Invitae Completes Acquisition of CombiMatrix, Becoming a Leader in Family and Reproductive Health Genetic Information Services

On November 15, 2017 Invitae Corporation (NYSE: NVTA), one of the fastest growing genetic information companies, reported it has completed its acquisition of CombiMatrix, which specializes in providing genetic information for prenatal diagnosis, miscarriage analysis and diagnosis of pediatric developmental disorders, establishing Invitae as a new leader in family and reproductive genetic health services (Press release, CombiMatrix, NOV 15, 2017, View Source [SID1234522094]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"With the addition of CombiMatrix to Invitae, we have completed our entry into prenatal and perinatal genetics, currently the second-largest category of genetic testing services. Our integrated offering will build on the expertise and technologies developed by CombiMatrix to offer customers the most comprehensive offering from a single provider in the category," said Sean George, chief executive officer of Invitae. "Invitae’s platform now delivers comprehensive genetic information services that support the use of genetics in mainstream medical care throughout all stages of life."

CombiMatrix leverages cytogenomic and cytogenetic technologies such as single nucleotide polymorphism chromosomal microarray analysis and next generation sequencing, supported by long-standing expertise in technically challenging sample types, to provide in-depth answers for patients and clinicians addressing complex reproductive health questions.

"Access to actionable genetic information is essential for monitoring pregnancies, particularly for women going through IVF or facing recurrent miscarriages," said Robert Nussbaum, MD, chief medical officer of Invitae. "Our integrated platform and world-class expertise can provide genetic information that helps women and their clinicians with some of the most important decisions of their lives today, even as we continue to advance the understanding of the role genetics plays in having healthy pregnancies."

In connection with the closing, Invitae issued approximately $21.2 million in shares of its common stock to former CombiMatrix securityholders, or approximately 2.7 million shares. Together with the approximately 1.7 million shares of Invitae common stock underlying CombiMatrix Series F warrants assumed in the Merger, the transaction has a total enterprise value of approximately $34.9 million.

The acquisition of CombiMatrix complements Invitae’s recent acquisition of another reproductive genetics company, Good Start Genetics, to establish a category-leading menu with the breadth and depth needed to provide comprehensive support for women, their partners and clinicians to use genetic information when considering their reproductive health options, from carrier screening to preimplantation genetic screening and diagnosis to newborn diagnostics.

Transaction Details

At the closing of the Merger, Invitae issued shares of its common stock to (i) CombiMatrix’s common stockholders, at an exchange ratio of 0.8692 of a share of Invitae common stock (the "Merger Exchange Ratio") for each share of CombiMatrix common stock outstanding immediately prior to the Merger, (ii) CombiMatrix’s Series F preferred stockholders, at the Merger Exchange Ratio for each share of CombiMatrix common stock underlying Series F preferred stock outstanding immediately prior to the Merger, (iii) holders of outstanding and unexercised in-the-money CombiMatrix stock options, which were fully accelerated to the extent of any applicable vesting period and converted into the right to receive a number of shares of Invitae common stock adjusted for the Merger Exchange Ratio and reduced by the aggregate exercise price, and (iv) holders of outstanding and unsettled CombiMatrix restricted stock units ("RSUs"), which were fully accelerated to the extent of any applicable vesting period and converted into the right to receive a number of shares of Invitae common stock adjusted for the Merger Exchange Ratio. No fractional shares were issued in connection with the Merger and Invitae will pay cash in lieu of any such fractional shares. The Merger Exchange Ratio was determined through arm’s-length negotiations between Invitae and CombiMatrix.

In addition, at the closing of the Merger, (a) all outstanding and unexercised out-of-the money CombiMatrix stock options were cancelled and terminated without the right to receive any consideration, (b) all CombiMatrix Series D Warrants and Series F Warrants outstanding and unexercised immediately prior to the closing of the Merger were assumed by Invitae and converted into warrants to purchase the number of shares of Invitae common stock determined by multiplying the number of shares of CombiMatrix common stock subject to such warrants by the Merger Exchange Ratio, and with the exercise price adjusted by dividing the per share exercise price of the CombiMatrix common stock subject to such warrants by the Merger Exchange Ratio, and (c) certain entitlements under CombiMatrix’s executive compensation transaction bonus plan (the "Transaction Bonus Plan") were paid in shares of Invitae common stock or RSUs to be settled in shares of Invitae common stock. All outstanding and unexercised CombiMatrix Series A, Series B, Series C, Series E, and PIPE warrants were repurchased by CombiMatrix prior to closing pursuant to that certain CombiMatrix Common Stock Purchase Warrants Repurchase Agreement dated July 11, 2016.

Invitae’s previously announced offer to exchange each outstanding Series F warrant (the "CombiMatrix Series F warrants") to acquire one share of common stock of CombiMatrix for 0.3056 of a share of Invitae common stock (the "Exchange Offer") expired at 12:00 midnight (one minute after 11:59 p.m.), New York City time, on November 13, 2017. Because the minimum tender condition of 90% was not achieved in the Exchange Offer, Invitae did not accept any of the CombiMatrix Series F warrants that were tendered in the Exchange Offer prior to its expiration. Accordingly, any CombiMatrix Series F warrants that were tendered will be promptly returned to the holder by the exchange agent.

