Tyra Biosciences to Present at Oppenheimer’s 34th Annual Healthcare Life Sciences Conference

On February 7, 2024 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that Todd Harris, CEO of TYRA, will present at Oppenheimer’s 34th Annual Healthcare Life Sciences Conference on Tuesday, February 13, 2024, at 2pm ET (Press release, Tyra Biosciences, FEB 7, 2024, View Source [SID1234639921]). The conference is being held in a virtual format.

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A live and archived webcast of the presentation will be available via the For Investors page on the Investor section of the TYRA website.

QSAM Biosciences Signs Definitive Agreement to be Acquired by Telix Pharmaceuticals

On February 7, 2024 QSAM Biosciences Inc. (OTCQB: QSAM) ("QSAM or the "Company") reported that it has signed a definitive Agreement and Plan of Merger (the "Agreement") providing for the acquisition of the Company by Telix Pharmaceuticals Limited (ASX: TLX) ("Telix") (Press release, QSAM Biosciences, FEB 7, 2024, View Source [SID1234639942]).

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Pursuant to the Agreement, QSAM stockholders will receive (i) $33.1 million in Telix ordinary shares ("Telix Shares") or cash, less an adjustment amount equal to QSAM’s indebtedness and payables as of the merger closing (the "Closing Consideration"), and (ii) contingent value rights ("CVRs") to receive future payments of up to $90 million upon the achievement of four clinical and commercial milestones within ten years of closing.

Prior to closing the merger, QSAM will effect a reverse stock split of its common stock in a ratio between 1:1000 and 1:2000. Each whole share of QSAM common stock outstanding after the reverse split will receive Telix Shares. Any remaining fractional shares of QSAM common stock resulting from the reverse split will be exchanged for an equivalent value in cash on a per share basis based on the per share price of Telix Shares as of the signing date of the Agreement. All QSAM stockholders will receive one CVR for each QSAM common share held prior to the reverse split.

Telix Shares issued to QSAM stockholders will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), but will be issued pursuant an exemption to the registration requirements thereunder, and more specifically, Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D; and as a result, will be subject to resale restrictions under Rule 144 of the Securities Act.

QSAM stockholders representing greater than a majority of the total voting stock of the Company have already approved the merger. Closing, however, is subject to various conditions set forth in the Agreement including, among others, the filing of a definitive information statement pursuant to Regulation 14C of the Securities Exchange Act of 1934, as amended (the "Information Statement"). The merger cannot be closed until 20 days after the mailing of the Information Statement to QSAM stockholders.

Dr. C. Richard Piazza, QSAM’s Executive Chairman and co-Founder, stated, "The signing of our Merger Agreement with Telix marks a major milestone for QSAM and our shareholders. We are thrilled to advance this transaction to signing and expect to complete the transaction in the first half of 2024, subject to the timing of our Information Statement and the satisfaction of customary closing conditions. We believe strongly that Telix is the right partner to advance Samarium-153-DOTMP through clinical trials and give this important technology the best chance to improve the lives of patients suffering from bone cancer. We are equally excited for our shareholders, as we believe this is a great outcome for their investments."

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix said, "The acquisition of QSAM provides Telix with an additional near-term therapeutic pipeline asset, further differentiating our innovation position in radiopharmaceuticals and building depth in Telix’s key disease focus areas of urological and musculoskeletal oncology. Samarium is a highly optimal radionuclide for treating bone metastases, and the combination of Orphan Drug Designation and Rare Pediatric Disease Designation status with Telix’s demonstrated experience in pharmacy-based cold-kit distribution has strong potential for a rapid pathway to commercialisation of this asset."

Additional details about the Agreement, the CVRs and other material aspects of the merger and agreements and transactions contemplated by the merger will be provided in the Company’s Form 8-K to be filed subsequently with the SEC.

I-Mab (Hangzhou) Signs Major Strategic Restructuring Agreement and Receives C1 Round Financing of Over RMB 500 Million

On February 7, 2024 TJ Biopharma (the "Company") reported that in order to give full play to the advantages of the Company’s R&D system and biopharmaceutical production and enhance the market competitiveness of the Company’s overall innovative drug pipeline, I-Mab Biotech (Hangzhou) Co., Ltd. (the "Company") reported that it has reached an agreement with Nasdaq-listed I-Mab to integrate and reorganize all of I-Mab’s Chinese business, team and pipeline with the Company’s existing pipeline and assets (Press release, TJ Bio, FEB 7, 2024, View Source [SID1234653999]). At the same time, the Company also announced the completion of a C1 round of financing of more than RMB 500 million. This round of financing was jointly invested by Tailong Investment, Zhejiang Province’s "4+1" Biopharmaceutical and High-end Equipment Industry Fund, I-Mab, Hangzhou Qiantang Chengfa Technology Service Co., Ltd., Bruggemoon Limited, and Ningbo Kaitou Hanrun Capital. Haoyue Capital served as the exclusive financial advisor for this transaction.

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After the reorganization is completed, the company will achieve a leapfrog improvement in the R&D system, talent team and commercial production of innovative biological drugs. The integrated innovative drug pipeline includes 10 clinical stage projects (including two products including Etan long-acting growth hormone, which will soon submit applications for listing in China), and 7 innovative drug projects in the preclinical or clinical application stage. The company’s first phase biological drug production base in Qiantang New District, Hangzhou has been put into operation, providing clinical research and recent commercial drug supply. Its 70-acre second phase commercial production base has also completed completion acceptance, which will greatly enhance the company’s ability to provide clinical and commercial drug supply for internal pipelines and domestic and foreign strategic partners.

