Core Points - Dr. Pardeep Nijhawan has acquired beneficial ownership of more than 2% of Edesa Biotech, Inc.'s common shares since the last early warning report filed on November 18, 2022 [1] - The acquisition was triggered by a grant of 3,055 restricted share units (RSUs) on September 3, 2024, as part of his compensation as CEO [2] - Prior to recent transactions, Dr. Nijhawan held 3,775,809 common shares, representing approximately 19.51% on a non-diluted basis and 22.48% on a partially-diluted basis [3] - After the consolidation of shares and recent transactions, he now holds 544,401 common shares, representing approximately 16.76% on a non-diluted basis and 20.06% on a partially-diluted basis, indicating a decrease in ownership percentage [4] - The beneficial ownership percentages are based on 3,247,389 common shares outstanding as of the news release date [5] - Dr. Nijhawan acquired the common shares for investment purposes and may adjust his ownership in the future based on the evaluation of Edesa's business and financial condition [6]

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)

EXHIBIT 99.1 Edesa Biotech Reports Fiscal 3rd Quarter 2024 Results TORONTO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and nine months ended June 30, 2024 and provided an update on its business. During the quarter, the company's anti-TLR4 drug candidate, EB05 (paridiprubart), was selected by the U.S. Department ...

TORONTO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and nine months ended June 30, 2024 and provided an update on its business. During the quarter, the company's anti-TLR4 drug candidate, EB05 (paridiprubart), was selected by the U.S. Department of Health and Human Services for use in a U.S. government-funded pl ...

For the quarterly period ended March 31, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Registrant's telephone number, including area OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37619 EDESA BIOTECH, INC. (Exact name of registrant as specified in its charter) British Co ...

