On August 7, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the second quarter ended June 30, 2025 (Press release, Puma Biotechnology, AUG 7, 2025, View Source [SID1234654995]). Unless otherwise stated, all comparisons are for the second quarter 2025 compared to the second quarter 2024.

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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 second quarter of 2025 was $49.2 million, compared to product revenue, net of $44.4 million in the second quarter of 2024. Product revenue, net in the first six months of 2025 was $92.3 million, compared to $84.6 million in the first six months of 2024.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $5.9 million, or $0.12 per basic and diluted share, for the second quarter of 2025, compared to a net loss of $4.5 million, or $0.09 per share, for the second quarter of 2024. Net income for the first six months of 2025 was $8.8 million, or $0.18 per basic and diluted share, compared to a net loss of $9.3 million, or $0.19 per share, for the first six months of 2024.

Non-GAAP adjusted net income was $7.5 million, or $0.15 per basic and diluted share, for the second quarter of 2025, compared to a non-GAAP adjusted net loss of $2.5 million, or $0.05 per share, for the second quarter of 2024. Non-GAAP adjusted net income for the first six months of 2025 was $12.4 million, or $0.25 per basic and diluted share, compared to a non-GAAP adjusted net loss of $4.9 million, or $0.10 per share, for the first six months of 2024. Non-GAAP adjusted net income (loss) 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 second quarter of 2025 was $14.1 million, compared to $1.0 million in the second quarter of 2024. Net cash provided by operating activities for the first six months of 2025 was $17.7 million, compared to net cash provided by operating activities of $12.3 million in the first six months of 2024. At June 30, 2025, Puma had cash, cash equivalents and marketable securities of $96.0 million, compared to cash, cash equivalents and marketable securities of $101.0 million at December 31, 2024.

"We are pleased to report both the growth in revenues in the second quarter as well as the positive net income for the quarter," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We are pleased to see the year over year growth being driven by NERLYNX demand and we are also pleased with the progress in the clinical development of alisertib in both chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer and small cell lung cancer as well."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim 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 2025) and (ii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Q4 2025)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the second quarter ended June 30, 2025, total revenue was $52.4 million, of which $49.2 million was net product revenue and $3.2 million was royalty revenue. This compares to total revenue for the second quarter of 2024 of $47.1 million, of which $44.4 million was net product revenue and $2.7 million was royalty revenue. For the first six months of 2025, total revenue was $98.4 million, of which $92.3 million was net product revenue and $6.1 million was royalty revenue. This compares to total revenue for the first six months of 2024 of $90.8 million, of which $84.6 million was net product revenue and $6.2 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $45.8 million for the second quarter of 2025, compared to $49.3 million for the second quarter of 2024. Operating costs and expenses in the first six months of 2025 were $87.8 million, compared to $95.3 million in the first six months of 2024.

Cost of Sales

Cost of sales was $12.3 million for the second quarter of 2025, compared to $10.7 million for the second quarter of 2024. Cost of sales was $22.9 million for the first six months of 2025, compared to $21.4 million for the first six months of 2024. The increase in the first six months of 2025 was due to higher royalty expense and product costs resulting from increased worldwide net sales.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $18.0 million for the second quarter of 2025, compared to $25.0 million for the second quarter of 2024. SG&A expenses for the first six months of 2025 were $35.6 million, compared to $46.7 million for the first six months of 2024. The $11.1 million year-over-year decrease for the first six months resulted primarily from legal fees associated with the AstraZeneca litigation in the prior year.

Research and Development Expenses

Research and development (R&D) expenses were $15.5 million for the second quarter of 2025, compared to $13.6 million for the second quarter of 2024. R&D expenses for the first six months of 2025 were $29.3 million, compared to $27.2 million for the first six months of 2024. The $2.1 million year-over-year increase for the first six months resulted primarily from increased alisertib study activity.

Total Other Income (Expenses)

Total other income/expenses were $0.4 million for the second quarter of 2025, compared to total other expenses of $2.0 million for the second quarter of 2024. Total other income/expenses were $1.2 million for the first six months of 2025, compared to total other expenses of $4.2 million for the first six months of 2024. The $3.0 million year-over-year decrease in other expenses for the first six months of 2025 was primarily due to a lower debt balance as we continue to pay down our principal.

