Duyuru • Jun 06
Edesa Biotech, Inc. Reports Positive Exploratory Data for Paridiprubart in Patients with Acute Kidney Injury Edesa Biotech reported favorable exploratory data for paridiprubart, its first-in-class anti-TLR4 monoclonal antibody, in patients with acute kidney injury (AKI) and respiratory distress. The data, which expand upon previously reported Phase 3 clinical results through new exploratory analyses, will be presented in a scientific oral presentation at the 63rd European Renal Association Congress in Glasgow, Scotland. These new analyses are based on exploratory evaluations from the company’s completed clinical studies in hospitalized patients with acute respiratory distress syndrome (ARDS). Because TLR4-mediated inflammation plays a central role in both lung and kidney injury, Edesa conducted additional analyses to evaluate paridiprubart’s effect in patients with concurrent AKI, a high-mortality complication that currently lacks approved, targeted pharmacological therapies. Patients with AKI and ARDS represent a high-risk population, with substantially elevated mortality relative to patients without renal dysfunction. Among the findings, paridiprubart plus standard of care treatments (SOC) was associated with a 32% relative reduction in mortality in these AKI patients at 28 days. The observed reductions in mortality were supported by concordant improvements in kidney-specific outcomes, including the MAKE30 composite endpoint. The AKI findings reported here expand on previously reported exploratory results in 48 AKI patients from the Phase 3 ITT population by incorporating additional patients from the Phase 2 study and the broader 278-patient treatment population, for a combined AKI cohort of 101 patients. The AKI subgroup included all patients with AKI present at baseline, and outcomes were analyzed using the same multivariate methodology prespecified in the Phase 3 statistical analysis plan for ARDS. Patients in this AKI cohort were severely ill, with approximately 90% having moderate-to-severe ARDS at baseline and approximately 50% requiring invasive mechanical ventilation or ECMO, consistent with a population at high risk of mortality. Mean age was 58 years. Paridiprubart + SOC reduced adjusted 28-day mortality to 33% (95% CI: 28%–39%) from 49% (95% CI: 41%–57%) with placebo + SOC, a 32% relative reduction in the risk of death. New Risk • Jun 04
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$140k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (38% average weekly change). Earnings are forecast to decline by an average of 28% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$42m net loss in 3 years). Shareholders have been diluted in the past year (27% increase in shares outstanding). Significant insider selling over the past 3 months (US$140k sold). Market cap is less than US$100m (US$61.0m market cap). Board Change • Jun 01
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 6 experienced directors. No highly experienced directors. Independent Director David Liu was the last director to join the board, commencing their role in 2025. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Duyuru • Apr 06
Edesa Biotech, Inc., Annual General Meeting, May 27, 2026 Edesa Biotech, Inc., Annual General Meeting, May 27, 2026. Location: edesa biotech, inc., 100 spy court, ontario l3r 5h6, markham Canada Duyuru • Mar 28
Edesa Biotech, Inc. Advances Vitiligo Program With Phase 2 Clinical Study of EB06 Edesa Biotech, Inc. provided an update on preparations and reaffirmed enrollment timeline guidance for its Phase 2 clinical study of EB06 in moderate-to-severe nonsegmental vitiligo. Edesa reported that it has selected JSS Medical Research, Inc. to act as its clinical research organization (CRO) for the proof-of-concept study, and outreach to potential clinical sites and investigators has begun. Based on this progress, the company reaffirmed its previous guidance that site activations and patient recruitment are expected to begin mid-2026. Enrollment is anticipated to commence first at investigational sites in Canada, where Edesa’s clinical trial application was approved (subject to administrative filings that may be required for protocol updates). Vitiligo is a chronic autoimmune disease that causes the loss of skin pigmentation in patches. It occurs when pigment-producing skin cells, melanocytes, are targeted and destroyed by autoreactive T-cells. CXCL10, the target of Edesa’s drug, has been shown to play both a key role in the trafficking of these anti-melanocytic T-cells to the epidermis as well as in inducing cell death. Elevated levels of CXCL10 are associated with the initiation of the disease as well as the maintenance of vitiligo lesions. As planned, Edesa’s Phase 2 study will evaluate the safety and efficacy of EB06 versus placebo in adults with non-segmental (generalized) vitiligo. Patients will receive intravenous infusions of either EB06 or placebo during the treatment period, followed by a follow-up period. EB06 is a monoclonal antibody candidate that binds specifically and selectively to chemokine ligand 10 (CXCL10) and inhibits the interaction of CXCL10 with its receptor(s). CXCL10 is highly expressed in vitiligo patients, and has been shown to play both a key role in the trafficking of anti-melanocytic T-cells to the epidermis as well as directly induces melanocyte apoptosis (cell death) via CXCR3B activation. Furthermore, EB06 neutralization of CXCL10 has been demonstrated to both prevent and reverse depigmentation in preclinical studies. Results from 65 subjects in three previous clinical studies demonstrated that EB06 produced the pharmacodynamic /biological activity required to address the dysfunctional immune response associated with vitiligo, and was generally safe and well tolerated. EB06 is currently formulated for intravenous administration, with a subcutaneous formulation anticipated to be ready for follow-on clinical evaluation. Vitiligo is a chronic autoimmune disease that causes the loss of skin pigmentation in patches. It occurs when melanocytes, the pigment-producing skin cells, die or stop producing melanin. The extent of color loss from vitiligo is unpredictable and can affect the skin on any part of the body. It is estimated that vitiligo prevalence is between 0.5 to 2% of the global population. Vitiligo patients are not born with lesioned skin. Rather, unpigmented spots appear over time, with about 50% of patients having symptom onset before 20 years of age. At present, there are limited treatment options for patients, and no approved systemic drug therapies. Recent Insider Transactions • Mar 25
Insider recently sold US$140k worth of stock On the 20th of March, Stephen Lemieux sold around 22k shares on-market at roughly US$6.24 per share. This transaction amounted to 100% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Despite this recent sale, insiders have collectively bought US$164k more than they sold in the last 12 months. Recent Insider Transactions • Mar 06
CEO, Company Secretary & Director recently bought US$104k worth of stock On the 3rd of March, Pardeep Nijhawan bought around 64k shares on-market at roughly US$1.63 per share. This transaction amounted to 18% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Pardeep's only on-market trade for the last 12 months. New Risk • Feb 25
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 22% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (22% average weekly change). Earnings are forecast to decline by an average of 27% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$7.50m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$33m net loss in 3 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Duyuru • Feb 25
