GRAFAPEX update

Commercialization progress on GRAFAPEX as of March 31, 2026 included the following operational highlights:

• As of March 31, 2026, 56 individual healthcare institutions (December 31, 2025 - 46), representing 31% of the 180 transplant centers in the United States (December 31, 2025 - 26%), have made positive formulary inclusion determinations.

• Wholesaler data as of March 31, 2026 shows that 64 of the 180 transplant centers have already ordered GRAFAPEX for procedures in their institutions (December 31, 2025 - 55).

These operating indicators are consistent with the expected product-level performance of GRAFAPEX described by Medexus in connection with its fiscal Q3 2026 results. Medexus expects to provide additional information regarding the ongoing GRAFAPEX commercialization and related financial performance in connection with the reporting of its fiscal year 2026 results, which is expected to occur in June.

Medexus remains encouraged by the trajectory of the commercialization efforts for GRAFAPEX in the United States, and believes it supports Medexus's expectation that annual product-level net revenue from GRAFAPEX will exceed $100 million within five years after commercial launch, as further described in Medexus's filings with the Canadian securities regulatory authorities.

"As previously disclosed, Medexus had identified fiscal Q4 2026 as an important quarter in the expected GRAFAPEX commercialization trajectory," commented Ken d'Entremont, Chief Executive Officer of Medexus. "These operating indicators as of March 31 are consistent with our previously disclosed expectations that GRAFAPEX will be accretive to quarterly operating cash flows starting in the just-completed calendar Q1 2026, which is our fiscal Q4 2026. We look forward to providing additional detail with our fiscal year 2026 results."

Capital allocation and capital structure update

Medexus has also continued to be active under its current normal course issuer bid, or NCIB, made in November 2025. As of March 31, 2026, Medexus had repurchased 710,100 common shares under the NCIB for an aggregate repurchase price of C$2.1 million ($1.5 million).

This figure includes the purchase of a block of 233,903 common shares that resulted from the issuance in March 2026 of common shares upon exercise of common share purchase warrants held by the sole underwriter of Medexus's October 2023 bought-deal public offering at an exercise price of C$2.95 per common share. Following the exercise of these warrants and the repurchase of the resulting common shares under the NCIB, and in light of the April 6, 2026 expiration of all then-unexercised common share purchase warrants issued in the 2023 offering in accordance with their terms, no warrants to purchase common shares of Medexus remain outstanding.

Mr Buschman commented: "These developments reflect continued execution against our capital allocation priorities. The repurchases completed under the NCIB, together with the April 6, 2026 expiration of all outstanding warrants issued in the October 2023 bought-deal public offering, have reduced potential dilution and further simplified our capital structure."

For more information about Medexus's share capitalization, please see Medexus's most recent MD&A, which is available on the company's corporate website at www.medexus.com and its issuer profile on SEDAR+ at www.sedarplus.ca.

Upcoming investor conferences

Company management will be available to discuss Medexus's business at the 2026 Bloom Burton & Co. Healthcare Investor Conference in Toronto from April 21 to 22, 2026 and the LD Micro Invitational XVI in Los Angeles from May 17 to 19, 2026. Details regarding Medexus's participation will be available on the Investors—News & Events section of Medexus's corporate website.

About GRAFAPEX™ (treosulfan) for Injection

GRAFAPEX™ (treosulfan) for Injection, an alkylating agent, is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients one year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). GRAFAPEX™ holds Orphan Drug Designation under the Orphan Drug Act, meaning that the product will benefit from a seven-year period of regulatory exclusivity in the FDA-approved indication. Full prescribing information for GRAFAPEX™ is available on the product's website at www.grafapex.com and on the Drugs@FDA drug database at www.fda.gov.

Efficacy was evaluated in MC-FludT.14/L Trial II (NCT00822393), a randomized active-controlled trial comparing treosulfan to busulfan with fludarabine as a preparative regimen for allogeneic transplantation. Eligible patients included adults 18 to 70 years old with AML or MDS, Karnofsky performance status ≥60%, and age ≥50 years or hematopoietic cell transplantation comorbidity index [HCTCI] score >2. There were 570 patients randomized to treosulfan (n=280) or busulfan (n=290).

The major efficacy outcome measure was overall survival (OS), defined as the time from randomization until death from any cause. The hazard ratio for OS (stratified by donor type and risk group) compared to busulfan was 0.67 (95% CI: 0.51, 0.90) in the randomized population, 0.73 (95% CI: 0.51, 1.06) in patients with AML, and 0.64 (95% CI: 0.40, 1.02) in patients with MDS.

The most common adverse reactions (≥20%) were musculoskeletal pain, stomatitis, pyrexia, nausea, edema, infection, and vomiting. Selected Grade 3 or 4 nonhematological laboratory abnormalities were increased GGT (gamma-glutamyl transferase), increased bilirubin, increased ALT (alanine aminotransferase), increased AST (aspartate aminotransferase), and increased creatinine.

The recommended treosulfan dose is 10 g/m2 daily on days -4, -3, and -2 in combination with fludarabine 30 mg/m2 daily on days -6, -5, -4, -3, and -2, and allogeneic hematopoietic stem cell infusion on day 0.

For more information about GRAFAPEX™, including important safety information (including boxed warning), see the full prescribing information, which is available on the product's website at www.grafapex.com and on the Drugs@FDA drug database at www.fda.gov.

GRAFAPEX™ (treosulfan) for Injection is approved by the FDA for sale and use in the United States only and is not intended for export outside the United States. Medexus makes no representation that GRAFAPEX™ (treosulfan) for Injection is appropriate for, or authorized for sale to or use by, persons who are not located in the United States.

Medexus Pharma, Inc. holds exclusive commercial rights to GRAFAPEX™ in the United States under a February 2021 agreement with medac GmbH. For more information about the terms of the GRAFAPEX agreement, see Medexus's most recent annual information form. A copy of the GRAFAPEX agreement, including all amendments, is included in the company's filings on SEDAR+ at www.sedarplus.ca.

About Medexus

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology and hemato-oncology and rheumatology and allergy. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.

Forward-looking statements

Certain statements in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "budget", "potential", "targets", "could", "estimates", "expects", "forecasts", "goals", "intends", "may", "might", "objective", "outlook", "plans", "projects", "schedule", "should", "will", "would", "prospects", and "vision", or similar words, phrases, or expressions, are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, information contained in statements regarding any of the following: Medexus's business strategy, outlook, and other expectations and plans regarding financial or operational performance, including those specific to GRAFAPEX™ (treosulfan) for Injection (including patient demand for GRAFAPEX, and its relationship with the operating indicators discussed in this news release, and any resulting impact of any of the foregoing on product-level performance of GRAFAPEX), in particular in light of investments in the ongoing commercialization of GRAFAPEX; expectations and plans regarding future growth, net revenues, and patient demand in respect of the commercialization of GRAFAPEX, including the potential product-level revenue to be generated from its commercialization in the United States (and its relationship with the operating indicators discussed in this news release); inventory levels and management of Medexus's single wholesaler for GRAFAPEX; expectations that GRAFAPEX will be accretive to quarterly operating cash flows starting in fiscal Q4 2026; the potential benefits of GRAFAPEX; expectations regarding the commercialization of GRAFAPEX™ (treosulfan) for Injection and the product's prospects and performance, including in respect of its potential adoption and use in the United States, its level of contribution to alloHSCT in the United States, and its, and the company's, potential competitive position; expectations regarding hospital adoption, payer coverage, reimbursement progress, and the contribution of GRAFAPEX to Medexus's future total net revenue and operating cash flow; expectations regarding the NCIB on dilution and the company's capital structure; and anticipated trends and potential challenges in Medexus's business and the markets in which the company and its products operate and compete, including in respect of the company's competitive position in and demographics of those markets. The forward-looking statements and information included in this news release are based on Medexus's current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments. In particular, and without limiting the generality of the foregoing, Medexus's estimate of potential product-level net revenue from commercialization of GRAFAPEX is based on a number of such factors and assumptions as most recently described in Medexus's most recent MD&A. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

This news release also includes preliminary estimates of operating indicators relating to GRAFAPEX derived from internal data, including internal EDI (electronic data interchange) data. All such figures are based on information currently available to Medexus management and are subject to change and adjustment as Medexus's financial results for fiscal Q4 2026 and fiscal year 2026 are finalized. Accordingly, final reported results may differ, and may differ materially, from these preliminary estimates, and investors therefore should not place undue reliance on any such preliminary estimates. All such preliminary estimates constitute forward-looking information within the meaning of applicable securities laws, are based on a number of assumptions, and are subject to a number of risks and uncertainties, including as discussed above.

Additional notes

This news release contains references to trademarks and other protected names and marks, including those belonging to other companies, persons, or entities. Solely for convenience, trademarks and other protected names and marks referred to in this news release may appear without the "®", "™", or other similar symbols. Each such reference should be read as though it appears with the relevant symbol. Any such references are not intended to indicate, in any way, that the holder or holders will not assert those rights to the fullest extent under applicable law.

The information in this news release is provided for informational purposes to investors in Medexus securities.

Uniform resource locators, or website addresses, that appear in this news release are intended to be provided as inactive textual references only. Information contained on or accessible through these website addresses is not a part of this news release and is not incorporated by reference into this news release or any of Medexus's public filings.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/292763

SOURCE Medexus Pharmaceuticals Inc.

Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - February 11, 2026) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company's third fiscal quarter ended December 31, 2025 (the company's fiscal Q3 2026). All dollar amounts in this press release are in US dollars unless specified otherwise.

Key update on GRAFAPEX

Medexus has continued to see a positive market response to GRAFAPEX™ (treosulfan) for Injection since the US commercial launch of the product in February 2025. The Company expects GRAFAPEX will account for a significant portion of total net revenue and operating cash flow over the coming fiscal years. For the three- and nine-month periods ended December 31, 2025, Medexus recognized product-level net revenue from GRAFAPEX of $2.0 million and $8.2 million, relative to $2.5 million and $8.5 million of GRAFAPEX personnel and infrastructure investments. Medexus continues to expect that annual product-level net revenue from GRAFAPEX will exceed $100 million within five years after commercial launch.