[Edesa Biotech Fiscal Q2 2024 Results](index=1&type=section&id=Edesa%20Biotech%20Reports%20Fiscal%202nd%20Quarter%202024%20Results) [Business Update and Strategic Outlook](index=1&type=section&id=Business%20Update%20and%20Strategic%20Outlook) Edesa Biotech advances its clinical pipeline, including Phase 3 ARDS study with **C$23M** funding, and dermatology assets - Expanded site selection for the Phase 3 study of its ARDS drug candidate, EB05 (paridiprubart), backed by up to **C$23 million** from the Canadian government[3](index=3&type=chunk) - The company plans to evaluate EB05 in a broader ARDS population and file an IND for a **Phase 2 study** in pulmonary fibrosis, positioning the anti-TLR4 technology for both acute and chronic conditions[3](index=3&type=chunk)[4](index=4&type=chunk) - For its dermatology portfolio, Edesa plans to seek U.S. regulatory approval for a **Phase 2 study** of its anti-CXCL10 antibody for vitiligo and seek strategic partners to develop or monetize its **EB01 asset** for dermatitis[4](index=4&type=chunk) - Management believes government funding provides a strong position to manage the **Phase 3 ARDS study** while opportunistically advancing its vitiligo and pulmonary fibrosis programs[6](index=6&type=chunk) [Financial Performance](index=1&type=section&id=Financial%20Performance) Edesa Biotech reported improved Q2 and H1 fiscal 2024 results, with reduced net loss from lower expenses and higher grant income [Three Months Ended March 31, 2024](index=1&type=section&id=Three%20Months%20Ended%20March%2031%2C%202024) Q2 2024 net loss narrowed to **$1.9 million** from **$2.3 million**, driven by lower operating expenses and higher grant income Q2 Fiscal 2024 vs. Q2 Fiscal 2023 Financial Highlights | Metric | Three Months Ended Mar 31, 2024 (USD) | Three Months Ended Mar 31, 2023 (USD) | Change (USD) | | :--- | :--- | :--- | :--- | | Total Operating Expenses | $2.2 million | $2.4 million | -$0.2 million | | Total Other Income | $360,000 | $77,000 | +$283,000 | | Net Loss | $1.9 million | $2.3 million | -$0.4 million | | Loss Per Common Share | $0.58 | $0.82 | -$0.24 | - Research and development (R&D) expenses decreased by **$0.3 million**, primarily due to lower external research costs for the completed dermatitis study[8](index=8&type=chunk) - General and administrative (G&A) expenses increased by **$0.1 million**, mainly due to higher fees for professional services[8](index=8&type=chunk) [Six Months Ended March 31, 2024](index=2&type=section&id=Six%20Months%20Ended%20March%2031%2C%202024) Net loss for the six months ended March 31, 2024, decreased to **$3.5 million** from **$4.7 million**, due to lower expenses and higher government reimbursement Six Months Fiscal 2024 vs. Six Months Fiscal 2023 Financial Highlights | Metric | Six Months Ended Mar 31, 2024 (USD) | Six Months Ended Mar 31, 2023 (USD) | Change (USD) | | :--- | :--- | :--- | :--- | | Total Operating Expenses | $4.1 million | $4.8 million | -$0.7 million | | Total Other Income | $0.5 million | $0.1 million | +$0.4 million | | Net Loss | $3.5 million | $4.7 million | -$1.2 million | | Loss Per Common Share | $1.12 | $1.70 | -$0.58 | - R&D expenses for the six-month period decreased by **$0.9 million**, while G&A expenses increased by **$0.2 million**[15](index=15&type=chunk) [Financial Position and Cash Flow](index=2&type=section&id=Financial%20Position%20and%20Cash%20Flow) As of March 31, 2024, Edesa held **$2.8 million** in cash and **$2.1 million** in working capital, with **$3.1 million** net cash used in operations Key Financial Position Data (as of March 31, 2024) | Metric | Amount (USD) | | :--- | :--- | | Cash and Cash Equivalents | $2.8 million | | Working Capital | $2.1 million | - Subsequent to the quarter end, the company received **$0.7 million** in reimbursement funding from