Third Quarter and Full Year 2025 Financial Outlook

Third Quarter 2025

Full Year 2025 (current)

Full Year 2025 (previous)

Net Product Revenue

$46-$48 million

$192–$198 million

$192–$198 million

Royalty Revenue

$2-$3 million

$20–$24 million

$20–$24 million

License Revenue

$0 million

$0 million

$0 million

Total Revenue $48-$51 million $212–$222 million $212–$222 million
Net Income/(Loss)*

$2-$4 million

$23–$28 million

$23–$28 million

Gross to Net Adjustment

22.5%–23.5%

21.5%–22.0%

20.5%–21.5%

*The outlook above does not include any adjustments for tax valuation allowance.

Conference Call

Puma Biotechnology will host a conference call to report its second quarter 2025 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PT/4:30 p.m. ET on Thursday, August 7, 2025. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On August 7, 2025 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for diseases with high unmet need, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Precision Biosciences, AUG 7, 2025, View Source [SID1234654994]).

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"Our team continues to be very disciplined about executing our plans and is making strong progress advancing our clinical stage PBGENE-HBV program while rapidly advancing PBGENE-DMD toward the clinic," said Michael Amoroso, Chief Executive Officer of Precision BioSciences. "The early Phase 1 safety and efficacy data for PBGENE-HBV from the first cohort of the Phase 1 ELIMINATE-B trial establishes proof of activity for our novel gene editing approach for chronic Hepatitis B. Our data shows that we have a novel, safe and active drug in all patients treated with a durable effect in one third of patients reinforcing the mechanism of PBGENE-HBV to eliminate cccDNA. We are very pleased with the safety profile demonstrated in Cohorts 1 and 2 which has enabled the Data Monitoring Committee to endorse enrolling Cohort 3 this month to test the next higher dose. Concurrently, we are accelerating the development of our second program, PBGENE-DMD, and were proud to receive both Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration (FDA), underscoring the significant unmet need for new therapeutic options for patients living with DMD."

"Given the unmet need, opportunity and enthusiasm for PBGENE-HBV and PBGENE-DMD, we are taking proactive steps to invest fully in these two programs while extending our expected cash runway to the second half of 2027 through a significant reduction in our non-program related annual operating expenses. These actions are expected to enable commencement of a Phase 2 study for PBGENE-HBV and a potential pivotal trial for PBGENE-DMD. Our team remains committed to delivering transformative therapies in areas with significant unmet need and, with a longer cash runway, we believe we are now even better positioned to deliver the meaningful clinical data that is expected by patients and shareholders for both of our wholly-owned programs," added Mr. Amoroso.

Wholly Owned Portfolio

PBGENE-HBV (Viral Elimination Program): PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic Hepatitis B, cccDNA, while inactivating integrated HBV DNA. The ELIMINATE-B trial is investigating PBGENE-HBV at multiple ascending dose levels with three dose administrations per dose level in patients with chronic Hepatitis B.

On August 6, 2025, Precision announced Phase 1 safety and efficacy data for Cohort 1, the lowest dose level in the ELIMINATE-B trial. Cohort 1 consisted of three patients each of whom received three planned administrations of 0.2 mg/kg of PBGENE-HBV dosed approximately eight weeks apart. The primary objective is to characterize the safety of PBGENE-HBV. PBGENE-HBV was well-tolerated in all three patients in Cohort 1. Across Cohort 1, no patient experienced above a Grade 2 treatment-related adverse event, a serious adverse event, or dose-limiting toxicity. No clinically significant lab abnormalities were observed, including liver enzymes and platelets.

PBGENE-HBV demonstrated a substantial HBsAg reduction in all three patients in Cohort 1 with best response reductions of 56%, 69% and 47% compared to baseline HBsAg levels (ranging between 562-11,813 IU/mL) in patients one, two and three, respectively. One of three patients (33%) in Cohort 1 achieved a durable HBsAg reduction of approximately 50% from baseline that was maintained as of the data cutoff-date (July 28, 2025), which was seven months after initial dosing. This data provides evidence of the ability of PBGENE-HBV to drive a durable antiviral response by editing the viral DNA at the source of chronic Hepatitis B infection. There was no association between baseline HBsAg and efficacy in Cohort 1.

