On August 5, 2026 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the second quarter ended June 30, 2026.

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"We are excited to present XmAb819 results at ESMO (Free ESMO Whitepaper) this fall and for other fast-approaching key milestones across our wholly owned clinical pipeline," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Enrollment remains on track for updates later this year for XmAb942 in the XENITH-UC study and for our two B-cell depleting bispecifics, plamotamab and XmAb657, in their respective Phase 1 studies. And we recently started the Phase 1 study of XmAb412, our first XenLock bispecific antibody, and plan to have healthy participant data in the first half of 2027. Xencor’s focus on clinical execution and data delivery is setting us up for an accelerating tempo of anticipated readouts in 2027 and beyond."

"Consistent with our focus on efficient clinical decision-making, we have prioritized the ongoing combination study of XmAb541 and XmAb808, which provides tumor-targeted co-stimulation through CD28 agonism, after observing moderate anti-tumor activity from early monotherapy data of XmAb541. CLDN6 remains a challenging tumor target, and we hope to expand upon an emerging therapeutic window through the orthogonal targeting provided by XmAb808."

Wholly Owned Pipeline Overview

XmAb819 (ENPP3 x CD3), a potential first-in-class, tumor-targeted, T-cell engaging XmAb 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma and other tumors with high ENPP3 expression, including colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma

Clear cell renal cell carcinoma (ccRCC): On track to initiate a registration enabling study of XmAb819 as a monotherapy in advanced ccRCC during 2027.
•Phase 1 results for patients with advanced ccRCC were accepted for a proffered paper oral presentation at the European Society For Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, to be held October 23-27 in Madrid, Spain. The presentation during ESMO (Free ESMO Whitepaper) will focus on dose levels in intravenous expansion cohorts under evaluation as recommended Phase 3 doses (RP3D).

•Dose escalation of subcutaneous administration in advanced ccRCC is ongoing with evaluation for further development expected prior to a registration enabling study.
•A sub-study for patients with intermediate- or poor-risk advanced ccRCC who have progressed after nivolumab in combination with ipilimumab as a first-line treatment (IO doublet therapy) is planned to open for enrollment in the third quarter of 2026.
•A sub-study evaluating the combination of XmAb819 and anti-PD1 therapy in patients with advanced ccRCC is currently being planned.

Additional tumors with high ENPP3 expression
•A sub-study for patients with ENPP3+ advanced colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma began enrollment in the second quarter of 2026.

XmAb541 (CLDN6 x CD3) in combination with XmAb808 (B7-H3 x CD28), in Phase 1 clinical development for T-cell engagement of Claudin-6 expressing tumors, including high-grade serous ovarian cancer

XmAb541 development in the ongoing Phase 1 dose-escalation study in combination with XmAb808 has been prioritized. XmAb541 monotherapy expansion cohorts at the putative RP3D (60 mg dosed every 3 weeks) in high-grade serous ovarian carcinoma (TPS≥50) and germ cell tumors are expected to complete enrollment by year end, with the data supporting combination development with XmAb808. The Phase 1 dose-escalation study of XmAb541 and XmAb808 is ongoing and expected to reach the combination’s target dose range in 2027. Prioritization of the combination is anticipated to reduce projected overall XmAb541 program expense for 2027 and 2028.

XmAb541 Clinical Data
•Emerging data from XmAb541 monotherapy indicate clinical activity to date at the putative RP3D in heavily-pretreated patients, with an approximate 14% overall response rate (ORR) in patients with ovarian cancer and an approximate 28% ORR in patients with germ cell tumors, which supports further evaluation in combination with XmAb808 to provide tumor-targeted CD28 agonism and additional T-cell stimulation.
•Potential additional anti-tumor activity was observed at doses above 60 mg, but reversible hearing impairment limited XmAb541 drug exposure due to the frequency of dose interruptions and dose reductions. Hearing impairment is potentially on target for CLDN6, which is expressed on cochlear hair cells.
•Cytokine release syndrome (CRS) has been low grade and no cases of Grade ≥3 CRS were reported at any dose level. At the putative RP3D, Grade 1 CRS was reported in approximately 14% of patients, and Grade 2 CRS was reported in approximately 17%.
•No other clinically significant safety signals were observed, and the profile is supportive of future outpatient administration.
•Based on monotherapy data, in July 2026 the U.S. FDA granted Fast Track designation to XmAb541 for the treatment of patients with germ cell tumors who have relapsed following two or more lines of platinum therapy or were refractory to prior platinum therapy.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026, Xencor presented data demonstrating the co-expression of CLDN6 and B7-H3 on high-grade serous ovarian carcinoma cells. Preclinical testing demonstrated that XmAb808 promoted durable T-cell-directed killing of cancer cells with XmAb541, enhanced XmAb541-induced killing by exhausted T cells, and enhanced anti-tumor activity of XmAb541. CLDN6 and B7-H3 have low expression overlap on normal tissues, potentially localizing T-cell co-stimulation to tumor cells.

XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease
•Xencor is conducting the XENITH-UC Study, a global Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderately to severely active UC, whose disease has progressed after at least one conventional or advanced therapy.
•Enrollment expectations continue to support a XENITH-UC blinded interim analysis around year-end 2026 and reaching the primary endpoint of the 12-week induction period in 2H27. The primary endpoint of XENITH-UC is the percentage of patients achieving clinical remission defined by the modified Mayo score at week 12.

XmAb412 (TL1A x IL23p19), a potential best-in-class, extended half-life bispecific antibody for dual targeting of inflammatory pathways in autoimmune and inflammatory disease, in Phase 1 development and enrolling healthy participants
•XmAb412 robustly suppresses both TL1A and IL-23 inflammatory pathways and is predicted to have a human half-life between 60 and 70 days. XmAb412 supports high-concentration, low viscosity and citrate-free formulation suitable for subcutaneous dosing. XmAb412 is Xencor’s first novel bispecific antibody developed using the XenLock platform.
•Xencor initiated a first-in-human study of XmAb412 in the third quarter of 2026 and plans to present initial data from the study in 1H27.

Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in Phase 1 development for patients with rheumatoid arthritis (RA), who have progressed through prior standard-of-care treatment
•Xencor plans to provide an update on progress achieved in the Phase 1b study of plamotamab in RA in 2H26.

XmAb657 (CD19 x CD3), a clinical-stage, potent, extended half-life B-cell depleting bispecific T-cell engager in Phase 1 dose escalation, enrolling healthy participants and patients with idiopathic inflammatory myopathies, systemic scleroderma and Sjögren’s disease
•Xencor plans to provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26.
Recent Partnership Developments
•Alexion: In July 2026, Xencor announced that it will receive $105 million from Alexion pursuant to a settlement agreement that resolves the previously disclosed dispute regarding U.S. royalties from sales of Ultomiris. Under the settlement agreement, Alexion is obligated to pay Xencor in two equal installments. The first $52.5 million payment is anticipated in August 2026, the second $52.5 million payment within 14 days following the one-year anniversary of the date of the settlement agreement, and Alexion will have no further obligation to pay royalties on U.S. sales of Ultomiris. Xencor expects to continue receiving royalties on ex-U.S. sales of Ultomiris under the existing terms of its license agreement with Alexion. Ultomiris is a drug being developed and commercialized by Alexion and is its registered trademark.

