Eledon Pharmaceuticals Announces Proposed Underwritten Public Offering of Common Stock and Pre-Funded Warrants




Eledon Pharmaceuticals Announces Proposed Underwritten Public Offering of Common Stock and Pre-Funded Warrants

IRVINE, Calif., Nov. 11, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), today announced that it has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares and pre-funded warrants in the proposed offering will be offered by Eledon. In addition, Eledon intends to grant the underwriters a 30-day option to purchase up to a number of additional shares of common stock equal to 15% of the total number of shares of common stock (and shares of common stock underlying pre-funded warrants) sold in the public offering, on the same terms and conditions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Leerink Partners and Cantor are acting as joint book-running managers for the offering.

Eledon currently intends to use the net proceeds from the proposed offering to support the continued clinical development of its product candidates and advance its pipeline programs as well as for general corporate purposes.

The offering is being made pursuant to a registration statement on Form S-3 (File No. 333-282260), previously filed with the Securities and Exchange Commission (the “SEC”) on September 20, 2024 and declared effective on October 2, 2024. The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to the offering will be filed with the SEC and available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, once available, may also be obtained by contacting Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com, or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59^th Street, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. Eledon’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. Eledon is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding Eledon’s expectations on the timing and completion of the offering and the anticipated use of proceeds therefrom. No assurance can be given that the offering will be completed on the terms described. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including market conditions, failure of customary closing conditions and the risk factors and other matters set forth in the preliminary prospectus supplement and final prospectus supplement that will be filed with the SEC and the other risks and uncertainties that could cause Eledon’s actual results to differ materially from the forward-looking statements contained herein are discussed in the company’s quarterly 10-Qs, annual 10-K, and other filings with the SEC, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com

Source: Eledon Pharmaceuticals

Extendicare Announces 2025 Third Quarter Results




Extendicare Announces 2025 Third Quarter Results

MARKHAM, Ontario, Nov. 11, 2025 (GLOBE NEWSWIRE) — Extendicare Inc. (“Extendicare” or the “Company”) (TSX: EXE) today reported results for the three and nine months ended September 30, 2025.

Third Quarter 2025 Highlights

• Completed the acquisition of Closing the Gap for approximately $75.1 million in cash, subject to customary working capital and other adjustments.
• Adjusted EBITDA⁽¹⁾, excluding out-of-period items, increased by $12.6 million or 36.6% to $46.9 million, driven by continued growth in the home health care segment, improvements in long-term care (“LTC”) and a full quarter of contributions from the acquisition of nine Class C LTC homes and Closing the Gap.
• Home health care average daily volume (“ADV”) increased by 7,428 or 24.6% to 37,609 from Q3 2024, including ADV of 3,500 from Closing the Gap.
• Third-party and joint venture beds serviced by SGP reached 152,100 beds, an increase of 6.0% from Q3 2024, driven by continued organic growth.

“This quarter marks our strongest performance in recent years, reflecting margin improvements across all segments, augmented by a full quarter impact of our recent acquisitions,” said Dr. Michael Guerriere, President and Chief Executive Officer. “Home health care volumes grew almost 25% from the prior year, reflecting 13% organic growth and the addition of Closing the Gap. The aging demographic is driving demand in a fragmented seniors care market, providing opportunity for further accretive acquisitions that demonstrate the value creation potential of our strategy.”

Completed the Acquisition of Closing the Gap

On July 1, 2025, the Company completed the acquisition of all of the issued and outstanding shares of Closing the Gap and certain affiliates (collectively “Closing the Gap”) (the “CTG Transaction”). CTG brings a team of 1,200 caregivers who delivered 1.1 million service hours in 2024 and have deep capabilities in nursing, allied health and paediatric services, broadening our home health services.

The purchase price of $75.1 million in cash, subject to customary working capital and other adjustments, was funded from cash on hand and a draw of $55.0 million on the senior secured credit facility. The CTG Transaction includes an earnout that rewards new business revenue generation in the twelve months after closing. The Company anticipates that the additional purchase price from the earnout would be in the range of $1.5 million to $2.0 million, payable on the first anniversary of closing, based on estimated new business revenue of $3.0 to $4.0 million. Additionally, the Company expects to generate approximately $1.1 million in annualized cost synergies in the first year as the operations are integrated.

Q3 2025 Financial Highlights (all comparisons with Q3 2024)

• Revenue increased $81.2 million to $440.3 million; excluding the impact of out-of-period LTC funding in both periods, revenue increased by $79.1 million or 22.1% to $436.4 million from $357.3 million, driven primarily by the acquisition of nine Class C LTC homes (the “LTC Acquisition”), the CTG Transaction, LTC funding increases, home health care ADV growth and rate increases, partially offset by the closure of two Class C LTC homes that were vacated following the opening of newly developed LTC homes in Axium JV.
• NOI⁽¹⁾ increased $15.8 million to $65.9 million; excluding the impact of out-of-period LTC funding, NOI improved by $13.7 million or 28.3% to $62.0 million from $48.3 million, reflecting revenue growth, partially offset by higher operating costs.
• Adjusted EBITDA⁽¹⁾ increased $14.7 million to $50.8 million; excluding the impact of out-of-period funding, Adjusted EBITDA increased by $12.6 million or 36.6% to $46.9 million (10.7% of revenue) in Q3 2025 from $34.3 million (9.6% of revenue) in Q3 2024, reflecting the increase in NOI, partially offset by higher administrative costs of $1.1 million, largely due to higher labour and technology costs.
• Other expense increased $0.9 million to $2.0 million, reflecting transaction-related legal and professional costs incurred in Q3 2025 compared to $1.1 million in strategic transformation costs incurred in Q3 2024.
• Net earnings increased $7.8 million or 48.0% to $24.1 million, largely driven by the increase in Adjusted EBITDA, partially offset by higher depreciation and amortization costs and net finance costs.
• AFFO⁽¹⁾ increased to $29.5 million ($0.349 per basic share) from $23.1 million ($0.274 per basic share); excluding the impact of out-of-period items, AFFO improved by $4.4 million or 20.1% to $26.2 million ($0.309 per basic share) from $21.8 million ($0.259 per basic share), largely reflecting the improvement in Adjusted EBITDA, partially offset by increased current income taxes and higher maintenance capex, in part due to the LTC Acquisition.

Nine Months Financial Highlights (all comparisons with Nine Months 2024)

• Revenue increased $123.7 million to $1,198.4 million; excluding the impact of out-of-period funding in both periods, revenue increased by $137.9 million or 13.2% to $1,185.1 million from $1,047.1 million, driven primarily by four months of the LTC Acquisition, three months of the CTG Transaction, LTC funding increases, home health care ADV growth and rate increases, partially offset by the closure of three Class C LTC homes that were vacated following the opening of new LTC homes in Axium JV.
• NOI⁽¹⁾ increased $23.4 million to $171.1 million; excluding the impact of out-of-period items, NOI improved by $28.4 million or 21.3% to $162.2 million from $133.8 million, reflecting revenue growth, partially offset by higher operating costs.
• Adjusted EBITDA⁽¹⁾ increased $21.3 million to $126.2 million; excluding the impact of out-of-period funding, Adjusted EBITDA increased by $26.3 million or 28.9% to $117.3 million (9.9% of revenue) from $91.0 million (8.7% of revenue), reflecting the increase in NOI, partially offset by higher administrative costs of $2.1 million, largely due to higher labour and technology costs.
• Other income increased $4.0 million to $6.7 million, reflecting a $5.0 million increase in gains from asset sales and a $1.6 million reduction in strategic transformation costs, partially offset by $2.6 million in transaction-related legal and professional costs.
• Net earnings increased $15.8 million or 28.6% to $71.1 million, largely driven by the increase in Adjusted EBITDA and contribution from other income of $4.0 million ($2.5 million net of tax), partially offset by a $0.9 million reduction in the share of profit from joint ventures and higher depreciation and amortization costs.
• Share of profit from joint ventures declined $0.9 million to $0.9 million; excluding a reduction in out-of-period items of approximately $0.4 million, the decline of $0.6 million related to increased depreciation and amortization costs and higher net finance costs associated with the opening of three new homes in the joint ventures and elevated operating costs associated with the opening of the new homes.
• AFFO⁽¹⁾ increased to $74.1 million ($0.877 per basic share) from $63.8 million ($0.758 per basic share); excluding the impact of out-of-period items, AFFO increased by $14.4 million or 27.2% to $67.3 million ($0.796 per basic share) from $52.9 million ($0.628 per basic share), largely reflecting the improvement in Adjusted EBITDA and lower maintenance capex, partially offset by increased current income taxes and an unfavourable change in the adjustment for non-cash share-based compensation.

Business Updates

The following is a summary of Extendicare’s revenue, NOI⁽¹⁾ and NOI margins⁽¹⁾ by business segment for the three and nine months ended September 30, 2025 and 2024.

Long-term Care

LTC average occupancy increased by 10 bps to 98.5% in Q3 2025 from 98.4% in Q3 2024.

Revenue increased by $36.1 million or 17.9% to $237.9 million in Q3 2025. Excluding out-of-period funding recognized of $3.9 million in Q3 2025 and $1.8 million in Q3 2024, revenue increased by $34.0 million, largely driven by approximately $32.9 million from the LTC Acquisition, funding increases, timing of spend and improved preferred occupancy, partially offset by a revenue reduction of approximately $8.0 million due to the closure of two Class C LTC homes replaced by newly opened LTC homes in Axium JV.

NOI and NOI margin were $31.6 million and 13.3% respectively in Q3 2025, compared to $24.6 million and 12.2% in Q3 2024. Excluding the increase in out-of-period funding of $2.1 million, NOI improved by $4.8 million or 21.2% to $27.7 million (11.8% of revenue) from $22.8 million (11.4% of revenue) in Q3 2024. This increase reflects approximately $3.2 million from the LTC Acquisition, funding enhancements, timing of spend, and improved preferred occupancy, partially offset by higher operating costs, and an NOI reduction of approximately $0.6 million due to the closure of two redeveloped Class C LTC homes.

Home Health Care

Home health care ADV of 37,609 in Q3 2025 increased by 24.6% from Q3 2024, consisting of 13.0% organic growth augmented by a full quarter of volume from the CTG Transaction.