"Product-level performance for GRAFAPEX continues to demonstrate strong momentum, which is consistent with the positive feedback we heard earlier this month at the 2026 Tandem Meetings^ in Salt Lake City, Utah," commented Ken d'Entremont, Chief Executive Officer. "Sequential quarter-over-quarter momentum remained strong with growth of 30% in underlying patient demand in fiscal Q3 2026 compared to fiscal Q2 2026. We have also observed a robust increase in monthly patient demand from December to January, which was one of the strongest months to date."

Mr d'Entremont continued: "We also saw greater GRAFAPEX utilization in adult hospitals in fiscal Q3 2026, which is an important indicator because we expect utilization in adult patient populations to be the primary driver of long-term growth for the product. Specifically, the 30% sequential quarter-over-quarter increase in underlying patient demand for GRAFAPEX includes a 56% increase in demand from hospitals that treat adult patient populations, compared to a 28% decrease from pediatric hospitals, given what we believe is greater seasonality in pediatric procedures versus a durable trend in this patient population. We also saw a 59% increase in utilization by hospitals that treat both adult and pediatric patient populations."

"The $8.5 million we have invested in the GRAFAPEX launch through December 31 continues to have a significant impact," concluded Mr d'Entremont. As of today, 32% of all 180 US transplant centers have already ordered GRAFAPEX for procedures in their institutions, and 77% of those 57 institutions have reordered."

^ The Tandem Meetings I Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR are the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and CIBMTR (Center for International Blood and Marrow Transplant Research).

Financial highlights

Medexus is currently focused on delivering strong performance from GRAFAPEX, and also remains focused on supporting stable overall performance across the Company's portfolio of products in both the United States and Canada.

Key financial highlights for fiscal Q3 2026 include the following:

• Net revenue of $25.3 million and $74.7 million for the three- and nine-month periods ended December 31, 2025, a decrease of $4.7 million and $8.9 million, or 15.7% and 10.6%, compared to $30.0 million and $83.6 million for the corresponding prior year periods. Net revenue for the three- and nine-month periods ended December 31, 2025 includes $2.0 million and $8.2 million of product-level net revenue from GRAFAPEX. The $4.7 million and $8.9 million year-over-year net revenue decrease was primarily due to reduced net sales of Rupall (due to significant generic competition, the impact of which Medexus expects is now largely reflected in product-level performance) and Gleolan in the United States (due to the March 2025 termination of the related license agreement), together with an approximately $2.0 million beneficial impact of customer buying patterns of IXINITY on net revenue for fiscal Q3 2025. The year-over-year decrease was partially offset by the positive effects on product-level net revenue from Rasuvo of a January 2025 change in Medicare Part D discounts for government-sponsored programs under the US Inflation Reduction Act, or IRA, and increased unit demand for Rasuvo following the withdrawal of another product in the branded methotrexate autoinjector market by its distributor.

• Adjusted EBITDA* of $4.5 million and $12.3 million for the three- and nine-month periods ended December 31, 2025. Fiscal Q3 2026 is the third consecutive fiscal quarter of Adjusted EBITDA* growth since the approval and launch of GRAFAPEX in fiscal Q4 2025. Adjusted EBITDA* for the three- and nine-month periods ended December 31, 2025 represents a decrease of $1.3 million and $5.6 million, or 22.4% and 31.3%, compared to $5.8 million and $17.9 million for the corresponding prior year periods, which predate the approval and launch of GRAFAPEX. The $1.3 million and $5.6 million year-over-year Adjusted EBITDA* decrease was primarily due to significant generic competition on Rupall and the March 2025 termination of the US Gleolan agreement, together with an approximately $2.0 million beneficial impact of customer buying patterns of IXINITY on net revenue for fiscal Q3 2025, and the other factors discussed in the MD&A. Adjusted EBITDA* for the three- and nine-month periods ended December 31, 2025 was also affected by product-level net revenue from GRAFAPEX of $2.0 million and $8.2 million, relative to $2.5 million and $8.5 million of GRAFAPEX personnel and infrastructure investments in the same periods.

• Operating income of $1.7 million and $3.9 million for the three- and nine-month periods ended December 31, 2025. Fiscal Q3 2026 is the third consecutive fiscal quarter of operating income growth since the approval and launch of GRAFAPEX in fiscal Q4 2025. Operating income for the three- and nine-month periods ended December 31, 2025 represents a decrease of $2.1 million and $5.5 million, or 55.3% and 58.5%, compared to $3.8 million and $9.4 million for the corresponding prior year periods, which predate the approval and launch of GRAFAPEX.

• Gross margin of 53.6% and 55.1%, and Adjusted Gross Margin* of 62.9% and 64.5%, for the three- and nine-month periods ended December 31, 2025, compared to gross margin of 50.7% and 52.8%, and Adjusted Gross Margin* of 56.3% and 58.3%, for the corresponding prior year periods, which predate the approval and launch of GRAFAPEX. The gross margin and Adjusted Gross Margin* increases are primarily due to changes in the relative contribution of product-level net revenue - in particular an increasing level of net sales of GRAFAPEX, which the Company launched in February 2025 and which is expected to have a relatively higher product-level gross margin and Adjusted Gross Margin*, and an absence of net sales of Gleolan in the United States, which the Company ceased commercializing in March 2025 and which had a relatively lower product-level gross margin and Adjusted Gross Margin*. Gross margin also benefited from the positive effects on product-level net revenue for Rasuvo of a January 2025 change in Medicare Part D discounts for government-sponsored programs under the IRA.

• Net income of $0.1 million and $0.3 million for the three- and nine-month periods ended December 31, 2025, a decrease of $0.6 million and $2.5 million compared to net income of $0.7 million and $2.8 million for the corresponding prior year periods, which predate the approval and launch of GRAFAPEX.

• Available liquidity of $15.0 million (December 31, 2025), consisting of cash and cash equivalents, compared to $24.0 million (March 31, 2025).

• Cash provided by operating activities of $7.8 million and $15.1 million for the three- and nine-month periods ended December 31, 2025, an increase of $1.1 million and a decrease of $6.7 million compared to $6.7 million and $21.8 million for the corresponding prior year periods. The Company has continued to generate positive cash flow from operations in the four fiscal quarters since the approval and launch of GRAFAPEX in fiscal Q4 2025, notwithstanding the $11.2 million of GRAFAPEX personnel and infrastructure investments during that period to support the commercial launch of the product beginning in February 2025.

* Refer to "Non-GAAP measures" at the end of this press release for information about non-GAAP measures and related items, including Adjusted EBITDA, Net Debt to Adjusted EBITDA, and Adjusted Gross Margin.

"Even while investing in the launch of GRAFAPEX, we have generated an average of $4.3 million of cash from operating activities per quarter in the four quarters since launch," commented Brendon Buschman, Chief Financial Officer of Medexus. "As GRAFAPEX continues to scale, we believe we are well positioned for further improvement in operating cash flow."

Mr Buschman continued: "We also meaningfully strengthened our balance sheet with our new credit agreement with National Bank of Canada, which includes scheduled principal repayments of only $0.5 million per quarter. With Net Debt to Adjusted EBITDA* of 0.71x for the trailing four fiscal quarters ended December 31, 2025, our financial strength enabled us to fully repay the remaining $7.5 million regulatory milestone obligation to medac from cash on hand on January 1, as scheduled, as well as repurchase 201,500 common shares to date under our NCIB."

Mr d'Entremont concluded: "As we enter the final quarter of our fiscal year 2026, we continue to be very pleased with the performance of GRAFAPEX to date, and we look forward to fiscal year 2027 as we expect product-level performance of GRAFAPEX to make up an increasing share of total net revenue and cash flow. Overall, we continue to execute with discipline and focus as we position Medexus for the opportunities ahead."

Key corporate highlights

• NBC Credit Agreement: In November 2025, Medexus entered into the NBC Credit Agreement, a senior secured credit agreement with National Bank of Canada as administrative agent and lender. The NBC Credit Agreement provides for a $21.0 million term loan facility, or Term Facility, and a $5.0 million revolving loan facility, or Revolving Facility. The Term Facility benefits from an additional $10.0 million delayed draw feature, intended to finance future licensing and acquisition transactions, and a $15.0 million uncommitted accordion feature. The facilities under the NBC Credit Agreement will mature on November 17, 2029, being four years from the date of the NBC Credit Agreement. Medexus used the net proceeds of the Term Facility to satisfy its obligations under the Company's now-repaid senior secured credit agreement with Bank of Montreal, or BMO, which otherwise would have matured in March 2026.

• 2025 NCIB: In November 2025, the Toronto Stock Exchange accepted Medexus's notice of intention to make a normal course issuer bid for its Common Shares (2025 NCIB). Under the 2025 NCIB, Medexus may purchase for cancellation up to 2,983,650 Common Shares. As of December 31, 2025, Medexus had repurchased 191,900 Common Shares under the 2025 NCIB for an aggregate repurchase price of C$0.5 million ($0.4 million).

Operational highlights

Leading products

Hematology and hemato-oncology

• GRAFAPEX (US): Medexus achieved $2.0 million and $8.2 million of product-level net revenue from GRAFAPEX for the three- and nine-month periods ended December 31, 2025, relative to the $2.5 million and $8.5 million of GRAFAPEX personnel and infrastructure investments discussed below. Underlying patient demand was $2.6 million for fiscal Q3 2026, representing sequential underlying patient demand growth of 30% compared to $2.1 million for fiscal Q2 2026, and $6.7 million for fiscal year 2026 to date. The cumulative net result of these demand patterns was an incremental $0.7 million benefit to product-level net revenue in fiscal Q3 2026 from end-of-quarter wholesaler purchases agreed by the Company. (Source: Internal EDI Data.) Since launch, wholesaler purchases of GRAFAPEX have exceeded demand by $1.8 million, resulting in an estimated 1.5 to 2 months of inventory on hand at December 31, 2025 held by the Company's single wholesaler for GRAFAPEX. This wholesaler inventory level is consistent with Medexus's expectations for a product launch; however, inventory management decisions by the wholesaler could affect the timing, volume, and commercial terms of wholesaler orders, and consequently product-level net revenue, in future quarters. Medexus expects that the underlying patient demand of GRAFAPEX will be approximately $3.0 million to $4.0 million in fiscal Q4 2026 – compared to $2.2 million in fiscal Q1 2026, $2.1 million in fiscal Q2 2026, and $2.6 million in fiscal Q3 2026. (Source: Internal EDI data.) Taking into account the estimated wholesaler inventory at December 31, 2025, Medexus anticipates that patient demand will result in product-level net revenue from GRAFAPEX recognized in fiscal Q4 2026 of between $3.0 million and $4.0 million, resulting in product-level net revenue of $11.0 million to $12.0 million for fiscal year 2026. Based on product-level performance to date, Medexus expects that product-level performance of GRAFAPEX, net of working capital changes, will be accretive to quarterly operating cash flows starting in fiscal Q4 2026 (calendar Q1 2026). Medexus continues to expect that the annual product-level Adjusted Gross Margin* of GRAFAPEX will ultimately be approximately 80%. For fiscal year 2026 to date, product-level Adjusted Gross Margin* has been slightly higher due to the evolving reimbursement and tariff dynamics for the product.
  