Invitae issued an aggregate of 2,726,324 shares of its common stock and 214,976 RSUs in connection with the Merger (including shares and RSUs issued pursuant to the Transaction Bonus Plan). Immediately after the Merger, (i) there were approximately 52.9 million shares of Invitae common outstanding, (ii) the former CombiMatrix securityholders and executives owned approximately 8.6% of the fully-diluted common stock of the combined company, and (iii) Invitae securityholders, whose shares of Invitae capital stock remain outstanding after the Merger, owned approximately 91.4% of the fully-diluted common stock of the combined company.

Upon completion of the Merger, CombiMatrix became a wholly owned subsidiary of Invitae. As a result, the CombiMatrix common stock and Series F warrants will cease trading on the Nasdaq Capital Market and will be delisted.

About Invitae’s Family and Reproductive Health Genetic Services

Invitae’s reproductive genetics products, which include CombiPGS, CombiPGD and CombiSNP from CombiMatrix and Good Start Genetics’ GeneVu, EmbryVu and VeriYou, provide affordable and accessible genetic information to help people have healthy families. Good Start Genetics became part of Invitae in August 2017.

ADC Therapeutics to Present New Clinical Data for ADCT-402 and ADCT-301 at the American Society of Hematology 2017 Annual Meeting

On November 15, 2017 ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, reported that five abstracts, including one oral presentation, have been accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 9-12, 2017 in Atlanta, USA (Press release, ADC Therapeutics, NOV 15, 2017, View Source [SID1234522071]). The presentations will highlight the clinical data from ADCT-402 and ADCT-301, the two most advanced programs in its portfolio of ADCs targeting haematological and solid tumours.

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"Interim data from a phase 1 study evaluating pyrrolobenzodiazepine-based antibody drug conjugate ADCT-402 (Loncastuximab tesirine) targeting CD19 for relapsed or refractory B-Cell acute lymphoblastic leukemia."
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ADCT-402 and ADCT-301 are currently in four Phase Ia/Ib clinical studies, and incorporate a novel class of highly potent pyrrolobenzodiazepine (PBD)-based warheads with a unique mode of action. ADCT-402 is an ADC targeting CD19 for the treatment of non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). ADCT-301 is an ADC targeting CD25 for the treatment of Hodgkin and non-Hodgkin lymphoma (HL/NHL), as well as acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

"We are excited by the clincal data we are presenting at ASH (Free ASH Whitepaper) this year. The presentation and posters cover two clinical stage programs where we have seen considerable single agent clinical activity, in relapsed and refractory disease settings, in patients who have undergone multiple prior therapies, and have very limited treatment options," said Dr. Chris Martin, CEO of ADC Therapeutics. "We look forward to further developing our ADC pipeline and are pleased that our ADCs continue to demonstrate encouraging clinical activity across multiple tumor types."

The titles for the oral presentation and poster presentations are as follows, including date and time:

Oral presentation:

ADCT-402 (Abstract #187):

– "Encouraging early results from the first-In-human clinical trial of ADCT-402 (Loncastuximab tesirine), a novel pyrrolobenzodiazepine-based antibody drug conjugate, in relapsed/refractory B-cell lineage non-Hodgkin lymphoma." Session 626 Saturday, December 9, 2017 at 2:00pm to 3:30 pm, Bldg A, Lvl 4, A411-A412

Poster presentations:

ADCT-402 (Abstract #1321)

– "Interim data from a phase 1 study evaluating pyrrolobenzodiazepine-based antibody drug conjugate ADCT-402 (Loncastuximab tesirine) targeting CD19 for relapsed or refractory B-Cell acute lymphoblastic leukemia." Session 614 Saturday, December 9, 2017 from 5:30pm to 7:30pm, Bldg A, Lvl 1, Hall A2

ADCT- 402 (Abstract #2543):

– "Elucidating exposure-response (safety and efficacy) of ADCT-402 (Loncastuximab tesirine), a novel pyrrolobenzodiazepine-containing antibody drug conjugate, for recommended phase 2 dose determination in patients with relapsed or refractory non-Hodgkin lymphoma." Session 614 Sunday, December 10, 2017 from 6:00pm to 8:00pm, Bldg A, Lvl 1, Hall A2

ADCT-301 (Abstract #1510):

– "Interim results from a phase 1 study of ADCT-301 (Camidanlumab tesirine) show promising activity of a novel pyrrolobenzodiazepine-based antibody drug conjugate in relapsed/refractory Hodgkin/non-Hodgkin lymphoma." Session 624 Saturday, December 9, 2017 from 5:30pm to 7:30pm, Bldg A, Lvl 1, Hall A2

ADCT-301 (Abstract #2662):

