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.

On August 7, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that US National Cancer Institute (NCI) sponsors Senhwa’s second program IND has been submitted to US FDA for clinical trial targeting MYC-aberrant lymphoma (Press release, Senhwa Biosciences, AUG 7, 2025, View Source [SID1234655010]). Following the initiation of the first trial using CX-5461 as a monotherapy in advanced solid tumors, the IND-submission of the second trial marks a milestone in the development of CX-5461.

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With sponsorship from the NCI, this program significantly reduces Senhwa’s clinical development expenditures, easing its R&D financial demands while enhancing the overall project value and commercialization potential—a major positive for the company’s future growth.

A Globally Innovative G4-Targeting Mechanism Against Hard-to-Treat MYC-Driven Lymphomas – 30% of Cancers Involve MYC Mutation

MYC is a critical oncogene, with approximately 28% of cancer patients exhibiting gene amplification or mutation, including in lung, breast, liver cancers, and lymphomas. The MYC protein drives cell proliferation, angiogenesis, and apoptosis suppression, playing a key role in multiple malignancies. CX-5461, developed by Senhwa, precisely stabilizes the G-quadruplex (G4) structures in DNA within cancer cells, suppressing MYC gene expression and effectively disrupting tumor growth pathways.

Preclinical research has demonstrated that CX-5461 exhibits strong inhibitory effects against MYC-overexpressing tumors, highlighting its potential as a next-generation targeted cancer therapy—especially promising for difficult-to-treat lymphomas.

With NCI Sponsorship Significantly Reduces R&D Costs

The clinical trial program is fully led and partially funded by the NCI, covering clinical trial design, operational personnel, trial sites, regulatory, and data management resources. According to Senhwa’s internal estimates, this sponsorship could reduce Senhwa’s clinical development expenditures, easing its R&D financial costs, enhancing development efficiency and accelerating commercialization progress.

Substantial Market Potential for B-cell Lymphomas – Global Annual Sales Expected to Surpass USD 10 Billion

According to BioSpace market data, global sales of B-cell lymphoma therapies reached USD 4.9 billion in 2024 and are projected to grow to USD 8.9 billion by 2035, with a steady compound annual growth rate (CAGR) of 5.79%. There is particularly strong demand for novel targeted therapies for relapsed and refractory lymphoma patients, revealing a significant market gap.

With its unique mechanism and precision medicine potential, Senhwa’s CX-5461 is well-positioned to enter the high-value niche market upon successful progression into late-stage clinical trials and potential regulatory approval, offering substantial commercial value.

CX-5461: The World’s First and Most Advanced G4-Quadruplex Stabilizer for Cancer Treatment

CX-5461 is the world’s first and most advanced anti-cancer investigational drug targeting G-quadruplex DNA structures. It specifically modulates the expression of key oncogenes like MYC, thereby inhibiting cancer cell proliferation and survival. The upcoming NCI-sponsored will evaluate CX-5461 dose optimization and treatment efficacy in Patients with MYC-aberrant, specific subtypes of aggressive B-cell non-Hodgkin lymphoma who have received at least one prior line of therapy and have no other available treatment options, aiming to address critical unmet medical needs with a potentially breakthrough therapeutic solution.

On August 7, 2025 LaNova Medicines Ltd. reported that its internally developed CEACAM5/4-1BB bispecific antibody, LM-24C5, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China to initiate a Phase II clinical trial (Press release, LaNova Medicines, AUG 7, 2025, View Source [SID1234656022]). The trial will evaluate LM-24C5 in combination with other anti-tumor agents in patients with CEACAM5-positive advanced solid tumors.

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CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5) is highly expressed in various solid tumors—including non-small cell lung cancer, colorectal cancer, and gastric cancer—making it a promising target for cancer therapy[1]. LM-24C5 is a conditionally activated bispecific antibody engineered using LaNova’s proprietary 4-1BB agonist platform. It is designed to simultaneously bind CEACAM5 on tumor cells and 4-1BB on immune cells, thereby directing and activating immune responses within the tumor microenvironment while minimizing off-target immune activation and associated systemic toxicities.

