On May 7, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the first quarter of 2026 and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to have aligned with the FDA on the pivotal ANTLER-3 trial design for vispa-cel," said Rachel Haurwitz, PhD, president and CEO of Caribou. "Vispa-cel continues to demonstrate a differentiated profile as an off-the-shelf CAR-T cell therapy with a well-tolerated safety profile and robust response rates resulting in long-term durable outcomes in high-risk patients. Our pivotal trial will compare vispa-cel to standard-of-care regimens that lack curative intent yet are often the only options available to the 75% of second-line large B cell lymphoma patients who do not receive autologous CAR-T cell therapy. We look forward to reporting longer follow up on the phase 1 data for vispa-cel at an upcoming medical conference this year as well as sharing longer follow up on dose escalation and initial dose expansion data for CB-011 in patients with relapsed or refractory multiple myeloma in 2026."

Clinical highlights

Vispacabtagene regedleucel (vispa-cel; formerly CB-010), a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma
•Caribou reached alignment with the U.S. Food and Drug Administration (FDA) regarding the vispa-cel pivotal trial design following interactions to date with the agency enabled by the Regenerative Medicine Advanced Therapy (RMAT) designation for vispa-cel.
•ANTLER-3 is expected to be a randomized, controlled pivotal phase 3 clinical trial enrolling approximately 250 CD19-naïve second-line (2L) large B cell lymphoma (LBCL) patients who are not eligible for transplant and not candidates or not eligible for autologous CAR-T cell therapy based on access challenges or medical criteria, including the need for urgent therapy.
◦Patients in the investigational arm will receive a single dose of 80×106 vispa-cel CAR-T cells following lymphodepletion.
◦Patients in the comparator arm will be treated with an investigator’s choice of standard-of-care regimen, such as: polatuzumab vedotin (Pola), bendamustine, rituximab (R) (Pola-BR); R, gemcitabine, and oxaliplatin (R-GemOx); Pola-R-GemOx (Pola-RGO); or tafasitamab and lenalidomide. Crossover to the vispa-cel arm is permitted after progressive disease.
◦The primary endpoint is progression-free survival (PFS).
◦Clinical trial sites will include both academic and sophisticated community centers in the United States and globally.

•Clinical data disclosed in November 2025 and in a poster presented at the 2026 Tandem Meetings highlight vispa-cel’s potential — as an immediately available, off-the-shelf CAR-T cell therapy manufactured at scale — to help meet the needs of the 75% of 2L LBCL patients who do not receive autologous CAR-T cell therapy.
•Longer follow up ANTLER phase 1 clinical trial data will be presented at a medical conference in 2026.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for patients with relapsed or refractory multiple myeloma (r/r MM)
•On March 31, 2026, Caribou announced the FDA granted RMAT designation to CB-011 for r/r MM.
•RMAT was granted based on promising initial clinical data, including previously disclosed data on the 12-patient, BCMA-naïve r/r MM patient cohort treated at the recommended dose for expansion: 92% overall response rate, 75% complete response (CR) or stringent CR rate, and 91% minimal residual disease negativity. These data highlight CB-011’s potential as the best-in-class allogeneic CAR-T cell therapy for patients with r/r MM.
•Caribou is enrolling BCMA-naïve and prior BCMA therapy-exposed r/r MM patients in the dose expansion portion of the CaMMouflage trial and expects to report longer follow up on dose escalation data and initial dose expansion data in 2026.

Upcoming events
•BofA Securities 2026 Health Care Conference, Las Vegas, NV
May 13, 2026, fireside chat at 8:40 am PT
Webcast
First quarter 2026 financial results
Licensing and other third-party revenue: Revenue from licensing and other third-party agreements was $2.4 million for the three months ended March 31, 2026, unchanged from the same period in 2025.

R&D expenses: Research and development expenses were $20.6 million for the three months ended March 31, 2026, compared to $35.5 million for the same period in 2025. The decrease was primarily related to decreased external contract manufacturing organization and contract research organization activities, expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025, facilities and allocated expenses, and expenses related to licenses, sublicensing revenue, and milestones.

