On February 6, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported it has achieved 50% of the patient enrolment target in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC).

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Immutep Chief Executive Officer, Marc Voigt, said, "The excellent pace of enrolment globally in the TACTI-004 trial speaks to the promise of efti and the need for more efficacious therapies in the first line setting for patients with advanced/metastatic non-small cell lung cancer. Our team continues to work hard to bring this innovative cancer immunotherapy to market and looks forward to delivering on additional important upcoming milestones ahead, including the futility analysis in the first quarter and completing patient enrolment in the third quarter this year."

The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC, one of the largest and deadliest indications in oncology, by expanding the number of patients who respond to anti-PD-1 therapy, across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients’ survival.

The registrational TACTI-004 Phase III has enrolled 378 patients globally and enrolment continues its robust pace. Additionally, over 140 clinical sites are now activated across 27 countries. The futility analysis and completion of patient enrolment remain on track for the first quarter and the third quarter of CY2026, respectively.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About TACTI-004
TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumour aberrations. The global trial will enrol approximately 756 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Patients will be randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo in the control arm. The study’s dual primary endpoints are progression-free survival and overall survival.

About Eftilagimod Alfa (Efti)
Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, FEB 6, 2026, View Source;v=undefined [SID1234662513])

On February 6, 2026 Ernexa Therapeutics Inc. (Nasdaq: ERNA) ("Ernexa" or the "Company"), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported the pricing of a best-efforts registered public offering of 21,000,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to 21,000,000 shares of common stock, at a combined public offering price of $0.50 per share (or per common stock equivalent in lieu thereof) and accompanying warrant.

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The warrants will have an exercise price of $0.68 per share, will be exercisable upon issuance, and will expire on the earlier to occur of (i) the five-year anniversary of the initial issuance date, or (ii) the 180th calendar day following the public release by the Company of clinical trial data from the first cohort of the Phase 1 study of ERNA-101. The closing of the offering is expected to occur on or about February 10, 2026, subject to the satisfaction of customary closing conditions.

Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as the exclusive placement agent for the offering.

Ernexa intends to use the net proceeds from the offering to support the advancement of its development programs, working capital, and general corporate purposes.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $10.5 million, before deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the exercise of the warrants, if fully exercised on a cash basis, would be approximately $14.3 million. No assurance can be given that any warrants will be exercised.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-293150), as amended, which was declared effective by the Securities and Exchange Commission (the "SEC") on February 5, 2026. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source and a final prospectus relating to the offering will be filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at View Source and may also be obtained, when available, by contacting Brookline Capital Markets, a division of Arcadia Securities, LLC at 600 Lexington Avenue, 30th Floor, New York, New York 10022, by phone at (646) 603-6716.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Ernexa Therapeutics, FEB 6, 2026, View Source [SID1234662596])

On February 6, 2026 Biogen Inc. (Nasdaq: BIIB) reported fourth quarter and full year 2025 financial results. Commenting on the results, President and Chief Executive Officer Christopher A. Viehbacher said:

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"Our 2025 performance reflected continued focus on strong execution and financial discipline, driven by our revenue of nearly $1 billion from LEQEMBI, SKYCLARYS, ZURZUVAE, and QALSODY, progression of our pipeline, and resilience of our MS franchise. Our pipeline momentum continues with a strong start in 2026, with the FDA recently granting Priority Review for LEQEMBI IQLIK initiation and Breakthrough Therapy Designation for litifilimab in CLE. These milestones highlight both the innovative and differentiated value of our medicines and the strength of our late-stage pipeline. Going into 2026, we are looking forward to data
1 Growth products include SKYCLARYS, QALSODY, ZURZUVAE, VUMERITY and SPINRAZA, plus Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.
1
from two Phase 3 studies in lupus for litifilimab, with 10 additional potentially registrational studies across our pipeline expected to read out sequentially over the next four years. This multi-year registrational data flow has the potential to drive meaningful innovation for patients and long-term value for shareholders."
Financial Highlights
Q4 ’25 Q4 ’24 fav/(unfav) fav/(unfav)
at CC* FY ’25 FY ’24 fav/(unfav) fav/(unfav)
at CC*
Total Revenue (in millions) $2,279 $2,455 (7)% (7)% $9,891 $9,676 2% 2%
GAAP diluted EPS $(0.33) $1.83 (118)% N/A $8.79 $11.18 (21)% N/A
Non-GAAP diluted EPS $1.99 $3.44 (42)% N/A $15.28 $16.47 (7)% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(In millions, except percentages) Q4 ’25 Q4 ’24 fav/(unfav) fav/(unfav)
at CC* FY ’25 FY ’24 fav/(unfav) fav/(unfav)
at CC*
Multiple Sclerosis (MS) product revenue(1)
$917 $1,070 (14)% (15)% $4,039 $4,350 (7)% (7)%
Rare disease revenue(2)
$515 $535 (4)% (4)% $2,154 $1,988 8% 9%
Biosimilars revenue $170 $202 (16)% (15)% $729 $793 (8)% (7)%
Other product revenue(3)
$66 $26 157% 158% $197 $83 139% 140%
Total product revenue $1,667 $1,833 (9)% (9)% $7,119 $7,214 (1)% (1)%
Revenue from anti-CD20 therapeutic programs $521 $465 12% 12% $1,861 $1,750 6% 6%
Alzheimer’s collaboration revenue(4)
$47 $27 77% 76% $178 $60 197% 197%
Contract manufacturing, royalty and other revenue $44 $130 (66)% (66)% $733 $653 12% 12%
Total revenue $2,279 $2,455 (7)% (7)% $9,891 $9,676 2% 2%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding. NMF = no meaningful figure.
(1) MS includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ZURZUVAE, ADUHELM and FUMADERM.
(4) Includes Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.
Expense Summary
(In millions, except percentages) Q4 ’25 Q4 ’24 fav/(unfav) FY ’25 FY ’24 fav/(unfav)
GAAP cost of sales*
$496 $583 15% $2,404 $2,310 (4)%
% of Total Revenue 22% 24% 24% 24%
Non-GAAP cost of sales*
$445 $540 18% $2,089 $2,137 2%
% of Total Revenue 20% 22% 21% 22%
GAAP R&D expense $509 $513 1% $1,779 $1,980 10%
Non-GAAP R&D expense $478 $509 6% $1,731 $1,868 7%
GAAP SG&A expense $683 $680 —% $2,434 $2,404 (1)%
Non-GAAP SG&A expense $678 $673 (1)% $2,421 $2,340 (3)%
GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense $222 $19 NMF $472 $62 NMF

2
Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
IPR&D = in-process R&D. NMF = no meaningful figure.
*Excluding amortization and impairment of acquired intangible assets.

•The decrease in fourth quarter 2025 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by favorable product mix including lower contract manufacturing revenue.

•The increase in full year 2025 GAAP cost of sales as a percentage of total revenue was driven primarily by a pre-tax charge related to a judgment on Genentech’s claim for past royalties and interest on sales of TYSABRI. The decrease in full year 2025 Non-GAAP cost of sales as a percentage of total revenue was driven primarily by favorable product mix.

•The decrease in fourth quarter and full year 2025 GAAP and Non-GAAP R&D expense was driven primarily by the favorable impact from the Company’s Fit for Growth initiative and R&D funding received, partially offset by increased investment in late-stage programs including felzartamab and litifilimab.

•The increase in fourth quarter and full year 2025 GAAP and Non-GAAP SG&A expense was driven primarily by sales and marketing spend to support product launches, partially offset by savings from the Company’s Fit for Growth initiative.

•Fourth quarter 2025 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was approximately $222 million.
Other Financial Highlights

•Fourth quarter 2025 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $70 million. This includes approximately $47 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $22 million related to Biogen’s collaboration with Supernus Pharmaceuticals, Inc. related to the commercialization of ZURZUVAE in the U.S.