Preclinical studies have demonstrated that LM-24C5 can induce durable anti-tumor immune memory and exhibits synergistic effects when used in combination with other immunotherapeutic agents. These results support its potential to become a first-in-class immunotherapy.

LM-24C5 is currently in Phase I/II clinical development in the United States.

On August 6, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the second quarter of 2025 (Press release, BeOne Medicines, AUG 6, 2025, View Source [SID1234654860]).

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"Our strong second quarter performance reinforces our trajectory as a global oncology powerhouse and underscores our proven ability to deliver sustainable, long-term growth," said John V. Oyler, Co-Founder, Chairman and CEO of BeOne. "We are executing with purpose and advancing our mission to deliver transformative medicines to more patients worldwide. BRUKINSA, the backbone of our hematology franchise, continues to set the standard as the best-in-class BTK inhibitor with the most approved indications and market leader in the US, a position earned from superior efficacy, favorable safety, and positive patient outcomes across its five indications. Building on this momentum, our two additional Phase 3 hematology assets, BCL2 inhibitor sonrotoclax and BTK CDAC BGB-16673, have the potential to further expand our franchise leadership with pivotal data readouts and new trial initiations anticipated in the near-term. At our recent Investor R&D Day, we outlined a bold path forward with more than 20 expected R&D milestones in the next 18 months. This includes potentially promising advances across our expansive solid tumor pipeline, where we are building future global franchises targeting a range of highly prevalent cancers."

(Amounts in thousands of U.S. dollars and unaudited)
Three Months Ended June 30, Six Months Ended June 30,
2025 2024 % Change 2025 2024 % Change
Net product revenues $ 1,302,076 $ 921,146 41 % $ 2,410,606 $ 1,668,064 45 %
Net revenue from collaborations $ 13,224 $ 8,020 65 % $ 21,973 $ 12,754 72 %
Total revenue $ 1,315,300 $ 929,166 42 % $ 2,432,579 $ 1,680,818 45 %
GAAP income (loss) from operations $ 87,885 $ (107,161) 182 % $ 98,987 $ (368,509) 127 %
Adjusted income (loss) from operations* $ 274,945 $ 48,464 467 % $ 414,302 $ (98,877) 519 %

GAAP net income (loss) $ 94,320 $ (120,405) 178 % $ 95,590 $ (371,555) 126 %
Adjusted net income (loss)* $ 252,822 $ 23,294 985 % $ 388,959 $ (122,602) 417 %
GAAP basic EPS per ADS $ 0.87 $ (1.15) 176 % $ 0.89 $ (3.56) 125 %
Adjusted basic EPS per ADS* $ 2.33 $ 0.22 959 % $ 3.61 $ (1.17) 409 %
GAAP diluted EPS per ADS $ 0.84 $ (1.15) 173 % $ 0.85 $ (3.56) 124 %
Adjusted diluted EPS per ADS* $ 2.25 $ 0.22 923 % $ 3.48 $ (1.17) 397 %
Free Cash Flow* $ 219,772 $ (205,538) 207 % $ 207,447 $ (670,688) 131 %

