On December 18, 2023 Eli Lilly and Company (NYSE: LLY) reported the extension of the expiration of the tender offer to acquire all of the issued and outstanding shares ("Shares") of common stock of POINT Biopharma Global Inc. (NASDAQ: PNT), for a purchase price of $12.50 per share in cash, without interest and less any applicable tax withholding (Press release, Eli Lilly, DEC 18, 2023, View Source [SID1234638645]).

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The tender offer, which was previously scheduled to expire at 5:00 p.m., Eastern time, on Dec. 15, 2023, has been extended until 5:00 p.m., Eastern time, on Dec. 22, 2023, unless the tender offer is further extended or earlier terminated, in order for the parties to satisfy the minimum tender condition. All regulatory approvals necessary for the consummation of the transaction have been obtained.

Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Lilly that, as of 5:00 p.m., Eastern time, on Dec. 15, 2023, approximately 24,338,647 Shares have been validly tendered and not properly withdrawn in the tender offer, representing approximately 22.81% of the issued and outstanding Shares, as of such date and time. Holders that have previously tendered their Shares do not need to re-tender their Shares or take any other action in response to the extension of the tender offer. Questions or requests for assistance may be directed to Georgeson LLC, the information agent for the tender offer, by calling toll free 1-800-932-9864 or via email to [email protected].

On December 18, 2023 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported the grant of inducement awards to four employees on December 15, 2023 (the "Grant Date") in connection with the employees’ commencement of employment at CymaBay (Press release, CymaBay Therapeutics, DEC 18, 2023, View Source [SID1234638644]). The Compensation Committee of the Board of Directors of CymBay approved the grant of non-qualified stock options to purchase an aggregate of 176,000 shares of CymaBay common stock as inducements material to the employees entering into employment with CymaBay in accordance with Nasdaq Listing Rule 5635(c)(4), and are subject to the terms and conditions of the applicable award agreement covering such grants.

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These stock option grants have an exercise prices of $22.03 per share, which was equal to the closing price of CymaBay’s common stock on the Grant Date. The stock options will vest and become exercisable as to 25% of the underlying shares on the first anniversary of the Grant Date, and will vest and become exercisable as to the remaining 75% of the underlying shares in 36 equal monthly installments from the first anniversary of the Grant Date, subject to the applicable employee’s continued employment with CymaBay on such vesting dates.

On December 18, 2023 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (CNS or the Company), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported the recommendation of the independent Data Safety Monitoring Board (DSMB) that the Company’s ongoing global, potentially pivotal trial of the investigational agent, Berubicin for the treatment of glioblastoma multiforme (GBM) continue without any modification (Press release, CNS Pharmaceuticals, DEC 18, 2023, View Source [SID1234638643]). The recommendation follows the DSMB’s pre-specified futility analysis of unblinded (to the DSMB only) efficacy and safety data in the Company’s trial of Berubicin versus Lomustine, a standard of care in patients with recurrent GBM. More specifically, the DSMB reviewed the primary endpoint of overall survival (OS) and secondary efficacy measures progression-free survival (PFF) and overall response rate (ORR), as well as safety data in evaluable patients. In order to support continuing the trial, Berubicin’s efficacy had to be at least comparable to Lomustine’s on the primary endpoint (OS).

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"Having successfully reached this milestone, we believe that this recommendation reflects Berubicin’s acceptable efficacy and safety profile, as defined in the trial protocol, as of the interim analysis. Building on the foundation of strong enrollment laid by our team, our investigators and their patients, the independent findings of the DSMB add to the Phase 1 trial data, where 44% of treated patients received a clinical benefit of stable disease or better," said John Climaco, CEO of CNS Pharma. "Finding an effective treatment for GBM remains one of the great challenges in oncology, and more meaningful options for the many patients who fail first-line therapy are still desperately needed after decades of research. With this recommendation to continue the study, our long-held belief that Berubicin will ultimately address the unmet clinical need of GBM patients now moves closer to becoming reality."

The potentially pivotal study of Berubicin is a multicenter, open-label, randomized controlled study in adult patients with recurrent GBM (WHO Grade IV) after failure of standard first-line therapy and compared to Lomustine. Overall Survival is a rigorous endpoint that the FDA has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.

For more information about this trial, visit clinicaltrials.gov and reference identifier NCT04762069.

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin, which enables more frequent interactions with the agency for guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA for using Berubicin to treat malignant glioma, which may provide seven years of marketing exclusivity upon approval of a New Drug Application (NDA).

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

On December 18, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the 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 early recruitment closure for its Phase II diagnostic 64Cu-SARTATE trial, DISCO (NCT04438304)1, for patients with known or suspected neuroendocrine tumours (NETs) (Press release, Clarity Pharmaceuticals, DEC 18, 2023, View Source [SID1234638642]). A total of 45 patients have been enrolled in the trial and all of the participants have now been administered and imaged with 64Cu-SARTATE. All trial participants have now progressed to or have completed the follow-up stage.

