Avalon GloboCare Announces Three-Way Material Transfer Agreement with Weill Cornell Medicine and Arbele Limited for Development of Next Generation Cellular Immunotherapy FLASH-CAR(TM) Technology

On June 11, 2020 Avalon GloboCare Corp. (NASDAQ: AVCO), a clinical-stage global developer of cell-based technologies and therapeutics, reported that it has entered into a three-way material transfer agreement (MTA) with Weill Cornell Medicine in New York City and the Company’s strategic partner, Arbele Limited (Press release, Avalon, JUN 11, 2020, View Source [SID1234609547]).

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With this agreement, Avalon GloboCare Corp. and Arbele Limited intend to collaborate with Weill Cornell Medicine and co-develop the standardized laboratory steps necessary to generate clinical-grade CAR-T and CAR-NK cells for use in future human clinical trials with Avalon’s first FLASH-CAR(TM) platform candidate, AVA-011. This step, called process development, will provide the bridge between Avalon’s benchtop research and the bio-manufacturing processes to potentially deliver the clinical-grade cellular immunotherapy product to patients.

"We are excited about this agreement to translate our cellular therapy candidates into standardized, clinical-grade cell products that could be used in future clinical trials. This step reflects our dedication to establishing an infrastructure to develop our cellular immunotherapy candidates and to maintain the highest possible standards for generating clinical-grade cells for human cancer trials," stated David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon GloboCare.

AVA-011 is a next generation cellular immunotherapy candidate using Avalon’s FLASH-CAR(TM) that targets both CD19 and CD22 tumor antigens on cancer cells. Avalon has already successfully completed pre-clinical research on AVA-011, including tumor cytotoxicity studies. (See May 8, 2020 press release, ‘Avalon GloboCare Advances Next Generation Cellular Immunotherapy with FLASH-CAR(TM) Technology for Blood Cancers’)

Avalon’s next generation immune cell therapy using FLASH-CAR(TM) technology is being co-developed with the Company’s strategic partner Arbele Limited. The adaptable FLASH-CAR(TM) platform may be used to create personalized cancer cell therapy from a patient’s own cells, as well as off-the-shelf cell therapy from a universal donor, expanding the reach of cancer patients that could be treated.

Bio-Techne And ZERO – The End Of Prostate Cancer Announce Partnership To Fund Education And Awareness Campaigns To Empower Men With Prostate Cancer

On June 11, 2020 Bio-Techne Corporation (NASDAQ:TECH) reported that Exosome Diagnostics, a Bio-Techne brand, has established a new partnership with ZERO – The End of Prostate Cancer, the leading national nonprofit organization in the fight against prostate cancer (Press release, Bio-Techne, JUN 11, 2020, View Source;the-end-of-prostate-cancer-announce-partnership-to-fund-education-and-awareness-campaigns-to-empower-men-with-prostate-cancer [SID1234560990]). ZERO advances research, improves the lives of men and families, and inspires action for patients, physicians, and advocates involved in the prostate cancer cause. ZERO offers comprehensive support for millions of men with prostate cancer, including raising awareness and education for cutting edge technologies, such as the ExoDx Prostate (EPI) test, of interest to patients exploring all of their options to manage prostate cancer.

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One in nine American men will be diagnosed with prostate cancer during their lifetime. Prostate cancer (PCa) is the second leading cause of cancer death among American men and is the most commonly diagnosed cancer. In 2020, it is estimated that 191,930 men will be diagnosed with prostate cancer and more than 33,000 men will die from the disease. Currently, nearly 3.1 million American men are living with the disease – more than the population of Chicago.

The EPI test is a urine-based genomic test that helps inform the prostate biopsy decision. This liquid biopsy test recently received coverage for the Veterans Health Administration under the General Services Administration (GSA) award, received a positive coverage decision from Medicare, and is included in the National Comprehensive Cancer Network (NCCN) guidelines for early detection in men for both initial and repeat biopsy. It is performed by Exosome Diagnostics in its CLIA, ISO, NY certified and CAP-accredited laboratory located in Waltham, Massachusetts. The EPI test is a risk assessment tool that assists physicians and their patients with determining if a prostate biopsy is needed when presented with an ambiguous PSA test result, thereby reducing complications from unnecessary and invasive procedures. ExoDx Prostate is now available with an At-Home Collection kit, enabling test access to patients unable to see a healthcare professional or preferring to collect their sample at-home.

"We are proud to partner with ZERO, an organization that through its support of prostate cancer research, diagnostics, therapeutics and patient initiatives has changed the lives of thousands of prostate cancer patients," said Chuck Kummeth, Bio-Techne’s President and Chief Executive Officer. "ZERO is an ideal partner to help spread the word about our ExoDx Prostate (EPI) test and educate men with indeterminate PSA scores that they can potentially avoid unnecessary biopsy procedures."

"We are excited to join forces with Bio-Techne, an organization that aligns with our mission, values, and goals. Having a new diagnostic that can be administered at home is an exciting new development for patients who face difficult choices managing their disease, especially during this COVID-19 crisis," said Jamie Bearse, ZERO President & CEO.

