☐~~TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934~~

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

As of May ~~12, 2022,~~10, 2023, the registrant had ~~15,462,287~~20,587,717 common shares issued and outstanding.

	March 31, 2022			September 30, 2021			March 31, 2023			September 30, 2022

Assets:

Current assets:
Cash and cash equivalents	$	15,887,199		$	7,839,259		$	7,471,252		$	7,090,919
Accounts and other receivable		1,249,371			3,302,827			50,233			1,255,451
Prepaid expenses and other current assets		863,319			948,645			608,109			745,543

Total current assets		17,999,889			12,090,731			8,129,594			9,091,913

Non-current assets:
Property and equipment, net		16,093			14,989			10,769			12,694
Long-term deposits								174,126			171,464
Intangible asset, net		2,331,778			2,382,364			2,230,606			2,281,192
Right-of-use assets		59,863			96,571			128,390			18,465

Total assets	$	20,407,623		$	14,584,655		$	10,673,485		$	11,575,728

Liabilities and shareholders' equity:

Current liabilities:
Accounts payable and accrued liabilities	$	3,273,699		$	1,379,842		$	1,499,380		$	2,121,802
Lease obligations on right-of-use assets		61,541			78,808
Short-term right-of-use lease liabilities								65,406			18,975

Total current liabilities		3,335,240			1,458,650			1,564,786			2,140,777

Non-current liabilities:

Long-term payables		47,970			47,202			44,340			43,662
Long-term lease obligations on right-of-use assets		0			20,512
Long-term right-of-use lease liabilities								64,422			-

Total liabilities		3,383,210			1,526,364			1,673,548			2,184,439

Commitments (Note 5)

Shareholders' equity:
Capital shares
Authorized unlimited common and preferred shares without par value
Issued and outstanding:
15,462,287 common shares (September 30, 2021 - 13,295,403)		40,264,080			34,887,721
20,058,665 common shares (September 30, 2022 - 16,662,014)								45,453,733			42,473,099
Additional paid-in capital		12,364,302			4,871,461			12,489,949			11,176,345
Accumulated other comprehensive loss		(160,347	)		(205,262	)		(230,026	)		(213,602	)
Accumulated deficit		(35,443,622	)		(26,495,629	)		(48,713,719	)		(44,044,553	)

Total shareholders' equity		17,024,413			13,058,291			8,999,937			9,391,289

Total liabilities and shareholders' equity	$	20,407,623		$	14,584,655		$	10,673,485		$	11,575,728

The accompanying notes are an integral part of these condensed interim consolidated financial statements.

	Three Months Ended						Six Months Ended						Three Months Ended						Six Months Ended
	March 31, 2022			March 31, 2021			March 31, 2022			March 31, 2021			March 31, 2023			March 31, 2022			March 31, 2023			March 31, 2022

Expenses:
Research and development		3,042,815			7,975,304			6,993,861			9,354,958		$	1,458,190		$	3,042,815		$	2,815,528		$	6,993,861
General and administrative		1,532,416			1,535,127			2,743,093			2,769,275			952,391			1,532,416			1,973,358			2,743,093

		4,575,231			9,510,431			9,736,954		��	12,124,233
Loss from operations														(2,410,581	)		(4,575,231	)		(4,788,886	)		(9,736,954	)

Loss from Operations		(4,575,231	)		(9,510,431	)		(9,736,954	)		(12,124,233	)

Other Income (Loss):
Other income (loss):
Reimbursement grant income		0			7,170,465			780,257			7,170,465			-			-			-			780,257
Interest income		3,748			747			9,868			1,669			85,718			3,748			135,147			9,868
Foreign exchange gain (loss)		2,967			80,032			(364	)		55,300			(8,686	)		2,967			(14,627	)		(364	)

		6,715			7,251,244			789,761			7,227,434			77,032			6,715			120,520			789,761

Loss before income taxes		(4,568,516	)		(2,259,187	)		(8,947,193	)		(4,896,799	)		(2,333,549	)		(4,568,516	)		(4,668,366	)		(8,947,193	)

Income tax expense		800			800			800			800			800			800			800			800

Net Loss		(4,569,316	)		(2,259,987	)		(8,947,993	)		(4,897,599	)
Net loss														(2,334,349	)		(4,569,316	)		(4,669,166	)		(8,947,993	)

Exchange differences on translation		13,066			(10,480	)		44,915			92,947			8,643			13,066			(16,424	)		44,915

Net Comprehensive Loss	$	(4,556,250	)	$	(2,270,467	)	$	(8,903,078	)	$	(4,804,652	)
Net comprehensive loss													$	(2,325,706	)	$	(4,556,250	)	$	(4,685,590	)	$	(8,903,078	)

Weighted average number of common shares		13,867,345			11,641,201			13,610,164			10,894,441			19,973,319			13,867,345			19,171,939			13,610,164

Loss per common share - basic and diluted	$	(0.33	)	$	(0.19	)	$	(0.66	)	$	(0.45	)	$	(0.12	)	$	(0.33	)	$	(0.24	)	$	(0.66	)

The accompanying notes are an integral part of these condensed interim consolidated financial statements.

	Six Months Ended						Six Months Ended
	March 31, 2022			March 31, 2021			March 31, 2023			March 31, 2022

Cash Flows from Operating Activities:
Cash flows from operating activities:
Net loss	$	(8,947,993	)	$	(4,897,599	)	$	(4,669,166	)	$	(8,947,993	)
Adjustments for:
Depreciation and amortization		59,633			58,647			54,502			59,633
Share-based compensation		1,239,286			1,190,347			621,221			1,239,286
Changes in working capital items:
Accounts and other receivable		2,068,473			(7,564,714	)		1,137,833			2,068,473
Prepaid expenses and other current assets		97,209			(1,928,522	)		140,852			97,209
Accounts payable and accrued liabilities		1,859,124			2,951,784			(648,482	)		1,859,124

Net cash used in operating activities		(3,624,268	)		(10,190,057	)		(3,363,240	)		(3,624,268	)

Cash Flows from Investing Activities:
Cash flows from investing activities:
Purchase of property and equipment		(4,339	)		(4,098	)		-			(4,339	)

Net cash used in investing activities		(4,339	)		(4,098	)		-			(4,339	)

Cash Flows from Financing Activities:
Cash flows from financing activities:
Proceeds from issuance of common shares and warrants		11,957,567			12,793,591			3,027,496			11,957,567
Proceeds from exercise of warrants		0			1,467,536			770,531			-
Proceeds from exercise of share options		0			26,079
Payments for issuance costs of common shares and warrants		(327,653	)		(349,408	)		(121,612	)		(327,653	)

Net cash provided by financing activities		11,629,914			13,937,798			3,676,415			11,629,914

Effect of exchange rate changes on cash and cash equivalents		46,633			8,856			67,158			46,633

Net change in cash and cash equivalents		8,047,940			3,752,499			380,333			8,047,940
Cash and cash equivalents, beginning of period		7,839,259			7,213,695			7,090,919			7,839,259

Cash and cash equivalents, end of period	$	15,887,199		$	10,966,194		$	7,471,252		$	15,887,199

Supplemental Disclosure of Noncash Financing Activities:
Preferred shares converted from temporary equity to common shares	$	0		$	2,496,480
Issuance costs withheld from gross proceeds from issuance of common shares and warrants		393,461			955,950		$	-		$	393,461
Fair value of placement agent/underwriter warrants		408,059			407,023
Fair value of placement agent warrants								-			408,059

The accompanying notes are an integral part of these condensed interim consolidated financial statements.

