ImmunityBio Reports Q2 Earnings Release Reflecting 60% Increase in Revenue in Q2 2025, With Year-to-Date Sales of $43 Million and 246% Unit Growth Since J-code

On August 5, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported its financial results for the fiscal quarter and six months ended June 30, 2025 (Press release, ImmunityBio, AUG 5, 2025, View Source [SID1234654788]).

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In the second quarter of 2025, ImmunityBio reported $26.4 million in revenue, representing a 60% increase from $16.5 million in the first quarter of 2025. This growth reflects continued commercial traction of ANKTIVA in combination with BCG in BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without Papillary tumors. The first half 2025 sales of $42.9 million represents a 246% increase in unit volume during the first two quarters of 2025 since the J-code approval versus the last two quarters of 2024. The Company ended the quarter with $153.7 million in cash, cash equivalents and marketable securities as of June 30, 2025.

"ANKTIVA continues to deliver clinical results and promising commercial potential for ImmunityBio," said Richard Adcock, President and CEO of ImmunityBio. "We’re seeing robust demand across U.S. urology practices of all sizes, driven in part by ANKTIVA’s ease of storage and administration. With commercial authorization now in place in the UK, we’re actively evaluating our go-to-market strategy for this important initial global market. In parallel, our recombinant BCG (rBCG) therapeutic has been administered safely to more than 150 patients to date in the United States under the expanded access protocol, helping urologists address the ongoing BCG shortage in the U.S. The recent equity financing further strengthens our balance sheet and enables us to accelerate key studies."

"Our goal has always been to use our innovative science to attack a broad range of cancers, and we are deeply committed to this goal in order to meet the urgent needs of millions of patients," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "To that end, we’ve begun global expansion of key clinical trials, including those for BCG-naïve NMIBC and second-line lung cancer. In addition, we’ve initiated enrollment across multiple trials to validate our novel lymphopenia rescue agent in prolonging duration of survival across multiple tumor types—a critical effort to address this life-threatening immune deficiency, and is often triggered by chemotherapy, radiation, or some immunotherapies."

Second-Quarter Ended June 30, 2025 Financial Summary and Comparison to Prior Year Quarter

Product Revenue, Net

Product revenue, net increased $25.4 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

Research and development (R&D) expense increased $4.1 million to $55.2 million during the three months ended June 30, 2025, as compared to $51.1 million during the three months ended June 30, 2024. The increase was due to higher manufacturing costs and higher distribution costs driven by more production and clinical trial activities, and higher license fees, partially offset by fewer sponsored research agreements.

Selling, General and Administrative Expense

Selling, general and administrative (SG&A) expense decreased $6.9 million to $42.3 million during the three months ended June 30, 2025, as compared to $49.2 million during the three months ended June 30, 2024. The decrease was due to lower costs related to litigation settlements and commercial consulting activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $92.6 million during the three months ended June 30, 2025, compared to $134.6 million during the three months ended June 30, 2024. The reduction of loss was primarily driven by increased product revenue, lower SG&A expense described above, lower related-party interest expense, changes in the fair value of warrant liabilities and a related-party convertible note, partially offset by changes in the fair value of derivative liabilities and an increase in interest expense related to the revenue interest liability.

Six Months Ended June 30, 2025 Financial Summary and Comparison to Prior Year Six Months Ended

Product Revenue, Net

Product revenue, net increased $41.9 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

R&D expense decreased $1.0 million to $103.5 million during the six months ended June 30, 2025, as compared to $104.5 million during the six months ended June 30, 2024. The decrease was mainly due to a reduction in outside service costs, CMO fees and drug materials purchased and used in manufacturing, partially offset by an increase in clinical trial costs and by higher manufacturing costs driven by increased production activities.

Selling, General and Administrative Expense

SG&A expense decreased $16.1 million to $75.0 million during the six months ended June 30, 2025, as compared to $91.1 million during the six months ended June 30, 2024. The decrease was primarily driven by lower costs related to litigation settlements and commercial consulting activities, partially offset by higher stock-based compensation expense, recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $222.2 million during the six months ended June 30, 2025, compared to $268.7 million during the six months ended June 30, 2024. This reduction of loss was primarily driven by increased product revenue, lower R&D and SG&A expense described above, lower related-party interest expense, and changes in the fair value of warrant liabilities, partially offset by changes in the fair value of derivative liabilities and a related-party convertible note, an increase in interest expense related to the revenue interest liability and lower interest and investment income.

