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MorphoSys Announces Launch of American Depositary Shares (ADS) Offering in the United States

On April 9, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that it has commenced an initial public offering in the United States of up to 8,300,000 American Depositary Shares ("ADSs") pursuant to a Registration Statement on Form F-1, as amended, filed with the U.S. Securities and Exchange Commission (Press release, MorphoSys, APR 9, 2018, View Source [SID1234556337]). Furthermore, MorphoSys expects to grant the underwriters a 30-day option to purchase additional ADSs of up to 15% of the total number of ADSs placed in the offering (i.e. up to 1,245,000 additional ADSs). Each ADS will represent 1/4 of a MorphoSys ordinary share. The new ordinary shares underlying the ADSs will be issued from MorphoSys’s authorized capital 2017-II, excluding pre-emptive rights of existing shareholders and representing up to 8.1% (including the underwriters’ option to purchase additional ADSs) of the registered share capital of MorphoSys prior to the consummation of the offering.

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The final price of the offered ADSs will be determined largely on the basis of the XETRA closing price of MorphoSys’s shares on the Frankfurt Stock Exchange on the pricing date (expected for the week of April 16, 2018) translated into U.S. dollars at the then prevailing exchange rate and using an ADS to share ratio of four to one. Application has been made to list the ADSs on the Nasdaq Global Market in the United States under the ticker symbol "MOR".

Within the United States of America, the securities referred to in this release are to be offered only by means of a prospectus. A copy of the preliminary prospectus can be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or by e-mailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by e-mailing [email protected].

A Registration Statement relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. The securities may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective.

RhoVac announces a rights issue of SEK 24.5 million aimed at strengthening business development activities

On 9 April 2018, RhoVac reported the board of directors resolved to propose the annual general meeting of 9 May 2018 to resolve on a rights issue of approximately SEK 24.5 million before issue costs (Press release, RhoVac, APR 9, 2018, View Source [SID1234555937]). The net proceeds of the rights issue are primarily intended to strengthen the Company’s position, thereby creating better conditions in the work of identifying potential partnerships or outsourcing opportunities. As part of this, the Company will also initiate preparations for Phase IIb clinical trials.

Persons, who on the record date 16 May 2018 are shareholders of RhoVac, have pre-emptive rights to subscribe for new shares in the rights issue, whereby six (6) existing shares entitle to subscription for one (1) new share at a subscription price of SEK 18 per share. The subscription period runs from 18 May 2018 up to and including 1 June 2018.

The rights issue is secured up to 80 percent through subscription undertakings on approximately 6.0 MSEK equal to approximately 24.4 percent and entered guarantee undertakings on approximately 13.6 MSEK equal to approximately 55.6 percent. All the members of the Board of Directors and senior executives participate through subscription undertaking. All external investors who entered guarantee undertakings also participate through subscription undertaking.

Background and reasons

RhoVac is a biotechnology company conducting research and development of an immunotherapeutic cancer vaccine. The Company’s primary focus is the development of the drug candidate RV001 with the potential to prevent or limit the spread and recurrence of cancer in the treatment of several different cancer indications. The Company’s development strategy is based on licensing or selling all or parts of the business as soon as possible after completion of clinical phase I/II trial regarding RV001. As the ongoing phase I/II study is in its final stages, RhoVac is investing aggressively in its business development through, among other things, to, as previously announced, employ David Colpman at Colpman Consulting Ltd. The reason for the rights issue of approximately SEK 24.5 million at full subscription (before issue costs) is to primarily strengthen the business development with the purpose of identifying possible licensing opportunities or partnerships, follow-up of clinical phase I/II study, regulatory preparations for a clinical phase IIb study and general working capital required.

A fully subscribed rights issue would provide the Company with SEK 21.5 million (after issue costs), which exceeds the Company’s capital requirements over the next 12 months. In this case, the Company will adjust scheduled activities and allocation of capital taking into account the status of potential licensing and partnership discussions. Focus will be on activities that at the time are deemed most relevant in order to increase the value of the Company. In a step to further strengthen the business development in the next 12 months, the Board will propose Gunnar Gårdemyr as a new Board member at the AGM. The Company wishes to use Mr. Gårdemyr’s extensive experience and contact network in the Life Science area to further strengthen the Company’s business development.