•Full year 2025 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $290 million. This includes approximately $219 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $71 million related to Biogen’s collaboration with Supernus Pharmaceuticals, Inc. related to the commercialization of ZURZUVAE in the U.S.

•Fourth quarter 2025 GAAP other expense was approximately $154 million and includes approximately $131 million related to litigation matters. Fourth quarter 2025 Non-GAAP other expense was approximately $46 million, primarily driven by net interest expense.

•Full year 2025 GAAP other expense was approximately $306 million and includes the aforementioned approximately $131 million related to litigation matters. Full year 2025 Non-GAAP other expense was approximately $179 million, primarily driven by net interest expense.

•Fourth quarter 2025 GAAP and Non-GAAP effective tax rates were 12.8% and 10.1%, respectively. Fourth quarter 2024 GAAP and Non-GAAP effective tax rates were 8.5% and 12.2%, respectively.

•Full year 2025 GAAP and Non-GAAP effective tax rates were 16.9% and 15.5%, respectively. Full year 2024 GAAP and Non-GAAP effective tax rates were 14.4% and 14.6%, respectively.
Financial Position

•Fourth quarter 2025 net cash flow from operations was approximately $512 million. Capital expenditures were approximately $44 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was approximately $468 million.

•Full year 2025 net cash flow from operations was approximately $2.2 billion. Capital expenditures were approximately $154 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was approximately $2.1 billion.
3

•As of December 31, 2025, Biogen had cash and cash equivalents totaling approximately $4.2 billion with approximately $6.3 billion in total debt, resulting in net debt of approximately $2.0 billion.

•For the fourth quarter of 2025 the Company’s weighted average shares were 147 million and 148 million, used to calculate the Company’s GAAP and Non-GAAP diluted EPS, respectively. All unvested equity-based awards are antidilutive for GAAP due to reporting a net loss for the fourth quarter of 2025. For full year 2025 the Company’s weighted average diluted shares were 147 million.

Full Year 2026 Financial Guidance

For the full year 2026, Biogen expects a Non-GAAP diluted EPS guidance range as follows:
Full Year 2026 Guidance
Non-GAAP diluted EPS
$15.25 to $16.25

Total revenue is expected to decline by a mid-single digit percentage for 2026 as compared to 2025 as further declines in multiple sclerosis product revenue, excluding VUMERITY, are expected to be partially offset by increases in revenue from growth products.

For full year 2026 as compared to full year 2025, Biogen expects the gross margin percentage, and combined Non-GAAP R&D expense and Non-GAAP SG&A expense to be roughly consistent year-over-year. Biogen expects full year 2026 Non-GAAP effective tax rate to be between approximately 17% and 18%.

This guidance also assumes that foreign exchange rates as of January 30, 2026, will remain in effect for the remainder of the year, net of hedging activities.

Unless expressly stated above, this financial guidance does not include any acquired IPR&D, impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential healthcare reform, as all are hard to predict. Other important financial considerations will be provided on the conference call and webcast.

Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2026 that could cause any of these assumptions and expectations to change and/or actual results to vary from this financial guidance.

Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable without unreasonable effort to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from equity security investments; and the ultimate outcome of pending or future litigation. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Conference Call and Webcast

The Company’s earnings conference call for the fourth quarter will be broadcast via the internet at 8:30 a.m. ET on February 6, 2026 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

(Press release, Biogen, FEB 6, 2026, View Source [SID1234662525])

On February 5, 2026 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the fourth quarter and fiscal year 2025.

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"The Illumina team delivered a strong finish to 2025, marking a return to growth through disciplined execution against our strategy," said Jacob Thaysen, Chief Executive Officer of Illumina. "Momentum built in the second half of the year – especially in clinical markets, where adoption of NGS-based testing is expanding – reinforces our confidence as we enter 2026."

