On March 2, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided an overview of recent developments.

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"2025 was a tremendously successful and transformative year for UroGen, highlighted by the FDA approval and commercial launch of ZUSDURI, the first and only approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer," said Liz Barrett, President and Chief Executive Officer of UroGen. "2026 is a pivotal year for the ZUSDURI launch, and we are encouraged by the early post-J Code trajectory. As expected, we are seeing an acceleration across key launch indicators, including physician uptake and adoption. We believe ZUSDURI is well positioned to address a significant unmet need and represents a greater than $1 billion peak sales opportunity."

Ms. Barrett continued, "We are advancing our pipeline with meaningful momentum across our next-generation clinical programs, UGN-103 and UGN-104. The UTOPIA trial evaluating UGN-103 demonstrated compelling complete response results consistent with the ENVISION trial, and we remain on-track to submit an NDA in the second half of 2026. We also plan to explore label expansion opportunities for UGN-103, including in high-grade NMIBC settings and as an adjuvant to TURBT in IR-NMIBC patients. Following the refinancing of our term loan agreement with Pharmakon, we have further strengthened our balance sheet, and believe we are well-positioned to execute on our long-term growth strategy and build upon our leadership in uro-oncology."

Q4 2025 and Recent Business Highlights:

ZUSDURI (mitomycin) for intravesical solution:

Commercial launch is progressing as expected for ZUSDURI, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. ZUSDURI was approved by the U.S. Food and Drug Administration (FDA) on June 12, 2025. The Company’s expanded field team is scaled and actively supporting the ZUSDURI launch.
On January 1, 2026, the permanent Healthcare Common Procedure Coding System Level II J Code (J9282) became effective, building buy-and-bill reimbursement confidence across hospital and community urology practices, removing a key barrier and supporting broader uptake.
ZUSDURI achieved net product sales of $15.8 million in 2025. As of December 31, 2025, UroGen reports:
838 activated sites of care
102 unique ZUSDURI prescribers
32 repeat ZUSDURI prescribers
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC):

Generated net product sales of $94.0 million in the year ended December 31, 2025, compared to $90.4 million reported in 2024 (which included CREATES Act sales of $0.2 million in 2025 and $3.0 million in 2024). Underlying demand revenue grew by 7% year-over-year.
Next-generation novel mitomycin-based formulation for urothelial cancers

UroGen announced robust results from its ongoing Phase 3 UTOPIA trial evaluating UGN-103 (mitomycin) for intravesical solution in recurrent LG-IR-NMIBC. UGN-103 demonstrated a 77.8% three-month complete response (CR) rate (95% CI, 68.3%, 85.5%). For more information on the UTOPIA trial, refer to clinicaltrials.gov/NCT06331299.
The FDA has agreed with the regulatory plan to submit a New Drug Application (NDA) based on the data from the Phase 3 UTOPIA trial to support potential approval of UGN-103 for recurrent LG-IR-NMIBC. UroGen plans to submit the NDA in the second half of 2026 with potential FDA approval in 2027.
UGN-103 is a next generation product designed to offer improvements over ZUSDURI, including a shorter manufacturing process and simplified reconstitution procedure. It combines UroGen’s RTGel technology with a novel mitomycin formulation licensed from medac GmbH. UroGen plans to continue evaluating lifecycle management and pipeline expansion opportunities, including potential applications in high-grade NMIBC settings and adjuvant use of UGN-103 in IR-NMIBC patients.
The Phase 3 clinical trial to explore the safety and efficacy of UGN-104 is ongoing and is expected to be fully enrolled by the end of 2026. UGN-104 is a next generation product for LG-UTUC. For more information on the UGN-104 Phase 3 trial, refer to View Source
UGN-501 (investigational next-gen oncolytic virus) for use in high-grade non-muscle invasive bladder cancer (HG-NMIBC)

