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Molecular Partners Presents New Data for DLL3 Targeting Radiotherapy MP0712 at TRP Summit Europe 2025, Highlighting Initial Human Images and Mechanism of Action

On November 12, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the presentation of new data on MP0712, its lead Radio-DARPin targeting DLL3, at the Targeted Radiopharmaceuticals (TRP) Summit Europe, highlighting first encouraging human images and supporting mechanism of action data. MP0712 is being developed with strategic partner Orano Med for the treatment of patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. Molecular Partners presents an example case with images of a patient today as courtesy of the Nuclear Medicine Research Infrastructure (NuMeRI) in South Africa. The NuMeRI team, led by Prof. Mike Sathekge, plans to report the full imaging and dosimetry data of MP0712 at the Theranostics World Congress (TWC) in January 2026.

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"The images show targeted delivery of MP0712 into tumors and limited exposure in healthy organs of concern such as kidney and liver. This is an important milestone for MP0712, which is indicative of its potential performance in a clinical setting when carrying 212Pb as therapeutic radioactive payload and providing a strong basis for advancing its clinical development. We are continuing preparations for the upcoming Phase 1 trial with MP0712 and look forward to advancing additional Radio-DARPin programs in 2026," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

The presented case study of a patient who received 203Pb-MP0712 indicates specific uptake in the tumor lesions visible at 24 hours and sustained over 4 days, with limited accumulation in healthy organs, as intended. To promote tumor uptake via internalization over time, MP0712 is half-life engineered to maintain sufficient amounts of drug in the blood, visible at the early imaging time points. These early results are in line with previously presented pre-clinical data and further support the intended mechanism of action of MP0712.

203Pb and 212Pb are an element-equivalent pair of lead (Pb) isotopes, with 203Pb used for imaging and 212Pb for therapeutic applications (targeted alpha therapy, TAT). As a "matched pair", pre-treatment imaging with 203Pb provides a prediction of treatment behavior with 212Pb.

The imaged patient was initially diagnosed with Stage 3 small cell lung cancer and had a treatment history of radiotherapy and chemotherapy; the patient was then re-classified as Stage 4 post imaging with MP0712 due to observed liver metastases. This patient is a case example of a series of patients who received MP0712 for imaging use as part of a Named Patient Access Program under the legal framework in South Africa for compassionate care (also referred to as Section 21 of the Medicines and Related Substances Act). The Company believes that, due to the prior treatment and tumor stage of the patient, this case is illustrative of the patient population likely to be recruited in its planned Phase 1/2a in the US.

In addition to first-in-human images, the presentation at TRP highlights that MP0712 is rapidly internalized and accumulates intracellularly in DLL3-expressing cells in vitro. The data suggests that MP0712 can achieve high tumor uptake in spite of very low DLL3 expression levels, leveraging internalization and replenishment pathways of DLL3 as well as optimal binding properties and tunable half-life of the DLL3-binding DARPin.

The Phase 1 Investigational New Drug (IND) application for MP0712, for the treatment of small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers, has been filed. Dialogue with the FDA is ongoing and, pending regulatory clearance, the Phase 1 trial is expected to initiate by the end of 2025. The Phase 1/2a study is a multi-center study in the US, with the objectives to assess safety and determine a recommended phase 2 dose for MP0712 (labeled with 212Pb). The study contains an imaging and dosimetry step with 203Pb-labeled MP0712. The Company expects initial clinical data from the study in 2026.

Details of the presentation at TRP:

Title: Internalisation of Targeted Radiopharmaceuticals: Strategic Imperative or Situational Choice?
Presenter: Daniel Steiner, PhD, SVP of Technology and Research
Time: Wednesday November 12 at 1.30pm CET
Location: Amsterdam, Netherlands

Webcast to be held today at 10am ET (4pm CET):

In addition to the presentation at TRP, Molecular Partners will host a webcast today to discuss the new data, as well as the upcoming clinical trial of MP0712 in the US. Details as follows:

For Participants who want to listen and view slides: Please register here.
For Participants who may want to ask a question following the presentation: Please register here.

