Financial Performance - Edesa Biotech reported a net loss of $1.6 million, or $0.48 per common share, for the first quarter of fiscal year 2025, compared to a net loss of $1.7 million, or $0.54 per common share, for the same period last year[6]. - Total operating expenses remained unchanged at $1.9 million for the three months ended December 31, 2024, compared to the same period in 2023[5]. - Total other income increased by $102,000 to $281,000 for the three months ended December 31, 2024, primarily due to increased reimbursement funding from the Canadian government's Strategic Innovation Fund[5]. - Cash and cash equivalents at December 31, 2024, were $1.6 million, up from $1.0 million at the end of the previous quarter[7]. - Edesa's total assets increased to $4.16 million as of December 31, 2024, compared to $3.81 million at the end of the previous quarter[15]. Research and Development - Research and development expenses increased by $0.3 million to $1.0 million for the three months ended December 31, 2024, primarily due to increased external research expenses related to drug manufacturing[7]. - The company anticipates submitting data to the FDA for its anti-CXCL10 monoclonal antibody candidate, EB06, in mid-2025, with topline results expected within 12 to 18 months post-regulatory clearance[3]. Operational Changes - General and administrative expenses decreased by $0.3 million to $0.9 million for the three months ended December 31, 2024, due to reductions in salaries and related costs[7]. - Edesa raised $15.0 million in gross proceeds from an equity financing, strengthening its balance sheet to support the advancement of its vitiligo program[4]. Market Engagement - The company plans to participate in several upcoming conferences, including the American Academy of Dermatology Annual Meeting and BIO Europe Spring 2025, to further its market presence[9].

Core Viewpoint - Edesa Biotech, Inc. is advancing its lead asset, EB06, an anti-CXCL10 monoclonal antibody for vitiligo treatment, with plans for a Phase 2 clinical trial and has reported financial results for Q1 FY2025, indicating a stable financial position and ongoing development efforts [1][2][3]. Financial Performance - Total operating expenses remained unchanged at $1.9 million for the three months ended December 31, 2024, compared to the same period in 2023 [4]. - Total other income increased by $102,000 to $281,000 for the three months ended December 31, 2024, primarily due to increased reimbursement funding from the Canadian government's Strategic Innovation Fund [4]. - Edesa reported a net loss of $1.6 million, or $0.48 per common share, for the quarter ended December 31, 2024, compared to a net loss of $1.7 million, or $0.54 per common share, for the same period in 2023 [5]. Cash Position and Working Capital - As of December 31, 2024, Edesa had cash and cash equivalents of $1.6 million and working capital of $0.2 million [6]. - The company received $15.0 million in gross proceeds from a private placement of preferred and common shares after the quarter ended, strengthening its balance sheet [6]. Research and Development - Research and development expenses increased by $0.3 million to $1.0 million for the three months ended December 31, 2024, primarily due to increased external research expenses related to the manufacturing of EB05 [8]. - Edesa is preparing for a manufacturing campaign for EB06, with data expected to be submitted to the FDA in mid-2025, and anticipates topline results within 12 to 18 months post-regulatory clearance [2][3]. Upcoming Events - Edesa plans to participate in several upcoming conferences, including the American Academy of Dermatology Annual Meeting and BIO Europe Spring 2025, providing opportunities for engagement with investors and stakeholders [9]. Company Overview - Edesa Biotech, Inc. focuses on developing innovative treatments for immuno-inflammatory diseases, with a clinical pipeline that includes EB06 for vitiligo and EB05 for Acute Respiratory Distress Syndrome [10].

