On December 29, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the following year end update (Press release, Greenwich LifeSciences, DEC 29, 2022, View Source [SID1234625662]).

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SABCS Update & New Flamingo-01 Steering Committee

At the 2022 San Antonio Breast Cancer Symposium (SABCS), the Company met with the Flamingo-01 Steering Committee and met with clinicians from the US and various countries in Europe who are participating or planning to participate in Flamingo-01.

The Steering Committee is comprised of the following members and may be expanded as Flamingo-01 is expanded into Europe:

Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center
Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology
Dr. Sara A. Hurvitz – Professor of Medicine at the David Geffen School of Medicine at UCLA, Medical Director of the Jonsson Comprehensive Cancer Center Clinical Research Unit, Co-Director of the Santa Monica-UCLA Outpatient Oncology Practices, Director of the Breast Cancer Clinical Trials Program at UCLA, and Chief Medical Officer of TRIO-US
Dr. Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas
Dr. Rimawi, Chair of the Steering Committee, commented, "We are excited about having initiated this trial. We believe that GP2 carries great potential to improve outcomes for patients with HER2 positive breast cancer. With growing interest and excitement about treatments that boost the immune response to cancer, this trial is as timely as it is innovative, and we look forward to conducting it with the exceptional team of investigators we will be collaborating with in Flamingo-01."

CEO Snehal Patel commented, "We were very encouraged by the meetings held at SABCS with clinicians who are participating in or interested in participating in Flamingo-01. The Company will continue to focus on opening more clinical sites than the 20 sites currently opened in the US, expanding Flamingo-01 into the largest countries in Europe, and enrolling and treating patients. We encourage potential patients to reach out to the clinical sites directly or to email the Company."

Clinical Sites Participating in Flamingo-01 Phase III Clinical Trial

Approximately 20 clinical sites with 63 locations at multiple hospitals and the largest oncology network in the US are currently recruiting patients. The Company has added a new page to its website to provide updates to Flamingo-01 which includes a map of participating clinical sites in the US (view here).

Patients who are interested in participating in the Flamingo-01 Phase III clinical trial can contact the Company by email at:

[email protected]

Patients can obtain the latest clinical site contact information to contact sites directly on www.clinicaltrials.gov with identifier NCT05232916 (view here, then click on "Contacts and Locations" near the top right corner or near the bottom of the web page). The current listing of US sites from www.clinicaltrials.gov with email contact information for some sites is also shown below and will be continually updated during the trial:

Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Principal Investigator: Erica Stringer-Reasor, MD

Arizona

Arizona Oncology Associates, PC – HOPE

Tucson, Arizona, United States, 85745

Contact: Stacey Kimbell, R.N. [email protected]

Principal Investigator: Aisha Ahmed, MD

California

University of Southern California

Los Angeles, California, United States, 90033

Principal Investigator: Danielle Sterrenberg, MD

University of California, Los Angeles

Los Angeles, California, United States, 90404

Principal Investigator: Sara Hurvitz

Torrance Memorial Physicians Network

Torrance, California, United States, 90505

Principal Investigator: David Chan, MD

PIH Hospital – Whittier

Whittier, California, United States, 90602

Principal Investigator: Lisa Wang, MD

Colorado

Rocky Mountain Cancer Centers

Denver, Colorado, United States, 80220

Principal Investigator: Mabel Mardones, MD

Florida

University of Miami

Coral Gables, Florida, United States, 33146

Principal Investigator: Mauricio Escobar, MD

Orlando Health Cancer Institute

Orlando, Florida, United States, 32806

Principal Investigator: Nikita Shah, MD

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Principal Investigator: Aixa Soyano, MD

Maryland

Maryland Oncology Hematology (USOR)

Annapolis, Maryland, United States, 21401

Principal Investigator: Jeanine Werner, MD

Nebraska

Nebraska Cancer Specialists (USOR)

Omaha, Nebraska, United States, 68114

Contact: Heather Cordes [email protected]

Principal Investigator: Mary Wells, MD

Nevada

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States, 89052

Principal Investigator: Stephani Christensen, MD

New York

Columbia University

New York, New York, United States, 10032

Contact: [email protected]

