On March 19, 2026 Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a pan-American (ex-US) specialty pharmaceutical company, reported financial results for its fourth quarter and year ended December 31, 2025. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

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2025 Highlights

Financial results

Revenues were $450,088, an increase of $78,784 or 21% over the prior year. The increase was primarily driven by the incremental revenues from the Paladin and Sumitomo Transactions and the growth of our key promoted products, partly offset by declines in our mature and branded generic products, the termination of a non-strategic agreement in Colombia and the impact of hyperinflation2.
Gross margin was 44% of revenues compared to 47% in prior year. The decrease was due to the impact of hyperinflation2 and the fair value adjustment on the inventory acquired in the Paladin transaction.
Operating loss was $2,350 compared to an operating income of $7,397 in prior year.
Net loss was $5,374, compared to a net income of $4,332 in prior year.
Loss per share was $0.05, compared to an earnings per share of $0.04 in prior year.
Cash inflow from operations was $68,957, an increase of $32,677 or 90% over prior year.
Non-GAAP measures

Adjusted Revenues1 were $452,351, an increase of $86,939 or 24% or an increase of $87,855 or 24% on a constant currency1 basis, primarily driven by the incremental revenues from the Paladin and Sumitomo Transactions and the growth of our key promoted products, partly offset by declines in our mature and branded generic products and the termination of a non-strategic agreement in Colombia.
Excluding the Paladin and Sumitomo acquisitions, the key promoted portfolio delivered a growth of 12% on a constant currency1 basis and a three-year CAGR exceeding 20%.
The growth products3 acquired in the Paladin and Sumitomo transactions grew by 68% in the second half compared to the first half of 2025, according to IQVIA Canada.
Adjusted Gross margin1 was 48% of Adjusted Revenues1 compared to 47% in prior year. The increase was mainly due to the contribution from the Paladin and Sumitomo portfolios as well as the growth of our key promoted products.
Adjusted EBITDA1 was $73,056, an increase of $15,273 or 26% over prior year.
Adjusted EBITDA per share1 was $0.74, an increase of $0.16 or 28% over prior year.
Corporate developments

Launched a NCIB in August 2025 to purchase up to 3,000,000 common shares of the Company over the next 12 months. In 2025, 1,130,600 common shares were purchased at an average price of $5.69 for aggregate cash consideration of $6,431.
Closed a secured syndicated revolving credit facility with four lenders for US$100 million with an accordion feature for an additional US$100 million.
Closed a working capital line of credit agreement with Citibank, N.A.
Settled the Synergy loan agreement and collected $13,758 [US$10,000] in cash and received warrants with a fair value of $1,116 [US$811].
Collected a strategic loan receivable with a life sciences company for $3,840 [US$2,771].
Products

Added profitable and growth assets and expanded our portfolio with over fifty products including eight pipeline and early launch stage assets.
Executed an asset purchase agreement with Paladin Pharma Inc., to acquire the Paladin business. Knight paid $90,002, an additional $23,008 for inventory and expects to pay $8,457 for the final and full settlement of the holdback from the purchase price. Furthermore, Knight may have to pay up to an additional US$15,000 upon achieving certain sales milestones.
Entered into exclusive license and supply agreements with Sumitomo to commercialize Myfembree (relugolix/estradiol/norethindrone acetate), Orgovyx (relugolix), Gemtesa (vibegron), and an asset purchase agreement to acquire certain mature products in Canada for $25,400. Knight may pay up to an additional $15,750 if certain sales milestones are met.
Expanded existing partnership with Helsinn and in-licensed Onicit IV (palonosetron) for Mexico, Brazil, and select LATAM countries.
Expanded existing partnership with Incyte and amended the Supply and Distribution Agreement to add the exclusive rights to distribute Zynyz (retifanlimab) and Niktimvo (axatilimab) in Latin America.
In-licensed one branded generic product for Brazil.
Submitted multiple products for regulatory approval across our territories:
Tavalisse (fostamatinib) in Argentina.
Crexont (carbidopa and levodopa) in Canada, Mexico, Chile, Argentina and Peru.
Supplemental indication of Minjuvi (tafasitamab) for follicular lymphoma (FL) in Brazil.
Obtained regulatory approval for multiple products across our territories:
Wynzora (calcipotriene and betamethasone dipropionate) in Canada.
Pemazyre (pemigatinib) in Argentina and Mexico.
Minjuvi (tafasitamab) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in Argentina.
Received Notice of Non-Compliance from Health Canada requesting additional information for its New Drug Submission for Qelbree (viloxazine) and expect to submit the response in 2026.
Received rejection from ANVISA regarding the marketing authorization application for Tavalisse in Brazil and submitted an appeal which was accepted by ANVISA.
Executed on 10 commercial launches across our territories
Onicit IV in Brazil and Mexico.
Pemazyre in Brazil and Mexico.
Minjuvi for the treatment of adult patients with relapsed or refractory diffuse DLBCL in Argentina and Mexico.
Xcopri, Myfembree and Orgovyx in Canada.
Jornay PM (methylphenidate HCI extended-release capsules) in Canada.
Subsequent to year-end