Condensed Interim Consolidated Statements of Changes in ~~Shareholders’~~Shareholders' Equity

																		Shares		Common Shares			Additional Paid-in Capital			Accumulated Other Comprehensive Loss			Accumulated Deficit			Total
Three Months Ended March 31, 2023
Balance - December 31, 2022																			19,353,351	$	44,473,823		$	12,417,672		$	(238,669	)	$	(46,379,370	)	$	10,273,456

Issuance of common shares upon exercise of warrants																			705,314		994,618			(224,087	)		-			-			770,531
Issuance costs																			-		(14,708	)		8,817			-			-			(5,891	)
Share-based compensation																			-		-			287,547			-			-			287,547
Net loss and comprehensive loss																			-		-			-			8,643			(2,334,349	)		(2,325,706	)

Balance - March 31, 2023																			20,058,665	$	45,453,733		$	12,489,949		$	(230,026	)	$	(48,713,719	)	$	8,999,937
	Shares #		Common Shares			Additional Paid-in Capital			Accumulated Other Comprehensive Loss			Accumulated Deficit			Total Shareholders' Equity
Three Months Ended March 31, 2022
Balance - December 31, 2021		13,518,799	$	36,116,225		$	5,480,739		$	(173,413	)	$	(30,874,306	)	$	10,549,245			13,518,799	$	36,116,225		$	5,480,739		$	(173,413	)	$	(30,874,306	)	$	10,549,245

Issuance of common shares and warrants in equity offering		1,943,488		4,952,013			6,702,293			0			0			11,654,306			1,943,488		4,952,013			6,702,293			-			-			11,654,306
Issuance costs including fair value of placement agent warrants		-		(804,158	)		(448,738	)		0			0			(1,252,896	)		-		(804,158	)		(448,738	)		-			-			(1,252,896	)
Share-based compensation		-		0			630,008			0			0			630,008			-		-			630,008			-			-			630,008
Net loss and comprehensive loss		-		0			0			13,066			(4,569,316	)		(4,556,250	)		-		-			-			13,066			(4,569,316	)		(4,556,250	)

Balance - March 31, 2022		15,462,287	$	40,264,080		$	12,364,302		$	(160,347	)	$	(35,443,622	)	$	17,024,413			15,462,287	$	40,264,080		$	12,364,302		$	(160,347	)	$	(35,443,622	)	$	17,024,413

Three Months Ended March 31, 2021
Balance - December 31, 2020		10,523,087	$	21,696,459		$	2,156,719		$	(183,777	)	$	(15,784,177	)	$	7,885,224
Six Months Ended March 31, 2023
Balance - September 30, 2022																			16,662,014	$	42,473,099		$	11,176,345		$	(213,602	)	$	(44,044,553	)	$	9,391,289

Issuance of common shares and warrants in equity offering		1,979,210		12,723,013			0			0			0			12,723,013			2,691,337		2,082,669			944,827			-			-			3,027,496
Issuance costs including fair value of underwriter warrants		-		(1,810,237	)		407,023			0			0			(1,403,214	)
Issuance of common shares upon exercise of warrants		98,437		570,228			(97,731	)		0			0			472,497			705,314		994,618			(224,087	)		-			-			770,531
Issuance of common shares upon exercise of share options		10,746		45,047			(18,968	)		0			0			26,079
Preferred return on convertible preferred shares		-		0			0			0			(5,914	)		(5,914	)
Conversion of convertible preferred shares		635,079		1,378,127			0			0			0			1,378,127
Issuance costs																			-		(96,653	)		(28,357	)		-			-			(125,010	)
Share-based compensation		-		0			467,439			0			0			467,439			-		-			621,221			-			-			621,221
Net loss and comprehensive loss		-		0			0			(10,480	)		(2,259,987	)		(2,270,467	)		-		-			-			(16,424	)		(4,669,166	)		(4,685,590	)

Balance - March 31, 2021		13,246,559	$	34,602,637		$	2,914,482		$	(194,257	)	$	(18,050,078	)	$	19,272,784
Balance - March 31, 2023																			20,058,665	$	45,453,733		$	12,489,949		$	(230,026	)	$	(48,713,719	)	$	8,999,937

Six Months Ended March 31, 2022
Balance - September 30, 2021		13,295,403	$	34,887,721		$	4,871,461		$	(205,262	)	$	(26,495,629	)	$	13,058,291			13,295,403	$	34,887,721		$	4,871,461		$	(205,262	)	$	(26,495,629	)	$	13,058,291

Issuance of common shares and warrants in equity offering		2,166,884		6,239,180			6,702,293			0			0			12,941,473			2,166,884		6,239,180			6,702,293			-			-			12,941,473
Issuance costs including fair value of placement agent warrants		-		(862,821	)		(448,738	)		0			0			(1,311,559	)		-		(862,821	)		(448,738	)		-			-			(1,311,559	)
Share-based compensation		-		0			1,239,286			0			0			1,239,286			-		-			1,239,286			-			-			1,239,286
Net loss and comprehensive loss		-		0			0			44,915			(8,947,993	)		(8,903,078	)		-		-			-			44,915			(8,947,993	)		(8,903,078	)

Balance - March 31, 2022		15,462,287	$	40,264,080		$	12,364,302		$	(160,347	)	$	(35,443,622	)	$	17,024,413			15,462,287	$	40,264,080		$	12,364,302		$	(160,347	)	$	(35,443,622	)	$	17,024,413

Six Months Ended March 31, 2021
Balance - September 30, 2020		9,615,119	$	18,500,853		$	1,550,480		$	(287,204	)	$	(13,132,954	)	$	6,631,175

Issuance of common shares and warrants in equity offering		2,148,963		13,749,541			0			0			0			13,749,541
Issuance costs including fair value of underwriter warrants		-		(1,871,220	)		407,023			0			0			(1,464,197	)
Issuance of common shares upon exercise of warrants		341,806		1,681,936			(214,400	)		0			0			1,467,536
Issuance of common shares upon exercise of share options		10,746		45,047			(18,968	)		0			0			26,079
Preferred return on convertible preferred shares		-		0			0			0			(19,525	)		(19,525	)
Conversion of convertible preferred shares		1,129,925		2,496,480			0			0			0			2,496,480
Share-based compensation		-		0			1,190,347			0			0			1,190,347
Net loss and comprehensive loss		-		0			0			92,947			(4,897,599	)		(4,804,652	)

Balance - March 31, 2021		13,246,559	$	34,602,637		$	2,914,482		$	(194,257	)	$	(18,050,078	)	$	19,272,784

The accompanying notes are an integral part of these condensed interim consolidated financial statements.

Edesa Biotech, Inc. (the ~~“Company”~~Company or ~~“Edesa”)~~Edesa) is a biopharmaceutical company focused on acquiring, developing and commercializing clinical-stage drugs for inflammatory and immune-related diseases with clear unmet medical needs. The Company is organized under the laws of British Columbia, Canada and is headquartered in Markham, Ontario. It operates under its wholly owned subsidiaries, Edesa Biotech Research, Inc., an Ontario, ~~Canada.~~Canada corporation, and Edesa Biotech USA, Inc., a California, USA corporation.

The Company’s common shares trade on The Nasdaq Capital Market in the United States under the symbol “EDSA”.

The ongoing COVID-19 pandemic has severely impacted global economic activity and has caused material disruptions to almost every industry directly or indirectly. The full impact of the pandemic remains uncertain and ongoing developments related to the pandemic may cause material impacts to the Company’s future operations, clinical study timelines and financial results. While the full impact of the COVID-19 pandemic to business and operating results presents additional uncertainty, the Company’s management continues to use reasonably available information to assess impacts to the Company’s business plans and financial condition.

The accompanying unaudited condensed interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q. They do not include all information and footnotes necessary for a fair presentation of financial position, results of operations and cash flows in conformity with U.S. GAAP for complete financial statements. These unaudited condensed interim consolidated financial statements should be read in conjunction with the consolidated financial statements and related notes contained in the Company’s Annual Report on Form 10-K for the year ended September 30, ~~2021,~~2022, which was filed with the Securities and Exchange Commission (SEC) on December ~~28, 2021.~~16, 2022.

The accompanying unaudited condensed interim consolidated financial statements include the accounts of the Company and its wholly owned ~~subsidiaries, Edesa Biotech Research, Inc., an Ontario corporation, and Edesa Biotech USA, Inc., a California corporation in the U.S.~~subsidiaries. All intercompany balances and transactions have been eliminated on consolidation. All adjustments (consisting of normal recurring adjustments and accruals) considered necessary for a fair presentation of the results of operations for the periods presented have been included in the interim periods. Operating results for the three and six months ended March 31, ~~2022~~2023 are not necessarily indicative of the results that may be expected for other interim periods or the fiscal year ending September 30, ~~2022.~~2023.

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the period or year. Actual results could differ from those estimates. Areas where significant judgment is involved in making estimates are valuation of accounts and other receivable; valuation and useful lives of property and equipment; intangible assets; operating lease right-of-use assets; deferred income taxes; the determination of fair value of share-based compensation; the determination of fair value of warrants in order to allocate proceeds from equity issuances; and forecasting future cash flows for assessing the going concern assumption.

