# EDGAR Filing Document

**Accession Number:** 0001540159
**File Stem:** 0001171843-25-007913
**Filing Date:** 2025-12
**Character Count:** 16713
**Document Hash:** 4ea4957c7869ec64dbc5b21c1c77a63a
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001171843-25-007913.hdr.sgml**: 20251212

**ACCESSION NUMBER**: 0001171843-25-007913

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251212

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251212

**DATE AS OF CHANGE**: 20251212

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Edesa Biotech, Inc.
- **CENTRAL INDEX KEY:** 0001540159
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** A1
- **FISCAL YEAR END:** 0930

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37619
- **FILM NUMBER:** 251568468

**BUSINESS ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 100 SPY COURT
- **CITY:** MARKHAM
- **PROVINCE COUNTRY:** A6
- **BUSINESS PHONE:** (905) 475-1234

**MAIL ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 100 SPY COURT
- **CITY:** MARKHAM
- **PROVINCE COUNTRY:** A6

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Stellar Biotechnologies, Inc.
- **DATE OF NAME CHANGE:** 20120120

?xml version='1.0' encoding='ASCII'? Form 8-K

### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

### Washington, D.C. 20549
_________________

### FORM 8-K
_________________

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): December 12, 2025
_______________________________

#### EDESA BIOTECH, INC.
(Exact name of registrant as specified in its charter)

_______________________________

---

| | | |
|:---|:---|:---|
| **British Columbia, Canada** | **001-37619** | **N/A** |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |

---

#### 100 Spy Court

#### Markham, Ontario L3R 5H6
(Address of Principal Executive Offices) (Zip Code)

(289) 800-9600

(Registrant's telephone number, including area code)

#### N/A
(Former name or former address, if changed since last report)

_______________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Shares | EDSA | The Nasdaq Stock Market LLC |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

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. ☐

**Item 2.02. Results of Operations and Financial Condition.**

On December 12, 2025, Edesa Biotech, Inc. (the "Company") issued a press release announcing its financial results for the fiscal year ended September 30, 2025 (the "Earnings Release"). The full text of the Earnings Release is attached hereto as Exhibit 99.1. The information furnished herein and therein shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

**Item 9.01. Financial Statements and Exhibits.**

**(d) Exhibits**

---

| | |
|:---|:---|
| **<u>Exhibit No.</u>** | **<u>Description</u>** |
| [99.1](exh_991.htm) | [Press release issued by Edesa Biotech, Inc. dated December 12, 2025.](exh_991.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

#### SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **EDESA BIOTECH, INC.** | **EDESA BIOTECH, INC.** |
| Date: December 12, 2025 | By: | <u>/s/ Peter J. Weiler&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</u> |
|  |  | Peter J. Weiler |
|  |  | Chief Financial Officer |

---

## Exhibit 99.1

**EXHIBIT 99.1**

**Edesa Biotech Reports Fiscal Year 2025 Results**

TORONTO, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the fiscal year ended September 30, 2025 and provided an update on its business.

During the year, the company initiated manufacturing activities for a Phase 2 study of Edesa's dermatology drug candidate, EB06 (an anti-CXCL10 monoclonal antibody), in patients with moderate-to-severe nonsegmental vitiligo. Edesa anticipates that recruitment will begin by midyear 2026, subject to the completion of clinical-grade drug manufacturing and regulatory approvals. In its respiratory program, Edesa reported that a Phase 3 study of its monoclonal antibody, paridiprubart (EB05), met primary and secondary endpoints with statistical significance. Edesa is currently exploring development and commercialization partnerships for paridiprubart as well as expedited regulatory pathways that may be available in certain jurisdictions.

"Our strategy to advance a high-impact dermatology asset alongside a now-validated respiratory therapeutic is bearing fruit, and we believe Edesa is well positioned for our mission to deliver transformative therapies to patients with high unmet medical needs," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "With new momentum and data in hand, we are engaging with potential strategic and government partners to seek additional non-dilutive support and collaborative arrangements that advance our programs."

Edesa's Chief Financial Officer Peter Weiler reported that financial results for the fiscal year reflected a ramp up in activities for the company's vitiligo program as well as the completion and close-out of the Phase 3 clinical study of paridiprubart. "This year, we strengthened our balance sheet and extended our Canadian government funding agreement to support manufacturing and development for our respiratory program. Looking ahead, our priorities include executing the Phase 2 vitiligo study, advancing respiratory assets toward partnering and commercialization, expanding manufacturing capacity, and maintaining financial discipline," he said.

**Financial Results for the Fiscal Year Ended September 30, 2025** 

Total operating expenses increased by $0.9 million to $7.9 million for the year ended September 30, 2025 compared to $7.0 million for the prior year:

* Research and development expenses increased by $0.8 million to $3.7 million for the year ended September 30, 2025 compared to $2.9 million for the prior year primarily due to increased expenses for manufacturing-related activities and other preparations for a planned Phase 2 clinical study of EB06 in vitiligo patients, as well as increased external research expenses related to the completion of a Phase 3 study of paridiprubart (EB05) and drug supply costs for an ongoing U.S. government study of paridiprubart, partially offset by lower spend on other development programs.

