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.

On August 5, 2025 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported financial results for the second quarter and provided a business update (Press release, Merus, AUG 5, 2025, View Source [SID1234654811]).

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"We were excited to share the unprecedented efficacy of petosemtamab with pembrolizumab in first-line head and neck cancer at 2025 ASCO (Free ASCO Whitepaper), and were thrilled by the response from clinicians and KOLs, which we believe continues to drive strong phase 3 site activation and support our expectation that both phase 3 trials will be substantially enrolled by year end 2025," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "Additionally, I believe these data substantially enhance the likelihood of clinical success of petosemtamab. We are looking forward to providing initial clinical data on mCRC in the second half of 2025."

Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics): Solid Tumors
LiGeR-HN1 phase 3 trial in 1L recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC) and LiGeR-HN2 phase 3 trial in 2/3L r/m HNSCC enrolling – with both trials expected to be substantially enrolled by YE25 and potential top line interim readout for one or both trials in 2026; phase 2 trial in 1L, 2L and 3L+ metastatic colorectal cancer (mCRC) enrolling; mCRC initial clinical data planned for 2H25

Merus provided updated interim clinical data from the phase 2 trial of petosemtamab with pembrolizumab as 1L treatment for PD-L1+ (CPS≥1) r/m HNSCC at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating a 63% response rate among 43 evaluable patients and a 79% overall survival rate at 12 months. The presentation was detailed in our press release, Merus’ Petosemtamab with Pembrolizumab Interim Data Demonstrates Robust Efficacy and Durability in 1L PD-L1+ r/m HNSCC (May 22, 2025).

LiGeR-HN1, a phase 3 trial evaluating the efficacy and safety of petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC compared to pembrolizumab, and LiGeR-HN2, a phase 3 trial evaluating the efficacy and safety of petosemtamab in 2/3L HNSCC compared to standard of care, are enrolling and we expect both trials to be substantially enrolled by YE25.

Merus believes a randomized registration trial in HNSCC with an overall response rate endpoint could potentially support accelerated approval and the overall survival results from the same study could potentially verify its clinical benefit to support regular approval for the Company’s phase 3 trial in 1L, and in phase 3 trial in 2/3L HNSCC. We expect to provide topline interim readout of one or both phase 3 registration trials in 2026.

In February 2025, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment of adult patients with recurrent or metastatic programmed death-ligand 1 (PD-L1) positive HNSCC with combined positive score (CPS) ≥ 1. This designation was detailed in our press release, Petosemtamab Granted Breakthrough Therapy Designation by the U.S. FDA for 1L PD-L1 Positive Head and Neck Squamous Cell Carcinoma (February 18, 2025). BTD was also granted for petosemtamab monotherapy for the treatment of patients with recurrent or metastatic HNSCC whose disease has progressed following treatment with platinum based chemotherapy and an anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) antibody, detailed in our press release, Petosemtamab granted Breakthrough Therapy Designation by the U.S. FDA (May 13, 2024).

Merus provided updated interim clinical data on petosemtamab monotherapy in 2L+ r/m HNSCC at the European Society for Medical Oncology Asia Congress, demonstrating a 36% response rate among 75 evaluable patients. The oral presentation was detailed in our press release, Merus’ Petosemtamab Monotherapy Interim Data Continues to Demonstrate Clinically Meaningful Activity in 2L+ r/m HNSCC (Dec. 7, 2024).

A phase 2 trial evaluating petosemtamab in combination with standard chemotherapy in 1L and 2L mCRC, and as monotherapy in heavily pretreated (3L+) mCRC, is enrolling. We expect to provide initial clinical data for petosemtamab in mCRC in 2H25.

BIZENGRI (zenocutuzumab-zbco: HER2 x HER3 Biclonics)
Approved by FDA for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy

Merus has exclusively licensed to Partner Therapeutics, Inc. (PTx) the right to commercialize BIZENGRI for the treatment of NRG1+ cancer in the U.S. This was detailed in our press release, Merus and Partner Therapeutics Announce License Agreement for the U.S. Commercialization of Zenocutuzumab in NRG1 Fusion-Positive Cancer (December 2, 2024).