Precision also announced initial safety data from Cohort 2 (0.4 mg/kg) in the ELIMINATE-B study. As of the data cutoff, one patient received three dose administrations with two weeks of follow-up, and two patients received one dose administration with four weeks of follow-up. In these patients, no adverse events above Grade 2 were observed. No serious adverse events or dose limiting toxicities were observed, and no cumulative adverse effects were observed. There were no clinically significant elevations of liver transaminases. One additional patient did not complete their dose due to a transient infusion-related serious adverse event that resolved within minutes. The Data Monitoring Committee determined that this transient reaction was not dose-related or dose-limiting. Given the favorable safety profile of Cohorts 1 and 2, the Data Monitoring Committee recently recommended initiation of Cohort 3.

The Company is on track to complete dosing of all three patients across all dose administrations in Cohort 2 and commence dosing Cohort 3. The Company expects to provide a data update later in 2025.

PBGENE-DMD (Muscle Targeted Excision Program): PBGENE-DMD is Precision’s development program for the treatment of DMD. DMD is a genetic disease caused by mutations in the dystrophin gene that prevent production of the dystrophin protein and affects approximately 15,000 patients in the U.S. alone. There are currently no approved therapies that can drive durable and significant functional improvements over time. PBGENE-DMD is designed to improve function for more than 60% of patients afflicted with DMD by employing two complementary ARCUS nucleases delivered in a single AAV to excise exons 45-55 of the dystrophin gene. The aim of this approach is to restore a near-full length functional dystrophin protein within the body that more closely resembles normal dystrophin as opposed to synthetic, truncated dystrophin approaches with minimal functional benefit.

The FDA granted PBGENE-DMD Rare Pediatric Disease designation in June 2025 for the treatment of DMD, highlighting the significant unmet need for new therapeutic options. This was followed in July 2025 by the FDA granting PBGENE-DMD Orphan Drug Designation, re-enforcing the need for new and better treatments. With the Rare Pediatric Disease designation, Precision may be eligible to receive a Priority Review Voucher upon FDA approval of PBGENE-DMD.

In preclinical data presented at the ASGCT (Free ASGCT Whitepaper) annual meeting in May 2025, PBGENE-DMD demonstrated significant and durable functional improvement in a humanized DMD mouse model. Following AAV delivery, PBGENE-DMD restored the body’s ability to produce a functional dystrophin protein broadly across multiple muscle types, including cardiac and skeletal muscles. Over the course of nine months, mice treated with PBGENE-DMD showed increased dystrophin protein expression resulting in substantial and sustained functional muscle improvement. In addition, PBGENE-DMD-edited dystrophin mRNA transcript in muscle satellite stem cells, which are progenitor cells for new muscle cells, supports the potential for long-term durability.

In July 2025, Precision announced new preclinical data building upon previous data shared at the ASGCT (Free ASGCT Whitepaper) annual meeting. These data demonstrated that PBGENE-DMD produced a three-fold increase in dystrophin-positive muscle cells between three and nine months in the quadricep, gastrocnemius (calf), heart, and diaphragm. In the gastrocnemius specifically, up to 85% of cells were dystrophin-positive, indicating a high degree of productive gene editing. This broad increase in dystrophin-positive cells combined with the increased dystrophin protein detected in tissues further validates the improved muscle function that was observed over time and may be attributable to edited satellite cells.

Precision is advancing the final U.S. investigational new drug (IND)-enabling toxicology studies with an anticipated IND and/or clinical trial application (CTA) filing targeted by the end of 2025 with initial clinical data expected in 2026.

PBGENE-3243 (Mutant Mitochondrial DNA Elimination Program): PBGENE-3243 is a first-of-its-kind potential treatment for m.3243-associated mitochondrial disease that is designed to specifically target and eliminate mutant m.3243G mitochondrial DNA, thereby eliminating the root cause of the disease. Precision has paused development of PBGENE-3243 to prioritize its two lead programs, PBGENE-HBV and PBGENE-DMD.