G&A expenses: General and administrative expenses were $8.1 million for the three months ended March 31, 2026, compared to $9.7 million for the same period in 2025. The decrease was primarily due to personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025 and lower legal expenses.

Cash, cash equivalents, and marketable securities: Caribou had $118.6 million in cash, cash equivalents, and marketable securities as of March 31, 2026, compared to $142.8 million as of December 31, 2025. Caribou expects its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan, including dose expansion for CB-011 and certain start-up activities for its planned vispa-cel pivotal trial, into 2H 2027. The Company is exploring multiple options to fully fund its planned vispa-cel pivotal trial.

About vispacabtagene regedleucel

Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About the ANTLER phase 1 clinical trial
The ANTLER phase 1 clinical trial evaluated vispa-cel in adult patients with r/r B-NHL in a multicenter, open-label trial. As of a September 2, 2025, data cutoff date, 84 patients were treated in the trial. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation who received a single dose of 40×106, 80×106, and 120×106 CAR-T cell CAR-T cells preceded by a lymphodepletion (LD) regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Eighty million (80×106) CAR-T cells was selected as the recommended phase 2 dose (RP2D). Sixty-three second-line large B cell lymphoma (2L LBCL) patients received a single dose of vispa-cel during dose expansion. Five patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at www.clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. The FDA granted CB-011 Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for r/r MM.

About the CaMMouflage phase 1 clinical trial

The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirteen patients were treated with a single dose of CB-011 (50×106 [N=3], 150×106 [N=7], and 450×106 [N=3] CAR-T cells) with an LD regimen of 300 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days, and 35 patients were treated with a single dose of CB-011 (150×106 [N=6], 300×106 [N=13], 450×106 [N=13], and 800×106 [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days. The dose expansion portion of the trial is evaluating safety and efficacy of CB-011 at 450×106 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, MAY 7, 2026, View Source [SID1234665313])

On May 7, 2026 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

"In the first quarter of 2026, momentum across Insmed’s commercial portfolio and pipeline continued to build," said Will Lewis, Chair and Chief Executive Officer of Insmed. "The trajectory of the BRINSUPRI launch continues to exceed our expectations, and we are especially encouraged by the positive topline results from the ENCORE Phase 3b study, which could enable us to extend our reach to even more patients. We remain focused on improving bronchiectasis diagnosis, expanding the ARIKAYCE label, advancing our Phase 3 programs for TPIP, and progressing our early-stage pipeline, with the ambition of delivering meaningful innovation and improving the lives of patients with serious diseases."

Progress and Anticipated Milestones by Therapeutic Area:

Respiratory

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BRINSUPRI

•
BRINSUPRI global revenue grew 44% in the first quarter of 2026 compared to the fourth quarter of 2025, driven by strong growth in the U.S. market.

•
In February 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization in the United Kingdom (U.K.) for BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more flare-ups or worsening of symptoms in the past 12 months.

•
Insmed anticipates a regulatory decision for brensocatib for the treatment of NCFB in Japan in 2026.

•
Insmed continues to evaluate the potential effect of evolving U.S. policies which will then impact the timing for future potential international commercial launches.

ARIKAYCE

•
ARIKAYCE global revenue grew 6% in the first quarter of 2026 compared to the first quarter of 2025, driven by strong growth in international markets.

•
In March 2026, Insmed reported positive topline results from the Phase 3b ENCORE study of ARIKAYCE in patients with Mycobacterium avium complex (MAC) lung disease, which met its primary and all multiplicity-controlled secondary culture conversion endpoints.

•
Insmed plans to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the second half of 2026. Similarly, Insmed plans to review the data with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026 to support potential label expansion in Japan.

TPIP

•
Insmed continues to enroll patients in the PALM-ILD trial, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

•
In January 2026, the Office of Orphan Products Development of the FDA granted orphan drug designation to treprostinil palmitil for the treatment of patients with pulmonary arterial hypertension (PAH).

•
In April 2026, Insmed initiated the Phase 3 PALM-PAH study of TPIP in patients with PAH.

•
Insmed expects to report data from the open-label extension (OLE) of its Phase 2b study of TPIP in PAH in the third quarter of 2026.