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors
Investigation of MCLA-129 is ongoing in METex14 NSCLC; phase 2 trial in combination with chemotherapy in 2L+ EGFR mutant (EGFRm) NSCLC enrolling

MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to develop MCLA-129, and potentially commercialize exclusively in China, while Merus retains global rights outside of China.

Collaborations

Incyte Corporation
Since 2017, Merus has been working with Incyte Corporation (Incyte) under a global collaboration and license agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics technology platform. For each program under the collaboration, Merus receives reimbursement for research activities and is eligible to receive potential development, regulatory and commercial milestones and sales royalties for any products, if approved. During the second quarter of 2025, Merus received the milestone payment of $1 million for the candidate nomination of a discovery program under the collaboration.

Eli Lilly and Company
In January 2021, Merus and Eli Lilly and Company (Lilly) announced a research collaboration and exclusive license agreement to develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies utilizing Merus’ Biclonics platform and proprietary CD3 panel along with the scientific and rational drug design expertise of Lilly. The collaboration is progressing well with two programs advancing through preclinical development.

Gilead Sciences
In March 2024, Merus and Gilead Sciences announced a collaboration to discover novel antibody based trispecific T-cell engagers using Merus’ patented Triclonics platform. Under the terms of the agreement, Merus will lead early-stage research activities for two programs, with an option to pursue a third. Gilead will have the right to exclusively license programs developed under the collaboration after the completion of select research activities. If Gilead exercises its option to license any such program from the collaboration, Gilead will be responsible for additional research, development and commercialization activities for such program. The collaboration is progressing well with two programs advancing through preclinical development.

Ono Pharmaceutical
In 2018, the Company granted Ono Pharmaceutical Co., Ltd. (Ono) an exclusive, worldwide, royalty-bearing license, with the right to sublicense, research, test, make, use and market a limited number of bispecific antibody candidates based on Merus’ Biclonics technology platform directed to an undisclosed target combination.

Biohaven
In January 2025, Merus and Biohaven announced a research collaboration and license agreement to co-develop three novel bispecific antibody drug conjugates (ADCs), leveraging Merus’ leading Biclonics technology platform, and Biohaven’s next-generation ADC conjugation and payload platform technologies. Under the terms of the agreement, Biohaven is responsible for the preclinical ADC generation of three Merus bispecific antibodies under mutually agreed research plans. The agreement includes two Merus bispecific programs generated using the Biclonics platform, and one program under preclinical research by Merus. Each program is subject to mutual agreement for advancement to further development, with the parties then sharing subsequent external development costs and commercialization, if advanced.

Corporate Activities
Completed public offering raising $345M gross proceeds
This equity raise is detailed in a press release: Merus N.V. Announces Pricing of Public Offering of Common Shares (June 4, 2025).

Cash Runway, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations at least into 2028

As of June 30, 2025, Merus had $892 million cash, cash equivalents and marketable securities. Based on the Company’s current operating plan, the existing cash, cash equivalents and marketable securities are expected to fund Merus’ operations at least into 2028.

Second Quarter 2025 Financial Results

Total revenue for the three months ended June 30, 2025 increased by $1.5 million as compared to the three months ended June 30, 2024, primarily as a result of increases in Incyte revenue of $1.5 million, PTx revenue of $0.5 million, and Gilead revenue of $0.1 million, partially offset by a decrease in Lilly revenue of $0.6 million.

Research and development (R&D) expense for the three months ended June 30, 2025 increased by $44.8 million as compared to the three months ended June 30, 2024. The increase in R&D expense is primarily driven by an increase of $37.9 million in clinical trial support provided by contract manufacturing and development organizations and contract research organizations, most of which is related to the petosemtamab clinical trials. The increase is also due to increases in personnel related expenses including share-based compensation of $7.2 million.

General and administrative expense for the three months ended June 30, 2025 increased by $2.7 million as compared to the three months ended June 30, 2024, primarily as a result of increases in personnel related expenses including share-based compensation of $5.0 million, increases in facilities and depreciation expense of $0.7 million, increases in legal expenses of $0.6 million, and increases in travel expenses of $0.2 million, partially offset by decreases in consulting expenses of $3.6 million and decreases in intellectual property and license expenses of $0.3 million.