Core Viewpoint - Edesa Biotech, Inc. has successfully completed a private placement, raising approximately $15.0 million to advance its clinical programs, particularly the CXCL10 monoclonal antibody for vitiligo treatment [3][10]. Group 1: Private Placement Details - Edesa sold 834 Series B-1 convertible preferred shares at a price of $10,000 each and 3,468,746 common shares at $1.92 each [1][2]. - The offering was led by Velan Capital and included participation from new and existing institutional investors, as well as company insiders [2][10]. - The offering closed on February 12, 2025, and was conducted without a placement agent or underwriter [2]. Group 2: Use of Proceeds - The net proceeds from the offering are expected to fund the advancement of EB06 into a Phase 2 clinical study for nonsegmental vitiligo, along with general corporate purposes [3][10]. - The company aims to fund its CXCL10 antibody program through the end of fiscal 2026 with the raised capital [10]. Group 3: Securities and Regulatory Information - The Series B-1 Preferred Shares are convertible into common shares at a conversion price of $1.92, with ownership limitations set at a maximum of 4.99% or 9.99% for individual holders [4]. - Edesa has agreed to file a registration statement with the SEC to register the resale of common shares and conversion shares within 30 days of the closing [7]. Group 4: Company Overview - Edesa Biotech is a clinical-stage biopharmaceutical company focused on developing treatments for immuno-inflammatory diseases, with a pipeline that includes EB06 for vitiligo and EB01 for allergic contact dermatitis [9][11]. - The company is also developing EB05 for Acute Respiratory Distress Syndrome (ARDS) and preparing an IND for EB07 to conduct a future Phase 2 study in pulmonary fibrosis [9][11].

Drug Development and Clinical Trials - The company is developing EB06, an anti-CXCL10 monoclonal antibody for vitiligo, with regulatory approval for a Phase 2 study in Canada and discussions ongoing with the FDA[21]. - EB05, a first-in-class monoclonal antibody, is being evaluated in a U.S. government-funded study for ARDS, showing a 28-day mortality rate of 7.7% in the treatment group compared to 40% in the placebo group[36]. - The Canadian government has committed up to C$23 million in funding for a Phase 3 clinical study of EB05, with C$5.75 million being non-repayable[39]. - EB07, another product candidate, is being prepared for an IND application to conduct a Phase 2 study in pulmonary fibrosis, targeting a chronic disease with high mortality[45]. - The BARDA-funded study for EB05 has shifted the clinical focus from COVID-19 to general ARDS, potentially increasing the commercial opportunity for the drug[38]. - EB06 is a fully human monoclonal antibody targeting CXCL10, currently in a Phase 2 study for moderate to severe nonsegmental vitiligo, with an expected topline result in 12 to 18 months[52]. - The Phase 2 study will involve approximately 150 subjects, measuring the percentage of patients achieving a ≥50% improvement in facial Vitiligo Area Scoring Index (F-VASI50)[52]. - In a Phase 2b clinical study of EB01, the 1.0% formulation showed a 60% average improvement in symptoms from baseline compared to 40% for placebo (p=0.027)[58]. - Clinical trials must demonstrate safety and efficacy to satisfy regulatory authorities; failure to do so may result in additional costs or delays[201]. - Clinical trials may be prolonged or delayed, leading to additional costs and potential inability to commercialize product candidates on time[207]. - The design of clinical trials is critical, and flaws may not be apparent until trials are well advanced or completed[203]. - The company may need to conduct additional clinical trials if initial results are negative or inconclusive, impacting timelines and costs[210]. - Changes in standard of care or regulatory requirements may necessitate amendments to clinical trial protocols, affecting costs and timelines[211]. Financial and Funding Aspects - The company has received over C$37 million in competitive government grants and funding awards, validating its technology and drug development capabilities[23]. - The company anticipates substantial additional funding will be required to finance operations through regulatory approval of its product candidates, with potential delays or reductions in development if capital is not raised[162]. - The company has entered into the 2023 SIF Agreement with the Government of Canada for up to C$23 million in partially repayable funding for the development of investigational therapy EB05, with a project completion deadline of December 31, 2025[172]. - The company has relied on government grants for the development of EB05, and failure to meet contractual obligations could result in delays or termination of the project[169]. - The company has historically financed operations primarily through equity offerings and has not completed the development of any drug candidates, raising concerns about its ability to sustain operations[158]. - The company estimates that allergic contact dermatitis (ACD) conditions cost up to $2 billion annually in the U.S. due to lost work and medical care[54]. Market Opportunities and Competition - The prevalence of vitiligo is estimated to be between 0.5% to 2% of the global population, indicating a significant market opportunity[46]. - The company plans to maximize the commercial potential of its product candidates through strategic licensing and partnerships, particularly in regions outside North America[30]. - The total addressable patient population for EB01 in the seven major markets and Canada is estimated to be as high as five million[54]. - The company faces competition from various companies in the pharmaceutical and biotechnology industry, including Aclaris Therapeutics, Pfizer, and Eli Lilly, which have greater financial