Kitov Pharma Receives Issue Notification for a U.S. Patent Covering its anti-CEACAM1 Cancer Drug, CM-24

On February 3, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported receipt from the U.S. Patent and Trademark Office (USPTO) of a Notification of Issuance for a patent application entitled, "Humanized antibodies against CEACAM1 (Press release, Kitov Pharmaceuticals , FEB 3, 2020, View Source [SID1234553782])." The patent, which expires in 2035, covers protein and DNA sequences pertaining to humanized antibodies capable of specific binding to human CEACAM1 molecules, including Kitov’s first-in-class monoclonal antibody, CM-24, pharmaceutical compositions comprising these antibodies, as well as methods for their use in treating and diagnosing cancer and other conditions.

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"This recognition from the USPTO validates the unique profile of Kitov’s CM-24. The mechanism of action of CM-24 results in an enhanced cytotoxic activity of the immune system cells, inducing a tumor’s death," commented Isaac Israel, Chief Executive Officer of Kitov. "CEACAM1 expression was found to correlate with poor prognosis in patients with non-small cell lung cancer (NSCLC). We strongly believe that the combination of CM-24 with nivolumab has the potential to result in a significant synergistic benefit in patients with NSCLC tumors expressing CEACAM1. We look forward to the initiation of our phase 1/2 clinical trial with CM-24 in the second half of 2020."

About CM-24

CM-24 is a clinical-stage monoclonal antibody blocking CEACAM1, a well-validated target which is highly expressed in many solid tumors as well as on immune cells and plays a pivotal role in the immune system by blocking immune cells’ access to tumors by CEACAM1-CEACAM1 and CEACAM1-CEACAM5 interaction. CEACAM1 was also shown to regulate TIM3 which induce immune fatigue. This unique mechanism of action positions CM-24 with a differentiated inhibitor of a multi-role immune checkpoint. In a monotherapy phase 1 study, CM-24 demonstrated safety and efficacy with standard dose in about 30% of patients. Kitov will advance CM-24 as a combination therapy with anti-PD1 checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC). Kitov has entered into a clinical collaboration agreement with Bristol Myers Squibb Company (NYSE:BMY) for the planned Phase 1/2 clinical trials to evaluate the combination of CM-24 with the PD-1 inhibitor nivolumab (Opdivo).

Integra Announces Amendment and Extension of Credit Facility and Private Placement of Convertible Senior Notes

On February 3, 2020 Integra LifeSciences Holdings Corporation (NASDAQ:IART) reported that it has amended and extended its credit facility and commenced a private offering of convertible senior notes (Press release, Integra LifeSciences, FEB 3, 2020, View Source [SID1234553780]).

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Amendment and Extension of Credit Facility

Integra reported that it has amended and extended its credit facility with a bank group led by Bank of America, N.A. The overall size of the credit facility is approximately $2.2 billion and consists of a revolving line of credit of $1.3 billion and an $877.5 million term loan. The maturity of the credit facility was extended to February 3, 2025.

"We are pleased to announce this two-year extension of our credit facility under favorable terms," said Carrie Anderson, chief financial officer, Integra. "With these new terms, we have strengthened our balance sheet and increased our flexibility to pursue our long-term revenue growth and profitability strategy. We appreciate the continued support and commitment from our lending group."

Borrowings from the credit facility will be used to cover fees and expenses incurred in connection with the credit facility, for general corporate purposes and other permitted uses.

Private Placement of Convertible Senior Notes

Integra reported that it has commenced a private offering, subject to market conditions, of $500,000,000 aggregate principal amount of convertible senior notes due 2025 (the "Notes"). Integra expects to grant the initial purchasers of the Notes a 13-day option to purchase up to an additional $75,000,000 aggregate principal amount of Notes.

The Notes will be senior, unsecured obligations of Integra, and interest will be payable semi-annually in arrears. The Notes will mature on August 15, 2025, unless earlier converted, repurchased or redeemed in accordance with the terms of the Notes. Prior to 5:00 p.m., New York City time, on the business day immediately preceding February 15, 2025, the Notes will be convertible at the option of holders of the Notes only upon satisfaction of certain conditions and during certain periods, and thereafter, at any time until 5:00 p.m., New York City time, on the second scheduled trading day immediately preceding the maturity date. Upon conversion, the Notes may be settled in shares of Integra’s common stock, cash or a combination of cash and shares of the common stock, at the election of Integra. Prior to February 20, 2023, the Notes will not be redeemable. On or after February 20, 2023, Integra may redeem for cash all or part of the Notes, at its option, if the last reported sale price of Integra’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Integra provides notice of redemption.

Holders of the Notes will have the right to require Integra to repurchase for cash all or a portion of their Notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of a fundamental change (as defined in the indenture relating to the Notes). Integra will also be required to increase the conversion rate for holders who convert their Notes in connection with certain fundamental changes occurring prior to the maturity date or following delivery by Integra of a notice of redemption.

The interest rate, conversion rate, offering price and other terms are to be determined upon pricing of the Notes.