UGN-501 is a potent and fast-replicating investigational next generation oncolytic virus therapy being developed as a locally administered cancer treatment. Investigational New Drug-enabling studies are currently ongoing, with the goal of submitting an IND and initiating a Phase 1 trial by the end of 2026. UroGen intends to evaluate several modes of administration, including delivery using its proprietary RTGel technology. The initial focus will be bladder cancer, and UroGen also intends to explore UGN-501’s potential in a broader range of cancers beyond the genitourinary system.
Expanded Debt Facility with Pharmakon Advisors

On February 26, 2026, UroGen entered into an amended and restated loan agreement with Pharmakon Advisors for two additional tranches of senior secured term loans. The first tranche of $200 million was funded at closing to refinance the existing $125 million loan facility and provide additional non-dilutive capital. A second tranche of $50 million may be drawn at the Company’s option no later than June 30, 2027, subject to customary conditions. All outstanding loans with Pharmakon Advisors will accrue interest at a fixed rate of 8.25% and be repaid in four equal quarterly payments commencing in the first quarter of 2030. All outstanding loans with Pharmakon Advisors can be prepaid in whole at UroGen’s discretion at any time, subject to prepayment premiums, make-whole amounts, as applicable, and fees.
Full Year 2025 Financial Results

Revenue: Total revenue was $109.8 million for the full year ended December 31, 2025, compared to $90.4 million for the full year ended December 31, 2024. The 21% year-over-year increase was primarily driven by the commercial launch of ZUSDURI in 2025 and JELMYTO revenue growth.

R&D Expenses: Research and development (R&D) expenses were $67.1 million for the full year ended December 31, 2025, including non-cash shared-based compensation expense of $2.3 million. This compares to $57.1 million, including non-cash shared-based compensation expense of $2.2 million, for the full year ended December 31, 2024. The increase in R&D expenses was primarily driven by higher ZUSDURI manufacturing costs, which are recognized as R&D expenses prior to receiving FDA approval, costs associated with the Phase 3 trials for UGN-103 and UGN-104, and the acquisition of UGN-501, partially offset by lower clinical trial costs and regulatory expenses in connection with ZUSDURI.

SG&A Expenses: Selling, general and administrative (SG&A) expenses were $155.1 million for the full year ended December 31, 2025, including non-cash shared-based compensation expense of $9.6 million. This compares to $121.2 million, including non-cash shared-based compensation expense of $10.9 million, for the full year ended December 31, 2024. The increase in SG&A expenses was primarily driven by ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval in 2025, as well as an increase in overall commercial operation costs.

Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $18.5 million and $23.4 million for the years ended December 31, 2025 and 2024, respectively. The decrease was driven primarily by changes in underlying assumptions for remeasuring the effective interest rate.

Interest Expense on Long-term Debt: Interest expense related to the prior $125 million term loan facility with funds managed by Pharmakon Advisors was $15.3 million and $12.5 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily attributed to the interest expense on the $25 million third tranche of the loan that was funded in September 2024.

Net Loss: UroGen reported a net loss of $153.5 million or ($3.19) per basic and diluted share for the year ended December 31, 2025, compared with a net loss of $126.9 million or ($2.96) per basic and diluted share for the year ended December 31, 2024.

Cash, Cash Equivalents and Marketable Securities: As of December 31, 2025, cash, cash equivalents and marketable securities totaled $120.5 million.

2026 JELMYTO Sales and Company Operating Expense Guidance: Guidance for full-year 2026 net product sales for JELMYTO are expected to be in the range of $97 million to $101 million. This implies a year-over-year growth rate of approximately 3% to 7% over the $94 million of JELMYTO sales reported in 2025. The Company is not providing full-year 2026 sales guidance for ZUSDURI at this time, as the product remains in the early stages of its commercial launch. Full-year 2026 operating expenses are expected to be in the range of $240 million to $250 million, including non-cash share-based compensation expense of $20 million to $24 million.

For further details on the Company’s financials, refer to our Annual Report on Form 10-K, being filed with the SEC today.

Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at investors.urogen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

(Press release, UroGen Pharma, MAR 2, 2026, View Source [SID1234663185])

On March 2, 2026 Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, reported financial results for the fourth quarter and year ended December 31, 2025 and provided a summary of recent business highlights.

