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.

On August 5, 2025 SERB Pharmaceuticals ("SERB"), a global specialty pharmaceutical company focused on medicines for rare diseases and medical emergencies, and Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) ("Y-mAbs" or "the Company"), a commercial-stage biopharmaceutical company focused on the development and commercialization of antibody-based therapeutics for the treatment of cancer, reported that they have entered into a definitive merger agreement under which SERB will acquire Y-mAbs, including its lead commercial oncology asset, DANYELZA (naxitamab-gqgk), in an all-cash transaction, representing an equity value for Y-mAbs of approximately $412 million (Press release, Y-mAbs Therapeutics, AUG 5, 2025, View Source [SID1234654803]).

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Under the terms of the merger agreement, SERB will commence an all-cash tender offer to purchase all outstanding shares of Y-mAbs common stock. Holders of Y-mAbs common stock would receive $8.60 per share in cash, representing a premium of approximately 105% to Y-mAbs’ closing share price on August 4, 2025, the last full trading day prior to the transaction announcement.

The transaction was unanimously approved by the Y-mAbs Board of Directors following a review of strategic alternatives to maximize value for Y-mAbs stockholders, with the assistance of external advisors. The process included discussions with numerous potential buyers for Y-mAbs or for the DANYELZA or Radiopharmaceuticals businesses on a standalone basis. In addition, the Board reviewed potential sources of additional capital to support accelerating the further development of the Company’s pipeline.

With a focus on pediatric oncology, Y-mAbs successfully developed and commercialized the anti-GD2 therapy, DANYELZA (naxitamab-gqgk). DANYELZA is the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma – a rare and aggressive pediatric cancer – and was approved in the United States under accelerated approval based on overall response rate and duration of response. DANYELZA is indicated for the treatment of pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. In addition to inpatient use, doctors can choose to administer DANYELZA in an outpatient setting, which may reduce the logistical burden on patients and their families. Y-mAbs’ portfolio also includes an investigational therapy targeting GD2 in solid tumors and CD38 in circulating tumors in ongoing Phase 1 clinical trial from its Self-Assembly DisAssembly ("SADA") Pretargeted Radioimmunotherapy Platform ("PRIT").

Vanessa Wolfeler, Chief Executive Officer of SERB: "High-risk neuroblastoma is not only a rare and devastating pediatric cancer but also one of the most difficult to treat. DANYELZA is recognized as a critical treatment option for patients and expands the treatment pathways available to providers in an outpatient setting. Working together with the team from Y-mAbs, I believe we can continue generating data for this product, expand partnerships to additional oncology centers, and have a positive impact on the lives of more neuroblastoma patients and their families."

Jeremie Urbain, Chairman of SERB: "Following SERB’s expansion into the United States five years ago, this acquisition reflects another milestone in the execution of our growth strategy to build a leading global specialty pharma platform. DANYELZA is an excellent strategic fit for SERB as it strengthens our existing rare oncology portfolio and will allow us to leverage our existing global footprint and our medical, regulatory, and commercial expertise to expand the reach of DANYELZA to new markets."

SERB has a growing portfolio of medicines for rare emergency medicine, rare diseases, and CBRN preparedness, supplying healthcare providers around the world. The acquisition of DANYELZA broadens SERB’s existing Rare Oncology portfolio (Voraxaze, Vistogard, Xermelo) and furthers its mission of building a leading portfolio of medicines that improve the standard of care for patients globally.

Michael Rossi, President, Chief Executive Officer and a member of the Board of Directors, Y-mAbs: "Our Board regularly reviews our business, including our strategy, the current state of the biopharmaceutical sector and the time and resources required to execute on our strategic plans. Following the thorough process to explore all of the potential paths forward for the Company, we are now moving forward with this agreement with SERB that we believe reflects the most attractive option available to Y-mAbs, providing significant, immediate and certain value to our stockholders."

