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NeuBase Therapeutics Reports Business Update and Financial Results for Fiscal Year 2020

On December 24, 2020 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company accelerating the genetic revolution using a new class of synthetic medicines, reported its financial results for the fiscal year ended September 30, 2020 (Press release, NeuBase Therapeutics, DEC 24, 2020, View Source [SID1234573253]).

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"Throughout 2020, we successfully executed against our development strategy, most notably with the generation of two very exciting datasets supporting our initial therapeutic pipeline, including our DM1 and Huntington’s disease programs. These initial data are a clear validation of our transformative platform and provide a strong foundation on which to build our IND-enabling studies for both programs," said Dietrich A. Stephan, Ph.D., chief executive officer of NeuBase. "In addition, these data support the broad potential of our PATrOL platform as a viable synthetic approach to genetic medicine. We believe the platform’s unique capabilities, which include increasing, decreasing and changing protein function, have the potential to redefine treatment for a multitude of patients suffering from both common and rare genetic conditions with insufficient or no therapeutic options."

"As we plan for the future, we’ve expanded our team with several key hires in the second half of the year, including the appointments of Drs. Curt Bradshaw and William Mann as chief scientific officer and chief operating officer, respectively. The expanded capabilities across our entire clinical team are expected to be a positive driver of our development activities as we enter the new year, and advance and expand our pipeline. In order to support this larger team, we recently signed a lease for a new headquarters which will offer more space and state-of-the-art lab facilities to support the rapid development of our pipeline. We look forward to providing greater insight into these activities during an investor R&D day expected to take place in the first half of CY2021," continued Dr. Stephan.

Fourth Fiscal Quarter of 2020 and Recent Operating Highlights

Announced positive preclinical in vitro and in vivo data for PATrOL-enabled anti-gene for the treatment of myotonic dystrophy type 1 (DM1), which further validate the potential of the Company’s proprietary platform to develop highly targeted genetic therapies
Appointed Curt Bradshaw, Ph.D., seasoned industry veteran and former chief scientific officer at Arrowhead Pharmaceuticals, as the new chief scientific officer of NeuBase
Further strengthened the management team with the appointment of William Mann, Ph.D., MBA, an experienced executive with a track record that spans the biopharma life cycle, as chief operating officer
Expanded the Company’s Scientific Advisory Board (SAB) with the appointments of Peter Nielsen, Ph.D., inventor of peptide nucleic acid technology, Eriks Rozners, Ph.D., an expert in alternative binding modes of peptide nucleic acids, and Randy Davis, MBA, a leader in biotech development, which complement the SAB’s existing team of renowned experts
Signed a lease for a new headquarters with office and lab space in Pittsburgh that will offer more space to support the Company’s expanding development activities around its rapidly advancing pipeline of PATrOL-enabled therapies
Financial Results for the Fiscal Year Ended September 30, 2020:

At September 30, 2020, the Company had cash and cash equivalents of approximately $32.0 million, compared with cash and cash equivalents of approximately $10.3 million at September 30, 2019. NeuBase estimates its cash and cash equivalents are sufficient to fund the currently planned operating and capital expenditures into the first quarter of CY2022;
For the fiscal year ended September 30, 2020, the Company reported a net loss of approximately $17.4 million, or a net loss of $0.89 per share, compared with a net loss of approximately $26.1 million, or a net loss of $3.16 per share, for the fiscal year ended September 30, 2019; and
For the fiscal year ended September 30, 2020, total operating expenses were approximately $17.1 million, consisting of approximately $10.1 million in general and administrative expenses and $6.9 million of research and development expenses. This compares with total operating expenses of $25.5 million for the fiscal year ended September 30, 2019, which was comprised of approximately $9.1 million in general and administrative expenses, $3.4 million in research and development expenses, and $13.0 million in research and development-license acquired expenses.

Oragenics, Inc. Announces $6.5 Million Registered Direct Offering

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.

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.

Genprex, Inc. Announces Closing Of $12 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules Without Warrants

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.

"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].

Cothera Bioscience completes series-B financing of 30 million dollars, aiming at innovative anti-tumor drugs

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.

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."

NETRIS PHARMA SUCCESSFULLY COMPLETES A €16.1M SERIES A

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 [SID1234611184]). The round was subscribed by historical investors converting their outstanding loans, and joined by New Investors collectively investing €7.5m.

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.