Principal Investigator: Julia McGuinness, MD

Stony Brook University

Stony Brook, New York, United States, 11794

Principal Investigator: Jules Cohen, MD

Oregon

Compass Oncology (USOR)

Tigard, Oregon, United States, 97223

Contact: Jennifer Thompson [email protected]

Principal Investigator: Jay Andersen, MD

Texas

Texas Oncology – Austin

Austin, Texas, United States, 78745

Contact: Sara Manning [email protected]

Principal Investigator: Debra A Patt, MD

Texas Oncology – Dallas (USOR)

Dallas, Texas, United States, 75246

Contact: Christine Terraciano [email protected]

Principal Investigator: Cynthia Osborne, MD

Baylor College of Medicine

Houston, Texas, United States, 77057

Contact: Mothaffar Rimawi, MD

Principal Investigator: Mothaffar Rimawi, MD

Texas Oncology San Antonio (USOR)

San Antonio, Texas, United States, 78240

Contact: Shannon Syring [email protected]

Principal Investigator: Emmalind Aponte, MD

Texas Oncology – Tyler (USOR)

Tyler, Texas, United States, 75702

Principal Investigator: Nanna Sulai, MD

Virginia

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

Principal Investigator: Shruti Tiwari, MD

The Colorado and Alabama sites listed above are not yet recruiting. An additional 10 sites near the following locations may be activated in the future: San Francisco, Boston, Chicago, Philadelphia, Houston, Cincinnati, Albany, Dallas, Omaha, and New Haven. Negotiations are under way to add an additional 60-75 sites in Europe, bringing the total number of potential sites in Flamingo-01 to over 90 sites.

Flamingo-01 Enrollment & Open Label Data

Future updates or abstracts/posters may include the patient enrollment status of the trial and potentially open label data results.

Mr. Patel further added, "We look forward to analyzing open label data, which may include injection site reactions, delayed type hypersensitivity testing, and immune response data as they become available by HLA type. The objective, although there is no assurance that any of this will be possible, is to assess how Flamingo-01 is progressing compared to the Phase IIb trial, where no recurrences were observed in the GP2 treated patients as previously reported. Along the way, the treatment of patients of different HLA types and the use of new T cell identification technologies may provide additional insights into GP2’s mechanism of action and market potential, including potential additional intellectual property for the Company."

Commercial Manufacturing & New Intellectual Property

In the fourth quarter of 2022, the Company initiated commercial manufacturing activities, which, if successful, would lead to the completion of the first 3 commercial lots of GP2 active ingredient in 2023 and which in total could be used to prepare approximately 200,000 doses of GP2. These commercial lots would be submitted to the FDA in the US and other regulatory agencies in Europe when a marketing application is filed seeking approval to sell GP2 in these respective locations.

In the fourth quarter of 2022, a new patent application was filed with regards to the use of GP2 in an immune response assay that could be used as a biomarker. Plans are in place to potentially file additional patent applications with regards to the use of GP2 in treating patients and with regards to GP2 manufacturing, pharmacy, or injection processes.

IR Calendar, Bloomberg Interview, & Updated Corporate Presentation Webcast

The Company’s events over the past 6 months can be seen on the events calendar (view here), which include Jefferies and Wainwright investor conferences, BIO Europe partnering conference, Susan G. Komen Race for Cure, and an interview of CEO Patel aired on Bloomberg (view here). The corporate presentation has also been updated, and the webcast will be updated shortly (view here).

