On May 7, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported financial results for the first quarter ended March 31, 2026, and highlighted recent business progress.

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"As we mark the one-year anniversary of the FDA-approval of AVMAPKI FAKZYNJA CO-PACK for KRAS-mutated recurrent low-grade serous ovarian cancer, I am incredibly proud of the progress we have made to deliver a meaningful impact for people living with this rare cancer," said Dan Paterson, president and chief executive officer at Verastem Oncology. "As we build on the foundation we have established with the commercial launch, we also look to continue accelerating VS-7375, our potential best-in-class oral, KRAS G12D (ON/OFF) inhibitor, and are pleased to announce the initiation of three Phase 2 registration-directed trials in pancreatic, non-small cell lung, and colorectal cancers. In an evolving competitive landscape, we remain encouraged by the efficacy data generated by our partner and emerging in the U.S., along with the safety and tolerability profile we are seeing across multiple solid tumor cancers and look forward to sharing data updates throughout this year. Altogether, we believe we are well-positioned to drive strong execution across our commercial launch and expedite VS-7375 development while maintaining disciplined capital management."

First Quarter 2026 and Recent Updates

AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) U.S. Commercial Performance

AVMAPKI FAKZYNJA CO-PACK generated net product revenue of $18.7 million for the first quarter of 2026.
In April, the Company announced the launch of a new healthcare professional and patient marketing campaign, Reimagine Recurrent Low-Grade Serous Ovarian Cancer (LGSOC), to drive awareness of AVMAPKI FAKZYNJA CO-PACK.
In April, the Company announced new two-year median follow up data from the Phase 2 RAMP 201 trial that demonstrated durable benefit of avutometinib plus defactinib across both KRAS mutant and KRAS wild-type recurrent LGSOC patients, with discontinuation rates consistent with the primary analysis, presented at the Society of Gynecologic Oncology 2026 Annual Meeting on Women’s Cancers. A new exposure-response analysis further demonstrated that the approved dose and schedule of avutometinib plus defactinib achieve the optimal therapeutic effect.
In February, the Company announced updated data for RAMP 201J in Japan evaluating the combination in patients with LGSOC with or without a KRAS mutation. As of a data cutoff of January 30, 2026, a confirmed overall response rate (ORR) of 38% (6/16) was achieved. Patients with a KRAS mutation achieved a confirmed ORR of 57% (4/7) and KRAS wild-type patients achieved a confirmed ORR of 22% (2/9). The safety profile was consistent with previously reported data outside of Japan.
Expected Key Milestones:

Report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027.
Continue to pursue regulatory paths for potential expansion into Europe and Japan.
VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor in Advanced Solid Tumors