Submitted Niktimvo for regulatory approval in Brazil.
Submitted supplemental indication of Minjuvi for FL for regulatory approval in Argentina and Mexico.
Obtained regulatory approval of supplemental indication of Minjuvi for the treatment of adult patients with relapsed or refractory FL in Brazil.
Obtained regulatory approval and launched Bapocil (palbociclib) in Colombia.
Executed certain agreements with two partners to return the Canadian commercial rights of six non‑core products in exchange for $21,500 and, in accordance with the Asset Purchase Agreement, will settle the holdback to Paladin for $8,457.
Repaid principal of $10,000 on the revolving credit facility.
Executed an asset purchase agreement to acquire a manufacturing facility in Argentina.
Up to March 12, 2026, the Company purchased additional 1,183,300 common shares at an average purchase price of $6.17 for an aggregate cash consideration of $7,296.
"I am pleased to announce that we delivered another year of record‑high adjusted revenues1 and adjusted EBITDA1 and cash flow from operations since Knight’s inception. While delivering record results, we strengthened our Canadian infrastructure and portfolio with multiple mature cashflow generating products as well as several early launch and pipeline products which positions Canada to be one of Knight’s largest contributors to revenue and profitability within the next 2 to 3 years. We also expanded our partnerships with Helsinn adding Onicit, and with Incyte adding Niktimvo and Zynyz, for Latin America. Over the past year we have licensed, submitted, obtained regulatory approval and launched multiple innovative products in Canada and Latin America. This is the result of the execution of our strategy which will continue into 2026 as we look to deliver nearly $500 million revenues representing a twofold increase in our business within five years," said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

SELECT FINANCIAL RESULTS REPORTED UNDER IFRS
[In thousands of Canadian dollars]

Change Change
Q4-25 Q4-24 $1
%2 2025
2024
$1
%2

Revenues 133,106 96,864 36,242 37 % 450,088 371,304 78,784 21 %
Gross margin 64,723 40,352 24,371 60 % 200,230 174,405 25,825 15 %
Gross margin % 49 % 42 % 44 % 47 %
Selling and marketing 20,421 14,576 (5,845 ) 40 % 67,927 53,861 (14,066 ) 26 %
General and administrative 15,033 10,741 (4,292 ) 40 % 56,182 45,488 (10,694 ) 24 %
Research and development 9,223 7,365 (1,858 ) 25 % 28,984 23,304 (5,680 ) 24 %
Amortization of intangible assets 13,836 10,630 (3,206 ) 30 % 49,487 44,355 (5,132 ) 12 %
Operating expenses 58,513 43,312 (15,201 ) 35 % 202,580 167,008 (35,572 ) 21 %

Operating income (loss) 6,210 (2,960 ) 9,170 310 % (2,350 ) 7,397 (9,747 ) 132 %

Net income (loss) 8,854 10,735 (1,881 ) 18 % (5,374 ) 4,332 (9,706 ) 224 %
1 A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss).
2 Percentage change is presented in absolute values.

Revenues: For the quarter ended December 31, 2025, the increase in revenues was driven by the addition of the Paladin and Sumitomo portfolios which contributed to $29,134 of incremental revenues. The remaining variance was mainly due to the growth of our key promoted products, the purchasing patterns of certain products partly offset by declines in our branded generic products and the termination of a non-strategic agreement in Colombia.

For the year ended December 31, 2025, the increase in revenues excluding the Hyperinflation Impact2 was $87,855 or 24% on a constant currency1 basis. The Paladin and Sumitomo portfolios contributed $56,532 of incremental revenues. The remaining variance was mainly driven by the growth of our key promoted products which grew by $32,488 or 12% on a constant currency1 basis and the purchasing patterns of certain products, partly offset by declines in our branded generic products and the termination of a non-strategic agreement in Colombia.

The table below provides revenues by therapeutic areas.

Change Change
Therapeutic Area Q4-25 Q4-241 $ % 2025 20241 $ %
Oncology/Hematology 41,988 35,823 6,165 17 % 146,373 140,837 5,536 4 %
Infectious Diseases 42,252 40,417 1,835 5 % 160,381 150,986 9,395 6 %
Neurology 26,989 12,480 14,509 116 % 85,460 53,229 32,231 61 %
Other Specialty 21,877 8,144 13,733 169 % 57,874 26,252 31,622 120 %
Total 133,106 96,864 36,242 37 % 450,088 371,304 78,784 21 %
1Comparative figures have been reclassified to align with the year-end 2025 reporting presentation. These reclassifications had no impact on total revenues.

The increase in revenues is explained by the following:

Oncology/Hematology: For the quarter ended December 31, 2025, the increase in revenues was mainly due to the addition of Orgovyx and Onicit, the growth of Minjuvi, the launch of Pemazyre as well as the purchasing patterns of certain customers.

For the year ended December 31, 2025, the revenues from our key promoted Oncology/Hematology products increased by $14,531 or 20% on a constant currency1 basis mainly driven by the addition of Orgovyx and Onicit, the growth of Minjuvi and Akynzeo as well as the launch of Pemazyre. This growth was partly offset by declines in our mature and branded generics due to their lifecycle and the termination of a non-strategic agreement in Colombia.
Infectious Diseases: For the quarter ended December 31, 2025, there was no material change in revenues of the portfolio.

For the year ended December 31, 2025, the increase in the revenues was primarily due to the growth of Cresemba and Ambisome, partly offset by the purchasing patterns of certain products.
Neurology: For the quarter ended December 31, 2025, the increase in revenues was driven by the addition of the Paladin and Sumitomo portfolios which contributed to $14,810 of incremental revenues.

For the year ended December 31, 2025, the increase in revenues was driven by the addition of the Paladin and Sumitomo portfolios which contributed to $28,184 of incremental revenues. The remaining variance was due to purchasing patterns of certain customers and the launch of Jornay PM.
Other Specialty: For the quarter ended December 31, 2025, the increase in revenues was driven by the addition of the Paladin and Sumitomo portfolios which contributed to $12,132 of incremental revenues. The rest of the variance was driven by growth of Imvexxy and Bijuva partly offset by the purchasing patterns of certain customers.

