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)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading SymbolName of each exchange on which registered Common Shares, without par value EDSA The Nasdaq Stock Market LLC 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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ C ...

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, 2021 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) | --- | --- | --- | |---------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 British Columbia, Canada N/A (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Title of each class Trading SymbolName of exchange on which registered Common Shares, without par value EDSA The Nasdaq Stock Market LLC Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 1 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol Name of exchange on which registered Common Shares, without par value EDSA The Nasdaq Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934 For the transition period from to Commission File Nu ...

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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934 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 jurisdicti ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2020 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. | --- | --- | |------------------------------------------------------------------------------------------ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol Name of exchange on which registered Common Shares, without par value EDSA The Nasdaq Stock Market LLC 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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934 For the transition period from to Commission File Number: 001-37 ...

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 March 31, 2020 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 ...