Today, the Company provided an update on its ongoing VS-7375 clinical trials, including branding the trials as the VS-7375 TARGET-D Clinical Trial Program. In the ongoing TARGET-D 101 (VS-7375-101) Phase 1/2 dose escalation, dose expansion and combination-evaluation trial, the Company is now evaluating the 1200 mg daily dose (QD). The Company is also evaluating VS-7375 900 mg QD in combination with cetuximab. The Company expects to finish enrollment across the various expansion cohorts and combination cohorts with chemotherapies in the near term.
In addition, the Company shared updated pharmacokinetic (PK) data that showed the 900 mg QD dose achieves target plasma levels of VS-7375 and provides clear separation from the 600 mg QD dose.
The Company has initiated three Phase 2 registration-directed trials, including:
TARGET-D 201 to evaluate VS-7375 at 900 mg QD both as monotherapy and in combination with cetuximab in patients with second-line pancreatic ductal carcinoma (PDAC). The study is also evaluating VS-7375 and cetuximab in the first-line PDAC setting.
TARGET-D 202 to evaluate VS-7375 at 900 mg QD in patients with advanced non-small cell lung cancer (NSCLC) who have received one to two prior lines of therapy. The study is also evaluating VS-7375 in NSCLC patients with asymptomatic untreated brain metastases.
TARGET-D 203 to evaluate VS-7375 at 900 mg QD as both monotherapy and in combination with EGFR inhibitors, including cetuximab or panitumumab, in previously treated colorectal cancer (CRC). The study will also evaluate VS-7375 in combination with chemotherapy in the first-line setting in patients with metastatic CRC.
In March, the Company announced that several late-breaking and regular abstracts were selected for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The abstracts included preclinical data demonstrating sustained tumor regressions with VS-7375 in combination with PRMT5 inhibitors in MTAP-deleted KRAS G12D mutant pancreatic cancer and improved efficacy in comparison to ON-only KRAS G12D or pan-RAS inhibitors.
In March, the Company reported an update on its progress with VS-7375, highlighting progress with its dose-escalation and dose-expansion trial, TARGET-D 101, a PK analysis, and a safety update, which demonstrated VS-7375 was generally well-tolerated across all monotherapy dose levels evaluated to date. Patients (n=23) receiving VS-7375 at either 400 mg QD, 600 mg QD or 900 mg QD with a mean duration of therapy of 1.6 months (0.7-5.6), reported no drug related liver function test abnormalities. As of the January 30, 2026 data cutoff, there was no drug-related neutropenia greater than Grade 2 and rates of nausea, vomiting and diarrhea remained lower than those reported by the Company’s partner in China. The Company also reported that the U.S. Food and Drug Administration (FDA) requested the Company develop separate Phase 2 trial protocols for their trials in PDAC, NSCLC and CRC.
In January, the Company reported progress from its ongoing TARGET-D 101 trial, with multiple dose levels cleared without dose-limiting toxicities or major toxicities. At that time, monotherapy cohorts and dose escalation combination cohorts were initiated across various KRAS G12D-mutated solid tumors.
The Company shared multiple updates from GenFleet Therapeutics, its partner developing VS-7375, known as GFH375 in China.

In April, GenFleet announced that GFH375 was granted Breakthrough Therapy Designation (BTD) in China for patients with KRAS G12D-mutated metastatic pancreatic cancer who have received at least one prior systemic therapy.
In March, GenFleet announced that GFH375 was granted BTD in China for patients with KRAS G12D-mutated NSCLC who have received prior systemic therapy.
Expected Key Milestones:

Report early data from the TARGET-D 101 trial in 1H 2026.
Report an update on the TARGET-D 101 trial in 2H 2026.
Announce first patient initiated in the TARGET-D 201, TARGET-D 202, and TARGET-D 203 clinical trials in mid-2026.
RAMP 205: Avutometinib Plus Defactinib in Combination with Chemotherapy in 1L Metastatic Pancreatic Cancer

Expected Key Milestone:

Report an update on the safety and efficacy of the RAMP 205 expansion cohort with at least six months of follow-up on all patients in Q2 2026.
Corporate Updates

The Company announced today the appointment of Daniel Lyons as chief commercial officer. Prior to joining, Mr. Lyons served as the Senior Vice President, Head of Rare Tumors International and Global Head of Market Access at SpringWorks Therapeutics.
First Quarter 2026 Financial Results

Verastem Oncology ended the first quarter of 2026 with cash, cash equivalents, and investments of $181.7 million.

Net product revenue for the three months ended March 31, 2026 (the "2026 Quarter") was $18.7 million, compared to no revenue recognized for the three months ended March 31, 2025 (the "2025 Quarter"). The Company began commercial sales of the AVMAPKI FAKZYNJA CO-PACK within the U.S. following receipt of FDA approval in May 2025.

Total operating expenses for the 2026 Quarter were $63.6 million, compared to $44.2 million for the 2025 Quarter. Cost of sales was $3.1 million for the 2026 Quarter, compared to no cost of sales recognized for the 2025 Quarter.

Research & development expenses for the 2026 Quarter were $38.2 million, compared to $29.2 million for the 2025 Quarter. The increase of $9.0 million, or 31%, was primarily due to higher costs for investigator fees, drug substance manufacturing, drug product manufacturing, clinical supply, and contract research organizations partially offset by the VS-7375 program option exercise fee paid to GenFleet in the 2025 Quarter.

Selling, general & administrative expenses for the 2026 Quarter were $22.3 million, compared to $15.0 million for the 2025 Quarter. The increase of $7.3 million, or 48%, was primarily due to higher costs for personnel and commercial operations.