resources[79][80]. - The commercial opportunity in conditions like vitiligo, chronic ACD, ARDS, or pulmonary fibrosis may be smaller than anticipated, adversely affecting future revenue[215]. - The company’s estimates of the patient population for targeted conditions may prove incorrect, impacting financial performance[216]. Regulatory Environment - The company is subject to stringent regulations from agencies like the FDA and Health Canada, requiring substantial time and financial resources for obtaining marketing approvals[84][85]. - The FDA requires an NDA or BLA submission after clinical trials, which includes comprehensive data on product development, human trials, and manufacturing details[88]. - Under PDUFA, each NDA or BLA submission must include a user fee, which is adjusted annually, with waivers available for small businesses[89]. - The FDA aims to review 90% of original standard NDAs or BLAs within 10 months and 90% of original priority NDAs or BLAs within 6 months of submission[90]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits of a product outweigh its risks, which must be submitted with the BLA if necessary[92]. - Orphan drug designation can be granted for drugs intended to treat rare diseases, providing marketing exclusivity for seven years if the first approval is obtained[99]. - The FDA has programs like Fast Track and Breakthrough Therapy to expedite the development of drugs addressing serious conditions, allowing for increased interactions during development[101][102]. - Emergency Use Authorizations (EUA) allow for the distribution of unapproved products during public health emergencies, contingent on demonstrating potential effectiveness[108][109]. - The FDA may impose conditions on EUAs to protect public health, including monitoring adverse events and ensuring adequate information dissemination[109]. - The approval process for drugs can take several years, particularly for chronic diseases, requiring extensive safety and efficacy data[97]. - The FDA may deny approval if the NDA or BLA does not meet regulatory criteria, issuing a complete response letter detailing deficiencies[94]. Company Structure and Workforce - The company has 16 full-time employees, with 9 in research and development and 7 in management and administration[132]. - More than 50% of the workforce are women, and over 50% represent underrepresented racial or ethnic groups[133]. - The company was founded in 2007 and operates through wholly owned subsidiaries in Canada and the U.S.[135]. - The company is currently classified as a "smaller reporting company," allowing for simplified disclosures in SEC filings[138]. - The company acquired its Ontario subsidiary through a reverse acquisition in June 2019[135]. Risks and Challenges - The company faces substantial competition in the biopharmaceutical sector, which may hinder its ability to successfully commercialize its product candidates[147]. - The marketing approval process for product candidates is expensive, time-consuming, and uncertain, with potential delays impacting revenue generation[151]. - The company is dependent on third parties for conducting clinical trials, and any failure by these parties could adversely affect the timeline and success of its product development[149]. - The ownership of common shares is highly concentrated, which may limit shareholder influence on corporate decisions and could lead to conflicts of interest[155]. - Future product revenues depend heavily on successful development and commercialization of drug candidates, with many factors influencing this success[177]. - The company faces risks related to economic conditions, including inflation and rising interest rates, which could adversely affect operations[182]. - The company has a limited operating history, making it difficult to evaluate its success and future viability[184]. - The company is exposed to risks related to currency exchange rates, impacting operating results when translated into U.S. dollars[185]. - The company relies on key executives and qualified personnel, and losing them could materially impact its objectives[196]. - Cybersecurity incidents pose a risk to the company's information technology systems, potentially disrupting operations and increasing costs[200].

Financial Performance - Edesa Biotech reported a net loss of $6.2 million, or $1.93 per common share, for the fiscal year ended September 30, 2024, compared to a net loss of $8.4 million, or $2.93 per common share, for the previous year[8]. - Total operating expenses decreased by $2.2 million to $7.0 million for the year ended September 30, 2024, down from $9.2 million in the prior year, reflecting a more than 20% reduction[6]. - Research and development expenses decreased by $1.9 million to $2.9 million for the year ended September 30, 2024, primarily due to reduced external research expenses and lower labor costs[6]. - Edesa's general and administrative expenses decreased by $0.3 million to $4.1 million for the year ended September 30, 2024, compared to $4.4 million in the prior year[7]. - Total other income remained unchanged at $0.8 million for the years ended September 30, 2024, and September 30, 2023[8]. Cash Position - Edesa's cash and cash equivalents stood at $1.0 million with negative working capital of $0.2 million as of September 30, 2024[9]. - The company received $1.5 million in gross proceeds under a securities purchase agreement after the fiscal year end[9]. Future Plans - The company anticipates topline results for its Phase 2 study could be available within 12 to 18 months following regulatory clearance in the U.S.[4]. - Edesa plans to manufacture EB06 and submit related data to the U.S. FDA as part of an investigational new drug application[4]. - Edesa has received two government funding awards to support the advancement of its anti-TLR4 technology, improving its position for future financing[5].