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"Over the past year, we have redefined our approach to what success can look like at Zymeworks. We have put in place a focused strategy, a refreshed leadership team, and a Board of Directors aligned around thoughtful capital allocation and long-term value creation for shareholders," said Kenneth Galbraith, Chair, Chief Executive Officer and interim Chief Financial Officer of Zymeworks. "Our objective is to combine a portfolio of predictable, recurring revenues driven by growing royalties with disciplined deployment of capital to deliver sustainable total shareholder returns over time. The additional capital from our recently announced non-recourse royalty-backed note provides non-dilutive capital to support the continued execution of our stock repurchase program and any potential strategic acquisitions aligned with our new business approach."

Galbraith continued, "We believe that our growing royalty portfolio positions us to generate durable and growing cash flows, while our R&D capabilities allow us to identify and advance internal or externally generated assets in ways that create incremental value. In 2026, we remain focused on timely execution of each element of our novel strategy. This means delivering clinical progress on our R&D portfolio, continued progress on development and commercialization of Ziihera and pasritamig by our partners, expanding partnerships and collaborations, and demonstrating tangible outcomes from our corporate strategy. The unique structured financing with Royalty Pharma illustrates our desire and capabilities to utilize creative financings and partnerships to drive long-term value for our shareholders."

Recent Developments

In March 2026, we entered into a $250.0 million royalty-backed note financing arrangement with Royalty Pharma. The structure of the loan facility was tailored to reflect the long-term potential of the underlying royalty of zanidatamab. This customized approach provides for only 30% of royalty interests related to Ziihera to be pledged as collateral and creates a longer-term duration than a traditional royalty loan, with any duration risk shared by us and Royalty Pharma. Compared to a traditional royalty-backed loan, we believe this structure enables us to preserve greater near-term royalty cash flows, which can be strategically deployed toward share repurchases or value-accretive acquisitions on an accelerated timeframe. In addition, we believe the transaction enhances strategic flexibility, with 70% of the Ziihera royalty remaining unencumbered through the duration of the loan, with full royalty rights reverting to us once the loan has been repaid in full. Importantly, the financing achieves these financial and strategic benefits with limited impact to our long-term economic participation in the Ziihera royalty stream compared to a traditional royalty-backed loan.

Wholly-Owned Programs

In January 2026, we announced our R&D priorities for 2026 and beyond, including our intention to continue conducting Phase 1 clinical studies for ZW191 and ZW251 in 2026. In addition, we announced that beyond 2026, we expect to focus our ADVANCE research efforts on multispecific antibody and engineered-cytokine platforms, funded partially with early-stage partnerships and collaborations. Investigational New Drug applications (IND) for multispecific programs, ZW209 and ZW1528, remain on track for submission in 2026. We anticipate that development of wholly-owned preclinical candidates from our multispecific antibody portfolio should provide for one planned IND filing per annum commencing in 2028. We intend to continue actively sharing peer-reviewed publications and data across preclinical and clinical programs, while we continue evaluating partnership opportunities.

"Results from the HERIZON-GEA-01 study point to the potential of this practice-changing, HER2-targeted therapy for patients with gastroesophageal cancer, a population with significant unmet need, and, if confirmed over time, across other HER2-expressing tumors," stated Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks. "Designed and developed in-house, zanidatamab reflects the strength of our proprietary Azymetric platform, with our teams now applying our capabilities to advance our next-generation assets with increasing innovation and biological insight. We look forward to presenting continued progress in our R&D portfolio during 2026, including at the AACR (Free AACR Whitepaper) Annual Meeting in April in San Diego, CA."