ImmunityBio, Inc.

Condensed Consolidated Statements of Operations

Three Months Ended

June 30,

Six Months Ended

June 30,

(Unaudited; in thousands, except per share amounts)

2025

2024

2025

2024

Revenue

Product revenue, net

$

26,421

$

990

$

42,930

$

990

Other revenues

4

57

12

97

Total revenue

26,425

1,047

42,942

1,087

Operating costs and expenses

Cost of sales

136

194

Research and development

52,430

48,832

98,406

100,154

Research and development – related parties

2,806

2,297

5,064

4,326

Selling, general and administrative

41,862

48,576

73,839

90,030

Selling, general and administrative – related parties

476

675

1,153

1,106

Total operating costs and expenses

97,710

100,380

178,656

195,616

Loss from operations

(71,285

)

(99,333

)

(135,714

)

(194,529

)

Other income (expense), net:

Interest and investment income, net

1,153

1,891

2,040

4,990

Change in fair value of warrant and derivative liabilities,
and related-party convertible notes

6,989

1,894

(30,463

)

(2,632

)

Interest expense – related party

(15,474

)

(29,787

)

(30,787

)

(59,245

)

Interest expense related to revenue interest liability

(13,405

)

(9,225

)

(26,939

)

(17,229

)

Interest expense

(5

)

(7

)

(23

)

(32

)

Other expense, net

(278

)

(17

)

(319

)

(37

)

Total other expense, net

(21,020

)

(35,251

)

(86,491

)

(74,185

)

Loss before income taxes and noncontrolling

interests

(92,305

)

(134,584

)

(222,205

)

(268,714

)

Income tax expense

(269

)

(35

)

Net loss

(92,574

)

(134,584

)

(222,240

)

(268,714

)

Net loss attributable to noncontrolling interests,

net of tax

(19

)

(20

)

(39

)

(41

)

Net loss attributable to ImmunityBio common

stockholders

$

(92,555

)

$

(134,564

)

$

(222,201

)

$

(268,673

)

Net loss per ImmunityBio common share – basic

$

(0.10

)

$

(0.20

)

$

(0.26

)

$

(0.40

)

Net loss per ImmunityBio common share – diluted

$

(0.10

)

$

(0.20

)

$

(0.26

)

$

(0.40

)

Weighted-average number of common shares used in

computing net loss per share – basic

888,216

686,938

870,786

679,885

Weighted-average number of common shares used in

computing net loss per share – diluted

888,216

686,938

870,786

679,885

ImmunityBio, Inc.

Selected Balance Sheet Data

(Unaudited; in thousands)

June 30,

2025

December 31,

2024

Cash and cash equivalents, and marketable securities

$

153,658

$

149,809

Total assets

402,076

382,933

Total related-party debt

492,084

461,877

Revenue interest liability

307,049

284,404

Total liabilities

971,895

871,062

Total ImmunityBio stockholders’ deficit

(570,749

)

(489,098

)

Total liabilities and stockholders’ deficit

402,076

382,933

ImmunityBio, Inc.

Summary Reconciliations of Cash Flows

Three Months Ended

June 30,

Six Months Ended

June 30,

(Unaudited; in thousands)

2025

2024

2025

2024

Cash (used in) provided by:

Net cash used in operating activities

$

(79,746

)

$

(100,347

)

$

(165,651

)

$

(207,329

)

Net cash used in investing activities

(16,142

)

(51,490

)

(12,013

)

(87,112

)

Net cash provided by financing activities

172,810

148,894

171,828

159,119

Effect of exchange rate changes on cash and cash

equivalents, and restricted cash

76

12

66

(27

)

Net change in cash and cash equivalents, and

restricted cash

76,998

(2,931

)

(5,770

)

(135,349

)

Cash and cash equivalents, and restricted cash,

beginning of period

61,144

133,369

143,912

265,787

Cash and cash equivalents, and restricted cash,

end of period

$

138,142

$

130,438

$

138,142

$

130,438

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating natural killer (NK) cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was approved by the FDA in 2024 and by UK MHRA in 2025 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit Anktiva.com.

