On July 30, 2025 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next generation therapeutics for cancer patients, reported that clinical data from the dose expansion cohort of the Phase 1/2 trial of solnerstotug alone and in combination with Libtayo (cemiplimab), Regeneron’s PD-1 inhibitor, will be presented in a mini oral session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, being held October 17-21, 2025 in Berlin, Germany (Press release, Sensei Biotherapeutics, JUL 30, 2025, View Source [SID1234654642]).

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Presentation Details:

Title: Results from a Phase 1 expansion cohort of solnerstotug (pH-selective anti-VISTA antibody) combined with cemiplimab in patients with advanced solid tumors resistant to prior PD-(L)1 therapy
Presenter: Dr. Kyriakos Papadopoulos, Co-Director of Clinical Research at START, San Antonio
Abstract Number: 3933
Presentation Date & Time: Friday, October 17, 2025 from 2:00 – 3:30 CEST

On July 30, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported the entry into definitive agreements to exercise certain outstanding warrants to purchase up to an aggregate of 928,596 shares of common stock of the Company originally issued in December 2024 and January 2025, having exercise prices between $2.00 and $3.00 per share (Press release, Phio Pharmaceuticals, JUL 30, 2025, View Source [SID1234654641]). Warrants to purchase 100,000 shares of common stock at the existing exercise price of $2.00 per share will be exercised at their existing exercise price of $2.00 per share and warrants to purchase 828,596 shares of common stock will be exercised at a reduced exercise price of $2.485 per share. The shares of common stock issuable upon exercise of the warrants are registered pursuant to effective registration statement on Form S-1 (No. 333-284381). The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $2.5 million, prior to deducting placement agent fees and offering expenses.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash and the payment of additional $0.125 per new unregistered warrant (additional $232,149 in the aggregate, which are included in the gross proceeds to the Company), the exercising holders will receive new unregistered warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The new warrants will be exercisable for an aggregate of up to 1,857,192 shares of common stock, at an exercise price of $2.485 per share and will be immediately exercisable upon issuance and (i) will have a term of twenty-four months with respect to new warrants to purchase up to 1,538,596 shares of common stock and (ii) will have a term of five years with respect to new warrants to purchase up to 318,596 shares of common stock, in each case, following the effective date of the resale registration statement registering the shares of common stock issuable upon exercise of the new warrants.

The offering is expected to close on or about July 28, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or 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 jurisdiction.

On July 30, 2025 PharmaMar Group (MSE: PHM) reported an 18% increase in total revenue in the first six months of the year, reaching €95.3 million. Recurring revenue, resulting from the sum of net sales plus royalties received from our partners, grew by 5% as of June 30th, 2025, reaching €72.5 million (Press release, PharmaMar, JUL 30, 2025, View Source [SID1234654640]).

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At the end of the first half of this year, total oncology sales amounted to €45.8 million, representing a 9% increase over the same period last year. These sales include commercial sales of Yondelis (trabectedin) in Europe, sales of raw materials to our partners for both trabectedin and lurbinectedin, distribution of Zepzelca (lurbinectedin) under the compassionate use program ("accès compassionnel"), and commercial sales of lurbinectedin in Switzerland. The increase, during the first half of the year, was driven by the positive performance of lurbinectedin revenues in Europe, where revenues recorded under the compassionate use program – mainly in France – increased by 26% to €15.4 million, as well as commercial sales of lurbinectedin in Switzerland amounting to €8.4 million, representing a growth of 75% compared to the same period in 2024.

At the end of the first half of 2025, oncology royalty income stood at €26.4 million, compared to €26.5 million recorded on June 30th, 2024. This amount corresponds mainly to royalties received from sales of lurbinectedin by our partners Jazz Pharmaceuticals in the US and Luye in China, which together amount to €21.0 million[1], as well as royalties from sales of trabectedin by our partners in the US and Japan, amounting to €5.4 million.

Regarding non-recurring income from licensing agreements, at the end of the first half of 2025, this increased by 87% to €23.0 million, compared to €12.3 million recorded on June 30th, 2024. The increase is driven by the lurbinectedin licensing agreement for Japan signed with Merck for €20.7 million, together with €2.0 million in deferred revenue from the 2019 agreement signed with Jazz Pharmaceuticals in relation to lurbinectedin.

During the first half of the year, €14.7 million was recognized as other net income/(expenses) corresponding to the completed portion of the Syoligo project, for which Sylentis was awarded a grant under the European IPCEI (Important Projects of Common European Interest) ‘Med4Cure’ program for the period January 2023 to August 2026. The total amount of the grant is €21.1 million.

The PharmaMar Group’s investment in R&D amounted to €47.5 million, representing a 7% reduction compared to the first half of 2024, due to the completion of two Phase 3 clinical trials.

Of the total R&D investment for the period, the oncology segment recorded €44.8 million, compared to €46.7 million as of June 30th, 2024. This variation is mainly due to the completion in December 2024 of recruitment for the Phase 3 LAGOON clinical trial with lurbinectedin in small cell lung cancer.

For its part, the RNAi segment recorded €2.7 million in R&D as of June 30th, 2025, compared to €4.6 million for the same period last year. This variation is due to the completion in the first months of 2024 of the Phase 3 PIVO1 clinical trial with tivanisiran for dry eye.