Partnered In Vivo Gene Editing Programs

iECURE-OTC (Gene Insertion Program): Led by iECURE, ECUR-506 is an ARCUS-mediated in vivo gene editing program currently in a first-in-human Phase 1/2 trial (OTC-HOPE) evaluating ECUR-506 as a potential treatment for neonatal onset ornithine transcarbamylase (OTC) deficiency. Preliminary data from the study presented at ASGCT (Free ASGCT Whitepaper) in May demonstrated a complete clinical response from three months post-exposure to the end of study at six months, as defined by the study protocol. The patient is now more than one year of age and is eating appropriate levels of protein for a child of his age. iECURE has reported that a second infant with severe OTC deficiency was dosed in the first half of 2025.

The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain, and iECURE expects to complete enrollment in 2025 and anticipates complete data from the trial in the first half of 2026.

PBGENE-NVS (Gene Insertion Program): Precision continues to advance its gene editing program with Novartis to develop a custom ARCUS nuclease for patients with hemoglobinopathies, such as sickle cell disease and beta thalassemia. The collaborative intent is to insert, in vivo, a therapeutic transgene as a potential one-time transformative treatment administered directly to the patient to overcome disparities in patient access to treatment with other therapeutic technologies, including those that are targeting an ex vivo gene editing approach.

Non-Core Ex Vivo Programs

Azer-Cel (azercabtagene zapreleucel allogeneic CAR T treatment for cancer): Imugene Limited, Precision’s clinical stage partner developing azer-cel for oncology indications, announced updated clinical data in July 2025. In the updated data in patients diagnosed with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), two additional patients achieved a Complete Response and three additional patients achieved a Partial Response. Imugene reported that, as a result of the new data, the best overall response rate for azer-cel in DLBCL reached 75% and the Complete Response rate reached 55%. Based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL, Imugene expects to request an end of Phase 1 meeting with the FDA in the fourth quarter of 2025 to present the data and discuss designs for a pivotal/registrational trial for azer-cel.

Other Announcements

Mark Sulkowski, M.D., Professor of Medicine at the Johns Hopkins University School of Medicine and renowned expert in hepatic and infectious diseases has expanded his advisory role with Precision BioSciences. In the newly created role, Head Clinical Development Advisor, Dr. Sulkowski will work closely with Precision’s leadership and cross-functional teams to support clinical strategy across the development lifecycle for the Company’s on-going PBGENE-HBV Phase 1 clinical trial as well as initiation of later stage trials. His advisory role will focus on optimizing clinical trials, including translational integration, and aligning scientific rationale with regulatory objectives.

Quarter Ended June 30, 2025 Financial Results

"As Precision advances the ELIMINATE-B clinical trial and prepares to file an IND and/or CTA for the PBGENE-DMD program we have been closely managing our operating costs. Cost management is evident in our decision to pause development on PBGENE-3243 in the second quarter and is reflected in a $3.9 million reduction in our second quarter total operating expenses as compared to the same period last year," said Alex Kelly, Chief Financial Officer of Precision BioSciences. "We have also extended our expected cash runway to the second half of 2027 to enable meaningful clinical data readouts for PBGENE-HBV and PBGENE-DMD. In July 2025, we initiated an operating efficiency program, including reductions in early research, manufacturing and general & administrative operating expenses which are aimed at reducing our annual cash operating expenses in each of 2026 and 2027 by approximately $25 million compared to the 2025 annual cash expense level."

"In addition to significantly reducing our operating expenses, Precision will continue to pursue less dilutive sources of cash to even further extend the cash runway, including business development collaborations for future or deprioritized ARCUS programs as well as opportunities to monetize non-core program royalties and milestones," added Mr. Kelly.

Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2025, Precision had approximately $84.8 million in cash, cash equivalents, and restricted cash. Based on its expected cash runway, Precision believes it is sufficiently capitalized to reach important milestones for both programs, including commencement of a Phase 2 study for PBGENE-HBV and a potential pivotal trial for PBGENE-DMD. The Company expects existing cash and cash equivalents, upfront and potential near-term cash from CAR T transactions, along with expected operating efficiencies, operational receipts, and availability of Precision’s at-the-market (ATM) facility to extend Precision’s cash runway into the second half of 2027.

