On January 28, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it has entered into a securities purchase agreement with a single healthcare-focused institutional investor for the purchase and sale of 19,685,040 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 19,685,040 shares of common stock in a registered direct offering (the "Offering") at a combined purchase price of $1.27 per share and accompanying warrant, priced at-the-market under Nasdaq rules (Press release, Sellas Life Sciences, JAN 28, 2025, View Source [SID1234649907]). The warrants will have an exercise price of $1.20 per share, will be immediately exercisable upon issuance and will expire 5 years from issuance.

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The closing of the Offering is expected to occur on or about January 29, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $25 million, before deducting placement agent fees and other estimated offering expenses. The Company intends to use the net proceeds from the Offering for working capital purposes and general corporate procedures, including the purchase of any pending or future acquisitions.

A.G.P./Alliance Global Partners is acting as lead placement agent for the Offering and Maxim Group LLC is acting as co-placement agent for the Offering.

The Offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-278334) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed Offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement 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 a solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or other jurisdiction.

On January 28, 2025 Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported that the European Patent Office (EPO) has granted Patent No. EP3583125 B1, entitled "Albumin Binding Domain Fusion Proteins," which covers Sonnet’s Fully Human Albumin Binding (FHAB) technology and includes therapeutic fusion proteins that utilize FHAB for tumor targeting and retention and provide extended pharmacokinetics (PK) (Press release, Sonnet BioTherapeutics, JAN 28, 2025, View Source [SID1234649908]). The EU patent carries a term effective until February 20, 2038. Additionally, the Company announced the release of a "What This Means" segment to discuss the EU patent and its global IP estate, which is now available here.

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"The granting of this EU patent represents another milestone that provides expanded global protection along with building our intellectual capital and differentiation from any existing or emerging competitive technologies that may leverage the beneficial characteristics of binding to human serum albumin," commented Pankaj Mohan, Ph.D., Founder and CEO of Sonnet. "Further, this European patent issuance expands the global IP protection for our product pipeline beyond previous patents issued in China, Japan, Russia and New Zealand, which we believe provides further validation for our FHAB platform."

Sonnet’s FHAB platform consists of a single, fully human construct of a FHAB antibody fragment that has high affinity to bind to human albumin. The platform provides an off-the-shelf lock and load opportunity to rapidly develop numerous therapeutic biologics.

John Cini, Ph.D., Co-Founder and CSO of Sonnet commented, "The FHAB platform technology provides each of Sonnet’s pipeline drug candidates with either a mono- or bi-functional mechanism of action, thus allowing for the potential of biological synergy between cytokines. Preclinical comparative in vivo studies with wild type cytokines have shown that FHAB-derived drug candidates have reproducibly extended pharmacokinetics, enhanced payload delivery to the tumor and improved efficacy."

On January 28, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the acceptance of two abstracts for presentation at the ASCO (Free ASCO Whitepaper) GU 2025 Conference on Clarity’s COBRA and CLARIFY trials and an abstract on the COBRA trial at the AUA Annual Meeting 2025 (Press release, Clarity Pharmaceuticals, JAN 28, 2025, View Source [SID1234649892]). These conferences are among the world’s most prestigious in oncology and urology, and the acceptance of these abstracts is testament to the strength of Clarity’s data and the exciting prospects for the diagnostic 64Cu-SAR-bisPSMA to change the paradigm in the diagnosis and treatment of cancer.

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The abstracts on Clarity’s COBRA trial showcase the improved efficacy of 64Cu-SAR-bisPSMA at detecting lesions compared to currently approved PSMA PET agents, and the potential for this product to become a best-in-class diagnostic. 64Cu-SAR-bisPSMA was able to identify lesions prior to detection by the standard-of-care (SOC) PSMA PET products, which are known to have low sensitivity.

In a subset of participants in the COBRA study who underwent follow-up SOC PSMA PET, 70% of participants had a positive scan on same-day imaging and 90% on next-day imaging using 64Cu-SAR-bisPSMA, compared to 60% of participants using SOC PSMA PET where only same-day imaging is possible. The number of lesions across all participants (average sum of lesions across all readers) identified by 64Cu-SAR-bisPSMA was also higher (26.3 lesions on same-day imaging, 52.6 on next-day imaging) than that detected by SOC PET agents (20 lesions). Results indicate that 64Cu-SAR-bisPSMA is able to identify lesions from 29 days to more than 6 months earlier than SOC PSMA agents. Across all participants in the study, histopathology confirmed the presence of prostate cancer in lesions identified by 64Cu-SAR-bisPSMA in up to 78% of cases in which biopsies were performed, which was considerably higher compared to less sensitive methods (e.g. SOC imaging) used to verify the 64Cu-SAR-bisPSMA PET findings. With regards to the biopsies, 100% of lesions which were located outside of the prostate bed were determined as positive, with only 2 participants showing negative results. These 2 participants had lesions located in the prostate bed and had undergone the complete removal of their prostate as part of their initial treatment. The prostate bed is an area notoriously difficult to biopsy following surgery due to anatomical changes and scarring of surrounding tissues as a result of the procedure, which may lead to negative results despite the presence of cancer. Investigators stated that they would change their intended treatment plan in approximately half (48%) of their patients due to the findings of the 64Cu-SAR-bisPSMA PET.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "Our lead product, SAR-bisPSMA, continues generating impressive results as we work with world-class experts to conduct clinical research at the highest standard, bringing us closer to improving the diagnostic paradigm for prostate cancer patients around the world. It is a huge testament to the quality and importance of our data that it continues to be accepted for presentation at some of the world’s most prominent conferences.

