On May 7, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported financial results for the quarter ended March 31, 2026, and provided recent corporate highlights.

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"This quarter reflects continued progress across our pipeline as we advance Phase 1 dose-escalation studies for HWK-007 and HWK-016, with a third IND planned for HWK-206 mid-year," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "We remain focused on high quality execution as we build toward initial data anticipated in 1H 2027, with the goal of delivering meaningful benefits for patients."

Q1 2026 and Recent Operational Highlights:

Continued to enroll patients into ongoing Phase 1 dose-escalation trials for HWK-007 and HWK-016.
HWK‑007 is being evaluated in patients with non-squamous, EGFR wild-type non-small cell lung cancer; platinum-resistant ovarian cancer; and endometrial cancer (NCT07444814).
HWK‑016 is being evaluated in patients with advanced ovarian and endometrial cancers (NCT07470853).
Presented comprehensive data highlighting preclinical proof-of-concept for Whitehawk’s next-generation ADC portfolio underpinned by its proprietary Carbon Bridge Cysteine Re-pairing (CBCR) platform. Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 demonstrate a consistent preclinical profile for HWK-007, HWK-016 and HWK-206 characterized by potent tumor regressions, high plasma stability and favorable tolerability in non‑human primates, coupled with low systemic levels of free payload.
Presented real-world analysis confirming MUC16 as a highly expressed clinically relevant target for gynecologic cancers. Whitehawk presented data at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting that established MUC16 as the highest-expressing ADC target in ovarian cancer, at least two-fold higher than other emerging targets, and showed MUC16 is highly and stably expressed in the most aggressive and most common subtypes of endometrial cancer.
First Quarter 2026 Financial Results:

Cash, cash equivalents and short-term investments as of March 31, 2026, were $123.0 million as compared to $145.7 million as of December 31, 2025. Cash is anticipated to fund operations into 2028 based on current plans.
Research and development expenses were $17.2 million for the three months ended March 31, 2026, including development milestone expenses of $5.3 million under our license agreement with WuXi Biologics, as compared to $8.8 million for the quarter ended March 31, 2025.
Net loss for the three months ended March 31, 2026, was $22.2 million as compared to a net income of $73.0 million for the three months ended March 31, 2025. The prior year quarter included an $87.4 million gain on the sale of Aadi Subsidiary.
Anticipated Milestones:

HWK-206 – plan to submit an Investigational New Drug application to the U.S. Food and Drug Administration in mid-2026 for HWK-206 in small-cell lung cancer and neuroendocrine tumors; Phase 1 recruitment planned to start in Q3 2026.
HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027.

(Press release, Whitehawk Therapeutics, MAY 7, 2026, View Source [SID1234665355])

On May 7, 2026 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 139.0 million in the first quarter of 2026 (Q1 2025: NOK 125.3 million), and an adjusted EBITDA of NOK 15.3 million (Q1 2025: NOK 9.7 million) for the company. In 2026, Photocure expects product revenue growth in the range of 7% to 11% on a constant currency basis and adjusted EBITDA margin expansion.

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"Photocure delivered a solid start to 2026, with strong growth across all territories and continued execution across both our commercial and strategic priorities. Revenue growth was robust in North America and Europe, reflecting accelerating adoption of blue-light cystoscopy and increasing procedural penetration in key markets," says Dan Schneider, President & Chief Executive Officer of Photocure.

The company continued to execute on its plan to expand blue-light cystoscopy (BLC) use in Q1 2026 with the installation of 11 new Saphira towers in the U.S. — 4 new accounts and 7 blue light tower upgrades. Photocure had 413 active accounts in the U.S. at the end of the quarter, an increase of 21% versus the first quarter of 2025. Across Europe, a total of 75 Olympus Visera Elite III BLC capable systems were installed since the launch in Q1 2025.

Total revenues ended at NOK 264.6 million in the first quarter of 2026, an increase from NOK 125.3 million in Q1 2025. The total revenue in Q1 2026 includes recognized milestone payments of NOK 125.6 million for the approval of Cevira in China and the acceptance of the marketing authorization approval request in Europe. Reported EBITDA was NOK 128.3 million (NOK 1.8 million). EBIT ended at NOK 120.7 million (NOK -5.6 million). Cash and cash equivalents were NOK 192.7 million at the end of the period.

