On September 25, 2025 Celyad Oncology (Euronext: CYAD) (the "Company"), reported its financial results for the first half year 2025 ended June 30, 2025 (Press release, Celyad, SEP 25, 2025, View Source [SID1234656232]).

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First Half 2025 financial review

As of June 30, 2025, the Company’s Treasury position amounted to €0.8 million.

After due consideration of detailed budgets and estimated cash flow forecasts for the years 2025 and 2026, the Company projects that its existing cash and cash equivalents will be sufficient to fund its estimated operating and capital expenditures into the fourth quarter of 2025.

Key financial figures for first half 2025, compared with the first half of 2024 and full year 2024, are summarized below:

Selected key financial figures (€ millions) Half Year 30 June 2025 Half Year 30 June 2024 Full Year 31 December 2024
Revenue – – 0.2
Research and development expenses (2.1) (1.5) (3.2)
General and administrative expenses (1.7) (1.7) (3.2)
Other income/(expenses) 0.1 0.2 0.4
Operating loss (3.7) (3.1) (5.9)
Loss for the period/year (3.7) (3.0) (5.9)
Net cash used in operations (3.3) (2.8) (5.7)
Cash and cash equivalents 0.8 6.2 4.2

Research and Development (R&D) expenses were €2.1 million in June 2025 as compared to €1.5 million during the same period in 2024, an increase of €0.6 million. The increase in the Company’s R&D expenses was primarily driven by the increase of the IP costs related to the licensing activities as well as the increase of the expenses linked to the redevelopment of the catheter.

General and Administrative (G&A) expenses remained stable with €1.7 million in June 2025 as in June 2024.

Net loss for the first half of 2025, was €3.7 million, or €(0.09) per share, compared to a net loss of €3.0 million, or €(0.07) per share, for the same period in 2024.

Net cash used in operations was €3.3 million for the first half of 2025 compared to €2.8 million for the first half of 2024. The increase of €0.5 million was primarily driven by the global increase of IP activities and catheter development costs.

As of June 30, 2025, the Company had cash and cash equivalents of €0.8 million. No capital increase occurred in the first half of 2025. The total number of basic shares outstanding was 41.4 million like in December 31, 2024.

The interim financial report for first half 2025 of the Company can be found on our website: View Source

On September 25, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the Japan Patent Office has issued a patent covering the Company’s proprietary use of Ampligen (Rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer (Press release, AIM ImmunoTech, SEP 25, 2025, View Source [SID1234656229]).

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"We remain committed to strengthening our global intellectual property protection for Ampligen as we continue to advance its clinical development. This Japan patent – which does not expire until December 20, 2039 – further strengthens our intellectual property portfolio in one of the world’s largest oncology markets and enhances exclusivity around combination therapies that address high-need cancer indications. Importantly, this patent further reinforces our ability to advance our clinical pipeline, secure strategic collaborations, and capture value in the growing global immuno-oncology sector. The scope of this patent enhances the value for any future strategic oncology transactions," AIM ImmunoTech CEO Thomas K. Equels stated.

The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad, encompassing multiple cancer types, including pancreatic cancer, skin cancer, colorectal cancer, ovarian cancer, melanoma, breast cancer/triple negative breast cancer, head and neck tumors, bladder cancer, renal cell carcinoma, and lung cancer. The claims also capture specific dosing regimens, administration routes, and synergistic therapeutic effects observed when Ampligen is combined with checkpoint inhibitors.

AIM also holds a U.S. patent (expires August 9, 2039) for methods involving use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab).

The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment. AIM believes this novel approach could revolutionize the treatment landscape for cancers that have historically been challenging to treat, such as pancreatic cancer and advanced recurrent ovarian cancer. In fact, in collaboration with AstraZeneca, Ampligen is in a Phase 2 clinical trial combined with AstraZeneca’s durvalumab (an anti-PD-L1) for the treatment of metastatic pancreatic cancer. AIM recently released a DURIPANC Mid-Year Interim Clinical Progress Update showing promising signs of superior Progression-Free Survival and Overall Survival, as well as no significant toxicity.