•
Insmed anticipates initiating a Phase 3 study of TPIP in patients with progressive pulmonary fibrosis (PPF) by the end of 2026 and a Phase 3 study in patients with idiopathic pulmonary fibrosis (IPF) in the first half of 2027.

INS1148

•
Insmed plans to advance a Phase 2 development program for INS1148, initially targeting PPF and IPF, and is exploring other diseases where inhibition of the inflammatory functions of SCF248 may be beneficial.

Immunology & Inflammation

INS1033

•
Insmed’s second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), with an initial investigational new drug (IND) filing expected in the second half of 2026.

Neuro & Other Rare

INS1201

•
Insmed continues to enroll patients in the Phase 1 ASCEND clinical study of INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

INS1202

•
Insmed continues to enroll patients in the Phase 1 ARMOR study of INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS).

2
INS1203

•
Insmed’s third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.

Corporate Updates

•
Insmed plans to present six abstracts from across its Respiratory Therapeutic Area (BRINSUPRI, ARIKAYCE, TPIP) at the American Thoracic Society (ATS) 2026 International Conference, taking place May 15-20, 2026.

(Press release, Insmed, MAY 7, 2026, View Source [SID1234665329])

On May 7, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will participate in the following investor conferences in May.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bank of America Health Care Conference 2026
Date / Time: May 13th, at 11:15 AM ET
Format: 1×1’s
Location: Las Vegas, NV
Webcast Link: Here

HC Wainwright 4th Annual BioConnect Investor Conference
Date / Time: May 19th, at 10:30 AM ET
Format: 1×1’s
Location: New York, NY
Webcast Link: Here

TD Cowen 7th Annual Oncology Innovation Summit
Date / Time: May 26th, at 10:30 AM ET
Location: Virtual
Webcast Link: Here

The webcasts from the conference will also be available on UroGen’s Investor Relations website. A replay will be available for approximately 90 days.

(Press release, UroGen Pharma, MAY 7, 2026, View Source [SID1234665345])

On May 7, 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 first quarter March 31, 2026 and provided a summary of recent business highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Having a U.S. PDUFA date established under priority review by the FDA for zanidatamab for the treatment of first-line HER2-positive advanced GEA, represents a significant regulatory and strategic milestone for Zymeworks. Zanidatamab’s progress across additional clinical indications continues to highlight the value of our strategy to accumulate long-term cash flows from differentiated assets, whether generated internally or externally, with meaningful clinical and commercial potential. Pending global approvals in GEA, we expect zanidatamab to contribute significant milestone payments and to generate long-term, high-quality royalty revenues," said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. "Over the past quarter, we have further strengthened our leadership team with the addition of individuals bringing extensive experience in strategic capital allocation, investment execution, and deal-making, enhancing our ability to identify and maximize value for our emerging royalty and R&D portfolios. We look forward to the potential of bringing an important new therapy to patients."

Recent Developments

Wholly-Owned Programs

In April 2026, we shared new preclinical and clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Presentations included new preclinical combination insights from ZW191, as well as additional clinical data from Part 1 of our Phase 1 trial of ZW191:

In Part 1 of our Phase 1 trial of ZW191 in platinum resistant ovarian cancer (PROC) patients, ZW191 demonstrated a confirmed objective response rate of 56% across all dose levels, with tumor regression observed in 68% of patients and disease control achieved in 94%. Notably, ZW191 demonstrated compelling efficacy in the 6.4-9.6 mg/kg dose range regardless of FRα expression, with confirmed objective response rates of 61% observed in both ovarian and 57% in endometrial cancers, with disease control observed in 100% of patients, and no new safety signals. These findings highlight the potential for ZW191 to benefit a broad patient population, including those with low or heterogeneous target expression. In March 2026, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW191, for the treatment of patients with advanced or metastatic PROC.
Part 2 of our Phase 1 study evaluating both 6.4 mg/kg and 9.6 mg/kg dose regimens in PROC is fully-enrolled with 60 total patients and remains ongoing.
ZW191’s differentiated clinical profile in nonclinical studies, including favorable tolerability, bodes well for combination strategies including chemotherapy, targeted therapies, and immunotherapies that are mechanistically supported by preclinical studies.
At AACR (Free AACR Whitepaper), we also presented preclinical data from our emerging RAS inhibitor antibody-drug conjugate (ADC) platform and three novel candidates designed to target treatment of RAS mutated cancers:

A pan-RASi ADC platform with high anti-tumor activity against RAS-driven cancers
ZW418, a biparatopic PTK7-targeting ADC incorporating a novel pan-RAS inhibitor payload for the treatment of non-small cell lung cancer (NSCLC)
ZW427, a Ly6E-targeting ADC bearing a novel pan-RAS inhibitor payload for the treatment of RAS mutated cancers including colorectal, pancreatic, and NSCLC
ZW439, a novel CLDN18.2-targeting pan-RAS inhibitor ADC for the treatment of RAS mutated pancreatic cancer
"At AACR (Free AACR Whitepaper), our team presented three posters highlighting novel preclinical RAS-targeting ADC candidates, demonstrating the breadth of our capabilities in antibody engineering, linker chemistry, and the development of new proprietary payloads. These programs reflect a modular, highly tunable platform designed to address historically challenging targets. In parallel, updated Phase 1 data for ZW191 continue to reinforce the differentiated profile we have seen to date, with breadth and durability of responses, along with activity across varying levels of FRα expression, that we believe position ZW191 as a potential best-in-class therapy," stated Adam Schayowitz, Ph.D., MBA., Head of R&D at Zymeworks. "Taken together, these data reflect the strength and scalability of our ADC platform and open up a range of future opportunities for both our ADC platforms and product candidates."

Partnered Programs

Zanidatamab

In April 2026, the U.S. FDA accepted our partner Jazz’s sBLA filing for Ziihera (zanidatamab-hrii) combinations for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or GEA for priority review with a PDUFA date of August 25, 2026. Pending approval, Jazz expects to commercially launch zanidatamab in the U.S. in this indication. Zymeworks is entitled to receive a $250.0 million milestone payment from Jazz related to approval of Ziihera in GEA in the United States.

In April 2026, BeOne announced that the U.S. FDA has granted Priority Review to a sBLA for TEVIMBRA (tislelizumab) in combination with Ziihera and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma. In April 2026, BeOne also received acceptance for the filing of the sBLA for zanidatamab by the Center for Drug Evaluation of the China National Medical Products Administration (NMPA) to seek approval for zanidatamab for the first-line treatment for HER2+ locally advanced or metastatic GEA, including cancers of the stomach, gastroesophageal junction, and esophagus. BeOne has also received filing acceptance for an sBLA for tislelizumab by the CDE in China based on the HERIZON-GEA-01 data. Zymeworks is entitled to receive a $15.0 million milestone payment from BeOne related to approval of Ziihera in GEA in China.

In April 2026, Jazz presented three posters and an oral presentation at AACR (Free AACR Whitepaper) exploring zanidatamab’s utility across HER2-expressing solid tumors beyond biliary tract cancer and GEA. Jazz also announced that they will present multiple presentations on zanidatamab at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including a rapid oral presentation of PD-L1 subgroup data from HERIZON-GEA-01 evaluating zanidatamab combinations, and additional analyses of tolerability, biomarker response and real-world treatment patterns in first-line HER2+ GEA. The second interim overall survival analysis for the HERIZON-GEA-01 trial is expected in mid-2026.

Our royalty revenue from Jazz and BeOne was $1.6 million in the three months ended March 31, 2026, driven primarily by net product sales of Ziihera by Jazz.

Business Updates

We recently announced leadership appointments and transitions to align with the evolution of our corporate strategy, including the following changes:

Ms. Kristin Stafford appointed as Executive Vice President, Chief Financial Officer, effective April 1, 2026.
Dr. Adam Schayowitz, Ph.D., MBA appointed as Executive Vice President, Head of R&D, effective April 9, 2026.
Mr. Scott Platshon appointed as Executive Vice President, Chief Business Officer, effective April 9, 2026.
Mr. Paul R. Schneider appointed as Executive Vice President, General Counsel, effective May 13, 2026.
Share Repurchase Program

In November 2025, the Board of Directors authorized a share repurchase program providing the ability to repurchase up to $125.0 million in common stock. As of May 6, 2026, the Company has utilized approximately $95.8 million of this approved repurchase program to acquire 3,930,734 shares at an average price of $24.37 per share (exclusive of commission expense and estimated excise tax). As of May 6, 2026, the Company had approximately 73.0 million common shares outstanding.