IDEAYA Biosciences, Inc. Reports Second Quarter 2025 Financial Results and Provides Business Update

On August 5, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an oncology company committed to advancing the discovery, development, and commercialization of transformative precision medicines to address unmet medical needs in cancer, reported a business update and announced financial results for the second quarter ended June 30, 2025 (Press release, Ideaya Biosciences, AUG 5, 2025, View Source [SID1234654787]).

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"We look forward to a catalyst rich period with six clinical data updates guided from now to year-end across three clinical stage programs, including two oral presentations that have been accepted at major medical conferences and our targeted top-line randomized median PFS results for the darovasertib and crizotinib combination in 1L HLA-A2 negative MUM to potentially enable our first accelerated approval filing in the U.S. We are also excited to host our 10-year Anniversary R&D Day in New York City on September 8th, where we will present multiple data updates across our potential first-in-class clinical pipeline and highlight our strategic vision and pioneering research in cancer biology and drug discovery," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Selected Pipeline Developments and Upcoming Milestones

Darovasertib


Metastatic uveal melanoma (MUM)
o
Median progression-free survival (PFS) data from the Phase 2/3 trial of darovasertib in combination with crizotinib in first line (1L) HLA-A2-negative MUM is on track to be reported by year-end 2025; this data has the potential to enable an accelerated approval filing in the United States. Over 350 patients have been enrolled in the trial as of August 4, 2025, and the company expects to complete full enrollment of approximately 400 patients by year-end. Based on feedback from the U.S. Food and Drug Administration (FDA), IDEAYA plans to submit median overall survival (OS) data from this trial to support full U.S. approval in HLA-A2-negative MUM.
o
Median OS data from a single-arm, Phase 2 trial of darovasertib in combination with crizotinib will be presented at a medical conference in the fourth quarter of 2025. The readout will include data in over 40 patients, including both HLA-A2-negative and HLA-A2-positive patients. IDEAYA continues to enroll HLA-A2-positive patients in this trial to assess the benefit of the darovasertib/crizotinib combination to support a potential real world evidence (RWE) regulatory submission and/or compendia listing. If granted, this has the potential to broaden the use of darovasertib in MUM patients, independent of HLA status.

Neoadjuvant therapy for primary uveal melanoma (UM)
o
IDEAYA is also evaluating darovasertib as a monotherapy in the neoadjuvant setting for primary UM, where the goal of treatment is to prevent enucleation (surgical eye removal), preserve vision prior to and post-plaque brachytherapy, and slow disease progression and metastasis. Initial safety and visual benefit data will be reported from the Phase 2 clinical trial from over 20 patients in the plaque brachytherapy-eligible cohort at IDEAYA’s R&D Day on September 8th, followed by additional data from over 90 patients in both the enucleation-eligible and plaque brachytherapy-eligible cohorts in a Proffered Paper Oral Presentation at ESMO (Free ESMO Whitepaper), taking place from October 17-21, 2025 in Berlin, Germany.
o
Following a successful Type D meeting with the FDA in April 2025, the company initiated a randomized Phase 3 registration-enabling trial of darovasertib in the neoadjuvant setting for primary UM in the third quarter of 2025. The trial, referred to as OptimUM-10, will enroll a total of approximately 520 patients in two cohorts of plaque brachytherapy-eligible and enucleation-eligible patients.
IDE397 (MAT2A)


IDEAYA is conducting a Phase 1/2 clinical trial pursuant to a clinical study collaboration and supply agreement with Gilead to evaluate IDE397 in combination with Trodelvy (sacituzumab govitecan-hziy), Gilead’s Trop-2 directed ADC, in patients with MTAP-deletion urothelial cancer, or UC, and non-small cell lung cancer, or NSCLC.

In April 2025, the companies announced expansion of the IDE397 and Trodelvy (sacituzumab govitecan-hziy) combination trial in NSCLC. IDEAYA will provide initial Phase 1 safety and efficacy data from two expansion cohorts in the IDE397 and Trodelvy (sacituzumab govitecan-hziy) combination trial in MTAP-deletion UC patients at the company’s R&D Day September 8th, with additional data targeted for a medical conference in the first half of 2026.
IDE849 (DLL3 TOP1i ADC)


IDEAYA’s partner, Hengrui Pharma, is conducting a multi-site, open label Phase 1 clinical trial for IDE849 in China for patients with small-cell lung cancer (SCLC). Hengrui will present clinical safety and efficacy data from over 70 patients in the trial at the International Association for the Study of Lung Cancer ("IASLC") 2025 World Conference on Lung Cancer (WCLC) taking place from September 6-9, 2025 in Barcelona, Spain. The presentation will include data from the dose escalation and multiple expansion doses.