Revenues: Total revenues for the quarter ended June 30, 2025, were less than $0.1 million, as compared to $49.9 million for the quarter ended June 30, 2024. The decrease was expected and primarily the result of $48.2 million of non-cash revenue recognized in the prior period which represented all remaining deferred revenue related to the Prevail Therapeutics Agreement at its conclusion in April 2024 under generally accepted accounting principles. The upfront cash from this collaboration was received and recorded on the balance sheet in January 2021.

Research and Development Expenses: Research and development expenses were $12.8 million for the quarter ended June 30, 2025, as compared to $17.2 million for the quarter ended June 30, 2024. The decrease of $4.4 million was primarily due to decreases in PBGENE-HBV direct expenses due to lower manufacturing and toxicology expenses as the program transitioned to the clinic in the fall of 2024. PBGENE-3243, which has been paused, and other research related expenses also decreased in the comparative period, offset by an increase in PBGENE-DMD expenses as the program was accelerated in the second quarter of 2025.

General and Administrative Expenses: General and administrative expenses were $9.1 million for the quarter ended June 30, 2025, as compared to $8.5 million for the quarter ended June 30, 2024 as an increase in employee-related costs, including non-cash employee-related costs, offset a decrease in other general and administrative expenses.

Net Loss: Net loss was $23.5 million, or ($2.13) per share (basic and diluted), for the quarter ended June 30, 2025. Net income was $32.7 million, or $4.70 per share (basic) and $4.67 per share (diluted), for the quarter ended June 30, 2024.

On August 7, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline and business achievements, reiterated key anticipated milestones, and announced second quarter 2025 financial results (Press release, Nuvalent, AUG 7, 2025, View Source [SID1234654993]).

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"With the initiation of our rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC and the dosing of the first patient in our ALKAZAR Phase 3 trial of neladalkib in TKI-naïve advanced ALK-positive NSCLC, 2025 has been marked by transformative milestones towards our mission to discover, develop, and deliver precisely targeted therapies for patients with cancer," said Alexandra Balcom, Chief Financial Officer of Nuvalent. "We remain focused on continuing to deliver value that is grounded in prioritizing patient impact with topline pivotal data from our ALKOVE-1 trial of neladalkib in TKI pre-treated advanced ALK-positive NSCLC expected by year-end and the first report of preliminary data for other ALK-positive solid tumors at ESMO (Free ESMO Whitepaper), continued momentum in our HEROEX-1 trial of NVL-330 for HER2-altered NSCLC, and a robust discovery pipeline."

"In parallel to our continued execution against development and regulatory milestones, we are actively building the strong commercial infrastructure needed to achieve our vision of becoming a fully integrated, commercial-stage biopharmaceutical company," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "Today we are proud to announce the promotion of Jason Waters to Senior Vice President, Commercial, in recognition of his leadership in establishing our commercial strategy and shaping a launch-ready organization that extends from our founding values of Patient Impact, Empowerment, and Collaboration. Supported by a growing team and strong cash runway into 2028, we believe we are well-positioned to achieve our goals."

Recent Pipeline Achievements and Anticipated Milestones

ROS1 Program

•
The company has initiated its rolling NDA submission for zidesamtinib, a novel ROS1-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). The FDA agreed to accept the NDA for participation in the Real-Time Oncology Review (RTOR) pilot program, which facilitates earlier submission of topline efficacy and safety results prior to the submission of the complete application, to support
an earlier start to the FDA’s evaluation of the application. Completion of the NDA submission is targeted for the third quarter of 2025.
•
The NDA submission is based on positive pivotal data for TKI pre-treated patients with advanced ROS1-positive NSCLC enrolled in the global ARROS-1 Phase 1/2 clinical trial. These data were recently reported along with preliminary data from the ongoing Phase 2 TKI-naïve cohort of ARROS-1, in which a total of 104 patients had been enrolled as of June 16, 2025. The company continues to engage with the FDA on potential opportunities for line-agnostic expansion.
ALK Program