•Zenas BioPharma: In May 2026, Zenas submitted a biologics license application (BLA) to the U.S. FDA for obexelimab in IgG4-related disease, and Xencor received a $10 million regulatory milestone payment in June 2026 in connection with this BLA submission. Obexelimab targets CD19 with its variable domain and uses an XmAb Immune Inhibitor Fc Domain. In November 2021, Xencor licensed obexelimab to Zenas, and under the license agreement, Xencor is eligible to receive up to $450 million in future milestone payments and tiered royalties on net sales that range from mid-single-digit to mid-teen percentages, dependent on geography.
Financial Guidance: Based on current operating plans, Xencor expects to end 2026 with between $420 million and $440 million in cash, cash equivalents and marketable debt securities, and to have sufficient cash resources to fund research and development programs and operations through 2028.

Financial Results for the Second Quarter Ended June 30, 2026

Cash, cash equivalents and marketable debt securities totaled $486.4 million as of June 30, 2026, compared to $610.8 million as of December 31, 2025.

Revenue for the second quarter ended June 30, 2026 was $51.2 million, compared to $43.6 million for the same period in 2025. Revenue earned in the second quarter of 2026 was primarily milestone revenue from Zenas BioPharma and royalty revenue from Alexion and Incyte.

As the Settlement Agreement with Alexion resolved the uncertainty surrounding the variable consideration associated with U.S. Ultomiris royalties, the Company recognized $27.6 million of royalty revenue during the second quarter ended June 30, 2026, representing royalty attributable to U.S. Ultomiris sales during the dispute period through June 30, 2026. The remaining $77.4 million of settlement consideration relates to royalty rights for periods subsequent to June 30, 2026 and will be recognized in the third quarter of 2026.

Research and development (R&D) expenses for the second quarter ended June 30, 2026 were $71.9 million, compared to $61.7 million for the same period in 2025. Increased R&D spending for the second quarter of 2026 compared to 2025 is primarily due to increased spending on pipeline programs, partially offset by lower stock-based compensation expense.

General and administrative (G&A) expenses for the second quarter ended June 30, 2026 were $16.4 million, compared to $15.1 million for the same period in 2025. G&A spending for the second quarter of 2026 compared to 2025 remained relatively consistent.

Other income, net, for the second quarter ended June 30, 2026 was $15.1 million, compared to $2.1 million for the same period in 2025. Increased other income, net, for the second quarter of 2026, compared to 2025, is primarily due to unrealized gains on an equity security.

Net loss attributable to Xencor for the second quarter ended June 30, 2026 was $21.7 million, or $(0.29) on a fully diluted per share basis, compared to net loss of $30.8 million, or $(0.41) on a fully diluted per share basis, for the same period in 2025.

(Press release, Xencor, AUG 5, 2026, View Source [SID1234669734])

On August 5, 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 second quarter ended June 30, 2026, and provided an overview of recent developments.

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"The second quarter marked another important step in establishing ZUSDURI as a foundational therapy for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer," said Liz Barrett, President and Chief Executive Officer of UroGen. "The continued increase in utilization, expanding adoption across community practices, and growing repeat use reinforce our confidence we are building a durable commercial franchise with blockbuster potential. During the quarter, we strengthened the long-term sustainability of the franchise through a new U.S. patent allowance that, once the patent is issued, is expected to provide intellectual property coverage for both ZUSDURI and UGN-103 into July 2044. We believe this meaningfully enhances the long-term commercial opportunity for both products and further reinforces the sustainability of the franchise. Combined with the life-cycle expansion of UGN-103 and initiation of clinical development for UGN-501, we believe we are exceptionally well positioned to build a durable growth company and create long-term shareholder value."

Q2 2026 and Recent Business Highlights:

ZUSDURI (mitomycin) for intravesical solution:

•

ZUSDURI achieved net product revenue of $50.4 million in the second quarter of 2026, representing 73% growth over the first quarter of 2026. As of June 30, 2026, UroGen reported:

•

1,444 activated sites of care

•

452 unique ZUSDURI prescribers

•

204 repeat ZUSDURI prescribers, representing approximately 45% of total prescribers, up from 40% in the first quarter of 2026

Updated results from the Phase 3 ENVISION trial of ZUSDURI showed a 36-month duration of response (DOR) of 64.5% (95% CI: 54.6, 72.8) by Kaplan-Meier estimate among patients who achieved a complete response (CR) at three months (79.6%). At a median follow-up of 35.5 months, the median DOR had not been reached. ZUSDURI’s durability was achieved without maintenance therapy, supporting a treatment approach that can provide lasting disease control while reducing treatment burden for patients.

•

UroGen received a Notice of Allowance from the U.S. Patent and Trademark Office for a new U.S. patent covering methods of treating patients with recurrent, low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) without transurethral resection of bladder tumor (TURBT). Once issued, the patent is expected to provide protection into July 2044, further strengthening the intellectual property supporting ZUSDURI and UGN-103 and reinforcing the long-term commercial opportunity for both products.

American Urological Association (AUA) Key Opinion Leader Webinar:
•

On May 17, 2026, UroGen hosted a Key Opinion Leader webinar at the AUA Annual Meeting in Washington, D.C., focused on real-world experience with ZUSDURI. The discussion highlighted patient selection, workflow integration, treatment patterns, and physician experience across both hospital and community practices, reinforcing growing confidence in the use of ZUSDURI in routine clinical practice. A replay of the event is accessible through the Investors section of the Company’s website.

JELMYTO (mitomycin) for pyelocalyceal solution in LG-UTUC:

•

Generated net product revenue of $22.0 million in the quarter ended June 30, 2026, compared with $24.2 million reported for the second quarter of 2025. The Company continues to add new users and remains on track to deliver within its JELMYTO full-year 2026 guidance range of $97 million to $101 million.

•

UroGen entered into a settlement and license agreement with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals, USA, Inc. (collectively, "Teva") that resolves the patent litigation UroGen initiated in response to Teva’s submission of an Abbreviated New Drug Application to the U.S. FDA for a generic version of JELMYTO prior to the expiration of the relevant UroGen patents. Under the terms of the agreement, UroGen granted Teva a non-exclusive license to sell its generic version of JELMYTO beginning on September 15, 2030, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur.

Next-generation novel mitomycin-based formulations for urothelial cancer:

•

UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) DOR at six months by Kaplan-Meier estimate, in the ongoing Phase 3 UTOPIA trial in patients with LG-IR-NMIBC. The six-month results from UTOPIA are generally consistent with the 91.9% (95% CI: 86.9, 95.0) six-month DOR by Kaplan-Meier estimate observed with ZUSDURI in the pivotal ENVISION trial.

