On October 31, 2025 Alpha Fusion Inc. (Headquarters: Chiyoda-ku, Tokyo; CEO: Sunao Fujioka; hereinafter "Alpha Fusion") reported the initiation of a company-sponsored Phase I clinical trial (jRCT2031250472) of the alpha-emitting radiopharmaceutical af-001, which contains [211At]NaAt as its active pharmaceutical ingredient, in patients with differentiated thyroid cancer (papillary and follicular carcinoma).

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This clinical trial is designed based on the results of an investigator-initiated Phase I study conducted at The University of Osaka, and consists of Part Ia and Part Ib.

In Part Ia, the maximum tolerated dose (MTD) of a single intravenous administration of af-001 will be determined in patients with differentiated thyroid cancer who are refractory to or intolerant of standard therapies. Part Ib will evaluate the efficacy and safety of multiple intravenous administrations of af-001 to determine the recommended dose for Phase II trials in patients with differentiated thyroid cancer who have not received prior radioactive iodine (RAI) therapy (RAI-naïve).

Part Ia of the study will be conducted at the National Cancer Center Hospital East (Principal Investigator: Dr. Makoto Tahara, Chief, Department of Head and Neck Medical Oncology), and Part Ib will be conducted at multiple sites in Japan.

The clinical development of af-001 will proceed with the goal of obtaining regulatory approval for use in patients with RAI-naïve differentiated thyroid cancer (papillary and follicular carcinoma). If clinical efficacy and safety are indicated in this patient population, af-001 is expected to contribute as a next-generation radiopharmaceutical and as a novel therapeutic option for differentiated thyroid cancer.

af-001 is manufactured under GMP for investigational products in collaboration with the Kobe City Medical Center General Hospital (Director: Dr. Yasuki Kihara; Chuo-ku, Kobe City, Hyogo), and promptly delivered to the National Cancer Center Hospital East after production.

Regarding the initiation of this study, Sunao Fujioka, CEO of Alpha Fusion Inc., commented as follows:

"Based on the achievements of the investigator-initiated Phase I study in patients refractory or intolerant to standard therapies, we expect to maximize the potential of af-001 by confirming its safety and efficacy in RAI-naïve patients. Alpha Fusion is fully committed to advancing the clinical development of af-001, with the ultimate goal of providing outpatient alpha-emitting radiopharmaceutical therapy to more patients with thyroid cancer. In addition, we are pursuing multiple research and development pipelines utilizing At-211, aiming to create innovative radiopharmaceuticals for various types of cancer."

Background

RAI therapy is the standard treatment for differentiated thyroid cancer. However, in cases involving multiple metastases or insufficient therapeutic response despite clear iodine uptake, repeated RAI treatments may be required.

Moreover, due to radiation protection requirements in Japan, RAI therapy must be administered in shielded rooms, leading to hospitalization that imposes psychological stress on patients and financial burdens on hospitals. A survey in Japan reported an average waiting time of approximately 3.7 months, and 23% of facilities having a wait time exceeding six months (Survey Report on the Utilization of RI Therapy Rooms for Thyroid Cancer, 2022).

Given these challenges, there is a growing demand for patient-centric radiopharmaceuticals that can achieve potent tumor-reducing effects in an outpatient setting.

About At-211 (af-001)

af-001 is a radiopharmaceutical containing astatine-211 (At-211) as its active pharmaceutical ingredient. It is selectively taken up by differentiated thyroid cancer cells through the sodium/iodide symporter (NIS) and exerts a cytotoxic effect by emitting alpha particles.

At-211 emits alpha particles with higher energy than beta particles, inducing double-strand DNA breaks in cancer cell nuclei and leading to tumor regression.
Because alpha particles have a very limited range (approximately several tens of micrometers), af-001 can deliver strong therapeutic effects while minimizing damage to surrounding normal tissues. Consequently, substituting RAI with the limited-range alpha emitter af-001 may enable outpatient-based treatment.

With these unique characteristics, af-001 is being developed as a next-generation radiopharmaceutical and a novel treatment for differentiated thyroid cancer, offering both efficacy and safety.

Results of the Investigator-Initiated Clinical Trial and Positioning of the Company-Sponsored Trial

Prior to this company-sponsored trial, an investigator-initiated Phase I clinical trial (Alpha-T1 Trial) of [211At]NaAt, identical in composition to af-001, was conducted at The University of Osaka under the supervision of Dr. Tadashi Watabe, Principal Investigator (NCT05275946).

The study indicated the safety and tolerability of [211At]NaAt in patients with differentiated thyroid cancer refractory or intolerant to standard therapies. Additionally, the study reported a ≥50% reduction in thyroglobulin concentration (a tumor marker) and cases of disappearance of 131I uptake on imaging.

The present company-sponsored trial aims to evaluate the efficacy and safety of af-001 (identical in pharmaceutical ingredient to TAH-1005, [211At]NaAt) in RAI-naïve patients, with the objective of determining the recommended dose for subsequent Phase II studies.

