On June 23, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and Debiopharm, a Swiss-based, global biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported that the first patient was imaged in a new study arm of a five-part, Phase 1/2 clinical trial (formerly GaLuCi) (NCT05706129) evaluating the theranostic pair ITM-94/ITM-91 for identification and treatment of patients who have unresectable, locally advanced or metastatic solid tumors. As a new component of a broad clinical development plan for ITM-91/ITM-94, Part D of the trial will evaluate the effectiveness of ITM-94 in classifying indeterminate renal mass as either ccRCC or non-cancerous.

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ITM-91/ITM-94 is a first-in-class, peptide-based theranostic pair combining the radiotherapeutic compound ITM-91 (Debio 0228) ([177Lu]Lu-DPI-4452), with the diagnostic agent ITM-94 (Debio 0328) ([68Ga]Ga-DPI-4452) to target Carbonic Anhydrase IX (CAIX). CAIX is a cell surface protein that plays a key role in the tumor microenvironment, promoting tumor growth, survival, invasion and metastasis. In September 2024, ITM gained the exclusive worldwide license from Debiopharm for the development and commercial rights of ITM-91/ITM-94. The initiation of this study arm represents a significant advancement for ITM and Debiopharm following their licensing agreement.

In the now initiated Part D of the trial, ITM-94 is being evaluated for its effectiveness to accurately classify an indeterminate renal mass as ccRCC or non-cancerous, when compared to CT/MRI imaging and histopathology. Secondary endpoints include sensitivity, specificity, and the positive and predictive value of ITM-94 PET/CT imaging compared to histopathology. This study arm is expected to enroll approximately 36 patients at around 15 clinical sites across the EU, US and Australia.

"The early results from the Gallium-68 CAIX PET/CT diagnostic are remarkable to date. I believe ITM-94 has the potential to change the way urologists and oncologists diagnose and stage patients with clear cell renal cell carcinoma, improving accuracy and reducing the need for biopsies. I have not seen a tracer with a similar profile since the PSMA PET/CT was established," added Prof. Michael Hofman, Director, Prostate Cancer Theranostics and Imaging Centre of Excellence (ProSTIC), Peter MacCallum Cancer Centre, Melbourne, Australia.

"Clear cell renal cell carcinoma is the most common form of kidney cancer, with more than 90% of cases overexpressing the CAIX encoding gene. As survival rates are highly dependent on the stage of progression, rapid and precise diagnosis is essential to provide patients with the best possible treatment options and therapeutic outcomes. ITM-94 has already demonstrated potential exceptional imaging qualities, including high tumor-to-background ratios and detecting lesions not visible by CT scan with a potential favorable safety profile. We look forward to exploring the full potential of the theranostic pair ITM-91/ITM-94 across this trial to characterize and treat CAIX expressing cancer cells, advancing the efficacy of targeted radiopharmaceutical therapies," said Dr. Celine Wilke, Chief Medical Officer of ITM.

"With high-quality imaging and high tumor uptake, ITM-94 has already demonstrated potentially significant diagnostic capabilities in solid tumors. The data gathered in Part D of the trial will be instrumental to the further validation of this theranostic pair. We highly value our partnership with ITM, which will continue to advance the rapid progression of these novel radio-diagnostics and -therapeutics through the clinic," said Angela Zubel, Chief Development Officer, Research & Development at Debiopharm.

About the Phase 1/2 ITM-91/ITM-94 Trial
The five-part clinical trial (NCT05706129) is designed to assess the safety and tolerability, imaging characteristics, and efficacy of the theranostic pair ITM-91/ITM-94 in patients with unresectable, locally advanced or metastatic solid tumors. In Part A of the trial, ITM-94 demonstrated exceptional tumor imaging characteristics, with a high tumor-to-background ratio and a favorable tolerability profile in patients with confirmed ccRCC, with results published in the Journal of Nuclear Medicine. Part B, which is ongoing, is assessing escalating doses of the therapeutic agent, ITM-91, in patients whose tumors show high uptake of the imaging tracer. Based on the recommended dose from Part B, Part C of the trial will assess the safety and preliminary efficacy of ITM-91 in patients with ccRCC, pancreatic ductal adenocarcinoma, colorectal cancer, urothelial carcinoma and potentially other tumor types. In addition to the newly initiated Part D, Part E will assess ITM-94 uptake in other tumors. ITM will assume full sponsorship of the program from Debiopharm once the transfer is completed.