•

UroGen remains on track to submit a New Drug Application (NDA) for UGN-103 in the third quarter of 2026, with potential FDA approval in 2027 and full launch anticipated following receipt of a unique J-Code. UGN-103 is designed to build on the clinical and commercial foundation of ZUSDURI. The benefits of UGN-103 include a more streamlined manufacturing process and simplified reconstitution, while preserving the innovative and proven RTGel technology that enables sustained drug exposure at tumor sites in the bladder.

•

The Company expects to initiate a randomized controlled Phase 3 trial evaluating UGN-103 in high-risk NMIBC in the second half of 2026, and a trial evaluating UGN-103 as adjuvant therapy in newly diagnosed intermediate-risk NMIBC patients in 2027.

•

The Phase 3 clinical trial evaluating UGN-104 in low-grade upper tract urothelial cancer (LG-UTUC) remains on track to complete enrollment by the end of 2026.

UGN-501 (investigational next-generation oncolytic virus) for use in high-grade non-muscle invasive bladder cancer:

•

UroGen’s Investigational New Drug application for UGN-501 has been accepted by the FDA, and the Company plans to initiate its Phase 1 clinical trial in NMIBC in the fourth quarter of 2026.

Second Quarter 2026 Financial Results

Revenue: Total revenue was $72.5 million in the second quarter ended June 30, 2026, compared with $24.2 million in the second quarter of 2025. The increase was driven by the continued commercial launch of ZUSDURI.

Research and Development (R&D) Expenses: R&D expenses were $17.3 million in the second quarter of 2026, including non-cash share-based compensation expense of $0.9 million. This compares to $18.9 million, including non-cash share-based compensation expense of $0.4 million, in the same period in 2025. The decrease in R&D expenses was primarily attributable to ZUSDURI manufacturing costs, which were recognized as an R&D expense in the second quarter of 2025 prior to receiving FDA approval.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $48.4 million in the second quarter of 2026, including non-cash share-based compensation expense of $4.4 million. This compares to $43.2 million, including non-cash share-based compensation expense of $2.3 million, in the same period in 2025. The increase in SG&A expenses was primarily attributable to ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval and higher brand marketing expenses, and 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 $4.5 million in the second quarter of 2026, compared with $4.6 million in the same period in 2025.

Interest Expense on Long-term Debt: Interest expense related to long-term debt was $4.9 million in the second quarter of 2026, compared with $4.1 million in the same period in 2025. The increase in interest expense was primarily attributable to the additional borrowings of $75.0 million in the first quarter of 2026 in connection with the Pharmakon refinancing of long-term debt, offset by the lower interest rate.

Net Loss: UroGen reported a net loss of $14.4 million, or $0.28 per basic and diluted share, in the quarter ended June 30, 2026, compared with a net loss of $49.9 million, or ($1.05) per basic and diluted share, in the second quarter of 2025.

Cash, Cash Equivalents and Marketable Securities: As of June 30, 2026, cash, cash equivalents and marketable securities totaled $108.0 million.

2026 JELMYTO Revenue and Updated Company Operating Expense Guidance: The Company continues to expect 2026 net product revenue for JELMYTO 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 revenue reported in 2025. The Company is not providing full-year 2026 revenue guidance for ZUSDURI at this time, as the product remains in the early stages of its commercial launch. The Company is increasing its full-year 2026 operating expenses guidance to be in the range of $260 million to $270 million, including non-cash share-based compensation expense of $20 million to $24 million. The increase reflects the decision to accelerate investment behind the business in response to the continued strength of the ZUSDURI launch. Specifically, the Company plans to increase investment in ZUSDURI peer-to-peer promotional education and patient awareness initiatives to support long-term commercial adoption, and also accelerate start-up activities for the UGN-103 high-grade NMIBC trial and development activities of UGN-501 with RTGel.

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.

UROGEN PHARMA LTD.

SELECTED CONSOLIDATED BALANCE SHEETS

(U.S. dollars in thousands)

(Unaudited)

June 30, 2026

December 31, 2025

Cash and cash equivalents and marketable securities

$ 107,976

$ 120,456

Total assets

$ 252,590

$ 200,455

Total liabilities

$ 384,986

$ 305,929

Total shareholders’ deficit

$ (132,396)

$ (105,474)

UROGEN PHARMA LTD.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(U.S. dollars in thousands, except share and per share data)

(Unaudited)

Three months ended June 30,

Six months ended June 30,

2026

2025

2026

2025

Revenue

$ 72,456

$ 24,215

$ 123,415

$ 44,469

Cost of revenue

6,572

3,550

10,711

5,880

Gross profit

65,884

20,665

112,704

38,589

Operating expenses:

Research and development expenses

17,336

18,914

32,933

38,785

Selling, general and administrative expenses

48,437

43,199

99,923

78,166

Total operating expenses

65,773

62,113

132,856

116,951

Operating income (loss)

111

(41,448)

(20,152)

(78,362)

Financing on prepaid forward obligation

(4,545)

(4,644)

(9,051)

(9,227)

Interest expense on long-term debt

(4,887)

(4,132)

(9,072)

(8,200)

Interest and other income, net

599

1,299

1,207

3,413

Loss before income taxes

$ (8,722)

$ (48,925)

$ (37,068)

$ (92,376)

Income tax expense

(5,629)

(1,015)

(857)

(1,407)

Net loss

$ (14,351)

$ (49,940)

$ (37,925)

$ (93,783)

Net loss per ordinary share basic and diluted

$ (0.28)

$ (1.05)

$ (0.75)

$ (1.97)

Weighted average shares outstanding, basic and diluted

50,380,112

47,739,816

50,282,221

47,582,610

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means.

APPROVED USE FOR ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove a tumor that did not work or is no longer working.

IMPORTANT SAFETY INFORMATION

You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.

Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:

●

have kidney problems.

●

are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.

Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.

Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose.

●

are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.

How will I receive ZUSDURI?
●

You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

●

During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

After receiving ZUSDURI:

●

ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.

●

To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.

●

Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel approved for the treatment of adult patients with LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through a nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemo-ablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

●

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.

●

are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.

●

Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?
●

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.

●

You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.

●

JELMYTO is given to your kidney through a tube called a catheter.

●

During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

●

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.

●

To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.

●

Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

●

JELMYTO may cause serious side effects, including:

●

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.

Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.

●

The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

(Press release, UroGen Pharma, AUG 5, 2026, View Source [SID1234669733])

On August 5, 2026 Royalty Pharma plc (Nasdaq: RPRX) reported financial results for the second quarter of 2026 and raised full year 2026 guidance for Portfolio Receipts.

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"Royalty Pharma delivered strong second quarter results with Royalty Receipts growth of 14%," said Pablo Legorreta, Royalty Pharma’s Chief Executive Officer and Chairman of the Board. "Our transaction pipeline remains exciting and we continued to bolster our development-stage pipeline in recent months, bringing total Capital Deployment to over $1 billion so far in 2026. Following our acquisition of a royalty on AstraZeneca’s cliramitug, our development-stage pipeline now totals 19 potential therapies. Lastly, our strong financial performance has allowed us to raise our top-line guidance for the second time this year, driven by the strength of our diversified portfolio. The fundamental tailwinds supporting our business are compelling and we remain well positioned as a premier capital allocator in life sciences to deliver consistent, compounding growth."