The rights issue

On 9 April 2018, the board of directors of RhoVac AB resolved to propose the annual general meeting of 9 May 2018 to resolve on a new share issue with pre-emptive rights for the Company’s existing shareholders of approximately SEK 24.5 million before issue costs. Persons, who on the record date 16 May 2018 are shareholders of RhoVac, have pre-emptive rights to subscribe for new shares in the rights issue, whereby six (6) existing shares entitle to subscription for one (1) new share (i.e. a 1:6 subscription ratio).

The subscription price amounts to SEK 18.00 per share. The subscription period runs from and including 18 May up to and including 1 June 2018. Through the rights issue, not more than 1,360,507 new shares will be issued, corresponding to a share capital increase of SEK 244,891.26.

Subscription and guarantee undertakings

The rights issue is secured through subscription and guarantee undertakings up to 80 percent of the rights issue, corresponding to approximately SEK 19.6 million. RhoVac has received subscription undertakings of approximately SEK 6.0 million, corresponding to approximately 24.4 percent of the rights issue, from all the members of the Board of Directors and senior executives and, in particular, from a limited number of external investors by overtaking subscription rights. In addition, the Company has received guarantee undertakings of approximately SEK 13.6 million, corresponding to approximately 55.6 percent of the rights issue, whereof all of them have agreed to takeover subscription rights.

Shareholders who choose not to participate in the rights issue will have their shareholdings diluted by approximately 14.3 percent but are able to fully or partially financially compensate for this dilution by selling their subscription rights. In the event that all shares are not subscribed for with subscription rights, the board will, within the framework of the maximum amount of the rights issue, decide on the allotment of shares subscribed for without subscription rights

The rights issue is subject to approval from the annual general meeting of 9 May 2018. The convening notice of the annual general meeting is announced through a separate press release.

The full terms and conditions of the rights issue, as well as other information about the Company, will be outlined in an information memorandum, which will be published prior to the commencement of the subscription period.

Indicative timetable

9 May 2018 Annual general meeting for resolution on the rights issue
14 May 2018 Last day of trading in the RhoVac share, including the right to participate in the rights issue
16 May 2018 Record date for the right to participate with pre-emptive right in the rights issue
18 May – 1 June 2018 Subscription period
18 May – 30 May 2018 Trading in subscription rights
Around 7 June 2018 Announcement of the results of the rights issue
Advisers

Arctic Securities AS, Sweden branch, is acting as financial adviser to RhoVac in connection with the rights issue. Advokatfirman Lindahl is acting as legal adviser to the Company.

FDA Accepts New Drug Application for Duvelisib and Grants Priority Review

On April 9, 2018 Verastem, Inc. (NASDAQ:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for its lead product candidate duvelisib (Press release, Verastem, APR 9, 2018, View Source [SID1234529549]). Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for which Verastem is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). The FDA target action date is October 5, 2018.

"Obtaining Priority Review in the U.S. for duvelisib marks another important milestone for Verastem and speaks to the unmet need in relapsed/refractory CLL/SLL and FL and the urgency to identify effective therapies to treat these patients," said Robert Forrester, President and Chief Executive Officer of Verastem. "As an orally administered therapy, we believe duvelisib will provide an important treatment option for patients with CLL/SLL and FL, and for the physicians who treat them. We look forward to working with the FDA during the review process. We are continuing our commercial preparations for duvelisib to execute the launch promptly in the U.S. if approved. In parallel, we are exploring ex-U.S. partnering opportunities for duvelisib and plan to file a European Marketing Application towards the end of the year."

Priority Review is granted by the FDA to drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. Duvelisib has received Fast Track Designation from the FDA for patients with CLL who have received at least one prior therapy and for patients with FL who have received at least two prior therapies. In addition, duvelisib received orphan drug designation in the United States and the European Union for patients with CLL, SLL and FL.

