Molecular Partners to Present at Upcoming Investor Conferences

On May 19, 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 that members of the management team will participate in two upcoming investor conferences (Press release, Molecular Partners, MAY 19, 2025, View Source [SID1234653218]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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H.C. Wainwright 3rd Annual BioConnect Investor Conference at NASDAQ:

Fireside Chat on Tuesday May 20, 2025 beginning at 3:30pm ET
TD Cowen’s 6th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper):

Fireside chat on Wednesday, May 28, 2025 beginning at 10:00am ET
Both events will be webcast and available on the Molecular Partners website, under the investors tab.

Porton Advanced Announces Collaboration with Hualong Biological to Accelerate MATC Cell Therapy Development for Solid Tumor Treatment Breakthroughs

On May 19, 2025 Porton Advanced, a leading contract development and manufacturing organization (CDMO) specializing in advanced therapy medicinal products (ATMPs), reported its partnership with Hualong Biological, an innovator in novel cancer therapeutics (Press release, Henan Hualong Biotechnology, MAY 19, 2025, View Source [SID1234653235]). Porton Advanced will provide end-to-end CDMO services for Hualong’s Multi-Activated T Cell (MATC) therapy, from process optimization to regulatory submission, accelerating its development progress.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Hualong Biological ‘s research team has established a strong clinical foundation for its MATC platform through multiple investigator-initiated trials (IITs), demonstrating significant therapeutic benefits across various solid tumor indications. Porton Advanced will leverage its industry-leading process development platforms, GMP manufacturing capabilities, and proven regulatory expertise to optimize the MATC therapy’s CMC strategy and facilitate its transition from research to clinical development.

Mingguang Huang, Chairman of Hualong Biological, commented: "We are delighted to partner with Porton Advanced. Their comprehensive CDMO technical expertise and regulatory experience in cell therapy will significantly enhance our MATC program’s development efficiency and IND preparation timeline. Together, we’re committed to advancing this innovative therapy into clinical trials to benefit patients worldwide."

Andrew Chen, CFO of Porton Advanced, stated: "Collaborating with Hualong Biological marks a strategic expansion of our CDMO services in cell therapy. We are honored to provide regulatory-compliant, high-quality MATC CMC services to support their IND application. Porton Advanced is committed to supporting partners through our integrated technology platform and regulatory experience to bring cutting-edge therapies to patients faster."

Innate Pharma Highlights Abstracts Selected for ASCO 2025 Annual Meeting

On May 19, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that four abstracts with Innate’s drugs in clinical development have been accepted for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, taking place May 30-June 3, 2025 in Chicago, Illinois (Press release, Innate Pharma, MAY 19, 2025, View Source [SID1234653219]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are looking forward to participating in the ASCO (Free ASCO Whitepaper) Annual Meeting 2025, where four abstracts with Innate’s drugs in clinical development have been selected. In particular, we are pleased to share the long-term follow-up data from the TELLOMAK Phase 2 study, which underscores our continued commitment to advancing innovative therapies for patients," commented Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma.

ASCO abstract details:

Lacutamab

Abstract: 2522
Abstract Title: Lacutamab in patients with relapsed and refractory Sézary syndrome: Long term follow-up from the TELLOMAK phase 2 trial
Session Type: Poster Session
Session Title: Developmental Therapeutics—Immunotherapy
Session Date and Time: Monday, June 2, 2025 – 1:30 – 4:30 PM CDT

Abstract: 2523
Abstract Title: Lacutamab in patients with relapsed and/or refractory mycosis fungoides: Long-term follow-up and translational data from the TELLOMAK phase 2 trial
Session Type: Poster Session
Session Title: Developmental Therapeutics—Immunotherapy
Session Date and Time: Monday, June 2, 2025 – 1:30 – 4:30 PM CDT