Double-digit growth in Royalty Receipts in the second quarter of 2026
•Royalty Receipts grew 14% to $768 million, driven by Tremfya, Voranigo, Imdelltra and Evrysdi.
•Portfolio Receipts increased by 6% to $773 million, reflecting lower milestones and other contractual receipts.
Strong transaction activity
•Acquired royalty on AstraZeneca’s cliramitug for transthyretin amyloidosis with cardiomyopathy in July 2026.
•Announced value of transactions of $1.7 billion and Capital Deployment of $1.1 billion as of August 4, 2026.
Positive portfolio updates
•Revolution Medicines’ NDA for daraxonrasib in pancreatic cancer accepted for review by FDA and the EMA has started its accelerated review; Gilead’s Trodelvy received FDA and EC approval for first-line metastatic triple-negative breast cancer; GSK’s Jideytro received FDA approval for ROS1+ non-small cell lung cancer; Amgen’s Imdelltra received EC approval for small cell lung cancer.
•GSK completed the acquisition of Nuvalent (Jideytro and neladalkib for lung cancer); Teva completed the acquisition of Emalex Biosciences (ecopipam for Tourette syndrome).
Raising financial guidance for full year 2026 (excludes contribution from future transactions)
•Royalty Pharma now expects 2026 Portfolio Receipts to be between $3,400 million and $3,500 million (previously $3,325 million to $3,450 million), representing expected Royalty Receipts growth of 7% to 10%.

Financial & Liquidity Summary
Three Months Ended June 30,
($ and shares in millions; unaudited)
2026 2025 Change
Portfolio Receipts 773 727 6%
Net cash provided by operating activities 728 364 100%
Adjusted EBITDA (non-GAAP)* 736 633 16%
Portfolio Cash Flow (non-GAAP)* 736 641 15%
Weighted average Class A ordinary shares outstanding – diluted 557 562 (1)%

2026 Financial Outlook
Royalty Pharma has provided guidance for full year 2026, excluding new transactions and borrowings announced after the date of this release, as follows:
Provided August 5, 2026
Previous
Portfolio Receipts
$3,400 million to $3,500 million
$3,325 million to $3,450 million
Payments for operating and professional costs
5.5% to 6.5% of Portfolio Receipts
5.5% to 6.5% of Portfolio Receipts
Interest paid
$350 million to $360 million
$350 million to $360 million

Portfolio Receipts is defined as the sum of Royalty Receipts and Milestones and other contractual receipts. The above Portfolio Receipts guidance provided on August 5, 2026 includes expected Royalty Receipts growth of 7% to 10% in 2026.
Royalty Pharma’s full year 2026 guidance reflects an estimated foreign exchange impact of approximately +1% to Portfolio Receipts, assuming current foreign exchange rates prevail for the rest of 2026.
Payments for operating and professional costs in 2026 are expected to decrease as a percentage of Portfolio Receipts, compared to 8.9% in 2025, primarily due to extinguishment of the management fee following the completion of the internalization transaction on May 16, 2025.
Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and the quarterly interest payment schedules for the term loan assumed as part of the internalization transaction and borrowings under our revolving credit facility. In 2026, Royalty Pharma anticipates interest paid to be approximately $350 million to $360 million. Interest paid in the third quarter of 2026 is anticipated to be approximately $175 million, with a de minimis amount anticipated in the fourth quarter of 2026. These projections reflect repayment of the $380 million term loan in July 2026 and assume no additional debt financing in 2026. In the second quarter of 2026, Royalty Pharma collected interest of $5 million on its cash and cash equivalents, which partially offset interest paid.
Royalty Pharma today provides this guidance based on its most up-to-date view of its prospects. This guidance assumes no major unforeseen adverse events or changes in foreign exchange rates and excludes the contributions from transactions announced subsequent to the date of this press release.

Portfolio Receipts Highlights
Three Months Ended June 30,
($ in millions; unaudited)
2026 2025 Change
Products: Marketers: Therapeutic Area:
Cystic fibrosis franchise Vertex Rare disease 194 194 0%
Tysabri Biogen Neuroscience 67 56 19%
Trelegy GSK Respiratory 58 57 3%
Tremfya Johnson & Johnson Immunology 57 37 53%
Evrysdi Roche Rare disease 47 33 42%
Voranigo Servier Oncology 46 26 72%
Xtandi Pfizer, Astellas Oncology 44 42 6%
Imbruvica AbbVie, Johnson & Johnson Oncology 36 44 (16)%
Cabometyx/Cometriq Exelixis, Ipsen, Takeda Oncology 23 20 12%
Imdelltra Amgen Oncology 17 — n/a
Trodelvy Gilead Oncology 14 10 36%
Spinraza Biogen Rare disease 11 12 (11)%
Amvuttra Alnylam Rare disease 9 — n/a
Promacta Novartis Hematology 8 33 (75)%
Other products(5)
139 109 28%
Royalty Receipts 768 672 14%
Milestones and other contractual receipts 5 56 (91)%
Portfolio Receipts 773 727 6%

Amounts shown in the table may not add due to rounding.
Royalty Receipts was $768 million in the second quarter of 2026, an increase of 14% compared to $672 million in the second quarter of 2025. The increase was primarily driven by Tremfya, Voranigo, Imdelltra and Evrysdi, partially offset by declines from Promacta due to U.S. generic competition and from Imbruvica. Royalty Receipts from Evrysdi included the benefit of the additional royalties acquired in December 2025.
Portfolio Receipts was $773 million in the second quarter of 2026, an increase of 6% compared to $727 million in the second quarter of 2025, primarily driven by the same Royalty Receipts increases noted above, partially offset by lower Milestones and other contractual receipts due to a one-time distribution received in the prior year period.

Liquidity and Capital Resources
Royalty Pharma’s liquidity and capital resources are summarized below:
As of June 30, 2026, Royalty Pharma had cash and cash equivalents of $812 million and total debt with principal value of $9.2 billion. In July 2026, Royalty Pharma repaid the $380 million term loan upon maturity.
In the second quarter of 2026, Royalty Pharma paid a quarterly dividend of $0.235 per share, equating to $135 million in dividends and distributions.
Royalty Pharma repurchased approximately 0.9 million Class A ordinary shares for $45 million in the second quarter and two million Class A ordinary shares for $96 million for the first six months of 2026. The weighted-average number of diluted Class A ordinary shares outstanding for the second quarter of 2026 was 557 million, a decline of 1% as compared to 562 million for the second quarter of 2025.
Liquidity Summary
Three Months Ended June 30,
($ in millions; unaudited)
2026 2025
Portfolio Receipts 773 727
Payments for operating and professional costs (37) (94)
Adjusted EBITDA (non-GAAP) 736 633
Interest (paid)/received, net (0) 8
Portfolio Cash Flow (non-GAAP) 736 641