Revenue increased to $186.8 million in Q3 2025, an increase of 35.0% from Q3 2024, driven by the $24.0 million contribution from the CTG Transaction, 13.0% growth in ADV and rate increases.

NOI and NOI margin were $25.4 million and 13.6% in Q3 2025, an increase of 63.2% from $15.6 million and 11.3% in Q3 2024. The increase in NOI of $9.9 million includes $3.1 million from a full quarter of the CTG Transaction, organic growth and rate increases, partially offset by increased wages and benefits.

Managed Services

At the end of Q3 2025, the number of third-party and joint venture beds served by SGP increased to approximately 152,100, an increase of 6.0% from the prior year period. Extendicare Assist held management contracts for 40 homes comprising 6,237 beds and provided a further 25 homes with consulting and other services.

Revenue decreased by $3.3 million or 17.4% to $15.6 million in Q3 2025 due primarily to the sale by Revera of 30 Class C LTC homes that had been operated by Extendicare Assist under management contracts, nine of which were acquired by the Company, partially offset by changes in the mix of Extendicare Assist services, management fees from newly opened homes in Axium JV and growth in SGP clients. NOI decreased by $1.0 million or 10.2% to $8.9 million (57.2% of revenue).

Financial Position

Extendicare had strong liquidity at September 30, 2025, with cash and cash equivalents on hand, excluding restricted cash, of $165.7 million and access to a further $154.0 million under its revolving credit facility.

Select Financial Information

The following is a summary of the Company’s consolidated financial information for the three and nine months ended September 30, 2025 and 2024.

Extendicare’s disclosure documents, including its Management’s Discussion and Analysis (“MD&A”), may be found on SEDAR+ at www.sedarplus.ca under the Company’s issuer profile and on the Company’s website at www.extendicare.com under the “Investors/Financial Reports” section.

November Dividend Declared

The Board of Directors of Extendicare today declared a cash dividend of $0.042 per share for the month of November 2025, which is payable on December 15, 2025, to shareholders of record at the close of business on November 28, 2025. This dividend is designated as an “eligible dividend” within the meaning of the Income Tax Act (Canada).

Conference Call and Webcast

Extendicare will hold a conference call to discuss its 2025 third quarter results on November 12, 2025, at 11:30 a.m. (EDT). The call will be webcast live and archived online at www.extendicare.com under the “Investors/Events & Presentations” section. Alternatively, the call-in number is 1-833-752-3395. A replay of the call will be available approximately two hours after completion of the live call until midnight on November 28, 2025, by dialing 1-855-669-9658 followed by the passcode 4860485#.

About Extendicare

Extendicare is a leading provider of care and services for seniors across Canada, operating under the Extendicare, ParaMed, Extendicare Assist, and SGP Purchasing Network brands. We are committed to delivering quality care to meet the needs of the growing seniors’ population, inspired by our mission to provide people with the care they need, wherever they call home. We operate a network of 99 long-term care homes (59 owned, 40 under management contracts), deliver approximately 13.5 million hours of home health care services annually, and provide group purchasing services to third parties representing approximately 152,100 beds across Canada. Extendicare proudly employs approximately 28,000 qualified, highly trained and dedicated team members who are passionate about providing high-quality care and services to help people live better.

Non-GAAP Measures

Certain measures used in this press release, such as “net operating income”, “NOI”, “NOI margin”, “Adjusted EBITDA”, “Adjusted EBITDA margin”, “AFFO”, and “payout ratio”, including any related per share amounts, are not measures recognized under GAAP and do not have standardized meanings prescribed by GAAP. These measures may differ from similar computations as reported by other issuers and, accordingly, may not be comparable to similarly titled measures as reported by such issuers. These measures are not intended to replace earnings (loss) from continuing operations, net earnings (loss), cash flow, or other measures of financial performance and liquidity reported in accordance with GAAP. Such items are presented in this document because management believes that they are relevant measures of Extendicare’s operating performance and ability to pay cash dividends.

Management uses these measures to exclude the impact of certain items, because it believes doing so provides investors a more effective analysis of underlying operating and financial performance and improves comparability of underlying financial performance between periods. The exclusion of certain items does not imply that they are non-recurring or not useful to investors.

Detailed descriptions of these measures can be found in Extendicare’s Q3 2025 MD&A (refer to “Non-GAAP Measures”), which is available on SEDAR+ at www.sedarplus.ca and on Extendicare’s website at www.extendicare.com.

Reconciliations for certain non-GAAP measures included in this press release are outlined below.

The following table provides a reconciliation of AFFO to “net cash from operating activities”, which the Company believes is the most comparable GAAP measure to AFFO.

The following table provides a reconciliation of “earnings before income taxes” to Adjusted EBITDA and “net operating income”.

Forward-looking Statements

This press release contains forward-looking statements concerning anticipated future events, results, circumstances, economic performance or expectations with respect to Extendicare and its subsidiaries, including, without limitation: statements regarding its dividend levels, business operations, business strategy, growth strategy, results of operations and financial condition, including anticipated timelines and costs in respect of development projects; and statements relating to the acquisition of Closing the Gap, including anticipated synergies, new business revenue and earnout amounts, and the agreements entered into with Revera, Axium and its affiliates, Axium JV and/or Axium JV II in respect of the acquisition, disposition, ownership, operation and redevelopment of LTC homes in Ontario and Manitoba. Forward-looking statements can often be identified by the expressions “anticipate”, “believe”, “estimate”, “expect”, “intend”, “objective”, “plan”, “project”, “will”, “may”, “should” or other similar expressions or the negative thereof. These forward-looking statements reflect the Company’s current expectations regarding future results, performance or achievements and are based upon information currently available to the Company and on assumptions that the Company believes are reasonable. These statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of the Company to differ materially from those expressed or implied in the statements. For further information on the risks, uncertainties and assumptions that could cause Extendicare’s actual results to differ from current expectations, refer to “Risks and Uncertainties” and “Forward-looking Statements” in Extendicare’s Q3 2025 MD&A and latest Annual Information Form filed by Extendicare with the securities regulatory authorities, available at www.sedarplus.ca and on Extendicare’s website at www.extendicare.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on Extendicare’s forward-looking statements. Except as required by applicable securities laws, the Company assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Extendicare contact:
David Bacon, Executive Vice President and Chief Financial Officer
T: (905) 470-4000
E: david.bacon@extendicare.com
www.extendicare.com

Extendicare Announces 2025 Third Quarter Results




Extendicare Announces 2025 Third Quarter Results

MARKHAM, Ontario, Nov. 11, 2025 (GLOBE NEWSWIRE) — Extendicare Inc. (“Extendicare” or the “Company”) (TSX: EXE) today reported results for the three and nine months ended September 30, 2025.

Third Quarter 2025 Highlights

• Completed the acquisition of Closing the Gap for approximately $75.1 million in cash, subject to customary working capital and other adjustments.
• Adjusted EBITDA⁽¹⁾, excluding out-of-period items, increased by $12.6 million or 36.6% to $46.9 million, driven by continued growth in the home health care segment, improvements in long-term care (“LTC”) and a full quarter of contributions from the acquisition of nine Class C LTC homes and Closing the Gap.
• Home health care average daily volume (“ADV”) increased by 7,428 or 24.6% to 37,609 from Q3 2024, including ADV of 3,500 from Closing the Gap.
• Third-party and joint venture beds serviced by SGP reached 152,100 beds, an increase of 6.0% from Q3 2024, driven by continued organic growth.

“This quarter marks our strongest performance in recent years, reflecting margin improvements across all segments, augmented by a full quarter impact of our recent acquisitions,” said Dr. Michael Guerriere, President and Chief Executive Officer. “Home health care volumes grew almost 25% from the prior year, reflecting 13% organic growth and the addition of Closing the Gap. The aging demographic is driving demand in a fragmented seniors care market, providing opportunity for further accretive acquisitions that demonstrate the value creation potential of our strategy.”

Completed the Acquisition of Closing the Gap

On July 1, 2025, the Company completed the acquisition of all of the issued and outstanding shares of Closing the Gap and certain affiliates (collectively “Closing the Gap”) (the “CTG Transaction”). CTG brings a team of 1,200 caregivers who delivered 1.1 million service hours in 2024 and have deep capabilities in nursing, allied health and paediatric services, broadening our home health services.

The purchase price of $75.1 million in cash, subject to customary working capital and other adjustments, was funded from cash on hand and a draw of $55.0 million on the senior secured credit facility. The CTG Transaction includes an earnout that rewards new business revenue generation in the twelve months after closing. The Company anticipates that the additional purchase price from the earnout would be in the range of $1.5 million to $2.0 million, payable on the first anniversary of closing, based on estimated new business revenue of $3.0 to $4.0 million. Additionally, the Company expects to generate approximately $1.1 million in annualized cost synergies in the first year as the operations are integrated.

Q3 2025 Financial Highlights (all comparisons with Q3 2024)

• Revenue increased $81.2 million to $440.3 million; excluding the impact of out-of-period LTC funding in both periods, revenue increased by $79.1 million or 22.1% to $436.4 million from $357.3 million, driven primarily by the acquisition of nine Class C LTC homes (the “LTC Acquisition”), the CTG Transaction, LTC funding increases, home health care ADV growth and rate increases, partially offset by the closure of two Class C LTC homes that were vacated following the opening of newly developed LTC homes in Axium JV.
• NOI⁽¹⁾ increased $15.8 million to $65.9 million; excluding the impact of out-of-period LTC funding, NOI improved by $13.7 million or 28.3% to $62.0 million from $48.3 million, reflecting revenue growth, partially offset by higher operating costs.
• Adjusted EBITDA⁽¹⁾ increased $14.7 million to $50.8 million; excluding the impact of out-of-period funding, Adjusted EBITDA increased by $12.6 million or 36.6% to $46.9 million (10.7% of revenue) in Q3 2025 from $34.3 million (9.6% of revenue) in Q3 2024, reflecting the increase in NOI, partially offset by higher administrative costs of $1.1 million, largely due to higher labour and technology costs.
• Other expense increased $0.9 million to $2.0 million, reflecting transaction-related legal and professional costs incurred in Q3 2025 compared to $1.1 million in strategic transformation costs incurred in Q3 2024.
• Net earnings increased $7.8 million or 48.0% to $24.1 million, largely driven by the increase in Adjusted EBITDA, partially offset by higher depreciation and amortization costs and net finance costs.
• AFFO⁽¹⁾ increased to $29.5 million ($0.349 per basic share) from $23.1 million ($0.274 per basic share); excluding the impact of out-of-period items, AFFO improved by $4.4 million or 20.1% to $26.2 million ($0.309 per basic share) from $21.8 million ($0.259 per basic share), largely reflecting the improvement in Adjusted EBITDA, partially offset by increased current income taxes and higher maintenance capex, in part due to the LTC Acquisition.

