Entry into a Material Definitive Agreement

On February 26, 2019, Alder BioPharmaceuticals, Inc. ("Alder") reported that it has entered into a common stock purchase agreement (the "Purchase Agreement") with Redmile Group, LLC and certain institutional and other accredited investors affiliated with or managed by Redmile Group, LLC (collectively, "Redmile") (Press release, Alder Biopharmaceuticals, FEB 26, 2019, View Source [SID1234533902]). The Purchase Agreement provides that, subject to the closing of the Offering (as defined in Item 8.01 below) and the satisfaction of other customary closing conditions, Redmile will purchase 1,739,130 shares of Alder’s common stock, par value $0.0001 per share ("Common Stock"), at a price per share of $11.50, which is equal to the price to the public in the Offering (the "Redmile Shares"). The issuance of the Redmile Shares will be made in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"). The Underwriters (as defined in Item 8.01 below) will serve as placement agents for the placement of the Redmile Shares and receive a placement agent fee equal to a percentage of the total purchase price of the Redmile Shares, which percentage will be equal to the percentage discount the underwriters will receive on shares sold in the Offering. In the event that the Offering has not closed within 20 business days of the date of the Purchase Agreement, either Alder or Redmile may terminate the Purchase Agreement. The net proceeds to Alder from the sale of the Redmile Shares are expected to be approximately $18.8 million, after deducting placement agent fees. The Purchase Agreement requires Alder to enter into a registration rights agreement with Redmile upon the closing of the issuance of the Redmile Shares. Under the registration rights agreement, Alder will be required to register the Redmile Shares for resale under the Securities Act no later than the day after the expiration of Alder’s 60-day lock-up period following the date of the Underwriting Agreement (as defined in Item 8.01 below). The Purchase Agreement contains customary representations, warranties and agreements by Alder and Redmile.

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The Purchase Agreement is filed as Exhibit 10.1 to this report, and the description of the terms of the Purchase Agreement is qualified in its entirety by reference to such exhibit.

Redmile is affiliated with one of Alder’s directors, Jeremy Green, and is Alder’s largest stockholder. In connection with Alder’s January 2018 issuance of convertible preferred stock to Redmile, Alder entered into a registration rights agreement with Redmile. Under the registration rights agreement, Alder filed a prospectus supplement under its effective registration statement on Form S-3 (SEC File No. 333-216199), and is required to file, if needed, one or more additional registration statements, as permissible and necessary, for the resale of the shares of Common Stock issued or issuable upon conversion of the convertible preferred stock and a warrant to purchase an aggregate of 75,000 shares of convertible preferred stock that Alder may be required to issue to Redmile.

Entry into a Material Definitive Agreement

On February 26, 2019 On February 26, 2019, Ultragenyx Pharmaceutical Inc. ("we," "Ultragenyx" or the "Company")reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Merrill Lynch, Pierce, Fenner & Smith Incorporated, and Cowen and Company, LLC (the "Underwriters"), providing for the offer and sale in an underwritten public offering (the "Offering") of 5,072,464 shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at a public offering price of $60.00 per share, to be purchased by the Underwriters from us at a price of $56.70 per share. Pursuant to the Underwriting Agreement, the Company granted the Underwriters a 30-day option (the "Option") to purchase up to an additional 760,869 shares of Common Stock on the same terms (Filing, 8-K, Ultragenyx Pharmaceutical, FEB 26, 2019, View Source [SID1234533869]). On February 27, 2019, the Underwriters exercised the Option in full.

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The Offering closed on March 1, 2019. In the Underwriting Agreement, the Company agreed to indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or to contribute to payments that the Underwriters may be required to make because of such liabilities.

We estimate that the net proceeds we will receive from the Offering will be approximately $330.4 million, after deducting the Underwriters’ discounts and commissions and estimated offering expenses payable by us.

The Offering was made under a prospectus supplement and related prospectus filed with the Securities and Exchange Commission pursuant to the Company’s automatically effective shelf registration statement on Form S-3 (Registration No. 333-223123). The Offering was not registered under any state blue sky laws.

Iovance Biotherapeutics was Granted Fast Track Designation for LN-145 for Cervical Cancer

On February 26, 2019 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical cancer who have progressed while on or after chemotherapy (Press release, Iovance Biotherapeutics, FEB 26, 2019, View Source;p=RssLanding&cat=news&id=2389051 [SID1234533762]). LN-145 is the Company’s adoptive cell therapy produced using its proprietary TIL manufacturing technology.

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"We are pleased to have received Fast Track designation for LN-145 for the treatment of cervical cancer in patients who have failed chemotherapy treatment," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "The designation is an important positive step for the development of LN-145 in a serious and unmet medical need patient population. We are excited about the clinical data for LN-145 in cervical cancer patients and look forward to a closer collaboration with the FDA as we advance the clinical development of LN-145 for the treatment of cervical cancer."

The Fast Track designation from the FDA is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, which includes providing a therapy that may be potentially better than the available ones. With the Fast Track designation for LN-145, Iovance is expected to have more frequent meetings and communication with the FDA and is eligible, if relevant criteria are met upon submission, for a Rolling Review of the Biologic License Application (BLA) and potentially Accelerated Approval.1

The Company had previously reported preliminary data from the Phase 2 study of LN-145 for cervical cancer (C-145-04) in October 2018 for 15 patients yielding an overall response rate (ORR) of 27%. Patients in the study had a median of five prior therapies. The most common treatment-emergent adverse events included chills, pyrexia and anaemia. The protocol for the cervical cancer study has since been amended to limit the number of prior therapies to no more than three and to exclude patients who have been treated with prior immunotherapy. The study is actively recruiting patients at 32 clinical sites in the United States and Europe. The company anticipates providing an update on this study at an upcoming medical meeting in 2019.

Ultragenyx Announces Pricing of Public Offering of Common Stock

On February 26, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported the pricing of its underwritten public offering of 5,072,464 shares of its common stock at a price to the public of $60.00 per share resulting in gross proceeds of $304.3 million, before underwriting discounts (Press release, Ultragenyx Pharmaceutical, FEB 26, 2019, View Source [SID1234533760]). In addition, the company has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 760,869 shares of the company’s common stock at the public offering price, less the underwriting discount.

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The offering is expected to close on or about March 1, 2019, subject to satisfaction of customary closing conditions. J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, BofA Merrill Lynch, and Cowen are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became automatically effective on February 21, 2018. This offering is being made solely by means of prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus related to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at prospectus- [email protected]; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; and Cowen, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, United States, Attn.: Prospectus Department or by telephone 1-631-274-2806.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

Coherus BioSciences Management to Present at Two Investor Healthcare Conferences in March

On February 26, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported that senior management will present at two upcoming investor healthcare conferences (Press release, Coherus Biosciences, FEB 26, 2019, View Source [SID1234533743]).

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Management will deliver a company presentation at the 38thCowen & Company Healthcare Conference on Tuesday, March 12th at 10 a.m. ET taking place in Boston, Massachusetts.
Management will deliver a company presentation at Barclays Global Healthcare Conference on Wednesday, March 13th at 8:00 a.m. ET taking place in Miami, Florida.
The audio portion of the presentations will be available on the investors page of the Coherus BioSciences website at View Source