Amounts may not add due to rounding.
•Adjusted EBITDA (non-GAAP) was $736 million in the second quarter of 2026. Payments for operating and professional costs were 4.8% of Portfolio Receipts. Adjusted EBITDA is calculated as Portfolio Receipts minus payments for operating and professional costs.
•Portfolio Cash Flow (non-GAAP) was $736 million in the second quarter of 2026. Portfolio Cash Flow is calculated as Adjusted EBITDA minus interest paid or received, net. This measure reflects the cash generated by Royalty Pharma’s business that can be redeployed into value-enhancing royalty acquisitions, used to repay debt, returned to shareholders through dividends or share purchases, or utilized for other discretionary investments.
Refer to Table 4 for Royalty Pharma’s reconciliation of each non-GAAP measure to the most directly comparable GAAP financial measure, net cash provided by operating activities.
Capital Deployment reflects cash payments during the period for new and previously announced transactions. Capital Deployment was $349 million in the second quarter of 2026, consisting primarily of royalty funding for daraxonrasib and R&D funding for JNJ‑4804 and litifilimab.
The table below details Capital Deployment by category:
Capital Deployment
Three Months Ended June 30, Six Months Ended June 30,
($ in millions; unaudited)
2026 2025 2026 2025
Purchases of available for sale debt securities — (75) — (75)
Acquisitions of financial royalty assets (251) (1) (703) (2)
Development-stage funding payments (98) (301) (123) (351)
Milestone payments — (219) (50) (269)
Contributions from legacy non-controlling interests – R&D — 0 — 0
Capital Deployment (349) (595) (877) (696)

Royalty Transactions
As of August 4, 2026, Royalty Pharma has announced new transactions of up to $1.7 billion, which reflects the entire amount of potential capital committed for new transactions, including potential future milestones.
•In July 2026, Royalty Pharma acquired a portion of Neurimmune AG’s royalty interest in AstraZeneca’s cliramitug for up to $425 million, including $125 million upfront. Cliramitug is a Phase 3 first-in-class transthyretin (TTR)-fibril-depleting antibody designed to remove amyloid deposits in patients with TTR amyloidosis with cardiomyopathy, a progressive, degenerative and fatal disease caused by misfolded proteins that accumulate in the heart.
The information in this section should be read together with Royalty Pharma’s reports and documents filed with the SEC at www.sec.gov and the reader is also encouraged to review all other press releases and information available in the Investors section of Royalty Pharma’s website at www.royaltypharma.com.
Key Developments Relating to the Portfolio
The key developments related to Royalty Pharma’s royalty interests are discussed below based on disclosures from the marketers of the products.
daraxonrasib
In July 2026, Revolution Medicines announced that the U.S. Food and Drug Administration (FDA) accepted for review the company’s New Drug Application (NDA) for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma.
In July 2026, Revolution Medicines announced that the European Medicines Agency (EMA) started an accelerated assessment of daraxonrasib.
In April 2026, Revolution Medicines announced positive Phase 3 results from the RASolute-302 trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic cancer.
Jideytro (zidesamtinib) and neladalkib
In July 2026, GSK announced that the FDA approved Jideytro (zidesamtinib), a ROS proto-oncogene 1 (ROS1)-selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have received a prior ROS1 kinase inhibitor.
In July 2026, GSK announced that it completed the acquisition of Nuvalent for approximately $10.6 billion, including Jideytro (zidesamtinib) and neladalkib, two highly selective ROS1 and anaplastic lymphoma kinase inhibitors for the treatment of non-small cell lung cancer.
In May 2026, Nuvalent announced the FDA accepted its NDA for neladalkib for filing and granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) date of November 27, 2026.
TEV-’408
In July 2026, Teva Pharmaceuticals (Teva) announced plans to advance TEV-’408 into a Phase 2b study in patients with non-segmental vitiligo, following positive Phase 1b results.
deucrictibant
In July 2026, Pharvaris announced that the FDA accepted its NDA for deucrictibant immediate-release for the on-demand treatment of hereditary angioedema attacks and assigned a PDUFA date of April 23, 2027.
Trodelvy
In June 2026, Gilead announced that the FDA approved Trodelvy for the first-line treatment of certain patients with metastatic triple-negative breast cancer.
In June 2026, Gilead announced that the European Commission (EC) approved Trodelvy as a first-line treatment for certain patients with metastatic triple-negative breast cancer who are not candidates for PD-L1 inhibitors.
In June 2026, Gilead announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 study evaluating Trodelvy in combination with Keytruda for patients with previously untreated metastatic non-small cell lung cancer.
ecopipam
In June 2026, Teva announced the completion of its acquisition of Emalex Biosciences for up to $900 million, including $700 million at closing, which added ecopipam and other neuroscience therapies to its portfolio. Furthermore, Teva announced the submission of an NDA to the FDA for ecopipam for the treatment of pediatric Tourette syndrome.
Imdelltra
In June 2026, the EC approved Imdelltra for the treatment of adult patients with extensive-stage small cell lung cancer.
Erleada
In May 2026, Johnson & Johnson announced that the Phase 3 PROTEUS study evaluating Erleada in combination with androgen deprivation therapy before and after radical prostatectomy, in patients with high-risk localized or locally advanced prostate cancer, met its primary endpoints.

obexelimab
In May 2026, Zenas BioPharma announced the submission of a Biologics License Application (BLA) to the FDA for obexelimab for the treatment of Immunoglobulin G4-related disease.
Tremfya
In May 2026, Johnson & Johnson announced that the FDA approved a supplemental BLA for Tremfya to include the inhibition of progression of structural joint damage in adults with active psoriatic arthritis.
TEV-’749
In May 2026, Teva announced that the EMA accepted for review its Marketing Authorization Application for TEV-’749 for the treatment of schizophrenia in adults.
Myqorzo
In May 2026, Cytokinetics announced positive topline results from ACACIA-HCM, the pivotal Phase 3 clinical trial of Myqorzo in patients with non-obstructive hypertrophic cardiomyopathy. The study met both dual primary endpoints, demonstrating statistically significant improvements from baseline to week 36 versus placebo.
Ziihera
In April 2026, Jazz Pharmaceuticals announced that the FDA accepted for filing a supplemental BLA for Ziihera, in combination regimens for the first-line treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic gastroesophageal adenocarcinoma, and granted Priority Review, with a PDUFA date of August 25, 2026.

Financial Results Call
Royalty Pharma will host a conference call and simultaneous webcast to discuss its second quarter of 2026 results today at 8:00 a.m., Eastern Time. Please visit the "Investors" page of the company’s website at View Source to obtain conference call information and to view the live webcast. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

(Press release, Royalty Pharma , AUG 5, 2026, View Source [SID1234669732])

On August 5, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported its financial results for the quarter ended June 30, 2026, and provided an update on corporate progress.

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"This has been a transformational period for Revolution Medicines, as we rapidly translated unprecedented Phase 3 results for daraxonrasib into an active Expanded Access Program and the filing of our first New Drug Application to the U.S. Food and Drug Administration on behalf of patients with previously treated metastatic pancreatic cancer," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "We achieved U.S. launch readiness, advanced regulatory activities globally, and expanded our pancreatic cancer development programs across multiple lines of therapy. Beyond our deep commitment to pancreatic cancer, we are building significant momentum in lung cancer with a differentiated portfolio of RAS(ON) mutant-selective and multi-selective inhibitors designed to provide a broad range of options for patients across multiple stages of disease."