In May 2025, IDEAYA initiated a Phase 1 trial in the U.S. in SCLC. Patient dosing in NETs and other DLL3-expressing tumors is targeted by year-end 2025.
Other programs


IDE161, a potential first-in-class small molecule poly-(ADP-ribose) glycohydrolase, or PARG, inhibitor is currently in Phase 1 dose optimization to inform future combination studies with IDE849 and other TOP1i-based ADCs where PARG inhibition may synergize with the payload to deepen responses. IDEAYA plans to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025. The company will also share preclinical data in a poster presentation at WCLC providing combination mechanism and pre-clinical synergy data between TOP1-payload based ADCs and IDE161.

IDE275 (GSK959), a potential first-in-class small molecule inhibitor of Werner Helicase, is being developed in collaboration with GlaxoSmithKline (GSK). A Phase 1 dose escalation in patients with MSI-High solid tumors is ongoing.

IDE705 (GSK101), a potential first-in-class small molecule inhibitor of DNA Polymerase Theta Helicase, or Pol Theta, is being developed in collaboration with GSK. A Phase 1 clinical trial in combination with niraparib, GSK’s small molecule inhibitor of PARP, is ongoing in patients with BRCA-positive or other HRD-positive tumors.

Phase 2 expansion in HRD-positive solid tumors would trigger a $10 million milestone payment from GSK.

IDEAYA also plans to submit three investigational new drug, or IND, applications before the end of the year:
o
IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, in mid-2025;
o
IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, in the fourth quarter of 2025; and
o
IDE574, a potential first-in-class KAT6/7 dual inhibitor, in the fourth quarter of 2025.

R&D Day – September 8, 2025


IDEAYA will host an in-person and virtual R&D Day on September 8th, 2025 from 8:00-10:00 AM ET in New York City. The company will present multiple clinical data updates across the pipeline and highlight future growth drivers and upcoming milestones. Speakers will include members of IDEAYA’s senior leadership team and key opinion leader(s). Additional agenda details will be provided by the end of August 2025.

Registration for this event can be accessed here or at the investors section of the IDEAYA website at View Source
Other corporate updates


IDEAYA continues efforts to scale the organization in preparation for the potential U.S. launch of darovasertib, including key hires within the commercial, medical affairs and market access functions.
o
Gary Palmer, M.D., joined as Senior Vice President, Medical Affairs, where he will lead the company’s medical affairs activities. Gary joined IDEAYA with over 25 years of global leadership experience in medical affairs from biopharmaceutical companies of various sizes and stages, and across multiple therapeutic areas including oncology, pulmonary medicine, immunology and neurology. Most recently Gary was Senior Vice President of Medical Affairs at Pliant Therapeutics, and prior to that he was Senior Vice President of Global Medical Affairs Immunology & Neuroscience at Bristol-Myers Squibb Co (BMS) where he led the Worldwide Immunology, Fibrosis and Neuroscience Medical Affairs team covering a portfolio spanning four globally marketed medications and more than 15 development candidates across the areas of pulmonary fibrosis, dermatology, gastroenterology, rheumatology and neurology.

Financial Results for the Quarter Ended June 30, 2025

As of June 30, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $991.9 million, compared to $1.05 billion as of March 31, 2025. The decrease was primarily driven by net cash used in operations.

Research and development (R&D) expenses for the three months ended June 30, 2025 totaled $74.2 million compared to $70.9 million for the three months ended March 31, 2025. The increase was primarily due to higher clinical trial expenses to support our clinical pipeline and personnel-related expenses.

General and administrative (G&A) expenses for the three months ended June 30, 2025 totaled $14.6 million compared to $13.5 million for the three months ended March 31, 2025. The increase was primarily due to higher personnel-related expenses to support our growth.

The net loss for the three months ended June 30, 2025, was $77.5 million compared to the net loss of $72.2 million for the three months ended March 31, 2025. Total stock compensation expense for the three months ended June 30, 2025, was $11.9 million compared to $10.2 million for the same period in 2024.

