On May 16, 2023, Coherus BioSciences, Inc. (the "Company") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC and Citigroup Global Markets Inc. as representatives of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell an aggregate of 11,764,706 shares (the "Firm Shares") of its common stock, par value $0.0001 per share ("Common Stock") to the Underwriters (the "Offering") (Filing, 8-K, Coherus Biosciences, May 16, 2023, View Source [SID1234631841]). Additionally, under the terms of the Underwriting Agreement, the Company granted the Underwriters an option, for 30 days from the date of the Underwriting Agreement, to purchase up to an additional 1,764,705 shares of Common Stock (the "Optional Shares," and together with the Firm Shares, the "Shares"), which the Underwriters have elected to exercise in full. The price to the public in the Offering was $4.25 per share. The Underwriters agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $3.995 per share.

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The Offering was made under a prospectus supplement and related prospectus filed with the Securities and Exchange Commission pursuant to the Company’s effective shelf registration statement on Form S-3 (Registration No. 333-268252).

On May 18, 2023, the Company completed the sale and issuance of an aggregate of 13,529,411 shares of Common Stock, including the exercise in full of the Underwriters’ option to purchase additional shares. The Company received net proceeds of approximately $53.5 million, after deducting the Underwriters’ discounts and commissions and estimated offering expenses payable by the Company.

The Underwriting Agreement contains customary representations, warranties, covenants and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. The Company and the Company’s directors, executive officers and certain stockholders that are affiliated with the Company’s directors also agreed not to sell or transfer any Common Stock for 45 days after May 16, 2023, with respect to the Company, and 60 days after May 16, 2023, with respect to the other parties, without first obtaining the written consent of J.P. Morgan Securities LLC, on behalf of the Underwriters, subject to certain exceptions as described in the prospectus supplement.

A copy of the Underwriting Agreement, including the form of lock-up agreement, is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing descriptions of the Underwriting Agreement and lock-up agreements are not a complete description thereof, and are qualified in their entirety by reference to such exhibit.

A copy of the opinion of Latham & Watkins LLP relating to the validity of the securities issued in the Offering is filed herewith as Exhibit 5.1.

On May 17, 2023 Clinical stage oncology company Prescient Therapeutics (ASX: PTX) reported that it will present two of its abstracts at an annual conference of the International Society of Cell & Gene Therapy (ISCT) in France later this month (Press release, Prescient Therapeutics, MAY 16, 2023, View Source [SID1234631811]).

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Prescient researchers will showcase new preclinical data on the company’s next-generation immune receptor platform OmniCAR and its cell therapy enhancement platform CellPryme.

Both abstracts will also be published in the next issue of the ISCT’s official journal Cytotherapy.

The ISCT is focused on pre-clinical and translational aspects of cell and gene-based therapeutic developments and aims to advance scientific research into innovative treatments for patients.

The annual conference brings together clinicians, regulators, researchers and industry partners with a shared vision to translate cell and gene technologies into safe and effective therapies.

It attracts more than 2700 experts from 60 countries each year.

On May 16, 2023 Personalis, Inc. (Nasdaq: PSNL), National Cancer Center, and Ono Pharmaceutical Co., Ltd. reported they have entered into a collaborative agreement to examine the efficacy and safety of nivolumab, an immune checkpoint inhibitor, for resectable rectal cancer with mismatch repair deficiency (dMMR) (Press release, Personalis, MAY 16, 2023, View Source [SID1234631799]). As part of the collaboration on the VOLTAGE-2 study, an exploratory analysis will be conducted to evaluate specific biomarkers such as minimal residual disease (MRD) status that may have prognostic or predictive value for patient care.

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Under the agreement, National Cancer Center Hospital East (NCCHE) will recruit patients and conduct the clinical trial, Ono will provide nivolumab, and Personalis will perform MRD and biomarker testing. Biomarker research will be conducted throughout the study, including sample analysis from both tumor lesion tissue and plasma circulating tumor DNA (ctDNA). The Personalis NeXT Personal platform will be used to correlate MRD status with standard of care imaging and drug response data by monitoring variances in ctDNA. Tissue samples will be analyzed by the Personalis ImmunoID NeXT platform to capture tumor molecular profile and tumor microenvironment features to better understand immunotherapy responses.

"We deeply value the opportunity to work with NCCHE and Ono – respected oncology leaders worldwide – to demonstrate the clinical validity of our ultra-sensitive liquid biopsy MRD assay, NeXT Personal, in early-stage rectal cancer patients to better predict drug response and disease recurrence in subsequent interventional trials based on ctDNA status," said Richard Chen, MS, MD, Executive Vice President, R&D and Chief Medical Officer at Personalis. "We believe that data from this study will be another step towards supporting the use of our highly sensitive MRD assay in rectal cancer and other cancer types."