Clinical Highlights

Pancreatic Adenocarcinoma (PDAC)

Daraxonrasib in PDAC

Daraxonrasib, the company’s oral RAS(ON) multi-selective inhibitor, continues to demonstrate a differentiated clinical profile across lines of therapy and in both monotherapy and combination settings. At the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, detailed results from global RASolute 302 were presented in a Plenary Session and published simultaneously in The New England Journal of Medicine. The study demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of overall survival and progression-free survival (PFS) as well as in patient-reported quality of life compared with chemotherapy, with a manageable safety profile.

Following the unprecedented Phase 3 results from RASolute 302, the company announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for daraxonrasib for the treatment of patients with previously treated metastatic PDAC.

The company also announced that the European Medicines Agency (EMA) initiated a phased review of daraxonrasib in pancreatic cancer under its Cancer Medicines Pathfinder project to accelerate regulatory assessment by evaluating in phases as sections become available, ahead of submission of a full Marketing Authorization Application. In addition, daraxonrasib was granted Orphan Drug Status (ODS) by Swissmedic for the treatment of pancreatic cancer. As previously shared, daraxonrasib was also selected for the FDA Commissioner’s National Priority Voucher pilot program, which is designed to accelerate the review of medicines that address key national health priorities.

The company opened an FDA-cleared Expanded Access Program (EAP) in May and within three weeks began distributing daraxonrasib to participating treating physicians on behalf of patients. Since opening the EAP, daraxonrasib has been distributed to physicians on behalf of more than 2,000 patients through participating academic cancer centers and community oncology practices across nearly all 50 U.S. states and Puerto Rico.

The company also enhanced its commercial readiness during the quarter, putting in place the commercialization infrastructure needed to support a successful U.S. launch of daraxonrasib, if approved, while accelerating build out of global commercialization capabilities in preparation for potential international regulatory approvals.

The company continues to advance daraxonrasib across earlier lines of treatment for PDAC through the ongoing global Phase 3 RASolute 303 and RASolute 304 studies evaluating daraxonrasib in the first-line metastatic and adjuvant settings, respectively.

Zoldonrasib in PDAC

At the European Society for Medical Oncology Gastrointestinal Cancers Congress, the company presented new Phase 1/2 clinical data supporting two complementary development strategies for zoldonrasib, the company’s oral RAS(ON) G12D-selective covalent inhibitor, in metastatic PDAC.

•
Zoldonrasib in combination with chemotherapy demonstrated compelling preliminary antitumor activity and manageable safety and tolerability in patients with first-line RAS G12D PDAC. These findings support the ongoing global Phase 3 RASolute 305 trial.
•
The novel RAS(ON) inhibitor doublet of zoldonrasib plus daraxonrasib in previously treated RAS G12D PDAC demonstrated compelling preliminary antitumor activity and a manageable safety and tolerability profile. These findings support the recently initiated global Phase 3 RASolute 309 trial.

Non-Small Cell Lung Cancer (NSCLC)

Revolution Medicines continues to advance a broad RAS-targeted portfolio in NSCLC, with both clinical-stage RAS(ON) multi-selective and mutant-selective inhibitors designed to address a broad spectrum of RAS-driven malignancies, including inhibitors targeting RAS G12C, G12D and G12V that together account for more than 70% of RAS mutant NSCLC.

Daraxonrasib in NSCLC

Development of daraxonrasib in previously treated RAS mutant NSCLC continues to advance. Based on previously reported Phase 1 data in patients with tumors harboring RAS mutations other than G12C, the FDA granted Breakthrough Therapy Designation to daraxonrasib for the treatment of patients with previously treated metastatic NSCLC harboring KRAS mutations other than G12C who have received prior platinum-based chemotherapy and anti-PD-(L)1 therapy.

Enrollment in the global Phase 3 RASolve 301 trial evaluating daraxonrasib in patients with previously treated RAS mutant NSCLC is expected to be completed this year, supporting an anticipated initial readout in 2027.

Zoldonrasib in NSCLC

Zoldonrasib also continues to advance across multiple treatment settings in NSCLC. Today the company is reporting initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with first-line RAS G12D NSCLC.

The analysis included 38 patients, with efficacy evaluable in 28 patients who had at least 8 weeks of follow-up. PD-L1 tumor proportion score (TPS) was <1% in 39% of patients, 1–49% in 39% of patients, ≥50% in 16% of patients, and TPS score missing in 5% of patients.

As of a data cutoff of May 11, 2026, with a median follow-up of 3.4 months, the zoldonrasib plus standard of care combination demonstrated encouraging preliminary antitumor activity, including an overall response rate (ORR; confirmed and pending confirmation) of 82% and disease control rate (DCR) of 100%. Confirmed and pending ORRs ranged from 60% to 100% across PD-L1 TPS subgroups (<1% to ≥50%).

The combination demonstrated a manageable safety profile, with treatment-related adverse events (TRAEs) generally consistent with the established safety profile of
standard of care pembrolizumab and platinum doublet chemotherapy, with minimal added toxicity and a favorable liver safety profile.

These findings support the recently initiated global Phase 3 RASolve 308 study evaluating zoldonrasib in combination with standard of care in patients with first-line metastatic RAS G12D NSCLC, while the company continues following patients in a Phase 2 monotherapy expansion cohort in previously treated disease.

Elironrasib in NSCLC

Elironrasib, the company’s oral RAS(ON) G12C-selective covalent inhibitor, continues to demonstrate promising potential in NSCLC. Today the company is reporting clinical data evaluating elironrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with first-line RAS G12C NSCLC.

As of a data cutoff of May 11, 2026, the analysis included 39 patients who had at least 14 weeks of follow-up. PD-L1 TPS was <1% in 10% of patients, 1–49% in 67% of patients, and ≥50% in 23% of patients.

With a median follow-up of 8.7 months, the elironrasib plus standard of care combination demonstrated encouraging preliminary antitumor activity, including a confirmed ORR of 85% and DCR of 97%. Confirmed ORRs ranged from 50% to 100% across PD-L1 TPS subgroups (<1% to ≥50%). Early PFS findings suggest encouraging preliminary durability, with 95% of patients progression-free at 6 months.

The combination demonstrated a manageable safety profile, with TRAEs generally consistent with the established safety profile of standard of care pembrolizumab and platinum doublet chemotherapy, with minimal added toxicity and a favorable liver safety profile.

These findings support the planned global Phase 3 RASolve 307 study evaluating elironrasib in combination with standard of care for patients with first-line metastatic RAS G12C NSCLC, which the company expects to initiate in the fourth quarter of 2026.

Colorectal Cancer (CRC)

The company continues to evaluate multiple combination approaches in CRC, including RAS(ON) inhibitor doublets and combinations with standard of care and other investigational therapies. The company expects to provide updated clinical data and additional visibility into its CRC development strategy during the fourth quarter of 2026.