"As a very important regulatory and strategic update, the U.S. Food and Drug Administration has provided clarity on the reclassification pathway for OAY-related equipment (Diagnostic Endoscopic Light Source Systems) following its response to the Karl Storz Citizen Petition and has confirmed plans to initiate a proposed reclassification process in the second half of 2026. This marks an important step towards a more structured and predictable regulatory framework for BLC equipment in the U.S. market. For Photocure, reclassification has the potential to be a step-change driver for the business, unlocking a significantly larger commercial opportunity, as we move towards double-digit penetration across the expanded market relative to where we are today," Schneider adds.

Photocure’s partners Richard Wolf and Asieris achieved a significant milestone with the April approval of the System blue BLC platform in China, which will be commercialized alongside Hexvix following its prior approval by the National Medical Products Administration (NMPA) in November 2024, enabling a fully integrated drug–device offering. At the same time, the recent CE mark and early commercial traction of blue light–compatible systems in Europe from the leading global medtech company Stryker, reinforce the growing recognition of BLC as an important standard in bladder cancer management and supporting broader adoption over time.

"Cevira, originally developed by Photocure and out-licensed to Asieris, was approved in China by the NMPA in March as a first-in-class non-invasive therapy for cervical precancerous lesions. Shortly thereafter, Cevira was endorsed with Level 1A evidence in expert consensus guidelines in China, reinforcing its clinical adoption potential. In Europe, the European Medicines Agency accepted the Marketing Authorization Application for Cevira during the quarter as well. The approval of Cevira in China and the EMA acceptance serve as milestones with contractual payments owed to Photocure in the amounts of 11.0 million and 2.0 million dollars respectively. The NMPA approval milestone is in dispute, with Asieris having paid 6.6 million of the 11.0 million dollars owed. Photocure believes its legal position to collect the full amount is strong and intends to engage in discussions with Asieris to explore potential pathways forward," Schneider says, and continues:

"Furthermore, in addition to our Hexvix/Cysview base business and partnered developments mentioned above, Photocure also remains committed to advancing a strategy of building an integrated diagnostics platform and leveraging our existing strong commercial footprints in North America and Europe. The uro-oncology landscape is rapidly evolving toward more personalized and data-driven care pathways, increasing the importance of multi-modal precision diagnostics tools. During the quarter, we made a targeted 3.0 million dollar minority investment in Vesica Health, a company within precision diagnostics, developing and launching a multi-omic urine biomarker test for early detection of bladder cancer with best-in-class performance. Our initiatives in flexible cystoscopy with Richard Wolf, AI-enabled software with Claritas/ISC, biomarkers with Vesica Health, and other innovations are progressing as planned, with the goal of improving early detection, diagnostic confidence, surveillance and treatment decision-making."

Photocure sees multiple drivers supporting continued growth in its base business, including sustained procedural adoption, expansion of installed equipment, increased utilization across existing accounts, and continued upgrade cycles to next-generation imaging systems. In addition, several strategic catalysts will further enhance its trajectory, including FDA reclassification of BLC to bring additional rigid equipment manufacturers to the U.S. and the reintroduction of flexible BLC solutions.

"We remain confident in Photocure’s momentum and continued positive trajectory. We expect strong underlying revenue growth across all regions, with product revenue growth of 7% to 11% on a constant currency basis, supported by sustained commercial execution. As operating leverage improves, we anticipate further expansion in adjusted EBITDA margin, reflecting the scalability of our platform and disciplined execution across the base business alongside a strategic platform extension. Our focus remains on delivering consistent execution and building long-term shareholder value," Schneider concludes.

Please find the full financial report and presentation enclosed.

(Adjusted) EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the first quarter 2026 financial report on page 22.

The quarterly report and presentation will be published at 07:00 CET and will be publicly available at www.photocure.com. Dan Schneider, CEO, Erik Dahl, CFO, and Priyam Shah, VP of IR will host a live webcast at 14:00 CET.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through: View Source

The presentation is scheduled to conclude at 14:45 CET.

(Press release, PhotoCure, MAY 7, 2026, View Source [SID1234665212])

On May 7, 2026 ALX Oncology Holdings Inc. ("ALX Oncology" Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that data from exploratory analyses in the Phase 1b/2 clinical trial evaluating the company’s investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab (ZIIHERA) in patients with heavily pre-treated HER2-positive metastatic breast cancer (mBC) were presented for the first time today in a poster session at the ESMO (Free ESMO Whitepaper) Breast Cancer 2026 congress. The findings show that patients with centrally confirmed HER2-positive (ccHER2-positive) mBC and high CD47 expression experienced a promising, durable response.