Financial Outlook

Operating Expense Discipline: The Company today is reiterating its previously 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), reflecting 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 is also reiterating 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 Ended March 31, 2026

The key financial highlights for our 2026 first quarter results are as follows:

Revenue – Total revenue was $2.4 million in 1Q-2026, compared to $27.1 million for the same period in 2025. The decrease was driven mainly by the achievement of non-recurring clinical milestone payments in 2025, as well as continued declines in development support and drug supply revenue from Jazz . Revenue in the current‑year period reflects ongoing collaboration activity and increased royalty revenue, which is expected to grow over time as commercial sales of Ziihera increase.

Research and Development (R&D) Expenses – R&D expenses were $34.5 million in 1Q-2026, compared to $35.7 million for the same period in 2025, primarily reflecting a shift in program mix, as reduced spending on later‑stage and discontinued programs exceeded increased investment in early‑stage clinical studies and preclinical pipeline activities.

General and Administrative (G&A) Expenses – G&A expenses were $15.1 million in 1Q-2026, compared to $17.0 million for the same period in 2025. The decrease was primarily driven by lower professional fees, consulting, and information technology‑related costs reflecting the absence of prior-year non-recurring initiatives and post-implementation cost reductions, partially offset by higher salaries and benefits reflecting previously disclosed leadership transitions.

Other Income, net – Other income was $0.8 million in 1Q-2026, compared to $3.5 million for the same period in 2025. The change was driven primarily by $2.1 million of interest expense related to the royalty-backed note financing arrangement with Royalty Pharma executed in March 2026 and lower interest income.

Net Loss – Net loss was $44.2 million in 1Q-2026, compared to a net loss of $22.6 million for the same period in 2025. The change in 2026 was primarily due to a decrease in revenue, driven by the non-recurring clinical milestones earned in 1Q-2025.

Liquidity – As of March 31, 2026, we had $403.8 million of cash resources consisting of cash, cash equivalents and marketable securities, comprised of $244.3 million in cash and cash equivalents and $159.6 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 March 31, 2026, 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, 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, MAY 7, 2026, View Source [SID1234665363])

On May 7, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the first quarter 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Gilead teams have delivered another strong quarter with 8% year-over-year growth in our base business and 10% growth in HIV, supported by the successful launch of Yeztugo. We have raised our full year revenue guidance as a reflection of our performance," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "Building on the strongest pipeline in Gilead’s history, we are adding potentially best-in-disease assets and platforms in oncology and inflammation from our acquisitions of Arcellx, Ouro Medicines and Tubulis. With up to four potential launches and five Phase 3 updates anticipated in 2026, Gilead is well-positioned for sustained growth in the near and long term."

First Quarter 2026 Financial Results

Total first quarter 2026 revenues increased 4% to $7.0 billion compared to the same period in 2025, primarily driven by higher sales of HIV products, Trodelvy (sacituzumab govitecan-hziy), and Livdelzi (seladelpar), partially offset by lower sales of Veklury (remdesivir), as well as chronic hepatitis C virus ("HCV") and Cell Therapy products.
Diluted earnings per share ("EPS") was $1.61 in the first quarter 2026 compared to $1.04 in the same period in 2025. The increase was primarily driven by net unrealized gains from equity securities compared to net unrealized losses in 2025 and higher product sales, as well as lower acquired in-process research and development ("IPR&D") expenses. The increase was partially offset by higher income tax and selling, general and administrative ("SG&A") expenses.
Non-GAAP diluted EPS was $2.03 in the first quarter 2026 compared to $1.81 in the same period in 2025. The increase was primarily driven by higher product sales and lower acquired IPR&D expenses, partially offset by higher income tax and SG&A expenses.
As of March 31, 2026, Gilead had $8.6 billion of cash, cash equivalents and marketable debt securities compared to $10.6 billion as of December 31, 2025. The decrease was primarily driven by $2.8 billion of debt repayments, $1.0 billion of dividend payments and $419 million of common stock repurchases, partially offset by $2.5 billion of operating cash flow.
First Quarter 2026 Product Sales

Total first quarter 2026 product sales increased 5% to $6.9 billion compared to the same period in 2025. Total first quarter 2026 product sales excluding Veklury increased 8% to $6.8 billion compared to the same period in 2025, primarily due to higher sales of HIV products, Trodelvy and Livdelzi, partially offset by lower sales of HCV and Cell Therapy products.