Early-Stage Programs

RMC-5127

The company continues enrollment in an ongoing first-in-human trial studying RMC-5127, the company’s oral RAS(ON) G12V-selective inhibitor. RMC-5127 has been well tolerated at all dose levels evaluated to date, with no dose-limiting toxicities reported as of July 20, 2026. Encouraging early signs of antitumor activity have been seen across multiple tumor types, including objective responses starting at the first dose level. The company remains on track to identify a recommended Phase 2 dose during the second half of 2026 and expects to share initial clinical data in 2027.

Innovative New Class of RAS(ON) Inhibitors

The company also remains on track to initiate a first-in-human clinical trial evaluating RM-055, a representative from a novel class, during the fourth quarter of 2026.

Clinical Collaborations

The company’s development efforts continue to include clinical collaborations evaluating its RAS(ON) inhibitors in combination with other targeted therapies, including through ongoing collaborations with Summit Therapeutics, Tango Therapeutics and Bristol Myers Squibb. These collaborations are evaluating combinations across multiple RAS-driven solid tumors, including with PD-1/VEGF bispecific antibodies and MTA-cooperative PRMT5 inhibitors.

Financings

In April 2026, the company completed concurrent upsized public offerings of $1,725.0 million of common stock and $500.0 million aggregate principal amount of 0.50% convertible senior notes due 2033. Total gross proceeds from the offerings, before deducting underwriting discounts, commissions and other offering expenses, were $2,225.0 million.

Royalty Pharma Funding Arrangement

In May 2026, the company received a $250.0 million payment from Royalty Pharma in exchange for additional rights to royalty payments in connection with the second tranche under the royalty purchase agreement with Royalty Pharma.

Financial Highlights

Second Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $3.9 billion as of June 30, 2026. This balance includes the proceeds from the company’s concurrent public offerings of common stock and convertible notes in April 2026 as well as receipt of the second royalty tranche in May 2026 from Royalty Pharma. There remains up to an additional $1.5 billion in committed, flexible capital under the Royalty Pharma funding arrangements, subject to the achievement of specific milestones.

R&D Expenses: Research and development expenses were $394.9 million for the quarter ended June 30, 2026, compared to $224.1 million for the quarter ended June 30, 2025. The increase was primarily driven by higher clinical trial and manufacturing expenses for daraxonrasib and zoldonrasib, increased personnel-related costs due to additional headcount, and higher stock-based compensation expense related to changes in retirement provisions for equity awards and increased headcount.

G&A Expenses: General and administrative expenses were $110.2 million for the quarter ended June 30, 2026, compared to $40.6 million for the quarter ended June 30, 2025. The increase was primarily driven by higher stock-based compensation expense related to changes in retirement provisions for equity awards and increased headcount, higher personnel-related costs associated with additional headcount, increased commercial preparation activities, and higher administrative costs.

Net Loss: Net loss was $644.4 million for the quarter ended June 30, 2026, compared to net loss of $247.8 million for the quarter ended June 30, 2025. Net loss for the quarter ended June 30, 2026 included a non-cash charge of $151.0 million related to a change in the fair value of warrants assumed as part of the company’s acquisition of EQRx, Inc.

Financial Guidance

Revolution Medicines is updating its full year 2026 GAAP operating expense guidance to a range of $2.1 to $2.2 billion, which includes estimated non-cash stock-based compensation expense of between $270 and $290 million.

Webcast

Revolution Medicines will host a webcast this afternoon, August 5, 2026, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

(Press release, Revolution Medicines, AUG 5, 2026, View Source [SID1234669731])

On August 5, 2026 Recursion (Nasdaq: RXRX) a leading clinical stage TechBio company decoding biology to radically improve lives, reported business updates highlighting strong continued pipeline execution, clinical progress and platform advancement, as well as financial results for its second quarter ended June 30, 2026.

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Recursion will host an earnings Call on August 5, 2026 at 8:00 am ET / 6:00 am MT / 1:00 pm BST from Recursion’s X, LinkedIn, and YouTube accounts giving analysts, investors, and the public the opportunity to ask questions of the company by submitting questions here: View Source

"Recursion has reached a pivotal point where our AI-native platform is translating unique data into potential first-in-class therapeutic opportunities," said Najat Khan, Ph.D., Chief Executive Officer of Recursion. "The advancement of the first unexplored neuroscience target from our collaboration with Roche and Genentech into an early discovery program is an important proof point. Finding new targets in neuroscience has historically been challenging, and this milestone highlights our ability to uncover novel biology in areas where conventional approaches have struggled. We believe that combining disease-relevant data at scale, foundation models, an end-to-end learning system, and deep scientific collaboration can uncover new biology in ways that were not previously possible."

Business Highlights

Genentech Advances First Neuroscience Target into Early Discovery Program

Genentech has exercised the first Validated Target Option under the companies’ neuroscience collaboration, advancing a previously unexplored neuroscience target into a small molecule early discovery program.

The milestone provides additional early evidence that Recursion’s AI-native platform can both discover and play a key role experimentally validating novel therapeutic targets in neuroscience, one of medicine’s most challenging therapeutic areas, where decades of research have largely focused on a limited number of well-studied targets.

In partnership with Roche and Genentech, Recursion built the first whole-genome CRISPR knockout map generated from a subset of over 1 trillion internally manufactured iPSC-derived neuronal cells. Predictions generated from the Maps were experimentally evaluated through a rigorous validation process developed jointly with Genentech. Candidate targets advanced through successive stages of pathway validation, functional validation, and disease validation to determine whether modulating the target altered neurological disease phenotype. Only targets that consistently demonstrated compelling evidence across each stage advanced into a validation package. To learn more about how we collaborated to build disease-relevant whole genome maps of biology, see our blog here: View Source

Next steps will include advancing the target through small molecule design, hit generation and validation using Recursion’s AI-native chemistry platform. More broadly, the neuronal and microglial maps of biology remain reusable assets capable of being utilized with biological, genetics, and computational expertise to generate and experimentally validate additional therapeutic hypotheses. To date, Recursion has achieved $216 million in upfront and milestones payments from the Roche and Genentech collaboration. The collaboration includes up to 40 potential small molecule discovery programs, each carrying the potential for more than $300 million in development, commercialization, and net sales milestones as well as tiered royalties up to high single digits per small molecule program for Recursion.

Advancing joint portfolio with Sanofi across I&I and oncology

Recursion, in collaboration with Sanofi, made significant progress toward development candidate milestones over the past 12 months. Recursion and Sanofi are advancing a joint portfolio of differentiated molecules for challenging targets in I&I and oncology.

To date, Recursion has achieved $134 million in upfront and milestone payments from the Sanofi collaboration and has the potential for $343 million in milestone payments per program plus tiered double digit royalties.