  As of December 31, 2025, 46 individual healthcare institutions, representing 26% of the 180 transplant centers in the United States, have made positive formulary inclusion determinations. For the nine-month period ended December 31, 2025, approximately 75% of product-level net revenue from GRAFAPEX is attributable to institutions that have made such positive formulary inclusion determinations. Wholesaler data as of December 31, 2025 shows that 55 of the 180 transplant centers, representing an estimated 38% of total allo-HSCT procedures performed in the United States annually (source: Allogeneic HSCT in HRSA 2016-2020; Health Resources and Services Administration), have already ordered GRAFAPEX for procedures in their institutions, and 41, or 75%, of those institutions have placed repeat orders.

• Trecondyv (Canada): Patient unit demand for Trecondyv remained strong during the 12-month period ended December 31, 2025, which is reflected in the unit demand growth of 51% over the trailing 12-month period ended December 31, 2025. (Source: Hospitals Direct Sales Data, MAT December 2025.)

• IXINITY (US): Patient unit demand in the United States increased by 2% over the trailing 12-month period ended December 31, 2025. (Source: customer-reported dispensing data.) In fiscal Q3 2026, in an effort to further improve batch yield and manufacturing costs, Medexus entered into an agreement with the Company's third-party contract manufacturer of IXINITY for a $4.0 million manufacturing process upgrade (plus $2.0 million for a test batch of IXINITY that will, if successful, be saleable product), of which approximately $1.2 million is expected to be paid in fiscal year 2026.

Rheumatology and allergy

• Rasuvo (US): Patient unit demand for Rasuvo increased by 3% over the trailing 12-month period ended December 31, 2025. (Source: IQVIA TSA Monthly Data.) During fiscal Q2 2026, Medexus learned that another product in the branded methotrexate autoinjector market had been withdrawn by its distributor, which has resulted in increased unit demand for Rasuvo as patients and healthcare professionals have looked for alternatives. Medexus attributes the 17% increase in patient unit demand over fiscal Q3 2026 when compared to the prior year period to this change in the competitive landscape. Medexus expects that the effect of this one-time increase in unit demand is now largely reflected in product-level performance of Rasuvo.

• Metoject (Canada): Patient unit demand for Metoject decreased by 6% over the trailing 12-month period ended December 31, 2025. (Source: IQVIA - TSA Monthly Data.)

• Rupall (Canada): Rupall's market exclusivity, granted by Health Canada, expired in January 2025 and Rupall now faces generic competition in Canada. As a result, patient unit demand over the three- and nine-month periods ended December 31, 2025 has decreased 63.1% and 57% when compared to the corresponding prior year periods. (Source: IQVIA TSA Monthly Data.) Medexus expects that the adverse impact of generic competition is now largely reflected in product-level performance of Rupall, meaning that declines in net sales and product-level performance of Rupall for future fiscal quarters will be less severe. As a result of these dynamics, the Company has reduced operating expenses associated with the product since fiscal Q1 2026 and reallocated field support in fiscal Q3 2026.

Additional information

Medexus's financial statements and management's discussion and analysis for fiscal Q3 2026 are available on Medexus's corporate website at www.medexus.com and in the company's corporate filings on SEDAR+ at www.sedarplus.ca.

Conference call details

Medexus will host a conference call at 8:00 am Eastern Time on Thursday, February 12, 2026 to discuss Medexus's results for fiscal Q3 2026.

To participate in the call, please dial the following numbers:

• 877-545-0523 (toll-free) for Canadian and U.S. callers
  +1 973-528-0016 for international callers

• Access code: 138258

A live webcast of the call will be available on the Investors section of Medexus's corporate website or at the following link:

• https://www.webcaster5.com/Webcast/Page/2010/53553

A replay of the call will be available approximately one hour following the end of the call through Thursday, February 19, 2026. To access the replay, please dial the following numbers -

• 877-481-4010 for Canadian and U.S. callers
  +1 919-882-2331 for international callers

• Conference ID: 53553

A replay of the webcast will be available on the Investors section of Medexus's corporate website until Friday, February 12, 2027.

About Medexus

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology and hematology-oncology and rheumatology and allergy. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.

Preliminary estimates

The expected results discussed in this news release (which are distinct from the historical results included in Medexus's financial statements and discussed in this news release) are preliminary estimates only and have not been reviewed or audited by the Company's auditors. Expected results discussed in this news release include preliminary estimates of product-level net revenue generated from GRAFAPEX in fiscal Q4 2026. All such figures are based on information currently available to Medexus management and are subject to change and adjustment as Medexus's financial results for fiscal Q4 2026 are finalized. Accordingly, final reported results may differ, and may differ materially, from these preliminary estimates, and investors therefore should not place undue reliance on any such preliminary estimates. All such preliminary estimates constitute forward-looking information within the meaning of applicable securities laws, are based on a number of assumptions, and are subject to a number of risks and uncertainties. For more information, see "Forward-looking statements".

Forward-looking statements

Certain statements in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "budget", "potential", "targets", "could", "estimates", "expects", "forecasts", "goals", "intends", "may", "might", "objective", "outlook", "plans", "projects", "schedule", "should", "will", "would", "prospects", and "vision", or similar words, phrases, or expressions, are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, information contained in statements regarding any of the following: Medexus's business strategy, outlook, and other expectations and plans regarding financial or operational performance, including those specific to GRAFAPEX™ (treosulfan) for Injection (including patient demand for GRAFAPEX, and including the mix of pediatric and non-pediatric demand and any seasonality or other variability in such demand and any resulting impact of the foregoing on product-level performance of GRAFAPEX), in particular in light of investments in the recent commercial launch of GRAFAPEX; future growth, net revenues, and investments and expenses, including in respect of the commercialization of GRAFAPEX, IXINITY (including the manufacturing process improvement initiative, and including the occurrence or timing of any further investments in that initiative), and Medexus's other leading products, and including product-level performance in respect of same; the occurrence, attribution, and persistence of any increased demand for or other expected benefit to Rasuvo resulting from recent changes in the product's competitive landscape, including the withdrawal by a distributor of a product in the branded methotrexate autoinjector market; inventory levels and management of Medexus's single wholesaler for GRAFAPEX; patient demand for GRAFAPEX; and anticipated trends and challenges in Medexus's business and the markets in which it operates, including in respect of the Company's competitive position in and demographics of those markets, the Company's product pricing strategies, and product opportunities available to the Company, and, in particular, Medexus's ability to secure and fund commercialization rights to promising products and the performance of those products against expectations. The forward-looking statements and information included in this news release are based on Medexus's current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments. In particular, and without limiting the generality of the foregoing, Medexus's estimate of product-level net revenue from commercialization of GRAFAPEX is based on a number of such factors and assumptions as most recently described in Medexus's most recent management's discussion and analysis, and including the Company's planned commercial, market access, and medical strategies, the success of which will depend in part on the US regulatory landscape and related dynamics, including potential future changes to each, and can introduce and affect exposure to commercial, legal, and regulatory risk. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

Protected names and marks

This news release contains references to trademarks and other protected names and marks, including those belonging to other companies, persons, or entities. Solely for convenience, trademarks and other protected names and marks referred to in this news release may appear without the "®", "™", or other similar symbols. Each such reference should be read as though it appears with the relevant symbol. Any such references are not intended to indicate, in any way, that the holder or holders will not assert those rights to the fullest extent under applicable law.

Non-GAAP measures

Company management uses, and this news release refers to, financial measures that are not recognized under IFRS and do not have a standard meaning prescribed by generally accepted accounting principles (GAAP) in accordance with IFRS or other financial or accounting authorities (non-GAAP measures). These non-GAAP measures may include "non-GAAP financial measures", "non-GAAP ratios", and "supplementary financial measures" (each defined in National Instrument 52-112, Non-GAAP and Other Financial Measures Disclosure). Medexus's method for calculating these measures may differ from methods used by other companies and therefore these measures are unlikely to be comparable to similarly-designated measures used or presented by other companies.

In particular, management uses Adjusted EBITDA, Adjusted EBITDA Margin (Adjusted EBITDA divided by net revenue, expressed as a percentage), Adjusted Gross Profit (Loss) (gross profit (loss) before amortization of intangible assets), product-level Adjusted Gross Profit (Loss), Adjusted Gross Margin (Adjusted Gross Profit (Loss) divided by net revenue, expressed as a percentage), product-level Adjusted Gross Margin, Net Debt and Net Debt to Adjusted EBITDA (Net Debt as of a given date by Adjusted EBITDA for a given period ending on that same date, expressed as a multiple), and product-level net revenue as measures of Medexus's performance. EBITDA (earnings before interest, taxes, depreciation, and amortization), Adjusted EBITDA, Adjusted Gross Profit (Loss), product-level Adjusted Gross Profit (Loss), and Net Debt are non-GAAP financial measures; Adjusted EBITDA Margin, Adjusted Gross Margin, product-level Adjusted Gross Margin, and Net Debt to Adjusted EBITDA are non-GAAP ratios; and product-level net revenue and gross margin (gross profit (loss) divided by net revenue, expressed as a percentage) are supplementary financial measures.