IPH4502

Abstract: TPS3159
Abstract Title: A phase 1, open-label, multi-center study of the safety, tolerability, and efficacy of IPH4502 as a single agent in advanced solid tumors
Session Type: Poster Session
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Monday, June 2, 2025 – 1:30 – 4:30 PM CDT

Monalizumab (partnered with AstraZeneca)

Abstract: 8046
Abstract Title: Neoadjuvant durvalumab (D) + chemotherapy (CT) + novel anticancer agents and adjuvant D ± novel agents in resectable non-small-cell lung cancer (NSCLC): Updated outcomes from NeoCOAST-2.
Session Type: Poster Session
Session Title: Lung Cancer—Non–Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Session Date and Time: Saturday, May 31, 2025 – 1:30 – 4:30 PM CDT

Pfizer Enters into Exclusive Licensing Agreement with 3SBio

On May 19, 2025 Pfizer Inc. (NYSE: PFE) reported it has entered into an exclusive global, ex-China, licensing agreement with 3SBio, Inc. (01530.HK), a leading Chinese biopharmaceutical company, for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, currently undergoing several clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors (Press release, Pfizer, MAY 19, 2025, View Source [SID1234653236]). SSGJ-707 has shown initial efficacy and safety data in a promising class of cancer medicines. 3SBio plans to initiate the first Phase 3 study in China in 2025.

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Under the terms of the agreement, 3SBio and its subsidiaries Shenyang Sunshine Pharmaceutical Co., Ltd. and 3S Guojian Pharmaceutical (Shanghai) Co., Ltd. will grant Pfizer an exclusive global license to develop, manufacture and commercialize SSGJ-707 worldwide, excluding China. The agreement also provides Pfizer the option of commercialization rights in China. 3SBio will receive an upfront payment of $1.25 billion and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $4.8 billion as well as tiered double-digit royalties on sales of SSGJ-707, if approved.

The transaction is expected to close in the third quarter subject to fulfillment of customary closing conditions, including receipt of required regulatory approvals and 3SBio shareholder approval. Upon close, Pfizer will make a $100 million equity investment in 3SBio subject to an agreed upon securities subscription agreement between the parties. Pfizer plans to manufacture drug substance for SSGJ-707 in Sanford, North Carolina, and drug product in McPherson, Kansas.

Alpha Tau Announces First Quarter 2025
Financial Results and Provides Corporate Update

On May 19, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported first quarter 2025 financial results and provided a corporate update (Press release, Alpha Tau Medical, MAY 19, 2025, View Source [SID1234653221]).

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"2025 has started off with a bang at Alpha Tau, with a flurry of important milestones as we continue to evaluate Alpha DaRT in treating internal organ tumors, expand our manufacturing capabilities, and prepare for commercial activities," said Alpha Tau Chief Executive Officer Uzi Sofer. "With four active U.S. IDEs approved by the FDA, and U.S. trials expected to begin soon in patients with newly-diagnosed pancreatic cancer and recurrent GBM, construction of the first phase of our Hudson, NH facility nearing completion, and our ambitions for the continued expansion of our clinical trial program, our recently completed financing came at the perfect time to ensure that our momentum continues to accelerate throughout the course of the year."

Recent Corporate Highlights:

● In April, Alpha Tau announced the completion of a $36.9 million registered direct financing from, and strategic marketing alliance with, an affiliate of Oramed Pharmaceuticals, Inc. (Oramed). Oramed CEO, President and Chairman Nadav Kidron has also joined the Alpha Tau Board of Directors, bringing years of public company biotech experience.

● In April, Alpha Tau announced receipt of an IDE from the FDA to conduct a U.S. pilot study of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM). The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation.

● In February, Alpha Tau announced achievement of Medical Device Single Audit Program (MDSAP) certification for the Company’s manufacturing facility in Jerusalem. MDSAP was established by a coalition of international medical device regulatory authorities from Australia, Brazil, Canada, Japan and the U.S., to enable medical device manufacturers to be audited once for compliance with ISO 13485 and the standards of these five different markets. MDSAP certification may also speed the timetable to commercialization within these participating geographies, as it allows for a streamlined auditing process, providing manufacturers with a comprehensive approach to meet international regulatory standards efficiently.

