Invitae Announces $1.15 Billion Investment Supporting Ongoing Growth Initiatives

On April 5, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported that a small group of investors, led by SB Management, a subsidiary of Softbank Group Corp., will make an investment of $1.15 billion in convertible senior notes to support the Company’s future growth initiatives (Press release, Invitae, APR 5, 2021, View Source [SID1234577561]).

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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)

"Invitae’s mission is to deliver genetic information to improve healthcare for billions of people at all stages of life. With the support of our long-term shareholders, we’re creating the platform to support the routine use of genetics in mainstream medicine to result in better healthcare for everyone," said Sean George, co-founder and chief executive officer of Invitae. "This investment will help us continue to fuel our growth, including expanding our platform, services and menu through both in-house development and the addition of complementary companies and technologies as we work to build a differentiated platform uniquely capable of driving the transition to personalized medicine."

"Invitae has a definitive head start in the rapidly expanding market for clinical genetic sequencing. Their comprehensive diagnostic products are well positioned to further grow the global understanding of how genomics predispose populations for certain diseases. These datasets will inform treatment and dramatically improve patient outcomes," said Akshay Naheta, chief executive officer of SB Management, a subsidiary of SoftBank Group Corp.

Under the terms of the investment, the participating investors, including SB Management, will purchase a total aggregate principal amount of $1.15 billion in Convertible Senior Notes due 2028 (the "Notes"). The Notes will have an initial conversion price of $43.18 per share of the Company’s common stock, subject to customary anti-dilution and other adjustments. The initial conversion price of $43.18 represents a 20% premium to the Company’s average 5-day trailing volume-weighted average price as of April 1, 2021. The Notes will mature on April 1, 2028, unless earlier converted, redeemed or repurchased. The Notes will bear 1.5% interest per year. Upon conversion, the Company will have the right to elect settlement in cash, shares, or any combination thereof in its sole discretion.

Additional information regarding this announcement may be found in a Current Report on Form 8-K that the Company intends to file today with the U.S. Securities and Exchange Commission.

J. Wood Capital Advisors LLC and Perella Weinberg Partners LP acted as financial advisors and J.P. Morgan acted as placement agent to Invitae on the transaction.

Invitae to acquire Genosity to accelerate access to personalized oncology testing worldwide

On April 5, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported it has entered into a definitive agreement to acquire Genosity Inc. ("Genosity"), a genomics company offering innovative software and laboratory solutions to enable development and deployment of complex sequencing based tests (Press release, Invitae, APR 5, 2021, View Source [SID1234577562]). The acquisition would bring Genosity’s specialized capabilities onto the Invitae platform to accelerate the time to market and decentralization of Invitae’s personalized oncology offerings, including somatic and germline offerings poised to help transform how cancer is diagnosed, treated and monitored.

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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)

"Each individual cancer is unique. The way we diagnose and treat it must be as well," said Robert Nussbaum, M.D., chief medical officer of Invitae. "Our goal is to move as quickly as we can toward the day where each cancer patient receives timely, comprehensive genetic information that is used to guide their care from diagnosis to monitoring for disease recurrence. Together with Genosity, we believe our combined novel capabilities and capacity will help us reach that day sooner for patients around the globe."

Genosity has built an industry-leading suite of highly specialized capabilities designed to support the use of next generation sequencing in oncology development and clinical care, ranging from basic research to clinical testing for regulated studies. The company currently works with Invitae on a number of projects and clinical trials. Becoming a part of Invitae is expected to provide important advantages for the development and launch of Invitae’s oncology products, which include three devices under development that have received breakthrough device designation from the U.S. Food and Drug Administration (FDA), including the capacity, speed, and efficiency required to serve mainstream medicine cost effectively both with central laboratory services and decentralized kitted products.

"Genosity, under the insightful leadership of Marc Grodman, MD, has been able to develop solutions which enable broader adoption of genomic testing. Our laboratory services, end-to-end software solutions and data management platform are an ideal fit as Invitae develops best-in-class options for MRD-based cancer monitoring," said Robert D. Daber, Ph.D., president and chief technology officer of Genosity. "In Invitae we have found a like-minded partner focused on making genomics more affordable and accessible worldwide."

Maximum flexibility to accelerate the future of cancer care worldwide

Invitae is currently developing its Personalized Cancer MonitoringTM (PCM) platform as an in vitro diagnostic (IVD) intended for regulatory submission. PCM analyzes a patient’s unique genetic profile of their specific cancer and uses it to monitor their blood to detect cancer recurrence early when it is most curable. Invitae’s PCM test, if approved for use, will be augmented by Genosity technology and capabilities to distribute PCM globally, increasing accessibility and reducing turnaround time. With this capability, we believe Invitae will be uniquely able to meet the needs of cancer patients worldwide, whether their clinicians send out to a central testing service or rely on tests that are completed locally by in-house laboratories.

In January 2020, Invitae received Breakthrough Device Designation from the FDA for PCM.

Transaction Terms

Under the terms of the agreement, Invitae will acquire Genosity for approximately $200 million, consisting of (i) approximately $120 million in cash and (ii) approximately $80 million in shares of Invitae common stock (based upon a trailing average closing price prior to the date of closing but subject to certain potential adjustments), with such stock and cash consideration subject to reduction based upon certain debt and transaction expenses of Genosity determined at closing.