For the year ended December 31, 2025, the increase in revenues was driven by the addition of the Paladin and Sumitomo portfolios which contributed to $24,267 of incremental revenues. The rest of the variance was driven by growth of Imvexxy and Bijuva as well as purchasing patterns of certain customers.
Gross margin: The Adjusted Gross Margin1 as a % of Adjusted Revenues1, was 51% in Q4-25 compared to 47% in Q4-24. The increase was driven by the higher contribution of the Canadian business in Q4-25 compared to Q4-24 as well as our product mix, which generates a higher adjusted gross margin as a % of Adjusted Revenues1.

For the year ended December 31, 2025, the Adjusted Gross Margin1 as a % of Adjusted Revenues1 was 48% in 2025 compared to 47% in prior year. The increase was primarily driven by the higher contribution of the Canadian business in 2025 compared to 2024, which generates a higher adjusted gross margin as a % of Adjusted Revenues1, partly offset by product mix .

Selling and marketing ("S&M") expenses: For the quarter and year ended December 31, 2025, the increase in S&M expenses was mainly driven by an expansion in our sales and commercial structure behind the Paladin portfolio, the new launches in the Sumitomo portfolio as well as the launch of Minjuvi in Mexico and Jornay PM in Canada. In addition to structure, the increase also included our promotion and marketing expenses for the newly launched brands acquired in the Paladin and Sumitomo Transactions including Orgovyx, Myfembree, Xcopri and Envarsus PA as well as on our recently launched brands including Jornay PM in Canada, Minjuvi in Mexico and Argentina, Pemazyre in Mexico and Brazil, Onicit and pre-launch activities including Tavalisse in Mexico.

General and administrative ("G&A") expenses: For the quarter ended December 31, 2025, the increase in G&A expenses was mainly due to an incremental $2,903 in share-based compensation mainly as a result of periodic reassessment of achieving vesting targets. The remaining variance was driven by an increase in our structure due to the Paladin and Sumitomo Transactions and higher spending on professional and consulting fees.

For the year ended December 31, 2025, the increase in G&A expenses was primarily driven by acquisition and transaction costs of $4,567 related to the Paladin Transaction, as well as an additional $5,063 in share-based compensation as a result of periodic reassessment of achieving vesting targets. The remaining variance was driven by an increase in our structure due to the Paladin and Sumitomo transactions and higher spending on professional and consulting fees.

Research and development ("R&D") expenses: For the quarter and year ended December 31, 2025, the increase in R&D expenses was mainly due to the expansion of our scientific affairs structure including field-based medical science liaison personnel related to the Paladin and Sumitomo portfolios. In addition to structure, the increase included incremental medical, regulatory and pharmacovigilance spend on the Paladin and Sumitomo portfolios as well as development, regulatory, pre-launch and launch expenses on our pipeline and new launches including Niktimvo, Minjuvi, Jornay PM and Pemazyre.

Net income (loss)

For the quarter ended December 31, 2025, the net income was $8,854 compared to $10,735 for the same period in prior year. For the year ended December 31, 2025, the net loss was $5,374 compared to a net income of $4,332 in prior year. These variances were mainly driven by the above-mentioned items, as well as changes in amortization of intangible assets, net gains and losses on financial instruments measured at fair value through profit or loss, foreign exchange effects, hyperinflation gains, interest income, and income tax expense or recovery.

SELECT BALANCE SHEET ITEMS
[In thousands of Canadian dollars]

Change
December 31, 2025 December 31, 2024 $ %

Cash, cash equivalents and marketable securities 95,283 142,331 (47,048 ) 33 %
Trade and other receivables 178,598 154,518 24,080 16 %
Inventories 135,866 102,698 33,168 32 %
Financial assets 98,430 133,932 (35,502 ) 27 %
Intangible assets 379,510 283,612 95,898 34 %
Accounts payable and accrued liabilities 125,755 83,173 42,582 51 %
Bank loans 67,895 43,385 24,510 56 %

"Over the past year, we have further strengthened and diversified our pharmaceutical business through strategic transactions in both Canada and Latin America. Our disciplined financial management approach and focus on sustainable growth have delivered results. We improved our cash position from net debt of $1 million at the end of Q3-2025 to net cash of $27 million at the end of 2025. In fact, as of today, we have already repaid half of the principal of the revolving credit facility that was withdrawn to finance the Paladin Transaction. Our Debt to Adjusted EBITDA leverage ratio significantly improved from over 1.5x in Q3-25 to under 1x in Q4-25. Our business continues to deliver both record financial results and record free cash flow. Looking forward, we remain committed to our disciplined capital allocation strategy to deliver long term shareholder value," said Arvind Utchanah, Chief Financial Officer of Knight Therapeutics Inc.

Cash, cash equivalents and marketable securities: As at December 31, 2025, Knight had $95,283 in cash, cash equivalents and marketable securities, a decrease of $47,048 or 33% as compared to December 31, 2024. The decrease is mainly driven by the payment of $141,867 related to the Paladin and Sumitomo Transactions and certain intangibles, the repurchase of common shares through the NCIB for $6,352, interest on bank loans and lease liabilities of $11,945, partly offset by cash inflows from operations of $68,957, as well as collection from strategic loan repayments and distribution from funds of $25,250. In addition, during the year, Knight drewdown $60,000 on the revolving credit facility and used free cash flows generated for the principal repayments of $35,134. Subsequent to the end of the year, Knight repaid another $10,000 of principal on the revolving credit facility.

