On July 3, 2020 Medivir AB (Nasdaq Stockholm: MVIR) reported that the European Commission, in accordance with the opinion from the European Medicines Agency (EMA), has granted orphan medicinal product designation in the EU for MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer (Press release, Medivir, JUL 3, 2020, View Source [SID1234561669]).

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Orphan Medicinal Product designation provides certain regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10 000 persons in the European Union. This designation can give access to several incentives, including protocol assistance, the EU centralized authorization procedure and reduced regulatory fees and a potential for a 10-year market exclusivity in the EU.

About hepatocellular carcinoma

HCC represents the fifth most common cancer worldwide but is a rare disease in Europe and the US. Although therapies exist, treatment benefits for intermediate and advanced HCC are low and death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without the tumor-specific mutations. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

About MIV-818

MIV-818 is a pro-drug designed to selectively treat liver cancer cells and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug for patients with HCC.

On July 2, 2020 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) reported the successful completion of its acquisition of Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) (Press release, Alexion, JUL 2, 2020, View Source [SID1234574865]). The acquisition adds Factor Xa inhibitor reversal agent Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], marketed as Ondexxya in Europe, to Alexion’s commercial portfolio. Andexxa is the first and only approved Factor Xa inhibitor reversal agent and has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in severe and uncontrolled bleeding.

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"This acquisition provides the opportunity to grow our commercial portfolio, which builds on the significant progress we’ve made diversifying our pipeline over the last few years," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. "We are excited to add a transformative, first-in-class medicine like Andexxa, which rapidly reverses life-threatening bleeds that result from Factor Xa inhibitors, to our growing critical care portfolio. This important medicine is also a clear strategic fit with our existing expertise in hematology and neurology, and we are confident we can apply our demonstrated global commercial excellence to enhance access and broaden the number of patients helped by Andexxa."

Transaction Details

Alexion completed the acquisition through a tender offer and subsequent merger of Portola with Odyssey Merger Sub Inc., a wholly owned subsidiary of Alexion ("Buyer"). Portola is now a wholly owned subsidiary of Alexion. The tender offer for all of the outstanding shares of common stock of Portola at a price of $18.00 per share expired as scheduled, one minute following 11:59 p.m., New York City time, on July 1, 2020. American Stock Transfer & Trust Company, LLC, the depositary and paying agent for the tender offer, has advised Alexion that 62,654,962 shares of Portola common stock were validly tendered and not validly withdrawn in the tender offer, representing approximately 79.7% of the shares outstanding. In addition, the depositary has advised Alexion that, as of the offer expiration time, Notices of Guaranteed Delivery had been delivered with respect to 2,701,052 additional shares, representing approximately 3.4% of the shares outstanding. All of the conditions to the tender offer having been satisfied, Buyer has accepted for payment and will promptly pay for all shares tendered. The transaction will be funded with cash on hand.

On July 2, 2020, Alexion completed its acquisition of Portola through the merger of Buyer with and into Portola without a vote of Portola’s shareholders pursuant to Section 251(h) of the Delaware General Corporation Law. As a result of the merger, Portola became a wholly owned subsidiary of Alexion. In connection with the merger, all shares of Portola common stock outstanding immediately prior to the effective time (other than shares owned by Alexion, Buyer, Portola, any other subsidiary of Alexion or any subsidiary of Portola, or shares that are held in Portola’s treasury, or shares held by any Portola stockholder who has properly demanded and perfected appraisal rights under Delaware law) have been converted into the right to receive $18.00 per share in cash, without interest (less any required withholding taxes), the same amount paid for all shares validly tendered and not validly withdrawn in the tender offer. As a result of the merger, as of July 2, 2020, Portola common stock will cease to be traded on the NASDAQ Global Select Market.

On July 2, 2020 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported the completion of its business combination with Arya Sciences Acquisition Corp. (NASDAQ: ARYA; or "Arya"), a special purpose acquisition company (SPAC) sponsored by Perceptive Advisors (Press release, Immatics Biotechnologies, JUL 2, 2020, View Source [SID1234569528]). Today, Immatics N.V. will commence trading its shares under the symbol "IMTX" and its warrants under the symbol "IMTXW" on the Nasdaq Capital Market. Proceeds from this transaction were approximately $253 million, which included funds held in Arya’s trust account and the common stock private investment in public equity (PIPE) financing contributed by a group of leading US healthcare institutional investors. The shareholders of Arya approved the transaction on June 29, 2020, and none of Arya’s shareholders redeemed their shares in connection with the ARYA shareholder approval. The transaction had been previously approved by Immatics shareholders. Immatics’ management team, led by Chief Executive Officer Harpreet Singh, Ph.D., will continue to run the combined company.