HALOZYME RAISES 2025 FINANCIAL GUIDANCE RANGES AND REPORTS STRONG SECOND QUARTER 2025 RESULTS

On August 5, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the second quarter ended June 30, 2025, provided an update on its recent corporate activities and raised its 2025 financial guidance (Press release, Halozyme, AUG 5, 2025, View Source [SID1234654786]).

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"We are very excited to report another quarter of exceptional growth with a 65% increase in royalty revenue driven by our current three blockbuster therapies, DARZALEX SC, Phesgo, and VYVGART Hytrulo. In the second quarter, four notable approvals include RYBREVANT SC in Europe, VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy in Europe and the VYVGART Hytrulo pre-filled syringe for gMG and CIDP in the U.S and Europe. Additional regulatory milestones were achieved with ENHANZE, including new indications and geographic expansion for DARZALEX SC, Opdivo SC, HYQVIA and Phesgo, which will further accelerate our future growth trajectory and enhance patient access. Based on the strong performance and growth trends, we are pleased to increase our full-year 2025 financial guidance ranges for the second time this year," said Dr. Helen Torley, President and CEO, Halozyme.

"The strong results highlight the momentum and durability across our business, powered by high-margin royalty streams and increasing global demand for our industry-leading ENHANZE drug delivery technology. In the quarter, we completed a total of $303 million in share repurchases, including the $250 million program that we announced in May. Our outperformance and strong cash generation supports a balanced capital allocation strategy, including investing in growth through M&A and returning capital to shareholders," concluded Dr. Torley.

Second Quarter and Recent Corporate Highlights:
•In June 2025, Halozyme initiated the third $250 million share repurchase tranche under the $750 million approved program from February 2024, of which $53.5 million was used to repurchase approximately 1.0 million shares at an average price of $52.40 per share in June 2025 for a total of $303.4 million of share repurchases in the second quarter.
•In May 2025, Halozyme announced a second $250 million share repurchase under the $750 million approved program from February 2024. The second $250 million share repurchase was completed in June 2025, resulting in a total purchase of 4.8 million shares at an average price of $52.09 per share.
•In April 2025, Halozyme filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. ("Merck") in the U.S. District Court in New Jersey alleging that Merck is using Halozyme’s patented MDASE subcutaneous ("SC") drug delivery technology to develop SC Keytruda. Halozyme is seeking damages and injunctive relief to stop Merck’s infringement of Halozyme’s MDASE intellectual property.

Second Quarter and Recent Partner Highlights:
•In July 2025, Janssen announced the European Commission approved a new indication for DARZALEX SC as a monotherapy for the treatment of adult patients with smouldering multiple myeloma ("SMM") at high risk of developing multiple myeloma.
•In June 2025, Takeda announced the Ministry of Health, Labour and Welfare in Japan approved HYQVIA SC with ENHANZE for treatment of patients with chronic inflammatory demyelinating polyneuropathy ("CIDP") and multifocal motor neuropathy.
•In June 2025, argenx announced European Commission approval of VYVGART SC with ENHANZE for the treatment of adult patients with progressive or relapsing active CIDP after prior treatment with corticosteroids or immunoglobulins. VYVGART SC injection is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional.
•In May 2025, Bristol Myers Squibb received European Commission approval of Opdivo SC, the SC formulation of Opdivo (nivolumab) developed with ENHANZE for use across multiple adult solid tumors, resulting in the recognition of $12.0 million in milestone revenue.
•In May 2025, argenx initiated a Phase 1 study to evaluate ARGX-213 with ENHANZE.
•In May 2025, Janssen announced the U.S. Food and Drug Administration ("FDA") Oncologic Drug Advisory Committee voted in favor of the benefit-risk profile of DARZALEX Faspro for the treatment of adult patients with high risk SMM.
•In April 2025, Roche received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending an update to the European Union ("EU") label for Phesgo for human epidermal growth factor receptor 2-positive breast cancer. Administration of Phesgo outside of a clinical setting (such as in a person’s home) by a healthcare professional will be possible, once safely established in a clinical setting.
•In April 2025, argenx received FDA approval of VYVGART Hytrulo prefilled syringe for self-injection for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive and adult patients with CIDP.