An explanation and discussion of each of these non-GAAP measures, including their limitations, is set out under the heading "Preliminary Notes-Non-GAAP measures" in Medexus's most recent management's discussion and analysis, and is hereby incorporated by reference. A reconciliation of Adjusted EBITDA to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted EBITDA to Net Income (Loss)" below. A reconciliation of Adjusted Gross Margin and product-level Adjusted Gross Margin to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted Gross Profit (Loss) and Adjusted Gross Margin" below. A reconciliation of Net Debt to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Net Debt to current portion of long-term debt and long-term debt" below.

The following tables are derived from and should be read together with Medexus's consolidated financial statements for the corresponding fiscal periods. The supplementary disclosure is intended to more fully explain disclosures related to Adjusted EBITDA, Adjusted Gross Margin and product-level Adjusted Gross Margin, and Net Debt and Net Debt to Adjusted EBITDA, and provides additional information related to Medexus's operating performance. However, Medexus's non-GAAP measures have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of Medexus's financial information as reported under IFRS.

Reconciliation of Adjusted EBITDA to Net Income (Loss)

Reconciliation of Adjusted Gross Profit (Loss) and Adjusted Gross Margin

Company

GRAFAPEX

Reconciliation of Net Debt to current portion of long-term debt and long-term debt

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/283622

SOURCE Medexus Pharmaceuticals Inc.

To participate in the call, please dial the following numbers:

877-545-0523 (toll-free) for Canadian and U.S. callers
+1 973-528-0016 for international callers

Access code: 138258

A live webcast of the call will be available on the Investors section of Medexus's corporate website or at the following link:

https://www.webcaster5.com/Webcast/Page/2010/53553

A replay of the call will be available approximately one hour following the end of the call through Thursday, February 19, 2026. To access the replay, please dial the following numbers -

877-481-4010 for Canadian and U.S. callers
+1 919-882-2331 for international callers

Conference ID: 53553

A replay of the webcast will be available on the Investors section of Medexus's corporate website until Friday, February 12, 2027.

About Medexus

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology and hematology-oncology and rheumatology and allergy. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.

Forward-looking statements

Certain statements made in this news release contain forward-looking information within the meaning of applicable securities laws (forward-looking statements). The words "anticipates", "believes", "expects", "will", "plans", "potential", and similar words, phrases, or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions, and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/282535

SOURCE Medexus Pharmaceuticals Inc.

"We intend to carefully monitor the market price of the common shares," said Brendon Buschman, Medexus's Chief Financial Officer. "Purchases under this new NCIB could be an appropriate use of our available funds, where we believe the market price of the common shares may be undervalued. Any such purchases we make will benefit the company and its investors by seeking to uphold a liquid, stable, and orderly market for our common shares."

Purchases under the NCIB may commence on November 24, 2025 and continue through November 23, 2026 or such earlier date as Medexus completes the maximum aggregate purchases permitted under the NCIB. The NCIB will be conducted by means of open market transactions through the facilities of the TSX or alternative Canadian trading systems at the prevailing market price on the TSX or applicable alternative Canadian trading system at the time of purchase or as otherwise permitted. The NCIB will be funded using Medexus's general funds. Any common shares purchased by Medexus under the NCIB will be cancelled.

During the six months ended October 31, 2025, the average daily trading volume, or ADTV, of the common shares on the TSX was 40,066. Accordingly, under TSX rules and policies, purchases under the NCIB on any trading day will be limited to a maximum of 10,016 common shares, being 25% of the ADTV, other than any purchases made in accordance with the TSX's block purchase exception.

About Medexus

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology and hematology-oncology and rheumatology and allergy. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.

Forward-looking statements

Certain statements in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "budget", "potential", "targets", "could", "estimates", "expects", "forecasts", "goals", "intends", "may", "might", "objective", "outlook", "plans", "projects", "schedule", "should", "will", "would", "prospects", and "vision", or similar words, phrases, or expressions, are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, information contained in statements regarding potential future purchases of Medexus's common shares under the NCIB and Medexus's overall capital allocation strategy. The forward-looking statements and information included in this news release are based on Medexus's current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments, and including, but not limited to, Medexus's expectations with respect to cash flow generation and the availability of funds. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/275259

SOURCE Medexus Pharmaceuticals Inc.

"We are pleased to announce this long term, non-dilutive financing, which demonstrates our access to capital on competitive terms," commented Brendon Buschman, Chief Financial Officer of Medexus. "Medexus has demonstrated an improving financial and operating profile since the launch of GRAFAPEX™ (treosulfan) for Injection in February 2025, and we are pleased that our new partners at National Bank of Canada have recognized the strength and potential of our business, including as we look beyond the GRAFAPEX™ launch."

Medexus used the net proceeds of the new term loan facility to satisfy its obligations under Medexus's existing senior secured credit facilities which otherwise would have matured in March 2026. Borrowings under the new term loan facility bear interest at a rate of adjusted term SOFR (or other customary base rate, depending on the type of borrowing) plus a margin determined quarterly based on Medexus's consolidated net leverage ratio. The weighted average interest rate will initially be 6.74%. This rate compares favorably to Medexus's now-repaid term loan and revolving loan facilities, which had a weighted average interest rate of 6.95% as of the repayment date.

In furtherance of Medexus's capital allocation strategy, Medexus also intends to commence a normal course issuer bid, or NCIB, for its common shares, subject to the approval of the Toronto Stock Exchange (TSX). If approved by the TSX, Medexus would be permitted to purchase for cancellation, through facilities of the TSX or such other permitted means, up to 10% of the public float (calculated in accordance with TSX rules) of Medexus's issued and outstanding common shares during the 12 months following any such TSX acceptance at prevailing market prices or as otherwise permitted in accordance with TSX rules. The actual number of common shares, if any, that Medexus may elect to purchase under the NCIB, and the timing of any such purchases, will be determined by Medexus, subject to applicable terms and limitations of the NCIB, including any related automatic share purchase plan. There cannot be any assurance as to how many common shares, if any, Medexus will ultimately purchase under the NCIB.

"An NCIB adds an important lever to our capital allocation strategy," Mr Buschman said. "Purchases under this new NCIB, if approved by the TSX, could be an appropriate use of our available cash flow from operating activities, where we believe the market price of the common shares may be undervalued. Any such purchases we make will benefit the company and its investors by seeking to uphold a liquid, stable, and orderly market for our common shares."

About Medexus

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology and hematology-oncology and rheumatology and allergy. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.

Forward-looking statements

Certain statements in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "budget", "potential", "targets", "could", "estimates", "expects", "forecasts", "goals", "intends", "may", "might", "objective", "outlook", "plans", "projects", "schedule", "should", "will", "would", "prospects", and "vision", or similar words, phrases, or expressions, are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, information contained in statements regarding any of the following: Medexus's overall capital allocation strategy, including expectations regarding availability of funds from financing activities, funds from operations, cash flow generation, and capital allocation, and including expectations regarding the use of proceeds from the new credit facilities discussed in this news release and regarding product opportunities available to the Company, and, in particular, Medexus's ability to secure and fund commercialization rights to promising products and the performance of those products against expectations; the strength and potential of Medexus's business, including opportunities and expectations beyond the GRAFAPEX™ launch and Medexus's potential pursuit of additional product and pipeline opportunities in certain therapeutic areas and markets; the timing and expected outcome of the TSX review process for the NCIB as discussed in this news release; and potential future purchases of Medexus's common shares under the NCIB, including expectations regarding available cash flow from operating activities and otherwise regarding capital allocation. The forward-looking statements and information included in this news release are based on Medexus's current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/274735

SOURCE Medexus Pharmaceuticals Inc.

Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - November 12, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company's second fiscal quarter ended September 30, 2025 (the company's fiscal Q2 2026). All dollar amounts in this press release are in United States dollars unless specified otherwise.

Key business update

Medexus is currently focused on delivering strong performance from GRAFAPEX™ (treosulfan) for Injection. For the three- and six-month periods ended September 30, 2025, Medexus recognized product-level net revenue from GRAFAPEX of $3.1 million and $6.2 million, relative to $3.0 million and $6.0 million of GRAFAPEX personnel and infrastructure investments. Medexus also remains focused on delivering strong overall performance across the company's portfolio of products in both the United States and Canada.

"Product-level performance of GRAFAPEX to date has exceeded our expectations, with October 2025 representing the strongest month of patient demand we have seen since our February 2025 launch," commented Ken d'Entremont, Chief Executive Officer of Medexus. "The $6.0 million we have invested in the GRAFAPEX launch through September 30 is already having a significant impact. As of today, we have engaged with 83% of all 180 US transplant centers, 29% of US transplant centers have already ordered GRAFAPEX for procedures in their institutions, and 69% of those 52 institutions have reordered. We are confident that GRAFAPEX will be accretive to quarterly operating cash flows by calendar Q4 2025, which is our fiscal Q3 2026 — demonstrating that the infrastructure we have built will be a solid foundation supporting the product for years to come."

Financial highlights

Key financial highlights for fiscal Q2 2026 include the following:

• Net revenue of $24.7 million and $49.4 million for the three- and six-month periods ended September 30, 2025, a decrease of $1.6 million and $4.2 million, or 6.1% and 7.8%, compared to $26.3 million and $53.6 million for the corresponding prior year periods. The $1.6 million and $4.2 million year-over-year net revenue decrease was primarily due to reduced net sales of Rupall (due to significant generic competition, resulting in lower unit demand, and the effects of the resulting effective unit-level price reductions) and Gleolan in the United States (due to the March 2025 termination of the US Gleolan Agreement), partially offset by $3.1 million and $6.2 million of product-level net revenue from GRAFAPEX for the three- and six-month periods ended September 30, 2025 and the positive effects of a January 2025 change in Medicare Part D discounts for government-sponsored programs under the IRA that has, among other factors, benefited product-level net revenue for Rasuvo.

• Adjusted EBITDA* of $4.4 million and $7.8 million for the three- and six-month periods ended September 30, 2025. Fiscal Q2 2026 is the second consecutive fiscal quarter of Adjusted EBITDA* growth since the approval and launch of GRAFAPEX in fiscal Q4 2025. Adjusted EBITDA* for the three- and six-month periods ended September 30, 2025 represents a decrease of $1.6 million and $4.3 million, or 26.7% and 35.5%, compared to $6.0 million and $12.1 million for the corresponding prior year periods, which predate the approval and launch of GRAFAPEX. The $1.6 million and $4.3 million year-over-year Adjusted EBITDA* decrease was primarily due to significant GRAFAPEX personnel and infrastructure investments in fiscal year 2026 to date together with the effect of significant generic competition on Rupall, partially offset by a reduction of operating expenses associated with Rupall starting in fiscal Q1 2026.