In connection with the pricing of the offering of the Notes, Integra expects to enter into privately negotiated convertible note hedge transactions with dealers, which may include initial purchasers and/or their respective affiliates (the "option counterparties"). These transactions are expected generally to reduce potential dilution to Integra’s common stock upon conversion of the Notes. Integra also expects to enter into warrant transactions with the option counterparties. The warrant transactions could separately have a dilutive effect on Integra’s common stock if the market price of Integra’s common stock exceeds the strike price of the warrants.

In connection with establishing their initial hedge of the convertible note hedge and warrant transactions, the option counterparties expect to enter into various derivative transactions with respect to Integra’s common stock concurrently with or shortly after the pricing of the Notes. These activities could have the effect of increasing (or reducing the size of any decrease in) the market price of Integra’s common stock.

Integra intends to use:

A portion of the net proceeds from the offering of the Notes to pay the cost of the convertible note hedge transactions (after such cost is partially offset by the proceeds from the sale of the warrant transactions).

Up to $100 million of the net proceeds from the offering of the Notes to repurchase shares of Integra’s common stock, including from certain purchasers of Notes in privately negotiated transactions effected through one of the initial purchasers or an affiliate thereof as Integra’s agent concurrently with the closing of the offering of the Notes, and through an accelerated share repurchase transaction (the "ASR transaction") with a dealer, which may be one of the initial purchasers or an affiliate thereof (the "ASR counterparty"), following the pricing of the offering of the Notes.

The remainder of the net proceeds from the offering of the Notes for general corporate purposes, which may include repayment of a portion of the indebtedness under Integra’s senior credit facility.

If the initial purchasers exercise their option to purchase additional Notes, Integra may sell additional warrants and use the net proceeds from the sale of the additional Notes, together with the proceeds from the additional warrants, to enter into additional convertible note hedge transactions. In addition, if the initial purchasers exercise their option to purchase additional Notes, Integra may use the remainder of the net proceeds from the sale of the additional Notes and the additional warrants for general corporate purposes, which may include the repayment of a portion of the indebtedness under Integra’s senior credit facility.

The settlement of the share repurchases from certain purchasers of Notes in privately negotiated transactions is conditioned upon the closing of the offering of the Notes. Integra expects the purchase price per share of common stock repurchased from certain purchasers of Notes in privately negotiated transactions concurrently with the closing of the offering of the Notes to equal the closing price per share of Integra’s common stock on the date of the pricing of the offering of the Notes. The purchase price per share of the common stock repurchased through the ASR transaction will generally be equal to the average volume-weighted average price of Integra’s common stock during a period beginning after the ASR transaction becomes effective, less a discount. The exact number of shares repurchased pursuant to the ASR transaction will be determined based on such purchase price.

In connection with the ASR transaction, the ASR counterparty or its affiliate expects to purchase or sell Integra’s common stock in secondary market transactions during the term of the ASR transaction. These activities and Integra’s repurchases of its common stock may raise or maintain the market price of Integra’s common stock or the Notes above market levels that otherwise would have prevailed or prevent or retard a decline in such market price. In the case of transactions in Integra’s common stock effected concurrently with the offering of the Notes, these transactions could affect the market price of Integra’s common stock concurrently with, or shortly after, the pricing of the Notes, and could result in a higher effective conversion price for the Notes.

The Notes will be offered to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The Notes and the shares of Integra’s common stock issuable upon conversion of the Notes, if any, are not being registered under the Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and any applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of 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.

Genprex to Present at NobleCon16 Investor Conference

On February 3, 2020 Genprex, Inc.("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company utilizing a unique, non-viral proprietary platform designed to deliver tumor suppressor genes to cancer cells, reported the Company will present at the Noble Capital Markets 16th Annual Investor Conference on Monday, February 17, 2020 at 1:30 p.m. EST (Press release, Genprex, FEB 3, 2020, View Source [SID1234553779]). The conference is being held on February 16-18, 2020 at the Seminole Hard Rock Hotel & Casino in Hollywood, Florida.

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Event: NobleCon16 – Noble Capital Markets’ 16th Annual Investor Conference

Presentation Date: Monday, February 17, 2020

Presentation Time: 1:30 p.m. EST – Terrace Ballroom A

Location: Seminole Hard Rock Hotel & Casino – Hollywood, FL

Mr. Rodney Varner, Chief Executive Officer of Genprex, will deliver an overview of the Company and provide updates on its product pipeline, including the recent Fast Track Designation received from the Food and Drug Administration for its Oncoprex immunogene therapy in combination with AstraZeneca’s Tagrisso. To arrange a one-on-one meeting with the Company, please email [email protected].

A high-definition video webcast of Mr. Varner’s presentation will be available for playback at the link below approximately 24 hours following his live address, and it will be archived for 90 days following the conference:

Presentation Webcast Playback: http://bit.ly/2S5AR7Z

This is the 16th year Noble Capital Markets has hosted "NobleCon" and has invited emerging growth companies to present to and meet with attending investors. NobleCon will feature approximately 125 small growth companies presenting across four tracks and will be broadening access to investors worldwide by hosting the conference site on Channelchek.com, its web-based market platform that emphasizes emerging growth companies.