•In April 2025, Janssen received European Commission marketing authorization of the SC formulation of RYBREVANT (amivantamab) with ENHANZE, in combination with LAZCLUZE (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer ("NSCLC") with epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 L858R substitution mutations. Additionally, RYBREVANT (amivantamab) is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy. This represents the tenth partnered product with ENHANZE to be commercialized. In May 2025, amivantamab was made available to patients in the EU resulting in a $10.0 million milestone payment.
•In April 2025, Janssen received European Commission approval for an indication extension of DARZALEX SC in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma regardless of transplant eligibility.

Second Quarter 2025 Financial Highlights:
•Revenue was $325.7 million, compared to $231.4 million in the second quarter of 2024. The 41% year-over-year increase was primarily driven by royalty revenue growth and an increase in milestone revenues. Revenue included $205.6 million in royalties, an increase of 65% compared to $124.9 million in the second quarter of 2024, primarily attributable to increases in revenue of DARZALEX SC, VYVGART Hytrulo and Phesgo.
•Cost of sales was $46.4 million, compared to $39.6 million in the second quarter of 2024. The increase in cost of sales was primarily due to an increase in product sales and labor allocation initiatives.
•Amortization of intangibles expense remained flat at $17.8 million, compared to the second quarter of 2024.
•Research and development expense was $17.5 million, compared to $21.0 million in the second quarter of 2024. The decrease in research and development expense was primarily due to lower compensation expense driven by resource optimization and labor allocation initiatives, and timing of planned investments in ENHANZE related to the development of our new high-yield rHuPH20 manufacturing process.
•Selling, general and administrative expense was $41.6 million, compared to $35.7 million in the second quarter of 2024. The increase was primarily due to an increase in consulting and professional service fees, including $2.6 million of litigation costs incurred in connection with a patent infringement litigation case, and an increase in compensation expense.
•Operating income was $202.4 million, compared to $117.2 million in the second quarter of 2024.
•Net income was $165.2 million, compared to $93.2 million in the second quarter of 2024.
•EBITDA was $222.9 million, compared to $137.0 million in the second quarter of 2024. Adjusted EBITDA was $225.5 million, compared to $137.0 million in the second quarter of 2024.1
•GAAP diluted earnings per share was $1.33, compared to $0.72 in the second quarter of 2024. Non-GAAP diluted earnings per share was $1.54, compared to $0.91 in the second quarter of 2024.1
•Cash, cash equivalents and marketable securities were $548.2 million on June 30, 2025, compared to $596.1 million on December 31, 2024. The decrease was primarily a result of share repurchase activities during the year, partially offset by cash generated from operations.

Foghorn Therapeutics Provides Second Quarter 2025 Financial and Corporate Update

On August 5, 2025 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended June 30, 2025 (Press release, Foghorn Therapeutics, AUG 5, 2025, View Source [SID1234654785]). With an initial focus in oncology, Foghorn’s Gene Traffic Control Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases.

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"We continue to make meaningful progress advancing our pipeline to treat a wide range of cancers," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "The FHD-909 dose escalation trial, which is part of our strategic collaboration with Lilly, is enrolling well and remains on track. Additionally, preclinical synergistic activity of FHD-909 in combination with KRAS inhibitors and pembrolizumab supports clinical exploration of FHD-909 in difficult-to-treat NSCLC."

Mr. Gottschalk continued, "Our wholly owned selective degrader programs targeting CBP, EP300 and ARID1B, continue to advance with strong momentum. Our Selective CBP degrader has shown encouraging activity in ER+ breast cancer with potential beyond EP300-mutant tumors, and we are targeting an IND in 2026. Additionally, we anticipate program updates in the fourth quarter of 2025 for both our Selective EP300 degrader, which has shown robust anti-tumor activity across a range of hematologic malignancies, and our Selective ARID1B degrader, which has achieved selective targeted degradation. Backed by a strong balance sheet and a cash runway into 2028, we are well positioned to further advance our differentiated programs."

Program Overview and Upcoming Milestones

FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC alone and implicated in a significant number of solid tumors.