HIV product sales increased 10% to $5.0 billion in the first quarter 2026 compared to the same period in 2025, primarily driven by higher demand and average realized price, partially offset by unfavorable inventory dynamics.

Biktarvy(bictegravir 50mg/emtricitabine ("FTC") 200mg/tenofovir alafenamide ("TAF") 25mg) sales increased 7% to $3.4 billion in the first quarter 2026 compared to the same period in 2025, primarily driven by higher demand and average realized price, partially offset by unfavorable inventory dynamics.
Descovy(FTC 200mg/TAF 25mg) sales increased 38% to $807 million in the first quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand.
The Liver Disease portfolio sales increased 1% to $767 million in the first quarter 2026 compared to the same period in 2025, primarily reflecting higher demand for Livdelzi, partially offset by unfavorable inventory dynamics and lower sales for HCV products.

Veklury sales decreased 52% to $144 million in the first quarter 2026 compared to the same period in 2025, primarily driven by lower rates of COVID-19-related hospitalizations.

Cell Therapy product sales decreased 12% to $407 million in the first quarter 2026 compared to the same period in 2025, reflecting ongoing competitive headwinds.

Yescarta (axicabtagene ciloleucel) sales decreased 14% to $332 million in the first quarter 2026 compared to the same period in 2025, primarily driven by in- and out-of-class competition.
Tecartus (brexucabtagene autoleucel) sales decreased 4% to $75 million in the first quarter 2026 compared to the same period in 2025, primarily driven by in-class competition.
Trodelvy (sacituzumab govitecan-hziy) sales increased 37% to $402 million in the first quarter 2026 compared to the same period in 2025, primarily driven by higher demand, favorable inventory dynamics and higher average realized price.

First Quarter 2026 Product Gross Margin, Operating Expenses and Effective Tax Rate

Product gross margin was 79.2% in the first quarter 2026 compared to 76.7% in the same period in 2025. Non-GAAP product gross margin was 87.5% in the first quarter 2026 compared to 85.5% in the same period in 2025. These increases are primarily due to the expiration of a royalty-related obligation and product mix.
Research and development ("R&D") expenses remained relatively flat at $1.4 billion in the first quarter 2026 compared to the same period in 2025, primarily due to lower oncology clinical study activity and lower restructuring costs being fully offset by higher investment in virology clinical manufacturing. Non-GAAP R&D expenses were $1.4 billion in the first quarter 2026 compared to $1.3 billion in the same period in 2025, primarily driven by higher investment in virology clinical manufacturing, partially offset by lower oncology clinical study activity.
Acquired IPR&D expenses were $107 million in the first quarter 2026, primarily related to an $80 million upfront payment related to our collaboration with Suzhou Genhouse Bio Co., Ltd. ("Genhouse").
SG&A expenses were $1.5 billion in the first quarter 2026 compared to $1.3 billion in the same period in 2025, primarily driven by higher HIV promotional expenses and donations of equity securities made to the Gilead Foundation. Non-GAAP SG&A expenses were $1.4 billion in the first quarter 2026 compared to $1.2 billion in the same period in 2025, primarily due to higher HIV promotional expenses.
The effective tax rate ("ETR") was 21.7% in the first quarter 2026 compared to 20.2% in the same period in 2025. The non-GAAP ETR was 18.3% in the first quarter 2026 compared to 16.3% in the same period in 2025. These increases are primarily driven by a prior year state tax benefit that did not recur.
Guidance and Outlook

For the full year 2026, Gilead now expects:

(in millions, except per share amounts)