•
Nuvalent recently announced the dosing of the first patient 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 will be randomized 1:1 to receive neladalkib monotherapy or alectinib monotherapy, a front-line standard of care, reflecting input from collaborating physician-scientists and alignment with global regulatory agencies.
•
Evaluation of neladalkib is ongoing in the ALKOVE-1 Phase 1/2 trial for patients with advanced ALK-positive NSCLC and other solid tumors:
o
The company expects to report pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC by year-end 2025.
o
The company will present preliminary data from the Phase 2 exploratory cohort for patients with ALK-positive solid tumors beyond NSCLC during a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17-21, 2025, in Berlin, Germany. Details of the presentation are as follows:
Title: Neladalkib (NVL-655) efficacy and safety in patients with ALK-positive solid tumors in the ALKOVE-1 study
Presentation Number: 972P
Session Category: Poster Session
Session Title: Developmental Therapeutics
Presentation Date and Time: Sunday, October 19, 2025, 12:00 – 12:45 CEST
Location: Hall 25
Presenter: Benjamin J. Solomon, MBBS, Ph.D. (Peter MacCallum Cancer Centre, Melbourne, Australia)

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 2025.

Business Updates

•
Jason Waters, MBA, Promoted to Senior Vice President, Commercial: Jason joined Nuvalent in 2024, bringing more than 20 years of experience in biopharma, and 15 years in commercial oncology focused on product launches and commercialization. Most recently, Jason served as the Head of Commercial at Mersana Therapeutics, where he led launch preparedness efforts and companion diagnostic strategy for the market entry of a novel antibody-drug conjugate. Prior to this, he held various commercial leadership roles at GSK, including Field Vice President and US Brand Lead for ZEJULA, where he led the integration and multiple launches of the brand following the acquisition of TESARO in acquisition in 2019. At TESARO, Jason served as the Global Brand Lead for ZEJULA, coordinating its EU launch. Earlier in his career, Jason was Senior Director, Sales Strategy at Takeda Oncology, where he contributed to the launches of subcutaneous VELCADE and NINLARO. He also held various sales, operational, and leadership roles at Sanofi, Aventis, and Abbott Laboratories.
•
Christy Oliger Appointed to Board of Directors: Nuvalent announced the appointment of Christy Oliger to its board of directors. Ms. Oliger brings more than 30 years of commercial and business experience in the pharmaceutical and biotechnology industry to the Nuvalent board. Most recently, Ms. Oliger served as Senior Vice President of the Oncology Business Unit at Genentech, where she was responsible for all commercial activities in the U.S. During her 20-year tenure at Genentech, Ms. Oliger held a number of senior leadership roles in both commercial and research and development across a variety of therapeutic areas, including oncology, neurology, rare disease, respiratory, dermatology and immunology. Prior to Genentech, she held management positions at Schering-Plough.

Second Quarter 2025 Financial Results

•
Cash Position: Cash, cash equivalents and marketable securities were $1.0 billion as of June 30, 2025. Nuvalent continues to believe its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028.
•
R&D Expenses: Research and development (R&D) expenses were $80.9 million for the second quarter of 2025.
•
G&A Expenses: General and administrative (G&A) expenses were $23.7 million for the second quarter of 2025.
•
Net Loss: Net loss was $99.7 million for the second quarter of 2025.

On August 7, 2025 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, reported a business update and announced second quarter 2025 financial results (Press release, NextCure, AUG 7, 2025, View Source [SID1234654992]).

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"Our recent strategic acquisition of the global rights, excluding greater China, for SIM0505 targeting CDH6 (cadherin-6 or K-cadherin) positions us uniquely within the antibody-drug conjugate ("ADC") field. We now are developing ADCs against two clinically validated targets leveraging two distinct payloads, a Topoisomerase 1 Inhibitor (SIM0505) and a Tubulin Inhibitor (LNCB74)," said Michael Richman, NextCure’s president and CEO. "We are on track to dose our first SIM0505 patient in the United States this quarter and plan to provide program updates on both SIM0505 and LNCB74 by the fourth quarter of 2025, along with proof of concept data readouts in the first half of 2026."

Business Highlights and Near-Term Milestones

LNCB74 (B7-H4 ADC)

● First patient dosed in January 2025 in the Phase 1 trial, cleared cohort 3 in June 2025.
● Currently treating patients in cohort 4.
● Plan to initiate backfill cohorts in the second half of 2025.
● Plan to provide a program update by the fourth quarter of 2025 and proof of concept data readout in the first half of 2026.

