On December 23, 2020 Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, reported that it has executed a securities purchase agreement to raise gross proceeds of $110 million resulting from the sale of shares of its common stock and/or pre-funded warrants through a private investment in public equity (PIPE) financing at a price per share of $3.34 (Press release, Gritstone Oncology, DEC 23, 2020, View Source [SID1234573685]). The financing was led by certain existing and new investors, Redmile Group, Avidity Partners and EcoR1 Capital.

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The PIPE financing is subject to customary closing conditions and is expected to close on December 28, 2020. The PIPE financing was done in compliance with applicable Nasdaq rules and priced at the "Minimum Price" (as defined in the Nasdaq rules). Cowen served as the sole placement agent for the financing. The company expects to use net proceeds from this private placement to fund research and development expenses, including the clinical development of its lead cancer immunotherapies, GRANITE and SLATE, and advancement of opportunities from its core technologies including Gritstone EDGE and vaccine platforms, as well as for working capital and other general corporate purposes.

"We believe these additional resources position us well to accelerate the advancement of our two lead cancer immunotherapies, GRANITE and SLATE," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. "Additionally, we are exploring the broader potential of our first-in-class technology platforms – EDGE as a leading T cell antigen identification technology complementing our highly immunogenic vaccine platforms, now well established in human clinical studies."

The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the U.S. except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Gritstone has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in this private placement.

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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 23, 2020 NETRIS Pharma, a clinical-stage biopharmaceutical company developing next generation molecules targeting cancer, reported the closing of a €16.1m Series A financing and the reinforcement of its Board of Directors (Press release, Netris Pharma, DEC 23, 2020, View Source [SID1234573284]). The round was subscribed by historical investors converting their outstanding loans, and joined by New Investors collectively investing €7.5m.

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Patrick Mehlen, NETRIS Pharma Founder and CEO, commented "NETRIS Pharma is proud to have achieved major milestones in these highly turbulent times and thank BPDG for its active role in this fundraising process. Further to the signature of a collaboration Agreement with MSD for the coming Phase 1B/2 trial in combination with Pembrolizumab,such funding creates opportunities to accelerate the clinical development plan of NETRIS Pharma in other indications of interest."

Banque Profil de Gestion (BPDG) acted as the sole advisor for the fundraising process led by Gianpaolo Chiriano, Managing Director and Head of Healthcare & Life Sciences at BPDG, who added: "we are glad to have contributed to the achievement of this milestone for NETRIS Pharma with the hope to impact lives of cancer patients."

Netris Pharma was founded as a spin-off of Centre Léon Bérard to develop a complete novel approach in oncology based on the biology of dependence receptors. The company, driven by scientific excellence and strong clinical insights, successfully develop NP137 targeting Netrin-1, which exhibited encouraging signs of clinical activity in its Phase 1A trial and extensions.

Netris Pharma will primarily use the proceeds of the Series A to conduct the planned Phase1B /2 clinical trial to investigate the safety and efficacy of NP137 in combination with KEYTRUDA in patients with advanced/metastatic uterine tumors and for general corporate purposes.

On December 23, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported the pricing of its previously announced underwritten public offering of its common stock for gross proceeds of approximately $24.5 million at a public offering price of $1.35 per share of common stock, prior to deducting underwriting discounts and commissions and estimated offering expenses (Press release, Cellectar Biosciences, DEC 23, 2020, View Source [SID1234573281]).

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The shares of common stock in the public offering were offered pursuant to a registration statement on Form S-3 (File No. 333-244362), which was declared effective by the Securities and Exchange Commission (SEC) on August 20, 2020. The public offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and the accompanying prospectus relating to the public offering will be filed by the Company with the SEC. Copies of the prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].

In a separate concurrent private placement transaction led by healthcare-focused institutional investors, Cellectar offered and sold 1,518.5180 shares of Series D convertible preferred stock convertible into a number of shares of common stock equal to $13,500 divided by $1.35 (the "Conversion Price") (or 10,000 shares of common stock for each share of Series D Preferred Stock converted), at a price of $13,500 per share of Series D Preferred Stock. The gross proceeds from the private placement are expected to be approximately $20.5 million, prior to deducting placement agent fees and estimated expenses. The Series D Preferred Stock will only be convertible into common stock upon receipt of stockholder approval of the issuance of the shares of common stock as required by Nasdaq Marketplace Rule 5635(d) at a special stockholder meeting to be called for that purpose. The Series D Preferred Stock and the shares of our common stock issuable upon the exercise of the Series D Preferred Stock are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. Such preferred shares and common shares issuable upon conversion of the preferred shares have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

Oppenheimer & Co. Inc. acted as the sole book-running manager in connection with the public offering and the lead placement agent in connection with the private placement. Roth Capital Partners, Maxim Group LLC and Ladenburg Thalmann & Co. Inc. acted as co-managers in connection with the public offering and as co-placement agents in connection with the private placement.