•Phase 1 trial enrolling well and remains on track. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909 is progressing well. The trial in patients with NSCLC as the primary target population is on track, following the dosing of the first patient in October 2024.
◦At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2025, Lilly presented, on behalf of the collaboration, the clinical study design poster for the Phase 1 trial evaluating FHD-909 in patients with SMARCA4 mutated locally advanced or metastatic solid tumors who have exhausted standard treatment options. The primary target population is NSCLC.

•Synergistic preclinical data of FHD-909 in combination with pembrolizumab and KRAS inhibitors. Preclinical data presented at AACR (Free AACR Whitepaper) demonstrates enhanced anti-tumor activity of FHD-909 in combination with standard-of-care (SoC) chemotherapies, anti-PD-1 pembrolizumab and several novel KRAS inhibitors in NSCLC animal models. The combination data will inform further development plans of FHD-909.

Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a U.S. 50/50 U.S. co-development and co-commercialization agreement for its selective SMARCA2 oncology program that includes both a selective inhibitor and a selective degrader, as well as an additional undisclosed oncology target. The collaboration also includes three discovery programs from Foghorn’s proprietary Gene Traffic Control platform.

Selective CBP degrader program. Foghorn’s Selective CBP degrader selectively targets CBP in EP300-mutated cancer cells, which are found in various cancer types, including bladder, gastric, and endometrial cancers. CBP and EP300 are closely related acetyltransferases, and when EP300 is mutated, this creates a synthetic lethal relationship that the therapy exploits. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been associated with dose-limiting toxicities.
•Presented preclinical combination data with Selective CBP degrader in ER+ breast cancer. In April 2025, preclinical data showing Selective CBP degraders have combination benefit with approved chemotherapies and targeted agents in solid tumors beyond EP300-mutant cancers was presented as a poster at the AACR (Free AACR Whitepaper) Annual Meeting.
•Synergistic combination activity demonstrated including with paclitaxel and CDK4/6 inhibitor abemaciclib in ER+ breast cancer.

•Findings support combination opportunities for selective CBP degraders in solid tumors beyond EP300-mutant cancers.
•On track for IND-enabling studies, targeting an IND in 2026.
Selective EP300 degrader program. Foghorn is developing a Selective EP300 degrader for the treatment of hematological malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been associated with dose limiting toxicities. EP300 lineage dependencies are established in diffuse large b-cell lymphoma (DLBCL) and multiple myeloma (MM).

•Presented preclinical data showing combination with DLBCL and MM SoC in April 2025.
•Anti-tumor activity in a broad range of hematological malignancies in vitro, including DLBCL, MM, and follicular lymphoma.
•Combination of EP300 degrader with SoC in both DLBCL and MM are highly synergistic in vitro.
•Selective EP300 degradation is effective in IMiD-resistant MM cell lines.
•Program update expected in Q4 2025.

Selective ARID1B degrader program. Foghorn’s Selective ARID1B degrader selectively targets and degrades ARID1B in ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including ovarian, endometrial, colorectal, and bladder. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target. ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors.

•Developed highly potent and selective binders. Preclinical data demonstrated potent and selective small molecule binders to ARID1B.
•Selective degradation of ARID1B achieved. Foghorn has successfully selectively degraded ARID1B.
•Program update expected in Q4 2025.

Chromatin Biology and Degrader Platform. Foghorn continues to advance its chromatin biology and degrader platform with investments in novel ligases, long-acting injectables, oral delivery, and induced proximity.

Second Quarter 2025 Financial Highlights

•Collaboration Revenue. Collaboration revenue was $7.6 million for the three months ended June 30, 2025, compared to $6.9 million for the three months ended June 30, 2024. The increase was driven by the continued advancement of programs under the Lilly Collaboration Agreement.

•Research and Development Expenses. Research and development expenses were $21.8 million for the three months ended June 30, 2025, compared to $23.8 million for the three months ended June 30, 2024. The decrease is attributed to a decrease in FHD-286 costs, decreases in personnel-related costs, early development and other research external costs and facilities and IT-related expenses, partially offset by an increase in Lilly-partnered programs.

•General and Administrative Expenses. General and administrative expenses were $6.9 million for the three months ended June 30, 2025, compared to $7.3 million for the three months ended June 30, 2024. This decrease was primarily due to lower consulting costs and lower facilities and IT related expenses.

•Net Loss. Net loss was $17.9 million for the three months ended June 30, 2025, compared to a net loss of $23.0 million for the three months ended June 30, 2024.