Fourth quarter results

GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
Q4 2025
Q4 2024
Q4 2025
Q4 2024
Revenue
$ 1,159 $ 1,104 $ 1,159 $ 1,104
Gross margin
65.5 % 65.9 % 67.0 % 67.4 %
Research and development (R&D) expense $ 239 $ 256 $ 238 $ 255
Selling, general and administrative (SG&A) expense $ 310 $ 279 $ 264 $ 271
Legal contingency and settlement $ 8 $ 18 $ — $ —
Operating profit
$ 202 $ 175 $ 275 $ 218
Operating margin 17.4 % 15.8 % 23.7 % 19.7 %
Tax provision $ 44 $ 70 $ 50 $ 47
Tax rate 11.6 % 37.9 % 19.5 % 23.7 %
Net income $ 334 $ 117 $ 208 $ 152
Diluted EPS $ 2.16 $ 0.73 $ 1.35 $ 0.95

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.

Capital expenditures for free cash flow purposes were $54 million for Q4 2025. Cash flow provided by operations was $321 million, compared to $364 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $267 million for the quarter, compared to $322 million in the prior year period. Depreciation and amortization expense was $67 million for Q4 2025. At the close of the quarter, the company held $1.63 billion in cash, cash equivalents and short-term investments.
Fiscal year results
GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
2025 2024 2025 2024
Revenue (b) $ 4,343 $ 4,332 $ 4,343 $ 4,332
Gross margin
66.1 % 67.1 % 68.2 % 68.6 %
R&D expense
$ 967 $ 988 $ 950 $ 982
SG&A expense
$ 1,086 $ 900 $ 1,009 $ 1,069
Goodwill and intangible impairment $ — $ 3 $ — $ —
Legal contingency and settlement $ 10 $ (456) $ — $ —
Operating profit
$ 807 $ 1,473 $ 1,004 $ 922
Operating margin 18.6 % 34.0 % 23.1 % 21.3 %
Tax provision $ 236 $ 229 $ 194 $ 204
Tax rate 21.7 % 20.4 % 20.5 % 23.6 %
Net income $ 850 $ 894 $ 756 $ 663
Diluted EPS $ 5.45 $ 5.61 $ 4.84 $ 4.16

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.
(b)Core Illumina revenue for 2024 included intercompany revenue of $15 million, which, prior to the spin-off of GRAIL in Q2 2024, was eliminated in consolidation.

Capital expenditures for free cash flow purposes were $148 million for fiscal year 2025. Cash flow provided by operations was $1.1 billion and free cash flow was $931 million. Depreciation and amortization was $270 million.

Key announcements since our last earnings release
•Completed the acquisition of SomaLogic, expanding Illumina’s multiomics portfolio and strengthening its position in scalable, NGS-enabled proteomics
•Introduced the Billion Cell Atlas, the first data product of the BioInsight business, to support AI-enabled drug discovery; AstraZeneca, Merck, and Eli Lilly are the first pharmaceutical partners
•Announced appointment of veteran genomics leader Eric Green, MD, PhD, as Chief Medical Officer to advance clinical genomics and expand access to precision medicine
•Achieved progress in China, where the Chinese Ministry of Commerce (MOFCOM) lifted the export ban on Illumina sequencers; the company remains on the Unreliable Entities List (UEL) in China, requiring approvals for instrument purchases

A full list of recent announcements can be found in the company’s News Center.

Financial outlook and guidance
The company provides forward-looking guidance on a non-GAAP basis, including on a constant currency basis for revenue and revenue growth rates. The company is unable to provide a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures because it is unable to predict with reasonable certainty the impact of items such as acquisition-related expenses, fair value adjustments to contingent consideration, gains and losses from strategic investments, potential future asset impairments, restructuring activities, the ultimate outcome of pending litigation, and currency exchange rate fluctuations without unreasonable effort. These items are uncertain, inherently difficult to predict, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the company is unable to address the significance of the unavailable information, which could be material to future results.