Mr. Rossi continued: "This transaction is a testament to our team’s hard work in building a strong foundation as a commercial organization with a differentiated, FDA-approved product in DANYELZA. We believe that Y-mAbs has made important progress advancing DANYELZA and our Radiopharmaceuticals platform. By combining our expertise and resources with SERB’s specialty commercial capabilities, we can extend our shared commitment of improving the lives of even more patients and families on a global scale."

Transaction Details

Under the terms of the merger agreement, SERB is obligated to commence a tender offer by August 19, 2025, to purchase all of Y-mAbs’ outstanding shares for $8.60 per share in cash. Assuming a majority of the outstanding Y-mAbs shares are tendered into, and not withdrawn from, the tender offer, and subject to the satisfaction of other customary conditions, including the receipt of a majority of Y-mAbs shares in the tender offer and expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, SERB is required to close the tender offer, following which, Y-mAbs will be merged with a subsidiary of SERB. After such merger, Y-mAbs shares that were not tendered in the tender offer will be converted into the right to receive the same $8.60 per share in cash paid for shares in the tender offer, and Y-mAbs’ stock will no longer be listed on the Nasdaq exchange.

Y-mAbs stockholders holding approximately 16% of Y-mAbs’ outstanding shares of common stock have entered into a tender and support agreement with SERB, pursuant to which such stockholders have agreed, among other things, to tender all of their shares of Y-mAbs common stock in the tender offer, subject to the terms and conditions of such agreement.

The transaction is expected to close by the fourth quarter of 2025.

Advisors

Rothschild & Co. is acting as exclusive financial advisor, Freshfields US LLP is acting as legal counsel and H/Advisors Abernathy is acting as strategic communications advisor to SERB.

Centerview Partners is acting as exclusive financial advisor, Cooley LLP is acting as legal counsel and Joele Frank, Wilkinson Brimmer Katcher is acting as strategic communications advisor to Y-mAbs.

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.

On August 5, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, reported the dosing of the first patient in its TRACTr collaboration with Merck, known as MSD outside of the United States and Canada. Under the terms of the collaboration that was entered in December 2020, Janux is eligible to receive development and commercial milestone payments and royalties (Press release, Janux Therapeutics, AUG 5, 2025, View Source [SID1234654890]).

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"This milestone underscores the strength of our approach to generating value through both internal innovation and strategic partnerships, and it reflects the growing promise of our TRACTr pipeline—precision engineered to selectively modulate T cells to fight cancer," said David Campbell, Ph.D., President and CEO of Janux.

"We’re thrilled to mark this pivotal achievement with the first clinical program emerging from our collaboration with Merck. This event displays strong collaboration with our partner and the ability to advance novel therapeutics derived from our underlying platforms from discovery into clinical trials," said Janeen Doyle, Chief Corporate and Business Development Officer of Janux.

Janux’s TRACTr, TRACIr and ARM Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development.

On August 5, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported financial results for the three-month and six-month periods ended June 30, 2025, and highlighted recent business updates, including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced ovarian cancer (Press release, IMUNON, AUG 5, 2025, View Source [SID1234654789]).

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"IMUNON continues to make significant progress in advancing its mission to transform cancer treatment," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "With groundbreaking IMNN-001 clinical data, a clear clinical development and regulatory strategy, including a Phase 3 trial currently in progress, and significant unmet patient need, IMUNON is well positioned to potentially deliver an innovative therapy for women with newly diagnosed advanced ovarian cancer who urgently need new treatment options."

"Our clinical success has attracted increasing interest from potential institutional investors and from potential partners, reflecting confidence in our technology and business strategy. As we advance the Phase 3 OVATION 3 Study, which will evaluate IMNN-001 in women with stage IIIC or IV ovarian cancer, we are committed to funding this pivotal trial strategically. We have taken steps to conserve cash and align our critical needs with available capital on hand, while securing the resources needed to advance this potentially transformative therapy with select financing opportunities," Dr. Lindborg continued.