"64Cu-SAR-bisPSMA has shown an impeccable safety profile and impressive diagnostic performance to date compared to current SOC PSMA PET agents, which are known to have significant sensitivity limitations. Not only is our product more effective on same-day imaging due to its dual-targeting "bis" structure, but the unique property of next-day imaging, enabled by the longer half-life of copper-64 isotopes, also opens a myriad of opportunities for significantly improving the accuracy of cancer diagnosis and making more informed treatment decisions for men with prostate cancer.

"The results presented in the most recent COBRA abstracts highlight how 64Cu-SAR-bisPSMA could change the scene of prostate cancer diagnostics. With 90% of next-day scans identifying prostate cancer, in comparison to only 60% on SOC PSMA PET scans, and identifying over 2.6 times the number of lesions with 64Cu-SAR-bisPSMA over the approved diagnostics, 64Cu-SAR-bisPSMA could be the game changer. The data provides physicians crucial information to make more informed decisions about treatment, and the high response from investigators in the COBRA trial who intended to change their treatment plan is an indication of how far reaching these changes could be. This opens the door for patients to potentially receive better treatment for their cancer based on these findings, improving their outcomes and quality of their lives.

"The data from the COBRA study, as well as from our earlier PROPELLER trial in the pre-prostatectomy setting, were used to support the design of our second registrational trial with 64Cu-SAR-bisPSMA, AMPLIFY, in patients with biochemical recurrence (BCR) of prostate cancer, planned to commence in the coming months. This trial, in conjunction with the ongoing pivotal CLARIFY trial, which currently has over 20 sites actively recruiting in the U.S. and Australia, is intended to provide evidence to support the U.S. Food and Drug Administration (FDA) approval of 64Cu-SAR-bisPSMA as a novel diagnostic imaging agent for newly diagnosed prostate cancer patients as well as those in BCR of their disease, bringing us closer to achieving our ultimate goal of improving treatment outcomes for people with cancer."

Title Conference and Session details
COBRA: Assessment of the efficacy of 64Cu-SAR-bisPSMA using histopathology as reference standard in patients with biochemical recurrence of prostate cancer following definitive therapy ASCO GU
Date: Thursday, February 13, 2025

Time: 11:25 AM – 12:45 PM PT; 5:45 PM – 6:45 PM PT

Session Title: Trials in Progress Poster Session A: Prostate Cancer

Abstract #: 44

Poster Bd #: A22

CLARIFY: Positron emission tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy — A phase 3 diagnostic performance study ASCO GU
Date: Thursday, February 13, 2025

Time: 11:25 AM – 12:45 PM PT; 5:45 PM – 6:45 PM PT

Session Title: Trials in Progress Poster Session A: Prostate Cancer

Abstract #: TPS429

Poster Bd #: M27

COBRA: Assessment of 64Cu-SAR-bisPSMA and standard of care prostate-specific membrane antigen Positron Emission Tomography in patients with biochemical recurrence of prostate cancer following definitive therapy AUA
Date: Sunday, April 27, 2025

Time: 9:30 AM – 11:30 AM PT

Session Title: MP13: Prostate Cancer: Staging

Room: To be announced

Presentations will be available on Clarity’s website after the conferences: claritypharmaceuticals.com/pipeline/scientific_presentations

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

64Cu-SAR-bisPSMA is an unregistered product. The safety and efficacy of 64Cu-SAR-bisPSMA has not been assessed by health authorities such as the U.S. FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. Among 82 patients who received 64Cu-SAR-bisPSMA in PROPELLER and COBRA, 2 adverse reactions were reported in 2 participants (mild occasional metallic taste and moderate worsening of type II diabetes, both resolved).

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide3. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the U.S. and around 35,770 deaths from the disease.

On January 28, 2025 Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., reported that the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib (development code: CLN-081/TAS6417) monotherapy in patients with non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutations who have received prior therapy, met its primary endpoint of overall response rate (Press release, Taiho, JAN 28, 2025, View Source [SID1234649911]). The safety profile was generally consistent with previous data presentations. These results are based on the Phase 2b part of this study.

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Full results from REZILIENT1 will be submitted for presentation at an upcoming international medical conference. Pending discussions with the U.S. Food and Drug Administration (FDA), the companies plan to submit for U.S. regulatory approval in the second half of 2025.