The consolidated financial statements of the Company are presented in U.S. dollars, unless otherwise stated, which is the ~~functional currency of the Company~~Company’s and its ~~U.S. subsidiary.~~wholly owned subsidiary’s, Edesa Biotech USA, Inc., functional currency. The functional currency of the Company’s ~~Canadian~~wholly owned subsidiary, Edesa Biotech Research, Inc., as determined by management, is Canadian dollars.

In April 2020, the Company entered into a license agreement with a pharmaceutical development company to obtain exclusive world-wide rights to know-how, patents and data relating to certain monoclonal antibodies ~~(“the Constructs”)~~(the Constructs), including sublicensing rights. Unless earlier terminated, the term of the license agreement will remain in effect for 25 years from the date of first commercial sale of licensed products containing the Constructs. Subsequently, the license agreement will automatically renew for five-year periods unless either party terminates the agreement in accordance with its terms.

Under the license agreement, the Company is exclusively responsible, at its expense, for the research, development manufacture, marketing, distribution and commercialization of the Constructs and licensed products and to obtain all necessary licenses and rights. The Company is required to use commercially reasonable efforts to develop and commercialize the Constructs in accordance with the terms of a development plan established by the parties.

The Company has determined that the license has multiple alternative future uses in research and development projects and sublicensing in other countries or for other disease indications. The value of the acquired license is recorded as an intangible asset with amortization over the estimated useful life of 25 years and evaluation for impairment at the end of each reporting period.

The required upfront license payment of $2.5 million was paid by issuance of Series A-1 Convertible Preferred Shares, which ~~were subsequently~~have been fully converted to common shares. The value of the license includes acquisition legal costs. See Note 5 for license commitments.

	March 31, 2022			September 30, 2021			March 31, 2023			September 30, 2022

The Constructs	$	2,529,483		$	2,529,483		$	2,529,483		$	2,529,483

Less: accumulated amortization		(197,705	)		(147,119	)		(298,877	)		(248,291	)

Total intangible assets, net	$	2,331,778		$	2,382,364		$	2,230,606		$	2,281,192

Amortization expense amounted to ~~$0.25~~$0.03 million for each of the three months ended March 31, 2023 and 2022 and ~~2021 and $0.51~~$0.05 million for each of the six months ended March 31, 2023 and 2022 ~~and 2021.~~.

Total estimated future amortization of intangible assets for each fiscal year is as follows:

Year Ending
September 30, 2022	$	50,586
September 30, 2023		101,172	$	50,586
September 30, 2024		101,172		101,172
September 30, 2025		101,172		101,172
September 30, 2026		101,172		101,172
September 30, 2027				101,172
Thereafter		1,876,504		1,775,332

	$	2,331,778	$	2,230,606

The Company leases ~~facilities~~a facility used for executive offices from a ~~company controlled by~~related company. The original lease expired in December 2022, and the ~~Company’s CEO for~~Company executed a ~~six-year term~~two-year extension through December ~~2022, with options to renew for another two-year term. The option period is not included in the right-of-use assets and related lease obligation.~~2024.

~~Lease terms and discount rates~~The future minimum lease payments under right-of-use leases at March 31, 2023 were as follows:

~~The approximate future minimum lease payments under operating leases at March 31, 2022 were as follows:~~

Year Ending
September 30, 2022	$	42,146
September 30, 2023		21,073	$	39,995
September 30, 2024				79,989
September 30, 2025				19,997

Total lease payment		63,219
Total lease payments				139,981
Less imputed interest		1,679		10,153

Present value of lease liabilities, short-term	$	61,540
Present value of right-of-use lease liabilities				129,828
Present value included in current liabilities				65,406

Present value included in long-term liabilities			$	64,422

The Company has commitments for contracted research organizations ~~that~~who perform clinical trials for the Company’s ongoing clinical studies and other service ~~providers and the drug substance acquired in connection with a license agreement. Aggregate~~providers. Approximate aggregate future contractual payments at March 31, ~~2022~~2023 are as follows:

Year Ending
September 30, 2022	$	3,871,000
September 30, 2023		371,000	$	1,670,600
September 30, 2024		75,000		400,000
September 30, 2025		16,000		48,000
September 30, 2026				35,000
September 30, 2027				11,000

	$	4,333,000	$	2,164,600

In April 2020, through its Ontario subsidiary, the Company entered into a license agreement with a third party to obtain exclusive world-wide rights to certain know-how, patents and data relating to certain monoclonal antibodies ~~(“the Constructs”)~~(the Constructs), including sublicensing rights. An intangible asset for the acquired license has been recognized. See Note 3 for intangible assets. Under the license agreement, the Company ~~recorded an expense of $3.5 million as a result of meeting a milestone during the three and six months ended March 31, 2021 and~~ is committed to ~~remaining~~ payments of up to an aggregate amount of ~~$352.5~~$356 million contingent upon meeting certain milestones outlined in the license agreement, primarily relating to future potential commercial approval and sales milestones. ~~No milestone payments were made to the third party during the three and six months ended March 31, 2022.~~ The Company also has a commitment to pay royalties based on any net sales of products containing the Constructs in the countries where the Company directly commercializes the products containing the Constructs and a percentage of any sublicensing revenue received by the Company and its affiliates in the countries where it does not directly commercialize the products containing the Constructs. No milestone, royalty or sublicensing payments were made to the third party during the three and six months ended March 31, ~~2022~~2023 and ~~2021.~~

In connection with this license agreement and pursuant to a purchase agreement entered into in April 2020, the Company acquired drug substance of one of the Constructs for an aggregate purchase price of $5.0 million, payable in two future installments based on the earlier of certain clinical trial progress or fixed dates. A payment of $2.5 million was made for the drug substance during the three and six months ended March 31, 2021. No payments for drug substance were made during the three and six months ended March 31, 2022.

~~The remaining purchase commitment is included in the table above for the year ending September 30,~~ 2022.

In 2016, through its Ontario subsidiary, the Company entered into a license agreement with a third party to obtain exclusive rights to certain ~~know-how,~~know- how, patents and data relating to a pharmaceutical product. The Company will use the exclusive rights to develop the product for therapeutic, prophylactic and diagnostic uses in topical dermal applications and anorectal applications. No intangible assets have been recognized under the license agreement with the third party. Under the license agreement, the Company is committed to payments of various amounts to the third party upon meeting certain milestones outlined in the license agreement, up to an aggregate amount of ~~$18.6 million.~~$18.4 million after deducting $0.08 million that is included in the commitments table above for the year ending September 30, 2023. Upon divestiture of substantially all of the assets of the Company, the Company ~~shall~~would pay the third party a percentage of the valuation of the licensed technology sold as determined by an external objective expert. The Company also has a commitment to pay the third party a royalty based on net sales of the product in countries where the Company, or an affiliate, directly commercializes the product and a percentage of sublicensing revenue received by the Company and its affiliates in the countries where it does not directly commercialize the product. Milestone payments totaling $0.06 million and $0.12 million were made to the third party during the three and six months ended March 31, 2023, respectively. No ~~milestone, license~~milestones were met during the three and six months ended March 31, 2022. No royalty or ~~royalty~~sublicensing payments were made to the third party during the three and six months ended March 31, ~~2022~~2023 and ~~2021.~~2022.

In March 2021, through its Ontario subsidiary, the Company entered into a license agreement with the inventor of the same pharmaceutical product to acquire global rights for all fields of use beyond those named under the 2016 license agreement. ~~The Company recorded an expense~~Milestone payments of ~~$0.11~~$0.03 million ~~as a result of meeting milestones outlined in~~were made under the 2021 ~~license~~ agreement ~~for the three months ended March 31, 2021 and $0.03 and $0.11 for~~during the six months ended March 31, ~~2022 and 2021, respectively.~~2022. No milestones were met during the three and six months ended March 31, 2023 or the three months ended March 31, 2022. The Company is committed to remaining milestone payments of up to an aggregate amount of $68.9 million, primarily relating to future potential commercial approval and sales milestones. In addition, if the Company fails to file an investigational new drug application or foreign equivalent ~~(“IND”)~~(IND) for the product within a certain period of time following the date of the agreement, the Company is required to remit to the inventor a fixed or prorated license fee annually as long as the requirement to file an IND remains unfulfilled.