Partnered Programs

Zanidatamab Demonstrated its Potential as HER2-Targeted Agent-of-Choice

In November 2025, together with our partners Jazz and BeOne, we announced positive topline results from the Phase 3 HERIZON-GEA-01 trial supporting Ziihera as the potential HER2-targeted agent-of-choice and new standard of care in first-line HER2+ locally advanced or metastatic GEA regardless of PD-L1 status. Based on these data, our partner Jazz expects to complete the supplemental Biologics License Application submission for zanidatamab in the first quarter of 2026 for the treatment of first-line HER2+ locally advanced or metastatic GEA under the real-time oncology review program in the U.S., where zanidatamab has been granted Breakthrough Therapy Designation. Jazz has also submitted these data for inclusion in the National Comprehensive Cancer Network Guidelines (NCCN Guidelines). Upon regulatory review, Jazz expects a potential commercial launch for zanidatamab in first-line HER2+ locally advanced or metastatic GEA to take place in the second half of 2026.

In January 2026, Jazz updated enrollment guidance for EmpowHER-303 in which they expect to complete enrollment in the first half of 2027, with a top-line data readout later in 2027 or in early 2028. The EmpowHER-BC-303 study is a randomized clinical trial comparing zanidatamab plus physician’s choice of chemotherapy against trastuzumab plus physician’s choice of chemotherapy for the treatment of patients with metastatic HER2+ breast cancer. Jazz is also pursuing collaborations with partners to combine zanidatamab with novel therapies. For example, the Phase 1 Beamion-BCGC1 trial (NCT06324357) in combination with Boehringer Ingelheim’s zongertinib was recently initiated to explore the combination in metastatic HER2+ breast cancer, along with other potential tumor types.

In January 2026, the New Drug Submission for Ziihera was approved by Health Canada for the treatment of adults with previously treated, unresectable locally advanced or metastatic HER2+ (IHC 3+) biliary tract cancer, as monotherapy. Ziihera’s market authorization has been issued with conditions, pending the results of trials to verify its clinical benefit. Subsequently, in February 2026 Ziihera was approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of biliary tract cancer.

In addition to the $53.0 million in milestone payments already received for Ziihera in biliary tract cancer, Zymeworks is entitled to receive up to $440.0 million in milestone payments from Jazz and BeOne related to approvals of Ziihera in GEA in the U.S., Europe, Japan, and China. Zymeworks also has the potential to receive milestone payments related to future regulatory approvals in further indications, beyond biliary tract cancer and GEA, totaling $89.0 million, collectively, from Jazz and BeOne. For Jazz this includes a $50.0 million milestone payment upon regulatory approval of zanidatamab from the U.S. Food and Drug Administration in a third indication and a $25.0 million milestone payment upon regulatory approval of zanidatamab from the European Commission in a third indication. For BeOne this includes a $4.0 million payment upon first patient dosed with zanidatamab in a third registrational study in the territory and a $10.0 million payment upon approval of zanidatamab by a regulatory authority for the third indication in the territory.

Under the collaboration agreement with Jazz, Zymeworks is eligible to receive tiered royalties of 10% to high teens on global annual sales of Ziihera up to $2.0 billion and 20% on annual net sales above $2.0 billion. Jazz holds global marketing rights to Ziihera, excluding Asia, and holds marketing rights in Japan.

Under the collaboration agreement with BeOne, Zymeworks is eligible to receive tiered royalties of mid-single to mid-double digits on global annual net sales of Ziihera up to $1.0 billion and 19.5% on annual net sales above $1.0 billion. BeOne holds marketing rights to Ziihera in Asia (excluding Japan).

Zymeworks expects that royalty revenue from Ziihera sales will increase as potential regulatory approvals are obtained in global markets for GEA. In addition, Zymeworks could be eligible to receive future commercial milestones totaling $977.5 million and increased royalties as additional indications of Ziihera are developed, approved and commercialized by Jazz and BeOne.

Pasritamig

In 2025, J&J initiated two Phase 3 trials studying pasritamig as monotherapy in late-line metastatic castration-resistant prostate cancer (mCRPC) and pasritamig in combination with docetaxel in participants with metastatic castration-resistant prostate cancer (KLK2-PASenger).

In February 2026, J&J presented new clinical data on pasritamig at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO-GU) annual meeting as follows:

Poster – 171: Safety and efficacy of pasritamig + docetaxel in participants with metastatic castration-resistant prostate cancer: Initial results of a phase 1b study.
Poster – 172: Phase 1 safety, efficacy, pharmacokinetics and pharmacodynamics of pasritamig in Asian population with mCRPC.