Similarly, a Phase 2 study in collaboration with Merck Sharp & Dohme LLC in advanced recurrent ovarian cancer combing Ampligen with Keytruda has been completed and we expect the final data report within the next two months.

On September 24, 2025 Lantheus Holdings, Inc. (NASDAQ: LNTH) and GE HealthCare (NASDAQ: GEHC) reported an exclusive licensing agreement for GE HealthCare to develop, manufacture, and commercialize Lantheus’ piflufolastat F18 (PYLARIFY in U.S. market) in Japan for prostate cancer diagnostics and companion diagnostic use. PYLARIFY is used for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

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The agreement includes the transfer of regulatory dossiers, manufacturing competencies and technical support to enable GE HealthCare to drive clinical development in Japan, towards potential regulatory submissions and commercial launch. GE HealthCare will draw on its extensive manufacturing network and R&D expertise following its acquisition in March 2025 of Nihon Medi-Physics Co., Ltd. (NMP), a leading radiopharmaceutical company in Japan.

Prostate cancer is the fourth most common cancer worldwide, with Japan recording the third highest number of cases in the world in 2022, after the U.S. and China.1

"This partnership is expected to meaningfully extend the reach of our diagnostic imaging agent in key international markets," said Brian Markison, CEO of Lantheus. "GE HealthCare and NMP’s deep regional expertise will enable us to advance the detection and care of prostate cancer and drive significant impact in an important market."

"Bringing targeted PET imaging agents to new geographies supports Lantheus’ Purpose to Find, Fight and Follow disease to deliver better patient outcomes," added Jean-Claude Provost, Chief Science Officer at Lantheus. "By aligning with GE HealthCare, we’re addressing a critical clinical need in Japan, and helping to lay the foundation for a more personalized approach to prostate cancer detection, diagnosis and monitoring."

"This collaboration represents a strategic advancement for GE HealthCare as we expand our pipeline of radiopharmaceuticals and continue to deliver on our commitment to improving patient access to innovative diagnostics," said Kevin O’Neill, President & CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare and President of NMP. "Working alongside Lantheus gives us access to one of the best-in-class PET imaging agents that is already approved in the U.S. and in Europe, and if approved locally, could provide clinicians and their patients with a powerful new option for detecting and monitoring prostate cancer."

Under the terms of the agreement, GE HealthCare will pay Lantheus an upfront license fee, development milestones and tiered royalties based on product sales in Japan. The companies will also establish a Joint Steering Committee to oversee development and commercialization activities.

Piflufolastat F 18 (also known as 18F-DCFPyL, PYLARIFY or PYLCLARI) was FDA-approved in 2021 and is marketed as PYLARIFY. PYLARIFY has made a profound impact on the lives of patients battling prostate cancer and is the number one utilized PSMA PET imaging agent in the U.S. It is a proven diagnostic backed by real-world experience, including in over 500,000 scans across 48 states. In 2023, it was approved in the European Union and is marketed there as PYLCLARI. The European rights were licensed to Curium from Progenics Pharmaceuticals, Inc., a Lantheus company.

About PYLARIFY (piflufolastat F 18) Injection
PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PYLCLARI) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.

PYLARIFY (piflufolastat F 18) Injection in the U.S.

Indication

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Important Safety Information

Contraindications
None.

Warnings and Precautions

Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please read the accompanying full Prescribing Information also available at PYLARIFY.com.

(Press release, Lantheus, SEP 24, 2025, View Source [SID1234662958])

On September 24, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and TerThera BV, a leading provider of GMP-grade Terbium-161, reported a supply agreement for non-carrier-added (n.c.a.) Terbium-161 (Tb-161), a novel medical radioisotope with distinct chemical properties and emerging potential in radiopharmaceutical therapy. Under the terms of the agreement, TerThera will supply Good Manufacturing Practice (GMP)-compliant n.c.a. Tb-161 to ITM to support the development of its Terbium-based pipeline candidates, complementing ITM’s established manufacturing capabilities in cooperation with the Paul Scherrer Institute (PSI).