On March 27, 2023, the Company entered into an equity distribution agreement with Canaccord Genuity LLC (Canaccord), as sales agent, pursuant to which the Company may offer and sell, from time to time, common shares through an at-the-market equity offering program for up to $20 million in gross proceeds, subject to certain offering limitations that currently allow the Company to offer and sell common shares having an aggregate gross sales price of up to $8.37 million. The Company has no obligation to sell any of the common shares and may at any time suspend sales or terminate the equity distribution agreement in accordance with its terms. During the three months ended March 31, 2023, there were no sales under the equity distribution agreement.

From November 22, 2021 until terminated March 21, 2022, the Company had an equity distribution agreement for an at-the-market equity offering program with another sales agent. During the six months ended March 31, 2022, the Company sold a total of 626,884 common shares pursuant to the agreement for net proceeds of $2.62 million.

On November 2, 2022, the Company completed a private placement of units consisting of 2,691,337 common shares, Class A warrants to purchase up to an aggregate of 1,345,665 common shares and Class B warrants to purchase up to an aggregate of 1,345,665 common shares. Net proceeds from the offering were $2.91 million, which were allocated between the relative fair values of the common shares (using a fair value of $2.69 million) and the common share purchase warrants (using a total fair value of $1.22 million). The warrants became exercisable December 23, 2022. The Class A warrants have an exercise price of $1.50 per share and will expire on December 23, 2025. The Class B warrants have an exercise price of $1.00 per share and will expire on December 23, 2023. The warrants are considered contracts on the Company’s own shares and are classified as equity.

On March 24, 2022, the Company completed a registered direct offering of 1,540,000 common shares, no par value, and pre-funded warrants to purchase up to an aggregate of 1,199,727 common shares. In a concurrent private placement, the Company issued common share purchase warrants to purchase an aggregate of up to 2,739,727 common shares. ~~Aggregate gross~~Net proceeds tofrom the ~~Company~~offering were ~~approximately $10.0 million.~~

$9.01 million, which were allocated between the relative fair values of the common shares and pre-funded warrants (using a total fair value of $5.87 million) and the common share purchase warrants (using a total fair value of $4.13 million). The common share purchase warrants were immediately exercisable at an exercise price of $3.52 per share and will expire on September 24, 2027. The pre-funded warrants were immediately exercisable at an exercise price of $0.0001 per share and do not expire. The warrants are considered contracts on the Company’s own shares and are classified as equity. In connection with the offering, the Company ~~also~~ issued warrants to purchase an aggregate of 191,780 common shares to certain affiliated designees of the placement agent as part of the placement agent’s compensation. The placement agent warrants are exercisable on or after March 24, 2022, at an exercise price of $4.5625 per share, and will expire on March 21, ~~2027.~~

The direct costs related to the issuance of the common shares and warrants were $0.99 million. These direct costs were recorded as an offset against gross proceeds. The warrants are considered contracts on the Company’s own shares and are classified as equity. The Company allocated gross proceeds2027 with $5.87 million as the value of common shares and pre-funded warrants and $4.13 million as the value of common share purchase warrants under additional paid-in capital in the unaudited condensed interim consolidated statements of changes in shareholders’ equity on a ~~relative fair value basis. The Company also recorded the~~ fair value of ~~underwriter warrants in the amount of~~ $0.41 ~~million as share-based compensation to non-employees under additional paid-in capital and an offset against gross proceeds.~~

On March 2, 2021, the Company closed an underwritten offering of 1,562,500 common shares, no par value, at a price to the public of $6.40 per share less underwriting discounts and commissions. Gross proceeds from the offering amounted to $10.0 million. The Company granted to the underwriters a 30-day option to purchase up to an additional 234,375 common shares, which expired with no further shares issued. On the closing date, the Company issued underwriter warrants to purchase an aggregate of up to 109,375 common shares at an exercise price of $8.00 per share, expiring on February 26, 2026. The direct costs related to the issuance of the common shares were $0.99 million. These direct costs were recorded as an offset against gross proceeds. The Company also recorded the fair value of underwriter warrants in the amount of $0.41 million as share-based compensation to non-employees under additional paid-in capital and an offset against gross proceeds.

On November 22, 2021, the Company entered into an equity distribution agreement with RBC Capital Markets, LLC (RBCCM), as sales agent. Pursuant to the terms of the agreement, as amended March 4, 2022, the Company could offer and sell common shares having an aggregate offering price of up to $15.4 million from time to time through RBCCM. For the six months ended March 21, 2022, the Company sold a total of 626,884 common shares pursuant to the agreement for gross proceeds of $2.94 million. The commissions and direct costs of the offering program totaled approximately $0.32 million and were recorded as an offset against gross proceeds. On March 21, 2022, the Company and RBCCM entered into an agreement terminating the agreement effective March 21, 2022.

The Company uses the Black-Scholes option valuation model to determine the fair value of share-based compensation for share options and compensation warrants granted and the fair value of warrants issued. Option valuation models require the input of highly subjective assumptions including the expected price volatility. The Company calculates expected volatility based on historical volatility of the Company’s share price. When there is insufficient data available, the Company uses a peer group that is publicly traded to calculate expected volatility. The Company adopted interest-free rates by reference to the U.S. treasury yield rates. The Company calculated the fair value of share options granted based on the expected life of 5 years considering expected forfeitures during the option term of 10 years. Expected life of warrants is based on warrant terms. The Company did not and is not expected to declare any dividends. Changes in the subjective input assumptions can materially affect the fair value estimates, and therefore the existing models do not necessarily provide a reliable single measure of the fair value of the Company’s warrants and share options.

The weighted average contractual life remaining on the outstanding warrants at March 31, ~~2022~~2023 is 5637 months.

The following table summarizes information about the warrants outstanding at March 31, ~~2022:~~2023:

The fair value of warrants granted during the ~~three and~~ six months ended March 31, ~~2022 and 2021~~2023 was estimated using the Black-Scholes option valuation model using the following assumptions:

	Six Months Ended March 31, 2022						Six Months Ended March 31, 2021			Six Months Ended March 31, 2023						Six Months Ended March 31, 2022
	Common Warrants			Placement Agent Warrants			Underwriter Warrants			Class A Warrants			Class B Warrants			Class A Warrants			Class B Warrants

Risk free interest rate		2.37	%		2.37	%		0.67	%		4.54	%		4.76	%		2.37	%		2.37	%
Expected life	5.5 years			5 years			5 years			3.14 years			1.14 years			5.5 years			5 years
Expected share price volatility		87.09	%		87.09	%		94.20	%		90.73	%		89.70	%		87.09	%		87.09	%
Expected dividend yield		0.00	%		0.00	%		0.00	%		0.00	%		0.00	%		0.00	%		0.00	%

There were no pre-funded warrants during the six months ended March 31, ~~2021.~~

The Company adopted an Equity Incentive Compensation Plan in 2019 (the ~~“2019 Plan”)~~2019 Plan) administered by the independent members of the Board of Directors, which amended and restated ~~the 2017 Incentive Compensation Plan (the “2017 Plan”).~~prior plans. Options, restricted shares and restricted share units are eligible for grant under the 2019 Plan. ~~The remaining number of options available for grant is 364,617. The~~At March 31, 2023, the total number of shares available for issuance is 2,625,951 including shares available for the exercise of outstanding options under the 2019 ~~and 2017 Plans as described below.~~Plan. The remaining number of options available for grant at March 31, 2023 is 89,540.

The Company’s 2019 Plan allows options to be granted to directors, officers, employees and certain external consultants and advisers. Under the 2019 Plan, the option term is not to exceed 10 years and the exercise price of each option is determined by the independent members of the Board of Directors.

Options granted for directors normally have monthly vesting in equal proportions over 12 months beginning on the grant date. Options granted for employees normally have monthly vesting in equal proportions over 36 months beginning on the grant date. Options granted for new employees normally have monthly vesting in equal proportions over 36 months beginning on the monthly anniversary of the grant date following 90 days of employment.

