On October 30, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC), a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat cancer patients by leveraging its novel PDAOAI platform and deep knowledge in nanomedicines and the tumor microenvironment, reported that Sapu Nano will be featuring its investigational intravenous Deciparticle everolimus (Sapu003) have been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), to be held December 9-12, 2025, at the Henry B. Gonzalez Convention Center, San Antonio, Texas. Sapu Nano is the developer of DeciparticleTM and is part of Sapu family of companies and a joint venture between Oncotelic (OTCQB:OTLC) and Dragon Oversea.

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Sapu003 is a novel Deciparticle formulation of everolimus for intravenous administration, designed to overcome the pharmacologic limitations of oral mTOR inhibitors (Afinitor), including poor bioavailability, dose-limiting toxicity, and restricted tumor penetration. Collectively, the accepted abstracts highlight the clinical rationale, molecular biomarkers, and pharmacokinetic justification supporting the ongoing Phase 1 trial of Sapu003 in hormone receptor-positive (HR )/HER2 metastatic breast cancer and RCC and NET.

Renal Cell Carcinoma (RCC): FDA approved oral Everolimus for advanced RCC after failure of sunitinib and/or sorafenib. Approval was based on RECORD-1 randomized phase III (everolimus 10 mg PO daily vs placebo + best supportive care) showing a PFS benefit (median 4.9 vs 1.9 mo; HR 0.33).
Pancreatic NET (pNET): FDA approved Everolimus for Pancreatic NET (pNET). Approval was based on RADIANT-3 (everolimus vs placebo in progressive, advanced pNET), which significantly prolonged PFS.
GI and Lung NET (lNET): FDA approved Everolimus for GI & lung NET. Approval was based on RADIANT-4 (non-functional, well-differentiated, nonresectable/metastatic GI or lung NET), showing a PFS benefit.
Patients and Investigators – please contact Ingenu for trial participation.

Australia Headquarters
22/456 St Kilda Rd
Melbourne 3004 VIC
Australia
Phone: 1300 633 226
Email: [email protected]

Presentation Session:
Thursday, December 11, 2025 | 5:00 PM – 6:30 PM CST

Abstract Number Presentation Number Title
1834 PS4-04-04 High RICTOR / Low RPTOR Gene Expression Signature as a Predictive Biomarker for Intravenous Everolimus Nanoparticle (Sapu003): Rationale for the First in Human Trial
1702 PS4-04-21 Deciparticle Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing
1811 PS4-06-05 Sapu003: Everolimus for Injection – Pharmacokinetic Rationale for Phase I Evaluation in HR /HER2 Metastatic Breast Cancer

The studies were conducted in collaboration with Southern Oncology Clinical Research Unit (SOCRU), Ingenu CRO, and Medicilon, and reflect a coordinated clinical-translational effort bridging molecular biomarker discovery, pharmacokinetic modeling, and scalable GMP manufacturing of Deciparticle everolimus.

(Press release, Oncotelic, OCT 30, 2025, View Source [SID1234657169])

On October 30, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix, will participate in fireside chats at the following investor conferences in November.

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Stifel 2025 Healthcare Conference, New York, NY
Thursday, November 13, 2025, from 9:20 – 9:50 a.m. ET
Jefferies Global Healthcare Conference – London, UK
Wednesday, November 19, 2025, from 11:00 – 11:25 a.m. GMT
The fireside chats will be webcast live and can be accessed via a link in the Investors section of the Nurix website. The archived webcasts will be available for 30 days after the event.

(Press release, Nurix Therapeutics, OCT 30, 2025, View Source [SID1234657168])

On October 30, 2025 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported that Michael A. Metzger, Chief Executive Officer, as well as members of the Syndax management team, will participate in the following upcoming investor conferences:

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UBS Global Healthcare Conference 2025 with a fireside chat on Monday, November 10, 2025, at 11:00 a.m. ET.
Guggenheim Second Annual Healthcare Innovation Conference with a fireside chat on Tuesday, November 11, 2025, at 3:00 p.m. ET.
Stifel 2025 Healthcare Conference with a fireside chat on Thursday, November 13, 2025, at 10:00 a.m. ET.
Jefferies 2025 London Healthcare Conference with a fireside chat on Thursday, November 20, 2025, at 10:00 a.m. GMT/ 5:00 a.m. ET.
A live webcast of the fireside chats will be available in the Investor section of the Company’s website at www.syndax.com, where a replay will also be available for a limited time.

(Press release, Syndax, OCT 30, 2025, View Source [SID1234657166])

On October 30, 2025 REGiMMUNE Limited ("REGiMMUNE" or "the Company"), a clinical stage biopharma company developing novel immune therapeutics targeting regulatory T cells (Treg), reported preclinical data of its antibody program at the meeting of Antibody Engineering & Therapeutics Asia 2025 in Kyoto, Japan from Oct. 20 – 22.

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REGiMMUNE, while pursuing RGI-2001 in advanced clinical development for (Graft vs Host Disease (GvHD), armed with our long-time expertise in human immunology and Treg cells, has been actively developing its therapeutic antibody program. This pipeline currently includes RGI-6004 and AB01, both targeting tumor infiltrating Treg cells, reflecting the two strategies of therapeutic modulation of Treg cells, namely, depleting vs silencing, and AB08-H1 targeting a surface marker shared by blood-borne and solid malignancies.

The presentation in Kyoto included RGI-6004 and AB08-H1. RGI-6004 was developed to highly selectively target tumor infiltrating Treg cells while maintaining all other immune effector cells intact to alleviate the immune suppression in the tumor microenvironment, and consequently enhance anti-cancer immunity. AB08-H1 is an antibody developed to kill malignant cells of Hodgkin & Non-Hodgkin diseases and solid cancer cells via a unique target.