Total revenue for the six months ended June 30, 2025 increased by $20.1 million as compared to the six months ended June 30, 2024, primarily as a result of commercial material revenue sold to PTx of $13.3 million and increases in collaboration revenue of $6.8 million. The collaboration revenue increase is primarily due to increases in Biohaven upfront payment amortization of $5.1 million.

Research and development expense for the six months ended June 30, 2025 increased by $86.3 million as compared to the six months ended June 30, 2024. The increase in R&D expense is primarily driven by an increase of $73.7 million in clinical trial support provided by contract manufacturing and development organizations and contract research organizations, most of which is related to the petosemtamab clinical trials.

General and administrative expense for the six months ended June 30, 2025 increased by $8.7 million as compared to the six months ended June 30, 2024, primarily as a result as a result of increases in personnel related expenses including share-based compensation of $10.3 million, increases in facilities and depreciation expense of $1.0 million, increases in legal expenses of $0.8 million, increases in finance and human resources expenses of $0.1 million and increases in travel expenses of $0.1 million, partially offset by decreases in consulting expenses of $3.4 million.

Other income (loss), net consists of interest earned and fees paid on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange (losses) gains on our foreign denominated cash, cash equivalents and marketable securities. Other gains or losses relate to the issuance and settlement of financial instruments.

MERUS N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(Amounts in thousands, except share and per share data)

June 30,
2025 December 31,
2024
ASSETS
Current assets:
Cash and cash equivalents $ 442,791 $ 293,294
Marketable securities 267,433 243,733
Accounts receivable 16,889 1,261
Prepaid expenses and other current assets 41,169 30,784
Total current assets 768,282 569,072
Marketable securities 181,729 187,008
Property and equipment, net 11,346 10,770
Operating lease right-of-use assets 10,320 9,254
Intangible assets, net 1,797 1,679
Equity Investment 2,430 —
Deferred tax assets 758 1,520
Other assets 3,514 3,390
Total assets $ 980,176 $ 782,693
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 21,075 $ 4,164
Accrued expenses and other liabilities 41,387 43,957
Income taxes payable 478 7,317
Current portion of lease obligation 2,245 1,704
Current portion of deferred revenue 26,394 29,934
Total current liabilities 91,579 87,076
Lease obligation 8,754 8,208
Deferred revenue, net of current portion 38,107 39,482
Total liabilities 138,440 134,766
Commitments and contingencies – Note 6
Shareholders’ equity:
Common shares, €0.09 par value; 105,000,000 shares authorized at June 30, 2025 and December 31, 2024; 75,565,138 and 68,828,749 shares issued and outstanding as at June 30, 2025 and December 31, 2024, respectively 7,647 6,957
Additional paid-in capital 2,038,795 1,664,822
Accumulated other comprehensive income 18,373 (55,465 )
Accumulated deficit (1,223,079 ) (968,387 )
Total shareholders’ equity 841,736 647,927
Total liabilities and shareholders’ equity $ 980,176 $ 782,693

MERUS N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(Amounts in thousands, except share and per share data)

Three Months Ended
June 30, Six Months Ended
June 30,
2025 2024 2025 2024
Commercial material revenue $ — $ — $ 13,331 $ —
Collaboration revenue 8,828 7,332 21,976 15,221
Royalty revenue — — 9 —
Total revenue 8,828 7,332 35,316 15,221
Operating expenses:
Research and development 93,926 49,119 174,042 87,703
General and administrative 25,252 22,587 47,364 38,701
Total operating expenses 119,178 71,706 221,406 126,404
Operating loss (110,350 ) (64,374 ) (186,090 ) (111,183 )
Other income, net:
Interest income, net 7,122 7,130 14,325 12,047
Foreign exchange gains (loss) (51,854 ) 9,519 (76,170 ) 18,053
Other expense (1,265 ) — (3,031 ) —
Total other income (loss), net (45,997 ) 16,649 (64,876 ) 30,100