SIM0505 (CDH6 ADC)

● Acquired global rights, excluding greater China, where Simcere Zaiming will retain rights.
● Phase 1 clinical trial ongoing in China with initial data as of April 16, 2025 reporting clinical activity in cohort 1 with a partial response based on a six-week assessment.
● Investigational New Drug application transferred to NextCure in June 2025, with anticipated first patient dosed in the US within the third quarter of 2025.
● Plan to provide a program update by the fourth quarter of 2025 and a proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026.

Assets For Which We Are Seeking Partners

● Clinical programs NC410 (LAIR-2 fusion) and NC525 (LAIR-1 antibody).
● Preclinical data for NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease, have demonstrated amyloid clearance, prevention of amyloid deposition, plaque clearance and reduced neuroinflammation.
● Preclinical data for NC605 (Siglec-15), a humanized antibody for the treatment of osteogenesis Imperfecta (OI), have demonstrated that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI.

Other

● Simcere Zaiming US affiliate $2.0 million equity investment in NextCure in June 2025.
● Regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing.
Financial Results for Quarter Ended June 30, 2025

● Cash, cash equivalents, and marketable securities as of June 30, 2025 were $35.3 million as compared to $68.6 million as of December 31, 2024. The decrease of $33.3 million was primarily due to cash used to fund operations. We expect current financial resources to be sufficient to fund operating expenses and capital expenditures into mid-2026.
● Research and development expenses were $24.1 million for the three months ended June 30, 2025, as compared to $12.4 million for the three months ended June 30, 2024. The increase of $11.7 million was due to $17.0 million of up-front license fees incurred in connection with the licensing agreement announced June 16, 2025. This fee was partially offset by lower costs related to other programs, lower preclinical development costs and lower personnel-related costs.
● General and administrative expenses were $3.2 million for the three months ended June 30, 2025, as compared to $4.1 million for the three months ended June 30, 2024. The decrease of $0.9 million was primarily related to lower personnel costs and lower insurance costs.
● Net loss was $26.8 million for the three months ended June 30, 2025, as compared to a net loss of $15.4 million for the three months ended June 30, 2024 as the $17.0 million up-front license fee was partially offset by lower other research and development costs and lower general and administrative costs as described above.

On August 7, 2025 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the second quarter ended June 30, 2025 (Press release, Nektar Therapeutics, AUG 7, 2025, View Source [SID1234654991]).

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Cash and investments in marketable securities on June 30, 2025 were $175.9 million as compared to $269.1 million on December 31, 2024. Nektar’s cash and marketable securities at June 30, 2025 do not include $107.5 million of approximate net proceeds from the secondary offering closed on July 2, 2025. With the net proceeds from the secondary offering, we expect our cash and investments in marketable securities to support our operations into the first quarter of 2027.

"This quarter, we announced transformative data for rezpegaldesleukin from the Phase 2b study in patients with moderate to severe atopic dermatitis," said Howard W. Robin, President and CEO of Nektar. "The 16-week induction data demonstrated that rezpegaldesleukin resulted in a rapid onset of EASI response and itch relief and showcased the advantage of a broad-based Treg mechanism over other mechanistic approaches in development to treat atopic dermatitis. We look forward to seeing the effect of continued treatment with rezpegaldesleukin when we report the 52-week data in early 2026. In alopecia areata, we will report the data from a separate Phase 2b study in December of this year. We believe the data from both randomized studies will demonstrate the potential of rezpegaldesleukin to provide a new treatment paradigm for patients with chronic and serious diseases that significantly impact quality of life. As a first-in-class, T regulatory cell biologic, rezpegaldesleukin is poised to become an important novel mechanism to treat millions of patients with autoimmune disorders."

"We are proceeding in our IND-enabling studies for our next T reg program, NKTR-0165, which targets the TNFR2 receptor to stimulate tissue-specific T regulatory cells," continued Robin. "Our goal is to advance NKTR-0165 into the clinic in 2026. Finally, we are making significant progress on advancing preclinical studies with a new bispecific antibody, NKTR-0166, which combines the TNFR2 epitope with a validated antibody target."

