NuVasive, Inc. Announces Pricing Of Offering Of $450 Million Of 0.375% Convertible Senior Notes Due 2025

On February 26, 2020 NuVasive, Inc. (NASDAQ: NUVA) reported the pricing of its offering of $450,000,000 aggregate principal amount of 0.375% Convertible Senior Notes due 2025 (the "Convertible Notes") in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, NuVasive, FEB 26, 2020, View Source;301012315.html [SID1234554951]). NuVasive also granted to the initial purchasers of the Convertible Notes a 13-day option to purchase up to an additional $50,000,000 aggregate principal amount of the Convertible Notes. The sale of the Convertible Notes to the initial purchasers is expected to settle on March 2, 2020, subject to customary closing conditions, and is expected to result in approximately $435.9 million in net proceeds to NuVasive after deducting fees and estimated offering expenses payable by NuVasive (assuming no exercise of the initial purchasers’ option to purchase additional Convertible Notes).

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The Convertible Notes will be general unsecured obligations of NuVasive and interest will be paid semiannually in arrears on March 15 and September 15 of each year, beginning on September 15, 2020. The Convertible Notes will mature on March 15, 2025, unless earlier repurchased, redeemed or converted. Prior to the close of business on the business day immediately preceding September 15, 2024, the Convertible Notes will be convertible at the option of holders only upon the satisfaction of certain conditions and during certain periods. Thereafter until close of business on the second scheduled trading day preceding maturity, the Convertible Notes will be convertible at the option of the holders at any time regardless of these conditions. Conversions of Convertible Notes will be settled in cash, shares of NuVasive common stock or a combination thereof, at NuVasive’s election. The Convertible Notes will not be redeemable at NuVasive’s option prior to March 20, 2023. On or after March 20, 2023 until the close of business on the business day immediately preceding September 15, 2024, the Convertible Notes will be redeemable at NuVasive’s option if the last reported sale price of NuVasive’s common stock for at least 20 trading days in any 30 trading day period has been at least 130% of the conversion price for the Convertible Notes.

The initial conversion rate is 10.7198 shares of common stock per $1,000 principal amount of Convertible Notes (equivalent to an initial conversion price of approximately $93.29 per share of NuVasive common stock). The conversion rate and the corresponding conversion price will be subject to adjustment upon the occurrence of certain events, but will not be adjusted for any accrued and unpaid interest. The initial conversion price of the notes represents a premium of approximately 35% to the $69.10 per share closing price of NuVasive’s common stock on February 26, 2020.

If NuVasive undergoes a fundamental change (as defined in the indenture governing the Convertible Notes), holders may require NuVasive to purchase for cash all or part of their Convertible Notes at a purchase price equal to 100% of the principal amount of the Convertible Notes to be purchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change purchase date. In addition, if the Company calls any or all of the Convertible Notes for redemption or certain make-whole fundamental changes occur, NuVasive will, in certain circumstances, increase the conversion rate for any Convertible Notes converted in connection with such redemption or such make-whole fundamental change.

In addition, in connection with the pricing of the Convertible Notes, NuVasive entered into privately negotiated convertible note hedge transactions and warrant transactions with certain dealers, including affiliates of certain of the initial purchasers of the Convertible Notes (the "Option Counterparties"). The convertible note hedge transactions are expected generally to reduce the potential dilution to NuVasive’s common stock upon any conversion of Convertible Notes and/or offset any cash payments NuVasive is required to make in excess of the principal amount of converted Convertible Notes, as the case may be, in each case upon conversion of the Convertible Notes. The warrant transactions could separately have a dilutive effect to the extent that the market price per share of NuVasive’s common stock exceeds the applicable strike price of the warrants. However, subject to certain conditions, NuVasive may elect to settle all or a portion of the warrants in cash. The strike price of the warrant transactions will initially be approximately $127.84 per share, which represents a premium of approximately 85% over the last reported sale price of NuVasive’s common stock on February 26, 2020, and is subject to certain adjustments under the terms of the warrant transactions.

NuVasive expects that in connection with establishing their initial hedges of these transactions, the Option Counterparties and/or their respective affiliates will enter into various derivative transactions with respect to NuVasive’s common stock and/or purchase NuVasive’s common stock in secondary market transactions concurrently with, or shortly after, the pricing of the Convertible Notes. This activity could increase (or reduce the size of any decrease in) the market price of NuVasive’s common stock or the Convertible Notes at that time. In addition, NuVasive expects that the Option Counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to NuVasive’s common stock and/or purchasing or selling NuVasive’s common stock or other securities of NuVasive in secondary market transactions following the pricing of the Convertible Notes and prior to the maturity of the Convertible Notes (and are likely to do so during any observation period related to a conversion of Convertible Notes). This activity could also cause or avoid an increase or a decrease in the market price of NuVasive’s common stock or the Convertible Notes, which could affect the ability of holders of Convertible notes to convert the Convertible Notes and, to the extent the activities occur during any observation period related to a conversion of the Convertible Notes, could affect the amount of cash and/or the number and value of shares of NuVasive common stock that holders will receive upon conversion of the Convertible Notes.