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"Driving innovation across isotopes, targeting molecules and cancer indications keeps ITM at the forefront of the rapidly evolving radiopharmaceutical industry," said Dr. Andrew Cavey, CEO of ITM. "We see strong potential in Terbium-161 as a critical new isotope for targeted radiopharmaceutical therapy, and our partnership with TerThera will allow us to advance its use in our pipeline. With supply of Terbium-161, we are well-positioned to harness its radiation properties to deliver meaningful advances for people living with cancer."

Currently, Tb-161-based radiopharmaceuticals are being clinically investigated for various types of cancers. Tb-161 is gaining attention in the radiopharmaceutical field for its unique emission profile. Like Lu-177, it emits medium-range beta particles and has a similar half-life. However, Tb-161 also emits low-energy Auger and internal conversion electrons, delivering highly localized radiation that can effectively target isolated cancer cells and micro-metastases with minimal off-target effects.

"As industry interest in Terbium-161 grows, a safe and sustainable supply of this radionuclide is crucial to support the development of new treatment options and strategies and we see this as our core mission," added Philippe van Overeem, CEO of TerThera. "ITM is a true innovator in the dynamic radiopharmaceutical field and we look forward to supplying them with our GMP-grade Terbium-161 as they advance their pipeline candidates and make progress in bringing the benefit of this valuable isotope to patients."

(Press release, ITM Isotopen Technologien Munchen, SEP 24, 2025, View Source [SID1234661163])

On September 24, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), reported key preclinical data demonstrating the potential of its novel antibody drug conjugate (ADC) spliceosome modulating payload, PH1, for the treatment of tumors fueled by alternative splicing-drivers, such as the Androgen Receptor splice variant 7 (AR-V7) in prostate cancer (Press release, Akari Therapeutics, SEP 24, 2025, View Source [SID1234656230]).

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AR-V7 is a key driver for progression of metastatic castration resistant prostate cancer (mCRPC). During progression of hormone-sensitive prostate cancer, many patients fail to respond to current first-line therapies known as Androgen Receptor Pathway Inhibitors (ARPIs), which include enzalutamide (Xtandi, $6B/annual sales), apalutamide (Erleada, $3B/annual sales) and darolutamide (Nubeqa, $1.6B/annual sales). Importantly, as patients lose ARPI response, their tumors transform and significantly increase in AR-V7 expression. As a result, there is an increasing and significant unmet need for targeted therapy options in ARPI-resistant hormone refractory patients, where there are currently limited options such as traditional chemotherapy like taxanes.

As referenced in the Company’s recent patent filing, preclinical data demonstrated that Akari’s ADC payloadPH1 is able to suppress the expression levels of the AR-V7 receptor in a hormone-refractory mCRPC model called 22Rv1. As a control, ARPIs had no effect on AR-V7 receptor expression in these experiments, which was expected given the refractory nature of these prostate cancer cell lines.

Surprisingly, in a different model, of hormone-sensitive LnCAP cells that express high levels of normal Androgen Receptor (i.e. ARPI sensitive) and lack AR-V7, PH1 demonstrated a benefit as a single agent, and additive effect when combined with either Xtandi or Erleada. The Company believes this combined efficacy data may potentially lead to the development of robust first-line combination regimens of Xtandi or Erleada with a PH1 payload conjugated ADC (PH1 ADC) to target prostate cancer that is sensitive to ARPIs. As progression is often linked to AR-V7 expression, and PH1 reduces AR-V7 expression, it is hypothesized that the combination of ARPI plus PH1 ADCs may slow the development of resistance and AR-V7-driven tumor progression which typically occurs after patients progress on Xtandi or Erleada. Akari has plans to test this hypothesis using PH1 ADCs against different prostate cancer targets in future research.

Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics commented, "We believe these compelling preclinical data support the rationale for Akari to develop a novel ADC with our PH1 spliceosome-modulating payload targeting prostate cancer either alone or in partnership with potential partners. Our goal is to develop the first ADC therapeutic in prostate cancer, either as a first-line combination therapy with ARPIs or a second-line therapy post ARPI failures in tumors driven by AR-V7. We are excited to continue to advance this novel spliceosome modulating payload to drive robust anti-cancer biological mechanisms to treat difficult alternative splicing-driven tumors, for which there are currently no effective treatment options today."

The Company plans to present the preclinical data at an upcoming scientific conference.