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Harpreet Singh, Ph.D., Co-Founder and CEO of Immatics, commented: "I would like to thank the team at Immatics, our partners at Perceptive, existing Immatics and Arya shareholders, the PIPE investors, and all our advisors for making this transaction a success. It will provide us runway and flexibility for our pursuit of unlocking new therapeutic options for cancer patients by advancing our clinical and pre-clinical programs for Adoptive Cell Therapies and TCR Bispecifics. Our programs are directed against a range of targets that address multiple rare as well as common cancers that have been hard to treat."

New investors supporting the transaction include Perceptive Advisors, Redmile Group, Federated Hermes Kaufmann Funds, RTW Investments and Sphera Funds, alongside existing Immatics investors dievini Hopp BioTech, AT Impf and Wellington Partners.

Adam Stone, Chief Investment Officer of Perceptive Advisors and the Chief Executive Officer of Arya, added: "Immatics’ technology platforms open up a breadth of novel targets and therapeutic strategies that could help overcome some of the challenges we have seen with immunotherapy to date. We believe that the Immatics approach could provide truly novel opportunities for patients in need and we look forward to supporting the Company as it advances its key programs addressing solid tumors."

Immatics is developing targeted immunotherapy candidates based on its suite of technologies which enables the identification of otherwise inaccessible intracellular protein targets displayed on a cell’s surface. Accessing these targets is generally recognized as an important key to unlocking hard-to-treat cancers, particularly solid tumors. Immatics is leveraging this to develop a pipeline of novel T cell receptor (TCR)-based products designed to deliver a robust and specific T cell response against cancer cells. Immatics’ international team, located in Munich and Tuebingen, Germany, as well as in Houston, Texas, is committed to advancing its proprietary therapeutic pipeline and collaboration programs with global pharmaceutical leaders to address significant unmet medical needs in oncology.

About this transaction
On March 17, 2020, Immatics, a privately held biotechnology company, entered into a definitive business combination agreement with Arya, a special purpose acquisition company (SPAC) sponsored by Perceptive Advisors, that was created for the purpose of entering into a business combination with a selected biopharmaceutical company and bringing the combined entity to the NASDAQ.

As a result of the business combination, Immatics received proceeds of approximately $253 million, prior to transaction expenses, which includes cash proceeds of approximately $149 million from Arya’s trust account and $104 million from PIPE investors led by Perceptive Advisors, other top-tier US healthcare investors and existing Immatics investors.

The description of the business combination contained herein is only a high-level summary and is qualified in its entirety by reference to the underlying documents filed with the U.S. Securities and Exchange Commission. A more detailed description of the terms of the transaction has been provided in a registration statement on Form F-4 filed with the U.S. Securities and Exchange Commission by Immatics.

Advisors
Goldman Sachs International is acting as lead financial advisor with SVB Leerink, BofA Securities, and Kempen serving as financial advisors to Immatics. Jefferies LLC is acting as lead financial and capital markets advisor to Arya as well as sole private placement agent. Chardan Capital Markets LLC is also serving as advisor to Arya. Goodwin Procter LLP and CMS Legal Services EEIG are acting as legal counsel to Immatics. Kirkland & Ellis LLP is serving as legal counsel to Arya.

On July 2, 2020 Neoleukin Therapeutics, Inc. ("Neoleukin") (Nasdaq: NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported the pricing of an underwritten public offering of 3,262,471 shares of its common stock at a price to the public of $15.25 per share (Press release, Neoleukin Therapeutics, JUL 2, 2020, View Source [SID1234563920]). In addition, and in lieu of common stock, Neoleukin is offering to certain investors pre-funded warrants to purchase up to an aggregate of 1,737,529 shares of common stock at a purchase price of $15.249999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.000001 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds from this offering are expected to be approximately $76.2 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Neoleukin. The offering is expected to close on or about July 7, 2020, subject to customary closing conditions. Neoleukin has also granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock in connection with the public offering. All of the securities are being offered by Neoleukin.