Trade and other receivables: As at December 31, 2025, trade and other receivables were $178,598, an increase of $24,080 or 16% as compared to December 31, 2024, mainly due to the trade receivables generated by the revenues from the Paladin and Sumitomo portfolios and the growth across the remainder of the portfolio.

Inventories: As at December 31, 2025, inventories were $135,866, an increase of $33,168 or 32% of which approximately $26,000 related to inventory balance of the Paladin and Sumitomo portfolios as at December 31, 2025. The remaining variance was due to the timing of purchases as well as investments on our new product launches, partly offset by the Balance Sheet Hyperinflation Impact2 on inventory held in Argentina as well as foreign exchange revaluation.

Financial assets: As at December 31, 2025, financial assets were $98,430, a decrease of $35,502 or 27%, as compared to December 31, 2024, mainly driven by strategic loan repayments of $21,116 and a decrease in fund investments of $12,540, which included a return of capital of $7,626 and a decrease in fair value of $4,914.

Intangible assets: As at December 31, 2025, intangible assets were $379,510, an increase of $95,898 or 34%, mainly due to the recognition of the intangible assets acquired in the Paladin Transaction for $102,761 and the Sumitomo Transaction for $29,718, partly offset by amortization, foreign exchange revaluation and the de-recognition of certain milestones not expected to be met.

Accounts payable and accrued liabilities: As at December 31, 2025, accounts payable and accrued liabilities were at $125,755, an increase of $42,582 or 51%. The increase was driven by a higher level of payables in our Canadian operations due to the increase in the portfolio as a result of the Paladin and Sumitomo Transactions, as well as the purchase of inventory for our key promoted products.

Bank Loans: As at December 31, 2025, bank loans were at $67,895, an increase of $24,510 or 56% as compared to December 31, 2024, mainly driven by the drawdown of $60,000 from the revolving credit facility on June 17, 2025, partly offset by loan repayments of $34,771, including repayments of $20,000 on the revolving credit facility and $12,690 to IFC. Subsequent to year end, Knight repaid principal of $10,000 on the revolving credit facility.

Transactions in 2025

Paladin Transaction
In June 2025, Knight closed a definitive Asset Purchase Agreement to acquire the international business of Endo Operations Limited which was mainly its Canadian business operating as Paladin Pharma Inc. ("Paladin Transaction"). Knight paid $90,002 and an additional $23,008 for inventory and upon receipt of the Partner Payment expects to pay $8,457 for the final and full settlement of the holdback from the purchase price. Furthermore, Knight may pay future contingent payments of up to US$15,000 upon achieving certain sales milestones.

Sumitomo Transaction
In June 2025, Knight entered into exclusive license and supply agreements with Sumitomo Pharma America Inc. ("Sumitomo") and its affiliates to commercialize Myfembree, Orgovyx and Gemtesa in Canada, as well as an asset purchase agreement under which Knight acquired certain mature products ("Sumitomo Transaction"). Under the terms of the agreements, Knight acquired the exclusive rights to distribute, promote, market and sell the in-licensed and acquired products in Canada. Knight paid $25,400 and may pay certain future contingent sales milestones up to $15,750.

Expansion of the existing partnerships
Knight expanded its relationship with Helsinn Healthcare SA ("Helsinn") and added exclusive rights to distribute, and commercialize Onicit in Mexico, Brazil and select LATAM countries. Knight assumed commercial activities for Onicit in Mexico and Brazil in Q1 2025.

Knight expanded its relationship with Incyte Biosciences International Sàrl ("Incyte") and added the exclusive rights to distribute Zynyz (retifanlimab) and Niktimvo (axatilimab) for Latin America.

Return of commercial rights
In March 2026, Knight executed certain agreements with two partners to return the Canadian commercial rights of six non-core products in exchange for a payment of $21,500 ("Partner Payment"). These products generated revenues of $7,527 4 in 2025.

In accordance with the Asset Purchase Agreement of the Paladin Transaction, as a final and full settlement, Knight will release $8,457 of the Settlement Agreement Holdback to Paladin.

Acquisition of a manufacturing facility in Argentina

In March 2026, Knight executed an asset purchase agreement to acquire a pharmaceutical development and manufacturing facility (including land, building and certain equipment) in an industrial zone outside of Buenos Aires in Argentina ("Facility"). Knight expects to move portions of its branded generic manufacturing activities to this Facility over the next three years.

Q4-25 Product Updates

Oncology/Hematology

Minjuvi (tafasitamab)
Knight obtained regulatory approval for Minjuvi in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory DLBCL, who are not eligible for ASCT in Argentina in Q4-25. Knight launched Minjuvi in Argentina in Q4-25.

Knight submitted supplemental applications seeking regulatory approvals for an additional indication of Minjuvi in combination with rituximab and lenalidomide for the treatment of adult patients with previously treated follicular lymphoma (FL) in Argentina and Mexico in Q1-26. Furthermore, Knight received the approval of Minjuvi in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL in Brazil in Q1-26.

Niktimvo (axatilimab)
Knight submitted Niktimvo (axatilimab) for regulatory approval in Brazil in Q1-26, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients 6 years and older.

Tavalisse (fostamatinib)
Knight received a rejection from ANVISA regarding its marketing authorization applicable for Tavalisse in Brazil and filed an appeal with ANVISA.

Pemazyre (pemigatinib)
Knight launched Pemazyre in Brazil and Mexico in Q4-25 and expects to launch in Argentina in the first half of 2026, as a monotherapy for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Bapocil (palbociclib)
Bapocil was approved and launched in Colombia. Bapocil in combination with endocrine therapy is indicated for the treatment of patients with metastatic or advanced breast cancer that is hormone receptor positive and human epidermal growth factor receptor 2 (HER2) negative, in combination with: an aromatase inhibitor as initial endocrine-based therapy in post-menopausal women; or with fulvestrant in patients with disease progression after endocrine therapy.