Summary of Financial Results

Revenue in the second quarter of 2025 was $11.2 million as compared to $23.5 million in the second quarter of 2024. Revenue for the first half of 2025 was $21.6 million as compared to $45.1 million in the first half of 2024. Revenue has decreased year over year because we no longer recognize product sales due to the sale of the Huntsville manufacturing facility in December 2024.

Total operating costs and expenses in the second quarter of 2025 were $47.4 million as compared to $73.3 million in the second quarter of 2024. Total operating costs and expenses in the first half of 2025 were $102.4 million as compared to $130.3 million in the first half of 2024. Operating costs and expenses for the first half of 2025 decreased due to the elimination of cost of goods sold following the sale of the Huntsville manufacturing facility, as well as a decrease in restructuring and impairment charges.

R&D expense in the second quarter of 2025 was $29.9 million as compared to $29.7 million for the second quarter of 2024. R&D expense in the first half of 2025 was $60.4 million as compared to $57.1 million for the first half of 2024. R&D expense increased for the first half of 2025 primarily due to an increase in expenses for the development of rezpegaldesleukin and NKTR-0165, partially offset by a decrease in expense for the development of NKTR-255.

G&A expense was $17.1 million in the second quarter of 2025 as compared to $20.5 million in the second quarter of 2024. G&A expense was $41.4 million in the first half of 2025 as compared to $40.7 million in the first half of 2024. G&A expense increased slightly in the first half of 2025 due to an increase in legal expenses, partially offset by decreases in facilities and stock-based compensation expenses.

Non-cash restructuring and impairment charges were not material in the second quarter and first half of 2025. Non-cash restructuring and impairment charges in the second quarter of 2024 were $13.3 million and $14.3 million in the first half of 2024. These non-cash charges were related to the declining San Francisco commercial real estate market and real estate lease obligations held by Nektar.

In the first quarter of 2025, we began accounting for our investment in the new portfolio company, Gannet BioChem, under the equity method of accounting which calculates our gain or loss based on the change in our share of Gannet BioChem’s equity each quarter. This resulted in non-cash losses from the equity method investment of $2.4 million in the second quarter of 2025 and $6.8 million in the first half of 2025.

Net loss for the second quarter of 2025 was $41.6 million or $2.95 basic and diluted loss per share as compared to a net loss of $52.4 million or $3.761 basic and diluted loss per share in the second quarter of 2024. Net loss in the first half of 2025 was $92.5 million or $6.57 basic and diluted loss per share as compared to a net loss of $89.2 million or $6.631 basic and diluted loss per share in the first half of 2024. Excluding the $2.4 million and $6.8 million non-cash loss from our equity method investment in Gannet BioChem, net loss, on a non-GAAP basis, for the second quarter and first half of 2025 were $39.2 million and $85.6 million, respectively, or $2.78 and $6.08 basic and diluted loss per share, respectively.

Recent Business Highlights

● In July of 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms.

● In July of 2025, Nektar announced the successful closing of a public offering of its common stock including the full exercise of underwriters’ option to purchase additional shares, raising $115 million in gross proceeds.

● In June of 2025, Nektar announced that the REZOLVE-AD study achieved statistical significance on the primary endpoint at week 16 for mean percent change in EASI score from baseline for all rezpegaldesleukin arms versus placebo and achieved statistical significance for key secondary endpoints at week 16, including EASI-75, EASI-90, Itch NRS, vIGA-AD and BSA. The rapid onset of EASI reduction and magnitude of itch improvement show potential differentiation of this novel regulatory T-cell mechanism as a first and best-in-class immune-modulator.

● In June of 2025, Nektar collaborators at the Fred Hutchinson Cancer Center presented oral data for NKTR-255 as adjunctive treatment to cell therapy at the 30th Annual European Hematological Association (EHA) (Free EHA Whitepaper) Congress entitled, "Enhanced CAR T-cell Expansion and Durable Complete Responses with NKTR-255 Plus Lisocabtagene Maraleucel in Relapsed/Refractory Large B-cell Lymphoma."

Conference Call to Discuss Second Quarter 2025 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on August 7, 2025.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through September 8, 2025.

To access the conference call by phone, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.