31, 2025, primarily due to an increase in noncash share-based compensation[97]. - The company recorded grant income of $0.1 million for the three months ended December 31, 2025, a decrease from $0.3 million in the same period last year[105]. Off-Balance Sheet Arrangements - The company has no off-balance sheet arrangements that could materially affect its financial condition[117].

Financial Performance - For the first quarter ended December 31, 2025, Edesa reported a net loss of $2.2 million, or $0.28 per common share, compared to a net loss of $1.6 million, or $0.48 per common share for the same period in 2024[6]. - Total operating expenses increased by $0.4 million to $2.3 million for the three months ended December 31, 2025, compared to $1.9 million for the same period in the previous year[5]. - General and administrative expenses increased by $0.3 million to $1.2 million for the three months ended December 31, 2025, primarily due to an increase in noncash share-based compensation[8]. - The company reported a decrease in total other income by $0.2 million to $0.1 million for the three months ended December 31, 2025, primarily due to reduced reimbursement funding from the Canadian government's Strategic Response Fund[5]. Research and Development - Research and development expenses rose by $0.1 million to $1.1 million for the three months ended December 31, 2025, primarily due to increased manufacturing-related activities[8]. - Edesa is exploring accelerated commercialization pathways for its monoclonal antibody paridiprubart following positive Phase 3 study results[4]. - Edesa plans to present its Phase 3 respiratory and subgroup data at upcoming scientific and medical conferences[3]. - The company plans to begin recruitment for its Phase 2 study in moderate-to-severe nonsegmental vitiligo by midyear 2026, subject to regulatory approvals[3]. Financial Position - Edesa had cash and cash equivalents of $12.1 million and working capital of $12.0 million as of December 31, 2025[7]. - Total assets increased to $14.7 million as of December 31, 2025, compared to $13.5 million as of September 30, 2025[15].

TORONTO, Feb. 13, 2026 (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 months ended December 31, 2025 and provided an update on its business. During the first quarter, Edesa progressed manufacturing of its dermatology drug candidate, EB06 (an anti-CXCL10 monoclonal antibody), and placebo for an upcoming Phase 2 study in moderate-t ...