Net loss (GAAP basis) for the 2026 Quarter was $36.6 million, or $0.37 per share (basic), compared to $52.1 million, or $0.96 per share (basic and diluted) for the 2025 Quarter.

Non-GAAP adjusted net loss for the 2026 Quarter was $42.7 million, or $0.43 per share (basic) compared to non-GAAP adjusted net loss of $42.9 million, or $0.79 per share (basic), for the 2025 Quarter. Please refer to the GAAP to non-GAAP Reconciliation attached to this press release.

Conference Call and Webcast

Verastem will host a conference call and webcast today at 4:30 p.m. ET to review the first quarter 2026 financial results and recent business updates. To access the live audio webcast of the call, along with accompanying slides, please visit the "Events & Presentations" page in the Investor section of the Company’s website, View Source A replay of the webcast will be archived and available following the event.

(Press release, Verastem, MAY 7, 2026, View Source [SID1234665350])

On May 7, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported financial results for the first quarter of 2026, along with recent product highlights and corporate updates.

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"We continue to accelerate the development of our global pipeline, with numerous clinical trials underway across oncology and immunology," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "During the quarter, we made strong progress advancing zoci, with AACR (Free AACR Whitepaper) data reinforcing its differentiated profile in both SCLC and epNECs, collaborations with Amgen and Boehringer Ingelheim to evaluate zoci as a potential backbone therapy, and rapid enrollment in the registrational DLLEVATE study, which is on track to be fully enrolled in the first half of 2027. We also continue to advance our growing portfolio of global clinical programs, including ZL-1503 (IL-13/IL-31Rα) for atopic dermatitis. This reflects the strength of our R&D engine, which is designed to scale and deliver a pipeline of differentiated new products. At the same time, our commercially profitable regional business provides a stable foundation, with several near-term opportunities expected to support future growth."

"We are deepening our presence in key markets to capitalize on underlying demand for VYVGART and are expanding our regional footprint as we prepare for the launch of KarXT in China in the second quarter," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "Supported by national guidelines and an addressable population of ~8 million schizophrenia patients, KarXT’s launch positions us to bring the first novel therapy in decades to this critical market, with potential NRDL inclusion next year. In addition, we anticipate a potential regulatory approval for TIVDAK this year, and with positive Phase 3 readouts for povetacicept and elegrobart, we have additional opportunities for future growth. Across all efforts, we remain focused on driving consistent execution throughout our commercial portfolio."

First Quarter 2026 Financial Results

•Total revenue was $99.6 million in the first quarter of 2026, compared to $106.5 million for the same period in 2025, representing a decrease of 6% y-o-y. Product revenue, net was $95.6 million in the first quarter of 2026, compared to $105.7 million for the same period in 2025, representing a 10% y-o-y decrease, 12% y-o-y decrease at constant exchange rate (CER). This decrease was primarily driven by decreased sales for ZEJULA, partially offset by increased sales for XACDURO and NUZYRA:

–ZEJULA was $30.0 million in the first quarter of 2026, compared to $49.5 million for the same period in 2025. Sales declined due to a shift in hospital utilization patterns following volume-based procurement for generic olaparib.

–VYVGART was $17.6 million in the first quarter of 2026, compared to $18.1 million for the same period in 2025. Sales declined primarily due to a pricing adjustment related to NRDL renewal.

–XACDURO, was $8.6 million in the first quarter of 2026, compared to $1.1 million for the same period in 2025. Growth was driven by strong patient demand and expanding hospital adoption but was partially constrained by supply limitations.

–NUZYRA was $16.3 million in the first quarter of 2026, compared to $15.1 million for the same period in 2025. This growth was supported by increased market coverage and penetration.

•Research and Development (R&D) expenses were $65.6 million in the first quarter of 2026, compared to $60.7 million for the same period in 2025. This increase was primarily due to increased clinical trial-related expenses and licensing fees.

•Selling, General and Administrative (SG&A) expenses were $65.1 million in the first quarter of 2026, compared to $63.4 million for the same period in 2025. This increase was primarily driven by higher general selling expenses.

•Loss from operations was $69.4 million in the first quarter of 2026, $51.9 million when adjusted to exclude certain non-cash expenses including depreciation, amortization, and share-based compensation. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release.