(Press release, Alpha Fusion, OCT 31, 2025, View Source [SID1234659210])

On October 31, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy in oncology and inflammation & immunology (I&I), reported that it will present a late-breaking oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting, taking place November 5–9, 2025, in National Harbor, Maryland.

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The presentation will include initial Phase 2 monotherapy results from the ongoing STARt-001 trial, which is evaluating Invikafusp alfa in tissue-agnostic, tumor mutational burden-high (TMB-H) advanced cancers. The findings underscore Invikafusp alfa’s potential to selectively activate unique T cell subsets, leading to reinvigoration of anti-tumor immunity across a broad range of solid tumors.

Presentation Details:

Title: Initial monotherapy clinical activity of invikafusp alfa, a first-in-class TCR β-chain-targeted bifunctional antibody, in tissue-agnostic, TMB-H patients from STARt-001, a Phase 1/2 trial
Conference: SITC (Free SITC Whitepaper) Annual Meeting 2025
Abstract Number: LBA1316
Session Title: Clinical Oral Abstract Session 1
Session Date and Time: Friday, November 7, 2025, 11:30 AM ET
Presenter: Aurélien Marabelle, MD, PhD (Gustave Roussy Cancer Center, France)
Marengo will also present data from its TriSTAR T cell engager platform in addition to four preclinical analyses in collaboration with the National Cancer Institute (NCI) exploring rational combinations of Invikafusp alfa with standard-of-care modalities.

(Press release, Marengo Therapeutics, OCT 31, 2025, View Source [SID1234659211])

On October 31, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or the "Company"), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported that it has entered into a securities purchase agreement with a new long-term fundamental investor for the purchase and sale of 5,000,000 shares of common stock at a purchase price of $0.80 per share, in a registered direct offering, for gross proceeds of approximately $4 million, before deducting placement agent commissions and other offering expenses. The offering is expected to close on or about November 3, 2025, subject to the satisfaction of customary closing conditions.

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The Company expects to use the net proceeds from the offering for the advancement of their clinical trials, working capital and general corporate purposes. Upon closing of the offering, the Company expects it will have cash runway until the end of the first quarter of 2027.

A.G.P./Alliance Global Partners is acting as the sole placement connection with the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333- 280681) which was declared effective by the Securities and Exchange Commission (the "SEC") on July 11, 2024. The offering is being made only by means of a prospectus which is part of the effective registration statement. A prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Additionally, when available, electronic copies of the prospectus supplement and the accompanying base prospectus may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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, Intensity Therapeutics, OCT 31, 2025, View Source [SID1234659212])

On October 30, 2025 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the third quarter of fiscal year 2025.

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"I am pleased to announce that the Illumina team delivered Q325 results that exceeded the high-end of our guidance range for revenue and earnings, driven by revenue acceleration in clinical, our largest market segment," said Jacob Thaysen, Chief Executive Officer. "During the quarter, we returned to growth ex-China and are executing on our strategic pillars that support our long-range financial targets."

Third quarter results

GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
Q3 2025 Q3 2024 Q3 2025 Q3 2024
Revenue
$ 1,084 $ 1,080 $ 1,084 $ 1,080
Gross margin
67.6 % 68.9 % 69.2 % 70.5 %
Research and development (R&D) expense $ 229 $ 253 $ 228 $ 249
Selling, general and administrative (SG&A) expense $ 277 $ 239 $ 256 $ 268
Legal contingency and settlement $ — $ (488) $ — $ —
Operating profit
$ 227 $ 741 $ 265 $ 244
Operating margin 21.0 % 68.6 % 24.5 % 22.6 %
Tax provision $ 70 $ 77 $ 47 $ 48
Tax rate 31.8 % 10.8 % 18.6 % 21.0 %
Net income $ 150 $ 642 $ 206 $ 181
Diluted EPS $ 0.98 $ 4.03 $ 1.34 $ 1.14

(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 $31 million for Q3 2025. Cash flow provided by operations was $284 million, compared to $316 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $253 million for the quarter, compared to $284 million in the prior year period. Depreciation and amortization expense was $67 million for Q3 2025. At the close of the quarter, the company held $1.28 billion in cash, cash equivalents and short-term investments.

Key announcements since our last earnings release
•Launched 5-base solution, enabling simultaneous genomic and epigenomic insights
•Introduced Constellation mapped read technology, uncovering hard-to-see genomic variants in GeneDx pilot
•Launched BioInsight, a new business to accelerate technology and data-driven discovery initiatives
•Expanded personalized cancer care efforts through new pharmaceutical development partnerships enabled on the TruSight Oncology (TSO) Comprehensive genomic profiling test
•Welcomed Alnylam Pharmaceuticals to the Alliance for Genomic Discovery (AGD), broadening the consortium’s diverse clinical genomic dataset and utilizing it to inform development of ‘gene silencing’ medicines
•Introduced Illumina Protein Prep, driving deeper proteomic insights to enhance drug discovery and development, with a streamlined sample-to-insights solution for discovery and clinical research

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, October 30, 2025. 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, OCT 30, 2025, View Source [SID1234657151])

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])