"In our VOLTAGE study, we will include patients with dMMR resectable rectal cancer, who are being treated with nivolumab. Using NeXT Personal, we would like to investigate if an MRD negative result can be the surrogate marker of clinical complete response," said Hideaki Bando, MD, Assistant Chief, Department of Gastroenterology at NCCHE and Principal Investigator and Research Secretariat of the VOLTAGE-2 study. "We also would like to explore the association between immune microenvironment and efficacy of nivolumab using ImmunoID NeXT. These comprehensive assays may enable the selection of cases with high efficacies and will promote the non-operative management in dMMR rectal cancer."

On May 16, 2023 RadioMedix and Orano Med, two clinical stage radiopharmaceutical companies, reported that the last patient has been dosed in the Phase II trial of the targeted alpha emitter therapy, 212Pb-DOTAMTATE (AlphaMedix) (Press release, RadioMedix, MAY 16, 2023, View Source [SID1234631798]). This trial is being conducted to evaluate the safety and effectiveness of AlphaMedix in peptide receptor radionuclide therapy (PRRT) of naive patients with somatostatin receptor-expressing neuroendocrine tumors (NET), regardless of the location of the primary tumor. Top-line data from the trial is expected in mid-2024. Remarkably, based on data already collected, the objective response rate (ORR) endpoint has already been achieved and is more than twice as high as the current standard of care.

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"The completion of the Phase II trial enrolment is a significant milestone in the clinical development of our innovative targeted alpha-emitter radiotherapy, AlphaMedix, and brings us one step closer to having this drug available to patients," said Ebrahim Delpassand, MD, Chairman and Chief Executive Officer of RadioMedix. "Previous studies have shown targeted alpha therapy (TAT) with AlphaMedix is well-tolerated. The preliminary efficacy data seen to date are very promising, particularly achieving the planned ORR endpoint. As the trial progresses, we believe the ORR could improve further. We look forward to reporting data on the study in 2024, which we believe will show that AlphaMedix will provide substantial benefit over currently FDA approved therapies for patients with metastatic or inoperable SSTR-expressing NETs."

This Phase II trial is a multi-center, single arm, non-randomized, open-label basket trial. Forty-one patients with histologically confirmed NETs and positive somatostatin analogue imaging who have not received prior PRRT have been enrolled across four sites in the United States. Treatment consists of four cycles of AlphaMedix at 8-week intervals. The primary endpoint of the trial is safety and effectiveness of AlphaMedix. Efficacy endpoints include objective response rate (ORR) using RECIST v1.1 criteria, progression-free survival (PFS), and overall survival (OS). Additional information about the trial can be found on clinicaltrials.gov: NCT 05153772.

Julien Dodet, President, and Chief Executive Officer of Orano Med, noted: "Completing this Phase II trial enrolment on schedule is a great achievement everyone involved and confirms the strong interest of the medical community for targeted alphatherapies with lead-212. We are convinced that targeted alphatherapies, such as AlphaMedixTM, are the future of radiopharmaceutical therapies, providing an increased cytotoxic potential against cancer cells with limited toxicity to surrounding healthy cells. This reinforces Orano Med’s commitment to make innovative lead-212-based therapies available to the medical community and patients worldwide."

About Targeted Alpha Therapy

Targeted alpha therapy (TAT) relies on a simple concept: combining the ability of biological molecules to target cancer cells with the short-range cell-killing capabilities of alpha-emitting radioisotopes. Alpha decay consists of the emission of a helium nucleus (alpha particle) together with very high linear energy transfer and a range emission of only few cell layers, resulting in irreparable double strand DNA breaks in cells adjacent only to area of alpha emission. This approach results in an increased cytotoxic potential toward cancer cells while limiting toxicity to nearby healthy cells. As a result, alpha emitters are considered as the most powerful payloads to be found for targeted therapies.

About AlphaMedixTM

AlphaMedixTM is a radiolabeled SSTR-targeting therapeutic investigational drug for the treatment of NETs patients. The product consists of SSTR-targeting peptide complex radiolabeled with 212Pb that serves as an in vivo generator of alpha-emitting particles. 212Pb isotope is particularly suitable for SSTR therapy applications based upon its half-life, energy, and decay properties.