– "Results from an ongoing phase 1 Study indicate ADCT-301 (Camidanlumab tesirine) is well tolerated in patients with relapsed or refractory CD25-positive acute leukemia." Session 616 Sunday, December 10, 2017 from 6:00pm to 8:00pm, Bldg A, Lvl 1, Hall A2

Learn more about the ADC programs at the ADC Therapeutics Booth #323 in the Exhibition Hall B2

About ADCT-402 ADCT-402 is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD)-dimer toxin. Once bound to a CD19-expresing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of certain CD19-expressing B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in two ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory B-cell lineage non-Hodgkin lymphoma and relapsed or refractory B-cell lineage acute lymphoblastic leukemia. (www.adct-402.com)

About ADCT-301 ADCT-301 is an antibody-drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax(R)-TAC, licensed from Genmab A/S), conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD25-expresing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. CD25 is an attractive target for an ADC approach as it is expressed in a wide range of hematological malignancies, including certain forms of lymphomas and leukemias, while its expression in healthy organs is restricted. ADCT-301 is being evaluated in two ongoing phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL), and in patients with relapsed or refractory CD25-positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). (www.adct-301.com)

Third quarter 2017 report

On November 15, 2017 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its revenues and cash position for the first nine months of 2017 (Press release, Innate Pharma, NOV 15, 2017, View Source [SID1234522077]).

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Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, commented: "Our robust cash position as of September 30 2017, provides us with the ability to further invest in our proprietary discovery and development portfolio of first-in-class immuno-oncology programs, including our lead product candidates IPH4102 and IPH5401. Clinical development plans for both candidates are in the process of being shaped and we expect to provide an update early in 2018. Following the promising results for IPH4102 presented at the 2017 EORTC meeting, Innate Pharma remains committed to bringing IPH4102 to patients on our own as quickly as possible, in line with our strategy of becoming an independent, fully integrated biopharmaceutical company."

Cash, cash equivalents and financial assets of the Company amounted to €195.7 million at September 30, 2017, including current and non-current financial assets (€239.6 million at September 30, 2016). At the same date, its financial liabilities amounted to €4.9 million (€5.6 million at September 30, 2016).

The net consumption of cash, cash equivalents and financial assets* amounted to €8.4 million for the third quarter of 2017. This includes the collection during the period of the research tax credit relating to the year 2016 (€8.8 million).

For the nine-month period ended September 30, 2017, revenue results from the co-development and commercialization agreement with AstraZeneca, corresponding to the recognition over the period of the initial payment received in April 2015 (€27.2 million for the same period in 2016).

The nine-month period ended September 30, 2016 included a €0.7 million amount resulting from the collaboration and licensing agreement with Bristol-Myers Squibb corresponding to the recognition of the upfront payment received in July 2011.

Regarding the co-development and commercialization agreement with AstraZeneca, the Company recognizes the initial payment of $250 million over the period during which the Company is committed to complete the studies and based on actual expenses incurred. The measurement of progress has been based on actual expenses incurred compared to the total estimated amount of expenses to be incurred for these studies.

Arvinas Expands Strategic License Agreement with Genentech

On November 15, 2017 Arvinas LLC, a private biotechnology company creating a new class of drugs based on protein degradation, reported it has expanded its ongoing license agreement with Genentech, a member of the Roche Group, for the development of new therapeutics using Arvinas’ novel PROTAC technology (Press release, Arvinas, NOV 15, 2017, View Source [SID1234558785]). The multi-year strategic license agreement, initiated in October 2015, will encompass additional disease targets and expand the collaboration.

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Under the revised terms of the agreement, Arvinas is eligible to receive development and commercialization milestone payments in excess of $650 million based on achievement of certain predetermined milestones. In addition, Arvinas is eligible to receive tiered-royalties on sales of products resulting from the license agreement. Full financial terms have not been disclosed.

"Genentech’s decision to expand our original agreement to include additional disease targets shows the promise seen in our first two years together and further supports our targeted protein degradation platform as a novel drug modality to treat a broad array of diseases," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "This expansion also supports our initial decision to work with Genentech in 2015 and we look forward to this growing collaboration."

The PROTAC Platform offers potential improvements over traditional small molecule inhibitors using the ubiquitin and proteasome system within a cell to degrade disease causing proteins. By removing target proteins directly rather than inhibiting them, PROTACs can provide multiple advantages over small molecule inhibitors, which can require high systemic exposure to achieve sufficient inhibition, often resulting in toxic side effects and eventual drug resistance.

West Announces Upcoming Investor Conference

On November 15, 2017 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that management will be presenting a West business overview at the upcoming Jefferies 2017 London Healthcare Conference, at the Waldorf Hilton Hotel in London, UK, at 8:40 a.m. GMT on Thursday, November 16, 2017 (Press release, West Pharmaceutical Services, NOV 15, 2017, View Source;p=RssLanding&cat=news&id=2317078 [SID1234522080]).

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A live audio webcast of the presentation and a copy of the presentation will be accessible from the Company’s website at www.westpharma.com/en/investors.