• Operating income of $1.4 million and $2.2 million for the three- and six-month periods ended September 30, 2025. Fiscal Q2 2026 is the second consecutive fiscal quarter of operating income growth since the approval and launch of GRAFAPEX in fiscal Q4 2025. Operating income for the three- and six-month periods ended September 30, 2025 represents a decrease of $0.2 million and $3.4 million, or 12.5% and 60.7%, compared to $1.6 million and $5.6 million for the corresponding prior year periods.

• Gross margin of 55.7% and 55.8%, and Adjusted Gross Margin* of 65.2% and 65.4%, for the three- and six-month periods ended September 30, 2025, compared to gross margin of 53.7% and 54.0%, and Adjusted Gross Margin* of 59.5% and 59.4%, for the corresponding prior year periods, which predate the approval and launch of GRAFAPEX. The gross margin and Adjusted Gross Margin* increases are primarily due to changes in the relative contribution of product-level net revenue — in particular an increasing level of net sales of GRAFAPEX, which the Company launched in February 2025 and which is expected to have a relatively higher product-level gross margin and Adjusted Gross Margin*, and an absence of net sales of Gleolan in the United States, which the Company ceased commercializing in March 2025 and which had a relatively lower product-level gross margin and Adjusted Gross Margin*.

• Net loss of $0.3 million and net income of $0.2 million for the three- and six-month periods ended September 30, 2025, a decrease of $0.4 million and $1.9 million compared to net income of $0.1 million and $2.1 million for the corresponding prior year periods.

• Available liquidity of $9.4 million (September 30, 2025), consisting of cash and cash equivalents, compared to $24.0 million (March 31, 2025). The primary factor in this net decrease in cash was the Company's aggregate principal payments of $16.6 million under the BMO Credit Agreement since March 31, 2025, which reduced the Company's debt and cash balance by the same amount.

• Cash provided by operating activities of $3.3 million and $7.3 million for the three- and six-month periods ended September 30, 2025, a decrease of $3.6 million and $7.7 million compared to $6.9 million and $15.0 million for the corresponding prior year periods. The Company has continued to generate positive cash flow from operations in the three fiscal quarters since the approval and launch of GRAFAPEX in fiscal Q4 2025.

* Refer to "Non-GAAP measures" at the end of this press release for information about non-GAAP measures and related items, including Adjusted EBITDA and Adjusted Gross Margin.

"We continue to be very pleased with our ongoing launch of GRAFAPEX in the United States," commented Ken d'Entremont, Chief Executive Officer of Medexus. "We believe this sequential quarter-over-quarter momentum we have seen, with two consecutive fiscal quarters of growth in operating income and Adjusted EBITDA* since the approval and launch of GRAFAPEX in fiscal Q4 2025, will continue to build going forward."

Brendon Buschman, Chief Financial Officer of Medexus, added: "In addition to the successful progress on GRAFAPEX commercialization, we achieved $3.3 million of cash flow from operating activities for fiscal Q2 2026, and a healthy $4.4 million of Adjusted EBITDA* from $24.7 million of net revenue. We realized gross margin of 55.7% and Adjusted Gross Margin* of 65.2% for fiscal Q2 2026, compared to last year's 53.7% and 59.5%, respectively, demonstrating meaningful year-over-year improvement. We have continued to repay principal and interest under our term loan, substantially reducing total debt under our credit facilities by $16.6 million since March 31, 2025 — meaning that total long-term debt now sits at a combined $21.1 million as of September 30, 2025."

Mr Buschman concluded: "We have entered fiscal year 2026 with strong momentum and expect continued quarter-over-quarter performance as our commercialization efforts for GRAFAPEX advance. Overall, we continue to execute with discipline and focus as we position Medexus for the opportunities ahead."

Operational highlights

Leading products

Hematology and hemato-oncology

• GRAFAPEX (US): Medexus has seen a positive market response to GRAFAPEX since the US commercial launch of the product in February 2025. Based on internal estimates and research, and the preliminary market response to GRAFAPEX, Medexus continues to expect that annual product-level net revenue from GRAFAPEX will exceed US$100 million within five years after commercial launch, with the specific nature and level of success of Medexus's commercialization initiatives in support of GRAFAPEX, among other factors, determining the extent to which the Company realizes this potential.

In August 2025, the US Centers for Medicare & Medicaid Services (CMS) approved New Technology Add-On Payment (NTAP) reimbursement for eligible cases covered by Medicare involving the use of GRAFAPEX for CMS's fiscal year 2026, which runs from October 1, 2025 to September 30, 2026. The NTAP program is designed to provide temporary supplemental reimbursement to institutions that use designated new higher-cost medical technologies in the first few years after introduction to the market. To receive NTAP approval, designated technologies must demonstrate substantial clinical improvement in the diagnosis or treatment of Medicare beneficiaries compared to existing alternatives. Starting October 1, 2025, eligible procedures involving the use of GRAFAPEX are eligible for additional reimbursement through the NTAP program. Cases involving the use of GRAFAPEX that are eligible for NTAP will benefit from a maximum NTAP of $21,411 for CMS's fiscal year 2026. The GRAFAPEX approval was one of only five approvals for CMS's fiscal year 2026 under the new technology add-on payment traditional pathway, out of the 13 applications considered by CMS. The NTAP program is designed to make it easier for hospitals to adopt products such as GRAFAPEX and thereby improve Medicare patient access to cutting-edge care. Medexus believes that the NTAP program's objectives are being met in respect of GRAFAPEX, and the Company expects that NTAP eligibility for GRAFAPEX has and will contribute to adoption and utilization starting in fiscal Q3 2026. GRAFAPEX will be eligible to retain its NTAP approved status, and Medexus expects that GRAFAPEX will retain its status, for up to two additional CMS fiscal years.

Medexus achieved $3.1 and $6.2 million of product-level net revenue from GRAFAPEX for the three- and six-month periods ended September 30, 2025, relative to the $3.0 million and $6.0 million of GRAFAPEX personnel and infrastructure investments discussed below. For the same periods, underlying patient demand was $2.1 million and $4.3 million, respectively, resulting in an incremental $1.0 million benefit to product-level net revenue in fiscal Q2 2026 from end-of-quarter wholesaler purchases agreed by the Company. (Source: Internal EDI Data.) Since launch, wholesaler purchases of GRAFAPEX have exceeded demand by $2 million, resulting in an estimated 1.5 to 2 months of inventory on hand at September 30, 2025 held by the Company's single wholesaler for GRAFAPEX. This wholesaler inventory level is consistent with Medexus's expectations for a product launch; however, inventory management decisions by the wholesaler could affect the timing, volume, and commercial terms of wholesaler orders, and consequently product-level net revenue, in future quarters. Medexus continues to expect that product-level performance of GRAFAPEX, net of working capital changes, will be accretive to quarterly operating cash flows starting in fiscal Q3 2026 (calendar Q4 2025).

In July 2025, the current US administration announced a 15% tariff on imports of pharmaceutical products from the EU (July 2025 pharmaceutical tariffs). Based on the Company's preliminary assessment, which remains ongoing, the July 2025 pharmaceutical tariffs will apply to the Company's imports of GRAFAPEX at the announced rate of 15%, and are likely to be reflected in product-level performance commencing in fiscal year 2027. Medexus does not currently expect the impact of these tariffs on product-level performance to be material.

• Trecondyv (Canada): Patient unit demand for Trecondyv remained strong during the 12-month period ended September 30, 2025, which is reflected in the unit demand growth of 69% over the trailing 12-month period ended September 30, 2025. (Source: Hospitals Direct Sales Data, MAT September 2025.) This strong performance reflects successful execution of the Company's initiatives since its September 2021 commercial launch.

• IXINITY (US): Patient unit demand in the United States decreased by 3% over the trailing 12-month period ended September 30, 2025. (Source: customer-reported dispensing data.) Medexus expects that 12-month trailing unit demand will remain relatively stable, with only slight continuing decreases, in the near term, as the Company works to maintain a patient base who are stable and satisfied with the product. This performance reflects the success of the Company's efforts to maintain existing demand, despite a reduced allocation of sales force resources to IXINITY since January 2024. Medexus's investments in its IXINITY manufacturing process improvement initiative have generally had a positive impact on batch yield and manufacturing costs over fiscal years 2024 and 2025 and now continuing into fiscal year 2026. This initiative has resulted in a 30% decrease in product-level cost of sales of product, comparing fiscal Q2 2026 to fiscal Q1 2021 (being the first full fiscal quarter following acquisition of the product in February 2020). In fiscal Q3 2026, in an effort to further improve batch yield and manufacturing costs, Medexus entered into an agreement with the Company's third-party contract manufacturer of IXINITY for a $4.0 million manufacturing process upgrade (plus $2.0 million for a test batch of IXINITY that will, if successful, be saleable product), of which approximately $1.2 million is expected to be paid in fiscal year 2026.

Rheumatology and allergy

• Rasuvo (US): Patient unit demand for Rasuvo decreased by 2% over the trailing 12-month period ended September 30, 2025. (Source: IQVIA MAT September 2025.) Sustained competition in the US branded methotrexate autoinjector market, among other factors, has historically adversely affected total product-level net revenue. During fiscal Q2 2026, Medexus learned that another product in the branded methotrexate autoinjector market had been withdrawn by its distributor, which Medexus expects to result in increased unit demand for Rasuvo over time as inventory of the withdrawn product already in the market decreases and patients and healthcare professionals look for alternatives. Medexus continues to evaluate the potential effects of this development on future unit demand for Rasuvo. Based on the Company's preliminary assessment, which remains ongoing, the July 2025 pharmaceutical tariffs will apply to the Company's imports of Rasuvo at the announced rate of 15%. Medexus does not currently expect the impact of these tariffs on product-level performance to be material.