Participants who wish to ask a question will be provided with additional dial-in instructions to join the live conference call. These participants will have the ability to "raise their hand" and ask a verbal question during the Q&A.

About 212Pb-based Radio-DARPins
Molecular Partners’ Radio-DARPin platform is being developed to provide a unique and innovative delivery system for radioactive payloads, with exquisite targeting capabilities of DARPins combined with the optimally balanced safety and tumor killing of 212Pb. DARPins are ideal vectors for efficient delivery of therapeutic radionuclides to solid tumors, while overcoming some historic limitations of radioligand therapy approaches, thanks to their small size as well as high specificity and affinity. Molecular Partners and Orano Med are developing targeted alpha radio-therapeutics against up to ten targets, including the tumor-associated protein Delta-like ligand 3 (DLL3) and mesothelin (MSLN).

(Press release, Molecular Partners, NOV 12, 2025, View Source [SID1234659758])

Cogent Biosciences Announces Pricing of Concurrent Public Offerings of Common Stock and 1.625% Convertible Senior Notes Due 2031

On November 12, 2025 Cogent Biosciences, Inc. ("Cogent") (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the pricing of its previously announced underwritten public offering of 9,677,420 shares of its common stock at a public offering price of $31.00 per share (such offering, the "Equity Offering") and its underwritten public offering of $200.0 million aggregate principal amount of its 1.625% convertible senior notes due 2031 (the "Convertible Notes" and such offering, the "Convertible Notes Offering"). The Equity Offering was upsized from the previously announced offering size of $200.0 million of shares of common stock.

Cogent estimates that the net proceeds from the Equity Offering and the Convertible Notes Offering will be approximately $475.3 million, after deducting underwriting discounts and commissions and Cogent’s estimated offering expenses. In addition, Cogent has granted the underwriters of the Equity Offering a 30-day option to purchase up to an additional 1,451,613 shares of its common stock, on the same terms and conditions, and granted the underwriters of the Convertible Notes Offering a 30-day option to purchase up to an additional $30.0 million aggregate principal amount of Convertible Notes, solely to cover over-allotments in the Convertible Notes Offering, on the same terms and conditions.

The Equity Offering is expected to close on November 13, 2025, while the Convertible Notes Offering is expected to close on November 18, 2025, in each case, subject to satisfaction of customary closing conditions. The closing of neither the Equity Offering nor the Convertible Notes Offering is conditioned upon the closing of the other offering.

The Convertible Notes will be general, unsecured, senior obligations of Cogent. The Convertible Notes will accrue interest payable semi-annually in arrears on May 15 and November 15 of each year, beginning on May 15, 2026, at a rate equal to 1.625% per year. The Convertible Notes will mature on November 15, 2031, unless earlier converted, redeemed or repurchased by Cogent.

Before August 15, 2031, noteholders may convert their Convertible Notes at their option only in certain circumstances. At any time from, and including, August 15, 2031 until the close of business on the scheduled trading day immediately before the maturity date, the Convertible Notes will be convertible at the option of the holders. Cogent will settle conversions by paying or delivering, as applicable, cash, shares of its shares of its common stock, or a combination of cash and shares of its common stock, at Cogent’s election. The initial conversion rate is 22.2469 shares of its common stock, per $1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $44.95 per share of common stock and represents a conversion premium of approximately 45.0% above the public offering price per share of common stock in the Equity Offering. If a "make-whole fundamental change" (as defined in the indenture that will govern the Convertible Notes) occurs, then Cogent will in certain circumstances increase the conversion rate for a specified period of time.

The Convertible Notes will be redeemable, in whole or in part (subject to certain limitations), at Cogent’s option at any time, and from time to time, on a redemption date on or after November 20, 2029 and on or before the 26th scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds 130% of the conversion price for the Convertible Notes on (1) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date Cogent sends the related redemption notice; and (2) the trading day immediately before the date Cogent sends such notice.

If a "fundamental change" (as defined in the indenture that will govern the Convertible Notes) occurs, then, subject to certain exceptions, noteholders may require Cogent to repurchase their Convertible Notes at a cash repurchase price equal to the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date.

