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 ...

Financial Performance - Total operating expenses decreased by $3.74 million to $2.06 million for the three months ended June 30, 2023, compared to $5.80 million for the same period last year[87] - Net loss for the three months ended June 30, 2023, was $1.98 million, or $0.10 per common share, compared to a net loss of $5.79 million, or $0.37 per common share, for the same period last year[88] - Total operating expenses decreased by $8.68 million to $6.85 million for the nine months ended June 30, 2023, compared to $15.53 million for the same period last year[89] - Net loss for the nine months ended June 30, 2023, was $6.65 million, or $0.34 per common share, compared to a net loss of $14.74 million, or $1.04 per common share, for the same period last year[90] - As of June 30, 2023, the company had cash and cash equivalents of $6.46 million, working capital of $5.39 million, and shareholders' equity of $7.85 million, with an accumulated deficit of $50.70 million[98] Research and Development - Research and development expenses decreased by $3.52 million to $1.03 million for the three months ended June 30, 2023, compared to $4.55 million for the same period last year[87] - Research and development expenses for the nine months ended June 30, 2023, were $3.84 million, a decrease from $11.54 million in the same period of 2022, primarily due to reduced external research expenses[100] - Research and development activities focus on innovative therapeutics for inflammatory and immune-related diseases, with costs incurred as activities progress[99] - The fluctuation in research and development costs is influenced by study initiation expenses and patient recruitment rates, expected to continue varying significantly[100] Clinical Trials and Regulatory Affairs - The company plans to increase the number of investigational centers from 23 to up to 60 hospitals in the U.S. and Canada for clinical trials[83] - The FDA granted Fast Track designation for the drug candidate EB05 based on significant mortality reductions observed in a Phase 2 study[78] - The company is preparing for an End of Phase 2 meeting with the FDA for the drug candidate EB01 following positive preliminary results[79] Financing and Funding - The company has entered into an equity distribution agreement for up to $20 million in gross cash proceeds, with $0.69 million net proceeds from sales in the three months ended June 30, 2023[93] - Under a contribution agreement with the Canadian government's Strategic Innovation Fund, the company was eligible to receive cash reimbursements up to approximately $11 million USD for certain R&D expenses[97] - The company plans to finance operations over the next twelve months through cash on hand and equity sales, with potential additional financing from government grants, debt, or strategic transactions[98] - Market volatility, inflation, interest rates, and geopolitical concerns may significantly impact the availability and terms of funding sources[98] Miscellaneous - The company does not have any off-balance sheet arrangements that could materially affect its financial condition or operations[101] - As a smaller reporting company, the company is not required to provide disclosures regarding market risk[102]

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)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) (289) 800-9600 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2022 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, ...

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, 2022 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, 2022 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) | --- | --- | --- | |--------------------------- ...

PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=2&type=section&id=Item%201.%20Financial%20Statements) This section presents Edesa Biotech's unaudited interim consolidated financial statements, showing increased assets and a higher net loss [Condensed Interim Consolidated Balance Sheets](index=2&type=section&id=Condensed%20Interim%20Consolidated%20Balance%20Sheets) The balance sheet shows increased cash and total assets, primarily from equity issuances, boosting shareholders' equity Consolidated Balance Sheet Highlights (in USD) | Financial Metric | March 31, 2022 | September 30, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $15,887,199 | $7,839,259 | | Total current assets | $17,999,889 | $12,090,731 | | Total assets | $20,407,623 | $14,584,655 | | **Liabilities & Equity** | | | | Total current liabilities | $3,335,240 | $1,458,650 | | Total liabilities | $3,383,210 | $1,526,364 | | Total shareholders' equity | $17,024,413 | $13,058,291 | [Condensed Interim Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Operations) Net loss increased due to reduced grant income, despite decreased research and development expenses Statement of Operations Summary (in USD) | Metric | Three Months Ended Mar 31, 2022 | Three Months Ended Mar 31, 2021 | Six Months Ended Mar 31, 2022 | Six Months Ended Mar 31, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,042,815 | $7,975,304 | $6,993,861 | $9,354,958 | | General and administrative | $1,532,416 | $1,535,127 | $2,743,093 | $2,769,275 | | Loss from Operations | ($4,575,231) | ($9,510,431) | ($9,736,954) | ($12,124,233) | | Reimbursement grant income | - | $7,170,465 | $780,257 | $7,170,465 | | **Net Loss** | **($4,569,316)** | **($2,259,987)** | **($8,947,993)** | **($4,897,599)** | | Loss per common share | ($0.33) | ($0.19) | ($0.66) | ($0.45) | [Condensed Interim Consolidated Statements of Cash Flows](index=4&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) Operating cash outflow improved, while financing activities significantly increased the ending cash balance Cash Flow Summary for Six Months Ended March 31 (in USD) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,624,268) | ($10,190,057) | | Net cash used in investing activities | ($4,339) | ($4,098) | | Net cash provided by financing activities | $11,629,914 | $13,937,798 | | **Net change in cash** | **$8,047,940** | **$3,752,499** | | **Cash, end of period** | **$15,887,199** | **$10,966,194** | [Notes to Condensed Interim Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20Condensed%20Interim%20Consolidated%20Financial%20Statements) Notes detail biopharmaceutical operations, significant future license commitments, and recent equity offerings - The company is a biopharmaceutical firm focused on developing and commercializing clinical-stage drugs for inflammatory and immune-related diseases[21](index=21&type=chunk) - The company has license and royalty commitments contingent upon meeting certain milestones, with remaining payments of up to **$352.5 million** for one agreement and up to **$68.9 million** for another[48](index=48&type=chunk)[51](index=51&type=chunk) - On March 24, 2022, the company completed a registered direct offering and concurrent private placement, raising aggregate gross proceeds of approximately **$10.0 million**[52](index=52&type=chunk) - Through an equity distribution agreement, the company sold **626,884 common shares** for gross proceeds of **$2.94 million** during the six months ended March 31, 2022, with the agreement terminated on March 21, 2022[57](index=57&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=14&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses product candidates, R&D expenses, net loss, and liquidity from recent equity offerings - The company's lead product candidates are EB05 for Acute Respiratory Distress Syndrome (ARDS) and EB01 for chronic allergic contact dermatitis (ACD)[92](index=92&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk) - In March 2022, the company completed a registered direct offering, receiving net proceeds of **$9.01 million** for working capital and R&D expenses[96](index=96&type=chunk) Comparison of Operating Results (in USD millions) | Period | Total Operating Expenses | Change | Net Loss | Change | | :--- | :--- | :--- | :--- | :--- | | **Three Months Ended Mar 31** | | | | | | 2022 | $4.58 | ($4.93) | $4.57 | $2.31 | | 2021 | $9.51 | | $2.26 | | | **Six Months Ended Mar 31** | | | | | | 2022 | $9.74 | ($2.38) | $8.95 | $4.05 | | 2021 | $12.12 | | $4.90 | | - As of March 31, 2022, the company had cash and cash equivalents of **$15.89 million** and working capital of **$14.66 million**, with management planning to finance operations using cash on hand and government grant reimbursements[112](index=112&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=17&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Edesa Biotech, Inc. is exempt from providing market risk disclosures - The company is a smaller reporting company and is not required to provide disclosure under this item[118](index=118&type=chunk) [Item 4. Controls and Procedures](index=17&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were effective with no material changes to internal financial reporting controls - The company's CEO and CFO concluded that disclosure controls and procedures were effective as of March 31, 2022[121](index=121&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[123](index=123&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=18&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings or claims - The company is not currently a party to any material legal proceedings[125](index=125&type=chunk) [Item 1A. Risk Factors](index=18&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors previously disclosed in the Annual Report on Form 10-K - No material changes have been made to the risk factors discussed in the Annual Report on Form 10-K for the year ended September 30, 2021[126](index=126&type=chunk) [Other Items (2, 3, 4, 5)](index=18&type=section&id=Other%20Items) The company reported no information for Items 2, 3, 4, and 5 - The company reports "None" or "Not applicable" for Items 2, 3, 4, and 5[128](index=128&type=chunk)[130](index=130&type=chunk)[132](index=132&type=chunk)[134](index=134&type=chunk) [Item 6. Exhibits](index=18&type=section&id=Item%206.%20Exhibits) This section indexes exhibits filed with the Form 10-Q, including warrants and CEO/CFO certifications - The report includes an index of exhibits filed, such as forms of warrants, amendments to employment agreements, and required CEO/CFO certifications[136](index=136&type=chunk)[138](index=138&type=chunk)