Potential upcoming milestones across partnered discovery:

–Potential for differentiated AI-enabled oral molecules to reach development candidate and late-stage discovery milestones with Sanofi over the next 6-12 months
–Translating AI-driven insights from maps of biology into new potentially novel targets from reusable high-dimensional data/maps
–Using Recursion’s Chemistry Platform to design a potential first-in-class molecule for the collaboration’s neuroscience target announced today with Genentech
–Continuing to combine our phenomics dataset with Genentech’s proprietary transcriptomics data to build multi-modal maps designed to explore potential novel targets and pathways by systematically linking gene perturbations to cellular phenotypes

Internal Pipeline Updates

Continued Momentum for REC-4881 (MEK1/2): REC-4881, Recursion’s MEK1/2 inhibitor, is a potential first-in-class drug designed to address both known drivers of FAP polyp growth: the Wnt/β-catenin initiation pathway and the MAPK evolution pathway. This dual mechanism differentiates REC-4881 from other investigational FAP therapies, which to date have targeted only a single pathway.

REC-4881 is being developed for FAP, an orphan disease affecting an estimated >50,000 diagnosed patients across the US and EU5, representing a >$10 billion total addressable market opportunity. FAP is a serious, lifelong chronic disease with no approved medicines today. REC-4881 has received both Orphan Drug Designation and Fast Track Designation from the US FDA. REC-4881 has demonstrated meaningful activity across the GI tract, including the Upper GI, an area of particularly high unmet need.

Key updates:
•Discussions with FDA were initiated in 1H26 and an update to define the registrational path is expected in 2H26
•TUPELO now enrolling patients ages 18 and older, as well as a cohort with an alternative dosing schedule
•Additional Phase 2 safety and efficacy data from the TUPELO clinical trial contextualized with real world data will be presented at the Collaborative Group of the Americas on Inherited Gastrointestinal Cancer (CGA-IGC) Annual Meeting in November. CGA-IGC is a leading annual meeting dedicated specifically to hereditary GI cancer syndromes including FAP.
◦Presentation title: Updated safety and efficacy data of REC-4881 monotherapy in familial adenomatous polyposis: Phase 1b/2 trial results contextualized with real-world registry data
◦Session name: Presidential Plenary I
◦Session date and time: Monday November 2, 2026; 13:30 – 15:00 MST

Phase 1/2 Trial Initiation for REC-7735 expected in 2H26:

•REC-7735, Recursion’s AI-designed PI3Kα H1047R inhibitor, was built to improve therapeutic index for a validated oncology target

•REC-7735 was precision designed to show >100-fold selectivity for the H1047R mutant over wild type in order to drive high, sustained target inhibition while avoiding hyperinsulinemia-driven reactivation
•The differentiated development candidate was delivered in 10 months and 242 compounds from first novel hit through Recursion’s AI-native design platform, demonstrating the Company’s ability to rapidly translate platform insights into optimized clinical candidates
•With the IND cleared, the Phase 1/2 ZINNIA clinical study for patients with select PIK3CA H1047R-mutant solid tumors will be initiated in the second half of 2026

For the rest of the portfolio, programs continue to progress as planned.

Additional expected upcoming milestones across Recursion’s internal pipeline:

•REC-1245 (RBM39): Additional Phase 1 dose escalation data expected in 2H26
•REC-617 (CDK7): Early Phase 1 safety and PK combination data expected in 1H27
•REC-3565 (MALT1): Early Phase 1 safety and PK monotherapy data expected in 1H27
•REC-4539 (LSD1): Early Phase 1 safety and PK monotherapy data expected in 2H27

Agentic AI is compounding Recursion’s advantage across Biology, Design, and ClinTech:

•Target Discovery Agent pairs frontier AI reasoning with Recursion’s proprietary multimodal maps to surface novel drug targets, enabling scientists to mine and extract insights from proprietary maps in hours rather than weeks.
•Drug Design Agents reason across Recursion’s full set of structure-activity relationship (SAR) and structural data to identify what to solve next and how, with structural analysis time reduced from 4 hours to 30 minutes and agent-generated hypotheses now driving design cycles in active programs.
•Clinical Strategy Orchestration Agent coordinates patient, site, operational, CMC, and biometrics data to inform clinical development decisions, with agent-supported enrollment strategies contributing to a 1.3 to 1.6x increase in enrollment rates versus historical benchmarks.

Continuing to strengthen our leadership team:

•Hoifung Poon, Ph.D., appointed Chief AI Officer: Poon brings more than 15 years of experience at Microsoft, where he led groundbreaking work in biomedical AI, including foundation models in digital pathology and spatial omics published in Nature and Cell. His open-weight models have been downloaded tens of millions of times and deployed at major health systems.
•Donovan Chin, Ph.D., appointed Senior Vice President, Drug Design: Chin brings more than 20 years of experience spanning small molecules, RNA-targeted therapeutics, proximity approaches and novel peptide modalities. At Parabilis Medicines, he led the AI and physics-based computational drug discovery strategy behind Helicons, a novel class of constrained ⍺-helical peptides. Earlier, at Arrakis Therapeutics, he pioneered computational approaches for RNA-targeted drug discovery, unlocking small-molecule engagement of previously inaccessible RNA structures.

Second Quarter 2026 Financial Results

•Cash Position: Cash, cash equivalents and restricted cash were $556.8 million as of June 30, 2026 compared to $753.9 million as of December 31, 2025. Based on current operating plans
with no additional financing, the Company continues to expect its cash runway to extend into early 2028.
•Revenue: Total revenue, consisting primarily of revenue from collaboration agreements, was $7.7 million for the second quarter of 2026, compared to $19.2 million for the second quarter of 2025. Roche and Genentech revenue recognized was less in the current period due to the successful completion of certain project phases in the prior period.
•Research and Development Expenses: Research and development expenses decreased to $89.6 million for the second quarter of 2026, from $128.6 million for the second quarter of 2025. The decrease was primarily due to lower platform costs resulting from the timing of Tempus record purchases as well as lower costs due to improved operating efficiency. Specifically, the second quarter of 2025 included $22.7 million in non-cash expenses for the use of Tempus’ patient-centric multimodal oncology data within the Company’s R&D pipeline, compared to $3.1 million in the second quarter of 2026.
•General and Administrative Expenses: General and administrative expenses were $41.5 million for the second quarter of 2026 compared to $46.7 million for the second quarter of 2025. The decrease of $5.1 million compared to the prior period was primarily driven by a decrease in salaries of $4.9 million as a result of headcount reductions in the year.
•Net Loss: Net loss was $131.0 million for the second quarter of 2026, compared to a net loss of $171.9 million for the second quarter of 2025.
•Operational cash flows: Net cash used in operating activities was $105.9 million for the three months ended June 30, 2026, compared to net cash used in operating activities of $76.4 million for the three months ended June 30, 2025. The increase in cash used in operating activities was primarily driven by working capital movements, during the three months ended June 30, 2025, the Company received a $28.6 million inflow related to a UK R&D tax credit.
•Cash Operating Expense: Cash operating expense, excluding partnership inflows and transaction costs, for the six months ended June 30, 2026 was $191.0 million compared to $199.1 million for the six months ended June 30, 2025. The Company is lowering its cash operating expense guidance for the full year 2026 by $15 million to $375 million based on additional identified operating efficiencies.

(Press release, Recursion Pharmaceuticals, AUG 5, 2026, View Source [SID1234669730])