ZERO and Exosome Diagnostics will kick off this newly formed partnership by hosting a Facebook Live broadcast on June 17th at 4:00 p.m. EDT with ZERO President & CEO, Jamie Bearse and Urology expert, Dr. Ali Kasraeian. The event will be broadcast live and will be available for replay on the ExoDx Prostate Test Facebook page (View Source) and on the Zero – The End of Prostate Cancer page (View Source) and on ZERO’s Youtube channel. Mr. Bearse and Dr. Kasraeian will discuss current challenges in prostate cancer management and how this is changing during the COVID-19 era where patients and their physicians are adjusting to new rules and regulations. Members will have the opportunity to address questions directly to either Dr. Kasraeian or Mr. Bearse. To see the broadcast tune in on Facebook at 4:00PM Eastern Time.

Precigen to Participate in Upcoming JMP Securities Hematology and Oncology Forum

On June 11, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported Helen Sabzevari, PhD, President and CEO of Precigen, will participate in a virtual fireside chat at the JMP Securities Hematology and Oncology Forum on June 18, 2020, at 1:40 PM ET (Press release, Precigen, JUN 11, 2020, View Source [SID1234561007]). Participants may access the live webcast of the event through Precigen’s website in the Press & Events section at View Source

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BIOLASE, Inc. Announces Closing of $6.9 Million Registered Direct Offering Priced At-The-Market

On June 11, 2020 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported the closing on June 10, 2020 of its previously announced registered direct offering of approximately $6.9 million of its common stock in a registered direct offering priced at-the-market under Nasdaq rules and warrants to purchase common stock in a concurrent private placement (Press release, Biolase Technology, JUN 11, 2020, View Source [SID1234561023]). The combined purchase price for one share of common stock and warrant to purchase one share of common stock was $0.64. BIOLASE intends to use the net proceeds for working capital and for other general corporate purposes.

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Under the terms of the securities purchase agreement, BIOLASE sold 10,800,000 shares of common stock. In a private placement, which was consummated concurrently with the offering, BIOLASE issued warrants to purchase up to an aggregate of 10,800,000 shares of common stock. The warrants are immediately exercisable, will expire 5 years from the date of issuance and have an exercise price of $0.515 per common share.

Maxim Group LLC, The Benchmark Company, LLC and Colliers Securities LLC acted as co-placement agents for the offering.

The shares of common stock were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-233172) previously declared effective by the SEC on August 23, 2019. The offering of the shares of common stock was made by means of a prospectus supplement that was filed with the SEC and forms a part of the registration statement.

BIOLASE intends to move forward with a proposed rights offering in the next few weeks. BIOLASE believes that the capital raised in this registered direct offering bolsters its balance sheet and will enable it to approach the proposed rights offering from an enhanced liquidity and capitalization position. BIOLASE previously filed a registration statement on Form S-1 (File No. 333-238914) with respect to the proposed rights offering with the SEC.

Entry into a Material Definitive Agreement

On June 11, 2020, Mustang Bio, Inc. ("Mustang" or the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with Cantor Fitzgerald & Co., as representative of the underwriters named therein (each, an "Underwriter" and collectively with Cantor Fitzgerald & Co., the "Underwriters") (Filing, 8-K, Mustang Bio, JUN 11, 2020, View Source [SID1234561090]). Pursuant to the Underwriting Agreement, the Company agreed to sell to the Underwriters, in a firm commitment underwritten public offering, 10,769,231 shares (the "Firm Shares") of the Company’s common stock, $0.0001 par value per share ("Common Stock"), at a price to the public of $3.25 per share, less underwriting discounts and commissions. In addition, pursuant to the Underwriting Agreement, the Company has granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 1,615,384 shares of Common Stock (the "Additional Shares," together with the Firm Shares, the "Shares"). The transactions contemplated by the Underwriting Agreement are expected to close on June 15, 2020, subject to the satisfaction of customary closing conditions. A copy of the Underwriting Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

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Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering. Oppenheimer & Co. Inc. is acting as lead manager for the offering.

The gross proceeds to the Company are expected to be approximately $35 million, assuming no exercise of the option to purchase Additional Shares and excluding underwriting discounts and commissions and other offering-related expenses.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions.

The offering is being made pursuant to the Company’s effective "shelf" registration statements on Form S-3 (File Nos. 333-226175 and 333-233350) (the "Registration Statements") filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on July 27, 2018 and September 30, 2019, respectively, as supplemented by a preliminary prospectus supplement filed with the SEC on June 10, 2020 and a final prospectus supplement filed with the SEC on June 12, 2020, pursuant to Rule 424(b) under the Securities Act.

Alston & Bird LLP, counsel to the Company, delivered an opinion as to the validity of the Shares, a copy of which is attached hereto as Exhibit 5.1 and is incorporated by reference herein.

This Current Report on Form 8-K is being filed to incorporate the Underwriting Agreement and opinion by reference into such Registration Statements. The foregoing summary description of the offering and the documentation related thereto, including without limitation, the Underwriting Agreement, does not purport to be complete and is qualified in its entirety by reference to such Exhibits.

The Underwriting Agreement has been included to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Underwriting Agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under the Underwriting Agreement and should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Underwriting Agreement, and this subsequent information may or may not be fully reflected in the Company’s public disclosures.