About neuroendocrine tumors

Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas but can also occur in other tissues including the thymus, lung, and other uncommon sites such as ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors (SSTRs). In the United States, around 12,000 patients are expected to be diagnosed with neuroendocrine tumors, with an average 5-year survival rate of 60% at a metastatic stage.

On May 16, 2023 Boundless Bio, a clinical stage, next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) for patients with oncogene amplified cancers, reported the closing of a $100 million Series C financing co-led by Leaps by Bayer, the impact investment arm of Bayer AG, and RA Capital Management, with participation from additional new investors, Sectoral Asset Management and Piper Heartland Healthcare Capital (Press release, Boundless Bio, MAY 16, 2023, View Source [SID1234631797]). Boundless Bio will use the financing to advance BBI-355, the first ecDNA-directed therapy (ecDTx), through meaningful clinical readouts from its ongoing Phase 1/2 clinical trial in patients with oncogene-amplified cancers.

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Historically, targeted therapies and immunotherapies have been largely ineffective in treating patients with oncogene amplified cancers. Boundless Bio is the first company wholly dedicated to developing novel therapeutics for patients with oncogene amplified cancers, specifically those enabled by ecDNA. Absent in normal healthy tissue, ecDNA have been observed in 14% of early-stage cancers and up to 40% of metastatic cancers and drive both oncogenesis as well as resistance to current therapeutic approaches. Boundless Bio is leveraging a unique understanding of the vulnerabilities of ecDNA biology with the aim to deliver potentially transformative therapies to the up to 400,000 patients newly diagnosed in the US each year with previously intractable oncogene amplified cancers.

The capital raised will fund initial clinical development of BBI-355, as a single agent and in combination with select therapies, for multiple cancer indications with oncogene amplifications being evaluated in the ongoing Phase 1/2 POTENTIATE clinical trial (NCT05827614). BBI-355 is an orally available, potent, and selective CHK1 inhibitor, which has been shown preclinically to be synthetically lethal to ecDNA-bearing oncogene-amplified cancer cells. The new funds will also support advancement of Boundless Bio’s preclinical pipeline of differentiated ecDTx candidates and its proprietary ecDNA diagnostic clinical trial assay, ECHO (ecDNA Harboring Oncogenes), which is being developed in partnership with SOPHiA GENETICS.

"At Leaps by Bayer, we invest in fundamental breakthroughs in healthcare," said Juergen Eckhardt, M.D., EVP and Head of Leaps by Bayer. "The ability to address oncogene amplified cancers has remained one of the industry’s greatest challenges in the treatment of cancer. We are thrilled to support Boundless Bio, a company whose innovations have the potential to impact the lives of patients who currently have no effective standard of care."

The Series C financing included participation from existing investors Fidelity Management & Research Company LLC, ARCH Venture Partners, Nextech Invest, Wellington Management, Vertex Ventures HC, Redmile Group, Surveyor Capital (a Citadel company), GT Healthcare Capital Partners, Alexandria Venture Investments, PFM Health Sciences, Logos Capital, and City Hill Ventures. In conjunction with the financing, Fabio Pucci, Ph.D., Senior Director of Venture Investments Health at Leaps by Bayer, will join the Boundless Bio Board of Directors.

"We are excited to have Leaps by Bayer join our world-class investor syndicate and to welcome Fabio Pucci to our Board of Directors," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "The support from new investors along with the continued commitment of our existing investors emphasizes our momentum and progress in bringing the first ecDNA-directed therapies to patients with oncogene-amplified cancers."

About BBI-355

BBI-355 is a potentially best-in-class checkpoint kinase 1 (CHK1) inhibitor and the first ecDNA-directed therapy (ecDTx) being investigated to treat patients with oncogene amplified cancer. CHK1 is a master regulator of DNA replication stress (RS), which frequently arises from oncogene amplification on ecDNA. Inhibition of CHK1 by BBI-355 is synthetic lethal in cancer cells with oncogene amplification on ecDNA due to their heightened RS. CHK1 was identified and validated as an ecDNA essential target via Boundless Bio’s proprietary Spyglass research platform, leading Boundless Bio to develop BBI-355, an orally available, potent, and selective CHK1 inhibitor. BBI-355 is being evaluated in a first-in-human trial ("POTENTIATE": Precision Oncology Trial Evaluating Novel Therapeutic Interrupting Amplifications Tied to ecDNA) designed to evaluate the safety, maximum tolerated dose, and recommended Phase 2 dose of BBI-355 as a single agent and in combination with select therapies in patients with locally advanced or metastatic solid tumors with oncogene amplifications (NCT05827614).