RECENT DEVELOPMENTS

IMNN-001 Immunotherapy

First Patient Dosed in the Phase 3 OVATION 3 Study of IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer – On July 30, 2025, the Company announced treatment of the first patient in the OVATION 3 Study and is working with trial investigators to expand clinical sites and accelerate enrollment. Three sites have been activated and are open for patient enrollment, with a corporate goal of having 20 sites activated by the end of 2025.

The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard of care (SoC) N/ACT alone. Study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3C or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency (HRD), including BRCA1 or BRCA2 mutations. Participants who are HRD positive will receive poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints.

Oral Presentation of Phase 2 OVATION 2 Study at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting Reinforces Unprecedented Overall Survival IMNN-001 Data in Advanced Ovarian Cancer – During an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois on June 3, 2025, the Company presented positive data from its Phase 2 OVATION 2 Study showing that treatment with IMNN-001 in women with newly diagnosed advanced ovarian cancer resulted in consistent, clinically meaningful improvements in several key endpoints across treatment groups, including OS, progression-free survival (PFS), chemotherapy response score and surgical response. Treatment with IMNN-001 also showed a favorable safety profile, with no elevation in immune-related adverse events. The review of full data was simultaneously published in the peer-reviewed journal Gynecologic Oncology, titled OVATION-2: A Randomized Phase I/II study Evaluating the Safety and Efficacy of IMNN-001 (IL-12 gene therapy) with Neo/Adjuvant Chemotherapy in Patients Newly- Diagnosed with Advanced Epithelial Ovarian Cancer.

The data presented at ASCO (Free ASCO Whitepaper) 2025 and published in Gynecologic Oncology demonstrated consistent results across all treatment groups, with the following key highlights:

Patients in the intent-to-treat (ITT) population administered IMNN-001 plus SoC N/ACT achieved a median increase in OS of 13 months compared to SoC N/ACT alone (46 vs. 33 months), with a hazard ratio of 0.69.
Better therapeutic effect observed with IMNN-001 treatment compared to the control arm (p=0.0375), as shown by mean 6.5-month extension of time free of progression or death (PFS + OS) captured in totality of treatment effect.
Use of PARP inhibitors as part of maintenance therapy further enhanced outcomes, with median OS not yet reached in IMNN-001 treatment arm after more than five years (vs. 37 months in the control arm), with a hazard ratio of 0.38.

For additional details, please refer to our press release (Press Release). The OVATION 2 Study oral presentation and journal manuscript are both available on the "Scientific Presentations" page of IMUNON’s website at View Source

Positive Phase 2 Translational Data of IMNN-001 in Advanced Ovarian Cancer Presented at ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress 2025 – On June 18, 2025, at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress 2025, the Company presented new positive translational data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational gene-based interleukin-12 (IL-12) immunotherapy based on its proprietary TheraPlas technology platform, for the treatment of newly diagnosed advanced ovarian cancer. The data demonstrated that IMNN-001 creates a "hot" anti-tumor microenvironment by recruiting CD8+ T cells, macrophages and dendritic cells into the tumor microenvironment and decreasing Treg suppressor cells. This biomarker research further validates IMNN-001’s mechanism of action and selective immune activation at the tumor site.

PlaCCineDNA Vaccine Technology

Six-Month Data Show Durability of Protection for Next-Generation DNA Vaccine Platform in Phase 1 Clinical Trial in COVID-19 – On May 15, 2025, we announced six-month data from the Phase 1 proof-of-concept trial of IMNN-101, our investigational DNA plasmid vaccine based on the Company’s proprietary PlaCCine platform. In 24 healthy volunteers previously vaccinated against the Omicron XBB1.5 variant, a single dose targeting this antigen induced up to a 3-fold median increase in serum neutralizing antibody (NAb) titers from baseline at six months, with stronger responses in the higher dose cohorts (2.0 mg and 1.0 mg) compared to the lower dose (0.5 mg). The highest observed individual increase was 8-fold from baseline among the participating volunteers. Modest T-cell response increases were also observed in trial participants who received multiple immunizations prior to the study. IMNN-101 remained safe and well-tolerated, with no serious adverse events reported.