We remain eligible to receive up to $18.0 million in development milestone payments and up to $186.5 million in commercial milestone payments relating to pasritamig, as well as royalties on product sales.

Share Repurchase Program Update

In November 2025, the Board of Directors authorized a new share repurchase program providing the ability to repurchase up to $125.0 million in common stock. This followed the completion of a $60.0 million share repurchase program originally announced in August 2024. The share repurchase program underscores our confidence in Zymeworks’ long-term growth prospects and helps enhance shareholder value by reducing share count, while maintaining cash resources for operations and growth investments and preserving financial flexibility for strategic opportunities.

As of March 2, 2026, the Company has utilized approximately $62.5 million of this approved repurchase program to acquire 2,580,415 shares at an average price of $24.22 per share (exclusive of commission expense and estimated excise tax). As of March 2, 2026, the Company had approximately 73,749,607 million common shares outstanding (unaudited).

Financial Outlook

Operating Expense Discipline: In January 2026, the Company provided guidance on adjusted gross operating expense (non-GAAP), which combines adjusted research and development (R&D) expense (non-GAAP) and adjusted general and administrative (G&A) expense (non-GAAP) (excluding stock compensation expense), outlining a disciplined framework of approximately $300.0 million in aggregate adjusted gross operating expenditures (non-GAAP) over a three-year period ending December 31, 2028. The Company also announced that it expects a greater proportion of adjusted gross operating expense (non-GAAP) to be incurred in 2026 and decline in 2027 and 2028, reflecting a deliberate and measured investment across R&D and G&A aligned with clearly defined strategic priorities. This outlook reflects current expectations, underscores the Company’s continued focus on cost discipline and capital allocation rigor, and does not include any potential acquisition-related expenses or new partnerships and collaborations. The Company’s GAAP gross operating expenses in 2025 were $198.5 million and the Company currently expects adjusted gross operating expenses (non-GAAP) in 2026 to be approximately 20% lower than adjusted gross operating expenses (non-GAAP) in 2025 of $170.5 million, excluding the impact of any acquisition-related expenses or new partnerships and collaborations.

Financial Results for the Quarter and Year Ended December 31, 2025

The key financial highlights for our 2025 results are as follows:

Revenue – Total revenue was $2.5 million in 4Q-2025, and $106.0 million for 2025, compared to $31.0 million and $76.3 million for the same periods in 2024, respectively. The increase for the year was driven mainly by achievement of significant clinical and regulatory milestones and exercise of an option under our collaborations with J&J, BeOne, GSK, Daiichi Sankyo, and BMS, which collectively contributed to the majority of the year‑over‑year growth. This growth was partially offset by a decline in development‑support and drug‑supply revenue from Jazz, reflecting the transition of responsibility for certain zanidatamab clinical activities to Jazz under our amended agreements. As Jazz continues to assume these activities, we expect development‑support revenue from Jazz to continue decreasing, while royalty revenue from Jazz is expected to grow over time as commercial sales of Ziihera increase.

Research and Development (R&D) Expenses – R&D expenses were $31.2 million in 4Q-2025, and $137.0 million for 2025, compared to $37.1 million and $134.6 million for the same periods in 2024, respectively. The increase for the year was primarily due to an increase in preclinical and research expenses for ZW209 and ZW1528 and higher costs from the progression of clinical studies for ZW251, ZW191 and ZW171 until ZW171 was discontinued. The increase was also driven by non-cash stock-based compensation expense and an increase in consulting and rent expense. These impacts were partially offset by reduced spending on ZW220 (paused), zanidatamab (transitioned to Jazz), and zanidatamab zovodotin (discontinued in 2023).

General and Administrative (G&A) Expenses – G&A expenses were $15.4 million in 4Q-2025, and $61.5 million for 2025, compared to $16.2 million and $61.5 million for the same periods in 2024, respectively. Year-over-year changes were driven by an increase in non-cash stock-based compensation, offset by a decrease in salaries and benefits due to reduced headcount, consulting, rent, and information technology expenses.