Cogent intends to use the net proceeds from the Equity Offering and the Convertible Notes Offering to repay $50 million of loans outstanding under its existing term loan facility, plus accrued interest and associated fees, and the remainder for development and regulatory activities relating to bezuclastinib and other product candidates, the anticipated commercial launch and commercialization of bezuclastinib, as well as for working capital and general corporate purposes.

J.P. Morgan, Jefferies, Leerink Partners and Guggenheim Securities are acting as joint-book running managers for the Equity Offering. LifeSci Capital is acting as lead manager and Raymond James is acting as co-manager for the Equity Offering.

Jefferies and J.P. Morgan are acting as joint book-running managers for the Convertible Notes Offering.

The securities described above are being offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-291384), which was filed with the Securities and Exchange Commission ("SEC") on November 7, 2025 and automatically became effective upon filing.

Preliminary prospectus supplements and the accompanying base prospectuses relating to and describing the terms of each offering were filed with the SEC on November 10, 2025 and are expected to be available on the SEC’s website on November 12, 2025. Final prospectus supplements and the accompanying base prospectuses relating to and describing the terms of each offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or 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. The offerings can be made only by means of prospectus supplements and accompanying base prospectuses, copies of which may each be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected].

(Press release, Cogent Biosciences, NOV 12, 2025, View Source [SID1234659753])

FDA Approves Promega OncoMate® MSI Dx Analysis System as Companion Diagnostic for KEYTRUDA® in Combination with LENVIMA® In Advanced Endometrial Carcinoma

On November 11, 2025 The U.S. Food and Drug Administration (FDA) reported it has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic designed to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. This is the first Promega companion diagnostic to receive FDA approval.

OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue. MSI status can be used to guide treatment decisions and support precision oncology strategies in endometrial carcinoma.

"This approval underscores the critical role diagnostics play in accurately matching the right patients, at the right time with the right therapy," says Alok Sharma, Global Clinical Market Director at Promega. "We are committed to delivering reliable tools that guide clinical decisions and help improve patient outcomes."

The approval was supported through a collaboration with Merck, which markets KEYTRUDA plus LENVIMA in collaboration with Eisai Co., Ltd. Together, the companies are working to advance personalized medicine and expand access to diagnostics that enable informed therapeutic choices.

OncoMate MSI Dx Analysis System was previously cleared by the FDA as the first PCR-based molecular diagnostic for identifying colorectal cancer patients who may benefit from additional testing to diagnose Lynch syndrome. This approval applies to the United States and its territories. Promega MSI technology has received additional regulatory approvals in China and the European Union.

Learn more about Promega MSI technology here.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

(Press release, Promega, NOV 11, 2025, View Source [SID1234659767])

TriSalus Life Sciences to Participate in Upcoming Investor Conferences

On November 11, 2025 TriSalus Life Sciences Inc. (Nasdaq: TLSI) ("TriSalus" or the "Company"), an oncology company integrating novel delivery technology with standard of care therapies to transform treatment for patients with solid tumors, reported that Mary Szela, Chief Executive Officer and President, and David Patience, Chief Financial Officer, will participate in the following investor conferences in November:

Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum
Management will participate in one-on-one meetings and participate in a corporate overview on Thursday, November 20, at 2:30 p.m. ET. Click here for a link to the live webcast.

37th Annual Piper Healthcare Conference in New York, NY
Management will participate in one-on-one meetings and participate in a corporate overview on Tuesday, December 2, at 3:10 p.m. ET. Click here for a link to the live webcast.

A webcast replay of the corporate overview will be available for 90 days following the presentation in the Events section of the TriSalus Investor website at www.investors.trisaluslifesci.com.

(Press release, TriSalus Life Sciences, NOV 11, 2025, View Source [SID1234659766])

iLeukon Therapeutics Presents Phase I Data for ILKN421H at SITC 2025

On November 11, 2025 iLeukon Therapeutics, Inc., a San Diego-based clinical-stage biotechnology company developing next-generation mRNA-based immunotherapies, reported new clinical results from the ongoing first-in-human Phase I trial (NCT05978102) of ILKN421H, presented during a Late-Breaking Clinical Oral Session at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD.