the Canadian government's Strategic Innovation Fund[11](index=11&type=chunk) - Net cash used in operating activities for the six months ended March 31, 2024, was **$3,066,687**[22](index=22&type=chunk) [Corporate Information](index=2&type=section&id=Corporate%20Information) Edesa Biotech is a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, with key pipeline assets EB05, EB06, and EB01 - Edesa's most advanced drug candidate is **EB05** (paridiprubart), a monoclonal antibody being evaluated in a **Phase 3 study** for Acute Respiratory Distress Syndrome (ARDS)[13](index=13&type=chunk) - The company's pipeline also includes **EB06** for vitiligo and **EB01** for chronic Allergic Contact Dermatitis (ACD)[13](index=13&type=chunk) - Management plans to attend the **RBC Capital Markets Global Healthcare Conference** (May 14-15, 2024) and the **BIO International Convention** (June 5-8, 2024)[12](index=12&type=chunk) [Condensed Financial Statements](index=3&type=section&id=Condensed%20Financial%20Statements) This section presents unaudited condensed interim consolidated financial statements, including Statements of Operations, Balance Sheets, and Cash Flows [Condensed Interim Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Operations) The statement details expenses and income, showing a net loss of **$1,861,331** for Q2 and **$3,539,782** for H1 2024 Condensed Interim Consolidated Statements of Operations (Unaudited) | | Three Months Ended March 31, (USD) | Six Months Ended March 31, (USD) | | :--- | :--- | :--- | | | **2024** | **2023** | **2024** | **2023** | | **Expenses:** | | | | | | Research and development | $1,176,337 | $1,458,190 | $1,880,795 | $2,815,528 | | General and administrative | $1,044,137 | $952,391 | $2,197,108 | $1,973,358 | | **Loss from operations** | **($2,220,474)** | **($2,410,581)** | **($4,077,903)** | **($4,788,886)** | | **Other Income (Loss):** | | | | | | Reimbursement grant income | $304,002 | - | $424,836 | - | | Other income (loss) | $55,941 | $77,032 | $114,085 | $120,520 | | **Net loss** | **($1,861,331)** | **($2,334,349)** | **($3,539,782)** | **($4,669,166)** | | **Loss per common share** | **($0.58)** | **($0.82)** | **($1.12)** | **($1.70)** | [Condensed Interim Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Interim%20Consolidated%20Balance%20Sheets) As of March 31, 2024, total assets were **$6,475,056** and shareholders' equity **$4,324,333**, a decrease from September 30, 2023 Condensed Interim Consolidated Balance Sheets (Unaudited) | | March 31, 2024 (USD) | September 30, 2023 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,799,631 | $5,361,397 | | Other current assets | $1,442,587 | $1,075,455 | | Non-current assets | $2,232,838 | $2,453,585 | | **Total Assets** | **$6,475,056** | **$8,890,437** | | **Liabilities and Shareholders' Equity** | | | | Current liabilities | $2,150,723 | $1,821,864 | | Non-current liabilities | - | $19,773 | | Shareholders' equity | $4,324,333 | $7,048,800 | | **Total liabilities and shareholders' equity** | **$6,475,056** | **$8,890,437** | [Condensed Interim Consolidated Statements of Cash Flows](index=4&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities for the six months ended March 31, 2024, was **$3,066,687**, with an ending cash balance of **$2,799,631** Condensed Interim Consolidated Statements of Cash Flows (Unaudited) | | Six Months Ended March 31, (USD) | | :--- | :--- | :--- | | | **2024** | **2023** | | Net cash used in operating activities | ($3,066,687) | ($3,363,240) | | Net cash provided by financing activities | $517,441 | $3,676,415 | | Net change in cash and cash equivalents | ($2,561,766) | $380,333 | | Cash and cash equivalents, beginning of period | $5,361,397 | $7,090,919 | | **Cash and cash equivalents, end of period** | **$2,799,631** | **$7,471,252** |