Neurology

Crexont (carbidopa and levodopa)
Knight submitted Crexont for approval in Chile, Argentina and Peru in Q4-25. Crexont is a novel, oral formulation of carbidopa ("CD")/levodopa ("LD") extended-release capsules designed for the treatment of Parkinson’s disease.

Qelbree (viloxazine)
Knight received a Notice of Non-Compliance (NON) from Health Canada for its New Drug Submission for Qelbree, for the treatment of Attention-Deficit Hyperactivity Disorder ("ADHD"). Knight will submit its response to Health Canada in 2026.

Jornay PM (methylphenidate HCI extended-release capsules)
Knight launched Jornay PM in Canada in Q4 2025. Jornay PM is the first and only evening-dosed methylphenidate product commercially available in Canada to treat ADHD in children from 6 to 12 years of age.

Other Specialty

Wynzora (calcipotriol and betamethasone dipropionate)
Knight received Health Canada’s approval of Wynzora for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12-17 years for up to 8 weeks. Knight expects to launch Wynzora in 2026.

(Press release, Knight Therapeutics, MAR 19, 2026, View Source [SID1234663759])

On March 19, 2026 TG Therapeutics, Inc. ("TG" or "the Company"), (NASDAQ: TGTX), reported that it has entered into a new five-year, $750 million senior secured credit facility with funds managed by Blue Owl Capital ("Blue Owl"). As part of the transaction, the Company will repay its outstanding $250 million senior secured credit facility, resulting in a net raise of $500 million in non-dilutive capital. The new facility also provides for up to an additional $250 million of incremental capital, for a total facility size of up to $1 billion, available at the mutual discretion of TG and Blue Owl.

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                  Schedule Your 30 min Free Demo!

In connection with the new facility, the Company’s Board of Directors authorized an increase to its share repurchase program from $100 million to $300 million. As of March 18, 2026, the Company has repurchased approximately $38 million of common stock under the existing share repurchase program at an average price of $28.98 per share.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, "We are pleased to announce this expanded credit facility with funds managed by Blue Owl, which significantly enhances our financial position with increased scale and improved terms compared to our prior facility. This financing builds on our cash flow positive business and provides substantial non-dilutive capital to support opportunistic share repurchases and business development, while continuing to invest in the growth of BRIUMVI and advancement of our pipeline." Weiss continued, "The expansion of our share repurchase program underscores our confidence in our business and our commitment to delivering long-term shareholder value. We appreciate Blue Owl’s continued relationship and support."

"TG Therapeutics continues to demonstrate strong commercial execution with BRIUMVI and a disciplined approach to growth," said Sandip Agarwala, Managing Director and Head of Life Sciences at Blue Owl. "We are pleased to deepen our relationship with TG through this expanded facility and support the Company as it continues to advance its strategic initiatives."

Additional details regarding the credit facility will be filed with the Securities and Exchange Commission on Form 8-K.

ABOUT BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

A list of authorized specialty distributors can be found at www.briumvi.com.

IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:

Active Hepatitis B Virus infection
A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.

Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.

Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.

(Press release, TG Therapeutics, MAR 19, 2026, View Source [SID1234663756])

On March 19, 2026 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported financial results for the full year ended December 31, 2025, and provided a corporate update.

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"Based upon continued progress in our GPS and SLS009 clinical programs in AML, we believe 2026 is shaping up to be a pivotal year for SELLAS," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We are advancing toward the final analysis of our Phase 3 REGAL trial evaluating GPS in AML patients who have achieved complete remission following second-line salvage therapy. Once we reach the required pre-specified 80th event, which will be announced, we will proceed with the necessary procedures towards database lock completion, statistical analysis, unblinding, and disclosure of topline results. If positive, REGAL could position GPS as a first- and best-in-class immunotherapeutic option in this AML population and serve as a significant value-inflection point for SELLAS."

Dr. Stergiou continued, "We also continue to make significant progress in our SLS009 clinical program for AML. Following the positive Phase 2 results of SLS009 in r/r AML presented at ASH (Free ASH Whitepaper), particularly in high-risk molecular subtypes, we have now dosed the first patient in the expansion cohort, which is evaluating SLS009 in newly diagnosed, first-line AML patients. Additionally, our preclinical data presented at ESMO (Free ESMO Whitepaper) in T-PLL demonstrated a statistically significant survival benefit of SLS009 both as monotherapy and in combination with venetoclax in a patient-derived xenograft model, further supporting the breadth of the CKD9 inhibition strategy. With a catalyst rich outlook, continued clinical execution, our strongest financial position in history and expansion into earlier treatment settings, we look forward to an important year ahead."

Recent Corporate Highlights:

European Collaboration to Advance SLS009 Clinical Program: In January 2026, SELLAS entered into a strategic collaboration with IMPACT-AML to expand SLS009 clinical program in Europe. Under the agreement, IMPACT-AML’s STREAM clinical network will conduct a study of SLS009 in combination with AZA/VEN in newly diagnosed AML patients. The enrollment of approximately 40 patients in Europe is anticipated in Q2 2026.

Phase 3 REGAL Trial of GPS: On December 29, 2025, the Company provided an update on the pivotal Phase 3 REGAL trial, announcing that a total of 72 events had been recorded as of December 26, 2025, with the study remaining fully blinded. After reaching the required pre-specified 80th event, customary database lock and blinded data review procedures must be completed before statistical analysis, unblinding, and disclosure of topline results. Because the final analysis is event-driven, the timing of studies with overall survival as an endpoint can vary; SELLAS will announce the 80th event when it occurs.