Nine Months Financial Highlights (all comparisons with Nine Months 2024)

• Revenue increased $123.7 million to $1,198.4 million; excluding the impact of out-of-period funding in both periods, revenue increased by $137.9 million or 13.2% to $1,185.1 million from $1,047.1 million, driven primarily by four months of the LTC Acquisition, three months of the CTG Transaction, LTC funding increases, home health care ADV growth and rate increases, partially offset by the closure of three Class C LTC homes that were vacated following the opening of new LTC homes in Axium JV.
• NOI⁽¹⁾ increased $23.4 million to $171.1 million; excluding the impact of out-of-period items, NOI improved by $28.4 million or 21.3% to $162.2 million from $133.8 million, reflecting revenue growth, partially offset by higher operating costs.
• Adjusted EBITDA⁽¹⁾ increased $21.3 million to $126.2 million; excluding the impact of out-of-period funding, Adjusted EBITDA increased by $26.3 million or 28.9% to $117.3 million (9.9% of revenue) from $91.0 million (8.7% of revenue), reflecting the increase in NOI, partially offset by higher administrative costs of $2.1 million, largely due to higher labour and technology costs.
• Other income increased $4.0 million to $6.7 million, reflecting a $5.0 million increase in gains from asset sales and a $1.6 million reduction in strategic transformation costs, partially offset by $2.6 million in transaction-related legal and professional costs.
• Net earnings increased $15.8 million or 28.6% to $71.1 million, largely driven by the increase in Adjusted EBITDA and contribution from other income of $4.0 million ($2.5 million net of tax), partially offset by a $0.9 million reduction in the share of profit from joint ventures and higher depreciation and amortization costs.
• Share of profit from joint ventures declined $0.9 million to $0.9 million; excluding a reduction in out-of-period items of approximately $0.4 million, the decline of $0.6 million related to increased depreciation and amortization costs and higher net finance costs associated with the opening of three new homes in the joint ventures and elevated operating costs associated with the opening of the new homes.
• AFFO⁽¹⁾ increased to $74.1 million ($0.877 per basic share) from $63.8 million ($0.758 per basic share); excluding the impact of out-of-period items, AFFO increased by $14.4 million or 27.2% to $67.3 million ($0.796 per basic share) from $52.9 million ($0.628 per basic share), largely reflecting the improvement in Adjusted EBITDA and lower maintenance capex, partially offset by increased current income taxes and an unfavourable change in the adjustment for non-cash share-based compensation.

Business Updates

The following is a summary of Extendicare’s revenue, NOI⁽¹⁾ and NOI margins⁽¹⁾ by business segment for the three and nine months ended September 30, 2025 and 2024.

Long-term Care

LTC average occupancy increased by 10 bps to 98.5% in Q3 2025 from 98.4% in Q3 2024.

Revenue increased by $36.1 million or 17.9% to $237.9 million in Q3 2025. Excluding out-of-period funding recognized of $3.9 million in Q3 2025 and $1.8 million in Q3 2024, revenue increased by $34.0 million, largely driven by approximately $32.9 million from the LTC Acquisition, funding increases, timing of spend and improved preferred occupancy, partially offset by a revenue reduction of approximately $8.0 million due to the closure of two Class C LTC homes replaced by newly opened LTC homes in Axium JV.

NOI and NOI margin were $31.6 million and 13.3% respectively in Q3 2025, compared to $24.6 million and 12.2% in Q3 2024. Excluding the increase in out-of-period funding of $2.1 million, NOI improved by $4.8 million or 21.2% to $27.7 million (11.8% of revenue) from $22.8 million (11.4% of revenue) in Q3 2024. This increase reflects approximately $3.2 million from the LTC Acquisition, funding enhancements, timing of spend, and improved preferred occupancy, partially offset by higher operating costs, and an NOI reduction of approximately $0.6 million due to the closure of two redeveloped Class C LTC homes.

Home Health Care

Home health care ADV of 37,609 in Q3 2025 increased by 24.6% from Q3 2024, consisting of 13.0% organic growth augmented by a full quarter of volume from the CTG Transaction.

Revenue increased to $186.8 million in Q3 2025, an increase of 35.0% from Q3 2024, driven by the $24.0 million contribution from the CTG Transaction, 13.0% growth in ADV and rate increases.

NOI and NOI margin were $25.4 million and 13.6% in Q3 2025, an increase of 63.2% from $15.6 million and 11.3% in Q3 2024. The increase in NOI of $9.9 million includes $3.1 million from a full quarter of the CTG Transaction, organic growth and rate increases, partially offset by increased wages and benefits.

Managed Services

At the end of Q3 2025, the number of third-party and joint venture beds served by SGP increased to approximately 152,100, an increase of 6.0% from the prior year period. Extendicare Assist held management contracts for 40 homes comprising 6,237 beds and provided a further 25 homes with consulting and other services.

Revenue decreased by $3.3 million or 17.4% to $15.6 million in Q3 2025 due primarily to the sale by Revera of 30 Class C LTC homes that had been operated by Extendicare Assist under management contracts, nine of which were acquired by the Company, partially offset by changes in the mix of Extendicare Assist services, management fees from newly opened homes in Axium JV and growth in SGP clients. NOI decreased by $1.0 million or 10.2% to $8.9 million (57.2% of revenue).

Financial Position

Extendicare had strong liquidity at September 30, 2025, with cash and cash equivalents on hand, excluding restricted cash, of $165.7 million and access to a further $154.0 million under its revolving credit facility.

Select Financial Information

The following is a summary of the Company’s consolidated financial information for the three and nine months ended September 30, 2025 and 2024.

Extendicare’s disclosure documents, including its Management’s Discussion and Analysis (“MD&A”), may be found on SEDAR+ at www.sedarplus.ca under the Company’s issuer profile and on the Company’s website at www.extendicare.com under the “Investors/Financial Reports” section.

November Dividend Declared

The Board of Directors of Extendicare today declared a cash dividend of $0.042 per share for the month of November 2025, which is payable on December 15, 2025, to shareholders of record at the close of business on November 28, 2025. This dividend is designated as an “eligible dividend” within the meaning of the Income Tax Act (Canada).

Conference Call and Webcast

Extendicare will hold a conference call to discuss its 2025 third quarter results on November 12, 2025, at 11:30 a.m. (EDT). The call will be webcast live and archived online at www.extendicare.com under the “Investors/Events & Presentations” section. Alternatively, the call-in number is 1-833-752-3395. A replay of the call will be available approximately two hours after completion of the live call until midnight on November 28, 2025, by dialing 1-855-669-9658 followed by the passcode 4860485#.

About Extendicare

Extendicare is a leading provider of care and services for seniors across Canada, operating under the Extendicare, ParaMed, Extendicare Assist, and SGP Purchasing Network brands. We are committed to delivering quality care to meet the needs of the growing seniors’ population, inspired by our mission to provide people with the care they need, wherever they call home. We operate a network of 99 long-term care homes (59 owned, 40 under management contracts), deliver approximately 13.5 million hours of home health care services annually, and provide group purchasing services to third parties representing approximately 152,100 beds across Canada. Extendicare proudly employs approximately 28,000 qualified, highly trained and dedicated team members who are passionate about providing high-quality care and services to help people live better.

Non-GAAP Measures

Certain measures used in this press release, such as “net operating income”, “NOI”, “NOI margin”, “Adjusted EBITDA”, “Adjusted EBITDA margin”, “AFFO”, and “payout ratio”, including any related per share amounts, are not measures recognized under GAAP and do not have standardized meanings prescribed by GAAP. These measures may differ from similar computations as reported by other issuers and, accordingly, may not be comparable to similarly titled measures as reported by such issuers. These measures are not intended to replace earnings (loss) from continuing operations, net earnings (loss), cash flow, or other measures of financial performance and liquidity reported in accordance with GAAP. Such items are presented in this document because management believes that they are relevant measures of Extendicare’s operating performance and ability to pay cash dividends.

Management uses these measures to exclude the impact of certain items, because it believes doing so provides investors a more effective analysis of underlying operating and financial performance and improves comparability of underlying financial performance between periods. The exclusion of certain items does not imply that they are non-recurring or not useful to investors.

Detailed descriptions of these measures can be found in Extendicare’s Q3 2025 MD&A (refer to “Non-GAAP Measures”), which is available on SEDAR+ at www.sedarplus.ca and on Extendicare’s website at www.extendicare.com.

Reconciliations for certain non-GAAP measures included in this press release are outlined below.

The following table provides a reconciliation of AFFO to “net cash from operating activities”, which the Company believes is the most comparable GAAP measure to AFFO.

The following table provides a reconciliation of “earnings before income taxes” to Adjusted EBITDA and “net operating income”.

Forward-looking Statements

This press release contains forward-looking statements concerning anticipated future events, results, circumstances, economic performance or expectations with respect to Extendicare and its subsidiaries, including, without limitation: statements regarding its dividend levels, business operations, business strategy, growth strategy, results of operations and financial condition, including anticipated timelines and costs in respect of development projects; and statements relating to the acquisition of Closing the Gap, including anticipated synergies, new business revenue and earnout amounts, and the agreements entered into with Revera, Axium and its affiliates, Axium JV and/or Axium JV II in respect of the acquisition, disposition, ownership, operation and redevelopment of LTC homes in Ontario and Manitoba. Forward-looking statements can often be identified by the expressions “anticipate”, “believe”, “estimate”, “expect”, “intend”, “objective”, “plan”, “project”, “will”, “may”, “should” or other similar expressions or the negative thereof. These forward-looking statements reflect the Company’s current expectations regarding future results, performance or achievements and are based upon information currently available to the Company and on assumptions that the Company believes are reasonable. These statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of the Company to differ materially from those expressed or implied in the statements. For further information on the risks, uncertainties and assumptions that could cause Extendicare’s actual results to differ from current expectations, refer to “Risks and Uncertainties” and “Forward-looking Statements” in Extendicare’s Q3 2025 MD&A and latest Annual Information Form filed by Extendicare with the securities regulatory authorities, available at www.sedarplus.ca and on Extendicare’s website at www.extendicare.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on Extendicare’s forward-looking statements. Except as required by applicable securities laws, the Company assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Extendicare contact:
David Bacon, Executive Vice President and Chief Financial Officer
T: (905) 470-4000
E: david.bacon@extendicare.com
www.extendicare.com

COSCIENS Biopharma Inc. Reports Third Quarter 2025 Financial Results and Provides Strategic Initiatives Update




COSCIENS Biopharma Inc. Reports Third Quarter 2025 Financial Results and Provides Strategic Initiatives Update

COSCIENS voluntarily delists from Nasdaq, while retaining the Company’s listing on the TSX

COSCIENS restructuring results in significantly lower cash outflow with operating expenses down 59% vs. Q3 2024.