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Specifically, patients in the trial with ccHER2-positive disease and high CD47 expression (defined as total membrane staining of >20%) had a confirmed objective response rate (cORR) of 100% (n=5/5), while the cORR was 25% (n=1/4) among those with lower CD47 expression (<20%). Those patients whose tumors expressed higher levels of CD47 also had longer median progression-free survival (mPFS): 22.1 months as compared to 3.4 months in the low-CD47 expression group. The median duration of response (mDOR) among patients whose tumors expressed high levels of CD47 was also notable at 20.2 months.

"There is a large and growing population of patients with advanced breast cancer who need novel treatment options once their disease has progressed following treatment with currently available therapies, including trastuzumab deruxtecan," said Funda Meric-Bernstam, M.D., Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, who presented the findings today. "Our data suggest that adding evorpacept to HER2-targeted agents may provide one such option, and we may be able to optimize patient selection for these regimens by using a biomarker-driven approach that incorporates CD47."

The Phase 1b/2 open-label, multi-center clinical trial (NCT05027139) evaluating evorpacept plus zanidatamab included patients with heavily pre-treated HER2-positive mBC (median of five prior HER2-targeted therapies), all of whom had received prior ENHERTU therapy. The primary trial results, presented at the 2024 San Antonio Breast Cancer Symposium (SABCS), demonstrated that the investigational combination generated promising anti-tumor activity and a manageable safety profile.

The exploratory analyses comprised 24 patients, including 10 with ccHER2-positive disease. Seventeen of 24 samples were evaluable for CD47 expression, including samples from nine of the 10 ccHER2-positive patients. Patients received zanidatamab plus evorpacept at dosages of 20 mg/kg (n=3) or 30 mg/kg (n=21). As of the August 1, 2024 data cut-off, key findings from the analyses include:

The cORR among all 24 patients was 33% and the mPFS was 3.6 months.
Patients with ccHER2-positive disease (n=10) had higher response rates, with a cORR of 60% and mPFS of 8.3 months.
All of the patients (n=5/5) with ccHER2-positive disease and high CD47 expression (defined as total membrane staining of >20%) responded (including one complete response and four partial responses), with an mDOR of 20.2 months and mPFS of 22.1 months. In comparison, among the patients with ccHER2-positive disease and low CD47 expression (defined as total membrane staining of <20%), cORR was 25% (n=1/4) and mPFS was 3.4 months.
"The findings from these exploratory analyses provide additional evidence that adding evorpacept to HER2-targeted therapies may generate durable responses in heavily pretreated HER2-positive breast cancers, including in patients in the post-ENHERTU setting," said Barbara Klencke, M.D., Chief Medical Officer at ALX Oncology. "They also further support the use of a biomarker-driven approach to predict treatment response, as we previously observed in the HER2-positive gastric cancer setting. We designed the ongoing ASPEN-09-Breast Phase 2 trial of evorpacept plus trastuzumab and chemotherapy to provide additional insight into this approach and, we hope, move closer to delivering a new therapeutic option for this group of patients."

Q1 2026 Results Conference Call and Webcast Details

ALX Oncology management will host a webcast tomorrow (Friday, May 8), to provide an overview of Q1 2026 financial results. Sara Hurvitz, M.D., will join the call to discuss and provide perspective on the Phase 1b/2 trial data shared at the ESMO (Free ESMO Whitepaper) Breast Cancer congress.

Date & Time: Friday, May 8, 2026, 8:30 a.m. ET
Guest Speaker: Sara Hurvitz, M.D., Professor, Senior Vice President and Director, Clinical Research Division and Smith Family Endowed Chair in Women’s Health at Fred Hutchinson Cancer Center; Professor and Head, Division of Hematology and Oncology, Department of Medicine, University of Washington
Webcast Access: View Source;tp_key=2800839c82
Participant Listening Options by Phone: To access the conference call, please dial 1-877-407-0752 or +1-201-389-0912 and ask to be joined into the ALX Oncology First Quarter 2026 Financial Results Conference Call.

Another option for instant telephone access to the event is to use the Call Me link below:
View Source;passcode=13755276&h=true&info=company&r=true&B=6

A live audio webcast of the call, along with the ALX Oncology corporate presentation, will be available under "Events & Presentations" in the Investor section of the Company’s website, www.alxoncology.com. An archived webcast will be available on the Company’s website after the event.