Net loss before income taxes (156,347 ) (47,725 ) (250,966 ) (81,083 )
Income tax expense 1,871 2,317 3,726 3,415
Net loss $ (158,218 ) $ (50,042 ) $ (254,692 ) $ (84,498 )
Other comprehensive loss:
Currency translation adjustment 50,733 (8,978 ) 73,838 (16,366 )
Comprehensive loss $ (107,485 ) $ (59,020 ) $ (180,854 ) $ (100,864 )
Net loss per share attributable to common shareholders:
Basic and diluted $ (2.23 ) $ (0.81 ) $ (3.64 ) $ (1.41 )
Weighted-average common shares outstanding:
Basic and diluted 71,096,937 61,851,260 69,996,121 59,968,338

On August 5, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the second quarter of 2025 and updated financial guidance for 2025 (Press release, Jazz Pharmaceuticals, AUG 5, 2025, View Source [SID1234654790]).

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"It has been a privilege to lead Jazz over my 22-year tenure. I am proud of what we have achieved on behalf of patients and confident that our new President and CEO, Renee Gala, will build on Jazz’s momentum and serve as a catalyst in driving long-term growth," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. "We continue to see significant opportunity across our diversified portfolio in sleep, epilepsy, and oncology, as evidenced by the strong performance this quarter from our sleep portfolio with robust continued growth from Xywav in both narcolepsy and IH. We remain confident in the outlook of the business driven by multiple anticipated near-term oncology catalysts that each represent significant opportunities to drive greater revenue and create long-term value, most notably the top-line data readout for zanidatamab from the HERIZON-GEA-01 trial and upcoming PDUFA dates for dordaviprone and Zepzelca."

Key Highlights

•Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in 4Q25.
•Ziihera granted conditional marketing authorization by the European Commission in 2L BTC.
•Zepzelca and atezolizumab (Tecentriq) combination granted U.S. FDA Priority Review for 1L maintenance treatment of ES-SCLC based on positive data from IMforte trial; PDUFA action date of October 7, 2025.
•2025 Financial Guidance
◦Updating total revenue range to $4.15 – $4.30 billion representing 4% growth at the midpoint.
◦Raising lower end of net (loss)/income and (loss)/earnings per share ranges due to reductions in SG&A and R&D and improvement in the effective tax rate ranges.

Business Updates

Commercial Updates
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 13% to $415.3 million in 2Q25 compared to 2Q24.
•Meaningful Xywav net patient adds in 2Q25 (approximately 625 patients) with approximately 15,225 active Xywav patients exiting 2Q25, comprised of:
◦Approximately 10,600 narcolepsy patients.
◦Approximately 4,625 idiopathic hypersomnia (IH) patients, with 400 net patient adds.
•Presented data at the SLEEP 2025 meeting including results from the Phase 4 open-label XYLO trial showing that a switch from high-sodium oxybate to the same dose of low-sodium oxybate was associated with clinically meaningful reductions in blood pressure. Additionally, two presentations from the DUET trial evaluating sleep architecture demonstrated the effectiveness of Xywav on improvements in sleep quality among patients with IH or narcolepsy.
•Xywav, which the U.S. Food and Drug Administration (FDA) describes as clinically superior to Xyrem by means of greater safety, is the only low-sodium oxybate, the #1 branded treatment for narcolepsy1 and the only FDA-approved therapy to treat IH.

Xyrem (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties:
•Xyrem net product sales were $35.3 million in 2Q25.
•Royalties from high-sodium oxybate AGs were $54.1 million in 2Q25.

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales increased 2% to $251.7 million in 2Q25 compared to 2Q24; underlying demand continues to be strong with year-over-year net product sales growth impacted by a number of factors, including inventory dynamics in the U.S. compared to 2Q24.
•Outside of the U.S., Epidyolex is approved in more than 35 countries.
•Remain confident in achieving blockbuster status for Epidiolex/Epidyolex in 2025.

Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
•Rylaze/Enrylaze net product sales decreased 7% to $100.7 million in 2Q25 compared to 2Q24.
•While updates to pediatric treatment protocols for acute lymphoblastic leukemia (ALL) have been broadly adopted, pediatric asparaginase use as a class remains below levels seen prior to protocol implementation; Rylaze use within the asparaginase class remains broadly stable.