These results build on February 2025 data showing a persistent 2- to 4-fold NAb titer increase through week 4, with further gains between weeks 2 and 4, and cross-reactivity against XBB1.5 and newer variants. The findings align with preclinical data demonstrating more than 95% protection in non-human primates, comparable to mRNA vaccines. PlaCCine’s demonstrated advantages include durability of protection, simplified manufacturing, and stability (up to one year at 4°C and one month at 37°C), positioning it as a potential alternative to mRNA vaccines. Given our strategic deprioritization of this program, the Company plans to seek partners for further development of IMNN-101.

Corporate Highlights

IMUNON Announces Stock Dividend Boosting Shareholder Value – On July 28, 2025, the Company announced a 15% stock dividend, 0.15 shares of common stock per share of common stock and per each common stock equivalent with dividend rights. This stock grant reflects IMUNON’s confidence in its clinical programs, long-term growth strategy, and its dedication to rewarding shareholders. The stock dividend program will distribute a total of approximately 448,000 shares of additional shares of IMUNON common stock for each share (or common stock equivalent) held, payable to such holders of record as of August 7, 2025. The distribution is expected to occur on August 21, 2025.

Up To $9.75 Million Private Placement Offering Priced At-The-Market – On May 28, 2025, the Company announced the sale of common stock and short-term warrants at a purchase price of $0.45 per share in a private placement priced at-the-market under Nasdaq rules. The aggregate gross proceeds to the Company from the private placement was approximately $3.25 million, before deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the short-term warrants, if fully exercised on a cash basis, will be approximately $6.50 million. The Company intends to use the net proceeds from the offering for working capital focused on the pivotal Phase 3 OVATION 3 Study of IMNN-001 and general corporate purposes. The short-term warrants became exercisable on July 11, 2025, the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the warrants and have a three-year term.

Continued Listing Extension Granted by Nasdaq to Complete Compliance Plan – On July 15, 2025, the Company announced that the Nasdaq Hearing Panel has granted its request for an exception to complete its compliance plan, allowing the Company to maintain its listing on the Nasdaq Stock Market. Following a comprehensive review of IMUNON’s strategies to regain compliance, the Nasdaq Hearing Panel stated that IMUNON has already achieved compliance with the Equity Rule through recent fundraising activities. To ensure sustained compliance with the minimum shareholder equity requirement and to regain compliance with the minimum bid price requirement, the Company will implement the compliance plan recently presented to the Hearing Panel. The Panel has approved an exception tailored to the time needed for IMUNON to regain compliance, rather than the full 180-day period initially requested. The Company is committed to meeting these requirements within the designated timeframe. Should additional time be necessary, IMUNON may submit a request for an extension to the Panel.

Effected Reverse Stock Split and Increase in Authorized Shares – On July 25, 2025, the Company announced a 15-for-1 reverse stock split of its common stock, which was made effective for trading purposes as of 12:01 a.m. ET on July 25, 2025. All shares have been restated to reflect the effects of the 15-for-1 reverse stock split. Immediately prior to the reverse stock split, the Company had 31,828,425 shares of common stock outstanding which consolidated into 2,121,895 shares of the Company’s common stock. The reverse stock split did not impact the total authorized number of shares of common or preferred stock or the par value thereof. The number of outstanding options, stock awards and warrants were adjusted accordingly, with outstanding options and stock awards being reduced from approximately 1.9 million to approximately 0.1 million and outstanding warrants being reduced from approximately 12.7 million to approximately 0.8 million.

Also at the Company’s 2025 Annual Meeting of Stockholders held on July 11, 2025, IMUNON stockholders approved an amendment to the Company’s Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 112,500,000 shares to 350,000,000 shares, and to make a corresponding change to the number of authorized shares of capital stock.

