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.

On June 23, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing innovative therapies, reported that they will host a virtual Key Opinion Leader (KOL) event on Tuesday, June 24, 2025, at 3:30PM EST (Press release, Hoth Therapeutics, JUN 23, 2025, View Source [SID1234654070]). Access/join the event through the following link: View Source

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Hoth Therapeutics will host a Key Opinion Leader (KOL) event on June 24, 2025, at 3:30PM EST to highlight recent clinical progress with HT-001, a novel topical therapeutic developed to address EGFR inhibitor-induced skin toxicities in cancer patients. This event will feature insights from derm-oncology and dermatology specialists Jonathan Hale Zippin M.D., Ph.D., and Adam Friedman M.D., F.A.A.D., who will present interim results from the ongoing Phase 2 trial and discuss how HT-001 could redefine supportive care standards for oncology patients.

On June 23, 2025 Astrazeneca reported Datroway (datopotamab deruxtecan or Dato-DXd) has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy (Press release, AstraZeneca, JUN 23, 2025, View Source [SID1234654067]).

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This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The approval follows Priority Review and Breakthrough Therapy Designation by the Food and Drug Administration (FDA) based on results from a subgroup analysis of the TROPION-Lung05 Phase II trial and supported by data from the TROPION-Lung01 Phase III trial.

Jacob Sands, MD, Medical Oncology, Dana-Farber Cancer Institute and investigator in both trials, said: "Addressing disease progression in patients with advanced EGFR-mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options available. The US approval of datopotamab deruxtecan introduces a novel and needed treatment option to patients with advanced disease."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "This first approval of Datroway in lung cancer provides a much-needed option to patients with advanced EGFR-mutated lung cancer whose disease has become resistant to past treatments, regardless of the driving mutation. We have long supported patients with EGFR-mutated lung cancer and are proud to bring another innovative treatment option to this community."

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc, said: "With today’s accelerated approval, Datroway is now the first TROP2-directed medicine available for certain patients in the US living with lung cancer. We remain committed to our extensive clinical development programme to further identify where Datroway may be used in other types of lung and breast cancer."

Andrea E. Ferris, President and CEO, LUNGevity, said: "For people with advanced EGFR-mutated non-small cell lung cancer whose disease progresses on initial treatments, additional options are limited. Today’s approval of Datroway offers a new treatment option for patients whose disease has progressed following treatment with an EGFR-directed therapy and chemotherapy."

In TROPION-Lung05 and TROPION-Lung01, Datroway demonstrated a confirmed ORR of 45% (95% confidence interval [CI]: 35-54) in patients with previously treated locally advanced or metastatic EGFR-mutated NSCLC (n=114) as assessed by blinded independent central review (BICR). Complete responses were seen in 4.4% of patients and partial responses were seen in 40% of patients. The median DoR was 6.5 months (95% CI: 4.2-8.4).

The safety profile of Datroway was evaluated in a pooled analysis of 125 patients in the TROPION-Lung05, TROPION-Lung01 and TROPION-PanTumor01 trials. The safety profile observed across these trials was consistent with the known profile of this medicine with no new safety concerns identified.

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

AstraZeneca and Daiichi Sankyo are evaluating Datroway alone and with Tagrisso (osimertinib) in other advanced or metastatic EGFR-mutated NSCLC settings in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

Financial considerations
Following approval in the US, an amount of $45 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the locally advanced or metastatic EGFR-mutated NSCLC indication. Sales of Datroway in the US are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from July 2020.

Notes

Advanced non-small cell lung cancer
Nearly 2.5 million lung cancer cases were diagnosed globally in 2022.1 Lung cancer is broadly split into small or non-small cell lung cancer, the latter accounting for about 87% of cases.2 Approximately 10 to 15% of patients with NSCLC in the US and Europe, and 30 to 40% of patients in Asia have an EGFR mutation.3,4 The majority of EGFR mutations occur in tumours of nonsquamous histology.5 TROP2 is a protein broadly expressed in the majority of NSCLC tumours.6

For patients with tumours that have an EGFR mutation, the established 1st-line treatment in the metastatic setting includes EGFR-directed therapy with or without platinum-based chemotherapy.7 While these therapies have improved outcomes in earlier lines of treatment, most patients eventually experience disease progression and receive subsequent therapies.8-11

TROPION-Lung05
TROPION-Lung05 is a global, multicentre, single-arm, open-label Phase II trial evaluating the efficacy and safety of Datroway in patients with locally advanced or metastatic NSCLC with actionable genomic alterations who have progressed on at least one EGFR-directed therapy and platinum-based chemotherapy. Patients receiving up to four prior lines of treatment with tumours with one or more genomic alterations including EGFR, ALK, ROS1, NTRK, BRAF, RET or MET were eligible for the trial.

The primary endpoint of TROPION-Lung05 is ORR as assessed by BICR. Secondary efficacy endpoints include DoR, disease control rate (DCR), clinical benefit rate, PFS, time to response (TTR), OS and safety. TROPION-Lung05 enrolled 137 patients globally in Asia, Europe and North America. For more information, visit ClinicalTrials.gov.

Primary results from TROPION-Lung05 were published in the Journal of Clinical Oncology in January 2025.

TROPION-Lung01
TROPION-Lung01 is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy and safety of Datroway versus docetaxel in adult patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations who require systemic therapy following prior treatment. Patients with actionable genomic alterations were previously treated with an approved targeted therapy and platinum-based chemotherapy. Patients without known actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.

The dual primary endpoints of TROPION-Lung01 are PFS as assessed by BICR and OS. Key secondary endpoints include investigator-assessed PFS, ORR, DoR, TTR, and DCR as assessed by both BICR and investigator, and safety. TROPION-Lung01 enrolled 590 patients in Asia, Europe, North America, Oceania and South America. For more information visit ClinicalTrials.gov.

Primary results from TROPION-Lung01, as presented at the ESMO (Free ESMO Whitepaper) 2023 Congress, showed Datroway demonstrated a statistically significant improvement in PFS over docetaxel. OS results were presented at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer and simultaneously published in the Journal of Clinical Oncology in September 2024.

TROPION-PanTumor01
TROPION-PanTumor01 is a first-in-human, open-label, two-part, multicentre Phase I trial evaluating the safety and preliminary efficacy of Datroway in patients with advanced solid tumours that have relapsed or are refractory to standard treatment or for which no standard treatment is available. The dose escalation portion of the trial enrolled patients with NSCLC to assess the safety and tolerability of Datroway to determine the recommended dose for expansion (6mg/kg). The dose expansion part of TROPION-PanTumor01 enrolled several different cohorts including patients with NSCLC, triple-negative breast cancer (TNBC), HR-positive, HER2-negative breast cancer, small cell lung cancer, urothelial, gastric, pancreatic, castration resistant prostate and oesophageal cancer.

Safety endpoints include dose-limiting toxicities and serious adverse events. Efficacy endpoints include ORR, DoR, TTR, PFS and OS. Pharmacokinetic, biomarker and immunogenicity endpoints also are being evaluated. TROPION-PanTumor01 enrolled 890 patients in Asia and North America. For more information, visit ClinicalTrials.gov.

Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is approved in more than 30 countries worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial. Datroway is approved in Russia for the same population.

Datroway clinical development programme
A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and HR-positive, HER2-negative breast cancer. The programme includes eight Phase III trials in lung cancer and five Phase III trials in breast cancer evaluating Datroway as a monotherapy and in combination with other anticancer treatments in various settings.