Edesa Biotech, Inc. Reports Additional Positive Results from Phase 3 Paridiprubart Study Edesa Biotech, Inc. announced positive additional data from a Phase 3 study of paridiprubart. The results represent a broader, 278-patient population, which includes both previously reported 104 patients requiring invasive mechanical ventilation (IMV) as well as 174 non-IMV patients. Across this full population, the company’s first-in-class anti-TLR4 antibody demonstrated a statistically significant reduction in 28-day mortality. Treatment benefits were consistent across severity groups and in patients with serious comorbidities. The primary endpoint was achieved for the full treatment population of 278 randomized subjects. Paridiprubart reduced adjusted 28-day mortality to 24% from 33%, a 27% relative reduction in the risk of death (p<0.001). In addition, subjects receiving paridiprubart demonstrated a higher relative rate of clinical improvement by Day 28. Paridiprubart or placebo were provided in addition to standard of care treatments (SOC).in an exploratory analysis of a milder population of 174 randomized patients who did not meet the study’s IMV-based inclusion criteria, paridiprubart + SOC reduced adjusted 28-day mortality to 15% from 23% (placebo + SOC), a 35% relative reduction in the risk of death (p<0.05).Edesa also reported that exploratory analyses across a patient population of up to 108 randomized subjects consistently demonstrated reduced adjusted mortality for paridiprubart + SOC vs. placebo + SOC at 28 days in subjects with clinically important comorbidities:Acute Kidney Injury: 35% relative reduction (35% paridiprubart vs. 53% placebo; p<0.05, n=48); Sepsis: 36% relative reduction (40% paridiprubart vs. 63% placebo; p<0.05, n=41); Pneumonia: 30% relative reduction (35% paridiprubart vs. 49% placebo; p<0.05, n=108). Overall rates of adverse events, serious adverse events, infections and treatment discontinuations were low and similar between the paridiprubart and placebo groups. The safety profile was consistent with prior clinical exposures, with more than 400 patients now having received paridiprubart.Based in part on these positive results, Edesa has filed provisional patent applications with the United States Patent and Trademark Office covering the use of paridiprubart in the treatment of sepsis, acute kidney injury and pneumonia. The company’s core composition-of-matter patents extend into the 2030s. Paridiprubart is currently being evaluated in a separate U.S. government-funded study of ARDS patients. Enrollment is ongoing for up to approximately 200 randomized subjects for the Edesa cohort. The company’s paridiprubart development program, including manufacturing scale-up, late-stage development and commercial readiness, also receives funding from the Government of Canada.Edesa has been selected for an oral presentation at the American Thoracic Society (ATS) 2026 International Conference (May 15-20, 2026) and plans to present additional findings from its Phase 3 study at other upcoming medical and scientific conferences. Data were derived from the full study safety population of 278 patients; the previously reported 104-patient IMV ITT cohort represents a prespecified subset of this population. Patients in the full 278-patient safety population were randomly assigned (1:1) to SOC with paridiprubart (n=138), or SOC with placebo (n=140). Baseline characteristics and SOC were balanced between treatment groups. New Risk • Feb 01
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.75m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.3m free cash flow). Earnings are forecast to decline by an average of 29% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (140% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.75m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$26m net loss in 3 years). New Risk • Dec 27
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.3m free cash flow). Earnings are forecast to decline by an average of 29% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (140% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$26m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$10.8m market cap). New Risk • Dec 14
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$7.3m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.3m free cash flow). Earnings are forecast to decline by an average of 30% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (103% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$42m net loss in 3 years). Market cap is less than US$100m (US$12.2m market cap). Duyuru • Oct 28
Edesa Biotech Reports Positive Results in Phase 3 Respiratory Study Edesa Biotech, Inc. announced positive results from a Phase 3 study evaluating the company's drug candidate paridiprubart (EB05) as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. The data from the Phase 3 study demonstrated that paridiprubart met primary and secondary endpoints with statistical significance. Patient demographics and baseline disease parameters were similar for the two groups with overall mean (SD) age: 52 (20-86) years, female (34%), severe ARDS (55); moderate ARDS (38); mild ARDS (5%), antivirals (10%), orticosteroids (44%), immunomodulators (10%), IMV only (36%), IMV with additional organ support (64%), acute kidney injury (26%), sepsis (20%), pneumonia (40%). Duyuru • Sep 10
Edesa Biotech, Inc. has filed a Follow-on Equity Offering in the amount of $4.006544 million. Edesa Biotech, Inc. has filed a Follow-on Equity Offering in the amount of $4.006544 million.
Security Name: Common Shares
Security Type: Common Stock
Transaction Features: At the Market Offering New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$5.7m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$5.7m free cash flow). Earnings are forecast to decline by an average of 43% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (118% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$33m net loss in 3 years). Market cap is less than US$100m (US$14.3m market cap). Duyuru • Apr 07
Edesa Biotech, Inc., Annual General Meeting, May 28, 2025 Edesa Biotech, Inc., Annual General Meeting, May 28, 2025. Location: edesa biotech inc, 100 spy court, markham, ontario l3r 5h6, Canada Duyuru • Apr 05
Edesa Biotech, Inc. Announces Chief Financial Officer Changes, Effective May 1, 2025 Edesa Biotech, Inc. announced the appointment of Peter J. Weiler as Chief Financial Officer, effective May 1, 2025. Mr. Weiler will succeed Stephen Lemieux, who will be stepping down from the role effective May 1, 2025, to pursue other professional opportunities. Mr. Weiler brings extensive experience in finance and corporate strategy within the biotechnology and pharmaceutical industries. Since August 2018, Mr. Weiler served as President of Exzell Pharma, Inc. From August 2017 to August 2018, Mr. Weiler served as Vice President of Business Development at Biosyent Inc. Prior to that, he served in various roles at Cipher Pharmaceuticals Inc., including Vice President of Business Development from January 2015 to June 2017, Senior Director from January 2012 to January 2014, and Director from December 2008 to December 2011. Prior to Cipher, he served as Senior Director of Investment Analysis at DRI Capital Inc. and held research and financial positions at Eli Lilly Canada Inc. Mr. Weiler holds a Master of Business Administration degree from the Ivey School of Business, University of Western Ontario, a Masters of Science in Biology from the University of Western Ontario, and a Bachelor of Science (Honors Biology) degree and Diploma in Accounting from Wilfrid Laurier University. Following the planned transition, Mr. Lemieux will continue to provide financial advisory services to Edesa. New Risk • Feb 18
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 119% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (26% average weekly change). Earnings are forecast to decline by an average of 7.7% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (119% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$6.8m net loss in 2 years). Market cap is less than US$100m (US$18.7m market cap). Duyuru • Feb 15