(Press release, ALX Oncology, MAY 7, 2026, https://ir.alxoncology.com/news-releases/news-release-details/alx-oncologys-evorpacept-combination-zanidatamab-generates [SID1234665301])

On May 7, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, reported business update and announces first quarter 2026 financial results.

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Business highlights (since last quarterly update)
Evaxion has had a good start to the year executing on our plans and achieving our first milestone for 2026 as expected. Highlights include:

New data demonstrating an 86% vaccine target recognition by AI-Immunology in personalized cancer vaccine EVX-01 is a further scientific validation of the platform’s precision in driving immune response. This marked our first milestone for the year
Another new set of data confirming the platform’s unique scalability in glioblastoma
Successful completion of the one-year extension of our phase 2 trial with EVX-01 paving the way for presentation of three-year clinical data in the second half of 2026
Presentation of potentially superior design concepts for new polio vaccines stemming from our collaboration with The Gates Foundation
Organizational optimization for strategy execution with the promotion of Birgitte Rønø to the dual role of Chief Scientific and Chief Operating Officer and the election of Jens Bitsch-Nørhave to the Board of Directors
Cash runway unchanged with cash at hand to fund operations into the second half of 2027
"We maintain strong operational momentum as we continue our work to consolidate our position as a leader in AI-based target discovery, drug design and development. The validation of AI-Immunology continues to be reinforced with a host of new promising data presented, which forms a solid foundation for our ongoing business development efforts. We are pleased to have further strengthened our organization to focus on these with the promotion of Birgitte Rønø and inclusion of Jens Bitsch-Nørhave as a formal member of our Board of Directors," says Helen Tayton-Martin, CEO of Evaxion.

Conference call and webcast
Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions.

To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event.

To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event.

Research & Development (R&D) update
Evaxion has a R&D pipeline of innovative vaccine candidates for both cancer and infectious diseases.

EVX-01 is our most advanced asset. Developed with AI-Immunology, it is a personalized cancer vaccine designed to target multiple neoantigens; cancer unique proteins arising from mutations. We completed the initially planned two-years of treatment in the phase 2 trial with EVX-01 in patients with advanced melanoma (skin cancer) last year with unprecedented results and presented new immunogenicity data from the trial at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting last month.

The data demonstrates that AI-Immunology identifies and selects the most therapeutically relevant vaccine targets as 86% of the targets included in EVX-01 trigger a tumor-specific immune response. This is a success rate much higher than what has been reported for other methods.

The record-high vaccine target precision underscores the therapeutic potential of EVX-01 and is also a further validation of AI-Immunology as an effective tool for developing potentially transformational treatments in melanoma as well as potentially other cancer indications with high mutational burden. This is of course important for the technology itself, but also very supportive of our ongoing work to enter additional strategic partnerships and business development deals.

At AACR (Free AACR Whitepaper), we also presented new data confirming the scalability of AI-Immunology allowing for its application in several diseases. This includes the deadly brain cancer glioblastoma, for which the platform uniquely can identify a novel source of targets to include in therapeutic vaccines, potentially enhancing their efficacy.

The data was generated in collaboration with Duke University School of Medicine and has created significant interest in the field of glioblastoma, an area of high unmet medical need.

We have completed the one-year extension of the phase 2 trial with EVX-01 with the last patient having last physician visit in April. In the third year, patients received EVX-01 as monotherapy, allowing an evaluation of the vaccine’s effect also as stand-alone treatment. Further, the three-year data may provide additional insights into potential enhanced treatment effects and durability of the induced immune response. We expect to present this data in the second half of 2026.

We also maintain a high activity level within our infectious disease programs as showcased by our presentation of new polio vaccine design concepts stemming from our collaboration with The Gates Foundation. These could potentially be superior to currently used vaccines and provide a basis for designing a specific new polio vaccine.

Current polio vaccines are based on inactivated or attenuated versions of the virus. Whilst these vaccines are effective, they each have shortcomings in certain settings. Thus, it has been a long-standing – but so far unreachable – goal to create a novel polio vaccine that combines the strongest aspects of the existing vaccines.

To achieve this, we have deployed AI-Immunology to develop novel vaccine design concepts for a next-generation polio vaccine, which may enhance the chances of completing and sustaining polio eradication once and for all.

Business development update
We remain active in several parallel partnership discussions based on external interest in both our platform and pipeline as we continue to pursue our strategy of strengthening our platform and building value through multiple partnerships.

To this end, we were pleased to promote Birgitte Rønø to joint role of Chief Scientific and Chief Operating Officer reflecting optimal internal organization to support partnering activities and internal strategy execution.