Second Quarter 2025 Financial Results
Revenue for the second quarter of 2025 was $1.3 billion, compared to $929 million in the prior-year period driven primarily by growth in BRUKINSA (zanubrutinib) product sales in the U.S. and Europe.
Product Revenue totaled $1.3 billion for the second quarter of 2025 compared to $921 million in the prior-year period. The increase in product revenue was primarily attributable to increased sales of BRUKINSA. The U.S. continued to be the Company’s largest market, with product revenue of $685 million compared to $479 million in the prior-year period. In-licensed products from Amgen and TEVIMBRA (tislelizumab) also contributed to product revenue growth.
•U.S. sales of BRUKINSA totaled $684 million in the second quarter of 2025, representing growth of 43% over the prior-year period driven primarily by robust demand growth across all indications and modest benefit due to net pricing. BRUKINSA continues to maintain its leading new patient share across the BTKi class due to its differentiated, best-in-class clinical profile. BRUKINSA sales in Europe totaled $150 million in the second quarter of 2025, representing growth of 85% compared to the prior-year period, driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.
•Sales of TEVIMBRA totaled $194 million in the second quarter of 2025, representing growth of 22% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the second quarter of 2025 was 87.4% compared to 85.0% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in our portfolio. Gross margin also benefited from cost of sales productivity improvements for both BRUKINSA and TEVIMBRA. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 88.1% for the second quarter of 2025, compared to 85.4% in the prior-year period.
Operating Expenses
The following table summarizes operating expenses for the second quarter of 2025:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q2 2025 Q2 2024 % Change Q2 2025 Q2 2024 % Change
Research and development $ 524,896 $ 454,466 15 % $ 444,057 $ 382,509 16 %
Selling, general and administrative $ 537,913 $ 443,729 21 % $ 441,655 $ 363,922 21 %
Total operating expenses $ 1,062,809 $ 898,195 18 % $ 885,712 $ 746,431 19 %

The following table summarizes operating expenses for the first half of 2025:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q2 YTD 2025 Q2 YTD 2024 % Change Q2 YTD 2025 Q2 YTD 2024 % Change
Research and development $ 1,006,783 $ 915,104 10 % $ 865,252 $ 787,949 10 %
Selling, general and administrative $ 997,201 $ 871,156 14 % $ 837,166 $ 736,068 14 %
Total operating expenses $ 2,003,984 $ 1,786,260 12 % $ 1,702,418 $ 1,524,017 12 %

Research and Development (R&D) Expenses increased for the second quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage, and offset by lower development upfront and milestone fees. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $0.5 million and $12 million in the second quarter of 2025 and 2024, respectively.
Selling, General and Administrative (SG&A) Expenses increased for the second quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment in global commercial expansion, primarily in the U.S. and Europe. SG&A expenses as a percentage of product sales were 41% for the second quarter of 2025, compared to 48% in the prior-year period.
Net Income/(Loss) and GAAP/Non-GAAP Earnings Per Share
GAAP net income for the second quarter of 2025 was $94 million, an increase of $215 million over the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.
For the second quarter of 2025, basic and diluted earnings per share was $0.07 and $0.06 per share and $0.87 and $0.84 per American Depositary Share (ADS), respectively, compared to basic loss of $0.09 per share and $1.15 per ADS in the prior-year period.
Free Cash Flow for the second quarter of 2025 was $220 million, an increase of $425 million over the prior-year period.
For further details on BeOne’s Second Quarter 2025 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the second quarter of 2025 filed with the U.S. Securities and Exchange Commission.

Full Year 2025 Guidance
BeOne has updated its full year 2025 revenue guidance and maintained its expense guidance. Guidance is summarized below:
Prior FY 2025 Guidance1
Current FY 2025 Guidance1
Total Revenue $4.9 – $5.3B $5.0 – $5.3B
GAAP Operating Expenses
(R&D and SG&A) $4.1 – $4.4B $4.1 – $4.4B
GAAP Gross Margin % Mid-80% range Mid to high-80% range
GAAP Operating Income Positive FY 2025 Positive FY 2025
Cash Flow Positive FY 2025
cash flow from operations Positive FY 2025
free cash flow

1 Does not assume any potential new, material business development activity or unusual/non-recurring items. Assumes June 30, 2025, foreign exchange rates.
BeOne’s total revenue guidance for full year 2025 of $5.0 billion to $5.3 billion includes expectations for strong revenue growth driven by BRUKINSA’s U.S. leadership position and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the mid- to high- 80% range due to mix and production efficiencies as compared to 2024. BeOne’s guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage. Non-GAAP operating expenses, which exclude costs related to share-based compensation, depreciation and amortization expense, are expected to track with GAAP operating expenses, with reconciling items unchanged from existing practice. Operating expense guidance does not assume any potential new, material business development activity or unusual/non-recurring items.
Second Quarter Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•BRUKINSA is now approved in 75 markets globally with five new or expanded reimbursements in the quarter.
•Received U.S. Food and Drug Administration (FDA) approval and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of a new film-coated tablet formulation for all approved indications.