RGI-6004, an Afucosylated Antibody to Target GARP/LAP-TGFβ1 for Selective Depletion of Activated Tregs. RGI-6004, a fully human IgG1 against GARP/Latent-TGFb1 complex, designed to deplete tumor infiltrating activated Treg cells. The antibody specifically binds to activated human Treg cells with high affinity, but none to non-activated Treg cells, and CD4+ and CD8+ T effector cells. The antibody recognizes tumor infiltrating Treg cells in clinical solid tumor tissues. Its afucosylated version highly selectively depletes activated Treg cells with a significantly enhanced efficacy of ~10 pM, but none of CD4+ and CD8+ effector T cells, while granzyme B induction & proliferation of CD4+ and CD8+ effector T cells are not affected. RGI-6004 has minimal impact on platelets (counts and degranulation), minimal binding to major immune cells, nor observable impact on hematological profile of normal human blood. In cynomolgus monkey, its t1/2 is shown to be ~10 days, while its clinical hematology, coagulation, blood chemistry, immunophenotyping in peripheral blood, serum cytokine analysis, and pathology, does not demonstrate safety alarms. In sum, the behavior of RGI-6004 highlights the potential as a next-generation Treg-depleting agent in cancer immunotherapy.

AB08-H1, A humanized antibody that directly kills cancer target cells without ADCC and CDC. AB08-H1 is a humanized IgG that specifically targets pan MHC II (synonym for HLA II, human leukocyte antigen). Upon binding to the cell surface MHC class II molecule, the antibody induces homotypic aggregation, lysosomal membrane permeabilization, and ultimately cell lysis of the target malignant cells directly without the involvement of ADCC and CDC. REGiMMUNE overcame the original bottleneck of protein production of the humanized IgG, developed a high yield method to manufacture it in mammalian cells. As MHC Class II molecules are found highly expressed on lymphoid malignant cells, and have been increasingly recognized to express highly in major solid cancer cells, AB08-H1 is expected to treat various types of lymphoid malignancies (Hodgkin and Non-Hodgkin lymphomas), and solid cancers.

REGiMMUNE is encouraged by the recent news of Nobel Prize in Physiology granted to Dr. Shimon Sakaguchi and others, for their works on Treg cells. We are pleased to see that the fundamental roles of Treg cells in autoimmune disease, GvHD, cancer, and infectious disease are recognized in highest profile. REGiMMUNE is committed to developing therapeutics with, as Dr. Shimon Sakaguchi well put it, Treg-up strategies vs Treg-down strategies.

(Press release, REGimmune, OCT 30, 2025, View Source [SID1234657165])

On October 30, 2025 PharmaMar Group (MSE: PHM) reported a 3% increase in total revenue during the first nine months of this year, reaching €130.9 million. Recurring revenue, resulting from the sum of net sales plus royalties received from our partners, grew by 6% to €105.6 million as of September 30th, 2025.

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As of September 30th this year, total sales in oncology amounted to €62.4 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, both trabectedin and lurbinectedin, and the positive performance of Zepzelca (lurbinectedin) in Europe, whose revenues increased by 34.7% in the first nine months of this year, reaching €31.4 million. Of particular note are revenues from lurbinectedin under the compassionate use program—mainly in France—which increased by 22% to €21.8 million, and commercial sales of Zepzelca in Switzerland, which amounted to €9.6 million, representing growth of 76% compared to the same period in 2024.

As of September 30th, 2025, oncology royalty income grew by 2% to €43.2 million. This amount corresponds mainly to royalties received from sales of lurbinectedin by our partners Jazz Pharmaceuticals and Luye Pharma, which together amounted to €35.0 million[1].. Added to this amount are royalties from sales of trabectedin by our partners in the US and Japan, totaling €8.2 million.

Non-recurring income from licensing agreements amounted to €25.3 million at the end of the first nine months of 2025, compared to €26.9 million in the same period last year. Noteworthy is the lurbinectedin licensing agreement for Japan signed with Merck for €21.0 million in April 2025, together with €3.0 million in deferred revenue from the 2019 agreement signed with Jazz Pharmaceuticals in relation to lurbinectedin. In the current fiscal year, the annual revenue recognition for the latter agreement is estimated at €4 million, while the total amount to be recognized in the previous fiscal year was approximately €23 million. Of the total €300 million in revenue received in 2020 in relation to the agreement signed with Jazz Pharmaceuticals, 94% of the total has been recognized in the income statement.

PharmaMar group’s investment in R&D stood at €69.6 million as of September 30, compared to €75.98 million for the first nine months of the previous year.

Of the total R&D investment for the period, the oncology segment recorded €66.0 million, compared to €70.0 million as of September 30, 2024. This variation is mainly due to the completion, in December 2024, of recruitment for the LAGOON Phase III clinical trial with lurbinectedin in small cell lung cancer.

The Company continues to invest in the clinical development of other molecules in earlier Phase I stages with PM534 and PM54, all for the treatment of solid tumors.

The RNAi segment recorded €3.6 million in R&D as of September 30, 2025, compared to €6.0 million in the same period of the previous year. This variation is due to the completion in the first months of 2024 of the PIVO1 Phase III clinical trial with tivanisiran for dry eye.

As of September 30th, 2025, the Group’s EBITDA reached €23.1 million, compared to €6.3 million in the same period of the previous year.

As a result of all the above, the PharmaMar Group doubled its net profit compared to the same period last year, reaching €15.3 million vs. €7.4 million.

(Press release, PharmaMar, OCT 30, 2025, View Source [SID1234657164])