Zepzelca (lurbinectedin):
•Zepzelca net product sales decreased 8% to $74.5 million in 2Q25 compared to 2Q24. This decrease was driven by increased competition in second-line (2L) small cell lung cancer (SCLC) and treatment protocol updates delaying progression of first-line (1L) limited-stage SCLC patients to the 2L setting.
•Zepzelca and atezolizumab were granted U.S. FDA Priority Review for 1L extensive-stage (ES) SCLC in the maintenance setting with a Prescription Drug User Fee Act (PDUFA) action date of October 7, 2025.
•Potentially practice-changing data from the Phase 3 IMforte trial have been submitted to the National Comprehensive Cancer Network (NCCN) for consideration.

Ziihera (zanidatamab-hrii):
•Ziihera net product sales were $6.0 million in 2Q25 following product launch in December 2024.
•The Company was granted conditional marketing authorization by the European Commission for Ziihera as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.

Corporate Development
Chimerix Acquisition:
•The Company completed its acquisition of Chimerix, Inc in April 2025 (Chimerix Acquisition), adding dordaviprone to its late-stage pipeline. Dordaviprone is a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor that most commonly affects children and young adults.

Key Pipeline Highlights
Zanidatamab:
•The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L gastroesophageal adenocarcinoma (GEA), is expected to read out in 4Q25.
•New data presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from an ongoing Phase 2 trial of zanidatamab in combination with physician’s choice chemotherapy for the first-line treatment of HER2-positive metastatic GEA showed a median overall survival of 36.5 months after four-years of follow-up along with a 15.2 month median progression-free survival in patients who were centrally confirmed as HER2-positive.
•In August 2025, the Company initiated the Phase 2 EmpowHER-BC-208 trial to evaluate zanidatamab in patients with HER2-positive neoadjuvant and adjuvant breast cancer.

Dordaviprone:
•A New Drug Application for accelerated approval of dordaviprone in recurrent H3 K27M-mutant diffuse glioma was accepted and granted Priority Review by FDA. FDA has set a target PDUFA action date of August 18, 2025.
•The ongoing Phase 3 ACTION trial is evaluating dordaviprone in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting.

Share Repurchases of Approximately $125 Million
The Company resumed repurchases of its ordinary shares in the second quarter of 2025 as part of the Company’s previously authorized and announced repurchase program. Under this share repurchase program, the Company is authorized to repurchase its ordinary shares for up to an aggregate purchase price of $500 million, exclusive of any brokerage commissions. As of June 30, 2025, $225 million remained outstanding under this authorization, reflecting the purchase of shares worth approximately $125 million during the second quarter of 2025.

Financial Highlights
Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands, except per share amounts) 2025 2024 2025 2024
Total revenues $ 1,045,712 $ 1,023,825 $ 1,943,553 $ 1,925,808
GAAP net income (loss) $ (718,470) $ 168,568 $ (811,011) $ 153,950
Non-GAAP adjusted net income (loss)1
$ (504,849) $ 360,656 $ (399,616) $ 539,086
GAAP earnings (loss) per share $ (11.74) $ 2.49 $ (13.28) $ 2.35
Non-GAAP adjusted earnings (loss) per share1
$ (8.25) $ 5.25 $ (6.54) $ 7.88

GAAP net loss for 2Q25 was $(718.5) million, or $(11.74) per diluted share, compared to GAAP net income of $168.6 million, or $2.49 per diluted share, for 2Q24.
Non-GAAP adjusted net loss for 2Q25 was $(504.8) million, or $(8.25) per diluted share, compared to non-GAAP adjusted net income of $360.7 million, or $5.25 per diluted share, for 2Q24.
The GAAP and non-GAAP adjusted net loss in 2Q25 included acquired in-process research and development (IPR&D) expense of $905.4 million representing the value allocated to dordaviprone in the Chimerix Acquisition, which impacted our results by $14.78 per share and $14.75 per share on a GAAP and non-GAAP adjusted basis, respectively.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total Revenues
Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands) 2025 2024 2025 2024
Xywav $ 415,321 $ 368,472 $ 760,125 $ 683,772
Xyrem 35,349 62,180 72,590 126,412
Epidiolex/Epidyolex 251,730 247,102 469,467 445,818
Sativex 4,615 6,383 10,022 9,118
Total Neuroscience 707,015 684,137 1,312,204 1,265,120
Rylaze/Enrylaze 100,659 107,829 194,892 210,579
Zepzelca 74,541 81,047 137,574 156,147
Defitelio/defibrotide 48,106 45,421 88,768 93,097
Vyxeos 44,851 43,012 74,395 75,035
Ziihera 5,991 — 7,966 —
Total Oncology 274,148 277,309 503,595 534,858
Other 4,408 2,698 9,190 6,268
Product sales, net 985,571 964,144 1,824,989 1,806,246
High-sodium oxybate AG royalty revenue 54,138 54,164 103,084 104,111
Other royalty and contract revenues 6,003 5,517 15,480 15,451
Total revenues $ 1,045,712 $ 1,023,825 $ 1,943,553 $ 1,925,808