AboutITM-91/ITM-94 (Debio 0228/ 0328)
ITM-91/ITM-94 is an investigational theranostic pair originally discovered by 3B Pharmaceuticals GmbH and now exclusively licensed to ITM. ITM-94 ([68Ga]Ga-DPI-4452) is a PET imaging agent that may be used independently and is designed to identify patients whose cancers overexpress CAIX. Once identified, these patients may be treated with the lutetium-labelled radioligand, ITM-91 ([177Lu]Lu-DPI-4452), which delivers targeted radiation to the tumor with the aim to destroy it from the inside.

(Press release, ITM Isotopen Technologien Munchen, JUN 23, 2025, View Source [SID1234661161])

On June 23, 2025 Galapagos NV (Euronext & NASDAQ: GLPG) reported the appointment of Mr. Aaron Cox as Chief Financial Officer, effective July 7, 2025 (Press release, Galapagos, JUN 23, 2025, View Source [SID1234654108]). Mr. Cox succeeds Mr. Thad Huston, who will remain with the company through July 31, 2025, to ensure a smooth transition of responsibilities.

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Aaron brings more than two decades of leadership experience across biotechnology, capital markets, and M&A/corporate development. Most recently, he served as Executive Vice President and Chief Financial Officer at Horizon Therapeutics plc, where he played a pivotal role in the company’s $28 billion acquisition by Amgen. Prior to that, Aaron served as Horizon’s Head of Corporate Development and Chief of Staff to the CEO, supporting capital markets strategy, M&A execution, and the company’s transformation into a fully integrated biotech. His earlier career spans senior roles in investment banking.

"We are delighted to welcome Aaron to Galapagos," said Henry Gosebruch, CEO of Galapagos. "Aaron will be a key partner in accelerating pipeline growth through business development and focusing our resources through disciplined financial management. His dealmaking background and experience managing a global financial organization will be invaluable as we continue transforming Galapagos with the goal of making a meaningful impact on the lives of patients worldwide."

Aaron will lead the Finance, Accounting, Tax, Procurement, Communications and Investor Relations functions and will join the Executive Committee of Galapagos. As CFO, he will also work closely with leadership and the Board of Directors to execute transactions to build a new pipeline of innovative medicines and find a value-maximizing alternative for the cell therapy business.

"I am excited to join Galapagos at this pivotal moment," said Aaron Cox, incoming CFO of Galapagos. "I look forward to working with Henry and the talented team to help shape the company’s next chapter, create value for our shareholders, and advance meaningful innovations for patients."

Aaron holds a Bachelor’s degree in Finance from the University of Notre Dame and earned his MBA from the University of Chicago Booth School of Business.

In connection with this appointment, the Company will issue new restricted stock units (RSUs) and subscription rights.

On June 23, 2025 TriSalus Life Sciences Inc. (Nasdaq: TLSI), a company working to improve outcomes for patients with solid tumors by combining innovative drug delivery, current on-market therapeutics and immunotherapy ("TriSalus" or the "Company"), reported that it has commenced an exchange offer and consent solicitation involving its Series A Convertible Preferred Stock (the "Preferred Stock") identified in the Prospectus/Offer to Exchange (as defined below) (Press release, TriSalus Life Sciences, JUN 23, 2025, View Source [SID1234654077]).

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TriSalus is committed to simplifying its capital structure and reducing the potential impact of dilution from its Preferred Stock. By exchanging outstanding shares of Preferred Stock for common stock, the Company eliminates complex capital layers and potential preferential claims, providing investors with a clearer view of the Company’s equity value and improving transparency around ownership.

What’s Being Offered

TriSalus is offering all holders of outstanding shares of Preferred Stock the chance to exchange their shares for common stock. Each share of Preferred Stock can be exchanged for common stock based on the total value it would accrue (including dividends through August 10, 2027), divided by $4.00 per share.

In total, TriSalus is offering up to 11,860,206 shares of common stock to complete the exchange.

Consent Solicitation: Proposed Change to Preferred Stock Terms

Along with the exchange offer, TriSalus is asking preferred shareholders to approve an amendment to the Certificate of Designations of the Preferred Stock. If approved, this amendment would allow the Company to automatically convert all remaining Preferred Stock into common stock after the offer closes, based on a slightly lower exchange ratio (11.3% less than the current offer).