Other Income, net – Other income was $2.7 million in 4Q-2025, and $12.8 million for 2025, compared to $4.4 million and $20.5 million for the same periods in 2024, respectively. The change for the year was driven primarily by lower interest income due to a reduction in cash, cash equivalents and marketable securities as well as by a net foreign exchange loss.

Net Loss – Net loss was $41.2 million in 4Q-2025, and $81.1 million for 2025, compared to a net loss of $23.5 million and $122.7 million for the same periods in 2024, respectively. The change for the year was primarily due to an increase in revenue and decreases in total operating expenses and in income tax expense, partially offset by a decrease in interest income.

Liquidity – As of December 31, 2025, we had $270.6 million of cash resources consisting of cash, cash equivalents and marketable securities, comprised of $41.2 million in cash and cash equivalents and $229.4 million in marketable securities. Based on current operating plans, and assuming full execution of the $125.0 million share repurchase plan, we expect our existing cash resources as of December 31, 2025, when combined with anticipated regulatory milestone payments of $440.0 million related to the potential approvals of Ziihera in GEA in the U.S., Europe, Japan, and China, as well as the net proceeds from our royalty-backed note financing with Royalty Pharma, to fund our planned operations beyond 2028. This anticipated cash runway does not take into account any contribution from additional future milestone payments or royalties related to Ziihera, other current licensed product candidates or contributions from future partnerships and collaborations.

(Press release, Zymeworks, MAR 2, 2026, View Source [SID1234663201])

On March 2, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported its participation in upcoming investor conferences. Presentation details with President and Chief Executive Officer, Mark Velleca, M.D., Ph.D. and Chief Scientific Officer Elizabeth Buck, Ph.D., are as follows:

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46th Annual TD Cowen Healthcare Conference presentation at 1:10pm ET on Wednesday, March 4, 2026
25th Annual Needham Virtual Healthcare Conference presentation at 3:00pm ET on Wednesday, April 15, 2026

Webcasts will be available at the start of the presentations on the investor relations section of the Company’s website, www.blackdiamondtherapeutics.com. Replays of the presentations will also be available and archived on the site for 90 days. The Company will also meet with investors at the Raymond James BioPharma Conference on Tuesday, April 14, 2026.

(Press release, Black Diamond Therapeutics, MAR 2, 2026, View Source [SID1234663170])

On March 2, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, reported it has entered into an agreement with funds managed by Pharmakon Advisors, LP (Pharmakon) to revise the terms of its loan agreement entered into in March 2024.

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On February 26, 2026, the Company entered into an amended and restated loan agreement with funds managed by Pharmakon for a senior secured term loan of up to $250 million in two tranches. The first tranche of $200 million was funded at closing to refinance the existing $125 million loan facility and provide additional non-dilutive capital. The second tranche of $50 million may be drawn at the Company’s discretion no later than June 30, 2027, subject to customary closing conditions. All outstanding loans with funds managed by Pharmakon will accrue interest at a fixed rate of 8.25% and be repaid in four equal quarterly payments commencing in the first quarter of 2030. There are no financial covenants associated with the amended loan.

"We are pleased to announce our expanded partnership with Pharmakon," said Chris Degnan, Chief Financial Officer of UroGen. "This refinancing strengthens UroGen’s financial position by lowering our overall cost of capital, extending our maturity profile, and enhancing balance sheet flexibility. Importantly, it provides meaningful capital to support life-cycle management of our approved products and advancement of our pipeline. With a fixed interest rate and favorable long-dated maturity, this structure better positions UroGen to execute its long-term growth strategy and create value for both patients and shareholders."

"Pharmakon is proud to continue supporting UroGen’s mission to address meaningful unmet needs in urothelial cancers," said Martin Friedman, Principal at Pharmakon. "We have strong confidence in the company’s portfolio and commercial foundation, and this updated debt facility reflects our longstanding partnership and conviction in UroGen’s strategy as it enters its next phase of growth."