Options have been granted under the 2019 Plan allowing the holders to purchase common shares of the Company as follows:

								Number of Options (#)			Weighted Average Exercise Price		Weighted Average Grant Date Fair Value
Six Months Ended March 31, 2023
Balance - September 30, 2022									2,203,699		$	4.66	$	3.42

Granted									332,950			1.43		1.07
Expired									(238	)		304.08		304.08

Balance - March 31, 2023									2,536,411		$	4.20	$	3.09
	Number of Options (#)			Weighted Average Exercise Price		Weighted Average Grant Date Fair Value
Six Months Ended March 31, 2022
Balance – September 30, 2021		1,776,219		$	5.06	$	3.79
Balance - September 30, 2021									1,776,219		$	5.06	$	3.79

Granted		500,083			3.66		2.48		500,083			3.66		2.48
Forfeited		(14,754	)		6.48		5.06		(14,754	)		6.48		5.06
Expired		(214	)		502.68		477.65		(214	)		502.68		477.65

Balance – March 31, 2022		2,261,334		$	4.70	$	3.45

Six Months Ended March 31, 2021
Balance – September 30, 2020		675,437		$	3.30	$	2.56

Granted		450,000			7.35		5.84
Exercised		(10,746	)		2.44		1.67
Forfeited		(19,066	)		6.07		4.76
Expired		(238	)		768.60		715.60

Balance – March 31, 2021		1,095,387		$	4.79	$	3.96
Balance - March 31, 2022									2,261,334		$	4.70	$	3.45

During the ~~quarter~~six months ended March 31, 2023, the independent members of the Board of Directors granted 332,950 employee and new employee options pursuant to the 2019 Plan. During the six months ended March 31, 2022, the independent members of the Board of Directors granted ~~a total of~~ 415,083 employee options to employees of the Company pursuant to the 2019 Plan. The options have a term of 10 years with vesting in equal proportions over 36 months beginning on the monthly anniversary of the grant date (following 90 days of employment for new employees), and ~~an exercise price equal to the Nasdaq closing price on the grant dates.~~

~~During the quarter ended March 31, 2022, the independent directors of the Board of Directors granted a total of~~ 85,000 ~~options, respectively, to directors of the Company pursuant to the 2019 Plan.~~director options. The options have a term of 10 years and an exercise price equal to the Nasdaq closing price on the grant ~~dates. Options for directors have monthly vesting in equal proportions over 12 months beginning on the grant~~ date.

The weighted average contractual life remaining on the outstanding options at March 31, ~~2022~~2023 is ~~102~~94 months.

The following table summarizes information about the options under the 2019 Plan outstanding and exercisable at March 31, ~~2022:~~2023:

The fair value of options granted during the ~~three and~~ six months ended March 31, ~~2022~~2023 and ~~2021~~2022 was estimated using the Black-Scholes option valuation model using the following assumptions:

					Six Months Ended
	Six Months Ended March 31, 2022		Six Months Ended March 31, 2021		March 31, 2023			March 31, 2022

Risk free interest rate	1.71% - 2.54%		0.31% - 0.90%		3.62% - 4.18		%	1.71% - 2.54		%
Expected life	5 years		5 years		5 years			5 years
Expected share price volatility	85.91% - 86.59%		94.27% - 97.28%		95.3% - 97.34		%	85.91% - 86.59		%
Expected dividend yield		0.00%		0.00%		0.00	%		0.00	%

The Company recorded ~~$0.63~~$0.29 million and ~~$0.47~~$0.63 million of share-based compensation expenses for the three months ended March 31, ~~2022~~2023 and ~~2021,~~2022, respectively and ~~$1.24~~$0.62 million and ~~$1.19~~$1.24 million for the six months ended March 31, 2023 and 2022, ~~and 2021.~~respectively.

As of March 31, ~~2022,~~2023, the Company had ~~approximately $2.16~~$0.77 million of unrecognized share-based compensation expense, which is expected to be recognized over a period of 3435 months.

Reimbursement grant income for the Company’s federal grant with the Canadian government’s Strategic Innovation Fund (SIF) is recorded based on the claim period of eligible costs. At March 31, ~~2022,~~2023, the grant program is complete and all grant reimbursements ~~receivable of $1.1 million were included in accounts and other receivable.~~have been received.

The Company uses the fair value measurement framework for valuing financial assets and liabilities measured on a recurring basis in situations where other accounting pronouncements either permit or require fair value measurements.

~~Fair value of a financial instrument is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.~~

The Company follows the fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs are inputs that reflect assumptions market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances.

The carrying value of certain financial instruments such as cash and cash equivalents, accounts and other receivable, accounts payable and accrued liabilities approximates fair value due to the short-term nature of such instruments. The fair value of lease obligations on right-of-use assets approximates carrying value due to a fixed lease rate, which represents market rate.

Interest rate risk is the risk that the value of a financial instrument might be adversely affected by a change in interest rates. The Company does not believe that the results of operations or cash flows would be affected to any significant degree by a significant change in market interest rates, relative to interest rates on cash and cash equivalents due to the short-term nature of these balances.

The Company is also exposed to credit risk at period end from the carrying value of its cash and cash equivalents and accounts and other receivable. The Company manages this risk by maintaining bank accounts with Canadian Chartered Banks, U.S. banks believed to be credit worthy and money market mutual funds of U.S. government securities. The Company’s cash is not subject to any external restrictions. The Company assesses the collectability of accounts receivable through a review of the current aging and terms, as well as an analysis of historical collection rates, general economic conditions and credit status of ~~customers.~~government agencies. Credit risk for ~~reimbursement grant and~~the HST refunds receivable are not considered significant since amounts are due from the ~~Canadian government’s Strategic Innovation Fund (SIF) and the~~ Canada Revenue Agency.

The Company and its subsidiary have balances in Canadian dollars that give rise to exposure to foreign exchange ~~(“FX”)~~(FX) risk relating to the impact of translating certain non-U.S. dollar balance sheet accounts as these statements are presented in U.S. dollars. A strengthening U.S. dollar will lead to a FX loss while a weakening U.S. dollar will lead to a FX gain. The Company has not entered into any agreements or purchased any instruments to hedge possible currency risks. At March 31, ~~2022,~~2023, the Company and its Canadian subsidiary had assets denominated in Canadian dollars of approximately C$~~5.3~~5.2 million and the U.S. dollar exchange rate as at this date was equal to ~~1.2508~~1.3532 Canadian dollars. Based on the exposure at March 31, ~~2022,~~2023, a 10% annual change in the Canadian/U.S. exchange rate would impact the Company’s loss and other comprehensive loss by approximately ~~$425,000.~~ $0.4 million.

Liquidity risk is the risk that the Company will encounter difficulty raising liquid funds to meet commitments as they fall due. In meeting its liquidity requirements, the Company closely monitors its forecasted cash requirements with expected cash drawdown.

The Company had securities outstanding which could potentially dilute basic EPS in the future but were excluded from the computation of diluted loss per share in the periods presented, as their effect would have been anti-dilutive.

~~The Company incurred rent expense of $0.20 million during~~During each of ~~the~~ three ~~months ended March 31, 2022~~ and ~~2021 and $0.41 million and $0.40 million for the~~ six months ended March 31, 2023 and 2022, the Company paid cash of $0.02 million and ~~2021,~~$0.04 million, respectively, for a right of use lease from a company controlled by the Company’s CEO. These transactions are in the normal course of operations and are measured at the exchange amount, which is the amount of consideration established and agreed to by both parties. On December 31, 2022, the Company executed a two-year lease extension through December 31, 2024 in accordance with the terms of the original lease agreement.

Subsequent to March 31, 2023, equity sales under the Company’s “at the market” offering program have resulted in the issuance of 562,052 common shares and receipt of net cash proceeds of $0.60 million after deducting sales agent commissions.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following management’s discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed interim consolidated financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q as of March 31, ~~2022~~2023 and our audited consolidated financial statements for the year ended September 30, ~~2021~~2022 included in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission on December ~~28, 2021.~~16, 2022.

This Quarterly Report on Form 10-Q contains forward-looking statements. When used in this report, the words “expects,” “anticipates,” “suggests,” “believes,” “intends,” “estimates,” “plans,” “projects,” “continue,” “ongoing,” “potential,” “expect,” “predict,” “believe,” “intend,” “may,” “will,” “should,” “could,” “would” and similar expressions are intended to identify forward-looking statements. You should not place undue reliance on these forward-looking statements. Our actual results could differ materially from those anticipated in the forward-looking statements for many reasons, including the risks described in our Annual Report on Form 10-K for the year ended September 30, ~~2021~~2022 and other reports we file with the Securities and Exchange Commission. Although we believe the expectations reflected in the forward-looking statements are reasonable, they relate only to events as of the date on which the statements are made. We do not intend to update any of the forward-looking statements after the date of this report to conform these statements to actual results or to changes in our expectations, except as required by law.