About the REZILIENT1 Trial
REZILIENT1 is a Phase 1/2 clinical trial (NCT04036682) to evaluate efficacy and safety of zipalertinib in patients with NSCLC harboring EGFR exon 20 insertion mutations who have received prior therapy. The topline results obtained at this time are based on the Phase 2b part of this study. Preliminary results of REZILIENT1 have been published in the Journal of Clinical Oncology.1

REZILIENT: Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About the EGFR exon 20 insertion mutations
NSCLC is a common form of lung cancer and up to 4% of all cases have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype.2 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations, with insertions at exon 20 accounting for up to 12% of these mutations.

On January 28, 2025 Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported a definitive agreement to acquire Evergreen Theragnostics, Inc. ("Evergreen"), in an all-cash transaction consisting of an upfront payment of $250 million and up to an additional $752.5 million in potential milestone payments (Press release, Lantheus, JAN 28, 2025, View Source [SID1234649912]). Evergreen is a clinical-stage radiopharmaceutical company engaged in Contract Development and Manufacturing (CDMO) services as well as drug discovery and commercialization of proprietary products.

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This transaction is expected to solidify Lantheus’ capabilities as a fully integrated radiopharmaceutical company. The addition of Evergreen’s scalable manufacturing capabilities and infrastructure enhances Lantheus’ ability to meet the complex demands of radiopharmaceutical development and production. The acquisition also expands Lantheus’ oncology diagnostic pipeline by adding both OCTEVY, a registrational-stage PET diagnostic agent for certain neuroendocrine tumors (NETs) that could complement Lantheus’ therapeutic candidate PNT2003, as well as a number of clinical and pre-clinical novel theranostic pairs.

"As Lantheus continues to advance its industry leadership, this transaction, along with the agreement to acquire Life Molecular Imaging, enhances our operations across the radiopharmaceutical value chain," said Brian Markison, CEO of Lantheus. "With Evergreen’s manufacturing and development capabilities, we become fully integrated and will ultimately make a difference in the lives of more patients. We are pleased to welcome Evergreen’s talented team to Lantheus and are confident that their expertise in radiopharmaceutical theranostics and culture focused on developing new solutions for cancer patients will enrich our organization."

"Today marks an exciting new chapter for Evergreen as we look to join the Lantheus team," said James Cook, CEO of Evergreen. "Lantheus’ industry expertise and financial strength will help us bring our innovations to a broad patient population faster and support our mission to improve options for cancer patients through theranostic radiopharmaceuticals. We look forward to benefiting from Lantheus’ experience and resources to further advance our pipeline and continue developing cutting-edge therapies and diagnostics that have the potential to transform patient care. I am very pleased to have our Evergreen team join another industry-leading company with a shared vision."

Compelling Strategic and Financial Rationale

Enhanced Radiopharmaceutical Manufacturing Infrastructure: The acquisition advances Lantheus’ capabilities with the addition of Evergreen’s radioligand therapy (RLT) manufacturing infrastructure, including a revenue-generating CDMO business. Evergreen’s ability to work with a variety of diagnostic and therapeutic isotopes will enhance Lantheus’ ability to address the complexities of radiopharmaceutical development and production. Internalizing this infrastructure will enable Lantheus to develop technical and operational expertise, supply its clinical trials, scale manufacturing for commercial launches, mitigate third party risk, and support long-term growth.
Adds Near-Term Revenue with OCTEVY, which Complements PNT2003 Commercialization: Acquiring OCTEVY, a registrational-stage diagnostic imaging agent, provides Lantheus with additional growth potential while expanding its presence in NETs. Subject to FDA approval, OCTEVY is expected to be indicated for use with positron emission tomography (PET) for localization of somatostatin receptor-positive NETs in adult and pediatric patients. OCTEVY and Lantheus’ PNT2003 could be used as a theranostic pair.
Advanced Early Development Capabilities: Evergreen brings a fully integrated drug discovery and early-stage clinical development platform, promising early-stage oncology assets, and a highly skilled team that can generate novel targets and advance promising radiotherapeutic programs.
Additional Transaction Details
Under the terms of the agreement, Lantheus will pay an upfront amount of $250 million, payable in cash at closing, and up to $752.5 million in development and sales milestones related to OCTEVY and Evergreen’s clinical and pre-clinical pipeline. The transaction has been approved by the Boards of Directors of both companies and is expected to close in the second half of 2025, subject to customary closing conditions, including regulatory clearances.

Company Reaffirms Full Year 2024 Financial Guidance

Guidance Issued November 6, 2024

FY 2024 Revenue

$1.51 billion – $1.52 billion

FY 2024 Adjusted Fully Diluted
EPS

$6.65 – $6.70

Advisors
Solomon Partners Securities, LLC acted as financial advisor to Lantheus in this transaction, while Cooley LLP and Ropes & Gray LLP acted as legal advisors, and Ernst & Young LLP acted as financial and tax advisor.

Centerview Partners LLC acted as financial advisor to Evergreen, while Skadden, Arps, Slate, Meagher & Flom LLP and Lowenstein Sandler LLP acted as legal advisors, and Grant Thornton Advisors LLC acted as tax advisor.

Conference Call and Webcast Details
Lantheus will hold a conference call on Tuesday, January 28, 2025, at 8:30 AM ET. To access the live conference via webcast, please register here. A replay will be available after the conclusion of the call on Lantheus’ investor website at: View Source