•Net loss was $51.0 million in the first quarter of 2026, or a loss per ordinary share attributable to stockholders of $0.05 (or loss per American Depositary Share (ADS) of $0.46), compared to a net loss of $48.4 million for the same period in 2025, or a loss per ordinary share of $0.04 (or loss per ADS of $0.45). These increases in net loss were primarily due to lower product revenue and higher research and development expenses, partially offset by foreign currency gains.

•Cash and cash equivalents, short-term investments, and current restricted cash totaled $761.3 million as of March 31, 2026, compared to $789.6 million as of December 31, 2025.

Recent Corporate Updates

–In April 2026, we appointed Yizhe Wang, Ph.D., as Operating Partner, to strengthen Zai Lab’s commercial capabilities and execution. Dr. Wang brings extensive experience in global oncology and immunology commercial operations, having led commercial teams across China, the U.S., and the U.K. at GSK and Eli Lilly.

Recent Pipeline Highlights

Below are key product candidate updates since our last earnings release:

Oncology Pipeline

•Zocilurtatug Pelitecan (zoci, DLL3-Targeting ADC) (formerly ZL-1310):

–In April 2026, Zai Lab presented compelling clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 demonstrating that zoci delivers rapid and robust intracranial responses in patients with previously treated extensive stage small cell lung cancer (ES-SCLC) and brain metastases as measured by blinded independent assessment using mRANO-BM criteria, as well as promising data in patients with extrapulmonary neuroendocrine carcinomas (epNECs).
◦SCLC with Brain Metastases: Zoci showed a 53.7% confirmed intracranial objective response rate (iORR) with 62.5% (10/16) at the 1.6 mg/kg dose, including complete responses. Notably, responses were observed in patients without prior brain radiotherapy (9/15, 60%), highlighting the net drug effect on the intracranial lesions. Zoci was well tolerated, with Grade ≥3 treatment-related adverse events (TRAEs) in 19.9% (27/136) of the overall population and in 16.4% (9/55) of patients who received 1.6mg/kg.
◦epNECs: Encouraging activity was observed with a 38.2% confirmed objective response rate across epNEC tumors of different primary origins. The safety profile in epNEC was consistent with that previously observed in SCLC with Grade ≥3 TRAEs in 15.2% of patients in Phase 1b.

–In April 2026, Zai Lab announced a global clinical trial collaboration with Amgen to evaluate zoci in combination with Amgen’s IMDELLTRA (tarlatamab-dlle), a DLL3/CD3 bispecific T-cell engager (TCE), for ES-SCLC and a clinical collaboration with Boehringer Ingelheim to evaluate zoci in combination with obrixtamig, a DLL3/CD3 bispecific TCE, for SCLC and other NECs.

Immunology, Neuroscience, and Infectious Disease Pipeline

•ZL-1503 (IL-13/IL-31Rα): In April 2026, Zai Lab announced new data from a preclinical study of ZL-1503, demonstrating that the company’s internally developed IL-13/IL-31Rα bispecific antibody may lead to sustained suppression of intense pruritus (itch) and inflammation caused by atopic diseases. The findings reinforce the potential of ZL-1503 to be a first-in-class treatment option for moderate-to-severe atopic dermatitis and other IL-13 and IL-31-driven diseases. A global Phase 1/1b study is ongoing and Zai Lab expects to report the first-in-human data from the global Phase 1 portion in the second half of 2026.

•Povetacicept (APRIL/BAFF):

–IgA nephropathy (IgAN): In March 2026, Zai Lab partner Vertex announced positive data from a pre-specified Week 36 interim analysis of the global Phase 3 RAINIER trial of pove in IgA nephropathy (IgAN). The trial met its primary objective, with povetacicept-treated patients achieving a 52.0% reduction from baseline in 24-hour urine protein to creatinine ratio (UPCR), representing a statistically significant and clinically meaningful 49.8% UPCR reduction versus placebo (p<0.0001). Povetacicept was generally safe and well tolerated. Zai Lab participated in the global Phase 3 study in Greater China.

–Primary membranous nephropathy (pMN): Zai Lab partner Vertex has completed enrollment in the Phase 2 portion of the global pivotal Phase 2/3 OLYMPUS study and has initiated the Phase 3 portion. Zai Lab participated in the global study in Greater China.