Conference call information
The conference call will begin at 1:30 pm Pacific Time (4:30 pm Eastern Time) on Thursday, February 5, 2026. Interested parties may access the live webcast via the Investor Info section of Illumina’s website or directly through the following link – View Source To ensure timely connection, please join at least ten minutes before the scheduled start of the call. A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

(Press release, Illumina, FEB 5, 2026, View Source [SID1234662506])

On February 5, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported a strategic reorganization that will eliminate headcount not essential to the Phase 3 trial and redefine the job descriptions for additional employees to reduce operating expenses while supporting the company’s focused strategy to rapidly advance the pivotal OVATION 3 Phase 3 clinical trial in women with newly diagnosed advanced ovarian cancer. The company also announced that Khursheed Anwer, Ph.D., MBA, Executive Vice President and Chief Scientific Officer, who has been at IMUNON for nearly 12 years and who led the initial development of the company’s proprietary TheraPlas platform technology, will retire effective February 20, 2026.

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"We have made significant progress and built strong momentum in 2025 with our lead IMNN-001 program, including reporting unprecedented Phase 2 clinical data at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting and in the peer-reviewed journal Gynecologic Oncology that showed a median 13-month increase in overall survival in combination with standard of care chemotherapy," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "Our highest priority now is to continue enrollment ahead of projections and to activate a full complement of clinical sites to complete this landmark research as quickly as possible. To support this, as we have always done, we have taken steps to improve our efficient use of resources. The flexibility of our workforce, a hallmark of Imunon’s ability to achieve its objectives, will ensure that we have the resources in place to build new levels of momentum in our Phase 3 trial in the months ahead."

"Dr. Khursheed Anwer’s decision to retire comes at a time of transition for the Company as we move to focus on the commercial potential of his career research, DNA-mediated immunotherapy. His scientific leadership, many contributions to advancing our business strategy, and lifelong commitment to patients have played a central role in our success and our goal to transform the broader cancer treatment landscape. On behalf of IMUNON and our Board of Directors, I would like to express our deep gratitude to Khursheed for his extraordinary contributions to cancer research, the medical community, and IMUNON over the last decade," added Dr. Lindborg.

"It has been a privilege for us to use the scientific knowledge to develop the TheraPlas platform and I am very proud of the achievements and groundbreaking innovations we have advanced since joining IMUNON in 2014," said Dr. Anwer. "Building on this work, the IMUNON team has the clear potential to deliver a novel and highly effective IL-12 immunotherapy to the thousands of women with advanced ovarian cancer who desperately need new treatment options."

About the OVATION 3 Study

OVATION 3 is IMUNON’s pivotal Phase 3 study of IMMN-001, an IL-12 gene-mediated immunotherapy, in women with advanced stage epithelial ovarian cancer. The study is supported with unprecedented overall survival (OS) data from a large, 112-patient, randomized Phase 2 study (OVATION 2) showing the following:

Median 13-month increase in OS (HR 0.70) and median 3-month increase in PFS (HR 0.79) in IMNN-001 treatment arm compared to standard of care alone.
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 poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy, which further enhanced outcomes, with median OS not yet reached in the IMNN-001 treatment arm as patients surpass 5 years since randomization in the trial compared to median OS of 37 months on standard of care (HR 0.42).

The results from the OVATION 2 Study have led to invitations to present data from the Phase 2 Study at both the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) annual meetings and in the peer-reviewed journal Gynecologic Oncology.

The OVATION 3 trial is a robustly designed clinical study with at least 95% statistical power on the primary endpoint of overall survival. The trial design includes two planned interim analyses of the primary endpoint, designed to allow for an accelerated timeline for FDA submission of an IMNN-001 BLA if the primary endpoint reaches statistical significance. OVATION 3 is currently enrolling patients at five clinical sites with up to 46 additional sites being considered for activation.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, FEB 5, 2026, View Source [SID1234662507])