Edesa Biotech, Inc. Appoints David Liu to the Board of Directors Edesa Biotech, Inc. announced that on February 12, 2025, in connection with the closing of the Purchase Agreement and pursuant to the terms of the IRA, the Company appointed David Liu, the Lead Investor Nominee, to serve on the Board of Directors with an initial term expiring at the next general meeting of shareholders of the Company. Dr. Liu will also serve on the Compensation Committee of the Board of Directors. David Liu, age 39, has over 10 years of investment experience within the biopharmaceutical industry. From January 2023 to March 2024, and since December 2024, he has served as a Senior Analyst at Velan Capital Investment Management LP, a healthcare dedicated investment firm based in Alpharetta, Georgia. Prior to his current position, he served as a Biotech Analyst at Altium Capital Management, LP, an investment firm focused on healthcare companies from January 2019 to November 2022. He received his B.S. in Biological Sciences from Stanford University and his Ph.D. in Molecular Biology from Weil Cornell Graduate School of Medical Sciences. Dr. Liu is qualified to serve on the Board of Directors because of experience in the biopharmaceutical industry. Duyuru • Feb 14
Edesa Biotech, Inc. announced that it has received $14.999992 million in funding from Velan Capital Investment Management LP and another investor Edesa Biotech, Inc. announced that it has entered into a securities purchase agreement to issue 834 Series B-1 Convertible Preferred Shares at a price of $10,000 for the gross proceeds of 8,340,000 and 3,468,746 Common Shares at a price of $1.92 per share for the gross proceeds of $6,659,992.32 for the total gross proceeds of $14,999,992.32 led by new investor, Velan Capital Investment Management LP on February 12, 2025. The transaction included participation from returning investor, Pardeep Nijhawan for 100 Series B-1 Convertible Preferred Shares. The preferred shares will be convertible into approximately 5,208 common shares at a price of $1.92 per share. New Risk • Feb 13
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 25% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (25% average weekly change). Earnings are forecast to decline by an average of 6.5% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$6.45m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$7.2m net loss in 3 years). New Risk • Dec 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 33% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$6.85m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$13m net loss in 2 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (7.8% increase in shares outstanding). New Risk • Nov 05
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$8.35m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 33% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$8.35m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$13m net loss in 2 years). Shareholders have been diluted in the past year (7.8% increase in shares outstanding). Duyuru • Nov 01
Edesa Biotech, Inc. announced that it expects to receive $5.136066 million in funding from Pardeep Nijhawan Medicine Professional Corporation Edesa Biotech, Inc entered into a Securities Purchase Agreement to issue 500 shares of Series A-1 Convertible Preferred Shares, stated value $10,000 per share, at issue price $10,272.13 per share for gross proceeds $5,136,065 and warrants to purchase common shares on October 30, 2024.The transaction includes participation from returning investor, Pardeep Nijhawan Medicine Professional Corporation.
On same day, the company announced it has issued 150 Preferred Shares, at issue price $10,272.13 initially convertible into an aggregate of 435,414 Conversion Shares and Warrants to purchase up to an aggregate of 326,560 Warrant Shares for an aggregate purchase price of $1,540,819 in its first tranche. Duyuru • Oct 06
Edesa Biotech, Inc. has filed a Follow-on Equity Offering in the amount of $3.87 million. Edesa Biotech, Inc. has filed a Follow-on Equity Offering in the amount of $3.87 million.
Security Name: Common Shares
Security Type: Common Stock
Transaction Features: At the Market Offering Duyuru • Jun 25
BARDA Selects Edesa Biotech's Drug for U.S. Funded Platform Trial in General ARDS Edesa Biotech, Inc. announced 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 paridiprubartrepresents 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. 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. 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. Duyuru • Mar 30
Edesa Biotech, Inc., Annual General Meeting, May 30, 2024 Edesa Biotech, Inc., Annual General Meeting, May 30, 2024. Price Target Changed • Jan 18
Price target decreased by 35% to US$24.00 Down from US$36.67, the current price target is an average from 3 analysts. New target price is 457% above last closing price of US$4.31. Stock is down 58% over the past year. The company is forecast to post a net loss per share of US$3.76 next year compared to a net loss per share of US$2.93 last year. Duyuru • Nov 21
Edesa Biotech, Inc. Reports Final Phase 2b Results for Dermatitis Study Edesa Biotech, Inc. 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). Duyuru • Oct 26
Edesa Biotech, Inc. Approves Updated Phase 3 Trial Design for Edesa Biotech’S ARDS Drug Edesa Biotech, Inc. announced that Health Canada has approved the company's proposal to harmonize clinical trial designs in the U.S. and Canada for an ongoing Phase 3 study of EB05 (paridiprubart). Edesa's monoclonal antibody is currently being evaluated as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure characterized by widespread inflammatory injury to the lungs. Approximately 10% of all ICU admissions are ARDS related. The harmonized protocol calls for treatment of approximately 600 ARDS subjects hospitalized with SARS-CoV2 infections who are on invasive mechanical ventilation, both with and without additional organ support such as extracorporeal membrane oxygenation (ECMO). The primary endpoint is the mortality rate at 28 days. The amended study design replaces the previous protocol which targeted a population of more than 800 subjects, with two independent cohorts and cohort-specific endpoints. Earlier this year, Edesa and the U.S. Food and Drug Administration agreed on the primary efficacy endpoint and single, smaller population for the Phase 3 study. Paridiprubart is a first-in-class monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. This host-directed therapeutic (HDT) candidate inhibits toll-like receptor 4 (TLR4), a key immune signaling protein that has been shown to be activated both by viruses, like SARS-CoV2 and influenza, as well as in the pathogenesis of chronic autoimmune diseases. In a Phase 2 clinical study that the company completed during the pandemic EB05 (paridiprubart) reduced mortality by 84% among critically ill patients with ARDS. A parallel in vitro study also demonstrated that paridiprubart inhibits inflammation from influenza and other pathogens. Price Target Changed • Oct 21
Price target decreased by 10% to US$52.33 Down from US$58.33, the current price target is an average from 3 analysts. New target price is 1,421% above last closing price of US$3.44. Stock is down 51% over the past year. The company is forecast to post a net loss per share of US$3.08 next year compared to a net loss per share of US$7.37 last year. Duyuru • Oct 13
Edesa Biotech, Inc. to Receive Up to CAD 23 Million in Funding from Federal Government Edesa Biotech, Inc. has secured a commitment of up to CAD 23 million from the Government of Canada for a pivotal Phase 3 clinical study of the company's first-in-class therapeutic candidate. Edesa's experimental drug, called EB05 (paridiprubart), represents a new class of emerging therapies called Host-Directed Therapeutics (HDTs) that are designed to modulate the body's own immune response when confronted with infectious diseases or even chemical agents. Importantly, these therapies are agnostic to the causal agent and can be stockpiled preemptively for seasonal outbreaks and unexpected emergencies and threats. Edesa's current project builds on the success of a government-supported Phase 2 clinical study completed during the pandemic which demonstrated that paridiprubart reduced mortality by 84% among critically ill patients with a severe form of respiratory disease called Acute Respiratory Distress Syndrome (ARDS). A parallel in vitro study at the University of Toronto also demonstrated recently that paridiprubart inhibits inflammation from influenza and other pathogens. New Risk • Oct 11