The discussion and analysis of our financial condition and results of operations are based on our unaudited condensed interim consolidated financial statements as of March 31, ~~2022~~2023 and September 30, ~~2021,~~2022, and for the three and six months ended March 31, ~~2022~~2023 and ~~2021~~2022 included in Part I, Item 1 of this Quarterly Report on Form 10-Q, which we have prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments, including those described in greater detail below. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

We are a biopharmaceutical company ~~focused on acquiring,~~ developing ~~and commercializing clinical-stage drugs for~~innovative ways to treat inflammatory and immune-related ~~diseases with clear~~diseases.

Our approach is to acquire, develop and commercialize drug candidates based on mechanisms of action that have demonstrated proof-of-concept in human subjects. We prioritize our efforts on disease indications where there is compelling scientific rationale, no approved therapies or where there are unmet medical ~~needs. Our two lead~~needs, and where there are large addressable market opportunities, among other factors. We have multiple late-stage product candidates ~~EB05 and EB01, are~~ in ~~later stage clinical studies.~~our development pipeline.

Our most advanced drug candidate is EB05 is(paridiprubart), a monoclonal antibody ~~therapy~~developed for acute and chronic disease indications that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients. ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. ARDS can be also caused by bacterial pneumonia, sepsis, chest injury and other causes. Specifically,involve dysregulated innate immunity responses. EB05 inhibits toll-like receptor 4 (TLR4), a key immune signaling protein and an important mediator of ~~inflammation that has been shown to be activated by SARS-COV2~~inflammation. We are currently evaluating EB05 as ~~well as other~~a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory infections such as influenza. In multiple third-party studies, high serum levels of alarmins (damage signaling molecules) that bind to and activate TLR4 are associated with poor outcomes and disease progression in COVID-19 patients. Since EB05 has demonstrated the ability to block signaling irrespective of the presence or concentration of the various molecules that frequently bind with TLR4, we believe that EB05 could ameliorate TLR4-mediated inflammation cascades in ARDS patients, thereby reducing lung injury, ventilation rates and mortality.failure. In September ~~2021, an independent data and safety monitoring board pre-emptively unblinded~~2022, we reported final results from the Phase 2 part of a Phase 2/Phase 3 study of EB05 in ARDS patients who were hospitalized ~~COVID-19~~for Covid-19-related respiratory disease. Among the findings, EB05 demonstrated statistically significant mortality reductions in critically ill hospitalized patients treated with EB05 plus Standard of Care treatment (SOC). Based in part of these findings, the U.S. Food and ~~identified “a clinically important” mortality benefit. The monitoring board further recommended continuation of~~Drug Administration (FDA) granted us Fast Track designation. We are currently enrolling patients in the ~~study into a~~ Phase 3 ~~confirmatory trial. The Phase 2~~ part of the study was funded primarily by a $11 million (C$14 million) reimbursement grant that was awarded by the Canadian government’s Strategic Innovation Fund (SIF) following a multi-disciplinary technical review of our drug technology and plans.EB05 study.

In addition to EB05, we are developing ~~an sPLA2 inhibitor, designated as~~product candidates for a number of chronic dermatological and inflammatory conditions. We recently reported preliminary, topline results from a Phase 2b clinical study evaluating multiple concentrations of our drug candidate, EB01, as a ~~topical treatment~~monotherapy for moderate-to-severe chronic ~~allergic contact dermatitis~~Allergic Contact Dermatitis (ACD), a common ~~potentially debilitating condition and~~ occupational ~~illness.~~skin condition. Among the preliminary findings, 1.0% EB01 ~~employs a novel, non-steroidal mechanism of action and in two clinical studies has~~cream demonstrated statistically significant improvement over placebo for the primary endpoint and a key secondary endpoint. We are preparing for an End of ~~multiple symptoms~~Phase 2 meeting with FDA following full analysis. In January 2023, Health Canada approved our clinical trial application (CTA) for our EB06 monoclonal antibody candidate to conduct a future Phase 2 study in ~~ACD patients. EB01 is currently being evaluated~~vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. We are also preparing an investigational new drug application (IND) in the United States for our EB07 (paridiprubart) product candidate to conduct a future Phase ~~2b clinical study.~~

~~In addition to our current clinical programs, we intend to expand the utility~~2 study in systemic sclerosis (SSc), an autoimmune rheumatic disorder that causes fibrosis (scarring/hardening) of ~~our technologies~~skin and ~~clinical-stage assets across other indications.~~internal organs.

OnIn March ~~24, 2022,~~2023, we ~~completed~~announced that the company and the FDA agreed on the primary endpoint and population for the Phase 3 part of a ~~registered direct offering~~Phase 2/3 study evaluating our monoclonal antibody candidate, EB05, as a therapy for hospitalized Covid-19 patients with ARDS. Under the amended protocol design, Edesa will evaluate a single cohort of ~~1,540,000 common shares, no par value,~~severely ill patients on invasive mechanical ventilation, both with and ~~pre-funded warrants~~without additional organ support such as extracorporeal membrane oxygenation (ECMO). Edesa plans to ~~purchase up to an aggregate~~enroll approximately 600 evaluable hospitalized subjects. The primary endpoint will be the mortality rate at 28 days. Last year, Canadian regulators approved a similar Phase 3 study of ~~1,199,727 common shares. In a concurrent private placement,~~EB05 in Covid-19-induced ARDS among two separate cohorts of patients, and we are evaluating potential future harmonization of the Company issued common share purchase warrants to purchase an aggregate of up to 2,739,727 common shares. We received net proceeds of $9.01 million, after deducting fees to the placement agent and other offering expenses. The common share purchase warrants were immediately exercisable at an exercise price of $3.52 per share and will expire on September 24, 2027. The pre-funded warrants were immediately exercisable at an exercise price of $0.0001 per share and do not expire. In connectionCanadian protocol with the ~~offering,~~U.S. With recruitment now open in both the U.S. and Canada, we have discontinued recruitment at secondary sites, which were located in Poland and Colombia. In addition to Covid-19 induced ARDS, we are also ~~issued warrants~~exploring various approaches to ~~purchase an aggregate of 191,780 common shares to certain affiliated designees of~~evaluating EB05 in a general ARDS population.

In April 2023, we announced the ~~placement agent as part of~~World Health Organization and the placement agent’s compensation. The placement agent warrants are exercisable on or after March 24, 2022, at an exercise price of $4.5625 per share, and will expire on March 21, 2027. The net proceeds will be usedUnited States Adopted Name (USAN) Council have adopted the international nonproprietary name "paridiprubart" for ~~working capital, including research and development expenses, and held in temporary investments and cash equivalents until expended.~~our anti-TLR4 monoclonal antibody candidate.

Total operating expenses decreased by ~~$4.93~~$2.17 million to ~~$4.58~~$2.41 million for the three months ended March 31, ~~2022~~2023 compared to ~~$9.51~~$4.58 million for the same period last year:

Total other income ~~(loss) decreased~~increased by ~~$7.24~~$0.07 million to ~~an overall gain of $0.01~~$0.08 million for the three months ended March 31, ~~2022~~2023 compared to ~~an overall gain of $7.25~~$0.01 million for the same period last year primarily due to ~~a decrease~~an increase in ~~grant income associated with the completion of clinical study activities under our federal reimbursement grant with the Canadian government’s Strategic Innovation Fund.~~interest earned on cash balances.

For the three months ended March 31, ~~2022,~~2023, our net loss was ~~$4.57~~$2.33 million, or ~~$0.33~~$0.12 per common share, compared to a net loss of ~~$2.26~~$4.57 million, or ~~$0.19~~$0.33 per common share, for the three months ended March 31, ~~2021.~~2022.

Total operating expenses decreased by ~~$2.38~~$4.95 million to ~~$9.74~~$4.79 million for the six months ended March 31, ~~2022~~2023 compared to ~~$12.12~~$9.74 million for the same period last year:

Total other income ~~(loss)~~ decreased by ~~$6.44~~$0.67 million to ~~an overall gain of $0.79~~$0.12 million for the six months ended March 31, ~~2022~~2023 compared to ~~an overall gain of $7.23~~$0.79 million for the same period last year primarily due to a decrease in grant income associated with the completion of clinical study activities under our federal reimbursement grant with the Canadian government’s Strategic Innovation Fund.