About Duvelisib

Duvelisib is a first-in-class investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints and the FDA is reviewing a New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL). Duvelisib is also being developed by Verastem for the treatment of peripheral T-cell lymphoma (PTCL), which has Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

Allogene Therapeutics Completes Agreement for Pfizer’s Allogeneic CAR T Immuno-oncology Portfolio

On September 9, 2018 Allogene Therapeutics, Inc. (Allogene) reported the completion of the previously announced transaction between Pfizer Inc. (NYSE: PFE) and Allogene for Pfizer’s portfolio of assets related to allogeneic chimeric antigen receptor T cell (CAR T) therapy, an investigational immune cell therapy approach to treating cancer (Press release, Allogene, SEP 9, 2018, View Source [SID1234529314]).

On April 3, 2018, Allogene and Pfizer announced that the companies had entered into a definitive asset contribution agreement for Pfizer’s allogeneic CAR T portfolio .As a result of the completed agreement, Allogene has received from Pfizer the rights to 16 preclinical CAR T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier,UCART19, an allogeneic CAR T therapy that is being developed for treatment of CD19- expressing hematological malignancies. In partnership with Servier, UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase 1.UCART19 utilizesTALEN gene editing technology pioneered and owned by Cellectis.

With the agreement completed, Allogene is well-positioned to rapidly advance the portfolio of CAR T assets contributed by Pfizer into potential innovative new therapies,and ultimately to reach patients in need more quickly."The completion of our agreement with Pfizer represents a bold undertaking by leaders in the field to expedite the development of the next wave of cancer immunotherapies," said David Chang, M.D., Ph.D., President and Chief Executive Officer of Allogene.

Pfizer will continue to participate financially in the CAR T portfolio’s development through a 25 percent ownership stake in Allogene. Prior to the agreement’s completion, Gilead Sciences joined Allogene’s premier Series A investment consortium that already included TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, and Pfizer, among others.

Centerview Partners acted as financial advisor to Pfizer, with Ropes & Gray LLP acting as its legal advisor. Coole. LLP served as legal counsel to Allogene, Vida Ventures and TPG. Gibson Dunn & Crutcher LLP also served as legal counsel to TPG.

Morphotek Announces Agreement to License its Proprietary Eribulin-Linker Payload to Bliss Biopharmaceutical Co., Ltd. for Development of a Therapeutic Antibody-Drug Conjugate (ADC)

On April 9, 2018 Morphotek, Inc., a subsidiary of Eisai Inc., reported that it licensed its eribulin-linker payload to Bliss Biopharmaceutical Co., Ltd. (BlissBio) of China (Press release, Morphotek, APR 9, 2018, View Source [SID1234527215]). The licensing agreement grants BlissBio the exclusive right to use the eribulin-linker payload to develop a therapeutic ADC against an undisclosed oncology target for the China market. The licensing agreement includes an upfront payment, milestones and sales royalty payments, which are undisclosed. BlissBio has an exclusivity option to expand the territory beyond China to the global market and to develop therapeutic ADCs to two additional undisclosed oncology targets.

Morphotek’s ADC Services offer third parties the opportunity to license the proprietary eribulin-linker payload to develop investigational ADCs using either Morphotek’s REsidue-SPEcific Conjugation Technology (RESPECT) or an alternative approach to conjugation. The eribulin-linker payload consists of a cytotoxic agent, eribulin, modified by a chemical linker to facilitate optimal conjugation. Eribulin’s anti-tumor activity is mediated by the inhibition of microtubule elongation and mitotic spindle formation, resulting in apoptosis. Eribulin mesylate, marketed as Halaven, is approved in the U.S. for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting.

Our end-to-end ADC Services provide multiple entry points for clients, starting from development of an antigen site-specific bioconjugate-ready monoclonal antibody and ADC through in vivo safety and efficacy validation. Additional options include manufacture of GMP clinical trial material, GLP toxicology studies and development of immunohistochemistry (IHC) companion diagnostics for patient screening. For more information on Morphotek’s ADC Services business and RESPECT platform, please contact [email protected].

*The ADCs described herein are investigational, as efficacy and safety have not been established. There is no guarantee that the ADCs will be available commercially.