The study evaluates ILKN421H, a lipid-nanoparticle (LNP)-formulated mRNA encoding a non-α HSA–IL-2 variant (IL-2v), as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, including first-line non-small cell lung cancer (NSCLC). The presentation highlighted ILKN421H’s unique scientific design and distinct pharmacologic advantages that enable potent immune activation with a favorable safety profile.

Key Advantages of ILKN421H in Preclinical Research:

Stem-like CD8+ T Cell Amplification: ILKN421H selectively expands PD1- stem-like CD8⁺ T cells, a subset capable of self-renewal and durable antitumor immunity.
Lymphoid Specific Expression and Reduced Systemic Exposure: ILKN421H mRNA is predominantly expressed in lymphoid organs, such as the spleen and lymph nodes, with <5% expressed in liver and other organs. This targeted biodistribution reduces the systemic exposure of IL–2v while enhancing its immune activity.
Overcoming the Cytokine-Sink Effect and a Remarkable Amplification of CD8+ T and NK cells: Unlike protein-based IL-2 therapies that are rapidly internalized by the targeting cells which terminates the IL-2 signaling towards T cell proliferation, ILKN421H’s sustained mRNA–mediated production bypasses the cytokine-sink effect. This enables robust CD8+ T/NK cell proliferation with 1/100 of systemic IL-2v exposure compared with other protein based counterparts like PEG-IL-2v.
Favorable Safety and Tolerability
Across 45 patients with advanced solid tumors, ILKN421H was well tolerated with no dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) was not reached. There were no Grade 4 adverse events (AEs), no treatment-related deaths, and no serious adverse events (SAEs) occurring in more than one patient. The Grade 3 AEs observed in more than one patient included anemia, decreased neutrophil count, decreased platelet count, fever, and hypokalemia. The safety profile of ILKN421H in combination with pembrolizumab is generally similar to that of pembrolizumab alone. No vascular leak syndrome (VLS) or hypotension were observed. These findings highlight ILKN421H’s favorable safety and tolerability relative to earlier-generation IL-2 therapeutics.

Reliable and Robust PK/PD
Pharmacokinetic data from the Phase I study demonstrated prolonged IL-2v expression with a half-life of approximately 20 hours. Pharmacodynamic study showed marked increase of peripheral CD8⁺ T cells and NK cells, up to 10-fold and 25-fold respectively. No ADA was detected, and no sign of reduced IL-2v expression or pharmacological effect was observed after repeated administration up to 30 cycles (Q3W per cycle).

Clinical Efficacy
In patients with first-line (1L) non-small cell lung cancer (NSCLC) regardless of PD-L1 expression levels (n=20), ILKN421H in combination with pembrolizumab demonstrated promising efficacy, with a confirmed objective response rate (ORR) of 80% (16/20 patients). When analyzed by PD-L1 status, ORR was 87% in PD-L1–positive patients and 60% in PD-L1–negative patients. Median progression-free survival (PFS) has not yet been reached and is projected to exceed 12 months. In the post–immunotherapy (post-IO) NSCLC cohort (n=3), ILKN421H combined with pembrolizumab achieved an ORR of 33.3% (1/3 patients), including one partial response (PR) and one patient with durable stable disease (SD) lasting more than 14 months. Together, these results highlight the clinical promise of ILKN421H in both first-line and post-IO NSCLC, supporting its continued development across treatment settings.

Advancement to Phase II Development
Based on these favorable Phase I results, the FDA has cleared iLeukon’s IND application and Phase II protocol to evaluate ILKN421H in combination with pembrolizumab for both 1L and post-IO treatment of NSCLC. "These Phase I results validate the novel design of ILKN421H and demonstrate its potential to deliver meaningful clinical benefit for patients with cancer," said Haining Huang, Ph.D., Chief Executive Officer of iLeukon Therapeutics. "ILKN421H defines the next evolution of IL-2 therapy by combining mRNA technology with selective immune activation to deliver durable efficacy and a favorable safety profile. We look forward to advancing this program into Phase II evaluation."

(Press release, iLeukon Therapeutics, NOV 11, 2025, View Source [SID1234659765])