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The trial was originally planned for up to 63 patients based on an expected discordance level between imaging with Clarity’s 64Cu-SARTATE and the current standard of care, 68Ga-DOTATATE. The sample size was adjusted to 45 patients based on the pre-planned assessment of the images to generate sufficient evidence to plan for a Phase III trial in this indication, enabling recruitment to successfully close early.

DISCO, which derives from "Diagnostic Imaging Study of 64COpper-SARTATE Using PET on Patients with Known or Suspected Neuroendocrine Tumours", is assessing the performance of Clarity’s SARTATE imaging product as a potential new way to help diagnose and manage NETs. The DISCO trial recruited participants with Gastroenteropancreatic NETs (GEP-NETs) across four sites in Australia, comparing the diagnostic performance of 64Cu-SARTATE at 4 and 20 hours post-administration to 68Ga-DOTATATE at one hour.

The trial aims to build on earlier work with SARTATE2 which demonstrated that imaging at later time points, enabled by a longer half-life of 64Cu in comparison to 68Ga, may lead to better identification of disease.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are very pleased with the progress of our SARTATE product and the DISCO trial. Whilst the main focus for this product is on neuroblastoma in children, for both therapy and diagnosis, which includes two Rare Pediatric Disease Designations and two Orphan Drug Designations in this indication, the initial imaging data looks highly encouraging in NETs. We are optimistic the final trial results will underscore the diagnostic capability of 64Cu-SARTATE for patients with NETs, and we eagerly anticipate the comprehensive analysis from the DISCO trial.

"Unfortunately, misdiagnosis and delays in diagnosis are prevalent in this patient population, but we believe that SARTATE has the potential to play a vital role in improving NETs diagnosis and treatment outcomes for these patients. We are confident the clinical advantages of SARTATE, combined with the logistical benefits of Targeted Copper Theranostics (TCTs), will ensure timely and convenient diagnosis and access to critical treatments for cancer patients.

"The Clarity TCT platform comprises of products not only focused on NETs, but also on other malignancies with high unmet need. Regarding our diagnostic portfolio, we were pleased to recently announce the recruitment closure of one of our studies in Gastrin Releasing Peptide Receptor (GRPR)-positive biochemically recurrent prostate cancer using SAR-Bombesin (SABRE, NCT05407311)3,4 and the activation of the first site for our Phase III registrational study in pre-prostatectomy patients with SAR-bisPSMA (CLARIFY, NCT06056830)5,6. We are also eagerly awaiting to receive the data and initial analysis of the results from the COBRA study (biochemically recurrent prostate cancer using 64Cu-SAR-bisPSMA, NCT05249127)7 from our partnering contract research organisation, and at this stage we expect to share these results in early 2024".

About SARTATE
SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2), including neuroblastoma and neuroendocrine tumours (NETs). Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu-SARTATE) or copper-67 (67Cu) for therapy (67Cu-SARTATE).

64Cu-SARTATE and 67Cu-SARTATE are unregistered products. Individual results may not represent the overall safety and efficacy of the products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available.

About NETs
NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, represent a heterogeneous group of malignant transformations of cells of the diffuse neuroendocrine system8. They most commonly occur in the gastrointestinal tract (48%), lung (25%), and pancreas (9%), but may also originate in other areas, including the breast, prostate, thymus and skin9. NETs can either be benign or malignant, as well as non-functional and functional10. NETs traditionally have been considered uncommon; however, the incidence has been increasing as a worldwide phenomenon11. This increase is thought to be mostly related to improvements in the way NETs are diagnosed, including better imaging tests and endoscopy, and increased awareness of these tumours12.

Overall, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year, and approximately 175,000 people are living with this diagnosis12. Patients with GEP-NETs present with subtle clinical symptoms, which can lead to a delay in diagnosis of up to 5–7 years or result in inappropriate management13. As such, about 30-75% of NET patients have distant metastases at the time of diagnosis14. A 10-year relative survival rate for patients with metastatic GEP-NETs is 3–36%.

On December 18, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), reported that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for the cosibelimab biologic license application ("BLA") for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or radiation (Press release, Checkpoint Therapeutics, DEC 18, 2023, View Source [SID1234638640]). The CRL only cites findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission.

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The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.

"As the only deficiencies relate to the FDA’s inspection of our third-party contract manufacturing organization, we believe we can address the feedback in a resubmission to enable marketing approval in 2024," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We are committed to working closely with our third-party manufacturer and the FDA on our resubmission in order to make cosibelimab available to patients living with cSCC."