● In January, Alpha Tau hosted a virtual R&D Update Day to present interim results from multiple trials as well as more information regarding the expected regulatory path forward in internal organs. Principal investigators presented data showing high disease control rate and strong interim safety results observed across three trials exploring the use of Alpha DaRT in pancreatic cancer patients, following a subset of the data presented by investigators at Hadassah Medical Center on a poster at the prestigious 2025 ASCO (Free ASCO Whitepaper) GI Symposium. Principal investigators also reported strong interim results in median survival of patients treated with Alpha DaRT after prior therapy as compared to previously published studies of alternative monotherapies, across all analyzed subgroups.

● At the R&D Update Day, positive interim results were also reported for the first eight patients recruited in a combination trial of Alpha DaRT with pembrolizumab (Keytruda), a checkpoint inhibitor, in treating patients with recurrent unresectable or metastatic head and neck squamous cell carcinoma (HNSCC). A reported systemic objective response rate of 75% and complete response rate of 37.5% were observed, compared to historical benchmarks of 19% and 5%, respectively, for pembrolizumab on its own in the KEYNOTE-048 trial.

● Approvals for two forthcoming clinical trials exploring the use of Alpha DaRT in treating pancreatic cancer were also announced during the R&D Update Day:

o IDE received from the FDA to conduct a U.S. pilot study of Alpha DaRT together with first-line chemotherapy in patients with newly diagnosed pancreatic cancer, the first step toward regulatory approval in the U.S. The trial was initially approved for 12 patients with metastatic cancer and was then expanded to 30 patients in two cohorts of 15 patients each, one cohort of patients with newly diagnosed locally advanced cancer and the other of patients with newly diagnosed metastatic cancer.

o Approval from France’s Ministry of Health to commence a French multicenter clinical trial of Alpha DaRT alongside capecitabine for patients with locally advanced pancreatic cancer, as well as a second study at a single center in France examining the use of Alpha DaRT delivered via Fine Needle System, or FNS, in the treatment of locally advanced pancreatic cancer.

Expected Upcoming Milestone Targets:

● First patient enrolled in pancreatic cancer pilot study in the U.S. in Q3 2025. For more information, please see here: View Source

● First patient treated in Israel for brain cancer in Q2 or Q3 2025.

● Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q3 2025. For more information, please see here: View Source

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

● First patient treated in U.S. GBM pilot study in H2 2025. For more information, please see here: View Source

● Response from Japan’s PMDA in H2 2025 to application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.

Financial results for quarter ended March 31, 2025

R&D expenses for the three months ended March 31, 2025 were $7.2 million, compared to $6.4 million for the same period in 2024, due to increased employee compensation and benefits, increased production expenses and reduced government grants, offset by lower share-based compensation expenses.

Marketing expenses for the three months ended March 31, 2025 were $0.5 million, compared to $0.5 million for the same period in 2024.

G&A expenses for the three months ended March 31, 2025 were $1.7 million, compared to $1.4 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation, and increased professional fees (including legal expenses).

Financial income, net, for the three months ended March 31, 2025 was $0.7 million, compared to $0.4 million for the same period in 2024, due to a decrease in expense from remeasurement of warrants, offset by a decrease in interest from bank deposits.

For the three months ended March 31, 2025, the Company had a net loss of $8.7 million, or $0.12 per share, compared to a net loss of $8.0 million, or $0.11 per share, in the three months ending March 31, 2024.

Balance Sheet Highlights

As of March 31, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $54.8 million, compared to $62.9 million at December 31, 2024. In April 2025, Alpha Tau raised $36.9 million through a registered direct financing transaction.