NuVasive intends to use approximately $31.2 million of the net proceeds from the offering to pay the cost of the convertible note hedge transactions (after such cost is partially offset by the proceeds to NuVasive from the warrant transactions). Additionally, if the initial purchasers exercise their option to purchase additional Convertible Notes, NuVasive may sell additional warrants and use a portion of the proceeds from the sale of the additional Convertible Notes to enter into additional convertible note hedge transactions with the Option Counterparties.

NuVasive also expects to use approximately $75,000,000 of the net proceeds from the offering to repurchase shares of its common stock from purchasers of the Convertible Notes in the offering in privately negotiated transactions concurrently with the offering. NuVasive intends to use the remaining net proceeds of the offering for working capital and other general corporate purposes, which may include potential mergers and acquisitions, to refinance indebtedness, and for repurchases of outstanding Convertible Senior Notes due 2021 (the "2021 Notes"). NuVasive may also use net proceeds from the offering for additional repurchases of shares of common stock in accordance with the Company’s stock repurchase program, which NuVasive’s Board of Directors recently amended to allow for repurchases of up to $150,000,000 of the Company’s common stock through December 31, 2021. The repurchase of shares of common stock and any repurchase of the 2021 Notes could have the effect of raising or maintaining the market price of NuVasive’s common stock above levels that would otherwise have prevailed, or preventing or retarding a decline in the market price of NuVasive’s common stock, and thereby impacting the trading price of the Convertible Notes. In the case of repurchases of common stock effected concurrently with the offering, this activity could have affected the market price of NuVasive’s common stock and could have resulted in a higher effective conversion price for the Convertible Notes.

The offering is only being made to qualified institutional buyers pursuant to Rule 144A under the Securities Act. Neither the Convertible Notes nor any shares of NuVasive’s common stock issuable upon conversion of the Convertible Notes have been or are expected to be registered under the Securities Act or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This news release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.

Nouscom Strengthens Its Management Team

On February 26, 2020 Nouscom, an immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, reported that it has appointed Marina Udier, PhD, as Chief Executive Officer (CEO) and Patricia Delaite, MD, as Chief Medical Officer (CMO) with immediate effect (Press release, NousCom, FEB 26, 2020, View Source [SID1234554910]).

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Dr. Guido Magni, Chairman of the Board of Nouscom, said, "The board has been impressed with the operational and strategic achievements made since Marina was appointed CEO on an interim basis in May 2019. During this time, Nouscom received IND clearance for its lead program NOUS-209, an off-the-shelf cancer vaccine based on shared frame shift neoantigens, and advanced this exciting candidate into its First-in-Human clinical studies in the US. She has also been instrumental in building a strong team with the recruitment of Patricia as CMO. The Board has therefore decided to make Marina’s appointment as CEO permanent and has confidence in her ability to lead the business into its next chapter."

Marina Udier said, "Nouscom is establishing a clearly differentiated position in the development of next generation neoantigen cancer vaccines based on its technology platform. I am excited and fully committed, alongside our team, to advancing our corporate and development strategy."

Commenting on Patricia Delaite’s appointment, Marina Udier added: "I am pleased to welcome Patricia to the team. Attracting a CMO of her caliber underlines the continued transition that Nouscom is making from a research-led to a clinical-stage company. Given her prior experience as CMO and a strong track record in drug development, Patricia brings new skills to our team, which will be vital as we advance our Phase I study evaluating NOUS-209 and progress our personalized program, NOUS-PEV, into clinical studies, which are expected to start later this year."

Marina Udier, PhD, joined Nouscom as Chief Operating Officer (COO) in 2016 from Versant Ventures and was appointed interim CEO in May 2019 upon the retirement of former CEO and founder Dr. Alfredo Nicosia. Prior to Versant, she held senior development and commercial roles at Novartis in Basel. Previously, Dr. Udier worked for McKinsey & Company in the US. She has a Ph.D. in Organic Chemistry from Yale University.

Patricia Delaite, MD, joins from AMAL Therapeutics (acquired by Boehringer Ingelheim) where she was CMO and a key member of the Senior Executive Team. At AMAL, Dr. Delaite designed and implemented a First-in-Human therapeutic cancer vaccine trial enabling innovative proof-of-concept endorsed by clinical experts and regulators at agencies in the US and Europe. Prior to AMAL, Dr. Delaite held senior clinical roles at Incyte International Biosciences, ARIAD Pharmaceuticals, Novartis and Eli Lilly. She has also 10 years’ experience in patient clinical management at the University Hospital in Geneva.

Kineta Invited to Participate at the Cowen and Company 40th Annual Health Care Conference

On February 26, 2020 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, neuroscience and biodefense reported that Kineta’s management team has been invited to participate at Cowen and Company 40th Annual Health Care Conference in Boston, MA (Press release, Kineta, FEB 26, 2020, View Source;utm_medium=rss&utm_campaign=kineta-invited-to-participate-at-the-cowen-and-company-40th-annual-health-care-conference [SID1234554865]). Shawn Iadonato, Kineta Chief Executive Officer, will provide a corporate overview on Monday, March 2nd at 2:00-2:25 AM, Eastern Time at the Boston Marriott Copley Place.