SECOND QUARTER 2025 FINANCIAL RESULTS

Please note: All share amounts and per share amounts in this press release have been adjusted to reflect a 15-for-1 reverse split of our common stock, which we effected on July 25, 2025.

Net loss for the second quarter of 2025 was $2.7 million, or $2.15 per share, compared with a net loss of $4.8 million, or $7.64 per share, for the second quarter of 2024. Operating expenses were $2.8 million for the second quarter of 2025, a decrease of $2.2 million or 45% from $5.0 million for the second quarter of 2024.

Research and development (R&D) expenses were $1.2 million for the second quarter of 2025, a decrease of $1.6 million from $2.8 million for the second quarter of 2024. The decrease was due primarily to lower costs associated with the OVATION 2 Study, the Phase 1 proof-of-concept PlaCCine DNA vaccine trial, and development of the PlaCCine DNA vaccine technology platform.

General and administrative (G&A) expenses were $1.5 million for the second quarter of 2025, compared with $2.2 million for the second quarter of 2024. This decrease was primarily attributable to lower employee-related and legal expenses.

Investment income from short-term investments was $27,000 for the second quarter of 2025 compared to $225,000 for the same period in 2024 due to lower cash balances.

As of June 30, 2025, cash and cash equivalents were $4.7 million. During July 2025, the Company received $3.1 million in net proceeds from the exercise of warrants and sales under its ATM facility. The Company believes it has sufficient capital resources to fund its planned operations into the fourth quarter of 2025.

FIRST HALF OF 2025 FINANCIAL RESULTS

Please note: All share amounts and per share amounts in this press release have been adjusted to reflect a 15-for-1 reverse split of our common stock, which we effected on July 25, 2025.

For the six months ended June 30, 2025, the Company reported a net loss of $6.8 million, or $6.08 per share, compared with a net loss of $9.7 million, or $15.51 per share, for the same six-month period of 2024. Operating expenses were $6.9 million for the six months ended June 30, 2025, a decrease of $3.1 million or 31% from $10.0 million for the same period in 2024.

Net cash used for operating activities was $5.8 million for the first six months of 2025, compared with $10.4 million for the same period in 2024. This decrease was due to lower operating costs coupled with higher accounts payable and accrued liabilities.

R&D expenses were $3.4 million in the first half of 2025, compared with $6.1 million in the same period of 2024. Clinical costs associated with the OVATION program were $0.4 million in the first half of 2025 compared to $0.7 million in the same period of 2024. Clinical costs associated with the PlaCCine vaccine trial were $83,000 in the first half of 2025 compared to $0.9 million in the first half of 2024. R&D costs associated with the development of IMNN-001 to support the OVATION program were $1.5 million in the first half of 2025 compared to $0.7 million in same period of 2024. The development of the PlaCCine DNA vaccine technology platform was $2.0 million in the first half of 2024. CMC costs were $0.5 million in the first half of 2025 compared to $0.8 million in the same period of 2024.

G&A expenses were $3.5 million in the first half of 2025, compared with $3.9 million in the same period of 2024. The decrease was primarily attributable to lower employee-related expenses and lower legal and travel expenses.

Other non-operating income was $70,000 in the first half of 2025, compared with $307,000 in the same period of 2024. This decrease is due to lower cash and investment balances.

Conference Call and Webcast

The Company is hosting a conference call to review second quarter 2025 financial results and provide a business update today, August 5, 2025, at 11:00 a.m. ET. To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON Second Quarter 2025 Financial Results Call. A live webcast of the call will also be available here.

The call will be archived for replay until August 19, 2025. The replay can be accessed at 877-344-7529 (U.S. Toll Free), 855-669-9658 (Canada Toll Free) or 412-317-0088 (International Toll) using replay access code 9465184. An audio replay of the call will also be available here for 90 days.