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BofA Securities, Piper Sandler and Guggenheim Securities are acting as joint book-running managers for the offering. Canaccord Genuity is acting as lead manager and H.C Wainwright & Co. is acting as co-manager for the offering. Neoleukin intends to use the net proceeds from the offering, together with its existing cash resources, to advance development of its lead program, NL-201, to expand its de novo protein design technology, to develop its preclinical pipeline and to fund working capital and for general corporate purposes, including capital improvements to properties it leases.

The securities are being offered by Neoleukin pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying base prospectus may also be obtained, when available, from BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001 or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Neoleukin, 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 July 2, 2020, Atreca, Inc. (the "Company") reported that it has entered into a Collaboration and License Agreement (the "Agreement) with Xencor, Inc. ("Xencor") (Filing, 8-K, Atreca, JUL 2, 2020, View Source [SID1234561752]). Under the Agreement, the parties will collaborate to research, develop and commercialize T cell-engaging bispecific antibodies as potential therapeutics in oncology.

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During an initial three-year research term, the parties will generate and evaluate bispecific antibodies comprising Atreca antibodies engineered with Xencor’s CD3 platform that bind to both a tumor target and a CD3 target, and the parties will each bear their own personnel costs, and will share equally the external, out-of-pocket costs, incurred in conducting the research activities. If a bispecific antibody arising during the research term meets certain specified criteria, then (a) the parties may elect to jointly fund the development and commercialization of products using such antibody in a joint program, (b) each party may develop and commercialize such antibodies on its own behalf in a unilateral program, or (c) the parties may agree to grant the rights to such antibodies to a third party in an out-licensed program. Each party has the right to participate in up to two joint programs and up to two unilateral programs. Using commercially reasonable efforts, the Company will lead development and commercialization under the first joint program, and Xencor will lead such activities under the second joint program. Each party will grant licenses to the other party under its relevant patents and know how in connection with the development, manufacture and commercialization of the products arising from the applicable program. Each party is subject to specified exclusivity obligations in connection with the targets to which the products arising from each collaboration are directed, and the antibodies included in such products, with the scope of such exclusivity determined based on whether such program is a joint or unilateral program.

Under each joint program, the parties will share all development and commercialization costs and profits and losses equally (50%/50%), subject to certain rights for the non-lead party to opt-out of its co-funding obligations at certain specified development points or upon specified triggers. Upon a party’s exercise of its right to opt out of a joint program, the other party will bear all development and commercialization costs, and pay the other party (a) development and commercialization milestone payments up to an aggregate of $95.0 million, (b) running royalties on net sales of products at a percentage in the mid-single digit to high-teens, and (c) a portion of the amounts (excluding royalties and certain payments) it receives as a result of the grant of a sublicense under the program at a percentage ranging in the mid-double digits, in each case of (a)-(c) depending on the timing at which the opt-out rights are exercised. Under each unilateral program, the lead party under such program will bear all development and commercialization costs, and pay the other party (i) running royalties on net sales of products at a percentage in the mid- to high-single digits, and (ii) a portion of the amounts (excluding royalties and certain payments) it receives as a result of the grant of a sublicense under the program at a percentage ranging in the low-double digits. Under each out-licensed program, the parties will share all amounts (excluding royalties and certain payments) received as a result of the grant of a sublicense under the program. The royalties for the opted-out joint programs and the unilateral programs will be payable, on a product-by-product and country-by-country basis, until the later of the expiration of each party’s patents that cover such product in such country, expiration of regulatory exclusivity for such product in such country, or ten years from first commercial sale of such product in such country.

The Agreement will expire on the later of (a) the first anniversary of the end of the three-year research term, and (b) the date on which all joint programs and all unilateral programs, including out-licensed programs, are either terminated or the payment obligations under such programs have expired. Each party may terminate the Agreement in its entirety, or on a program-by-program basis, for the other party’s uncured material breach. Each party may terminate the Agreement in its entirety for the other party’s insolvency.

The foregoing description of the Agreement does not purport to be complete and is subject to, and is qualified in its entirety by, reference to the Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ending June 30, 2020. The Company intends to seek confidential treatment for certain portions of the Agreement pursuant to a Confidential Treatment Request submitted to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.