•Elegrobart (anti-IGF-1R, subcutaneous): Zai Lab partner Viridian Therapeutics announced positive topline data in both REVEAL-1 and REVEAL-2, elegrobart’s two pivotal phase 3 clinical trials for active and chronic TED, respectively. Elegrobart was generally well tolerated across both studies. Zai Lab holds an exclusive license from Zenas

BioPharma to develop and commercialize elegrobart in Greater China and is currently conducting a Phase 3 bridging study in the region.

–REVEAL-1 in active TED: met its primary endpoint with a highly statistically significant treatment effect. Both elegrobart Q4W and Q8W treatment arms showed rapid onset of treatment effect and achieved clinically meaningful 54% and 63% proptosis responder rates, respectively, versus 18% placebo at week 24. The Q4W treatment arm additionally provided meaningful diplopia benefit to patients with active TED.

–REVEAL-2 in chronic TED: met its primary endpoint with a highly statistically significant treatment effect. Both elegrobart Q4W and Q8W treatment arms achieved statistically significant and clinically meaningful 50% and 54% proptosis responder rates, respectively, versus 15% placebo at week 24. The Q4W treatment arm additionally provided meaningful diplopia benefit to patients with chronic TED.

Anticipated Major Milestones in 2026

Expected Clinical Developments and Data Readouts

Global Pipeline

Zocilurtatug Pelitecan (zoci, DLL3-Targeting ADC) (formerly ZL-1310)

•First-Line ES-SCLC: Zai Lab to provide data readout from the Phase 1 study evaluating zoci combination therapy (with atezolizumab and/or chemotherapy) in the second half of 2026 and advance zoci into a registrational study in 2026 based on emerging data.

•Extrapulmonary NECs: Zai Lab to complete the enrollment for the global Phase 2 portion of the ongoing Phase 1b/2 study evaluating zoci in patients with selected solid tumors and advance into registrational development in 2026.

ZL-1503 (IL-13/IL-31Rα)

•Zai Lab to provide the first-in-human data readout from the global Phase 1/1b study in 2026.

Regional Pipeline

Upcoming Potential NMPA Approvals

•TIVDAK (Tisotumab Vedotin, Tissue Factor ADC) in recurrent or metastatic cervical cancer following progression on or after chemotherapy

•Tumor Treating Fields (TTFields) in locally advanced pancreatic cancer

Expected Data Readouts

Efgartigimod (FcRn)

•Myositis: Zai Lab partner argenx to provide topline results from the global Phase 2/3 ALKIVIA study evaluating autoimmune inflammatory myopathies (AIM or myositis) in the third quarter of 2026. Zai Lab participated in the study in Greater China.

Elegrobart (Anti-IGF-1R, subcutaneous)

•Zai Lab to complete the enrollment for the Phase 3 registrational study in China in the third quarter of 2026.

Conference Call and Webcast Information

Zai Lab will host a live conference call and webcast today, May 7, 2026, at 8:00 a.m. ET (8:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call.

Details are as follows:

•Registration link for webcast (preferred): View Source
•Registration link for dial-in: View Source

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

(Press release, Zai Laboratory, MAY 7, 2026, View Source [SID1234665347])

On May 7, 2026 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the first quarter ended March 31, 2026.

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"Werewolf, assisted by its exclusive financial advisor, Piper Sandler & Co. ("Piper Sandler"), continues to explore a range of alternatives available to the Company to maximize shareholder value," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "As will be disclosed in more detail in our Quarterly Report on Form 10-Q that will be filed today, we have entered into an asset purchase agreement with Jazz Pharmaceuticals Ireland Limited ("Jazz") by which Jazz has acquired exclusive global development and commercialization rights to JZP898, an IFNα program, which was previously exclusively licensed by Jazz pursuant to a collaboration and license agreement entered into in 2022. Additionally, we have repaid all amounts owed under the loan and security agreement dated May 2, 2024, with K2 HealthVentures LLC ("K2") as of May 6, 2026. We continue to explore options for our INDUKINE and INDUCER platforms and programs."