For the six months ended March 31, ~~2022,~~2023, our net loss was ~~$8.95~~$4.67 million, or ~~$0.66~~$0.24 per common share, compared to a net loss of ~~$4.90~~$8.95 million, or ~~$0.45~~$0.66 per common share, for the six months ended March 31, ~~2021.~~2022.

Our capital expenditures primarily consist of computer and office equipment. There were no significant capital expenditures for the three and six months ended March 31, ~~2022~~2023 and ~~2021.~~2022.

As a clinical-stage company we have not generated significant revenue, and we expect to incur operating losses as we continue our efforts to acquire, develop, seek regulatory approval for and commercialize product candidates and execute on our strategic initiatives. Our operations have historically been funded through issuances of common shares, exercises of common share purchase warrants, convertible preferred shares, convertible loans, government grants and tax incentives. For the six-month periods ended March 31, ~~2022~~2023 and ~~2021,~~2022, we reported net losses of ~~$8.95~~$4.67 million and ~~$4.90~~$8.95 million, respectively.

On March ~~24,~~27, 2023, we entered into an equity distribution agreement with Canaccord Genuity LLC (Canaccord), as sales agent, pursuant to which the Company may offer and sell, from time to time, common shares through an at-the-market equity offering program for up to $20 million in gross cash proceeds, subject to certain offering limitations that currently allow the Company to offer and sell common shares having an aggregate gross sales price of up to $8.37 million. Canaccord will use commercially reasonable efforts to sell the common shares from time to time, based upon our instructions. We have no obligation to sell any of the common shares and may at any time suspend sales under the equity distribution agreement or terminate the equity distribution agreement in accordance with its terms. The total amount of cash that may be generated under this equity distribution agreement is uncertain and depends on a variety of factors, including market conditions and the trading price of our common shares. There were no sales in the quarter ended March 31, 2023. Subsequent to the quarter end, sales under our equity distribution agreement with Canaccord have resulted in the issuance of 562,052 common shares and receipt of net cash proceeds of $0.60 million after deducting sales agent commissions.

In November 2022, we completed a private placement of units consisting of 2,691,337 common shares, three-year warrants to purchase up to an aggregate of 1,345,665 common shares (Class A warrants) and twelve-month warrants to purchase up to an aggregate of 1,345,665 common shares (Class B warrants). The gross proceeds from this offering are approximately $3.03 million, before offering expenses. During the six months ended March 31, 2023, 705,314 shares have been issued upon the exercise of Class A and Class B warrants, with proceeds to the Company of $0.77 million.

In March 2022, we completed a registered direct offering of 1,540,000 common shares, no par value, and pre-funded warrants to purchase up to an aggregate of 1,199,727 common shares. In a concurrent private placement, we issued common share purchase warrants to purchase an aggregate of up to 2,739,727 common shares. After deducting the placement agent fees and offering expenses, net proceeds to the Company were approximately $9.01 million.

OnFrom November ~~22,~~ 2021 ~~we entered into an equity distribution agreement with RBC Capital Markets, LLC (RBCCM), as sales agent. Pursuant~~ to ~~the terms of the agreement, as amended~~ March ~~4, 2022, the Company could offer and sell, from time to time, common shares through an at-the-market offering program for up to $15.4 million in gross cash proceeds. For the six months ended March 21,~~ 2022, we sold a total of 626,884 common shares ~~pursuant to the agreement. After~~under an “at-the-market” equity distribution program which resulted in net proceeds of $2.62 million after deducting commissions and direct ~~costs, net proceeds totaled approximately $2.62 million. On March 21, 2022, the Company and RBCCM entered into an agreement terminating the agreement effective March 21, 2022.~~costs.

Under our contribution agreement with the Canadian government’s Strategic Innovation Fund (SIF), we ~~are~~were eligible to receive cash reimbursements up to C$14.05 million (approximately $11 million USD) in the aggregate for certain research and development expenses related to our EB05 clinical development program. For the ~~year~~years ended September 30, 2022 and 2021, we recorded grant income of $0.78 million and $10.34 million inrespectively. All grant ~~income, and for the six months ended March~~reimbursements were received by December 31, ~~2022, we recorded $0.78 million in grant income.~~

On March 2, 2021, we completed a registered public offering of an aggregate of 1,562,500 common shares, no par value, of the Company at an offering price of $6.40 per share for net proceeds of $8.89 million, after deducting underwriter fees and related offering expenses.

For the year ended September 30, 2021, the exercise of warrants and options as well as sales under an equity distribution agreement with RBCCM resulted in the issuance of 987,859 common shares and net cash proceeds to the Company of $5.12 million.2022.

At March 31, ~~2022,~~2023, we had cash and cash equivalents of ~~$15.89~~$7.47 million, working capital of ~~$14.66~~$6.56 million, shareholders’ equity of ~~$17.02~~$9.0 million and an accumulated deficit of ~~$35.44~~$48.71 million. We plan to finance company operations over the course of the next twelve months with cash and cash equivalents on hand and ~~reimbursements of eligible research and development expenses~~equity sales under ~~our contribution agreement with~~ the ~~Canadian government.~~at-the-market offering program. Management has flexibility to adjust this timeline by making changes to planned expenditures related to, among other factors, the size and timing of clinical trial expenditures and manufacturing campaigns, staffing levels, and the acquisition or in-licensing of new product candidates. To help fund our operations and meet our obligations in the future, we ~~are planning~~plan to seek additional financing through the sale of equity, government grants, ~~equity sales,~~ debt financings or other capital sources, including potential future licensing, collaboration or similar arrangements with third parties or other strategic transactions. ~~If we determine it is advisable to raise additional funds, there~~There is no assurance that adequate funding will be available to us or, if available, that such funding will be available on terms that we or our shareholders view as favorable. Market volatility, inflation, interest rates, government policies and concerns related to the ~~COVID-19~~war in Ukraine and the Covid-19 pandemic may have a significant impact on the availability of funding sources and the terms at which any funding may be available.

Our primary business is the development of innovative therapeutics for inflammatory and immune-related diseases with clear unmet medical needs. We focus our resources on research and development activities, including the conduct of clinical studies and product development, and expense such costs as they are incurred. Our research and development expenses have primarily consisted of employee-related expenses, including salaries, benefits, taxes, travel, and share-based compensation expense for personnel in research and development functions; expenses related to process development and production of product candidates paid to contract manufacturing organizations and contract testing organizations, including the cost of acquiring, developing, and manufacturing research material; costs associated with clinical activities, including expenses for contract research organizations; and clinical trials and activities related to regulatory filings for our product candidates, including regulatory consultants.

Research and development expenses, which have historically varied based on the level of activity in our clinical programs, are significantly influenced by study initiation expenses and patient recruitment rates, and as a result are expected to continue to fluctuate, sometimes substantially. Our research and development costs were ~~$6.99~~$2.82 million and ~~$9.35~~$6.99 million for the six months ended March 31, ~~2022~~2023 and ~~2021,~~2022, respectively. The decrease was due primarily to decreased ~~milestone and bulk drug substance payments and lower license fees, which were partially offset by higher~~ external research expenses related to ~~the~~our ongoing ~~Phase 2/Phase 3~~ clinical ~~study~~studies and manufacturing of our ~~EB05 drug candidate, higher manufacturing expenses and increased salary and related personnel expenses.~~investigational drugs.

We do not have any ~~off balance~~off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.

We are a smaller reporting company and are not required to provide disclosure under this item.

Our management is responsible for establishing and maintaining disclosure controls and procedures to provide reasonable assurance that material information related to our Company, including our consolidated subsidiaries, is made known to senior management, including our Chief Executive Officer and Chief Financial Officer, by others within those entities on a timely basis so that appropriate decisions can be made regarding public disclosure.

We carried out an evaluation, under the supervision and with the participation of our management, including our Principal Executive Officer and our Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) under the Securities and Exchange Act of 1934, as amended) as of March 31, ~~2022.~~2023. Our Chief Executive Officer and Chief Financial Officer concluded that the disclosure controls and procedures, as of March 31, ~~2022,~~2023, were effective.

There were no changes in our internal control over financial reporting that occurred during the quarter ended March 31, ~~2022~~2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

From time to time, we may be involved in legal proceedings, claims and litigation arising in the ordinary course of business. We are not currently a party to any material legal proceedings or claims outside the ordinary course of business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

There have been no material changes to the risk factors discussed in Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended September 30, ~~2021,~~2022, filed with the Securities and Exchange Commission on December ~~28, 2021.~~16, 2022.