Total revenues increased 2% in 2Q25 compared to the same period in 2024.
Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $761.2 million in 2Q25, an increase of 3% compared to $738.3 million in 2Q24. The increase in 2Q25 was due to higher Xywav and Epidiolex/Epidyolex net product sales, partially offset by decreased Xyrem net product sales.
Oncology net product sales were $274.1 million in 2Q25, a decrease of 1% compared to $277.3 million in 2Q24. The decrease in 2Q25 was primarily due to lower net product sales of Rylaze/Enrylaze and Zepzelca, partially offset by the inclusion of Ziihera net product sales.

On August 5, 2025 Intas Pharmaceuticals reported it has launched HETRONIFLY (Serplulimab), the first PD-1 inhibitor globally approved for the treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC), in the Indian market (Press release, Intas Pharmaceuticals, AUG 5, 2025, View Source [SID1234654812]). This marks another major milestone, following the successful Launch in Europe.

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This launch follows a strategic licensing agreement between Intas Pharmaceuticals Limited and Shanghai Henlius Biotech, Inc., further strengthening Intas’ oncology portfolio and reinforcing its commitment to delivering cutting-edge therapies to patients in India.

Serplulimab is the first PD-1 inhibitor worldwide to receive approval for ES-SCLC, and is currently present in over 40 countries, including key European markets. Its efficacy is supported by the landmark ASTRUM-005 trial, which demonstrated a 40% reduction in the risk of death and remarkably higher overall survival rate versus the current standard-of-care Chemotherapy regimen. Notably, Serplulimab achieved an ESMO (Free ESMO Whitepaper)-MCBS score of 4/5—the highest among current immunotherapies, signifying highest clinical benefit in this indication.

The novel humanized mAb has a unique dual-blockade mechanism of PD-L1 and PD-L2, along with the highest PD-1 internalization, which sets a new benchmark in deep immune engagement for solid tumors. Globally, Serplulimab has been administered to over a lakh patients across a range of malignancies including SCLC, NSCLC, ESCC, and MSI-high cancers.

Despite the promise of immuno-oncology, cost remains a significant barrier in India. HETRONIFLY, introduced at approximately 75% lower cost than the currently available immunotherapies for this indication, underscores Intas’ commitment to providing high-quality innovative therapies at affordable prices to cancer patients in India.

Commenting on the launch, Binish Chudgar, Chairman & Managing Director of Intas Pharmaceuticals said, "The launch of HETRONIFLY reinforces our strategic position in oncology and reflects Intas’ commitment to accelerating access to globally validated therapies. It aligns with our operating model of delivering high-impact innovations to the Indian market with speed and cost-efficiency."

On August 5, 2025 Leidos Holdings, Inc. (NYSE: LDOS) reported financial results for the second quarter of
fiscal year 2025, highlighted by robust earnings and revenue growth.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Our second quarter results showcase the strength of our differentiated portfolio and the alignment of our NorthStar 2030 strategy with the priorities of the new Administration," said Leidos Chief Executive Officer Tom Bell. "With record margins, continued double-digit EPS growth, and strong cash conversion, we are delivering on our financial commitments, and we are strategically deploying capital to grow shareholder value. We are pleased to improve our guidance outlook for 2025 given two quarters of exceptional performance and enhanced clarity on the macro environment."

(Press release, Leidos, AUG 5, 2025, View Source [SID1234661781])