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37619 EDESA BIOTECH, INC. (Exact name of registrant as specified in its charter) British Columbia, Canada N/A (State or other jurisdict ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37619 EDESA BIOTECH, INC. (Exact name of registrant as specified in its charter) British Columbia, Canada N/A (State or other jurisdiction of ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37619 EDESA BIOTECH, INC. (Exact name of registrant as specified in its charter) British Columbia, Canada N/A (State or other jurisdiction ...

PART I - FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited interim financials for March 31, 2023, show decreased assets and net losses, with financing as primary cash source [Condensed Interim Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Interim%20Consolidated%20Balance%20Sheets) Total assets decreased to **$10.67 million** by March 31, 2023, from **$11.58 million**, impacting shareholders' equity Condensed Consolidated Balance Sheet Highlights (in USD) | Balance Sheet Item | March 31, 2023 | September 30, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $7,471,252 | $7,090,919 | | Total current assets | $8,129,594 | $9,091,913 | | Total assets | $10,673,485 | $11,575,728 | | Total current liabilities | $1,564,786 | $2,140,777 | | Total liabilities | $1,673,548 | $2,184,439 | | Total shareholders' equity | $8,999,937 | $9,391,289 | [Condensed Interim Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Operations) Operating expenses and net losses significantly decreased for the three and six months ended March 31, 2023, due to reduced R&D Statement of Operations Summary (in USD) | Metric | Three Months Ended Mar 31, 2023 | Three Months Ended Mar 31, 2022 | Six Months Ended Mar 31, 2023 | Six Months Ended Mar 31, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $1,458,190 | $3,042,815 | $2,815,528 | $6,993,861 | | General and administrative | $952,391 | $1,532,416 | $1,973,358 | $2,743,093 | | Loss from operations | ($2,410,581) | ($4,575,231) | ($4,788,886) | ($9,736,954) | | Net loss | ($2,334,349) | ($4,569,316) | ($4,669,166) | ($8,947,993) | | Loss per share (basic & diluted) | ($0.12) | ($0.33) | ($0.24) | ($0.66) | [Condensed Interim Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was **$3.36 million**, offset by **$3.68 million** from financing, increasing cash by **$0.38 million** Cash Flow Summary for Six Months Ended March 31 (in USD) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,363,240) | ($3,624,268) | | Net cash used in investing activities | $0 | ($4,339) | | Net cash provided by financing activities | $3,676,415 | $11,629,914 | | Net change in cash and cash equivalents | $380,333 | $8,047,940 | | Cash and cash equivalents, end of period | $7,471,252 | $15,887,199 | [Condensed Interim Consolidated Statements of Changes in Shareholders' Equity](index=6&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity) Shareholders' equity decreased to **$9.00 million** due to a **$4.67 million** net loss, partially offset by equity offerings - Total shareholders' equity decreased from **$9,391,289** at the beginning of the six-month period to **$8,999,937** at March 31, 2023[20](index=20&type=chunk) - Key changes included a net loss of **$4.67 million**, offset by **$3.03 million** from an equity offering and **$0.77 million** from warrant exercises[20](index=20&type=chunk) [Notes to Condensed Interim Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Interim%20Consolidated%20Financial%20Statements) Notes detail biopharmaceutical operations, significant future commitments, and recent capital-raising activities including an ATM program - The company is a biopharmaceutical firm focused on developing and commercializing drugs for inflammatory and immune-related diseases[22](index=22&type=chunk) - The company has significant future commitments, including up to **$356 million** contingent on milestones for a 2020 license agreement and up to **$18.4 million** for a 2016 license agreement[40](index=40&type=chunk)[41](index=41&type=chunk) - In November 2022, the company raised net proceeds of **$2.91 million** through a private placement of shares and warrants[45](index=45&type=chunk) - In March 2023, the company entered an 'at-the-market' (ATM) equity distribution agreement to sell up to **$20 million** in common shares[43](index=43&type=chunk) - Subsequent to March 31, 2023, the company issued **562,052** common shares under the ATM program, receiving net proceeds of **$0.60 million**[69](index=69&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes decreased operating expenses and net loss to lower research costs, advancing the Phase 3 EB05 study, with cash and ATM proceeds funding operations - The company's most advanced drug candidate is **EB05 (paridiprubart)** for Acute Respiratory Distress Syndrome (ARDS), currently in a Phase 3 study[76](index=76&type=chunk) - In March 2023, the company and the FDA agreed on the primary endpoint and population for the Phase 3 study of **EB05** in hospitalized COVID-19 patients with ARDS, targeting **600** subjects[78](index=78&type=chunk) Comparison of Operating Expenses (in USD millions) | Expense Category | Three Months Ended Mar 31, 2023 | Three Months Ended Mar 31, 2022 | Six Months Ended Mar 31, 2023 | Six Months Ended Mar 31, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $1.46 | $3.04 | $2.82 | $6.99 | | General & Administrative | $0.95 | $1.53 | $1.97 | $2.74 | - As of March 31, 2023, the company had **$7.47 million** in cash and cash equivalents and plans to finance operations over the next twelve months with cash on hand and equity sales from its at-the-market (ATM) program[94](index=94&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=18&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide disclosures under this item - As a smaller reporting company, Edesa Biotech is not required to provide disclosure under this item[98](index=98&type=chunk) [Controls and Procedures](index=18&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2023, with no material changes in internal control - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2023[101](index=101&type=chunk) - No changes occurred in internal control over financial reporting during the quarter ended March 31, 2023, that have materially affected, or are reasonably likely to materially affect, these controls[102](index=102&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=19&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings or claims - The company is not currently a party to any material legal proceedings[104](index=104&type=chunk) [Risk Factors](index=19&type=section&id=Item%201A.Risk%20Factors) No material changes to risk factors previously disclosed in the Annual Report on Form 10-K - There have been no material changes to the risk factors discussed in the company's Annual Report on Form 10-K for the year ended September 30, 2022[105](index=105&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=19&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None reported[106](index=106&type=chunk) [Defaults Upon Senior Securities](index=19&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported - None reported[107](index=107&type=chunk) [Mine Safety Disclosures](index=19&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[108](index=108&type=chunk) [Other Information](index=19&type=section&id=Item%205.%20Other%20Information) No other information was reported for this item - None reported[109](index=109&type=chunk) [Exhibits](index=20&type=section&id=Item%206.%20Exhibits) Exhibits include CEO and CFO certifications required by Sarbanes-Oxley Act, and XBRL Interactive Data Files - The report includes certifications from the CEO and CFO pursuant to Rule 13a-14(a) and Section 906 of the Sarbanes-Oxley Act of 2002[112](index=112&type=chunk)[113](index=113&type=chunk) - XBRL Instance Document and related taxonomy files are also included as exhibits[113](index=113&type=chunk)