The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter, subject to customary closing conditions including the expiration or early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

In connection with the transaction, Invitae will grant restricted stock units ("RSUs") having a value of up to $15 million to certain continuing employees of Genosity. These RSUs will be granted under Invitae’s 2015 Stock Incentive Plan (the "2015 Plan"), which is being amended to create an additional pool of shares of Invitae common stock to be used exclusively for the grant of inducement awards in compliance with New York Stock Exchange Rule 303A.08 ("Rule 303A.08"). These RSUs were approved by the Invitae Board of Directors and will be granted as an inducement material for continued employment following the acquisition of Genosity in reliance on the employment inducement exemption under Rule 303A.08. These RSUs will vest annually over three years and, in certain instances, the number of RSUs that vest on each vesting date will be calculated based upon a trailing average closing price prior to the date of closing of the Genosity acquisition.

Advisors

Cowen served as exclusive financial advisor to Genosity in connection with the acquisition.

Other Inducement Grants for Previous Transaction

Unrelated to the Genosity transaction, Invitae reported inducement grants in connection with the addition of certain assets and key personnel from a small organization called IntelliGene Health Informatics, LLC. which was focused on specialized software capabilities and technologies and will augment Invitae’s oncology offerings.

In connection with Invitae’s acquisition of assets from IntelliGene Health Informatics, LLC ("IntelliGene") for approximately $2.7 million, Invitae granted RSUs having a value of up to $6.225 million to certain employees and consultants of IntelliGene who continue as employees of Invitae. These RSUs were granted under the 2015 Plan, which was amended to provide for an additional pool of shares of Invitae’s common stock to be used exclusively for the grant of inducement awards in compliance with Rule 303A.08. These RSUs were approved by the Invitae Board of Directors and were granted as a material inducement for continued employment following the acquisition of assets from IntelliGene in reliance on the employment inducement exemption under NYSE Rule 303A.08. These RSUs vest in two installments at 12 months and 24 months following the acquisition of IntelliGene assets. The number of RSUs that vest on each vesting date will be calculated based on the volume-weighted average trading price of the company’s common stock on the NYSE for a trailing 20 trading day period prior to the grant date or, in certain situations, the vesting date.

Spectrum Pharmaceuticals Presentations at the Upcoming AACR Virtual Meeting 2021 to Include Updated Poziotinib Twice Daily Dosing Data

On April 5, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported a poster presentation on safety and tolerability of twice daily administered poziotinib in patients with EGFR or HER2 exon 20 mutations (Press release, Spectrum Pharmaceuticals, APR 5, 2021, View Source [SID1234577580]). The company will also present a poster on the evaluation of same-day dosing of ROLONTIS (eflapegrastim) in neutropenic rats and patients with early-stage breast cancer. These poster presentations will be available at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, taking place from April 10-15, 2021. Details of the presentations are as follows:

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Title: Poziotinib administered twice daily improves safety and tolerability in patients with EGFR or HER2 exon 20 mutations
Speaker: Xiuning Le, M.D., Ph.D.
Session: PO.CT02 – Phase 2 Clinical Trials
Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET
Presentation Number: CT169

Title: Same-day administration of Eflapegrastim with chemotherapy enhances neutropenic recovery in neutropenic rats and in early-stage breast cancer patients
Speaker: John A. Barrett
Session: PO.CT01 – Phase 1 Clinical Trials
Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET
Presentation Number: CT116

The poster presentations will be available for viewing by registered participants during the conference via the AACR (Free AACR Whitepaper) website on April 10, 2021.

MEI Pharma to present at the 20th Annual Needham Virtual Healthcare Conference

On April , 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported its participation in the 20th Annual Needham Virtual Healthcare Conference (Press release, MEI Pharma, APR 5, 2021, View Source [SID1234577563]). MEI Pharma will present a company overview and business update on Monday, April 12, 2021 at 12:45 p.m. Eastern Time.

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A live webcast of the presentation can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source An archived replay of the webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.

Exelixis Announces U.S. FDA Accepts Investigational New Drug Application for XB002 in Patients with Advanced Solid Tumors

On April 5, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors (Press release, Exelixis, APR 5, 2021, View Source [SID1234577581]). As a next-generation tissue factor-targeting antibody-drug conjugate (ADC), XB002 has the potential for an improved therapeutic index and may provide a favorable safety profile compared with earlier-generation tissue factor-targeting ADCs.

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"The acceptance of our Investigational New Drug Application for XB002 gets us one step closer to our first biologic entering the clinic and learning more about its potential to help patients with difficult-to-treat cancers," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "Considering XB002’s promising preclinical data and potential differentiation from other tissue factor-targeting antibody-drug conjugates, we look forward to initiating our phase 1 trial in patients with advanced solid tumors."

XB002 (formerly ICON-2) is an ADC composed of a human monoclonal antibody against tissue factor that is conjugated to a cytotoxic agent. After binding to tissue factor on tumor cells, XB002 is internalized, and the cytotoxic agent is released, resulting in targeted tumor cell death. XB002 is a rationally designed next-generation ADC that leverages proprietary linker-payload technology.

Preclinical data demonstrated that XB002 binds to tissue factor without affecting the coagulation cascade, in contrast with prior therapies in this class. The data also demonstrated encouraging activity of XB002 in multiple solid tumor cancer models and improved tolerability compared with other tissue factor-targeting ADCs. XB002 has shown significant tumor growth inhibition and, in some cases, complete regression. The rational design and preclinical profile of this novel tissue factor-targeting ADC suggest that, if born out in clinical evaluation, XB002 could have an improved therapeutic index and favorable safety profile compared with earlier tissue factor-targeting ADCs.