Core Viewpoint - Edesa Biotech, Inc. reported a strategic pivot in its drug development focus, particularly on its anti-TLR4 drug candidate, and demonstrated improved financial management with a significant reduction in operating expenses while advancing its clinical pipeline through government funding opportunities [2][3][4]. Financial Performance - Total operating expenses decreased by $2.2 million to $7.0 million for the fiscal year ended September 30, 2024, compared to $9.2 million for the prior year [4]. - Research and development expenses decreased by $1.9 million to $2.9 million, primarily due to reduced external research expenses and labor costs [4]. - General and administrative expenses decreased by $0.3 million to $4.1 million, mainly due to a reduction in noncash share-based compensation [4]. - Edesa reported a net loss of $6.2 million, or $1.93 per common share, compared to a net loss of $8.4 million, or $2.93 per common share, for the previous fiscal year [5][11]. Cash Flow and Working Capital - As of September 30, 2024, Edesa had cash and cash equivalents of $1.0 million and negative working capital of $0.2 million [6]. - The company received $1.5 million in gross proceeds from a securities purchase agreement and $0.6 million in net proceeds from common shares sold under an at-the-market offering program after the fiscal year end [6]. Business Development and Pipeline - Edesa is focusing on the development of EB05 (paridiprubart) for Acute Respiratory Distress Syndrome (ARDS) and plans to submit an investigational new drug (IND) application for EB06, an anti-CXCL10 monoclonal antibody candidate [2][8]. - The company aims to maximize synergies between U.S. and Canadian government-funded projects related to its drug candidates [2][3]. Future Outlook - Edesa anticipates topline results for its Phase 2 study could be available within 12 to 18 months following regulatory clearance in the U.S. [2]. - The company plans to participate in one-on-one meetings during JP Morgan week in January 2025, indicating ongoing engagement with investors and stakeholders [7].

TORONTO, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today announced that the company has entered into a purchase agreement with an entity affiliated with Par Nijhawan, MD, Edesa’s Chief Executive Officer and Founder, to invest up to $5.0 million in the company, including an immediate investment of approximately $1.5 million. The entity will purchase shares o ...

TORONTO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that Edesa management and business development staff plan to participate in the following upcoming conferences: BIO-Europe, Stockholm, Sweden, November 4-6, 2024Dermatology Drug Development Summit, Boston, Mass., November 12-14, 2024LSX Investival Showcase, London, UK, November 18, 2024 To s ...

MARKHAM, Ontario, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Dr. Pardeep Nijhawan ("Dr. Nijhawan") announces that as a result of grants of restricted share units ("RSUs") of Edesa Biotech, Inc. ("Edesa"), when combined with a series of transactions (the "Transactions") that have occurred since the date of the most recent early warning report filed by Dr. Nijhawan on November 18, 2022 (the "Previous Report"), Dr. Nijhawan has acquired "beneficial ownership" of common shares in the capital of Edesa ("Common Shares") ...