Drug Development and Clinical Trials - The company is developing EB06, an anti-CXCL10 monoclonal antibody for vitiligo, with a Phase 2 study expected to enroll by mid-2026, pending regulatory approval[22]. - EB05, a new class of Host-Directed Therapeutics, showed statistically significant improvement in survival and recovery in a Phase 3 study for ARDS, which accounts for approximately 10% of ICU admissions globally[23][37]. - The Phase 2 study indicated a 28-day mortality rate of 7.7% for the EB05 plus SOC group versus 40% for the placebo plus SOC group in critically ill patients, with a p-value of 0.04[45]. - The U.S. government has selected EB05 for a Phase 2 platform study funded by BARDA, focusing on ARDS treatments[46]. - The Canadian government committed up to C$23 million in funding for a Phase 3 clinical study of EB05, with C$5.75 million being non-repayable[48]. - The company is evaluating additional product candidates targeting inflammatory and immune-related diseases, including potential treatments for pulmonary fibrosis[51]. - The company must complete extensive clinical trials to demonstrate the safety and efficacy of its product candidates, which are expensive and uncertain[159]. - Unacceptable adverse events in clinical trials could delay or prevent regulatory approval and commercialization of the company's product candidates[161]. - Prolonged or delayed clinical trials may incur additional costs and hinder the timely commercialization of product candidates[162]. - The company faces potential delays in clinical trials, which could increase development costs and affect commercial prospects for its product candidates[164]. - There is uncertainty regarding the clinical trial designs and endpoints required for obtaining marketing approval, which may lead to additional trials and financial impacts[165]. Market Opportunity and Financials - The estimated prevalence of vitiligo is between 0.5% to 2% of the global population, indicating a significant market opportunity[26]. - The total addressable patient population for EB01, a therapy for Allergic Contact Dermatitis, is estimated to be as high as 5 million in major markets and Canada[34]. - ARDS-related ICU admissions are estimated at 600,000 annually in the seven major markets and Canada, with average ICU costs exceeding $100,000 per patient[37]. - The company has received over C$37 million in competitive government grants and funding awards, validating its technology and drug development capabilities[24]. - The company expects research and development expenses to increase significantly, particularly for drug candidates beyond Phase 2 clinical development[127]. - Substantial additional funding will be needed to finance operations through regulatory approval of product candidates; failure to raise capital could delay or eliminate development programs[121]. - The company anticipates that its cash and cash equivalents may not be sufficient to fund operations for one year after the filing date unless additional capital is raised or spending is delayed[125]. - The company has entered into the 2023 SIF Agreement with the Government of Canada, which includes up to C$23 million in partially repayable funding for the development of investigational therapy EB05, with a project completion deadline of December 31, 2028[134]. - The company relies on government grants, including C$14.1 million from the 2021 SIF Agreement, to support its EB05 development program[133]. Regulatory Environment - The company plans to pursue expedited regulatory review and orphan drug programs to accelerate clinical development timelines for its product candidates[27]. - The FDA requires extensive preclinical testing and multiple phases of human clinical trials before a product candidate can be marketed in the U.S.[72][74]. - The company must submit an NDA or BLA to the FDA after completing clinical trials, which includes comprehensive data on product development and testing[74]. - The Prescription Drug User Fee Act mandates user fees for each NDA or BLA submission, which are adjusted annually by the FDA[75]. - The FDA reviews NDA or BLA submissions within 60 days to determine if they are substantially complete, with performance goals to review 90% of original standard NDAs or BLAs within 10 months and 90% of original priority NDAs or BLAs within 6 months[1]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) if the benefits of a biologic do not outweigh potential risks, which must be submitted before BLA approval[2]. - The FDA typically inspects manufacturing facilities and clinical sites before approving an NDA or BLA to ensure compliance with GMP and GCP requirements[3]. - If the FDA issues a complete response letter, it may outline specific deficiencies that could be minor or major, affecting the approval process[4]. - Orphan drug designation can provide exclusivity for seven years if the product receives the first FDA approval for a specific active ingredient for a rare disease[5]. - The FDA has programs like Fast Track and Breakthrough Therapy designations to expedite the development and review of drugs addressing serious conditions[6]. - Priority Review designation allows for a six-month review period for drugs that significantly improve safety or effectiveness compared to existing treatments[7]. - Accelerated Approval may require post-approval studies to verify clinical benefits, and the FDA can withdraw approval if confirmatory trials fail[8]. - The Biologics Price Competition and Innovation Act provides a 12-year exclusivity period for reference products, impacting the approval of biosimilars[9]. - Sponsors of clinical trials must register and disclose information on clinicaltrials.gov, with results required to be disclosed after trial completion[10]. Competition and Market Risks - The pharmaceutical industry is highly competitive, with potential competitors including large pharmaceutical companies and smaller biotech firms, many of which have greater resources[68]. - The company faces substantial competition, which may result in others commercializing products for target indications before it does[121]. - The competitive landscape is significant, with major pharmaceutical and biotechnology companies potentially developing more effective treatments[172]. - Regulatory pricing and reimbursement practices may adversely affect the company's ability to generate revenue from approved products[173]. - The company faces significant competition in securing partnerships for Phase 3 clinical testing, which is crucial for funding and advancing its product candidates[184]. Intellectual Property and Licensing - The company has an exclusive license agreement with NovImmune SA, which includes potential milestone payments up to $356 million[57]. - The company has exclusive rights to develop and commercialize a pharmaceutical product for topical dermal and anorectal applications under the Yissum License Agreement, with a total commitment of up to $18.4 million in milestone payments[62]. - The Inventor License Agreement grants the company global rights for all fields of use for the pharmaceutical product, with future potential payments totaling up to $69.1 million based on commercial approval and sales milestones[64]. - The company is dependent on maintaining patent protection for its technologies, as failure to do so could allow competitors to commercialize similar products[196]. - The company may face legal proceedings regarding intellectual property rights, which could adversely affect its business and market position[199]. - Intellectual property litigation may lead to significant expenses and distract management, potentially increasing operating losses[200]. Management and Workforce - The leadership team has extensive experience in drug development and commercialization, enhancing the company's competitive position in the biopharmaceutical sector[24]. - The company employs 17 full-time employees, with 10 in research and development and 7 in management and administration[114]. - More than 50% of the workforce consists of women, and over 50% are individuals from underrepresented racial or ethnic groups[115]. - The company is highly dependent on key executives, and the loss of any of these individuals could materially impact its objectives[155]. - The company faces competition in attracting and retaining qualified personnel, which is critical for achieving its business objectives[156]. - The company anticipates growth in employee numbers and operational scope, particularly in drug development and regulatory affairs, which may lead to management challenges[154]. Financial Position and Shareholder Information - The company is a late-stage biopharmaceutical firm with no products approved for commercial sale and has incurred significant losses since inception, expecting to continue incurring losses[121]. - As of September 30, 2025, the company has incurred an accumulated deficit of $65.9 million and expects to continue incurring significant operating losses for the foreseeable future[122]. - The company does not currently intend to pay dividends, relying on share price appreciation for investor returns[206]. - As of December 12, 2025, the CEO owns 19.99% of outstanding shares, and executive officers and directors collectively own 23.6%[211]. - Velan Capital beneficially owns 9.99% of outstanding shares and has the right to designate a director nominee[212]. - The company has filed Amended Articles for Series A-1 and Series B-1 Convertible Preferred Shares, each with a stated value of $10,000[216][217]. - Series A-1 Preferred Shares accrue a 10% annual return and are convertible at a fixed price of $3.445[219]. - Series B-1 Preferred Shares are convertible at a fixed price of $1.92[220]. - The market price of common shares may decline due to substantial sales or the perception of potential sales[207]. - The company must comply with Nasdaq listing requirements to avoid delisting, which could reduce liquidity and market price[204][205]. - The concentration of voting power among executives could delay or prevent beneficial corporate actions for other shareholders[213].