TORONTO, ONTARIO, Nov. 11, 2025 (GLOBE NEWSWIRE) — COSCIENS Biopharma Inc. (FINRA: CSCIF) (TSX: CSCI) (“COSCIENS” or the “Company”), a life science company focused on natural ingredients and pharmaceutical solutions, today reported its financial and operating results for the third quarter ended September 30, 2025 and provided a corporate update regarding operational and strategic developments during the quarter.

“Our focus in Q3 was to ensure the zero-based budgeting and restructuring plans we designed were executed successfully to establish our go forward cost structure,” said Anna Biehn, Chief Executive Officer of COSCIENS. “Management and the Board are encouraged with the early results and have made significant progress in an assessment of the existing projects, business development efforts and future growth opportunities.”

Focus on Revenue-Generating Base Business

Stabilizing the core business continues to be a strong priority and management implemented measures to drive discipline in base business management, forecasting and an end-to-end procurement to manufacturing review. As a result, Q3 gross margins showed an improvement of 700 basis points over the previous quarter, driven by both cost cuts and operational improvements.

Cost Structure Reset and Zero-Based Budgeting

The Company launched a zero-based budgeting (ZBB) initiative in Q2 to improve the efficiency of the organizational structure. The initiative included reduction in headcount and was implemented to further align costs with strategic priorities. The cost reset and restructuring initiative began showing results in Q3 with overall operating expenses down 59% vs. Q3 2024 resulting in significantly lower cash outflow for the quarter. The business will continue to seek lower operating costs as the discipline continues.

Nasdaq Delisting – Continued Listing on TSX– Application for quotation on the OTCQB^® Venture Market

As previously announced, during the quarter, the Company voluntarily delisted from Nasdaq effective as of September 5, 2025, while maintaining its listing on the TSX. Following the Nasdaq delisting, FINRA’s Department of Market Operations assigned the trading symbol “CSCIF” to the Company’s common shares for quoting and trading on the informal OTC market in the United States as of September 4, 2025. On November 3, 2025 the Company applied to the OTC Markets Group Inc. for its common shares to be quoted for trading on the OTCQB^® Venture Market, however, there can be no assurance that its application will be approved or the timing thereof or that any broker will make, or continue to make, a market in the Company’s common shares in the U.S. either on the informal OTC market or, if approved, on the OTCQB^® Venture Market. The Company’s voluntary delisting from Nasdaq marked the first step in the Company’s broader strategy to seek to cease its public reporting obligations in the U.S. Accordingly, the Company intends to file a Form 15-F with the SEC in the future once it is able to do so pursuant to the SEC’s rules to deregister from, and terminate its reporting obligations under, the Exchange Act, including its obligations to file and submit annual reports on Form 20-F and reports on Form 6-K in the U.S. with the SEC. Once the Company files a Form 15-F with the SEC, its U.S. reporting obligations with the SEC will be immediately suspended at that time, and deregistration from the Exchange Act would be effective 90 days after the filing of the Form 15-F, at which time the Company’s U.S. reporting obligations thereunder would be fully terminated.

As a life science company, it is important for the Company to continue to focus on both short term and future growth. Given the current economic environment and ecosystem, the Company believes this strategic decision will position COSCIENS to enhance efficiency and reduce costs, with efforts designed to elevate competitiveness and maintain the Company’s viability.

Portfolio Growth Assessment

During the quarter, the Company undertook a strategic assessment of its key segments. Certain key results of which are summarized below:

• Active Ingredients:

• Suspension of Juvente Cosmeceuticals Line of Business

• Pharmaceuticals:

• Technology

Summary of Third Quarter 2025 Financial Results

All amounts are in U.S. dollars.

Cash and cash equivalents

The Company had $8.5 million in cash and cash equivalents on September 30, 2025.

Results of operations for the three-month period ended September 30, 2025

For the three-month period ended September 30, 2025, the Company reported a consolidated net loss of $1.8 million, or $0.57 in net loss per common share, as compared with a consolidated net loss of $5.8 million, or $1.85 in net loss per common share for the same period in 2024. The $4.0 million decrease in net loss is attributable to the movements described below and a recognition of impairment expense on intangible assets in the amount of $1.5 million in 2024, offset by a recognition of impairment expense on property and equipment in the amount of $0.2 million in 2025 and a write-down of inventory in the amount of $0.1 million in 2025.

Revenues

 Operating Expenses

Results of operations for the nine-month period ended September 30, 2025

For the nine-month period ended September 30, 2025, the Company reported a consolidated net loss of $8.2 million, or $2.59 loss per common share, as compared with a consolidated net loss of $8.6 million, or $3.58 loss per common share for the same period in 2024. The $0.4 million decrease in net loss is mainly attributable to the merger in 2024 and the associated professional service fees which were not repeated in 2025 as well as management’s cost cutting measures which began in 2025.

Revenues

Operating expenses

Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the third quarter of 2025, as well as the Company’s consolidated financial statements as of September 30, 2025, will be available on the Company’s website (www.cosciensbio.com) in the Investors section or at the Company’s SEDAR+ and EDGAR profiles at http://www.sedarplus.ca and www.sec.gov, respectively.

About COSCIENS Biopharma Inc.

COSCIENS is a life science company with a diverse portfolio focused on the development of natural, plant-based active ingredients and engaged in the commercialization of pharmaceutical and diagnostic products. COSCIENS’ natural active ingredient business leverages the Company’s proprietary manufacturing and extraction technologies to develop Avenanthramides and Beta Glucan active ingredients currently used in leading skincare brands worldwide. COSCIENS’ lead pharmaceutical product Macimorelin (Macrilen; Ghryvelin), is the first and only U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD).

The Company’s common shares are listed on the Toronto Stock Exchange (“TSX”) under the symbol “CSCI”. The Company’s common shares were assigned the trading symbol “CSCIF” by FINRA’s Department of Market Operations for quoting and trading in the market for unlisted securities (i.e., the “over-the-counter market” or “OTC” market) in the United States as of September 4, 2025. For more information, please visit COSCIENS’ website at www.cosciensbio.com.

Forward-Looking Statements

Certain statements in this news release, referred to herein as “forward-looking statements”, constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended, and “forward-looking information” under the provisions of Canadian securities laws. All statements, other than statements of historical fact, that address circumstances, events, activities, or developments that could or may or will occur are forward-looking statements. When used in this news release, words such as “anticipate”, “assume”, “believe”, “could”, “expect”, “forecast”, “future”, “goal”, “guidance”, “intend”, “likely”, “may”, “would” or the negative or comparable terminology as well as terms usually used in the future and the conditional are generally intended to identify forward-looking statements, although not all forward-looking statements include such words. Specific forward-looking statements in this document includes, but is not limited to, statements relating to: plans to strengthen operational performance, drive shareholder value and growth; the intention to continue operating with a leaner organizational structure and lower operating costs; the possible trading of the common shares on the OTCQB^® Venture Market; the Company’s intention to deregister from, and terminate its U.S. reporting obligations and any projected cost savings resulting therefrom; the possible expansion into new markets; the winding down of operations for the for the cosmeceutical line, JuventeDC; possible next steps for advancing the expansion of Macrilen^® into the US market; the timing of the availability of the results of the Phase 2a study evaluating avenanthramides; possible commercialization strategies for PGX; expected future financial results; and the finalization and implementation of the remediation plan for the Company’s system of internal control over financial reporting. All forward-looking statements are given pursuant to the “safe harbour” provisions of applicable securities legislation.

The forecasts and projections that make up the forward-looking statements contained herein are based on the Company’s current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including, but not limited to assumptions based on historical trends, current conditions, and expected future developments, and assumptions regarding: the ability of the Company to terminate its U.S. reporting obligations in a timely manner;, the ability of the Company’s to execute on its strategic plans and find new customers and partners in connection therewith; the development of technologies and value-driving products; the extraction, production and commercialization of active ingredients from natural sources and our ability to successfully market related products; the successful development and marketing of our pipeline products as well as such products’ capability to address unmet needs within new markets; Macrilen^® (macimorelin) and the Company’s plans in respect of same; the Company’s business strategy; the Company’s positioning in its target markets; the impact of tariffs and other trade barriers , on our costs and revenues, as well as on the macroeconomic framework in which we operate, which may be material; the Company’s plans for its PGX Technology; pre-clinical and clinical studies and trials and their expected timing and results, including the potential to bring certain products to market following such studies and trials; the ability of our pharmaceutical therapeutic assets to address unmet medical needs across a number of indications; the adequacy of our financial resources to finance operations and expenditure requirements; limitations on internal controls over financial reporting and our ability to address identified material weaknesses; and the plans, objectives, future outlook and financial position of the Company in general.

Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statement. Such risks and uncertainties include, among others: the Company’s present and future business strategies, including that the strategic review and related initiatives undertaken by the Company as described herein may not have the expected or desired results in the short-term or long-term; operations and performance within expected ranges; anticipated future cash flows; local and global economic conditions and the environment in which the Company operates; the policies of the current presidential administration in the United States, including the ongoing use and effects of tariffs and other trade barriers to address the administration’s policy goals, as well as any counter-duties, counter-tariffs and/or other counter-measures implemented in response by other countries, could materially impact our costs and revenues, as well as the macroeconomic framework in which we operate; anticipated capital and operating costs; uncertainty in our revenue generation from our marketed products; product development and related clinical trials and validation studies; results from our products under development may not be successful or may not support advancing the product; the failure of the DETECT-trial to achieve its primary endpoint in Childhood Onset Growth Hormone Deficiency (“CGHD”) may impact the market for macimorelin (Macrilen^®; Ghryvelin^®) in adult hormone growth deficiency (“AGHD”) and the existing relationships we have for that product; our now heavy dependence on sales by and revenue from our main distributor of active ingredients and its customers; the continued availability of funds and resources to successfully commercialize our products; the ability to secure strategic partners for late stage development, marketing, and distribution of our products; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our ability to protect and enforce our patent portfolio and intellectual property; our ability to continue to list our common shares on the TSX; the continued trading and liquidity of our common shares on the informal OTC market and our ability to obtain a quotation for our common shares on the OTCQB® Venture Market and the liquidity and trading of our common shares on such market if obtained; and our ability to deregister from, and terminate our reporting obligations under, the Exchange Act, and to realize any projected cost savings therefrom, as well as any impact on the trading of our common shares as a result thereof.

These risk factors are not intended to represent a complete list of the risk factors that could affect the Company. These factors and assumptions, however, should be considered carefully. More detailed information about these and other factors is included under “Risk Factors” in the Annual Report on Form 20-F and in other documents furnished to the SEC and in our other public disclosure filed under our profile on SEDAR+ at www.sedarplus.ca.

Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. Many of these factors are beyond our control. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements, particularly in light of any resulting impacts on the global economy and on the Company’s business. Accordingly, readers should not place undue reliance on forward-looking statements. The Company does not undertake to update any forward-looking statements contained herein, except as required by applicable securities laws. New factors emerge from time to time, and it is not possible for the Company to predict all of these factors, or to assess in advance the impact of each such factor on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement.

Issuer:

Anna Biehn
Chief Executive Officer
E: ABiehn@cosciensbio.com

Investor Contact:

IR@cosciensbio.com 

COSCIENS Biopharma Inc. Reports Third Quarter 2025 Financial Results and Provides Strategic Initiatives Update




COSCIENS Biopharma Inc. Reports Third Quarter 2025 Financial Results and Provides Strategic Initiatives Update

COSCIENS voluntarily delists from Nasdaq, while retaining the Company’s listing on the TSX

COSCIENS restructuring results in significantly lower cash outflow with operating expenses down 59% vs. Q3 2024.

TORONTO, ONTARIO, Nov. 11, 2025 (GLOBE NEWSWIRE) — COSCIENS Biopharma Inc. (FINRA: CSCIF) (TSX: CSCI) (“COSCIENS” or the “Company”), a life science company focused on natural ingredients and pharmaceutical solutions, today reported its financial and operating results for the third quarter ended September 30, 2025 and provided a corporate update regarding operational and strategic developments during the quarter.

“Our focus in Q3 was to ensure the zero-based budgeting and restructuring plans we designed were executed successfully to establish our go forward cost structure,” said Anna Biehn, Chief Executive Officer of COSCIENS. “Management and the Board are encouraged with the early results and have made significant progress in an assessment of the existing projects, business development efforts and future growth opportunities.”

Focus on Revenue-Generating Base Business

Stabilizing the core business continues to be a strong priority and management implemented measures to drive discipline in base business management, forecasting and an end-to-end procurement to manufacturing review. As a result, Q3 gross margins showed an improvement of 700 basis points over the previous quarter, driven by both cost cuts and operational improvements.

Cost Structure Reset and Zero-Based Budgeting

The Company launched a zero-based budgeting (ZBB) initiative in Q2 to improve the efficiency of the organizational structure. The initiative included reduction in headcount and was implemented to further align costs with strategic priorities. The cost reset and restructuring initiative began showing results in Q3 with overall operating expenses down 59% vs. Q3 2024 resulting in significantly lower cash outflow for the quarter. The business will continue to seek lower operating costs as the discipline continues.

Nasdaq Delisting – Continued Listing on TSX– Application for quotation on the OTCQB^® Venture Market

As previously announced, during the quarter, the Company voluntarily delisted from Nasdaq effective as of September 5, 2025, while maintaining its listing on the TSX. Following the Nasdaq delisting, FINRA’s Department of Market Operations assigned the trading symbol “CSCIF” to the Company’s common shares for quoting and trading on the informal OTC market in the United States as of September 4, 2025. On November 3, 2025 the Company applied to the OTC Markets Group Inc. for its common shares to be quoted for trading on the OTCQB^® Venture Market, however, there can be no assurance that its application will be approved or the timing thereof or that any broker will make, or continue to make, a market in the Company’s common shares in the U.S. either on the informal OTC market or, if approved, on the OTCQB^® Venture Market. The Company’s voluntary delisting from Nasdaq marked the first step in the Company’s broader strategy to seek to cease its public reporting obligations in the U.S. Accordingly, the Company intends to file a Form 15-F with the SEC in the future once it is able to do so pursuant to the SEC’s rules to deregister from, and terminate its reporting obligations under, the Exchange Act, including its obligations to file and submit annual reports on Form 20-F and reports on Form 6-K in the U.S. with the SEC. Once the Company files a Form 15-F with the SEC, its U.S. reporting obligations with the SEC will be immediately suspended at that time, and deregistration from the Exchange Act would be effective 90 days after the filing of the Form 15-F, at which time the Company’s U.S. reporting obligations thereunder would be fully terminated.

As a life science company, it is important for the Company to continue to focus on both short term and future growth. Given the current economic environment and ecosystem, the Company believes this strategic decision will position COSCIENS to enhance efficiency and reduce costs, with efforts designed to elevate competitiveness and maintain the Company’s viability.

Portfolio Growth Assessment

During the quarter, the Company undertook a strategic assessment of its key segments. Certain key results of which are summarized below:

• Active Ingredients:

• Suspension of Juvente Cosmeceuticals Line of Business

• Pharmaceuticals:

• Technology

Summary of Third Quarter 2025 Financial Results

All amounts are in U.S. dollars.

Cash and cash equivalents

The Company had $8.5 million in cash and cash equivalents on September 30, 2025.

Results of operations for the three-month period ended September 30, 2025

For the three-month period ended September 30, 2025, the Company reported a consolidated net loss of $1.8 million, or $0.57 in net loss per common share, as compared with a consolidated net loss of $5.8 million, or $1.85 in net loss per common share for the same period in 2024. The $4.0 million decrease in net loss is attributable to the movements described below and a recognition of impairment expense on intangible assets in the amount of $1.5 million in 2024, offset by a recognition of impairment expense on property and equipment in the amount of $0.2 million in 2025 and a write-down of inventory in the amount of $0.1 million in 2025.

Revenues

 Operating Expenses

Results of operations for the nine-month period ended September 30, 2025

For the nine-month period ended September 30, 2025, the Company reported a consolidated net loss of $8.2 million, or $2.59 loss per common share, as compared with a consolidated net loss of $8.6 million, or $3.58 loss per common share for the same period in 2024. The $0.4 million decrease in net loss is mainly attributable to the merger in 2024 and the associated professional service fees which were not repeated in 2025 as well as management’s cost cutting measures which began in 2025.

Revenues

Operating expenses

Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the third quarter of 2025, as well as the Company’s consolidated financial statements as of September 30, 2025, will be available on the Company’s website (www.cosciensbio.com) in the Investors section or at the Company’s SEDAR+ and EDGAR profiles at http://www.sedarplus.ca and www.sec.gov, respectively.

About COSCIENS Biopharma Inc.

COSCIENS is a life science company with a diverse portfolio focused on the development of natural, plant-based active ingredients and engaged in the commercialization of pharmaceutical and diagnostic products. COSCIENS’ natural active ingredient business leverages the Company’s proprietary manufacturing and extraction technologies to develop Avenanthramides and Beta Glucan active ingredients currently used in leading skincare brands worldwide. COSCIENS’ lead pharmaceutical product Macimorelin (Macrilen; Ghryvelin), is the first and only U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD).

The Company’s common shares are listed on the Toronto Stock Exchange (“TSX”) under the symbol “CSCI”. The Company’s common shares were assigned the trading symbol “CSCIF” by FINRA’s Department of Market Operations for quoting and trading in the market for unlisted securities (i.e., the “over-the-counter market” or “OTC” market) in the United States as of September 4, 2025. For more information, please visit COSCIENS’ website at www.cosciensbio.com.

Forward-Looking Statements

Certain statements in this news release, referred to herein as “forward-looking statements”, constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended, and “forward-looking information” under the provisions of Canadian securities laws. All statements, other than statements of historical fact, that address circumstances, events, activities, or developments that could or may or will occur are forward-looking statements. When used in this news release, words such as “anticipate”, “assume”, “believe”, “could”, “expect”, “forecast”, “future”, “goal”, “guidance”, “intend”, “likely”, “may”, “would” or the negative or comparable terminology as well as terms usually used in the future and the conditional are generally intended to identify forward-looking statements, although not all forward-looking statements include such words. Specific forward-looking statements in this document includes, but is not limited to, statements relating to: plans to strengthen operational performance, drive shareholder value and growth; the intention to continue operating with a leaner organizational structure and lower operating costs; the possible trading of the common shares on the OTCQB^® Venture Market; the Company’s intention to deregister from, and terminate its U.S. reporting obligations and any projected cost savings resulting therefrom; the possible expansion into new markets; the winding down of operations for the for the cosmeceutical line, JuventeDC; possible next steps for advancing the expansion of Macrilen^® into the US market; the timing of the availability of the results of the Phase 2a study evaluating avenanthramides; possible commercialization strategies for PGX; expected future financial results; and the finalization and implementation of the remediation plan for the Company’s system of internal control over financial reporting. All forward-looking statements are given pursuant to the “safe harbour” provisions of applicable securities legislation.

