On June 1, 2020 Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported Ayala management will present at two upcoming investor conferences (Press release, Ayala Pharmaceuticals, JUN 1, 2020, View Source [SID1234563987]):

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Jefferies Virtual Global Healthcare Conference: Wednesday, June 3, 2020 at 10:30 am ET.
Raymond James 2020 Human Healthcare Innovation Conference: Thursday, June 18, 2020 at 8:20 am ET.
A live webcast of each presentation may be accessed by visiting the Investors and News section of Ayala’s website at www.ir.ayalapharma.com. An archived replay of each webcast will be available on the website for 90 days following the presentations.

On June 1, 2020 Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a pioneering, global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs) while lowering costs, reported that it has entered into a Clinical Study Agreement with The Edith Wolfson Medical Center, a leading public hospital in Israel (Press release, Orgenesis, JUN 1, 2020, View Source [SID1234561702]). Under the agreement, the parties will conduct a clinical study with a goal of utilizing and validating a number of Orgenesis’ proprietary POCare Technologies, including a novel, automated cell culturing system, designed to enable a faster, safer and metabolically optimized culturing and expansion process for the generation and expansion tumor infiltrating lymphocytes (TIL) for use in adoptive T-cell therapies.

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The goal of the cell culturing system is to provide an innovative and simplified method for TIL generation and expansion in an automated and controlled system from the initial TIL production to final product with minimal human operation.

Vered Caplan, CEO of Orgenesis, stated, "Partnering with Edith Wolfson Medical Center, an established and well-respected medical institution, to conduct this clinical trial will further validate our cell processing system for TIL generation and expansion. These POCare Technologies are not only highly versatile, but also highly expandable and as a result, could increase our ability to grow various types of cells for a broad range of customer needs. This latest collaboration is a further illustration of Orgenesis’ commitment to advance novel cell therapies and develop new approaches to immune-oncology in a cost effective, high quality and scalable manner through our CGT Biotech Platform. Orgenesis will deploy these solutions across its POCare Network. This network includes a growing number of leading medical institutions around the world, including our newly formed collaboration with Hospital Infantil Universitario Niño Jesús, Madrid."

Dr. Ronen Brenner, Head of the Oncology Division at The Edith Wolfson Medical Center, commented, "We look forward to collaborating with Orgenesis on this important clinical trial to advance and validate this breakthrough Orgenesis proprietary TILs technology, with the joint goal of reducing manufacturing costs and bringing new, cell and gene therapy products to cancer patients worldwide."

On June 1, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), reported the commencement of an underwritten public offering of $450.0 million of shares of its common stock (Press release, Allogene, JUN 1, 2020, View Source [SID1234560836]). In addition, Allogene expects to grant the underwriters a 30-day option to purchase up to an additional $67.5 million of shares of its common stock offered in the public offering. All of the shares of common stock to be sold in the offering will be sold by Allogene. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Goldman Sachs & Co. LLC, Jefferies LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.

The securities described above are being offered by Allogene pursuant to a shelf registration statement (including a prospectus) filed on November 5, 2019 with the Securities and Exchange Commission (SEC), which has become automatically effective. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (833) 297-2926, or by email at [email protected].

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 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 June 1, 2020 Cleveland BioLabs, Inc. (NASDAQ:CBLI), reported that it has entered into definitive agreements with several institutional and accredited investors for the issuance and sale of an aggregate of 1,515,878 shares of its common stock, at a purchase price of $2.0945 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Cleveland BioLabs, JUN 1, 2020, View Source [SID1234560792]). Cleveland BioLabs has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 757,939 shares of common stock. The closing of the offering is expected to occur on or about June 3, 2020, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price equal to $2.033 per share, are exercisable immediately upon issuance and will expire five years from the issuance date.

The gross proceeds from the offering are expected to be approximately $3.175 million. The Company currently intends to use the net proceeds from the offering for general corporate purposes.

The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-238578), including an accompanying prospectus previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on May 29, 2020. The offering of the shares of common stock will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct 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 and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

On June 1, 2020 argenx (Euronext & Nasdaq: ARGX) a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported the closing of its global offering of an aggregate of 4,600,000 ordinary shares (including in the form of American Depositary Shares (ADSs)), which includes the full exercise of the underwriters’ option to purchase 600,000 additional ADSs (Press release, argenx, JUN 1, 2020, View Source [SID1234560762]). The global offering consisted of (i) a public offering of 2,010,057 ADSs in the United States and certain other countries outside the European Economic Area (EEA) at a price to the public of $121.00 and (ii) a concurrent private placement of 2,589,943 of ordinary shares in the EEA at an offering price of €109.18. The gross proceeds from the global offering were approximately $557 million (approximately €502 million).

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Morgan Stanley, Cowen, BofA Securities and Evercore acted as joint bookrunning managers for the offering. Kempen acted as lead manager for the offering and Wolfe Capital Markets and Advisory acted as co-manager.

The securities were offered pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to the securities was filed with the SEC on November 6, 2019 and a final prospectus supplement relating to the securities was filed with the SEC on November 8, 2019 and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the global offering may be obtained for free from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, New York 10014, United States, Attention: Prospectus Department; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200.

In addition, argenx announced today the listing of and the commencement of dealings in its 4,600,000 new ordinary shares (including those underlying the ADSs) on the regulated market of Euronext Brussels, effective today, November 12, 2019.