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$8.66m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Earnings are forecast to decline by an average of 62% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$8.66m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$30m net loss in 2 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (36% increase in shares outstanding). New Risk • Aug 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$12m free cash flow). Earnings are forecast to decline by an average of 47% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$32m net loss in 2 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (33% increase in shares outstanding). Market cap is less than US$100m (US$18.1m market cap). Duyuru • Jun 29
Edesa Biotech's Ards Drug Inhibits Inflammation from Influenza and Other Pathogens Edesa Biotech, Inc. announced positive findings from an in vitro study of its monoclonal antibody candidate, paridiprubart, against a panel of respiratory pathogens. The study was completed by the University of Toronto in parallel to the company's ongoing clinical study of EB05 (paridiprubart) in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe form of respiratory failure characterized by widespread inflammatory injury to the lungs. Approximately 10% of all ICU admissions are ARDS related. The research results available in preprint demonstrated that multiple pathogens, including Influenza A, coronavirus and a common bacterium (H. influenzae), can initiate an overactive immune response through Toll-like Receptor 4 (TLR4), a key component of the innate immune system. More importantly, the study determined that inflammation signaling from each of these pathogens was inhibited by Edesa's TLR4 antagonist, paridiprubart. Paridiprubart represents a new class of emerging therapies called Host-Directed Therapeutics (HDTs) that are designed to modulate the body's own immune response when confronted with infectious diseases or even chemical agents. Importantly, these therapies are designed to work across multiple infectious diseases and threats, and could be stockpiled preemptively ahead of outbreaks. Duyuru • Jun 28
Edesa Biotech Appoints Biotech Deal Veteran to CFO, Effective July 15, 2023 Edesa Biotech, Inc. announced that the company's board of directors has appointed Stephen Lemieux, CPA to the role of Chief Financial Officer, effective July 15, 2023. He is a veteran of the healthcare and biopharmaceutical sectors, with more than 20 years of experience in financial planning and analysis, licensing and mergers & acquisitions. Prior to joining Edesa, Mr. Lemieux held senior financial leadership positions at healthcare and biopharmaceutical biotechnology companies, where he guided financial strategies, optimized capital structures, and supported significant corporate transactions and sales growth. From July 2021 until June 2023, Mr. Lemieux served as CFO of Titan Medical Inc., and from April 2019 to July 2021 as CFO and Secretary of NeuPath Health. Prior to NeuPath, he was the CFO and Secretary of Cipher Pharmaceuticals from September 2016 to March 2019 and during his tenure served as Interim-CEO from November 2016 to April 2017. Prior to Cipher Pharmaceuticals, he was CFO at Nuvo Pharmaceuticals and Crescita Therapeutics. Mr. Lemieux is a Chartered Professional Accountant and holds a Master of Management & Professional Accounting degree from the University of Toronto. Duyuru • Jun 25
Edesa Biotech Receives Non-Compliance Notice From Nasdaq On June 22, 2023, Edesa Biotech, Inc. (Company) received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, based on the closing bid price of the Company’s common shares, no par value per share (the “Common Shares”), for the last 30 consecutive business days, the Company is not in compliance with the minimum bid price requirement of $1.00 per share for continued listing, as set in Nasdaq Listing Rule 5550(a)(2). The Nasdaq notification has no immediate impact on the listing of the Company’s Common Shares on The Nasdaq Capital Market, and, therefore, the Company’s listing remains fully effective. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has an initial period of 180 calendar days, or until December 19, 2023, to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. If at any time before December 19, 2023, the closing bid price of the Company’s Common Shares closes at or above $1.00 per share for 10 consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance with the minimum bid price requirement, and the matter would be resolved. In the event the Company does not regain compliance by December 19, 2023, the Company may be eligible for an additional 180 calendar day period to regain compliance, provided the Company (i) meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and (ii) provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse share split, if necessary. The Company intends to actively monitor the bid price of its Common Shares and will consider available options to resolve the deficiency and regain compliance with the Nasdaq minimum bid price requirement. If the Company does not regain compliance within the allotted compliance periods, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company’s Common Shares will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the minimum bid price requirement during the 180-day compliance period, secure a second period of 180 days to regain compliance or maintain compliance with the other Nasdaq listing requirements. Board Change • Jun 02
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 5 non-independent directors. Independent Director Sean MacDonald was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Duyuru • Feb 02
Edesa Biotech Receives Regulatory Approval for Phase 2 Vitiligo Study Edesa Biotech, Inc. announced that it has received approval from Health Canada for a Phase 2 clinical study of the company's EB06 monoclonal antibody candidate as a treatment for vitiligo. Vitiligo is a life-altering autoimmune disease that causes skin to lose its color in patches. While it can affect any area, vitiligo commonly occurs on the face, neck and hands, and is a lifelong condition. According to the World Health Organization, vitiligo affects approximately 1% of the world's population. Edesa's drug targets autoreactive T cells that destroy the pigment-producing cells of the epidermis. Specifically, EB06 binds to chemokine ligand 10 (CXCL10) and inhibits the interaction of CXCL10 with its receptor(s). CXCL10 is highly expressed in vitiligo patients in both skin and serum, and CXCL10 is implicated in both the initiation of the disease and the maintenance of vitiligo lesions. Results from 65 subjects in three previous clinical studies demonstrated that EB06 produced the pharmacodynamic /biological activity required to address the dysfunctional immune response associated with vitiligo, and was generally safe and well tolerated. Preclinical studies have also demonstrated that neutralization of CXCL10 prevented and reversed depigmentation. Duyuru • Jan 18
Edesa Biotech, Inc. Reports Topline Phase 2B Results for Dermatology Drug Edesa Biotech, Inc. announced preliminary, topline results from a Phase 2b clinical study evaluating multiple concentrations of the company's drug candidate, EB01, as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD). The double-blind, placebo-controlled trial evaluated the safety and efficacy of EB01 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. The company reported 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 CDSI versus 39% for placebo/vehicle (p=0.02). The effect was also observed at 15 days (44% for 1.0% EB01 vs 29% for placebo; p=0.05) and continued at follow-up (64% for 1.0% EB01 vs. 44% for placebo; p=0.04). 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=0.04). Only 29% of patients in the placebo group reached the same endpoint. No serious treatment-related adverse events were reported across all concentrations. The 2.0% and 0.2% formulations did not show significant differences compared to placebo. The company is preparing for an End of Phase 2 meeting with FDA following full analysis. The company expects to complete the analysis of the Phase 2b data by midyear. Duyuru • Dec 21