About Flamingo-01 and GLSI-100

Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On December 29, 2022 F-star Therapeutics, Inc. (the "F-star") reported the following update regarding its Agreement and Plan of Merger, dated as of June 22, 2022, as amended (the "Merger Agreement"), by and among, the Company, invoX Pharma Limited ("invoX"), Fennec Acquisition Incorporated, a wholly owned subsidiary of invoX ("Fennec" and together with the F-star and invoX, the "Parties"), and Sino Biopharmaceutical Limited, as guarantor ( "Sino Biopharm") (Filing, 8-K, F-star, DEC 29, 2022, View Source [SID1234625661]):

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Effective at December 29, 2022 at 12:05 a.m. Eastern Time, the Committee on Foreign Investment in the United States ("CFIUS") issued an order (the "Interim Order") preventing the consummation of the transactions pursuant to the Merger Agreement, citing unresolved national security risks. The Interim Order also prohibits (1) the transfer, lease, license, sale, or otherwise acquisition of any asset or affiliate of F-star to Sino Biopharm, invoX, or any of their affiliates, or (2) the transfer, lease, license, sale, or acquisition otherwise of any securities, equity, or other ownership interests or rights in F-star or any affiliate of F-star, including any rights to acquire any of the foregoing, by Sino Biopharm, invoX, Fennec, or any affiliates of any of the foregoing, including through merger.

The Interim Order is for an indeterminate duration, lasting until: (1) CFIUS concludes action under Section 721 with respect to the transaction; (2) the President of the United States ("President") takes action or declines to take action under Section 721 with respect to the transaction; or (3) CFIUS or the President revokes or terminates this Interim Order.

The purpose of the Interim Order is to provide CFIUS adequate opportunity to continue its review and investigation. The Parties may provide CFIUS with additional relevant information and CFIUS will consider such information, including information regarding the Interim Order or proposals to mitigate the identified national security risks.

As described below, the extension of the tender offer enables the Parties to have additional time for discussions with CFIUS regarding the Interim Order and to evaluate whether mitigation steps can be taken to permit the timely closing of the transactions contemplated by the Merger Agreement. Previously, CFIUS had confirmed to the Parties that it had determined that mitigation measures would be available. However, other than outlining some core attributes of such mitigation, CFIUS had provided no specific information, had indicated its views were preliminary, and had not indicate a timetable for its determination of any specific requirements to be imposed.

Tender Offer Extended Until 5 p.m. Eastern Time on Friday December 30, 2022

On December 29, 2022, invoX, Fennec, and Sino Biopharm extended the Offer to 5:00 p.m., Eastern Time, on December 30, 2022. The End Date, as defined in the Merger Agreement, is one (1) minute past 11:59 p.m., Eastern Time, on December 30, 2022. As previously described, the Merger Agreement may be terminated by either party, subject to certain exceptions, if any of the Offer conditions, are not satisfied or waived, to the extent waiveable, by Purchaser on or before the End Date. The foregoing provides the Parties additional time to have discussions with CFIUS regarding the Interim Order and to evaluate any next steps.

The Offer was previously set to expire at one (1) minute past 11:59 p.m., Eastern Time, on December 28, 2022. As of such time, the Depositary had advised that Shares representing approximately 76% of the outstanding Shares had been validly tendered into and not properly withdrawn from the Offer.

On December 28, 2022, NeuBase Therapeutics, Inc. (the "Company") reported to have entered into a Purchase Agreement (the "Purchase Agreement") with Alumni Capital LP, a Delaware limited partnership ("Alumni Capital"), pursuant to which the Company agreed to sell, and Alumni Capital agreed to purchase, upon request of the Company in one or more transactions, a number of shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock") providing aggregate gross proceeds to the Company of up to $3,000,000 (subject to the right, but not the obligation, of the Company to increase such amount up to $10,000,000 pursuant to the terms of the Purchase Agreement) (the "Maximum Investment Amount") (Filing, NeuBase Therapeutics, DEC 28, 2022, View Source [SID1234625689]). The Purchase Agreement expires upon the earlier of the aggregate gross proceeds from the sale of shares of Common Stock meeting the Maximum Investment Amount or December 28, 2024.