In addition, the Company continues to invest in the clinical development of other molecules at earlier stages. In this regard, two Phase 2 clinical trials are underway with ecubectedin, as well as Phase 1 clinical trials with PM534 and PM54, all for the treatment of solid tumors.

As a result, the PharmaMar Group’s EBITDA reached €25.1 million as of June 30th, 2025, compared to -€0.8 million in the first half of 2024.

The Group’s net profit as of June 30th, 2025, stands at €19.4 million, compared to €3.5 million in the same period last year.

At the end of the first half of the year, the PharmaMar Group had cash and cash equivalents of €128.9 million, with a total financial debt of €48.3 million.

PharmaMar management will host a conference call and webcast for investors and analysts on July 31st, 2025, at 13:00 CET (07:00 AM, New York time) as follows: The numbers to connect to the teleconference are +34 91 901 16 44 (from Spain), +1 646 664 1960 (from USA or Canada), and +44 20 3936 2999 (other countries). Participants’ access code: 883194. Interested parties can also follow the conference call live via the following link: View Source

The recording of the teleconference will be available for thirty days and it can be accessed on PharmaMar’s website by visiting the Events Calendar section of the Company’s website www.pharmamar.com

On July 30, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has received a Notice of Intent to Grant for the European patent application titled, "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE (Press release, Moleculin, JUL 30, 2025, View Source [SID1234654639])." Such grant should solidify the Company’s European Union exclusivity of Annamycin, also known by its non-proprietary name of naxtarubicin, with the potential to become the first non-cardiotoxic anthracycline.

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The grant is subject to payment of fees and completion of final amendments and formalities. When issued, the patent claims will cover methods of making a preliposomal Annamycin lyophilizate with improved stability and high purity, with a base patent term currently extending until into 2040, subject to extension to account for time required to fulfill requirements for regulatory approval. Moleculin’s novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline to be approved and is currently being developed for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets). Additional preclinical studies performed at a world-renowned cancer center indicate Annamycin may be a potential treatment for many other types of cancers. The new chemical entity uses a unique lipid-based delivery technology and has shown the potential to be used in a wide range of cancers. In addition to the newly expected European patent and previously issued U.S. patents, Moleculin has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.

Walter Klemp, Chairman and CEO of Moleculin, said, "Our preliposomal formulation for Annamycin not only improves the stability and usability of Annamycin, but also creates a scalable platform that has the potential to be a catalyst for how lipophilic oncology drugs are delivered. We are pleased to add this newly granted European patent to our global intellectual property portfolio and believe it provides further validation of Annamycin’s potential. The current patent portfolio includes patents and patent applications with claims to methods of making our preliposomal Annamycin and liposomal Annamycin suspension as well as the resulting compositions for use in the treatment of cancers in the US, Europe, China, and India, among others. We remain committed to fortifying our global patent protection for Annamycin and advancing the development of this potentially transformative therapeutic candidate for hard-to-treat tumors."

Annamycin (naxtarubicin), currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.

On July 30, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, reported that the first patient has been dosed in the pivotal Phase 3 OVATION 3 Study evaluating the Company’s lead candidate, IMNN-001, for the treatment of women with newly diagnosed advanced ovarian cancer (Press release, IMUNON, JUL 30, 2025, View Source [SID1234654638]). The first patient was dosed by Melanie K. Bergman, M.D., FACOG, Gynecologic Oncologist with Providence Medical Group at Providence Health in Spokane, Washington.

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"IMNN-001 represents a potentially transformative therapy that, in combination with standard of care chemotherapy, may make a meaningful difference in the lives of women facing a new devastating diagnosis of advanced ovarian cancer," said Dr. Bergman. "IMNN-001 has shown significant therapeutic potential in clinical trials thus far, including consistent overall survival benefit across multiple treatment groups. We are pleased to be involved in the Phase 3 study and support its clinical development to further validate its safety and efficacy for women who currently have no effective options besides chemotherapy and surgery."

"It is very encouraging to see the strong interest and enthusiasm among the scientific community in our novel IMNN-001 program. Dosing the first patient is an important step forward and we expect to build on this momentum in the coming months as patient enrollment activities continue to accelerate in the OVATION 3 Study," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "We have great urgency around this program because patients do not have any other options besides the standard of care, which includes neoadjuvant and adjuvant chemotherapy and surgery. We have the resources in place needed to advance IMNN-001 efficiently and we are well positioned to fulfill our promise to help improve the standard of care for thousands of women worldwide with advanced ovarian cancer."

The Phase 3 OVATION 3 trial is designed to 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 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, 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.

In June 2025, IMUNON presented unprecedented positive overall survival data from the Phase 2 OVATION 2 Study of IMNN-001 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and in the peer-reviewed journal Gynecologic Oncology. Published OVATION 2 data showed that treatment with IMNN-001 plus SoC chemotherapy in women with newly diagnosed advanced ovarian cancer resulted in consistent, clinically meaningful improvements in several key endpoints across treatment groups, including overall survival, progression-free survival, chemotherapy response score and surgical response score, with a favorable safety profile. IMUNON also presented new translational data at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress demonstrating 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.

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response score.

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 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.