Fda Grants Fast Track to Edesa Biotech's Ards Drug Candidate Edesa Biotech, Inc. received Fast Track designation from the U.S. Food and Drug Administration for its monoclonal antibody candidate, EB05. Approval of the company's application follows favorable Phase 2 results from an international Phase 2/3 study of EB05 in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe form of respiratory failure characterized by widespread inflammatory injury to the lungs. The Fast Track program provides Edesa with the opportunity for more frequent communication with the agency to discuss the development path for EB05 as a treatment for ARDS in critically ill Covid-19 patients. Investigational drugs that receive Fast Track designation are also eligible for rolling review of their marketing application as well as potential pathways for accelerated regulatory approval. To receive this designation, drug candidates must both treat a serious disease and have non-clinical or clinical data that demonstrate the potential to address an unmet medical need. Breakeven Date Change • Nov 29
No longer forecast to breakeven The 2 analysts covering Edesa Biotech no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$52.7m in 2023. New consensus forecast suggests the company will make a loss of US$26.7m in 2024. Board Change • Nov 16
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 5 experienced directors. 1 highly experienced director. Independent Director Jenn Chao was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Duyuru • Nov 05
Edesa Biotech, Inc. announced that it has received CAD 3.027754 million in funding Edesa Biotech, Inc. announced the closing of the private placement of 2,691,337 common shares, 12-month warrants to purchase up to an aggregate of 1,345,665 common shares and 3-year warrants to purchase up to an aggregate of 1,345,665 common shares for gross proceeds of CAD 3,027,754 on November 3, 2022. Each common share was sold together with one-half of a whole 12-month warrant to purchase one common share and one-half of a whole 3-year warrant to purchase one common share. The common shares and accompanying warrants were sold at a combined offering price of CAD 1.125. The warrants will be exercisable on the earlier to occur of the date that is 60 days from the closing date and the date a registration statement for the common shares issuable upon exercise of the warrants is declared effective. The exercise price of the 12-month warrants is CAD 1.00, and the exercise price of the 3-year warrants is CAD 1.50. The securities issued will be subject to applicable Canadian hold periods imposed under applicable securities legislation. Duyuru • Oct 01
Edesa Biotech Reports Statistically Significant Mortality Reductions in Phase 2 ARDS Drug Study Edesa Biotech, Inc. announced final results from the Phase 2 portion of its ongoing Phase 2/Phase 3 clinical study. The study is evaluating the company's monoclonal antibody candidate, EB05, as a single-dose treatment for hospitalized patients with or at risk of developing Covid-19 induced Acute Respiratory Distress Syndrome (ARDS). The company previously reported initial topline data provided by the study's data safety monitoring board, which preemptively unblinded certain study data for efficacy signals. Edesa has now completed a formal Clinical Study Report (CSR) for U.S. regulators on the full, validated Phase 2 dataset. In the final Phase 2 clinical trial results, Edesa reported that EB05 demonstrated a statistically significant and clinically meaningful trend for mortality and survival time for all randomized subjects in the critically ill cohort (the intent to treat, or ITT, population). Today, the company reported a revised 28-day death rate of 7.7% in the EB05 plus standard of care (SOC) arm versus 40% in the placebo + SOC arm in critically severe patients on ECMO therapy (extracorporeal membrane oxygenation) or Invasive Mechanical Ventilation (IMV) plus organ support with ARDS at baseline (p=0.04). The revised Survival Analysis using Cox's Proportional Hazard Model demonstrated that patients treated with EB05 plus SOC had an 84.0% reduction in the risk of dying when compared to placebo + SOC at 28 days. The company submitted the Phase 2 CSR this week to the U.S. Food and Drug Administration as part of the review of Edesa's Phase 3 clinical protocol design and statistical plan. The Phase 3 study design has already been approved in Canada, Colombia and Poland, where recruitment is ongoing.Edesa's Phase 2 study of EB05 was funded in part by a CAD 14 million grant from the Canadian Government's Strategic Innovation Fund. Duyuru • Sep 08
Edesa Biotech, Inc. Reports Phase 2b Study Reaches Full Enrollment Edesa Biotech, Inc. announced that patient recruitment has been completed for a Phase 2b clinical study evaluating the company's drug candidate, designated EB01, as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD). EB01 represents a potentially new class of non-steroidal, anti-inflammatory treatment for this often-debilitating occupational disease. All the remaining subjects are expected to complete the primary treatment period within the next 30 days, and Edesa anticipates that topline data will be available by the end of the year. Edesa reported that while topline and final study results are pending and subject to regulatory review, the company is advancing its commercialization strategy for its EB01 drug candidate. This includes preparing trial design and regulatory filings, prioritizing potential add-on or adjacent disease indications for future studies, and exploring potential commercialization partners. EB01 is a topical vanishing cream that contains a novel, non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. When activated, sPLA2 enzymes have been shown to initiate a cascade of inflammatory lipid mediators along a well-known pathway that is currently the target of steroids. By targeting sPLA2 - 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 and allergic conditions. The double-blind, placebo-controlled confirmatory study is evaluating the safety and efficacy of 2.0% EB01 cream in approximately 170 evaluable subjects in total. In addition to the primary cohort, the company has included an exploratory, dose-ranging component of the study, which will separately evaluate lower-strength concentrations of EB01 in an additional 40 subjects. Due to physician and patient interest, the company also added a voluntary 90-day open-label extension with the 2% cream for study patients once they complete their treatment in the main study. The complete data package will be analyzed following the completion of the main study's primary and secondary endpoints as well as the open label extension. The company previously reported that EB01 met key interim parameters in the ongoing Phase 2b study. Though blinded to treatment assignment, the study's Data and Safety Monitoring Board reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percentage change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. The monitoring board also reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator's Static Global Assessment), a key secondary efficacy endpoint. A decrease in score relates to an improvement in signs and symptoms. No serious treatment-related adverse events were reported for either treatment group. 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 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. Edesa estimates that there are more than 30 million people globally with allergic contact dermatitis, with approximately 5 million patients estimated to have chronic or reoccurring exposure to the causal allergen. To the company's knowledge, there are currently no treatment options specifically labelled for ACD. Breakeven Date Change • Aug 18
