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.

HUS and University of Helsinki received funding for a new clinical breast cancer study

On June 11, 2020 University of Helsinki reported that 1,5 million euros funding supports a new investigator-initiated breast cancer clinical trial in Finland that takes on MYC (Press release, University of Helsinki, JUN 11, 2020, View Source [SID1234561087]).

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A Finnish Jane and Aatos Erkko Foundation awarded 1,5 million euros to support a VeMA clinical breast cancer study scheduled to start in HUS Comprehensive Cancer Center already this year. The clinical trial is among the first in the world having a biologic rationale rooted to MYC oncoprotein’s apoptosis promoting function.

The award is for a long-term translational collaboration project between breast cancer researchers at the University of Helsinki and clinicians in Helsinki University Hospital.

VeMA is an early phase investigator-initiated clinical trial in metastatic breast cancer setting, which tests the safety of a new combination treatment regimen that includes two targeted therapy agents combined with an immunotherapy agent anti-PD-L1. The study is expected to find the right dosage for further studies and biomarkers to guide patient selection with improved precision and to monitor treatment responses.

"We are truly excited to start VeMA in HUS, since the biologic rationale for the study comes from a research laboratory working next door. VeMA study is a beautiful example of translational research, that is a process where scientific discoveries made with cancer cells and animal models in a research laboratory serve as grounds for a clinical concept that will be tested in patients in the hospital," says the Principal clinical Investigator, Director and Chief Oncologist Johanna Mattson from HUS Comprehensive Cancer Center.

The study Co-Investigator, Research Director Juha Klefström from the University of Helsinki says that VeMA has been totally handcrafted as a local collaboration between the Medical Faculty and HUS Comprehensive Cancer Center.

"MYC oncoprotein drives abnormal pattern of cell proliferation in about half of the breast cancer cases. However, at the same time, MYC renders cells vulnerable to apoptotic cell death. The key question that has for a long time inspired our work is: can we somehow exploit this inherent apoptotic vulnerability of MYC expressing cancer cells in design of new therapies that would selectively kill cancer cell but leave normal cell unharmed? Now we are about to test this concept for the first time to help women suffering from breast cancer," he says.

Most clinical cancer trials are designed and funded by pharmaceutical industry. In the investigator-initiated trials, the researchers are allowed to design the trial by themselves but the main challenge is to find funding from public sources to support the study.

Thanks to the support of the Jane and Aatos Erkko Foundation, the VeMA study can now be launched as planned. Pharma has contributed to the study by donating the three drugs needed for the study for free.

Simcere Plans to Raise a Rumored $500 Million in Hong Kong IPO

On June 11, 2020 Simcere Pharma of Nanjing reported that it has filed with the Hong Kong Exchange for an IPO that is rumored to seek $500 million (Press release, Jiangsu Simcere Pharmaceutical Company, JUN 11, 2020, View Source [SID1234561028]). Previously, Simcere was listed in the US, but it was taken private in 2013 for $500 million by management and Hony Capital. The company is an active dealmaker, using partnerships and in-house R&D to build a portfolio of nearly 50 novel candidates in development. In 2019, the company’s ten generic products produced a profit of $140 million on $708 million in revenue.

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GeneQuantum OK’d to Start US Trials of Novel HER2 ADC

On June 11, 2020 GeneQuantum Healthcare of Suzhou reported that it received IND approval in the US for its proprietary next-gen antibody drug conjugate asset, GQ1001 (Press release, GeneQuantum Healthcare, JUN 11, 2020, View Source [SID1234561025]). GQ1001 is a novel ADC drug candidate that is aimed at HER2-positive tumors. The candidate was developed using GQ’s novel intelligent Ligase-Dependent Conjugation (iLDC) platform including a unique linker. GQ believes the platform will manufacture high quality ADCs in any mAb facility at a speed and yield similar to equivalent mAbs.

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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.