Investors holding approximately 55% of the outstanding Preferred Stock have previously agreed to exchange their shares and approve the proposed changes pursuant to tender and support agreements. If the remaining conditions outlined in the Company’s Prospectus/Offer to Exchange are met, these changes will go into effect.

Key Dates and Information

Deadline to Participate: The offer expires at 12:01 a.m. Eastern Time on July 23, 2025, unless extended.
Preferred Stock holders can withdraw their tendered shares any time before the deadline.
Offer Details

The offer is described in full in the Prospectus/Offer to Exchange and Schedule TO, both filed with the U.S. Securities and Exchange Commission (SEC) on June 23, 2025.

Common Stock Symbol: TLSI (traded on the Nasdaq Global Market);
Preferred Stock: Not publicly traded; 3,594,002 shares outstanding as of June 13, 2025;
Morrow Sodali LLC has been appointed as the Information Agent for the Offer and Consent Solicitation, and Continental Stock Transfer & Trust Company has been appointed as the Exchange Agent. Requests for documents should be directed to Morrow Sodali LLC at (800) 662-5200 (for individuals) or (203) 658-9400 (for banks and brokers) or via the following email address: [email protected].

On June 23, 2025 OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported a warrant exercise inducement and exchange offer to holders of its five-year warrants with a current exercise price of $1.12 per share that were issued in connection with a PIPE financing transaction that had an initial closing date of December 31, 2024 (the "Old Warrants") (Press release, OS Therapies, JUN 23, 2025, View Source [SID1234654076]). The Company is offering holders of Old Warrants the opportunity to exercise the Old Warrants now in consideration of the receipt of new five-year warrants to purchase a number of shares of common stock equal to the number of Old Warrants exercised with an exercise price of $3.00 per share, on substantially the same terms as the Old Warrants with the exception of exercise price (the "New Warrants"). The exercise of all Old Warrants would provide approximately $8 million in gross cash proceeds to the Company before offering related expenses. $1.76 million in Old Warrants exercise proceeds has already been received by the Company, extending its cash runway into the second half of 2026.

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The New Warrants also have an added forced exercise provision that allows the Company to require the holder to exercise the New Warrants in the event the closing price of the Company’s common stock equals or exceeds $9.00 (300% of the exercise price) for 20 consecutive days.

OS Therapies intends to use net proceeds from the offering to support US and International regulatory and pre-commercialization efforts aimed at securing marketing authorization for OST-HER2 in the prevention or delay of recurrent, fully resected, lung metastatic osteosarcoma, and for general corporate purposes.

The warrant exercise inducement and exchange offer is being made to the holders of Old Warrants during the period beginning on June 20, 2025 and ending at 5:00pm EDT on July 10, 2025 – subject to extension, termination or suspension by the Company in its sole discretion. The offering may be concluded in one or more closings with respect to exercises of the Old Warrants.

The Company reiterates that it will release additional data related to its Phase 2b clinical trial of OST-HER2 in the prevention or delay of recurrent, fully resected, lung metastatic osteosarcoma at the MIB Factor meeting in Salt Lake City on June 28, 2025. The Company also reiterates its intention to submit a Biologics Licensing Application (BLA) for OST-HER2 osteosarcoma to the FDA in the third quarter of 2025.

OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will be eligible to receive a Priority Review Voucher (PRV) that it intends to sell. The most recent PRV sale occurred in June 2025, valued at $160 million.

The New Warrants to be issued in the private placement, as well as the common stock issuable upon exercise of the New Warrants, have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws and may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. The Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock underlying the New Warrants issued in this private placement (the "Resale Shares").

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities being offered 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 jurisdiction. Any offering of the Resale Shares under the resale registration statement will only be made by means of a prospectus.

On June 23, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that the company will host a webcast and conference call on Tuesday, June 24, 2025 at 8:00 a.m. ET, to discuss pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer from the global ARROS-1 Phase 1/2 clinical trial (Press release, Nuvalent, JUN 23, 2025, View Source [SID1234654074]).

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Webcast and Conference Call Information

To access the call, please dial +1 (800) 836-8184 (domestic) or +1 (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined to the Nuvalent call.

Accompanying slides and a live video webcast will be available in the Investors section of the Nuvalent website at https://investors.nuvalent.com/events. A replay and accompanying slides will be archived on the Nuvalent website for 30 days.

About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial

Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose, characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with ROS1-positive NSCLC.