TD Cowen acted as the exclusive financial advisor to UroGen on the transaction. Cooley LLP acted as legal advisor to UroGen. Akin Gump acted as legal advisor to Pharmakon.

(Press release, UroGen Pharma, MAR 2, 2026, View Source [SID1234663186])

On March 2, 2026 Egle Therapeutics SAS (Egle), a clinical-stage biotechnology company pioneering precision medicines that modulate regulatory T cells (Tregs) to rebalance immune function in patients with autoimmune diseases and cancer, reported it was awarded approximately €8 million in grant funding by Horizon Europe, the European Commission’s key funding program for research and innovation. This funding from the European Union will support an Egle-led initiative in partnership with a consortium of four leading European scientific institutions to advance the clinical development of EGL-001, a novel anti-CTLA-4 x IL-2m fusion protein, and to facilitate a comprehensive translational research program to de-risk later-stage clinical development.

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"This Horizon Europe funding strengthens our ability to advance EGL-001’s clinical development and significantly expand the translational research needed to guide patient selection alongside several leading European partners. The grant enables the evaluation of EGL-001 by studying therapy-naïve patients in the neoadjuvant setting and focusing on head and neck squamous cell carcinoma as a single, well-defined indication," said John Celebi, CEO of Egle Therapeutics. "In parallel, we are advancing our ongoing Phase 1/2 study of EGL-001, where it has been well tolerated with early signs of single-agent activity in PD-(L)1-resistant disease. We remain on track to report top-line data from this study in the second half of this year and look forward to bringing our Treg-focused product candidates closer to patients in need."

As part of this initiative, Egle will collaborate with University College London (United Kingdom), Vall d’Hebron Institute of Oncology (VHIO) (Spain), Gustave Roussy (France), and Technical University of Dresden (Germany) to conduct a multicenter, randomized, open-label Phase 1/2 neoadjuvant clinical trial in patients with head and neck squamous cell carcinoma (HNSCC), a high-incidence, high-mortality cancer with limited benefit from current immunotherapies. This trial will evaluate the safety, tolerability, and early efficacy of EGL-001 in combination with pembrolizumab in these patients.

This initiative also integrates a comprehensive translational research program, including multi-omics profiling, immune monitoring, and AI-driven pathomics modeling, to deliver predictive biomarkers for patient stratification, ultimately supporting regulatory alignment and de-risking later-stage development. The consortium also provides cutting-edge expertise in immunology, genomics, pathology, and computational biology, alongside established clinical trial capacity across EU member states.

"EGL-001 represents a highly differentiated, Treg-based approach to cancer treatment that is designed to selectively disarm and remove regulatory T cells inside tumors, making tumor types with prominent Treg-driven immune suppression, including HNSCC, compelling settings for clinical evaluation," said Prof. Aurélien Marabelle, M.D., Ph.D., Gustave Roussy Cancer Center. "In addition, this project incorporates a rigorous, clinically actionable framework to evaluate a novel approach to tumor-driven immune suppression and to rapidly generate translational insights that can inform future development and patient selection. On behalf of the consortium partners, we are excited to partner with Egle to advance this work and generate the clinical and translational evidence needed to bring new options like EGL-001 to patients."

About EGL-001
EGL-001 is an investigational anti-CTLA-4-IL-2m fusion protein designed to selectively disarm and remove regulatory T cells (Tregs) in the tumor microenvironment and to block CTLA-4 to help restore effector T-cell priming and function. This dual-target approach is intended to induce tumor-selective Treg apoptosis through an Fc receptor-independent mechanism, with the goal of strengthening anti-tumor immunity while supporting tolerability and use in combination regimens, including with PD-(L)1 inhibitors. EGL-001 is currently being evaluated in an ongoing multicenter, open-label, first-in-human Phase 1/2 clinical trial (NCT06622486) in patients with selected advanced and/or metastatic solid tumors, with dose escalation underway both as a single agent and in combination with an anti-PD-(L)1 therapy to assess safety, tolerability, and preliminary anti-tumor activity and to identify recommended doses for expansion.

(Press release, Egle Therapeutics, MAR 2, 2026, View Source [SID1234663202])