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Among other limitations, unless otherwise agreed upon by Alumni Capital, each individual sale of shares of Common Stock will be limited to a sale of shares of Common Stock of up to $500,000 (subject to the right of the Company and Alumni Capital to mutually agree to increase such figure to $1,000,000) and further limited to no more than the number of shares of Common Stock that would result in the direct or indirect beneficial ownership by Alumni Capital of more than 9.99% of the then-outstanding shares of Common Stock. Alumni Capital will purchase the shares of Common Stock under the Agreement at the lowest traded price of the Common Stock during the three (3) business days immediately prior to the date of purchase of the shares of Common Stock multiplied by 95%. In addition, the total cumulative number of shares of Common Stock that may be issued to Alumni Capital under the Purchase Agreement may not exceed the requirements of Nasdaq Listing Rule 5635(d), except that such limitation will not apply in the event the Company obtains stockholder approval of the shares of Common Stock to be issued under the Purchase Agreement, if necessary, in accordance with the requirements of Nasdaq Listing Rule 5635(d).

In exchange for Alumni Capital entering into the Purchase Agreement, the Company issued 146,699 shares of Common Stock to Alumni Capital upon execution of the Purchase Agreement. The Company will issue to Alumni Capital, on December 28, 2023, shares of Common Stock in an amount equal to one-half of one percent (0.5%) of the Investment Amount (as defined in the Purchase Agreement) divided by the closing price of the Common Stock on the third business day prior to the date of issuance and delivery of such shares of Common Stock. In addition, the Company will issue to Alumni Capital, on the date of expiration of the Purchase Agreement, shares of Common Stock in an amount equal to one-half of one percent (0.5%) of the Investment Amount divided by the closing price of the Common Stock on the third business day prior to the date of issuance and delivery of such shares of Common Stock. If the Company elects to increase the Maximum Investment Amount, it shall issue to Alumni Capital Increase Commitment Shares (as defined in the Purchase Agreement) (based on each increase of Investment Amount) within five (5) business days of the Company’s written notice of such election.

The Purchase Agreement provides that the Company will file a prospectus supplement (the "Prospectus Supplement") to its Registration Statement on Form S-3, which was declared effective on April 14, 2021 (File No. 333-254980) (the "Base Registration Statement"), covering the offering and sale of the shares of Common Stock to Alumni Capital pursuant to the Purchase Agreement. Alumni Capital’s obligation to purchase shares of Common Stock under the Purchase Agreement is conditioned upon, among other things, the filing of the Prospectus Supplement and the Base Registration Statement remaining effective.

The Purchase Agreement contains customary representations, warranties and covenants by each of the Company and Alumni Capital. Actual sales of shares of Common Stock to Alumni Capital will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. Alumni Capital has no right to require any sales of shares of Common Stock by the Company, but is obligated to make purchases of shares of Common Stock from the Company from time to time, pursuant to directions from the Company, in accordance with the Purchase Agreement. During the term of the Purchase Agreement, Alumni Capital has covenanted not to cause or engage in any short selling of shares of Common Stock.

This Current Report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there be any sale of shares of Common Stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of Common Stock to Alumni Capital. The Company expects that any proceeds received by the Company from such sales of shares of Common Stock to Alumni Capital under the Purchase Agreement will be used for general corporate and working capital purposes.

The foregoing summary of the Purchase Agreement is qualified in its entirety by reference to the complete agreement, a copy of which is attached hereto as Exhibit 10.1 and incorporated herein by reference. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to the Purchase Agreement, and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Purchase Agreement, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Securities and Exchange Commission.

On December 28, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the company will be participating in the upcoming 41st Annual J.P. Morgan Healthcare Conference (Press release, Guardant Health, DEC 28, 2022, View Source [SID1234625653]).

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Guardant Health’s management is scheduled to present and participate in a Q&A session on Monday, January 9th at 3:00 p.m. Pacific Time / 6:00 p.m. Eastern Time. Interested parties may access a live and archived webcast of the presentation on the "Investors" section of the company website at: www.guardanthealth.com.

On December 28, 2022 Boundless Bio. a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported that its Chief Executive Officer, Zachary Hornby, will present at the 41st Annual J.P. Morgan Healthcare Conference which will take place in San Francisco (Press release, Boundless Bio, DEC 28, 2022, View Source [SID1234625652]). Presentation details are as follows:

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Date: Wednesday, January 11, 2023
Time: 8:00 – 8:25 AM PT
Location: The Westin St. Francis San Francisco