* General and administrative expenses increased by $0.1 million to $4.2 million for the year ended September 30, 2025 compared to $4.1 million for the prior year primarily due to an increase in noncash share-based compensation, which was partially offset by a decrease in professional fees. 

Total other income decreased by $0.1 million to $0.7 million for the year ended September 30, 2025 compared to $0.8 million for the prior year, primarily due to a decrease in interest income, which was partially offset by an increase in reimbursement funding from the Canadian government's Strategic Innovation Fund.

For the year ended September 30, 2025, Edesa reported a net loss of $7.2 million, or $1.27 per common share, compared to a net loss of $6.2 million, or $1.93 per common share, for the year ended September 30, 2024.

**Working Capital**

At September 30, 2025, Edesa had cash and cash equivalents of $10.8 million and working capital of $10.4 million. Subsequent to the fiscal year end, the company received $3.4 million in net proceeds, after deducting sales agent commissions, from common shares sold under an at-the-market offering program.

**Calendar**

Edesa management plans to participate in one-on-one meetings during JP Morgan week, which begins on January 12, 2026, in San Francisco, California. Attendees interested in meeting with management can request meetings by contacting Edesa at investors@edesabiotech.com.

**About Edesa Biotech, Inc.**

<u>Edesa Biotech, Inc.</u> (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company's most advanced Respiratory drug candidate is paridiprubart, which is being developed as a potential treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The paridiprubart program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset, and is currently being evaluated in a U.S. government-funded platform study. Edesa is also pursuing additional uses for paridiprubart in chronic respiratory diseases. Sign up for <u>news alerts</u>. Connect with us on <u>X</u> and <u>LinkedIn</u>.

**Edesa Forward-Looking Statements**

*This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: anticipated initiation of patient recruitment for a Phase 2 vitiligo study by midyear 2026, subject to manufacturing and regulatory approvals; efforts to pursue development and commercialization partnerships for paridiprubart; potential expedited regulatory pathways; strategic initiatives to secure non-dilutive funding and collaborative arrangements; ongoing priorities such as executing clinical studies, advancing respiratory assets toward partnering and commercialization, expanding manufacturing capacity, and maintaining financial discipline; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.*

**Contact:**

Gary Koppenjan

Edesa Biotech, Inc.

investors@edesabiotech.com

---

| | | |
|:---|:---|:---|
| **Consolidated Statements of Operations** | **Consolidated Statements of Operations** | **Consolidated Statements of Operations** |
|  | **Years Ended** | **Years Ended** |
|  | **September 30, 2025** | **September 30, 2024** |
| **Expenses:** | | |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | $**3668738** | $2881967 |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | **4242828** | 4132777 |
| **Loss from operations** | **(7911566)** | (7014744) |
| **Other Income (Loss):** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Reimbursement grant income | **783894** | 698277 |
| &nbsp;&nbsp;&nbsp;&nbsp;Other income (loss) | **(57051)** | 147222 |
| **Income tax expense** | **800** | 800 |
| **Net loss** | **(7185523)** | (6170045) |
| Exchange differences on translation | **76842** | (27965) |
| **Net comprehensive loss** | $**(7108681)** | $(6198010) |
| Weighted average number of common shares | **5676708** | 3197423 |
| **Loss per common share - basic and diluted** | $**(1.27)** | $(1.93) |

---

---

| | | |
|:---|:---|:---|
| **Consolidated Balance Sheets** | **Consolidated Balance Sheets** | **Consolidated Balance Sheets** |
|  | **September 30, 2025** | **September 30, 2024** |
| **Assets:** | | |
| Cash and cash equivalents | $**10792172** | $1037320 |
| Other current assets | **720704** | 638302 |
| Non-current assets | **2017642** | 2138360 |
| **Total Assets** | $**13530518** | $3813982 |
| **Liabilities and shareholders' equity:** |  |  |
| Current liabilities | $**1078536** | $1832827 |
| Shareholders' equity | **12451982** | 1981155 |
| **Total liabilities and shareholders' equity** | $**13530518** | $3813982 |

---

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| | | |
|:---|:---|:---|
| **Consolidated Statements of Cash Flows** | **Consolidated Statements of Cash Flows** | **Consolidated Statements of Cash Flows** |
|  | **Years Ended** | **Years Ended** |
|  | **September 30, 2025** | **September 30, 2024** |
| **Cash flows from operating activities:** | | |
| &nbsp;&nbsp;&nbsp;&nbsp;Net loss | $**(7185523)** | $(6170045) |
| &nbsp;&nbsp;&nbsp;&nbsp;Adjustments for non-cash items | **848915** | 708775 |
| &nbsp;&nbsp;&nbsp;&nbsp;Change in working capital items | **(985654)** | 571065 |
| **Net cash used in operating activities** | **(7322262)** | (4890205) |
| **Net cash provided by financing activities** | **17030898** | 592031 |
| Effect of exchange rate changes on cash and cash equivalents | **46216** | (25903) |
| Net change in cash and cash equivalents | **9754852** | (4324077) |
| Cash and cash equivalents, beginning of period | **1037320** | 5361397 |
| **Cash and cash equivalents, end of period** | $**10792172** | $1037320 |

---