Phase 2 SLS009 in r/r AML: On December 7, 2025, the Company announced that clinical data from its ongoing Phase 2 study of SLS009, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with r/r AML with myelodysplastic syndrome-related changes (AML-MR) after prior VEN-based treatment were presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2025. SLS009 in combination with AZA/VEN demonstrated clinically meaningful activity in patients with R/R AML-MR, and among the 35 evaluable patients, the overall response rate (CR/Cri/MLFS) was 46%, including 29% achieving CR/CRi. Patients harboring ASXL1 or TP53 mutations achieved response rates of 48% and 57%, respectively. The median overall survival (mOS) was exceedingly higher than the expected 2.6 months in this R/R AML patient population, and in the least pretreated cohort, mOS reached 8.9 months. Across all cohorts, patients with one prior line of therapy experienced the greatest benefit, with a 58% response rate and mOS not yet reached. No dose-limiting toxicities (DLTs) or treatment-related deaths were observed, and the combination was well tolerated.

Expansion of SLS009 into Earlier-Line AML Treatment: Following the encouraging Phase 2 results of SLS009 in r/r AML particularly in patients with high-risk molecular subtypes, the Company has expanded the development program into earlier lines of therapy. After receiving constructive feedback from the FDA, SELLAS dosed the first patient in an 80-patient trial in newly diagnosed AML patients as well as those who become refractory early to AZA/VEN treatment which we established through our extensive transcriptomics, genomics, and proteomics models.

Preclinical Data on SLS009 in AML at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper): The data shows that SLS009 induces apoptosis in AML cell lines, including those harboring high-risk ASXL1 and TP53 mutations. Pharmacodynamic changes were observed as early as 8 hours after treatment and became more pronounced over time, with reductions in MCL-1 and survivin, correlating with increased apoptosis. The poster, entitled, "Tambiciclib (SLS009), a CDK9 inhibitor, promotes apoptosis and suppresses MCL-1 levels in AML cell lines" will be presented on April 21, 2026.

Preclinical Data on SLS009 in T-PLL Presented at ESMO (Free ESMO Whitepaper) 2025: In October 2025, preclinical data demonstrating statistically significant survival benefit of SLS009 were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany. The results showed that SLS009, as a monotherapy and in combination with VEN, significantly prolonged survival compared to VEN alone in an in vivo patient-derived xenograft model of T-cell prolymphocytic leukemia (T-PLL). These findings further support the therapeutic potential of SLS009 to improve outcomes across multiple hematologic malignancies.

Virtual R&D Day on Advancing Novel Therapies in AML: On October 29, 2025, SELLAS hosted a virtual R&D Day on "Advancing Novel Therapies in Acute Myeloid Leukemia (AML)" featuring key opinion leaders and Company management. The event provided a detailed review of the Company’s ongoing Phase 3 REGAL trial of GPS and the SLS009 program, underscoring each therapy’s potential to address multiple stages of disease progression along the AML treatment continuum. To access a replay of the R&D Day, please click here.

Received $67.2 Million in Gross Proceeds from Warrant Exercises in 2025: In September and October 2025, SELLAS received a total of approximately $54.6 million in gross proceeds from the immediate exercise of existing warrants, including $23.6 million from warrants issued in January 2025 and $31.0 million from warrants issued in March and August 2024. An additional $12.6 million in proceeds was received during 2025 from the exercise of other previously outstanding warrants.

Received Additional $42.6 Million in Proceeds from Warrant Exercises in Q1 2026: Subsequent to December 31, 2025, the Company received an additional $42.6 million in proceeds from the exercise of previously outstanding warrants. These additional proceeds bolster the reported $71.8 million cash and cash equivalents as of December 31, 2025, and provide the Company with the strongest financial position in its history.

Financial Results for the Full Year 2025:

Research and Development Expenses: Research and development expenses for the year ended December 31, 2025, were $16.0 million, compared to $19.1 million for the year ended December 31, 2024. The decrease was primarily due to decreases in clinical trial expenses and clinical and regulatory consulting costs, which were primarily driven by the completion of enrollment in the REGAL study in the first quarter of 2024.

General and Administrative Expenses: General and administrative expenses for the year ended December 31, 2025, were $12.3 million, as compared to $12.4 million for the year ended December 31, 2024. The decrease was primarily attributable to a decrease in personnel related expenses.

Net Loss: The net loss was $26.9 million for the year ended December 31, 2025, or a basic and diluted loss per share of $0.25, as compared to a net loss of $30.9 million for the year ended December 31, 2024, or a basic and diluted loss per share of $0.50.

Cash Position: As of December 31, 2025, cash and cash equivalents totaled approximately $71.8 million. Subsequent to December 31, 2025, the Company received an additional $42.6 million in proceeds from the exercise of previously outstanding warrants.

(Press release, Sellas Life Sciences, MAR 19, 2026, View Source [SID1234663755])

On March 19, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported audited financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update highlighting significant progress across its pipeline.

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"This has truly been a transformational year for Relmada, marked by significant progress with our lead program NDV-01," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. "Our recently reported 12-month data for NDV-01 demonstrated durable complete responses with a favorable safety profile, reinforcing the program’s potential to become a best-in-class therapy for patients with non-muscle invasive bladder cancer. With a successful $160 million PIPE financing and regulatory alignment with the FDA on two registrational pathways, we believe that we are well positioned to advance NDV-01 into the Phase 3 RESCUE program in mid-2026. Our team is now focused on executing this plan and initiating the RESCUE registrational program as we work to bring NDV-01 to patients as efficiently as possible."