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Corporate Presentation

On February 26, 2020 Helix BioPharma Corporation Presented the corporate Presentation (Presentation, Helix BioPharma, FEB 26, 2020, View Source [SID1234554855]).

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The Power Behind Gene Therapy Drug Combinations

On February 26, 2020 Genprex, a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and other serious diseases, reported that is harnessing the power of a combinational treatment approach that utilizes its leading gene therapy drug candidate, Oncoprex, in combination with approved targeted and immunotherapies in order to overcome treatment limitations and offer patients new treatment options (Press release, Genprex, FEB 26, 2020, View Source [SID1234554850]). In January 2020, the U.S Food and Drug Administration granted Fast Track Designation for Genprex’s lead drug candidate, Oncoprex immunogene therapy for non-small cell lung cancer (NSCLC) in combination therapy with osimertinib (AstraZeneca’s Tagrisso).

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Targeted Therapies
Targeted therapies work by targeting the cancer or disease’s specific gene, protein or tissue that contributes to the disease1 while sparing normal tissue. This therapy is different from chemotherapies, which usually destroy all dividing cells, irrespectively.

Unfortunately, targeted therapies require patients to have an activating genetic mutation specific to the drug. In NSCLC, the vast majority of lung cancer patients do not have the genetic mutations found in lung cancer that qualify them for targeted therapies, such as the EGFR or ALK gene. One study found that only about 10 percent of NSCLC patients had the EGFR mutation2. In addition, the few patients who do have the right genetic mutation to receive some of the available targeted therapies are likely to develop resistance to these drugs over time3.

To overcome the limitations of targeted therapies, many companies and researchers are studying the combination of approved targeted therapies with potential new drug candidates. The hope of these combinations is to improve outcomes for patients. In fact, Genprex has studied its lead drug candidate, Oncoprex, in combination with erlotinib, an approved targeted therapy for NSCLC.

Preclinical and clinical data show that Oncoprex works synergistically with erlotinib to help destroy the cancer cells and may help patients who have become resistant to erlotinib alone.

The company’s recent Fast Track Designation by the FDA is for the combination of Oncoprex and osimertinib (marketed as Tagrisso by Astra Zeneca), a third generation EGFR inhibitor. The company received this designation based on its preclinical data of Oncoprex combined with osimertinib and its clinical trial data for Oncoprex combined with erlotinib. Tagrisso is AstraZeneca’s highest grossing product, which had worldwide sales in 2018 of $1.86 billion and $3.18 billion in 2019.

Immunotherapies
Immunotherapy is a type of treatment that helps the immune system fight disease4. Biomarker testing can help determine if high levels of PD-1/PD-L1 proteins are detected in the patient, signifying that the body’s immune system is not working to fight cancer or disease as it should. These patients could qualify for approved immunotherapies, however, only about 12 percent of patients benefit from immunotherapies5.

Similar to targeted therapies, immunotherapy combinations are being studied to see how these limitations can be overcome. Genprex is conducting preclinical studies to evaluate Oncoprex in combination with checkpoint inhibitors.

Preclinical data shows that Oncoprex is synergistic with anti-PD1 therapy and could result in a stronger antitumor response compared to either agent alone.

Additionally, the combination of Oncoprex increased the effectiveness of anti-PD1 checkpoint blockade combined with chemotherapy in a humanized mouse model with lung metastases.

Genprex believes its lead drug candidate in combination with checkpoint inhibitor pembrolizumab may have similar synergistic results for patients.

The Power of Immunogene Therapy Combinations
Genprex is working to provide new treatment options to a larger group of patients who would not otherwise be candidates for targeted therapies or immunotherapies or who have built up resistance to currently approved drugs.

The company’s lead drug candidate, Oncoprex immunogene therapy, is unlike the approved targeted therapies and immunotherapies available today. Because Oncoprex is a gene therapy that also modulates immune activity around the cancer cell, it is poised and positioned to help NSCLC patients who cannot benefit from today’s treatment options. It may also be able to be combined with a variety of approved drugs to improve outcomes for patients in a variety of cancers.

To learn more about the company’s lead drug candidate, please visit the Technology page on Genprex’s website.

*Oncoprex is currently in development and is not FDA approved.

References:

1. Understanding Targeted Therapy. Cancer.Net. View Source Published December 5, 2019. Accessed February 20, 2020.

2. El-Telbany A, Ma PC. Cancer genes in lung cancer: racial disparities: are there any?. Genes Cancer. 2012;3(7-8):467–480. doi:10.1177/1947601912465177.

3. Meyers DE, Bryan PM, Banerji S, Morris DG. Targeting the PD-1/PD-L1 axis for the treatment of non-small-cell lung cancer. Curr Oncol. 2018;25(4):e324–e334. doi:10.3747/co.25.3976

4. Immunotherapy for Cancer. National Cancer Institute. View Source Accessed February 20, 2020.

5. Haslam A, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs. JAMA Netw Open. 2019;2(5):e192535. doi:10.1001/jamanetworkopen.2019.2535.