TEVIMBRA (tislelizumab)
•TEVIMBRA is now approved in 47 markets globally with 20 new reimbursements in the quarter, including in Japan, Europe and Australia.
•Received European Commission (EC) approval in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma.
•Received EC approval for the treatment of first-line extensive-stage small cell lung cancer.
•Received a positive CHMP opinion recommending approval of TEVIMBRA in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
•Received FDA approval of alternative dosing regimens of 150 Q2W and 300 Q4W for the treatment of first-line gastric cancer and second-line esophageal squamous cell carcinoma.

Select Clinical-Stage Programs
Hematology
•Sonrotoclax (BCL2 inhibitor):
◦Achieved acceptance of submissions in China with priority reviews for the treatment of relapsed refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R mantle cell lymphoma (MCL).
◦Achieved first subject enrolled in global Phase 3 trial in combination with CD20 antibody for the treatment of R/R CLL.
•BGB-16673 (BTK CDAC):
◦Received EMA PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.
◦Achieved first subject enrolled for global Phase 3 BGB-16673-302 trial for the treatment of R/R CLL.
◦Achieved first subject enrolled for China Phase 3 BGB-16673-303 trial for the treatment of R/R/ CLL.
◦Initiated enrollment of potentially registration enabling Phase 2 trial for the treatment of R/R WM.
Lung Cancer
•Tarlatamab (AMG 757):
◦Achieved acceptance of BLA and priority review in China for the treatment of 3L+ small cell lung cancer (SCLC).
◦Achieved acceptance of BLA in China for the treatment of 2L SCLC.
GI Cancers
•Zanidatamab (HER2-targeting bispecific antibody): Received regulatory approval and achieved commercial launch in China for the treatment of second-line HER2-high-expression biliary tract cancer.
Inflammation & Immunology
•BGB-45035 (IRAK4 CDAC): Achieved first subject enrolled in Phase 1b trial for the treatment of atopic dermatitis and prurigo nodularis.
•BGB-16673 (BTK CDAC): Achieved first subject enrolled in Phase 1 trial for the treatment of chronic spontaneous urticaria.

Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•EC approval of tablet formulation.
2H 2025
•Interim analysis of Phase 3 MANGROVE trial for the treatment of treatment-naïve MCL.
2H 2025
TEVIMBRA
•EU approval for the treatment of neoadjuvant and adjuvant early stage NSCLC.
2H 2025
•Initiate Phase 3 trial for subcutaneous formulation.
2H 2025
Hematology
•Sonrotoclax: Data readout of Phase 2 trial and potential global accelerated approval submissions for the treatment of R/R MCL.
2H 2025
•BGB-16673: Initiate Phase 3 head-to-head trial compared to noncovalent BTK inhibitor pirtobrutinib for the treatment of R/R CLL.
2H 2025
Breast Cancer
•BGB-43395 (CDK4 inhibitor):
◦Initiate Phase 3 trial for the treatment of second-line hormone receptor-positive, HER2-negative metastatic breast cancer.
2026
◦Initiate Phase 3 trial for the treatment of first-line hormone receptor-positive, HER2-negative metastatic breast cancer.
2026
Lung Cancer
•BGB-58067 (PRMT5 inhibitor) and BG-89894 (MAT2A inhibitor): Anticipate first subject enrolled in combination trial.
2H 2025
GI Cancers
•Zanidatamab (HER2-targeting bispecific antibody): Readout of primary progression-free survival data from Phase 3 trial in collaboration with Zymeworks/Jazz for the treatment of first-line HER2-positive gastroesophageal adenocarcinoma.
2H 2025
Inflammation and Immunology
•BGB-45035 (IRAK4 CDAC):
◦Anticipate first subject enrolled in Phase 2 trials.
2H 2025
◦Proof-of-concept data for tissue IRAK4 degradation.
2H 2025

Other Highlights
•Completed renaming to BeOne Medicines Ltd., and redomiciliation to Switzerland.
Conference Call and Webcast
The Company’s earnings conference call for the second quarter 2025 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, August 6, 2025, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation and a replay of the webcast will also be available.