No longer forecast to breakeven The 3 analysts covering Edesa Biotech no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$14.8m in 2023. New consensus forecast suggests the company will make a loss of US$19.6m in 2024. Duyuru • May 26
Edesa Biotech, Inc. Adds Mechanically Ventilated Patients to Phase 3 ARDS Study Edesa Biotech, Inc. announced that the company has initiated enrollment for a second cohort of patients for the Phase 3 part of a Phase 2/3 study of the company's critical care drug candidate, designated EB05. Edesa is currently evaluating EB05, a monoclonal antibody, in critically ill patients with Covid- 19-induced Acute Respiratory Distress Syndrome (ARDS), a severe respiratory illness that can result in long ICU stays and high mortality rates. The company's first study cohort is recruiting the most critically severe patients receiving mechanical ventilation plus additional organ support, including extracorporeal membrane oxygenation (ECMO) therapy, also known as Level 7 patients under the World Health Organization's Covid-19 Severity Scale. This new, second cohort is open to hospitalized patients on invasive mechanical ventilation alone (WHO Level 6 patients). Edesa's decision to include the second cohort followed a company review of drug product inventories of EB05. The primary endpoint for the Level 6 patients will be the number of ventilator free days at Day 28 following administration of a single intravenous infusion of EB05. Secondary endpoints will include ventilator free days at Day 60 as well as the mortality rate at Day 28 and Day 60. The protocol for the Level 6 cohort calls for approximately 500 evaluable subjects. As previously reported, the primary endpoint for the Level 7 patients will be 28-day mortality. Ventilator free days and 60-day mortality will also be measured among other secondary endpoints. The protocol for the Level 7 patients calls for approximately 315 evaluable subjects. The evaluation of EB05 in both the Level 6 and Level 7 patient populations was previously approved by regulators in Canada, Colombia and Poland. Edesa, however, prioritized the initiation of the most severe cohort first given the urgent medical need. Enrollment for both cohorts is now running in parallel, and results will be evaluated independently. The company is currently in discussions with regulators in the U.S. regarding the approval of the final Phase 3 design. ARDS involves 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 meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year. Price Target Changed • May 21
Price target decreased to US$16.33 Down from US$18.00, the current price target is an average from 3 analysts. New target price is 797% above last closing price of US$1.82. Stock is down 73% over the past year. The company is forecast to post a net loss per share of US$1.52 next year compared to a net loss per share of US$1.00 last year. Board Change • Apr 27
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. No experienced directors. 1 highly experienced director. Director Frank Oakes is the most experienced director on the board, commencing their role in 2010. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Breakeven Date Change • Apr 21
No longer forecast to breakeven The 3 analysts covering Edesa Biotech no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$14.0m in 2023. New consensus forecast suggests the company will make a loss of US$19.6m in 2024. Duyuru • Apr 02
Edesa Biotech, Inc., Annual General Meeting, May 18, 2022 Edesa Biotech, Inc., Annual General Meeting, May 18, 2022, at 10:30 Eastern Daylight. Location: Edesa Biotech Corporate Offices 100 Spy Court, Markham, ON L3R 5H6 Markham Canada Agenda: To consider the election of seven directors, nominated by the Company's Board of Directors, to serve until the Company's annual meeting of shareholders to be held in 2023 or until their successors are duly elected and qualified; to consider an advisory vote on executive compensation; to consider an advisory vote on the frequency of an advisory vote on executive compensation; to consider the appointment of MNP LLP as the Company's auditors and independent registered public accounting firm for the ensuing year; and to transact such other business as may properly come before the Annual Meeting or any adjournments or postponements thereof. Duyuru • Mar 30
Edesa Biotech, Inc. Appoints Jennifer M. Chao to Its Board of Directors Edesa Biotech, Inc. announced the appointment of Jennifer M. Chao to the company's Board of Directors. Ms. Chao has more than 25 years of experience in the biotech and life sciences industries focused primarily on finance and corporate strategy. She is the founder of CoreStrategies Management, LLC, which provides corporate and financial consulting to biotech and life sciences companies. Ms. Chao currently serves as a Board Director of Endo International plc. and is a member of its Audit Committee and Compliance Committee. Duyuru • Mar 04
Edesa Biotech, Inc. Announces Peter Van Der Velden Resign from Board and Its Committees Edesa Biotech, Inc. announced that on February 28, 2022, Peter van der Velden notified the Board of Directors (the “Board”) of Edesa Biotech, Inc. (the “Company”) of his decision to resign from the Board and its committees, effective as of February 28, 2022. Mr. van der Velden had been on the Board since 2015 and the resignation is in line with normal course activities of his firm which remains an investor in the Company. His departure is not the result of any disagreement with the Company regarding its operations, policies or procedures. Duyuru • Feb 18
Edesa Biotech Reports Enrollment Milestone in Phase 3 ARDS Study Edesa Biotech, Inc. provided an update on the Phase 3 part of a Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate, designated EB05, as a single-dose therapy for hospitalized Covid-19 patients. Edesa reported that more than 25% of the subjects have been randomized to date under the Phase 3 protocol design approved by Health Canada. The enrollment milestone follows favorable Phase 2 results, which demonstrated compelling preliminary evidence of EB05's ability to reduce mortality in the sickest patients. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days. EB05 was developed to regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure that accounts for ~10% of all ICU admissions and is the leading cause of death among Covid-19 patients. Specifically, EB05 inhibits toll-like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. In September 2021, the company reported that an independent monitoring board for the Phase 2/3 study concluded that "a clinically important efficacy signal" was detected. The monitoring board further recommended continuation of the study into a Phase 3 confirmatory trial. Edesa's Phase 2 study of EB05 in hospitalized Covid-19 patients was funded in part by a C$14 million grant from the Canadian Government's Strategic Innovation Fund. The Phase 3 double-blind study is designed to assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus organ support (IMV+), defined as Level 7 on the World Health Organization's COVID-19 Severity Scale. The primary endpoint for the Level 7 patients will be 28-day mortality. Ventilator free days and 60-day mortality will also be measured among other secondary endpoints. The amended trial protocol design calls for approximately 315 evaluable subjects. Edesa has filed similar protocol amendments with the U.S. Food and Drug Administration (FDA) as well as other jurisdictions. In the U.S., the company is currently in discussions with the FDA on the design of the final Phase 3 protocol. About ARDS Acute Respiratory Distress Syndrome is the leading cause of death in Covid-19 patients. The U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized Covid-19 patients develop ARDS, which increases to 67% to 85% for patients admitted to the ICU. Mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and characteristics of patient population, according to the CDC. ARDS involves 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 meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year. Duyuru • Sep 21
