On December 22, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the closing of its previously announced underwritten public offering of common stock, resulting in gross proceeds to the Company of $26.4 million (Press release, Greenwich LifeSciences, DEC 22, 2020, View Source [SID1234573204]).. The Company intends to use the net proceeds for completion of all manufacturing and all clinical trial activities to complete an interim analysis and data readout of the GP2 Phase III clinical trial, for the submission of a Biologics Licensing Application to the FDA seeking conditional marketing approval of GP2, for the in-licensing or acquisition and development of additional products, including the coronavirus vaccine program, and for working capital and general corporate purposes.

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The Company has also granted the underwriters a 45-day option to purchase up to an additional 99,000 shares of common stock offered in the public offering to cover over-allotments, if any, at the public offering price, which would increase the total gross proceeds of the offering to approximately $30.4 million, if exercised in full.

Aegis Capital Corp. acted as sole bookrunner for the offering.

This offering was made pursuant to a registration statement on Form S-1 (File No. 333-251366) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and subsequently declared effective on December 17, 2020 and a registration statement on Form S-1 (File No. 333-251438) previously filed with the SEC and immediately declared effective on December 17, 2020. A final prospectus related to the offering was filed and is available on the SEC’s website. Electronic copies of the final prospectus may be obtained by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

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 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 22, 2020 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported the issuance of a U.S. patent (US 10,450,340) covering compositions of matter for a novel family of camsirubicin analogs (Press release, Monopar Therapeutics, DEC 22, 2020, https://ir.monopartx.com/news/detail/23/monopar-announces-issuance-of-u-s-patent-covering-compositions-of-matter-for-a-novel-family-of-camsirubicin-analogs [SID1234573202]). The patent, which expands the Company’s camsirubicin intellectual property portfolio, is expected to expire in 2038 not including any patent term extensions.

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"The analogs covered in this patent have been designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin and the potent broad-spectrum antitumor activity of doxorubicin; further, preclinical evidence suggests that this new family of 2-pyrrilino camsirubicin analogs could be active in doxorubicin-resistant tumor cells. This may enable us to address additional cancer types beyond those possible with camsirubicin," said Andrew Mazar, PhD, Monopar’s Chief Scientific Officer.

Doxorubicin is FDA approved in 14 different types of cancers including soft tissue and bone sarcomas; metastatic stomach, ovarian, thyroid, lung, and breast cancer; acute myeloid and lymphoblastic leukemia; Hodgkin and non-Hodgkin lymphoma; and neuroblastoma. However, cumulative dose effects of doxorubicin can result in irreversible heart damage and death, which is why a restrictive lifetime cumulative dose limitation has been placed on its use.

"If successful, camsirubicin and its analogs could overcome the restrictive dose limitation and be administered at higher doses and for longer periods of time than doxorubicin," said Chandler Robinson, MD, Monopar’s Chief Executive Officer. "This could lead to improved efficacy and better patient outcomes."

Monopar’s clinical trial collaboration partner, Grupo Español de Investigación en Sarcomas (GEIS), an internationally renowned non-profit organization focused on the research and development of drugs for sarcomas, is on track to initiate an open-label Phase 2 clinical study in early 2021 evaluating camsirubicin head-to-head against doxorubicin in advanced soft tissue sarcoma (ASTS), where doxorubicin is currently the first-line treatment.

On December 22, 2020 Bayer and Veracyte (Nasdaq: VCYT) reported a new collaboration to advance the Precision Oncology Patient Identification Program in thyroid cancer (Press release, Veracyte, DEC 22, 2020, View Source [SID1234573201]). Through the program, Bayer will offer testing with Veracyte’s Afirma Xpression Atlas (XA) to identify underlying genomic drivers, including NTRK gene fusions, within patients’ tumors. The program will focus on patients with advanced or metastatic thyroid cancer that is radioactive iodine refractory (RAIR) who may potentially benefit from biomarker-driven therapies.