"NDV-01’s compelling efficacy, durability, and favorable safety profile, combined with operational ease-of-use are the cornerstone of its differentiated product profile and best-in-class potential," said Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics. "We continue to be encouraged by the high response rates and durable clinical benefit observed through 12 months, including in the BCG-unresponsive population, alongside a favorable safety profile with no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations. Our clinical program builds on the urologic oncology community’s comfort with conventional Gem/Doce’s efficacy and safety profile with a sustained release product that could provide physicians and patients with a streamlined, less than 5-minute in-office procedure. These results reinforce our confidence as we advance NDV-01 into the Phase 3 RESCUE registrational program in mid-2026."

Highlights of the 12-month follow-up data from the ongoing Phase 2 study of NDV-01:

In the 12-month follow-up of the Phase 2a study (March 9, 2026 Company press release) treatment with NDV-01 produced:

Durable 76% complete response (CR) rate at 12 months with 95% CR rate at any time in high-risk NMIBC
BCG-unresponsive patients achieved an 80% CR rate at 12 months and 94% CR rate at any time
No patient had progression to muscle-invasive disease, and no patient underwent a radical cystectomy
Favorable overall tolerability – no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations or dose interruptions.
Phase 3 RESCUE Registrational Pathways:

As previously disclosed in the Company’s January 12, 2026 regulatory update, Relmada has received written feedback from the U.S. Food and Drug Administration (FDA) confirming alignment on two registrational development pathways for NDV-01, including study design, patient populations and primary endpoints.

Registrational Pathway 1 – An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (NDV-01 vs. observation). There are no approved treatments for adjuvant intermediate risk NMIBC, which we estimate affect ~75,000 patients/year in the U.S. The primary endpoint of the study is disease free survival (DFS).

Registration Pathway 2 – A single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) patients who are currently refractory to approved or developmental therapies. Patients with BCG-unresponsive NMIBC with CIS who fail first line (1L) therapies, which we estimate to affect ~5,000 patients/year in the U.S., have few, if any, effective treatment alternatives to radical cystectomy. The primary endpoint of the study is complete response (CR) rate at any time.

Expected Upcoming Relmada Milestones:

NDV-01 United States IND clearance – Mid-2026
NDV-01 Phase 3 RESCUE Program initiation – Mid-2026
Sepranolone Phase 2 initiation in Prader-Willi syndrome – Mid-2026
Initial 3-month NDV-01 data from Phase 3 2L BCG-unresponsive study expected by YE 2026
Financial Results

Fourth Quarter 2025 Financial Results

Research and development expense for the three months ended December 31, 2025, totaled $8.1 million, compared to $11.0 million for the three months ended December 31, 2024, a decrease of $2.9 million. The decrease was primarily driven by a decrease in study costs associated with the completion of two Phase 3 trials for REL-1017, partially offset by increased costs related to the start-up the Phase 3 NDV-01 trials and Phase 2b sepranolone study and additional R&D personnel.
General and administrative expense for the three months ended December 31, 2025, totaled $12.3 million compared to $8.1 million for the three months ended December 31, 2024, an increase of approximately $4.2 million. The increase was primarily driven by an increase in compensation costs partially offset by a decrease in stock based compensation costs.
Net cash used in operating activities for the three months ended December 31, 2025, totaled $14.6 million compared to $8.8 million for the three months ended December 31, 2024.
The net loss for the three months ended December 31, 2025, was $19.9 million, or $0.27 per basic and diluted share, compared with a net loss of $18.6 million, or $0.62 per basic and diluted share, for the three months ended December 31, 2024.
Twelve Month Ended December 31, 2025 Financial Results

Research and development (R&D) expense for the 12 months ended December 31, 2025, totaled $26.9 million, compared to $46.2 million for the 12 months ended December 31, 2024, a decrease of $19.3 million. The decrease was primarily driven by a decrease in study costs associated with completion and conclusion of two Phase 3 trials for REL-1017, partially offset by increased costs related to the acquisition of NDV-01 and sepranolone, as well as the start-up of the Phase 3 NDV-01 trials and Phase 2b sepranolone study.
General and administrative (G&A) expense for the 12 months ended December 31, 2025, totaled $32.2 million compared to $37.7 million for the 12 months ended December 31, 2024, a decrease of approximately $5.5 million. The decrease was primarily driven by a decrease in stock-based compensation expense and lower professional fees, partially offset by an increase in personnel-related costs.
Net cash used in operating activities for the 12 months ended December 31, 2025, totaled $45.8 million compared to $51.8 million for the 12 months ended December 31, 2024.
The net loss for the 12 months ended December 31, 2025, was $57.4 million, or $1.45 per basic and diluted share, compared with a net loss of $80.0 million, or $2.65 per basic and diluted share, for the 12 months ended December 31, 2024.
The Company’s cash balance of $93.0 million in cash, cash equivalents, and short-term investments, includes net proceeds of approximately $94 million from an underwritten stock offering announced November 5, 2025. This compares to cash, cash equivalents, and short-term investments of approximately $44.9 million at December 31, 2024.
On March 9, 2026, the Company announced a private financing with gross proceeds of $160 million. This financing, along with the cash, cash equivalents, and short-term investments as of December 31, 2025, is expected to provide sufficient resources to fund Company operations through 2029, including completion of the Phase 3 NDV-01 RESCUE program.
The Company had 104,890,223 shares outstanding, as of March 16, 2026
Conference Call and Webcast Information:
Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results.