May 7, 2026 Guidance

Comparison to February 10, 2026 Guidance

Low End

High End

Product sales

$

30,000

$

30,400

Previously $29,600 to $30,000

Product sales excluding Veklury

$

29,400

$

29,800

Previously $29,000 to $29,400

Veklury

$

600

$

600

Unchanged

Diluted (loss) earnings per share

$

(3.25

)

$

(2.85

)

Previously $6.75 to $7.15

Non-GAAP diluted (loss) earnings per share

$

(1.05

)

$

(0.65

)

Previously $8.45 to $8.85

As compared to our February guidance, our updated full year 2026 GAAP and non-GAAP diluted earnings per share guidance was reduced by approximately $9.50 due to the anticipated acquired IPR&D charges of $11.5 billion as well as financing costs related to the Arcellx, Inc. ("Arcellx"), Ouro Medicines, LLC ("Ouro"), and Tubulis GmbH ("Tubulis") transactions discussed further below.

Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2026 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below.

Key Updates Since Our Last Quarterly Release

Virology

Announced U.S. Food and Drug Administration ("FDA") accepted New Drug Application for bictegravir and lenacapavir ("BIC/LEN") for virologically suppressed people with HIV under priority review, with a Prescription Drug User Fee Act ("PDUFA") target action date of August 27, 2026.
Presented late-breaking Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials at the 2026 Conference on Retroviruses and Opportunistic Infections (CROI), evaluating the investigational daily oral single-tablet regimen of BIC/LEN for virologically suppressed people with HIV. BIC/LEN maintained high levels of virologic suppression, demonstrating comparable efficacy to complex regimens and to Biktarvy at Week 48 in people with HIV who switched antiretroviral therapy. These data support global regulatory filings.
Announced a $12 million investment to the Community Health Worker Comprehensive HIV Prevention Initiative program to expand HIV prevention initiatives across 14 U.S. states and the District of Columbia.
Announced a new investment from the U.S. State Department, the U.S. President’s Emergency Plan for AIDS Relief ("PEPFAR") and The Global Fund to deliver lenacapavir for HIV prevention to an additional 1 million people, bringing the total commitment up to 3 million people in countries supported by both PEPFAR and the Global Fund.
Oncology

Completed the acquisition of Arcellx for $115 per share, or an implied equity value of $7.8 billion, and one contingent value right of $5 per share. This acquisition builds on an existing collaboration agreement with Arcellx for the development of anitocabtagene autoleucel ("anito-cel") in relapsed or refractory ("R/R") multiple myeloma ("MM"), and also adds Arcellx’s D-Domain BCMA binder that has the potential to strengthen Gilead’s portfolio in oncology and inflammation.
Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026.
Announced a definitive agreement to acquire Tubulis, a private clinical-stage biotechnology company developing next-generation antibody-drug conjugates ("ADC"), including lead asset TUB-040, a NaPi2b-directed topoisomerase-I inhibitor ADC currently in Phase 1b/2 development for platinum-resistant ovarian cancer and non-small cell lung cancer. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions.
Received FDA full approval for Tecartus in adult patients with R/R mantle cell lymphoma, following an accelerated approval in this setting in July 2020. Tecartus’ label now includes efficacy, safety and pharmacokinetic data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor-naïve.
Inflammation

Announced a definitive agreement to acquire Ouro, a private clinical-stage biotechnology company developing T cell engager ("TCE") therapies for autoimmune diseases. This acquisition adds Ouro’s lead asset, OM336 (gamgertamig), a BCMAxCD3 TCE, to Gilead’s portfolio. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions. Gilead has entered into a framework agreement with Galapagos NV ("Galapagos") in relation to this acquisition, which includes equally splitting the $1.675 billion upfront payment and up to $500 million in milestone payments, among other terms.
Corporate

The Board declared a quarterly dividend of $0.82 per share of common stock for the second quarter of 2026. The dividend is payable on June 29, 2026, to stockholders of record at the close of business on June 15, 2026. Future dividends will be subject to Board approval.
Certain amounts and percentages in this press release may not sum or recalculate due to rounding.

Conference Call

At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on View Source and will be archived on www.gilead.com for one year.

(Press release, Gilead Sciences, MAY 7, 2026, View Source [SID1234665389])