The forecasts and projections that make up the forward-looking statements contained herein are based on the Company’s current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including, but not limited to assumptions based on historical trends, current conditions, and expected future developments, and assumptions regarding: the ability of the Company to terminate its U.S. reporting obligations in a timely manner;, the ability of the Company’s to execute on its strategic plans and find new customers and partners in connection therewith; the development of technologies and value-driving products; the extraction, production and commercialization of active ingredients from natural sources and our ability to successfully market related products; the successful development and marketing of our pipeline products as well as such products’ capability to address unmet needs within new markets; Macrilen^® (macimorelin) and the Company’s plans in respect of same; the Company’s business strategy; the Company’s positioning in its target markets; the impact of tariffs and other trade barriers , on our costs and revenues, as well as on the macroeconomic framework in which we operate, which may be material; the Company’s plans for its PGX Technology; pre-clinical and clinical studies and trials and their expected timing and results, including the potential to bring certain products to market following such studies and trials; the ability of our pharmaceutical therapeutic assets to address unmet medical needs across a number of indications; the adequacy of our financial resources to finance operations and expenditure requirements; limitations on internal controls over financial reporting and our ability to address identified material weaknesses; and the plans, objectives, future outlook and financial position of the Company in general.

Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statement. Such risks and uncertainties include, among others: the Company’s present and future business strategies, including that the strategic review and related initiatives undertaken by the Company as described herein may not have the expected or desired results in the short-term or long-term; operations and performance within expected ranges; anticipated future cash flows; local and global economic conditions and the environment in which the Company operates; the policies of the current presidential administration in the United States, including the ongoing use and effects of tariffs and other trade barriers to address the administration’s policy goals, as well as any counter-duties, counter-tariffs and/or other counter-measures implemented in response by other countries, could materially impact our costs and revenues, as well as the macroeconomic framework in which we operate; anticipated capital and operating costs; uncertainty in our revenue generation from our marketed products; product development and related clinical trials and validation studies; results from our products under development may not be successful or may not support advancing the product; the failure of the DETECT-trial to achieve its primary endpoint in Childhood Onset Growth Hormone Deficiency (“CGHD”) may impact the market for macimorelin (Macrilen^®; Ghryvelin^®) in adult hormone growth deficiency (“AGHD”) and the existing relationships we have for that product; our now heavy dependence on sales by and revenue from our main distributor of active ingredients and its customers; the continued availability of funds and resources to successfully commercialize our products; the ability to secure strategic partners for late stage development, marketing, and distribution of our products; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our ability to protect and enforce our patent portfolio and intellectual property; our ability to continue to list our common shares on the TSX; the continued trading and liquidity of our common shares on the informal OTC market and our ability to obtain a quotation for our common shares on the OTCQB® Venture Market and the liquidity and trading of our common shares on such market if obtained; and our ability to deregister from, and terminate our reporting obligations under, the Exchange Act, and to realize any projected cost savings therefrom, as well as any impact on the trading of our common shares as a result thereof.

These risk factors are not intended to represent a complete list of the risk factors that could affect the Company. These factors and assumptions, however, should be considered carefully. More detailed information about these and other factors is included under “Risk Factors” in the Annual Report on Form 20-F and in other documents furnished to the SEC and in our other public disclosure filed under our profile on SEDAR+ at www.sedarplus.ca.

Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. Many of these factors are beyond our control. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements, particularly in light of any resulting impacts on the global economy and on the Company’s business. Accordingly, readers should not place undue reliance on forward-looking statements. The Company does not undertake to update any forward-looking statements contained herein, except as required by applicable securities laws. New factors emerge from time to time, and it is not possible for the Company to predict all of these factors, or to assess in advance the impact of each such factor on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement.

Issuer:

Anna Biehn
Chief Executive Officer
E: ABiehn@cosciensbio.com

Investor Contact:

IR@cosciensbio.com 

Integra LifeSciences Receives FDA 510(k) Clearance for Use of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Cardiac Surgeries




Integra LifeSciences Receives FDA 510(k) Clearance for Use of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Cardiac Surgeries

PRINCETON, N.J., Nov. 11, 2025 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, is pleased to announce the FDA 510(k) clearance for use of its CUSA^® Clarity Ultrasonic Surgical Aspirator System for cardiac surgeries. The recent clearance for specific cardiac indications encompasses the debridement of unwanted tissue in cardiac surgeries, including valve replacement and repair.

In addition to cardiac surgery, the CUSA Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, such as neurosurgery, plastic and reconstructive surgery, orthopedic surgery, thoracic surgery, laparoscopic surgery, gynecological surgery, and liver resection and transplant surgery.

“The utilization of CUSA Clarity for cardiac surgery marks the next pivotal expansion of the ultrasonic surgical aspirator system’s breadth of indications,” said Mike McBreen, executive vice president and president of Integra’s Codman Specialty Surgical division. “As one of the leaders in the industry, this milestone strengthens our ability to deliver advanced surgical solutions to support restoring patients’ lives.”

Integra LifeSciences will spotlight the CUSA Clarity Ultrasonic Surgical Aspirator System at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on December 11 and 12, 2025.

About Integra LifeSciences
Integra LifeSciences (Nasdaq: IART) is a global medical technology leader dedicated to restoring lives. We are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated, gold-standard technologies is trusted by healthcare professionals to deliver transformative care. For the latest news and information about Integra and its products, please visit www.integralife.com.

Investor Relations:
Chris Ward
(609) 772-7736
chris.ward@integralife.com

Media Contact:
Laurene Isip
(609) 208-8121
laurene.isip@integralife.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2795c2cd-fb23-4998-8dd9-8147f524564c

Integra LifeSciences Receives FDA 510(k) Clearance for Use of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Cardiac Surgeries




Integra LifeSciences Receives FDA 510(k) Clearance for Use of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Cardiac Surgeries

PRINCETON, N.J., Nov. 11, 2025 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, is pleased to announce the FDA 510(k) clearance for use of its CUSA^® Clarity Ultrasonic Surgical Aspirator System for cardiac surgeries. The recent clearance for specific cardiac indications encompasses the debridement of unwanted tissue in cardiac surgeries, including valve replacement and repair.

In addition to cardiac surgery, the CUSA Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, such as neurosurgery, plastic and reconstructive surgery, orthopedic surgery, thoracic surgery, laparoscopic surgery, gynecological surgery, and liver resection and transplant surgery.

“The utilization of CUSA Clarity for cardiac surgery marks the next pivotal expansion of the ultrasonic surgical aspirator system’s breadth of indications,” said Mike McBreen, executive vice president and president of Integra’s Codman Specialty Surgical division. “As one of the leaders in the industry, this milestone strengthens our ability to deliver advanced surgical solutions to support restoring patients’ lives.”

Integra LifeSciences will spotlight the CUSA Clarity Ultrasonic Surgical Aspirator System at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on December 11 and 12, 2025.

About Integra LifeSciences
Integra LifeSciences (Nasdaq: IART) is a global medical technology leader dedicated to restoring lives. We are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated, gold-standard technologies is trusted by healthcare professionals to deliver transformative care. For the latest news and information about Integra and its products, please visit www.integralife.com.

Investor Relations:
Chris Ward
(609) 772-7736
chris.ward@integralife.com

Media Contact:
Laurene Isip
(609) 208-8121
laurene.isip@integralife.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2795c2cd-fb23-4998-8dd9-8147f524564c

Metagenomi Reports Third Quarter 2025 Financial Results and Announces Strategic Pipeline Prioritization and Leadership Updates




Metagenomi Reports Third Quarter 2025 Financial Results and Announces Strategic Pipeline Prioritization and Leadership Updates

New MGX-001 preclinical data supports advancement into clinical development; 
Demonstrated curative FVIII activity in non-human primates

Prioritized later-stage preclinical pipeline including wholly-owned MGX-001 hemophilia A program; pre-IND meeting for MGX-001 expected in 4Q 2025 with IND/CTA submissions expected in 4Q 2026

Organizational restructuring reduced workforce by 25%;
Capital allocation strategy anticipated to extend cash runway into the 4Q 2027

Jian Irish, Ph.D., M.B.A., currently President and Chief Operating Officer, appointed as Chief Executive Officer; Brian Thomas, Ph.D., former Chief Executive Officer, continuing on Board of Directors and Dr. Willard Dere serving as new Board Chair

Conference call today at 4:30 p.m. ET

EMERYVILLE, Calif., Nov. 11, 2025 (GLOBE NEWSWIRE) — Metagenomi, Inc. (Nasdaq: MGX) (the “Company”), an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients, today reported financial results for the quarter ended September 30, 2025, and announced a strategic evolution focusing capital on the development of its wholly-owned MGX-001 hemophilia A program and later-stage preclinical pipeline while reducing its workforce by 25%. To support the next phase of development, Jian Irish, Ph.D., M.B.A, the Company’s President and former Chief Operating Officer, has been promoted to the role of Chief Executive Officer, and Brian Thomas, Ph.D., the Company’s founder and former Chief Executive Officer, will remain on the Board of Directors (the “Board”) and current Board member Dr. Willard Dere will serve as the Company’s new Board Chair.

“In light of the encouraging preclinical MGX-001 hemophilia A results we reported today, we made the decision to strategically reprioritize our pipeline and discovery efforts to focus resources on driving forward our lead program for hemophilia A and pursuing programs that leverage our most advanced, signature gene-editing capabilities. These include programs addressing additional secreted protein deficiencies that deploy the site-specific genome integration system used in MGX-001, and cardiometabolic indications in collaboration with Ionis.” said Jian Irish, Ph.D., M.B.A., President and Chief Executive Officer of Metagenomi. “We are committed to our most compelling programs that have the highest probability of success, and potential to address unmet needs and create near-term value. We are capitalizing on our most advanced gene editing technologies while maintaining financial discipline to drive sustainable growth and long-term value. I am honored to share this vision with a seasoned leadership team as we enter this new phase of the Metagenomi story.”

Dr. Irish continued, “As part of this initiative, we are streamlining our organization to optimize our R&D efforts and cost structure, which is anticipated to extend our cash runway into the fourth quarter of 2027. I want to express my deepest gratitude to every member of the Metagenomi team, including those who were impacted by the workforce reduction, for their invaluable contributions toward advancing our mission. In addition, I would like to thank Dr. Thomas, whose novel vision in applying metagenomics towards drug discovery led to all we have accomplished to date. I look forward to continuing to work with him and the other members of the Board and appreciate their ongoing support.”

“The Board of Directors is pleased that Dr. Irish is assuming the role of CEO as Metagenomi advances toward the clinic and its next stage of development,” added Willard Dere, M.D., current director and newly appointed Board Chair. “She brings a wealth of experience having held development and global operations positions with Kite Pharma / Gilead, Sanofi and Amgen, and having played key roles in the launch of several breakthrough medicines. As a co-founder of Metagenomi, we believe this is the right time for her to step into this role.”