Conference Call and Webcast Information:

Date: Thursday, March 19, 2026 at 4:30 PM ET
Participant Dial-in (US): 1-877-407-0792
Participant Dial-in (International): 1-201-689-8263
Webcast Access: Click Here
A replay of the webcast will be available in the Investors section of the Relmada website at View Source

About NDV-01

NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is ready to use, convenient to administer in-office in less than 5 minutes and does not require anesthesia or specialized equipment. It is protected by patents through 2038.

About the Phase 2 Study

The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with high-grade non-muscle invasive bladder cancer (HG-NMIBC). Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).

About NMIBC

NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 – 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

About Sepranolone and GABA Modulation

Sepranolone, a synthetic isoallopregnanolone, selectively modulates GABAA receptors by antagonizing allopregnanolone (ALLO), without disrupting GABA signaling. It targets disorders linked to excess GABAergic activity such as Prader-Willi syndrome, Tourette syndrome, and Obsessive-Compulsive Disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with an excellent safety profile.

About Prader-Willi Syndrome (PWS)

PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications. Global prevalence is estimated to be 350,000-400,000 patients. Current treatments address symptoms but do not modify the underlying neurobehavioral pathology.

(Press release, Relmada Therapeutics, MAR 19, 2026, View Source [SID1234663754])

On March 19, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported two abstracts across distinct tumor types were accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2026, at the San Diego Convention Center from April 17-22, 2026. Pelareorep is an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways via double‑stranded RNA signaling, driving interferon production, dendritic cell activation, and cytotoxic T‑cell priming.

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"These new translational findings strengthen our understanding of pelareorep as a systemic immune‑priming agent that reshapes the tumor microenvironment," said Jared Kelly, Chief Executive Officer of Oncolytics. "The coordinated immune activation and tertiary lymphoid structure formation we are observing support pelareorep as a foundational backbone for combination therapy across multiple tumor types, including RAS-driven cancers. RAS mutations are especially prevalent in deadly cancers, including roughly 95% of pancreatic cancers and 45% of colorectal cancers. As we advance registrational programs in gastrointestinal cancers, we believe pelareorep will enhance immunotherapy activity and potentially help patients who did not respond initially."

Biomarker data from cohort 1 of the Phase 1/2 GOBLET trial in advanced pancreatic cancer suggest pelareorep plus atezolizumab and gemcitabine/nab-paclitaxel can shift tumors toward a more immune-active state. Patients with an immune activation signature after four weeks were more likely to achieve durable clinical benefit, supporting a potential biomarker. Pancreatic cancer continues to pose a significant unmet clinical need, with approximately 510,000 new cases reported globally each year.1

Additionally, new first-of-its-kind data from AWARE-1 show pelareorep can drive coordinated anti-tumor immune responses, including tertiary lymphoid structure ("TLS") formation, helping make immunologically cold tumors more susceptible to immunotherapy. This could include patients who have failed checkpoint inhibitors, representing a significant portion of the patient population and a meaningful unmet need in oncology.

Pelareorep has also been shown to stimulate RAS-specific T-cell clones in gastrointestinal cancers, which may enhance its ability to target RAS-mutated tumor cells. The Company will present more data on this topic at an upcoming scientific meeting.

Together, the data support pelareorep as a novel immune‑priming strategy capable of enhancing the activity of multiple therapeutic classes, including checkpoint inhibitors, targeted therapies, chemotherapy, and emerging immuno‑oncology modalities.

Abstract: Pelareorep combined with atezolizumab and chemotherapy shows immune conversion activity in advanced pancreatic cancer: Biomarker results of cohort 1 of the GOBLET trial

New biomarker data from cohort 1 of the Phase 1/2 GOBLET study demonstrated that pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel led to meaningful immune activation in patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC").

An exploratory analysis integrating routine serum markers, a 172-protein circulating panel, selected T-cell receptor sequencing, and clinical outcomes found early on-treatment changes showed increases in adaptive immune and cytotoxicity-associated proteins, including interferon signaling and CD8+/NK-related markers, alongside decreases in tumor/stroma-associated proteins. A 14-protein signature linked to oncolytic activity stratified patients at Week 4 into ‘hot’ vs. ‘cold’ immune phenotypes relative to baseline. Patients demonstrating immune activation signatures experienced longer median progression-free survival (7.5 months) compared with patients who did not exhibit similar immune responses (5.6 months).

As previously reported, the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel demonstrated a 62% objective response rate in first-line mPDAC patients, more than double the response rates historically observed with chemotherapy alone.

Abstract: Imaging mass cytometry of pelareorep treated early breast cancer samples reveals developing tertiary lymphoid structures

AWARE-1 is a window-of-opportunity study evaluating the effects of pelareorep in early-stage breast cancer. In biopsies from Cohort 2 (n=8), cellular neighborhood analysis identified immune-cell clusters, including cytotoxic T cells, dendritic cells, T helper cells, activated T helper cells, B cells, differentiated B cells, and M2 macrophages. Interactions between these cells developed into TLS in select patients. TLS function as localized immune hubs that facilitate antigen presentation, T‑cell activation, and sustained anti‑tumor immune responses. Published studies link TLS formation with improved responses to immunotherapy.

These findings support pelareorep’s potential to expand cytotoxic T cells, activate dendritic cells, and promote TLS formation, helping to convert immunologically ‘cold’ tumors into immune-responsive ‘hot’ tumors.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. The combination of pelareorep, letrozole, and atezolizumab resulted in 60% of patients experiencing 30% or greater increases in their CelTIL score.

(Press release, Oncolytics Biotech, MAR 19, 2026, View Source [SID1234663752])