• Metoject (Canada): Patient unit demand for Metoject decreased by 9% over the trailing 12-month period ended September 30, 2025. (Source: IQVIA - TSA database.) Medexus attributes this decrease in unit demand, which has corresponded with an adverse impact on product-level net revenue, to the continued effects of generic competition, in particular the launch of a second generic product in March 2024. Medexus implemented additional unit-level pricing strategies in April 2024 that resulted in effective unit-level price reductions to defend the product's strong market position, which has contributed to the adverse impact on product-level net revenue.

• Rupall (Canada): Rupall's market exclusivity, granted by Health Canada, expired in January 2025 and Rupall now faces generic competition in Canada. As a result, patient unit demand over the three- and six-month periods ended September 30, 2025 has decreased 58% and 55% when compared to the corresponding prior year periods. (Source: IQVIA TSA units - MAT September 2025.) While the impact of generic erosion on product-level net revenue appears to have slowed relative to fiscal Q1 2026, generic competition will continue to have an adverse impact on product-level performance. For example, Medexus initiated unit-level pricing strategies that resulted in effective unit-level price reductions in fiscal Q4 2025, which are expected to continue through fiscal year 2026 and thereafter. As a result of these emerging dynamics, the Company has reduced operating expenses associated with the product since fiscal Q1 2026 and is re-allocating field support in fiscal Q3 2026, seeking to optimize the product's contribution.

Additional information

Medexus's financial statements and management's discussion and analysis for fiscal Q2 2026 are available on Medexus's corporate website at www.medexus.com and in the company's corporate filings on SEDAR+ at www.sedarplus.ca.

Conference call details

Medexus will host a conference call at 8:00 am Eastern Time on Thursday, November 13, 2025 to discuss Medexus's results for fiscal Q2 2026.

To participate in the call, please dial the following numbers:

877-545-0523 (toll-free) for Canadian and U.S. callers
+1 973-528-0016 for international callers

Access code: 988000

A live webcast of the call will be available on the Investors section of Medexus's corporate website or at the following link:

https://www.webcaster5.com/Webcast/Page/2010/53180

A replay of the call will be available approximately one hour following the end of the call through Thursday, November 20, 2025. To access the replay, please dial the following numbers —

877-481-4010 for Canadian and U.S. callers
+1 919-882-2331 for international callers

Conference ID: 53180

A replay of the webcast will be available on the Investors section of Medexus's corporate website until Friday, November 13, 2026.

About Medexus

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology and hematology-oncology and rheumatology and allergy. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.

Preliminary estimates

The expected results discussed in this news release (which are distinct from the historical results included in Medexus's financial statements and discussed in this news release) are preliminary estimates only and have not been reviewed or audited by the Company's auditors. Expected results discussed in this news release include preliminary estimates of product-level net revenue generated from GRAFAPEX in fiscal Q3 2026. All such figures are based on information currently available to Medexus management and are subject to change and adjustment as Medexus's financial results for fiscal Q3 2026 are finalized. Accordingly, final reported results may differ, and may differ materially, from these preliminary estimates, and investors therefore should not place undue reliance on any such preliminary estimates. All such preliminary estimates constitute forward-looking information within the meaning of applicable securities laws, are based on a number of assumptions, and are subject to a number of risks and uncertainties. For more information, see "Forward-looking statements".

Forward-looking statements

Certain statements in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "budget", "potential", "targets", "could", "estimates", "expects", "forecasts", "goals", "intends", "may", "might", "objective", "outlook", "plans", "projects", "schedule", "should", "will", "would", "prospects", and "vision", or similar words, phrases, or expressions, are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, information contained in statements regarding any of the following: Medexus's business strategy, outlook, and other expectations and plans regarding financial or operational performance, including those specific to GRAFAPEX™ (treosulfan) for Injection (including patient demand for GRAFAPEX), in particular in light of investments in the recent commercial launch of GRAFAPEX; future growth, revenues, and investments and expenses, including in respect of the commercialization of GRAFAPEX, IXINITY (including the manufacturing process improvement initiative, and including the occurrence or timing of any further investments in that initiative), and Medexus's other leading products, and including product-level performance in respect of same, and including, among others, the potential impact of the July 2025 tariff on imports of pharmaceutical products from the EU announced by the current US administration; the impact of eligibility of GRAFAPEX under the NTAP program on product-level performance; reimbursement eligibility and status of GRAFAPEX under the NTAP program after September 30, 2026; the occurrence and persistence of any increased demand for or other expected benefit to Rasuvo resulting from recent changes in the product's competitive landscape, including the withdrawal by a distributor of a product in the branded methotrexate autoinjector market; inventory levels and management of Medexus's single wholesaler for GRAFAPEX; patient demand for GRAFAPEX; and anticipated trends and challenges in Medexus's business and the markets in which it operates, including in respect of the Company's competitive position in and demographics of those markets, the Company's product pricing strategies, and product opportunities available to the Company, and, in particular, Medexus's ability to secure and fund commercialization rights to promising products and the performance of those products against expectations. The forward-looking statements and information included in this news release are based on Medexus's current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments. In particular, and without limiting the generality of the foregoing, Medexus's estimate of product-level net revenue from commercialization of GRAFAPEX is based on a number of such factors and assumptions as most recently described in Medexus's most recent management's discussion and analysis, and including the Company's planned commercial, market access, and medical strategies, the success of which will depend in part on the US regulatory landscape and related dynamics, including potential future changes to each, and can introduce and affect exposure to commercial, legal, and regulatory risk. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

Protected names and marks

This news release contains references to trademarks and other protected names and marks, including those belonging to other companies, persons, or entities. Solely for convenience, trademarks and other protected names and marks referred to in this news release may appear without the "®", "™", or other similar symbols. Each such reference should be read as though it appears with the relevant symbol. Any such references are not intended to indicate, in any way, that the holder or holders will not assert those rights to the fullest extent under applicable law.

Non-GAAP measures

Company management uses, and this news release refers to, financial measures that are not recognized under IFRS and do not have a standard meaning prescribed by generally accepted accounting principles (GAAP) in accordance with IFRS or other financial or accounting authorities (non-GAAP measures). These non-GAAP measures may include "non-GAAP financial measures", "non-GAAP ratios", and "supplementary financial measures" (each defined in National Instrument 52-112, Non-GAAP and Other Financial Measures Disclosure). Medexus's method for calculating these measures may differ from methods used by other companies and therefore these measures are unlikely to be comparable to similarly-designated measures used or presented by other companies.

In particular, management uses Adjusted EBITDA, Adjusted EBITDA Margin (Adjusted EBITDA divided by net revenue, expressed as a percentage), Adjusted Gross Profit (Loss) (gross profit (loss) before amortization of intangible assets), product-level Adjusted Gross Profit (Loss), Adjusted Gross Margin (Adjusted Gross Profit (Loss) divided by net revenue, expressed as a percentage), product-level Adjusted Gross Margin, and product-level net revenue as measures of Medexus's performance. EBITDA (earnings before interest, taxes, depreciation, and amortization), Adjusted EBITDA, Adjusted Gross Profit (Loss), and product-level Adjusted Gross Profit (Loss) are non-GAAP financial measures; Adjusted EBITDA Margin, Adjusted Gross Margin, and product-level Adjusted Gross Margin are non-GAAP ratios; and product-level net revenue and gross margin (gross profit (loss) divided by net revenue, expressed as a percentage) are supplementary financial measures.

An explanation and discussion of each of these non-GAAP measures, including their limitations, is set out under the heading "Preliminary Notes—Non-GAAP measures" in Medexus's most recent management's discussion and analysis, and is hereby incorporated by reference. A reconciliation of Adjusted EBITDA to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted EBITDA to Net Income (Loss)" below. A reconciliation of Adjusted Gross Margin and product-level Adjusted Gross Margin to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted Gross Profit (Loss) and Adjusted Gross Margin" below.

The following tables are derived from and should be read together with Medexus's consolidated financial statements for the three- and six-month periods ended September 30, 2025. The supplementary disclosure is intended to more fully explain disclosures related to Adjusted EBITDA, Adjusted Gross Margin, and product-level Adjusted Gross Margin, and provides additional information related to Medexus's operating performance. However, Medexus's non-GAAP measures have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of Medexus's financial information as reported under IFRS.

Reconciliation of Adjusted EBITDA to Net Income (Loss)

Reconciliation of Adjusted Gross Profit (Loss) and Adjusted Gross Margin

Company

GRAFAPEX

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/274259

SOURCE Medexus Pharmaceuticals Inc.

To participate in the call, please dial the following numbers:

877-545-0523 (toll-free) for Canadian and U.S. callers
+1 973-528-0016 for international callers

Access code: 988000

A live webcast of the call will be available on the Investors section of Medexus's corporate website or at the following link:

https://www.webcaster5.com/Webcast/Page/2010/53180

A replay of the call will be available approximately one hour following the end of the call through Thursday, November 20, 2025. To access the replay, please dial the following numbers -

877-481-4010 for Canadian and U.S. callers
+1 919-882-2331 for international callers

Conference ID: 53180

A replay of the webcast will be available on the Investors section of Medexus's corporate website until Friday, November 13, 2026.

About Medexus

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology and hematology-oncology and rheumatology, allergy, and dermatology. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.

Forward-looking statements

Certain statements made in this news release contain forward-looking information within the meaning of applicable securities laws (forward-looking statements). The words "anticipates", "believes", "expects", "will", "plans", "potential", and similar words, phrases, or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions, and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/273015

SOURCE Medexus Pharmaceuticals Inc.

Detailed voting results for the election of directors are set out in the table below.

Shareholders also cast 14,240,037 (99.508%) votes for and withheld 70,444 (0.492%) votes from the appointment of PricewaterhouseCoopers LLP as the company's auditors. All proposals were therefore approved.

A report of the voting results on all matters voted on at the annual meeting will be filed with Canadian securities regulatory authorities at www.sedarplus.ca.

About Medexus

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology and hematology-oncology and allergy, dermatology, and rheumatology. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.

Forward-looking statements

Certain statements made in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "expects", "will", "plans", "potential", and similar words, phrases, or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/268018

SOURCE Medexus Pharmaceuticals Inc.