Further, we are excited to have welcomed Jens Bitsch-Nørhave to our Board of Directors. With more than 25 years of leadership experience in the biotech and pharmaceutical industry, specializing in corporate strategy, global expansion, and dealmaking, Jens will be a strong contributor to our business development activities.

First quarter 2026 financial results
The financial results for the first quarter 2026 showed a net loss of $3.6 million, compared to $1.6 million first quarter 2025. This is explained by financial income from remeasurement of derivative liability in the first quarter last year, whereas the operating expenses and results were slightly reduced in first quarter 2026.

Research and development (R&D) expenses were $2.3 million for the first quarter 2026, which is a slight increase compared to same period last year, as we progress our pipeline according to plan.

General and administrative (G&A) expenses were $1.5 million for the quarter, compared to $1.7 million in first quarter 2025. The decrease is primarily driven by lower capital market costs.

Financial income of $0.3 million first three months of 2026 compared to $2.4 million same period last year, is due to financial income recorded in 2025 from remeasurement of derivative liability from the January 2025 public offering.

Cash and cash equivalents as of March 31, 2026, were $18.4 million, compared to $23.2 million as of December 31, 2025, and confirms our current cash runway until second half of 2027.

Total equity amounts to $13.2 million as of March 31, 2026, reflecting the net result of the first quarter 2026 when compared to $17.0 million as of December 31, 2025.

Evaxion A/S
Consolidated statement of financial position data
(USD in thousands)

Mar 31,
2026 Dec 31,
2025
Cash and cash equivalents 18,440 23,234
Total assets 23,642 28,408
Total liabilities 10,435 11,369
Share capital 16,040 15,791
Other reserves 130,891 127,492
Accumulated deficit (133,724) (126,244)
Total equity 13,207 17,039
Total liabilities and equity 23,642 28,408

Evaxion A/S
Consolidated statement of comprehensive loss data
(USD in thousands, except per share data)

Three Months Ended
Mar 31,
2026 2025
Revenue 0 0
Research and development (2,298) (2,156)
General and administrative (1,521) (1,712)
Operating gain / loss (3,819) (3,868)
Finance income 305 2,493
Finance expenses (332) (397)
Net gain/ loss before tax (3,845) (1,772)
Income tax benefit 216 192
Net gain / loss for the period (3,629) (1,580)
Net loss attributable to shareholders of Evaxion A/S (3,629) (1,580)
Loss per share – basic and diluted (0.01) (0.01)
Number of shares used for calculation (basic and diluted) 417,010,756 276,311,927

(Press release, Evaxion, MAY 7, 2026, View Source [SID1234665322])

On May 7, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress, reiterated key anticipated milestones, and reported first quarter 2026 financial results.

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"The forward momentum continues at Nuvalent, with both of our parallel-lead programs advancing toward key US regulatory milestones and the opportunity to bring our first new medicine to patients this year," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "We recently submitted our NDA for neladalkib in TKI pre-treated ALK-positive NSCLC and are continuing to build our commercial infrastructure in preparation for a potential US launch of zidesamtinib in TKI pre-treated ROS1-positive NSCLC, if approved."

Dr. Porter continued, "Beyond these initial opportunities, we remain focused on progressing our label expansion strategies for ROS1- and ALK-positive NSCLC, as well as our earlier-stage pipeline, with the goal of driving meaningful, long-term impact in NSCLC and beyond. Through these efforts, we believe we are well positioned to realize our vision of becoming a sustainable biotechnology company capable of designing, developing and delivering precisely targeted therapies for patients with cancer."

