On December 24, 2020 Genprex, Inc. (Nasdaq: GNPX) ("Genprex" or the "Company"), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the closing of its previously announced registered direct offering of 3,116,884 shares of its common stock with a single healthcare-dedicated institutional investor (Press release, Genprex, DEC 24, 2020, View Source [SID1234573250]). The offering was priced at-the-market under Nasdaq rules at a price of $3.85 per share for gross proceeds to the Company of $12 million, before deducting commissions and estimated offering expenses. There were no warrants issued in the offering.

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"We believe that the closing of this transaction with a single, healthcare dedicated institutional investor is further evidence that the potential of our gene therapies for cancer and diabetes is gaining recognition within the community of sophisticated healthcare investors. The proceeds will provide additional resources to conduct our Acclaim-1 and Acclaim-2 clinical trials, combining our gene therapy, REQORSA, with Tagrisso (by Astra Zeneca) and Keytruda (by Merck & Co.), respectively, for the treatment of non-small cell lung cancer, as well as continue the pursuit of our pre-clinical programs in cancer and diabetes, and to potentially acquire additional technologies for our pipeline," said Rodney Varner, President and Chief Executive Officer of Genprex.

A.G.P./Alliance Global Partners acted as sole placement agent for the offering.

The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The securities were offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-239134) previously filed with the U.S. Securities and Exchange Commission (the "SEC").

A prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available for free on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities 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 24, 2020 Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company"), a company focused on the creation of the Terra CoV-2 vaccine candidate to combat the novel coronavirus pandemic, reported it has entered into definitive agreements with investors for the purchase and sale of 14,444,444 shares of its common stock at a purchase price of $0.45 per share in a registered direct offering (Press release, Oragenics, DEC 24, 2020, View Source [SID1234573252]). The closing of the offering is expected to occur on or about December 29, 2020, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333- 235763) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities 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 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that the Chinese Center for Drug Evaluation, a division of the China National Medical Products Association, has granted Breakthrough Therapy Designation ("Breakthrough Designation") to its partner Juventas Cell Therapy Ltd. for CNCT19, a potential CD19 CAR-T therapy for the treatment of adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) (Press release, CASI Pharmaceuticals, DEC 23, 2020, View Source [SID1234573227]). CASI has co-commercial rights to CNCT19 and is a shareholder of Juventas.

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The Breakthrough Designation for CNCT19 was granted based on initial data from the ongoing single arm, open-label, non-randomized, dose-escalation, Phase I study designed to determine the safety and efficacy of CNCT19 in B-ALL.

The Breakthrough Designation procedure is part of the recently revised Drug Registration Regulation which went into effect on July 1, 2020. The Breakthrough Designation process is designed to expedite the development and review of therapies that are intended for treatment of serious diseases for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over available treatment options.

Dr. Wei-Wu He, CASI’s Chairman, and CEO commented, "Our partner Juventas continues to make encouraging progress in developing their CD19 CAR-T therapy. Breakthrough Designation represents a significant regulatory milestone and has only been granted thirteen times in China. Receiving Breakthrough Designation is a very encouraging and important step forward for patients suffering from B-ALL."

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas will co-commercialize CNCT19 under the direction of the program’s joint steering committee.

About Juventas

Juventas Cell Therapy Ltd. is a China-based domestic company located in Tianjin City, China focused on cell therapy. The company’s lead product, CNCT19, devolved from the CD19 CAR-T, was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma.

On December 23, 2020 Cothera Bioscience, the parent company of Percans Oncology, reported that completed a series-B financing of nearly 30 million dollars (Press release, Cothera Bioscience, DEC 23, 2020, View Source [SID1234618853]). Led by Tsingsong Capital, this round of financing involves several domestic and foreign funds companies, such as CMB International, Sherpa Healthcare Partners, New World Investment, Langsheng Investment, Kunlun Fund, and Harbinger Venture. Old shareholders Legend Capital and Legend Star also participated in this investment as before. The funds raised will mainly be used to accelerate the global clinical development of the company’s multiple tumor-targeted innovative drugs.

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Founded by the core members of the founding team of the formerly well-known CRO CrownBio, Cothera Bioscience is an innovation-driven cancer drug company, focusing on the research and development of noveltumor-targeted drugs. By combining conditional reprogramming primary tumor cell culture technology and high-content drug screening system, the i-CR technology platform independently developed by Percans Oncology proliferate the primary tumor cells in vitro in a high-efficiency and undifferentiated way and can preserve the heterogeneity of the patient’s tumor.. The platform also uses patient primary tumor cells to screen efficient drug in vitro with a high-content drug screening system, making it more suitable for individualized drug screening and new drug development for clinical patients. Through cooperation with top domestic oncology medical centers to carry out a number of prospective comparative clinical trials, Cothera Bioscience has preliminarily proved that the i-CR system can effectively predict the actual clinical response of drugs, and it is expected to greatly improve the efficiency and clinical success rate of new anti-tumor drug development.

Taking advantage of the high correlation between the i-CR technology platform and clinical drug response, Cothera Bioscience has developed a series of new anti-cancer drugs in the fields of synthetic lethality and immunotherapy. And a number of international and domestic patents have been applied for the results of early research and development.

PC-002, the core product of Cothera Bioscience, is a first-in-class small molecule drug for MYC gene mutation tumors. MYC protein is highly expressed in more than 50% of tumors and is one of the most important "undruggable" tumor targets. PC-002 targets MYC protein degradation through a unique MOA and selectively induces MYC-dependent tumor cell to undergo apoptosis. PC-002 is about to undergo a Phase 2 clinical trial in the United States, and is expected to be quickly approved with the results of the Phase 2 trial as a blockbuster product for pan-cancer. The company’s another product, CTB-02, aiming at pan-KRAS variant bowel cancer and non-small cell lung cancer, is expected to enter Phase 1 clinical trials in Australia in 2021.

Dr. Wu Yue, co-founder and CEO of Cothera Bioscience, said: "Thank all investors for your support to the company. We will work together to explore new areas of new anti-tumor drug development and discover new values. The achievements of Cothera Bioscience come from the courage and strength to persist in science and innovation, and do what others can’t do. We will continue to base ourselves on the development of the world’s first-in-class drugs, give full play to the barriers and expertise of translational medicine that the company has accumulated over the years, fully understand the development of new drugs based on the solid drug mechanism research and tumor biology cognition to greatly increase its success rate, exploit the global market with innovative products, and strive to solve the unmet medical needs of cancer patients."

Dr. Zhang Song, a partner of Tsingsong Capital, said: "We are optimistic about the rich drug development experience and profound understanding about translational tumor medicine of the original founding team of Crown Bioscience International headed by Dr. Wu Yue, and firmly support the Cothera team’s exploration and drug development of multiple "undruggable" targets based on a unique drug screening system. Tsingsong Capital hopes to cooperate with the team for a long time from now on to help the company develop the first-in-class tumor-targeted drugs on a global scale in the context of intensified competition in the innovative drug market, and looks forward to working with the company to bring new breakthroughs in tumor treatment."

Zhang Xiao, Managing Director of China eCapital, said: "Cothera Bioscience has a world-class translational medicine team. Based on its unique i-CR drug screening platform, Cothera Bioscience has been focusing on drug development for undruggable targets for many years, and has made important progress in the research and development of new drugs for targets such as Myc and kras. We are honored to be able to help Cothera Bioscience complete this round of financing. And we are looking forward to more clinical progress of the company in the future, which will benefit more patients."

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.