$3.0 million of product-level net revenue from GRAFAPEX in fiscal Q1 2026, relative to $3.0 million of personnel and infrastructure investments, further supporting Medexus's confidence in the product's potential

Management to host conference call at 8:00 AM Eastern time on Wednesday, August 13, 2025

Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - August 12, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company's first fiscal quarter ended June 30, 2025 (the company's fiscal Q1 2026). All dollar amounts in this press release are in United States dollars unless specified otherwise.

Key business update

Medexus is currently focused on delivering strong performance from GRAFAPEX. March 2025 was the first full month, and fiscal Q1 2026 was the first full fiscal quarter, in which Medexus recognized product-level net revenue from GRAFAPEX, which totaled $3.0 million for fiscal Q1 2026, relative to $3.0 million of GRAFAPEX personnel and infrastructure investments. Medexus also remains focused on delivering strong overall performance across the company's portfolio of products in both the United States and Canada.

Medexus has seen a positive market response to GRAFAPEX to date, with progress consistent with Company expectations:

• As of June 30, 2025, nine large commercial payers, together covering an estimated 48 million patient lives, and 14 individual healthcare institutions, representing 8% of the 180 transplant centers in the United States, have made positive formulary inclusion determinations, a promising indicator of the product's commercial potential. An additional 29 commercial payers have added GRAFAPEX on their "prior authorization" lists.

• Wholesaler data as of June 30, 2025 shows that 36 of the 180 transplant centers, representing an estimated 24% of total allo-HSCT procedures performed in the United States annually (Source: Allogeneic HSCT in HRSA 2016-2020; Health Resources and Services Administration), have already ordered GRAFAPEX for procedures in their institutions.

• Medexus expects that product-level net revenue from GRAFAPEX in fiscal Q2 2026 will be $3.0 million to $3.5 million, taking into account the wholesaler purchasing patterns observed to date and expected seasonality attributable to a lower frequency of procedures scheduled during summer months. Based on product-level performance to date, Medexus expects that GRAFAPEX will be accretive to quarterly operating cash flows by fiscal Q3 2026 (calendar Q4 2025).

• Medexus also continues to expect that the annual product-level Adjusted Gross Margin* of GRAFAPEX will ultimately be approximately 80%, although, as demonstrated by product-level Adjusted Gross Margin* for fiscal Q1 2026, product level Adjusted Gross Margin* will be slightly higher in the initial months or quarters after commercial launch primarily due to the evolving reimbursement and tariff dynamics for the product (including as discussed below).

"The strong initial performance of GRAFAPEX™ is particularly important as other products in our portfolio shift to the later stages of their product life cycle," commented Ken d'Entremont, Chief Executive Officer of Medexus. "For instance, Rupall's revenues have experienced erosion after the loss of its exclusivity period in January 2025. Over time, we expect product-level performance of GRAFAPEX™ to significantly outweigh the relatively smaller impact of this decline in Rupall product-level performance in this transitional period. We design this portfolio approach to stay agile, resilient, and ultimately successful over the long term."

Medexus views product performance to date, and the response from the market and the attention to treosulfan from the medical and scientific community, as consistent with the Company's confidence that GRAFAPEX will make a substantial contribution to allo-HSCT in the United States, and also solidify Medexus's leadership position in this therapeutic field.

Financial highlights

Key financial highlights for fiscal Q1 2026 include the following:

• Net revenue of $24.6 million, a decrease of $2.7 million, or 9.9%, compared to $27.3 million for fiscal Q1 2025. The $2.7 million year-over-year net revenue decrease was primarily due to reduced net sales of Rupall (due to significant generic competition, resulting in lower unit demand, and the effects of the resulting effective unit-level price reductions) and Gleolan in the United States (due to the March 2025 termination of the US Gleolan Agreement), partially offset by $3.0 million of product-level net revenue from GRAFAPEX in fiscal Q1 2026.

• Adjusted EBITDA* of $3.4 million, a decrease of $2.7 million, or 44.3%, compared to $6.1 million for fiscal Q1 2025. The $2.7 million year-over-year Adjusted EBITDA* decrease was primarily due to the effect of significant generic competition on Rupall.

• Operating income of $0.9 million, a decrease of $3.1 million, or 77.5%, compared to $4.0 million for fiscal Q1 2025.

• Net income of $0.5 million, a decrease of $1.5 million compared to net income of $2.0 million for fiscal Q1 2025.

• Available liquidity of $9.3 million (June 30, 2025), consisting of cash and cash equivalents, compared to $24.0 million (March 31, 2025). The primary factor in this net decrease in cash was a payment of $15.5 million that Medexus made in June 2025 under the terms of a June 2025 amendment to the Company's credit agreement.

• Cash provided by operating activities of $3.9 million, a decrease of $4.3 million compared to $8.2 million for fiscal Q1 2025.

* Refer to "Non-GAAP measures" at the end of this press release for information about non-GAAP measures and related items, including Adjusted EBITDA and Adjusted Gross Margin.

"We are very pleased with the successful launch of GRAFAPEX™ in the United States," commented Ken d'Entremont, Chief Executive Officer of Medexus. "We believe this sequential quarter-over-quarter momentum we have seen will continue to build as GRAFAPEX™ is added to the formularies of additional key institutions and insurers, expanding patient access and driving further adoption. The positive initial response we have seen to date, including full results from the first full fiscal quarter of GRAFAPEX™ commercial availability, supports our expectation that GRAFAPEX™ will be accretive to quarterly operating cash flows by calendar Q4 2025, which is our fiscal Q3 2026."

Brendon Buschman, Chief Financial Officer of Medexus, added: "In addition to the successful progress on GRAFAPEX™ commercialization, we achieved $0.5 million of positive net income for fiscal Q1 2026, and a healthy $3.4 million of Adjusted EBITDA* from $24.6 million of net revenue. We realized gross margin of 56.0% and Adjusted Gross Margin* of 65.5% for fiscal Q1 2026, compared to last year's 54.4% and 59.3%, respectively, demonstrating meaningful year-over-year improvement relative to steady gross profits of $13.8 million and $14.8 million and Adjusted Gross Profits* of $16.1 million and 16.2 million, respectively. These strong results provided $3.9 million in cash flow from operating activities, which we have used in part to continue to repay principal and interest under our term loan, substantially reducing total debt under our credit facilities by $15.5 million in fiscal Q1 2026 - meaning that total debt now sits at a combined $22.0 million as of June 30, 2025, with remaining scheduled principal payments of $1.1 million in each of September and December 2025."

Mr Buschman concluded: "We have entered fiscal year 2026 with strong momentum and expect continued quarter-over-quarter performance as our commercialization efforts for GRAFAPEX™ advance. Overall, we continue to execute with discipline and focus as we position Medexus for the opportunities ahead."

Operational highlights

Leading products

Hematology and hemato-oncology

• GRAFAPEX (US): Medexus has seen a positive market response to GRAFAPEX since the US commercial launch of the product in February 2025. Based on internal estimates and research, and the preliminary market response to GRAFAPEX, Medexus continues to expect that annual product-level net revenue from GRAFAPEX will exceed US$100 million within five years after commercial launch, with the specific nature and level of success of Medexus's commercialization initiatives in support of GRAFAPEX, among other factors, determining the extent to which the Company realizes this potential.
  
  In August 2025, the US Centers for Medicare & Medicaid Services (CMS) approved New Technology Add-On Payment (NTAP) reimbursement for eligible cases involving the use of GRAFAPEX for CMS's fiscal year 2026, which runs from October 1, 2025 to September 30, 2026. The NTAP program is designed to provide temporary supplemental reimbursement to institutions that use designated new higher-cost medical technologies in the first few years after introduction to the market. To receive NTAP approval, designated technologies must demonstrate substantial clinical improvement in the diagnosis or treatment of Medicare beneficiaries compared to existing alternatives. Starting October 1, 2025, eligible procedures involving the use of GRAFAPEX™ will be eligible for additional reimbursement through the NTAP program. Cases involving the use of GRAFAPEX™ that are eligible for NTAP will be identified by ICD-10-PCS codes XW03388 or XW04388 and will benefit from a maximum NTAP of $21,411 for CMS's fiscal year 2026. The GRAFAPEX™ approval was one of only five approvals for CMS's fiscal year 2026 under the new technology add-on payment traditional pathway, out of the 13 applications considered by CMS.
  
  Medexus achieved $3.0 million of product-level net revenue from GRAFAPEX in fiscal Q1 2026, including a $1.0 million benefit from end-of-quarter wholesaler purchases in anticipation of future hospital demand, relative to the $3.0 million of GRAFAPEX personnel and infrastructure investments discussed below. Medexus expects that product-level net revenue from GRAFAPEX in fiscal Q2 2026 will be $3.0 million to $3.5 million, taking into account the wholesaler purchasing patterns observed to date and expected seasonality attributable to a lower frequency of procedures scheduled during summer months. Based on product-level performance to date, Medexus expects that GRAFAPEX will be accretive to quarterly operating cash flows by fiscal Q3 2026 (calendar Q4 2025).
  
  In July 2025, the current US administration announced a 15% tariff on imports of pharmaceutical products from the EU (July 2025 pharmaceutical tariffs). Based on the Company's preliminary assessment, which remains ongoing, the July 2025 pharmaceutical tariffs will apply to the Company's imports of GRAFAPEX at the announced rate of 15%. Medexus does not currently expect the impact of these tariffs on product-level performance to be material.

• Trecondyv (Canada): Unit demand for Trecondyv remained strong during the 12-month period ended June 30, 2025, which is reflected in the unit demand growth of 38% over the trailing 12-month period ended June 30, 2025. (Source: Hospitals Direct Sales Data, MAT June 2025.) This strong performance reflects successful execution of the Company's initiatives since its September 2021 commercial launch, but does not yet include the full effect of the successful November 2024 completion of the negotiation process with the pan-Canadian Pharmaceutical Alliance seeking to make Trecondyv accessible to publicly funded drug programs and patients in Canada and any subsequent decisions by participating government organizations on public reimbursement of Trecondyv for their regions and jurisdictions. For example, Medexus completed listing agreements for public reimbursement of Trecondyv with the provincial governments of Ontario and British Columbia in fiscal Q4 2025 and with the provincial governments of Quebec and Manitoba in fiscal Q1 2026. Medexus sees these developments in the Canadian market as important indicators of the product's prospects and potential in both the Canadian and US markets.