Recent Pipeline Achievements and Anticipated Milestones

ROS1 Program

•
The New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, is under review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI) with a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Nuvalent continues to advance commercial preparations ahead of an anticipated U.S. commercial launch of zidesamtinib in 2026, pending FDA review.
•
Nuvalent plans to submit data to the FDA to support a potential label expansion of zidesamtinib in TKI-naïve patients with advanced ROS1-positive NSCLC in the second half of 2026.
•
Nuvalent presented new clinical and preclinical data for zidesamtinib during poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, including:
o
Clinical data from a subgroup of patients with advanced ROS1-positive NSCLC in the ARROS-1 clinical trial who had been previously treated with the dual TRK/ROS1 TKIs repotrectinib and/or taletrectinib. Treatment with zidesamtinib resulted in clinically meaningful activity in this heavily pre-treated subgroup, including activity in tumors with the ROS1 G2032R resistance mutation and intracranial complete responses for patients with CNS disease. These results indicate that ROS1-positive NSCLC tumors may remain ROS1-dependent beyond treatment with repotrectinib or taletrectinib.
o
Preclinical analyses supporting the potential for differentiation of the brain penetrance and intracranial ROS1 G2032R antitumor activity of zidesamtinib compared to the dual TRK/ROS1 inhibitors repotrectinib and taletrectinib. Among these three ROS1 TKIs, zidesamtinib demonstrated the highest in vitro measures of brain penetrance, most sustained intracranial efficacy in a mouse ROS1 G2032R brain tumor model, and efficacy after progressive disease on earlier-line taletrectinib treatment in a mouse ROS1 G2032R brain tumor model. Data demonstrating that switching from repotrectinib to zidesamtinib resulted in more sustained tumor suppression in the same preclinical model have been previously reported.1
•
The company also plans to present preliminary data from the ongoing ARROS-1 Phase 1/2 clinical trial of zidesamtinib in patients with advanced ROS1-positive solid tumors outside of non-small cell lung cancer (NSCLC) during a poster session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 – June 2, 2026, in Chicago.
1Tangpeerachaikul et al. Annals of Oncology 2024; 35(2):S217.

ALK Program

•
Nuvalent submitted an NDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive NSCLC to the FDA. The application is based on data in TKI pre-treated patients with advanced ALK-positive NSCLC treated with neladalkib in the global, registration-directed ALKOVE-1 Phase 1/2 clinical trial. In this population, neladalkib demonstrated encouraging overall activity, including intracranial responses, the ability to address key drivers of disease progression, and a generally well-tolerated safety profile consistent with its ALK-selective, TRK-sparing design. The company plans to present pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from the ALKOVE-1 study, in addition to preliminary data for TKI-naïve patients, during an oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.
•
Enrollment is ongoing in ALKAZAR, the company’s global Phase 3 randomized, controlled trial designed to evaluate neladalkib for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients are randomized 1:1 to receive neladalkib or alectinib, a front-line standard of care, reflecting input from collaborating physician-scientists and alignment with global regulatory agencies. The company expects to continue to progress the ALKAZAR trial throughout 2026.

HER2 Program

•
Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2026.

Discovery Research Programs

•
Nuvalent continues to make progress across its discovery research programs and expects to disclose a new development candidate by year-end 2026.

Recent Leadership Promotions

•
Benjamin Lane, Ph.D., Promoted to Chief Technology Operations Officer: Ben joined Nuvalent in 2020, bringing more than 20 years of experience focused on the development of pre-clinical through commercial programs at both large and small biotech companies. Most recently, Ben served as Senior Director, Process Chemistry at Agios Pharmaceuticals where he led the process chemistry group and was responsible for pre-clinical to commercial drug substance development and manufacturing, including for the mitapivat program (now marketed as AQVESME and PYRUKYND). Prior to Agios, Ben served in various drug development leadership roles at Infinity Pharmaceuticals and Biogen.
•
Kirsten Duncan, Pharm.D., Promoted to Vice President, Medical Affairs: Kirsten joined Nuvalent in 2024, bringing more than 25 years of experience across biopharma, with a focus on oncology strategy and stakeholder engagement. Prior to joining Nuvalent, Kirsten spent more than five years at Pfizer, most recently as Director, Thoracic Oncology, where she led global medical affairs strategy across the lung cancer franchise. Prior to Pfizer, Kirsten served in various medical affairs leadership roles at Arivale, Percolation Communications, Duncan Communications, and OnCare.

Upcoming Events

•
TD Cowen 7th Annual Oncology Innovation Summit: Management will be participating in a virtual fireside chat on Wednesday, May 27, 2026, at 9:30 a.m. ET.
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2026 Jefferies Healthcare Conference in New York: Management will be participating in a fireside chat on Thursday, June 4, 2026, at 11:40 a.m. ET.
A live webcast of each fireside chat will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

First Quarter 2026 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $1.3 billion as of March 31, 2026. Nuvalent continues to believe that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into 2029.
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R&D Expenses: Research and development (R&D) expenses were $83.6 million for the first quarter of 2026.
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G&A Expenses: General and administrative (G&A) expenses were $35.8 million for the first quarter of 2026.
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Net Loss: Net loss was $109.3 million for the first quarter of 2026.

(Press release, Nuvalent, MAY 7, 2026, View Source [SID1234665338])