Financial Performance - For the fiscal year ended September 30, 2025, Edesa reported a net loss of $7.2 million, or $1.27 per common share, compared to a net loss of $6.2 million, or $1.93 per common share for the previous year[6]. - Total operating expenses increased by $0.9 million to $7.9 million for the year ended September 30, 2025, compared to $7.0 million for the prior year[5]. - Total other income decreased by $0.1 million to $0.7 million for the year ended September 30, 2025, primarily due to a decrease in interest income[5]. Research and Development - Research and development expenses rose by $0.8 million to $3.7 million for the year ended September 30, 2025, primarily due to increased manufacturing-related activities[8]. - A Phase 3 study of paridiprubart met primary and secondary endpoints with statistical significance, and Edesa is exploring development partnerships for this asset[3]. - The company initiated manufacturing activities for a Phase 2 study of EB06, with recruitment expected to begin by midyear 2026[3]. Financial Position - Edesa had cash and cash equivalents of $10.8 million and working capital of $10.4 million as of September 30, 2025[7]. - Edesa's balance sheet was strengthened, and the Canadian government funding agreement was extended to support manufacturing and development for the respiratory program[4]. Strategic Initiatives - The company plans to participate in one-on-one meetings during JP Morgan week starting January 12, 2026, to engage with potential partners[9]. - Edesa is focused on executing the Phase 2 vitiligo study, advancing respiratory assets toward commercialization, and expanding manufacturing capacity[4].

Core Insights - Edesa Biotech, Inc. reported financial results for the fiscal year ended September 30, 2025, highlighting advancements in its clinical programs and financial performance [1][4]. Financial Performance - Total operating expenses increased by $0.9 million to $7.9 million for the year ended September 30, 2025, compared to $7.0 million for the prior year [4]. - Edesa reported a net loss of $7.2 million, or $1.27 per common share, compared to a net loss of $6.2 million, or $1.93 per common share, for the year ended September 30, 2024 [5]. - Cash and cash equivalents at September 30, 2025, were $10.8 million, with working capital of $10.4 million [6]. Clinical Developments - The company initiated manufacturing activities for a Phase 2 study of EB06, an anti-CXCL10 monoclonal antibody, targeting moderate-to-severe nonsegmental vitiligo, with recruitment expected to begin by mid-2026 [2]. - A Phase 3 study of paridiprubart (EB05) met primary and secondary endpoints with statistical significance, and the company is exploring partnerships for its development and commercialization [2][3]. Strategic Initiatives - Edesa's CEO emphasized the company's strategy to advance both dermatology and respiratory assets, aiming to deliver transformative therapies to patients with high unmet medical needs [3]. - The CFO noted that the company strengthened its balance sheet and extended its Canadian government funding agreement to support manufacturing and development for its respiratory program [3]. Research and Development Expenses - Research and development expenses increased by $0.8 million to $3.7 million for the year ended September 30, 2025, primarily due to increased manufacturing-related activities and preparations for the Phase 2 clinical study of EB06 [7]. - General and administrative expenses rose by $0.1 million to $4.2 million, mainly due to increased noncash share-based compensation [7]. Future Outlook - Edesa plans to participate in one-on-one meetings during JP Morgan week starting January 12, 2026, to engage with potential strategic and government partners [7].

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Core Insights - Edesa Biotech, Inc. announced positive results from a Phase 3 study of paridiprubart (EB05) for treating Acute Respiratory Distress Syndrome (ARDS), showing significant improvements in mortality and clinical outcomes [1][2][5] Study Results - Paridiprubart met both primary and secondary endpoints with statistical significance, demonstrating a 39% risk of death at 28 days compared to 52% for placebo, indicating a 13% absolute improvement in survival [3][10] - At 60 days, the risk of death was 46% for paridiprubart versus 59% for placebo, also reflecting a 13% absolute improvement and a 22% relative risk reduction [3][10] - Patients receiving paridiprubart showed a 41% higher relative rate of clinical improvement, meaning they no longer required invasive mechanical ventilation or organ support by Day 28 [3][8] Safety Profile - The safety population included over 275 subjects, and paridiprubart was generally well-tolerated, consistent with its previously observed safety profile [4][5] Patient Demographics - The study enrolled patients aged 18 and older from 38 hospitals across the USA, Canada, and Colombia, with similar demographics in both treatment and placebo groups [7][8] Mechanism of Action - Paridiprubart is a host-directed therapeutic designed to modulate the immune response against various health threats, inhibiting toll-like receptor 4 (TLR4) [14] Company Overview - Edesa Biotech focuses on developing innovative treatments for inflammatory and immune-related diseases, with a clinical pipeline that includes paridiprubart for ARDS and other therapeutic areas [16][17]