•Cash, Cash Equivalents, and Marketable Securities. As of June 30, 2025, the Company had $198.7 million in cash, cash equivalents, and marketable securities, providing cash runway into 2028.

About FHD-909
FHD-909 (LY4050784) is a potent, first-in-class, allosteric, and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in SMARCA4 rely on SMARCA2 for their survival. FHD-909 has shown significant anti-tumor activity across multiple SMARCA4-mutant lung tumor models.

Day One Reports Second Quarter 2025 Financial Results and Corporate Progress

On August 5, 2025 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its second quarter 2025 financial results and highlighted recent corporate achievements (Press release, Day One, AUG 5, 2025, View Source [SID1234654784]).

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"We have strong momentum going into the second half of 2025. We continue to focus on our three core priorities: accelerating revenue growth with OJEMDA, advancing our pipeline, and pursuing value-driving portfolio expansion anchored in financial discipline," said Jeremy Bender, Ph.D., chief executive officer of Day One. "With strong execution across the organization and a solid financial foundation, we’re building a company that aims to deliver meaningful value to patients and to shareholders."

OJEMDA Commercial Performance


OJEMDA net product revenue was $33.6 million in the second quarter of 2025, an increase of 310% from the second quarter of 2024.


U.S. OJEMDA net product revenue increased 10% from the first quarter of 2025.


OJEMDA prescriptions exceeded 1,000 in the second quarter of 2025, representing a 15% increase compared to the first quarter of 2025 and a 346% increase compared to the second quarter of 2024.


Achieved $113.1 million in OJEMDA net product revenue for the most recent 12-month period ended June 30, 2025.


The Company is providing 2025 net product revenue guidance of $140 to $150 million.

Program Highlights


DAY301, the Company’s PTK7-targeted ADC, is actively enrolling patients in the Phase 1a portion of the Phase 1a/b clinical trial; the trial is progressing as planned.


Day One expects to present 3-year follow-up data from the FIREFLY-1 clinical trial in the fourth quarter of 2025.


Day One published additional data characterizing growth velocity recovery and effective rash management at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Abstract 10029: Growth recovery in patients with BRAF-altered pediatric low-grade gliomas (pLGGs) after discontinuation of tovorafenib
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Abstract 10037: Post hoc analysis of rashes reported in patients with BRAF-altered relapsed/refractory pediatric low-grade glioma treated with the type II RAF inhibitor tovorafenib in FIREFLY-1


Patient enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial is on track to achieve completion of trial enrollment in the first half of 2026.


Day One terminated its research collaboration and license agreement with Sprint Bioscience AB following careful consideration of the current development status for the VRK1 program and the Company’s overall strategic objectives.

Corporate Highlights


Industry leader Michael Vasconcelles, M.D., joined Day One in June 2025 as Head of Research and Development. Dr. Vasconcelles brings more than 25 years of extensive oncology research and development experience to the Company, most recently as Executive Vice President and Head of Research, Development and Medical Affairs at ImmunoGen.

Second Quarter 2025 Financial Highlights


Product Revenue, Net: OJEMDA net product revenue was $33.6 million for the second quarter of 2025 compared to $8.2 million for the second quarter of 2024.


License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $0.3 million for the second quarter of 2025.


R&D Expenses: Research and development expenses were $36.1 million for the second quarter of 2025 compared to $92.1 million for the second quarter of 2024. The decrease was primarily due to the MabCare Therapeutics license agreement upfront payment of $55.0 million in the second quarter of 2024.


SG&A Expenses: Selling, general and administrative expenses were $29.0 million for the second quarter of 2025 compared to $30.2 million for the second quarter of 2024. The decrease was primarily due to lower employee compensation costs.


Net Loss: Net loss totaled $30.3 million for the second quarter of 2025 with non-cash stock-based compensation expense of $10.9 million, compared to a net loss of $4.4 million for the second quarter of 2024, with non-cash stock-based compensation expense of $13.0 million and gain from sale of priority voucher of $108.0 million.


Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $453.1 million as of June 30, 2025.

Conference Call

Day One will host a conference call and webcast today, August 5 at 4:30 p.m. ET. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Media & Investors page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events section of the Day One Investors & Media page for 30 days following the event.

About OJEMDA

OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.

For more information, please visit www.ojemda.com.