Third Quarter 2025 Updates

MGX-001 Hemophilia A Program and Other Secreted Protein Deficiencies

• New dose range finding data presented today from the Company’s wholly-owned MGX-001 hemophilia A program demonstrated curative factor VIII (FVIII) activity in non-human primates (NHPs) and informs a clinical dose regimen strategy for a therapy with best-in-class treatment potential. Metagenomi intends to advance MGX-001 into clinical development. 

• On track to achieve NHP proof-of-concept data for lead secreted protein deficiency target in 2025, leveraging the MGX-001 site-specific genome integration system.

Cardiometabolic Indications

• On track to nominate one DC from the four Wave 1 collaboration targets in 2025.
• Plan to initiate IND-enabling activities for nominated DC and nominate additional DCs from the remaining Wave 1 targets in 2026.

Corporate Updates

• The Company has strategically evolved its pipeline and discovery efforts to focus on the advancement of its leading in vivo therapeutics including the MGX-001 program in hemophilia A, other secreted protein disorders leveraging the MGX-001 approach, and cardiometabolic indications in collaboration with Ionis. In line with this strategic focus, the Company deprioritized early discovery and platform research and reduced its workforce by 25%. As a result of these actions and its revised capital allocation strategy, the Company expects to extend its cash runway into the fourth quarter of 2027.
• In conjunction with the strategic evolution, Jian Irish, Ph.D., M.B.A, the Company’s President and former Chief Operating Officer, has been promoted to the role of Chief Executive Officer. Brian Thomas, Ph.D., the Company’s former Chief Executive Officer, will continue as a member of the Board; and Willard Dere, M.D., current director, will serve as Board Chair.

Third Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents, and available-for-sale marketable securities were $184.1 million as of September 30, 2025, which is anticipated to support operations into the fourth quarter of 2027.

R&D Expenses: Research and development (“R&D”) expenses were $25.3 million for the quarter ended September 30, 2025, as compared to $26.3 million for the comparable period in 2024.

G&A Expenses: General and administrative (“G&A”) expenses were $6.2 million for the quarter ended September 30, 2025, as compared to $7.6 million for the comparable period in 2024.

Conference Call

Metagenomi will host a live webcast today, Tuesday, November 11, 2025, at 4:30 p.m. ET, to discuss the MGX-001 preclinical results and business updates. The live event can be accessed in the “Events” section of Metagenomi’s website at ir.metagenomi.co.The webcast will be archived and available for replay for at least 30 days after the event.

About Hemophilia A

Hemophilia A is the most common X-linked inherited bleeding disorder, caused by a large variety of mutations in the FVIII gene leading to a loss of functional FVIII protein. Intracranial bleeding is of greatest concern as this can lead to major morbidity and mortality. Bleeding into joints leads to cumulative joint damage and is a major cause of morbidity. Diagnosis of severe disease typically occurs in infancy due to exaggerated bleeding in response to minor injury or routine medical procedures. Prevalence is estimated to be up to 26,500 patients in the US and more than 500,000 patients globally according to the World Federation of Hemophilia, with the vast majority of patients being male.

About Metagenomi

Metagenomi is an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients. The Company was founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel editing tools potentially capable of correcting any type of genetic mutation found anywhere in the human genome. The Company focuses on high value programs in disease indications with well-understood biology and clearly defined clinical development and regulatory pathways. Going forward, the Company intends to continue to expand its pipeline by leveraging its proprietary genetic editing capabilities in site specific deletion, integration and correction.

MGX-001, the Company’s lead, wholly-owned development program in hemophilia A, has demonstrated a preclinical profile potentially competitive with best-in-class treatment options, including targeted genome editing and durable gene expression in a one-time treatment. MGX-001 is designed to provide curative, life-long protection from bleeding events and joint damage in adults and children with hemophilia A. The Company is also currently pursuing other secreted protein deficiencies leveraging the MGX-001 site-specific genome integration system and partnered assets targeting cardiometabolic diseases. For more information, please visit https://metagenomi.co.

Cautionary Note Regarding Forward-Looking Statements
This press release contains ​“forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as​ “anticipate,” “believe,” “could,” “estimate,” ​“expect,” ​“goal,” ​“intend,” ​“look forward to,” ​“may,” ​“plan,” ​“potential,” ​“predict,” ​“project,” ​“should,” ​“will,” ​“would” and similar expressions include, but are not limited to, any statements relating to our product development programs, including the timing of and our ability to conduct IND-enabling studies and make regulatory filings such as INDs, expectations regarding MGX-001, including the preclinical profile being potentially competitive with best-in-class treatment options and timing to submit the IND/CTA package, statements regarding the Company’s plans to prioritize its preclinical pipeline and potential for value creation and sustainable growth, statements regarding upcoming milestones including the nomination of development candidates, statements concerning the potential of therapies and product candidates, statements concerning the impact of the organizational restructuring, statements concerning our anticipated cash runway, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of IND submissions and starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation and the current regulatory environment; patent and intellectual property matters; competition; the volatility of capital markets and other adverse macroeconomic factors; as well as other risks described in ​“Risk Factors,” in our most recent Form 10-K and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Investor Contacts:

Stephen Jasper
Gilmartin Group
stephen@gilmartinir.com

or

Kiki Patel, PharmD
Gilmartin Group
kiki@gilmartinir.com

Metagenomi Reports Third Quarter 2025 Financial Results and Announces Strategic Pipeline Prioritization and Leadership Updates




Metagenomi Reports Third Quarter 2025 Financial Results and Announces Strategic Pipeline Prioritization and Leadership Updates

New MGX-001 preclinical data supports advancement into clinical development; 
Demonstrated curative FVIII activity in non-human primates

Prioritized later-stage preclinical pipeline including wholly-owned MGX-001 hemophilia A program; pre-IND meeting for MGX-001 expected in 4Q 2025 with IND/CTA submissions expected in 4Q 2026

Organizational restructuring reduced workforce by 25%;
Capital allocation strategy anticipated to extend cash runway into the 4Q 2027

Jian Irish, Ph.D., M.B.A., currently President and Chief Operating Officer, appointed as Chief Executive Officer; Brian Thomas, Ph.D., former Chief Executive Officer, continuing on Board of Directors and Dr. Willard Dere serving as new Board Chair

Conference call today at 4:30 p.m. ET

EMERYVILLE, Calif., Nov. 11, 2025 (GLOBE NEWSWIRE) — Metagenomi, Inc. (Nasdaq: MGX) (the “Company”), an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients, today reported financial results for the quarter ended September 30, 2025, and announced a strategic evolution focusing capital on the development of its wholly-owned MGX-001 hemophilia A program and later-stage preclinical pipeline while reducing its workforce by 25%. To support the next phase of development, Jian Irish, Ph.D., M.B.A, the Company’s President and former Chief Operating Officer, has been promoted to the role of Chief Executive Officer, and Brian Thomas, Ph.D., the Company’s founder and former Chief Executive Officer, will remain on the Board of Directors (the “Board”) and current Board member Dr. Willard Dere will serve as the Company’s new Board Chair.

“In light of the encouraging preclinical MGX-001 hemophilia A results we reported today, we made the decision to strategically reprioritize our pipeline and discovery efforts to focus resources on driving forward our lead program for hemophilia A and pursuing programs that leverage our most advanced, signature gene-editing capabilities. These include programs addressing additional secreted protein deficiencies that deploy the site-specific genome integration system used in MGX-001, and cardiometabolic indications in collaboration with Ionis.” said Jian Irish, Ph.D., M.B.A., President and Chief Executive Officer of Metagenomi. “We are committed to our most compelling programs that have the highest probability of success, and potential to address unmet needs and create near-term value. We are capitalizing on our most advanced gene editing technologies while maintaining financial discipline to drive sustainable growth and long-term value. I am honored to share this vision with a seasoned leadership team as we enter this new phase of the Metagenomi story.”

Dr. Irish continued, “As part of this initiative, we are streamlining our organization to optimize our R&D efforts and cost structure, which is anticipated to extend our cash runway into the fourth quarter of 2027. I want to express my deepest gratitude to every member of the Metagenomi team, including those who were impacted by the workforce reduction, for their invaluable contributions toward advancing our mission. In addition, I would like to thank Dr. Thomas, whose novel vision in applying metagenomics towards drug discovery led to all we have accomplished to date. I look forward to continuing to work with him and the other members of the Board and appreciate their ongoing support.”

“The Board of Directors is pleased that Dr. Irish is assuming the role of CEO as Metagenomi advances toward the clinic and its next stage of development,” added Willard Dere, M.D., current director and newly appointed Board Chair. “She brings a wealth of experience having held development and global operations positions with Kite Pharma / Gilead, Sanofi and Amgen, and having played key roles in the launch of several breakthrough medicines. As a co-founder of Metagenomi, we believe this is the right time for her to step into this role.”

Third Quarter 2025 Updates

MGX-001 Hemophilia A Program and Other Secreted Protein Deficiencies

• New dose range finding data presented today from the Company’s wholly-owned MGX-001 hemophilia A program demonstrated curative factor VIII (FVIII) activity in non-human primates (NHPs) and informs a clinical dose regimen strategy for a therapy with best-in-class treatment potential. Metagenomi intends to advance MGX-001 into clinical development. 

• On track to achieve NHP proof-of-concept data for lead secreted protein deficiency target in 2025, leveraging the MGX-001 site-specific genome integration system.

Cardiometabolic Indications

• On track to nominate one DC from the four Wave 1 collaboration targets in 2025.
• Plan to initiate IND-enabling activities for nominated DC and nominate additional DCs from the remaining Wave 1 targets in 2026.

Corporate Updates

• The Company has strategically evolved its pipeline and discovery efforts to focus on the advancement of its leading in vivo therapeutics including the MGX-001 program in hemophilia A, other secreted protein disorders leveraging the MGX-001 approach, and cardiometabolic indications in collaboration with Ionis. In line with this strategic focus, the Company deprioritized early discovery and platform research and reduced its workforce by 25%. As a result of these actions and its revised capital allocation strategy, the Company expects to extend its cash runway into the fourth quarter of 2027.
• In conjunction with the strategic evolution, Jian Irish, Ph.D., M.B.A, the Company’s President and former Chief Operating Officer, has been promoted to the role of Chief Executive Officer. Brian Thomas, Ph.D., the Company’s former Chief Executive Officer, will continue as a member of the Board; and Willard Dere, M.D., current director, will serve as Board Chair.