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"Patients whose thyroid cancer contains actionable alterations and no longer responds to traditional radioactive iodine therapy now have targeted treatment options available to them. Our goal is to identify such patients so physicians can make more informed treatment decisions for their patients," said Bhavesh Ashar, Senior Vice President, Head of U.S. Oncology at Bayer. "With its comprehensive ability to identify broad genomic alterations through its Afirma XA test and its widespread reach among physicians who diagnose thyroid cancer, Veracyte is an ideal collaborator for this program."

The Afirma XA uses RNA whole-transcriptome sequencing to identify 905 DNA variants and 235 RNA fusions in 593 genes, including novel NTRK fusions, on fine needle aspirates taken from thyroid nodules or lymph nodes.1 Through this collaboration, Bayer will provide Afirma XA testing at no cost to all eligible patients when ordered by the physician, regardless of the final results and treatment decision. Additionally, physicians of patients found to harbor NTRK gene fusions as an underlying driver in their thyroid cancer will be alerted of the results. The companies anticipate the program to launch in the first quarter of next year.

"Our collaboration with Bayer will help ensure that all eligible thyroid cancer patients can be tested and identified for actionable genomic alterations – at no cost to them – so they may potentially benefit from biomarker-driven therapies," said Bonnie Anderson, Veracyte’s Chairman and Chief Executive Officer. "This is the first collaboration between the two companies, and we anticipate continued strategic programs to further precision oncology."

Approximately 53,000 people in the United States are expected to be diagnosed with thyroid cancer this year.2 For most of these patients, the cancer is contained in the thyroid when diagnosed.3 However, in approximately 30% of cases, the cancer has metastasized – most often to the nearby lymph nodes.4 NTRK gene fusions, which may drive tumor growth in some cancers, are more common in patients with RAIR thyroid cancer (2.4%-12% of patients).5-8

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On December 22, 2020 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it has entered into a securities purchase agreement with new and existing investors to sell an aggregate of 1.1 million shares of common stock in a registered direct offering at a price of $8.06 per share, which is the five-day average closing price of the Company’s common stock as of December 21, 2020 (Press release, Tracon Pharmaceuticals, DEC 22, 2020, View Source [SID1234573200]). The aggregate gross proceeds to TRACON from the offering are expected to be $8.8 million. The closing of the offering is expected to occur on or about December 22, 2020.

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TRACON intends to use the net proceeds from the offering to fund the ENVASARC pivotal study of envafolimab in sarcoma, further business development efforts, and for working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as a financial advisor for the offering.

The offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-229990) 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 Before investing in the 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 the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On December 22, 2020 Cytocom, Inc., a leading biopharmaceutical company creating second generation immune therapies, reported that the company is participating in Biotech Showcase Digital and H.C. Wainwright BioConnect (Press release, Cytocom, DEC 22, 2020, https://www.cytocom.com/2020/12/22/cytocom-to-participate-in-biotech-showcase-and-h-c-wainwright-bioconnect-2021/?utm_source=rss&utm_medium=rss&utm_campaign=cytocom-to-participate-in-biotech-showcase-and-h-c-wainwright-bioconnect-2021 [SID1234573199]). Both events will be held virtually and are scheduled alongside the J.P. Morgan 39th Annual Healthcare Conference 2021.

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Details of the events are as follows:

Event: Biotech Showcase Digital
Date: January 11-15, 2021
Registration: https://informaconnect.com/biotech-showcase/registration-options/

Event: H.C. Wainwright BioConnect 2021 Conference

Date: January 11-14, 2021
Registration: View Source
During both events, members of the Cytocom management team will participate in virtual one-on-one meetings with registered investors and pharmaceutical companies to discuss Cytocom’s business and highlight recent corporate achievements, as well as anticipated near-term milestones.

Cytocom’s two lead investigative compounds, CYTO-201 for the treatment of Crohn’s disease and CYTO-401 for the treatment of pancreatic cancer, are expected to enter Phase 3 clinical trials in 2021. In July 2020, Cytocom announced an agreement to acquire ImQuest Life Sciences, Inc., a drug development company and contract research organization. The company followed in October with a definitive merger agreement with Cleveland Biolabs, Inc. (Nasdaq: CBLI) and plans for a subsequent listing on Nasdaq Capital Market.