The public offering and the private placement are expected to close on or about December 28, 2020, subject to the satisfaction or waiver of customary closing conditions.

This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Cellectar being offered in the public offering or concurrent private placement, and shall not constitute an offer, solicitation or sale of any security in the public offering or concurrent private placement in any state or 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 jurisdiction.

On December 23, 2020 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, reported that it has received a "Study May Proceed" letter from the US Food and Drug Administration (FDA) to begin a Phase Ib study evaluating CX-5461, a first-in-class G-quadruplex stabilizer, to treat solid tumors with BRCA2 or PALB2 mutations (Press release, Senhwa Biosciences, DEC 23, 2020, View Source [SID1234573240]).

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"The FDA’s approval of our Phase Ib clinical trial application for testing CX-5461 in patients with BRCA2 or PALB2 mutations is an important milestone and marks a new paradigm in the treatment of cancers with specific pathogenic mutations," stated Dr. John Soong, the Chief Medical Officer of Senhwa Biosciences.

In 2016, Canadian Cancer Trial Group (CCTG), a recipient of the Stand Up to Cancer’s Dream Team Grant selected CX-5461 to study in their Phase I trial. In the CCTG Trial, CX-5461 demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers that were resistant to platinum and other chemotherapeutics. This new Phase Ib trial will occur in both the US and Canada, and study endpoints include a re-confirmation of the efficacy signal. This trial is currently under review with Health Canada.

CX-5461 was recently named as a PCF (Prostate Cancer Foundation)-Pfizer Global Challenge Award recipient. Specifically, it will be used together with Pfizer’s PARP inhibitor (PARPi), Talazoparib, to evaluate the combined therapeutic potential in treating prostate cancer. For American men, prostate cancer is the second-leading cause of cancer death. Due to a DNA repair defect, BRCA1/2 deficient tumor cells are more sensitive to PARPi through the mechanism of synthetic lethality; however, PARPi resistance is commonly seen in clinical use. More than 40% of BRCA1/2-deficient patients fail to respond to PARPi.

"CX-5461 has proven human efficacy across certain tumor types by accelerating dsDNA breaks. We believe CX-5461 has great potential as a therapeutic for patients who have developed resistance to PAPRi or other chemotherapies. Addressing treatment for resistant tumors continues to be an unmet medical need in cancer treatment," said Dr. Tai-Sen Soong, CEO of Senhwa Biosciences.

About CX-5461

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by CX-5461 through a synthetic lethality approach by targeting the DNA repair defects in Homologous Recombination Deficiency (HRD) tumors. Specifically, CX-5461 is designed to stabilize DNA G-quadruplexes of cancer cells which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death.

On December 23, 2020 Rakuten Medical, Inc. (Rakuten Medical) reported that their Phase 1b/2 clinical trial, an Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors (ClinicalTrials.gov Identifier: NCT04305795) has enrolled and treated its first patient in the United States, at The University of Texas MD Anderson Cancer Center, Houston, Texas (Press release, Rakuten Medical, DEC 23, 2020, View Source [SID1234573239]). Approximately 74 patients are planned for this trial in Head and Neck Squamous Cell Carcinoma (HNSCC) and Cutaneous Squamous Cell Carcinoma (CuSCC).

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The trial will enroll three cohorts of patients within distinct populations – all with locally advanced, recurrent and/or metastatic HNSCC or locally advanced or metastatic CuSCC. Primary endpoints of this study include safety, tolerability, and tumor response of the ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy.

"This trial is part of our commitment to develop ASP-1929 as part of our proprietary Illuminox platform for advancing treatment in HNSCC, as well as expanding into CuSCC," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical. "Based on the approval of ASP-1929 by the MHLW in Japan, we are hopeful in this latest expansion into CuSCC as part of our lifecycle management strategy."