PART I [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company's financial position weakened, with cash and cash equivalents decreasing from $5.4 million to $2.0 million and total shareholders' equity falling from $7.0 million to $2.9 million since September 30, 2023, while reporting a net loss of $5.2 million for the nine months ended June 30, 2024, an improvement from the prior year due to lower R&D expenses and new grant income. [Condensed Interim Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Interim%20Consolidated%20Balance%20Sheets%20%E2%80%93%20June%2030%2C%202024%20and%20September%2030%2C%202023) As of June 30, 2024, total assets significantly decreased to $5.2 million from $8.9 million on September 30, 2023, primarily due to a reduction in cash and cash equivalents, while total liabilities increased and total shareholders' equity sharply declined. Condensed Consolidated Balance Sheet Highlights (in USD) | Balance Sheet Item | June 30, 2024 | September 30, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,040,884 | $5,361,397 | | Total current assets | $3,046,634 | $6,436,852 | | Total assets | $5,227,722 | $8,890,437 | | **Liabilities & Equity** | | | | Total current liabilities | $2,360,627 | $1,821,864 | | Total liabilities | $2,360,627 | $1,841,637 | | Total shareholders' equity | $2,867,095 | $7,048,800 | [Condensed Interim Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Operations%20%E2%80%93%20Three%20and%20Nine%20Months%20Ended%20June%2030%2C%202024%20and%202023) For the nine months ended June 30, 2024, the net loss improved to $5.2 million from $6.7 million in the prior year, primarily driven by lower research and development expenses and the recognition of $0.66 million in reimbursement grant income. Statement of Operations Summary (in USD) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Nine Months Ended June 30, 2024 | Nine Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $897,305 | $1,025,622 | $2,778,100 | $3,841,150 | | General and administrative | $1,035,140 | $1,038,587 | $3,232,248 | $3,011,945 | | Loss from operations | $(1,932,445) | $(2,064,209) | $(6,010,348) | $(6,853,095) | | Reimbursement grant income | $236,226 | $0 | $661,062 | $0 | | Net loss | $(1,668,212) | $(1,984,906) | $(5,207,994) | $(6,654,072) | | Loss per share | $(0.52) | $(0.68) | $(1.64) | $(2.37) | [Condensed Interim Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows%20%E2%80%93%20Nine%20Months%20Ended%20June%2030%2C%202024%20and%202023) For the nine months ended June 30, 2024, net cash used in operating activities decreased to $3.9 million, while net cash provided by financing activities significantly declined to $0.6 million, resulting in an overall net decrease in cash and cash equivalents of $3.3 million. Cash Flow Summary (Nine Months Ended June 30, in USD) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,923,166) | $(5,168,461) | | Net cash provided by financing activities | $623,466 | $4,417,646 | | Net change in cash and cash equivalents | $(3,320,513) | $(633,749) | | Cash and cash equivalents, end of period | $2,040,884 | $6,457,170 | [Notes to Condensed Interim Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Interim%20Consolidated%20Financial%20Statements) The notes detail the company's biopharmaceutical operations, including a $2.1 million intangible asset for a licensed monoclonal antibody, significant future milestone and royalty commitments up to $356 million, and recent capital structure changes such as a new C$23 million government grant and an undrawn $3.5 million related-party revolving credit facility. - The company is a biopharmaceutical firm focused on developing and commercializing drugs for inflammatory and immune-related diseases[21](index=21&type=chunk) - An intangible asset for a licensed monoclonal antibody ('the Constructs') is valued at **$2.1 million** net of amortization as of June 30, 2024[25](index=25&type=chunk)[26](index=26&type=chunk) - The company has commitments for potential milestone payments up to **$356 million** related to its 2020 license agreement for 'the Constructs', contingent on commercial and sales milestones[31](index=31&type=chunk) - In October 2023, the company entered into a new agreement with the Canadian Government's Strategic Innovation Fund (SIF) for up to **C$23 million** in partially repayable funding to support the Phase 3 study of EB05[52](index=52&type=chunk) - In October 2023, the company secured a **$10.0 million** revolving credit agreement from an entity controlled by its CEO, with an immediate credit limit of **$3.5 million**, from which no funds have been drawn[64](index=64&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management highlights the company's focus on developing inflammatory disease treatments, with EB05 for ARDS being the most advanced candidate, recently selected for a U.S. government-funded platform study, prompting a strategic re-evaluation of the ongoing Phase 3 trial, while financially, the company reported a reduced net loss for the nine months ended June 30, 2024, but acknowledges the need for additional financing to sustain operations given limited cash and working capital. [Overview](index=21&type=section&id=Overview) Edesa is a biopharmaceutical company developing drugs for inflammatory and immune-related diseases, with