** The information in this exhibit is furnished and deemed not filed with the Securities and Exchange Commission for purposes of section 18 of the Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of Edesa Biotech, Inc. under the Securities Act of 1933, as amended, or the Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

British Columbia, Canada		N/A
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

100 Spy Court, Markham, ~~Ontario,~~ON, Canada L3R 5H6		(289) 800-9600
(Address of principal executive offices and zip code)		(Registrant’s telephone number, including area code)

Title of each class		Trading Symbol		Name of each exchange on which registered
Common Shares, without par value		EDSA		The Nasdaq Stock Market LLC

		Page
PART I	FINANCIAL STATEMENTS	3

Item 1.	Financial Statements (Unaudited)	3
	Condensed Interim Consolidated Balance Sheets – March 31, ~~2022~~2023 and September 30, ~~2021~~2022	3
	Condensed Interim Consolidated Statements of Operations – Three and Six Months Ended March 31, ~~2022~~2023 and ~~2021~~2022	4
	Condensed Interim Consolidated Statements of Cash Flows ~~–Six~~– Six Months Ended March 31, ~~2022~~2023 and ~~2021~~2022	5
	Condensed Interim Consolidated Statements of Changes in ~~Shareholders’~~Shareholders' Equity – Three and Six Months Ended March 31, ~~2022~~2023 and ~~2021~~2022	6
	Notes to Condensed Interim Consolidated Financial Statements	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	1615

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	1918

Item 4.	Controls and Procedures	1918

PART II	OTHER INFORMATION	2019

Item 1.	Legal Proceedings	2019

Item 1A.	Risk Factors	2019

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	2019

Item 3.	Defaults Upon Senior Securities	2019

Item 4.	Mine Safety Disclosures	2019

Item 5.	Other Information	2019

Item 6.	Exhibits	2120

	March 31, 2023			September 30, 2022
Remaining lease term (months):		21			3
Estimated incremental borrowing rate:		9.2	%		6.5	%

	Number of Warrant Shares (#)			Weighted Average Exercise Price
Six Months Ended March 31, 2022
Balance – September 30, 2021		720,446		$	5.69

Issued		2,931,507		$	3.59

Balance – March 31, 2022		3,651,953		$	4.00

Six Months Ended March 31, 2021
Balance – September 30, 2020		992,721		$	4.92

Issued		109,375			8.00
Exercised		(341,806	)		4.29

Balance – March 31, 2021		760,290		$	5.65

☒	☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated ~~Filer~~filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

Number of Warrants (#)		Exercise Prices		Expiry Dates
	28,124	$	15.90	May 2023
	563,685	$	4.80	July 2023
	7,484	$	4.81	June 2024
	11,778	$	3.20	January 2025
	109,375	$	8.00	February 2025
	191,780	$	4.56	March 2027
	2,739,727	$	3.52	September 2027
	3,651,953

	Number of Pre-funded Warrant Shares (#)

Six Months Ended March 31, 2022
Balance –- September 30, 2021		-

Issued		1,199,727

Balance –- March 31, 2022		1,199,727

Number of Options (#)		Exercisable at March 31, 2022 (#)		Range of Exercise Prices		Expiry Dates
	238		238	$	304.08	Dec 2022
	3,499		3,499	$	35.28 - 93.24	Sep 2023-Mar 2025
	296,403		296,403	C$	2.16	Aug 2027-Dec 2028
	332,822		266,482	$	3.16	Feb 2030
	418,452		213,616	$	7.44 - 8.07	Sep 2030-Oct 2030
	709,837		307,789	$	5.25 - 5.65	Jan 2031-Sep 2031
	500,083		34,724	$	2.94 - 3.71	Feb 2032-Mar 2032
	2,261,334		1,122,751

Number of Options (#)		Exercisable at March 31, 2023 (#)		Range of Exercise Prices		Expiry Dates
	3,499		3,499	$	35.28 - 93.24	Sep 2023 - Mar 2025
	296,403		296,403	C$	2.16	Aug 2027 - Dec 2028
	323,976		323,976	$	3.16	Feb 2030
	397,000		330,736	$	7.44 - 8.07	Sep 2030 - Oct 2030
	682,500		480,624	$	5.25 - 5.65	Jan 2031 - Sep 2031
	500,083		246,378	$	2.94 - 3.71	Feb 2032 - Mar 2032
	332,950		9,539	$	0.96 - 1.43	Dec 2032 - Feb 2033
	2,536,411		1,691,155

	·	Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.

	·	Level 2 - Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets and liabilities in markets that are not active.

	·	Level 3 - Unobservable inputs for the asset or liability that are supported by little or no market activity.

	·	Research and development expenses decreased by ~~$4.94~~$1.58 million to ~~$3.04~~$1.46 million for the three months ended March 31, ~~2022~~2023 compared to ~~$7.98~~$3.04 million for the same period last year primarily due to decreased ~~milestone and bulk drug substance payments, lower license fees and decreased~~ external research expenses ~~which were partially offset by higher~~related to our ongoing clinical studies and manufacturing ~~expenses, and increased salary and related personnel expenses.~~ of our investigational drugs.

	·	General and administrative expenses ~~remained relatively unchanged at $1.53~~decreased by $0.58 million to $0.95 million for the three months ended March 31, ~~2022~~2023 compared to ~~$1.54~~$1.53 million for the same period last ~~year.~~year primarily due to decreased personnel expenses and noncash share-based compensation.

	·	Research and development expenses decreased by ~~$2.36~~$4.17 million to ~~$6.99~~$2.82 million for the six months ended March 31, ~~2022~~2023 compared to ~~$9.35~~$6.99 million for the same period last year primarily due to decreased ~~milestone and bulk drug substance payments and lower license fees, which were partially offset by higher~~ external research expenses ~~higher~~related to our ongoing clinical studies and manufacturing ~~expenses and increased salary and related personnel expenses.~~ of our investigational drugs.

	·	General and administrative expenses decreased by ~~$0.03~~$0.77 million to ~~$2.74~~$1.97 million for the six months ended March 31, ~~2022~~2023 compared to ~~$2.77~~$2.74 million for the same period last year primarily due to ~~lower salary and related~~decreased personnel expenses ~~which were partially offset by increased legal~~ and ~~other professional service fees.~~noncash share-based compensation.

Exhibit No.		Description

~~4.1.~~		~~Form of Pre-Funded Warrant (included as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on March 23, 2022 and incorporated herein by reference).~~

~~4.2~~		~~Form of Private Placement Warrant (included as Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on March 23, 2022 and incorporated herein by reference).~~

~~4.3~~		~~Form of Placement Agent Warrant (included as Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on March 23, 2022 and incorporated herein by reference).~~

10.1*		~~Amendment to Employment Agreement, entered into on April 12, 2022, by and between Par Nijhawan and Edesa Biotech, Inc. (filed herewith).~~

10.2*		~~Amendment to Employment Agreement, entered into on April 12, 2022, by and between Kathi Niffenegger and Edesa Biotech USA, Inc. (filed herewith).~~

10.3*		~~Amendment to Employment Agreement, entered into on April 12, 2022, by and between Michael Brooks and Edesa Biotech USA, Inc. (filed herewith).~~

~~10.4~~		Form of Securities Purchase Agreement, dated March 21, 2022, by and between Edesa Biotech, Inc. and Purchaser (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 23, 2022 and incorporated herein by reference).

31.1		Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities and Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).

31.2		Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities and Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).

32.1**		Certification of the Chief Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (filed herewith).

32.2**		Certification of the Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (filed herewith).

101.INS		XBRL Instance Document

101.SCH		XBRL Taxonomy Extension Schema Document

101.CAL		XBRL Taxonomy Calculation Linkbase Document

101.DEF		XBRL Taxonomy Extension Definition Linkbase Document

101.LAB		XBRL Taxonomy Label Linkbase Document

101.PRE		XBRL Taxonomy Presentation Linkbase Document

Date: May 11, 2023		EDESA BIOTECH, INC.

~~Date: May 13, 2022~~	~~/s/ Kathi Niffenegger~~

		/s/ Kathi Niffenegger
		Kathi Niffenegger, Chief Financial Officer
		(Principal Financial Officer and Duly Authorized Officer)