• IXINITY (US): Unit demand in the United States decreased by 1% over the trailing 12-month period ended June 30, 2025. (Source: customer-reported dispensing data.) Medexus expects that 12-month trailing unit demand will remain relatively stable, with only slight continuing decreases, in the near term. See also "Selected Financial Information-Note regarding period-to-period variations" and "Discussion of Operations-Net revenue". This performance reflects the success of the Company's efforts to maintain existing demand, despite a reduced allocation of sales force resources to IXINITY since January 2024. Medexus's investments in its IXINITY manufacturing process improvement initiative have generally had a positive impact on batch yield and manufacturing costs over fiscal years 2024 and 2025 and now continuing into fiscal year 2026.

Allergy, dermatology, and rheumatology

• Rupall (Canada): Rupall's market exclusivity, granted by Health Canada, expired in January 2025 and Rupall now faces generic competition in Canada. As a result, unit demand over the six-month period ended June 30, 2025 has decreased 29% when compared to the corresponding prior year period. (Source: IQVIA TSA units - MAT June 2025.) Generic competition will continue to have an adverse impact on net sales of Rupall. Medexus initiated unit-level pricing strategies that resulted in effective unit-level price reductions in fiscal Q4 2025, which are expected to continue through fiscal year 2026 and thereafter.

• Rasuvo (US): Unit demand for Rasuvo decreased by 5% over the trailing 12-month period ended June 30, 2025. (Source: IQVIA MAT June 2025.) Sustained competition in the US branded methotrexate autoinjector market, among other factors, have and will continue to adversely affect total product-level net revenue. See also "Selected Financial Information-Note regarding period-to-period variations" and "Discussion of Operations-Net revenue". Based on the Company's preliminary assessment, which remains ongoing, the July 2025 pharmaceutical tariffs will apply to the Company's imports of Rasuvo at the announced rate of 15%. Medexus does not currently expect the impact of these tariffs on product-level performance to be material.

• Metoject (Canada): Unit demand for Metoject decreased by 5% over the trailing 12-month period ended June 30, 2025. (Source: IQVIA - TSA database.) Medexus attributes this decrease in unit demand, which has corresponded with an adverse impact on product-level net revenue, to the continued effects of generic competition, in particular the launch of a second generic product in March 2024. Medexus implemented additional unit-level pricing strategies in April 2024 that resulted in effective unit-level price reductions to defend the product's strong market position, which has contributed to the adverse impact on product-level net revenue.

Additional information

Medexus's financial statements and management's discussion and analysis for fiscal Q1 2026 are available on Medexus's corporate website at www.medexus.com and in the company's corporate filings on SEDAR+ at www.sedarplus.ca.

Conference call details

Medexus will host a conference call at 8:00 am Eastern Time on Wednesday, August 13, 2025 to discuss Medexus's results for fiscal Q1 2026.

To participate in the call, please dial the following numbers:

888-506-0062 (toll-free) for Canadian and U.S. callers
+1 973-528-0011 for international callers

Access code: 284388

A live webcast of the call will be available on the Investors section of Medexus's corporate website or at the following link:

https://www.webcaster4.com/Webcast/Page/2010/52801

A replay of the call will be available approximately one hour following the end of the call through Wednesday, August 20, 2025. To access the replay, please dial the following numbers -

877-481-4010 for Canadian and U.S. callers
+1 919-882-2331 for international callers

Conference ID: 52801

A replay of the webcast will be available on the Investors section of Medexus's corporate website until Thursday, August 13, 2026.

About Medexus

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology-oncology and allergy, dermatology, and rheumatology. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.

Preliminary estimates

The expected results discussed in this news release (which are distinct from the historical results included in Medexus's financial statements and discussed in this news release) are preliminary estimates only and have not been reviewed or audited by the Company's auditors. Expected results discussed in this news release include preliminary estimates of product-level net revenue generated from GRAFAPEX in fiscal Q2 2026. All such figures are based on information currently available to Medexus management and are subject to change and adjustment as Medexus's financial results for fiscal Q2 2026 are finalized. Accordingly, final reported results may differ, and may differ materially, from these preliminary estimates, and investors therefore should not place undue reliance on any such preliminary estimates. All such preliminary estimates constitute forward-looking information within the meaning of applicable securities laws, are based on a number of assumptions, and are subject to a number of risks and uncertainties. For more information, see "Forward-looking statements".

Forward-looking statements

Certain statements in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "budget", "potential", "targets", "could", "estimates", "expects", "forecasts", "goals", "intends", "may", "might", "objective", "outlook", "plans", "projects", "schedule", "should", "will", "would", "prospects", and "vision", or similar words, phrases, or expressions, are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, information contained in statements regarding any of the following: Medexus's business strategy, outlook, and other expectations and plans regarding financial or operational performance, including those specific to GRAFAPEX™ (treosulfan) for Injection, in particular in light of investments in the recent commercial launch of GRAFAPEX; future growth, revenues, and expenses, including in respect of the commercialization of GRAFAPEX and Medexus's other leading products, and including product-level performance in respect of same, and including, among others, the potential impact of the July 2025 tariff on imports of pharmaceutical products from the EU announced by the current US administration; the expected benefit to Trecondyv® (treosulfan for injection) of the listing agreements for public reimbursement with provincial health services, including in respect of product-level net revenue, and anticipated effects of Medexus's unit-level pricing strategies. The forward-looking statements and information included in this news release are based on Medexus's current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments. In particular, and without limiting the generality of the foregoing, Medexus's estimate of product-level net revenue from commercialization of GRAFAPEX is based on a number of such factors and assumptions as most recently described in Medexus's most recent management's discussion and analysis, and including the Company's planned commercial, market access, and medical strategies, the success of which will depend in part on the US regulatory landscape and related dynamics, including potential future changes to each, and can introduce and affect exposure to commercial, legal, and regulatory risk. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

Protected names and marks

This news release contains references to trademarks and other protected names and marks, including those belonging to other companies, persons, or entities. Solely for convenience, trademarks and other protected names and marks referred to in this news release may appear without the "®", "™", or other similar symbols. Each such reference should be read as though it appears with the relevant symbol. Any such references are not intended to indicate, in any way, that the holder or holders will not assert those rights to the fullest extent under applicable law.

Non-GAAP measures

Company management uses, and this news release refers to, financial measures that are not recognized under IFRS and do not have a standard meaning prescribed by generally accepted accounting principles (GAAP) in accordance with IFRS or other financial or accounting authorities (non-GAAP measures). These non-GAAP measures may include "non-GAAP financial measures", "non-GAAP ratios", and "supplementary financial measures" (each defined in National Instrument 52-112, Non-GAAP and Other Financial Measures Disclosure). Medexus's method for calculating these measures may differ from methods used by other companies and therefore these measures are unlikely to be comparable to similarly-designated measures used or presented by other companies.

In particular, management uses Adjusted EBITDA, Adjusted EBITDA Margin (Adjusted EBITDA divided by net revenue, expressed as a percentage), Adjusted Gross Profit (Loss) (gross profit (loss) before amortization of intangible assets), product-level Adjusted Gross Profit (Loss), Adjusted Gross Margin (Adjusted Gross Profit (Loss) divided by net revenue, expressed as a percentage), product-level Adjusted Gross Margin, and product-level net revenue as measures of Medexus's performance. EBITDA (earnings before interest, taxes, depreciation, and amortization), Adjusted EBITDA, Adjusted Gross Profit (Loss), and product-level Adjusted Gross Profit (Loss) are non-GAAP financial measures; Adjusted EBITDA Margin, Adjusted Gross Margin, and product-level Adjusted Gross Margin are non-GAAP ratios; and product-level net revenue and gross margin (gross profit (loss) divided by net revenue, expressed as a percentage) are supplementary financial measures.

An explanation and discussion of each of these non-GAAP measures, including their limitations, is set out under the heading "Preliminary Notes-Non-GAAP measures" in Medexus's most recent management's discussion and analysis, and is hereby incorporated by reference. A reconciliation of Adjusted EBITDA to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted EBITDA to Net Income (Loss)" below. A reconciliation of Adjusted Gross Margin and product-level Adjusted Gross Margin to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted Gross Profit (Loss) and Adjusted Gross Margin" below.

The following tables are derived from and should be read together with Medexus's consolidated financial statements for the three-month period ended June 30, 2025. The supplementary disclosure is intended to more fully explain disclosures related to Adjusted EBITDA, Adjusted Gross Margin, and product-level Adjusted Gross Margin, and provides additional information related to Medexus's operating performance. However, Medexus's non-GAAP measures have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of Medexus's financial information as reported under IFRS.

Reconciliation of Adjusted EBITDA to Net Income (Loss)

Reconciliation of Adjusted Gross Profit (Loss) and Adjusted Gross Margin
Company

GRAFAPEX

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/262276

SOURCE Medexus Pharmaceuticals Inc.

To participate in the call, please dial the following numbers:

• 888-506-0062 (toll-free) for Canadian and U.S. callers
  +1 973-528-0011 for international callers

• Access code: 284388

A live webcast of the call will be available on the Investors section of Medexus's corporate website or at the following link:

• https://www.webcaster4.com/Webcast/Page/2010/52801

A replay of the call will be available approximately one hour following the end of the call through Wednesday, August 20, 2025. To access the replay, please dial the following numbers —

• 877-481-4010 for Canadian and U.S. callers
  +1 919-882-2331 for international callers

• Conference ID: 52801

A replay of the webcast will be available on the Investors section of Medexus's corporate website until Thursday, August 13, 2026.

Company management will be available to discuss the company's commercialization activities at Cannacord Genuity's 45^th Annual Growth Conference in Boston from August 12 to 14, 2025 and the LD Micro Main Event in San Diego from October 19 to 21, 2025. Details regarding Medexus's participation will be available on the Investors-News & Events section of Medexus's corporate website.

About Medexus

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology and hematology-oncology and allergy, dermatology, and rheumatology. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.

Forward-looking statements

Certain statements made in this news release contain forward-looking information within the meaning of applicable securities laws (forward-looking statements). The words "anticipates", "believes", "expects", "will", "plans", "potential", and similar words, phrases, or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions, and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/261244

SOURCE Medexus Pharmaceuticals Inc.