Financial Results for the First Quarter of 2026:

•Cash position: As of March 31, 2026, cash and cash equivalents were $46.5 million, compared to $57.1 million as of December 31, 2025. Subsequent to the end of the first quarter of 2026, the Company entered into the asset purchase agreement with Jazz and repaid all obligations under the loan and security agreement with K2, in each case as described above. The Company plans to update cash runway guidance in the near future.
•Research and development expenses: Research and development expenses were $8.2 million for the first quarter of 2026, compared to $13.1 million for the same period in 2025.
•General and administrative expenses: General and administrative expenses were $5.1 million for the first quarter of 2026, compared to $4.9 million for the same period in 2025.
•Net loss: Net loss was $13.5 million for the first quarter of 2026, compared to $18.1 million for the same period in 2025.

(Press release, Werewolf Therapeutics, MAY 7, 2026, View Source [SID1234665346])

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.

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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 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2026. Unless otherwise stated, all comparisons are for the first quarter 2026 compared to the first quarter 2025.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the first quarter of 2026 was $42.0 million, compared to product revenue, net of $43.1 million in the first quarter of 2025.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $3.8 million, or $0.07 per basic and diluted share, for the first quarter of 2026, compared to net income of $3.0 million, or $0.06 per basic and diluted share, for the first quarter of 2025.

Non-GAAP adjusted net loss was $1.9 million, or $0.04 per basic and diluted share, for the first quarter of 2026, compared to non-GAAP adjusted net income of $5.0 million, or $0.10 per basic and diluted share, for the first quarter of 2025. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the first quarter of 2026 was $15.4 million, compared to net cash provided by operating activities in the first quarter of 2025 of $3.6 million. At March 31, 2026, Puma had cash, cash equivalents and marketable securities of $101.5 million, compared to cash, cash equivalents and marketable securities of $97.5 million at December 31, 2025. Total debt at March 31, 2026 was $11.3 million, compared to total debt of $22.5 million at December 31, 2025. On May 4, 2026, Puma remitted the final payment of principal, interest and exit fees due under its 2021 Note Purchase Agreement, which reduced outstanding debt to zero and terminated all remaining obligations, other than customary continuing indemnification obligations.

"We are very pleased that the first quarter of 2026 marked another quarter of year-over-year demand increase resulting in our raising revenue guidance for 2026. According to our current forecasts, FY 2026 will mark our second consecutive year of NERLYNX demand increase year over year," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "We are also pleased with the interim data from ALISCA-Breast1 and ALISCA-Lung1, which appear to demonstrate an increased clinical effect of alisertib in biomarker subgroups where aurora kinase A appears to be playing a role. We look forward to continuing the development of alisertib in ALISCA-Breast1 and ALISCA-Lung1 while carefully managing our resources to achieve positive net income for this year."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) expansion of enrollment in ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer to obtain more data in biomarker focused populations (H2 2026); (ii) expansion of ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H2 2026); and (iii) presentation of updated data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2026)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the first quarter ended March 31, 2026, total revenue was $44.8 million, of which $42.0 million was net product revenue and $2.8 million was royalty revenue. This compares to total revenue of $46.0 million in the first quarter of 2025, of which $43.1 million was net product revenue and $2.9 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $48.6 million for the first quarter of 2026, compared to $42.0 million for the first quarter of 2025.

Cost of Sales

Cost of sales was $10.4 million for the first quarter of 2026, compared to $10.6 million for the first quarter of 2025. Cost of sales was relatively consistent year-over-year as our product bottle sales were relatively consistent.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $18.4 million for the first quarter of 2026, compared to $17.6 million for the first quarter of 2025. The $0.8 million increase resulted primarily from a $0.9 million increase in employee compensation and a $0.4 million increase in marketing and market access costs, partially offset by decreases in provision for credit losses, facility and equipment costs, and stock-based compensation expense totaling $0.4 million.

Research and Development Expenses

Research and development expenses were $19.8 million for the first quarter of 2026, compared to $13.8 million for the first quarter of 2025. The $6.0 million increase resulted primarily from an increase of approximately $5.2 million in clinical trial expense, primarily due to increased alisertib study activity, and an increase of approximately $0.7 million in employee compensation expense.

(Press release, Puma Biotechnology, MAY 7, 2026, View Source [SID1234665344])