Edesa Biotech, Inc. Announces Positive Phase 2 Data of Monoclonal Antibody in Hospitalized Covid-19 Patients Edesa Biotech, Inc. announced positive results from the Phase 2 part of an ongoing Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate as a single-dose treatment for hospitalized COVID-19 patients. An independent Data and Safety Monitoring Board (DSMB), composed of subject matter experts, informed the company that during its initial analysis of the Phase 2 portion of the study they identified an important signal between the treatment arms for 28-day mortality, and requested that the study be preemptively unblinded. While the Phase 2 portion was primarily designed to refine patient stratification and statistical powering for the Phase 3 study, the DSMB concluded that "a clinically important efficacy signal" was detected and that the study has "met its objective." The DSMB further recommended continuation of the study into a Phase 3 confirmatory trial. Among the findings, the DSMB reported a Cox's Proportional Hazard estimate for death of 14.3% (2/14) in the EB05 arm versus 36.8% (7/19) in the placebo arm, representing a 217% improvement in the relative likelihood of survival (HR: 3.17; 95%CI: 0.66-15.35; p=0.15) in critically severe patients on ECMO therapy (extracorporeal membrane oxygenation) with or without invasive mechanical ventilation, at 28 days versus Standard of Care treatment alone. Approximately 100% of patients received dexamethasone (or other steroids), 60% received tocilizumab, and 60% received both, balanced across both arms of the study. The results from the Phase 2 analysis also suggest that EB05 has been generally well-tolerated and consistent with the observed safety profile to date. In addition, the DSMB identified another patient group with robust signals for mortality reduction at 28 days and the company plans to review this data as well as the full dataset. The analysis reviewed data from approximately 360 patients, 24 to 93 years of age, from investigational sites in the United States, Canada and Colombia. Participants were treated with a single intravenous infusion of either EB05 plus standard of care treatment, or placebo plus standard of care (randomized 1:1). The DSMB's initial analysis was limited to the mortality endpoint, and a review of other endpoints is ongoing. Duyuru • Aug 27
Edesa Biotech, Inc. Provides Update on Phase 2/3 Clinical Study Evaluating its Monoclonal Antibody Candidate as Single-Dose Therapy for Hospitalized COVID-19 Patients Edesa Biotech, Inc. provided an update on a phase 2/3 clinical study evaluating the company's monoclonal antibody candidate as a single-dose therapy for hospitalized COVID-19 patients. As of August 25, 2021, the company reported that more than 525 subjects have been randomized into the study to be treated with either the company’s monoclonal antibody (designated EB05) plus standard of care treatment, or placebo plus standard of care. Approximately 35 of these patients have been assigned to an investigation sub-study evaluating EB05 as a rescue therapy for patients with critically severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation (ECMO) therapy. Additionally, the company reported that all patients planned for a key interim analysis have been randomized and completed the treatment protocol. The company expects the analysis from third-party statisticians to be completed in the coming weeks. The company said that the interim analysis will include data from approximately 316 subjects. The blinded comparative interim analysis of treatment data and events is expected to inform patient segmentation and associated endpoints for the final part of study. As a phase 2/3 study, enrollment has continued during the analysis. Dr. Par Nijhawan, MD, Chief Executive Officer of the company, attributed the rapid pace of enrollment to the growing scientific rationale for targeting Toll-like Receptor 4 (TLR4), the attractiveness of the single-dose treatment, the broad potential utility for the drug candidate as well as increased disease incidence in regions where the company’s clinical sites are located. Dr. Blair Gordon, the company’s Vice President of Research and Development, reported that with support from the federal government, the company has now established a network of 46 clinical sites at hospitals in Canada, Colombia and the United States. EB05 is an experimental monoclonal antibody that the company believes could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS). ARDS is the cause of death in COVID-19 patients. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling – an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The company’s study of EB05 in hospitalized COVID-19 patients is being funded in part by a CAD 14 million grant from the Canadian Government. To date, the company has reached all clinical enrollment and project targets specified under the grant ahead of schedule. Duyuru • Jul 15
Edesa Biotech, Inc. Extends Dermatitis Study to Canada Edesa Biotech, Inc. announced that the company has expanded patient enrollment to Canada for the final part of a Phase 2b study evaluating its EB01 drug candidate as a monotherapy for chronic Allergic Contact Dermatitis (Eczema), or ACD. The first part of the ACD study was conducted in the United States, where enrollment is ongoing. ACD is one of the most common skin diseases. The Canadian Center for Occupational Health and Safety reports that ACD accounts for about 20% of all cases of occupational dermatitis. 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, according to the agency. Edesa recently reported that EB01, a non-steroidal anti-inflammatory compound, met a key interim study parameter and an independent data monitoring board recommended that the company continue to enroll subjects in the study. The company plans to enroll up to at least 120 additional evaluable subjects, who will be provided with either Edesa's EB01 topical treatment (at a 2.0%, 1.0% or 0.2% concentration) or a placebo cream. The study's primary outcome will be the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. A key secondary outcome will be the proportion of patients achieving success on the ISGA (Investigator's Static Global Assessment) scale. Due to physician and patient interest, the company is also adding an open-label extension for study patients. Duyuru • Jun 19
Edesa Biotech, Inc. Completes Independent Data and Safety Monitoring Board Interim Review of COVID-19 Drug Candidate Edesa Biotech, Inc. reported that an independent Data and Safety Monitoring Board (DSMB) has completed an interim review of the company's COVID-19 drug candidate, and based on blinded comparative data, has recommended that the company's international study continue as planned. The safety monitoring board, composed of independent subject matter experts, conducted a pre-planned interim review of the first patient cohort participating in Edesa's Phase 2/3 clinical study evaluating the company's EB05 drug candidate as a single-dose treatment for hospitalized COVID-19 patients. The DSMB assessed treatment data for safety and futility. After completing their analysis, the DSMB recommended that enrollment in the trial continue. Dr. Nijhawan said that Edesa is evaluating opportunities to expedite the timeline for completing the remaining part of the study and building a single robust dataset. As of June 16, 2021, more than 370 subjects in the U.S., Canada and Colombia have been enrolled in the Phase 2/3 study. The company plans to perform the next interim analysis on 316 evaluable subjects once treatment is completed and subject data is validated and aggregated. The company recently filed a trial amendment with the Food and Drug Administration to streamline the U.S. protocol and align it with other jurisdictions. Following the exploratory analysis, the company also plans to adjust its current patient segmentation and associated endpoints, and maintain blinded data through the end of Phase 3. EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS). ARDS is the leading cause of death in COVID-19 patients. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to Intensive Care Units (ICU) and intubation/ventilation procedures, and ultimately saving lives. JSS Medical Research is acting as Edesa's contract research organization for the international Phase 2/3 study. Duyuru • Jun 04