Dr. Jingwu Zang, founder and chairman of the company, said : "I-Mab has grown rapidly from a start-up to a Nasdaq-listed company, and has continued to evolve and develop amidst the dramatic changes and challenges in the market environment over the past few years. With this strategic reorganization, we will set sail again with China as our foundation to reshape the company’s future and strategic development space. We will leverage our core R&D competitiveness accumulated over the years and our advantages in global project transactions to accelerate the internationalization of early-stage innovative drug projects and realize the phased value of the projects. At the same time, the company will focus on Phase III innovative drug projects to achieve local product commercialization cooperation and sustainable revenue. We will stay true to our original aspiration and aspire to build a leading company in the field of tumor immunotherapy and autoimmune disease treatment in China and even the world, bringing hope and cure to patients."

Mr. Jin Yufeng, Chairman of Heda Financial, the Executive Representative of Zhejiang Province’s "4+1" Biopharmaceutical and High-end Device Industry Fund, said : "The Tianjing team has first-class innovative drug research and development, production and global commercial transaction capabilities in the field of immunology, and has a technology platform of tumor-targeted bispecific antibodies with independent and complete intellectual property rights and first-of-its-kind antibody-small molecule inhibitor fusion drugs. It has laid out mature and differentiated clinical pipelines in multiple tumor and autoimmune treatment fields. The total scale of Zhejiang Province’s "4+1" Biopharmaceutical and High-end Device Industry Fund is 5 billion. After its establishment in October 2023, during the cold winter of pharmaceutical investment, it accelerated investment and support for the pharmaceutical industry against the trend. This participation in the reorganization of Tianjing Hangzhou is an important investment layout of the fund in 2023. We are very optimistic about the capabilities of the Tianjing team and hope that Tianjing Hangzhou will become the leader of innovative drug research and development companies in Hangzhou, help the construction of Qiantang China Pharmaceutical Port, and contribute to the biopharmaceutical industry in Zhejiang Province and even China."

Mr. Ding Yameng, Founding Managing Partner and COO of Haoyue Capital, said : "Haoyue Capital is honored to serve as the exclusive financial advisor for Hangzhou Tianjing’s C1 round of financing and assist the company in completing this transaction. Although the capital market is in a periodic adjustment, truly outstanding companies and entrepreneurs will actively seek change and bravely meet challenges. Congratulations to Hangzhou Tianjing for successfully completing its C1 round of financing. We are firmly optimistic that Hangzhou Tianjing will grow into a leading Chinese biopharmaceutical company integrating R&D, production and product cooperative sales in the future."

Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable Non-Small Cell Lung Cancer

On February 7, 2024 Bristol Myers Squibb (NYSE: BMY) reported two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) (Press release, Bristol-Myers Squibb, FEB 7, 2024, View Source [SID1234639906]). The U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics Application (sBLA) and assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024. In late January, the European Medicines Agency (EMA) validated the type II variation application which confirms the submission is complete and begins the start of the EMA’s centralized review process.

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"Between 30% to 55% of non-small cell lung cancer patients who undergo surgery will experience disease recurrence. We are working to expand options that improve outcomes for patients with resectable disease, as part of our comprehensive approach to the treatment of multiple types of cancer, including and especially in earlier stages," said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. "With CheckMate -77T, we have evaluated the potential for neoadjuvant immunotherapy to induce pathological complete response and the role of perioperative Opdivo treatment in reducing the likelihood that the cancer will return and help make extended survival possible for patients. The acceptance of these applicationsunderscores our impactful progress in addressing unmet needs across several non-small cell lung cancer treatment settings and brings us one step closer to offering a new perioperative Opdivo-based regimen to patients who may benefit."

The submissions were based on results from the Phase 3 CheckMate -77T trial, which represents the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC, showing statistically significant and clinically meaningful improvements in event-free survival (EFS), the study’s primary endpoint. The study also showed benefits in key secondary endpoints including pathologic complete response (pCR) and major pathologic response (MPR). Additionally, the perioperative regimen had a safety profile consistent with previously reported studies in NSCLC and no new safety signals were identified. The EFS, pCR and MPR results from CheckMate -77T were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023. The study remains ongoing to assess another secondary endpoint of overall survival (OS).

Opdivo and Opdivo-based combinations have shown efficacy benefits in the neoadjuvant, adjuvant or perioperative settings across four cancers to date, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

About CheckMate -77T
CheckMate -77T is a Phase 3 randomized, double-blind, placebo-controlled, multi-center trial evaluating neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo in 452 patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The primary endpoint of the trial is event-free survival (EFS). Secondary endpoints include overall survival (OS), pathologic complete response (pCR) and major pathologic response (MPR).

About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.

Fusion Pharmaceuticals to Present at the Oppenheimer 34th Annual Healthcare Life Sciences Conference

On February 7, 2024 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will present virtually at the Oppenheimer 34th Annual Healthcare Life Sciences Conference on Wednesday, February 14, 2024, at 10:00 a.m. ET (Press release, Fusion Pharmaceuticals, FEB 7, 2024, View Source [SID1234639922]). Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

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A webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation date.