Third Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents, and available-for-sale marketable securities were $184.1 million as of September 30, 2025, which is anticipated to support operations into the fourth quarter of 2027.

R&D Expenses: Research and development (“R&D”) expenses were $25.3 million for the quarter ended September 30, 2025, as compared to $26.3 million for the comparable period in 2024.

G&A Expenses: General and administrative (“G&A”) expenses were $6.2 million for the quarter ended September 30, 2025, as compared to $7.6 million for the comparable period in 2024.

Conference Call

Metagenomi will host a live webcast today, Tuesday, November 11, 2025, at 4:30 p.m. ET, to discuss the MGX-001 preclinical results and business updates. The live event can be accessed in the “Events” section of Metagenomi’s website at ir.metagenomi.co.The webcast will be archived and available for replay for at least 30 days after the event.

About Hemophilia A

Hemophilia A is the most common X-linked inherited bleeding disorder, caused by a large variety of mutations in the FVIII gene leading to a loss of functional FVIII protein. Intracranial bleeding is of greatest concern as this can lead to major morbidity and mortality. Bleeding into joints leads to cumulative joint damage and is a major cause of morbidity. Diagnosis of severe disease typically occurs in infancy due to exaggerated bleeding in response to minor injury or routine medical procedures. Prevalence is estimated to be up to 26,500 patients in the US and more than 500,000 patients globally according to the World Federation of Hemophilia, with the vast majority of patients being male.

About Metagenomi

Metagenomi is an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients. The Company was founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel editing tools potentially capable of correcting any type of genetic mutation found anywhere in the human genome. The Company focuses on high value programs in disease indications with well-understood biology and clearly defined clinical development and regulatory pathways. Going forward, the Company intends to continue to expand its pipeline by leveraging its proprietary genetic editing capabilities in site specific deletion, integration and correction.

MGX-001, the Company’s lead, wholly-owned development program in hemophilia A, has demonstrated a preclinical profile potentially competitive with best-in-class treatment options, including targeted genome editing and durable gene expression in a one-time treatment. MGX-001 is designed to provide curative, life-long protection from bleeding events and joint damage in adults and children with hemophilia A. The Company is also currently pursuing other secreted protein deficiencies leveraging the MGX-001 site-specific genome integration system and partnered assets targeting cardiometabolic diseases. For more information, please visit https://metagenomi.co.

Cautionary Note Regarding Forward-Looking Statements
This press release contains ​“forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as​ “anticipate,” “believe,” “could,” “estimate,” ​“expect,” ​“goal,” ​“intend,” ​“look forward to,” ​“may,” ​“plan,” ​“potential,” ​“predict,” ​“project,” ​“should,” ​“will,” ​“would” and similar expressions include, but are not limited to, any statements relating to our product development programs, including the timing of and our ability to conduct IND-enabling studies and make regulatory filings such as INDs, expectations regarding MGX-001, including the preclinical profile being potentially competitive with best-in-class treatment options and timing to submit the IND/CTA package, statements regarding the Company’s plans to prioritize its preclinical pipeline and potential for value creation and sustainable growth, statements regarding upcoming milestones including the nomination of development candidates, statements concerning the potential of therapies and product candidates, statements concerning the impact of the organizational restructuring, statements concerning our anticipated cash runway, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of IND submissions and starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation and the current regulatory environment; patent and intellectual property matters; competition; the volatility of capital markets and other adverse macroeconomic factors; as well as other risks described in ​“Risk Factors,” in our most recent Form 10-K and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Investor Contacts:

Stephen Jasper
Gilmartin Group
stephen@gilmartinir.com

or

Kiki Patel, PharmD
Gilmartin Group
kiki@gilmartinir.com

Metagenomi Presents New Preclinical Data from MGX-001 Hemophilia A Program Supporting Advancement into Clinical Development




Metagenomi Presents New Preclinical Data from MGX-001 Hemophilia A Program Supporting Advancement into Clinical Development

MGX-001 demonstrated curative FVIII activity in non-human primates

Pre-IND regulatory meeting expected in Q4 2025 with investigational new drug (IND) and clinical trial application (CTA) submissions expected in 4Q 2026

EMERYVILLE, Calif., Nov. 11, 2025 (GLOBE NEWSWIRE) — Metagenomi, Inc. (Nasdaq: MGX) (the “Company”), an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients, today reported new dose range finding data from the Company’s MGX-001 hemophilia A program. The data demonstrated curative factor VIII (FVIII) activity in non-human primates (NHPs) and informs a clinical dose regimen strategy for a therapy with best-in-class treatment potential. Metagenomi intends to advance MGX-001 into clinical development.

“We are highly encouraged by the dose range finding results observed in this study where we have seen clear dose-dependent activity across both the AAV and LNP components of MGX-001, resulting in therapeutically relevant FVIII activity in each animal treated in all but the lowest AAV dose,” said Jian Irish, Ph.D., M.B.A., President and CEO of Metagenomi. “In contrast to bispecific FVIII mimetics or rebalancing therapies, MGX-001 enables endogenous production of FVIII for hemostatic regulation and restores the body’s own ability to produce FVIII for a potentially lifelong cure. Our new data builds upon an earlier study demonstrating durable and stable FVIII activity in NHPs over an approximately 19-month study, giving us confidence that our novel approach has the potential to be a curative, one-and-done treatment for patients suffering from hemophilia A. We are leveraging these results in discussions with regulators and our IND/CTA submissions are expected by the end of 2026.”

NHP study design and results:

In this preclinical dose range finding study, a single dose of AAV containing a B-domain deleted human FVIII gene was administered to 24 NHPs in six dose cohorts at varying doses from 5.0e11 vg/kg to 4.0e13 vg/kg followed by a single dose of LNP delivering the proprietary MG29-1 nuclease mRNA and associated guide RNA at either 0.2, 0.6 or 2.0 mg/kg. Each animal received a single dose of corticosteroids prior to both AAV and LNP doses.

A functional cure is generally defined as FVIII levels of 50% to 150% of normal human levels. Key highlights from the study are below:

• Therapeutically relevant levels of FVIII activity were achieved in the five highest AAV doses of the six dose cohorts
  • At a fixed LNP dose of 0.6 mg/kg and a variable AAV dose of 1.6e12 to 4e13, MGX-001 achieved average per cohort FVIII activity of 49% – 81%
  • At a fixed AAV dose of 5e12 vg/kg and a variable LNP dose of 0.2 to 2.0 mg/kg, MGX-001 achieved average per cohort FVIII activity of 17% – 72%
  • FVIII activity exhibited both AAV and LNP dose dependency with no animal exceeding 150% of normal, the maximum acceptable level of human FVIII activity
  • The treatment was well tolerated in all animals without significant elevation of liver enzymes except in the highest dose of LNP where transient elevations in liver enzymes were observed
• At a proposed clinical dose of AAV at 5e12 vg/kg and LNP at 0.6 mg/kg, MGX-001 achieved average FVIII activity of 49% within a range of 29.3% – 59.5%

The new data demonstrated improved FVIII activity with reduced variability, building upon previously announced results with the B-domain deleted FVIII construct that demonstrated durable FVIII activity over an approximately 19-month study. This earlier NHP study used a cynomolgus version of the FVIII gene (cFVIII) to avoid the confounding effects of anti-human FVIII antibodies. MGX-001 has also shown no identifiable off-target editing in a series of orthogonal assays employed to discover and validate potential off-target sites.

“The MGX-001 approach represents a potential paradigm shift for the treatment of hemophilia A patients who, even with currently approved therapies, are subject to rare but serious spontaneous bleeding events and must always ensure access to their treatment,” said Glenn F. Pierce, M.D., Ph.D., an expert in the treatment of hemophilia. “As a physician scientist, drug developer, and former hemophilia A patient myself, I can speak firsthand to the impact that a potential one-and-done curative treatment can have in enabling a new standard of life with a hemophilia-free mindset.”

About Hemophilia A

Hemophilia A is the most common X-linked inherited bleeding disorder, caused by a large variety of mutations in the FVIII gene leading to a loss of functional FVIII protein. Intracranial bleeding is of greatest concern as this can lead to major morbidity and mortality. Bleeding into joints leads to cumulative joint damage and is a major cause of morbidity. Diagnosis of severe disease typically occurs in infancy due to exaggerated bleeding in response to minor injury or routine medical procedures. Prevalence is estimated to be up to 26,500 patients in the US and more than 500,000 patients globally according to the World Federation of Hemophilia, with the vast majority of patients being male.

About Metagenomi

Metagenomi is an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients. The Company was founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel editing tools potentially capable of correcting any type of genetic mutation found anywhere in the human genome. The Company focuses on high value programs in disease indications with well-understood biology and clearly defined clinical development and regulatory pathways. Going forward, the Company intends to continue to expand its pipeline by leveraging its proprietary genetic editing capabilities in site specific deletion, integration and correction.

MGX-001, the Company’s lead, wholly-owned development program in hemophilia A, has demonstrated a preclinical profile potentially competitive with best-in-class treatment options, including targeted genome editing and durable gene expression in a one-time treatment. MGX-001 is designed to provide curative, life-long protection from bleeding events and joint damage in adults and children with hemophilia A. The Company is also currently pursuing other secreted protein deficiencies leveraging the MGX-001 site-specific genome integration system and partnered assets targeting cardiometabolic diseases. For more information, please visit https://metagenomi.co.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions include, but are not limited to, any statements relating to our product development programs, including the timing of and our ability to conduct IND-enabling studies and make regulatory filings such as INDs, statements concerning the potential of therapies and product candidates, expectations regarding MGX-001, including the preclinical profile being potentially competitive with best-in-class treatment options, benefits of the approach and timing to submit the IND/CLA packages, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of IND submissions and starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation and the current regulatory environment; patent and intellectual property matters; competition; the volatility of capital markets and other adverse macroeconomic factors; as well as other risks described in “Risk Factors,” in our most recent Form 10-K and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Investor Contacts:

Stephen Jasper
Gilmartin Group
stephen@gilmartinir.com

or

Kiki Patel, PharmD
Gilmartin Group
kiki@gilmartinir.com