Edesa Biotech Reports Positive Interim Results in Dermatitis Trial Edesa Biotech, Inc. announced that the company's drug candidate EB01 has met a key interim study parameter. The company has now passed the initial inflection point of its Phase2b study and will continue enrolling the final cohort of patients. Edesa reported that interim study data from the first cohort met statistical thresholds previously approved by the U.S. Food and Drug Administration as part of an adaptive Phase 2b trial evaluating EB01 as a monotherapy for moderate to severe chronic Allergic Contact Dermatitis (ACD). Though blinded to treatment assignment, the study's Data and Safety Monitoring Board (DSMB) reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. Likewise, the DSMB reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator's Static Global Assessment), a key secondary efficacy endpoint. Success on the ISGA is defined as a two-point reduction from baseline and a final ISGA score of '0' or '1' indicating clear or almost clear skin, respectively. A decrease in score relates to an improvement in signs and symptoms. For both the CDSI and ISGA endpoints, double-digit absolute differences were observed among the two treatment arms. No serious treatment-related adverse events were reported for either treatment group. Based on these findings, the DSMB has recommended progression to the second cohort of patients. Interim study data is preliminary and full study results are subject to change; and since the analysis remains blinded, it is not possible to definitively conclude if EB01 may be outperforming placebo or vice versa. The initial cohort analyzed consisted of a population of 46 subjects, of whom 36 completed the study follow-up and were used in the interim analysis. As of June 2, 2021, 66 total patients (including the first cohort) have been randomized in the Phase 2b study. Duyuru • Mar 16
Edesa Biotech, Inc. Completes Enrollment of More Than 50% of the Patients Planned for the Phase 2 Portion of Its Ongoing Phase 2/Phase 3 Clinical Study Edesa Biotech, Inc. announced that it has completed enrollment of more than 50% of the patients planned for the Phase 2 portion of its ongoing Phase 2/Phase 3 clinical study evaluating the company's EB05 drug candidate as a single-dose treatment for hospitalized COVID-19 patients with or at risk of developing Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients. The company reported that more than 160 of the expected 316 subjects in the Phase 2 portion of the study have been randomized and dosed with either EB05 or placebo. The patients were treated at hospital sites across Canada, the United States and Colombia. In preparation for the potential Phase 3 portion of the study, the company plans to activate approximately 20 additional hospital sites in the next two months. Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa reported that the company plans to continue adding hospital sites to speed enrollment and to provide broad access to a promising experimental therapy. As designed, the international study is an adaptive, double-blind study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Should the experimental antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study. EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with ARDS. Specifically, the drug inhibits toll- like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to Intensive Care Units (ICU) and intubation/ventilation procedures, and ultimately saving lives. Duyuru • Mar 10
Edesa Biotech Completes Enrollment for Interim Clinical Study Milestone Edesa Biotech, Inc. announced that it has completed enrollment of the first cohort of a Phase 2b clinical study evaluating the company's drug candidate EB01 as a monotherapy for chronic Allergic Contact
Dermatitis (ACD), a potentially debilitating condition and occupational illness. Edesa reported that all 46 subjects in the first cohort have been randomized and dosed with either Edesa's EB01 topical treatment or a placebo cream. EB01 contains a non-steroidal anti- inflammatory compound known as an sPLA2 inhibitor. Since EB01 is designed to inhibit the inflammatory process at its inception rather than after inflammation has occurred, the company believes that the drug could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids. Once all the subjects in the first cohort complete the 28-day treatment, Edesa plans to initiate a
blinded interim analysis. The interim results will determine the number of patients for the final part of the Phase 2b study based on probability thresholds previously approved by the Food and Drug Administration. In two previous clinical studies EB01 has demonstrated statistically significant improvement of multiple symptoms in ACD patients. Duyuru • Mar 04
Edesa Biotech, Inc., Annual General Meeting, Apr 22, 2021 Edesa Biotech, Inc., Annual General Meeting, Apr 22, 2021, at 10:30 Eastern Daylight. Location: Edesa Biotech Corporate Offices, located at 100 Spy Court, Markham Ontario Canada Agenda: The election of seven directors, nominated by the Company’s Board of Directors, to serve until the Company’s annual meeting of shareholders to be held in 2022 or until their successors are duly elected and qualified; to consider appointment of MNP LLP as the Company’s auditors and independent registered public accounting firm for the upcoming year; to the amendment to the Company’s 2019 Equity Incentive Compensation Plan (the “2019 Plan”) to increase the number of shares available for issuance under the 2019 Plan by 1,497,000 shares; and to consider such other business as may properly come before the AGM or any adjournments or postponements thereof. Price Target Changed • Feb 24
Price target raised to US$17.00 Up from US$15.50, the current price target is an average from 2 analysts. The new target price is 183% above the current share price of US$6.00. As of last close, the stock is up 80% over the past year. Recent Insider Transactions • Feb 19
Director recently sold US$58k worth of stock On the 18th of February, Frank Oakes sold around 8k shares on-market at roughly US$7.25 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$32k more than they bought in the last 12 months. Analyst Estimate Surprise Post Earnings • Feb 18
Earnings beat expectations, revenue disappoints Revenue missed analyst estimates by 100%. Earnings per share (EPS) exceeded analyst estimates by 37%. Over the next year, revenue is forecast to grow 2,783%, compared to a 981% growth forecast for the Biotechs industry in the US. Is New 90 Day High Low • Jan 27
New 90-day high: US$7.48 The company is up 23% from its price of US$6.08 on 28 October 2020. The American market is up 17% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Biotechs industry, which is up 27% over the same period. Is New 90 Day High Low • Jan 01
New 90-day low: US$4.25 The company is down 48% from its price of US$8.14 on 02 October 2020. The American market is up 13% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 14% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Dec 09
New 90-day low: US$4.63 The company is down 41% from its price of US$7.84 on 09 September 2020. The American market is up 12% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 20% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Reported Earnings • Dec 08
Full year 2020 earnings released: US$0.74 loss per share Full year 2020 results: Net loss: US$6.36m (loss widened 72% from FY 2019). Analyst Estimate Surprise Post Earnings • Dec 08
Revenue and earnings beat expectations Revenue exceeded analyst estimates by 6.0%. Earnings per share (EPS) also surpassed analyst estimates by 5.7%. Over the next year, revenue is expected to shrink by 39% compared to a 457% growth forecast for the Biotechs industry in the US. Is New 90 Day High Low • Nov 10
New 90-day low: US$5.40 The company is down 21% from its price of US$6.81 on 12 August 2020. The American market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.