On August 6, 2025 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class and best-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, reported financial results for the second quarter 2025 and highlighted recent operational progress (Press release, Zentalis Pharmaceuticals, AUG 6, 2025, View Source [SID1234654876]).

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"This quarter, we continued to execute on our focused strategy to advance the late-stage clinical development of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is no approved treatment option specifically for this biomarker selected population, which comprises approximately 50% of PROC patients," said Julie Eastland, Chief Executive Officer of Zentalis. "We are maintaining momentum with the DENALI Phase 2 clinical trial and remain on track to disclose topline data from DENALI Part 2 by year end 2026."

Business Updates

•Phase 2 DENALI clinical trial remains on track.
◦Enrollment is ongoing in DENALI Part 2a of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1-positive PROC. DENALI Part 2a is designed to confirm the primary dose-of-interest with a target enrollment of up to approximately 30 patients at each of two dose levels: 400mg QD 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule) and 300mg QD 5:2. DENALI Part 2b is designed to enroll approximately 70 patients at a single dose, the selection of which will be informed by the Part 2a results, subject to FDA feedback.
◦The Company expects to disclose topline data from DENALI Part 2 (Part 2a and Part 2b) by year end 2026. DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA review.

•Completed strategic restructuring announced in January 2025, supporting late-stage clinical development of azenosertib.
◦The Company has operationally completed the restructuring and does not expect to incur further associated related non-recurring expenses.
◦This restructuring prioritizes the late-stage development of azenosertib and extends the Company’s cash runway into late 2027, beyond the Company’s anticipated DENALI Part 2 topline data.

Second Quarter 2025 Financial Results

•Cash, Cash Equivalents and Marketable Securities Position: As of June 30, 2025, the Company had cash, cash equivalents and marketable securities of $303.4 million, which includes $16.8 million representing the June 30, 2025 fair value of Immunome common stock received by the Company from the sale of its ROR1 antibody-drug conjugate (ADC) product candidate and ADC platform to Immunome in October 2024. The Company believes that its existing cash, cash equivalents and marketable securities as of June 30, 2025 will be sufficient to fund its operating expenses requirements into late 2027.

•Research and Development Expenses: Research and development (R&D) expenses for the three months ended June 30, 2025 were $27.6 million, compared to $48.4 million for the three months ended June 30, 2024. The decrease of $20.8 million was primarily due to decreases of $15.9 million for clinical expenses, $3.6 million for lab services, $3.4 million for drug manufacturing, $0.6 million related to personnel expenses and $0.4 million of miscellaneous expenses. These decreases were partially offset by an increase in companion diagnostic expense of $3.1 million.

•General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2025 were $8.4 million, compared to $16.7 million during the three months ended June 30, 2024. This decrease of $8.3 million was attributable to a decrease of $6.8 million in personnel expense, $1.1 million related to consulting and $0.4 million miscellaneous expenses.
•Operating Expenses: Total operating expenses were $36.1 million for the three months ended June 30, 2025, compared to $65.1 million for the three months ended June 30, 2024.

About Azenosertib
Azenosertib is a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 clinical trial studying azenosertib in platinum-resistant ovarian cancer (PROC) patients. Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule). Interim results from Part 1b were presented at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting. Part 2 is ongoing and is enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff. Part 2 includes Part 2a, a dose confirmation portion evaluating two doses, 300mg 5:2 and 400mg 5:2, and Part 2b, a portion designed to complete enrollment at the selected dose. Part 2, in total, is designed for accelerated approval, pending study outcome and discussions with the U.S. Food and Drug Administration.