a pipeline including late-stage candidates such as EB05 for ARDS in Phase 3, EB06 for vitiligo, and EB01 for Allergic Contact Dermatitis, aiming to acquire and develop candidates with demonstrated proof-of-concept for unmet medical needs. - The company's most advanced drug candidate is **EB05 (paridiprubart)**, a Host-Directed Therapeutic (HDT) being evaluated in a Phase 3 study for Acute Respiratory Distress Syndrome (ARDS)[71](index=71&type=chunk) - Other pipeline assets include **EB06 for vitiligo** and **EB01 for chronic Allergic Contact Dermatitis (ACD)**, for which the company intends to seek strategic arrangements following favorable Phase 2b results[72](index=72&type=chunk) [Recent Developments](index=21&type=section&id=Recent%20Developments) In June 2024, the company's drug candidate EB05 was selected by BARDA for a Phase 2 platform trial in hospitalized ARDS patients, prompting a re-evaluation of its broader development strategy for EB05, including potential amendments to its ongoing Canadian government-supported Phase 3 study. - In June 2024, **EB05 was selected by BARDA** for evaluation in a U.S. government-funded Phase 2 platform trial for hospitalized adult patients with ARDS[34](index=34&type=chunk)[73](index=73&type=chunk) - Due to the BARDA study, the company is re-evaluating its development strategy for EB05, considering changes to its ongoing Phase 3 trial, which may require renegotiating its 2023 SIF Agreement with the Canadian government[74](index=74&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) For the nine months ended June 30, 2024, operating expenses decreased to $6.0 million from $6.9 million year-over-year, primarily due to a $1.0 million reduction in R&D expenses following the completion of the EB01 Phase 2 study, while total other income increased to $0.8 million due to $0.6 million in grant income, resulting in an improved net loss of $5.2 million. Comparison of Operating Results (Nine Months Ended June 30) | Item | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $2.8M | $3.8M | ($1.0M) | | G&A Expenses | $3.2M | $3.0M | $0.2M | | Total Operating Expenses | $6.0M | $6.9M | ($0.9M) | | Grant Income | $0.6M | $0 | $0.6M | | Net Loss | ($5.2M) | ($6.7M) | $1.5M | - The decrease in R&D expenses for the nine-month period was primarily due to reduced external research costs following the completion of the EB01 phase 2 study[79](index=79&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2024, the company had $2.0 million in cash and cash equivalents and $0.7 million in working capital, relying on existing cash, government grants, an at-the-market equity program, and an undrawn related-party credit line to fund operations, while acknowledging the need for additional financing through equity, debt, or strategic partnerships to sustain development programs. - As of June 30, 2024, the company had **$2.0 million in cash and cash equivalents** and an accumulated deficit of **$57.6 million**[89](index=89&type=chunk) - The company plans to finance operations over the next year using cash on hand, its Canaccord ATM facility (approx. **$6.3M available capacity**), advances under its related-party Credit Agreement, and SIF grant reimbursements[87](index=87&type=chunk)[89](index=89&type=chunk) - Management acknowledges the need to seek additional financing to fund future operations and meet obligations, stating that failure to do so may require significant delays or scaling back of product development[89](index=89&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide this disclosure. - As a smaller reporting company, Edesa Biotech is not required to provide disclosure under this item[93](index=93&type=chunk) [Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2024, with no material changes in internal control over financial reporting during the quarter. - Management concluded that the company's disclosure controls and procedures were **effective** as of the end of the period, June 30, 2024[94](index=94&type=chunk) - No changes occurred in the company's internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[94](index=94&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings or claims outside the ordinary course of business. - The company reports that it is not currently involved in any material legal proceedings[96](index=96&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended September 30, 2023. - No material changes to the risk factors from the Annual Report on Form 10-K for the fiscal year ended September 30, 2023, have been reported[97](index=97&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period. - None reported[97](index=97&type=chunk) [Other Information](index=27&type=section&id=Item%205.%20Other%20Information) No directors or officers of the company adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the fiscal quarter ended June 30, 2024. - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading plan during the quarter[98](index=98&type=chunk) [Exhibits](index=28&type=section&id=Item%206.%20Exhibits) The report lists several exhibits filed with the Form 10-Q, including certifications by the CEO and CFO pursuant to the Sarbanes-Oxley Act and Inline XBRL documents. - Exhibits filed include CEO and CFO certifications (31.1, 31.2, 32.1, 32.2) and Inline XBRL data files[100](index=100&type=chunk)