Catalent To Acquire Leading Cell Therapy Company MaSTherCell Global for $315 Million, Creating an Industry-Leading Cell & Gene Therapy Platform

On February 3, 2020 Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, and MaSTherCell Global, Inc., a technology-focused cell and gene therapy contract development and manufacturing organization to leading cell therapy innovators, reported that Catalent has agreed to acquire MaSTherCell Global, a company backed by Great Point Partners, SFPI-FPIM, and Orgenesis Inc. (NASDAQ:ORGS), for an aggregate of $315 million in cash, subject to a customary adjustments (Press release, Catalent, FEB 3, 2020, https://www.catalent.com/catalent-news/catalent-to-acquire-leading-cell-therapy-company-masthercell-global/ [SID1234553778]).

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"MaSTherCell extends our leadership position in the biotech industry, complements our leading gene therapy offering, and allows us to deliver comprehensive development, manufacturing, analytical, fill-finish, and clinical supply solutions for innovators across the large molecule space," said John Chiminski, Catalent’s Chair & Chief Executive Officer. "Both autologous and allogeneic cell therapies provide important new treatment options, with a rising number expected to gain regulatory approval over the coming years. Catalent is well-positioned to combine MaSTherCell’s expert teams and capabilities with our extensive resources and experience in scaling new platforms, and to help MaSTherCell build-out its development and commercial manufacturing capabilities."

Founded in 2011, MaSTherCell has a 25,000 square-foot facility in Gosselies, Belgium providing clinical services, and construction is in progress on a dedicated 60,000 square-foot adjacent commercial-scale production and fill-finish facility, which is scheduled to open in the fall of 2021 and ultimately add over 250 new jobs to the current team of over 240. Its 32,000 square-foot U.S. facility in Houston, Texas, upon completion of validation activities, will focus on development-scale projects and will employ a team of over 50 experts before the end of the year. MaSTherCell has a growing customer base and offers a unique portfolio of capabilities and technologies that include the development and manufacture of autologous and allogeneic cell therapies, as well as a variety of related analytical services. Its experience includes therapies based on chimeric antibody receptor-engineered T cells (CAR-T), T cell receptors (TCR), tumor-infiltrating lymphocytes (TIL), and mesenchymal stem cells (MSC).

Darren Head, MaSTherCell’s Chief Executive Officer, commented, "MaSTherCell has built comprehensive capabilities to address the complexities of cell therapy production. Like Catalent, our experience has taught us the importance of technology selection, advanced know-how, and quality and regulatory expertise for successful cell therapy programs that are aimed at producing life-altering treatments. We are excited to join the industry-leading team at Catalent and work together to scale-up our business. This combination will strengthen our service offering to our customers and, in the end, benefit patients who need innovative life-saving therapies. Catalent’s backing will position MaSTherCell for growth and enhance Catalent’s existing presence in Belgium."

Vered Caplan, Chief Executive Officer of Orgenesis, stated, "We are very proud of the developments and accomplishments at MaSTherCell, which has become a best-in-class contract development and manufacturing organization (CDMO) servicing many of the leading cell and gene therapy companies. Since we completed our acquisition of MaSTherCell in 2015, the business has grown along with this burgeoning industry. With Catalent’s expertise and resources, we believe MaSTherCell will be well positioned to continue on its current trajectory in order to meet the evolving needs of the industry."

Noah Rhodes, Managing Director at Great Point Partners, commented, "We identified MaSTherCell as the leading provider of development and manufacturing services to cell and gene therapy companies, and have enjoyed watching the company and its team continue to flourish. We cannot think of a better partner for MaSTherCell than Catalent, as the combined company will be a leading vertically-integrated provider able to serve customers and patients on a global basis."

Upon completion of the transaction, which is expected in the current, third quarter of Catalent’s 2020 fiscal year and is subject to customary closing conditions, MaSTherCell’s 240 talented employees, including its outstanding leadership team, will become part of the Catalent Biologics business.

The acquisition is an all-cash transaction, which Catalent expects to finance with either a partial drawn down of its revolving credit facility or the proceeds from future capital-raising activity. As part these activities, Catalent has obtained $200 million of committed financing, subject to customary conditions, from JPMorgan Chase Bank N.A. It should be noted, however, that the agreement governing the acquisition is not contingent on any financing activity. Catalent intends to file a Current Report on Form 8-K with the Securities and Exchange Commission, which will have further details concerning the acquisition and the committed financing.

Boston Pharmaceuticals Appoints Dr. Craig T. Basson, M.D., Ph.D., as Chief Medical Officer

On February 3, 2020 Boston Pharmaceuticalstoday reported the appointment of Dr. Craig T. Basson, M.D., Ph.D., as Chief Medical Officer (Press release, Boston Pharmaceuticals, FEB 3, 2020, View Source [SID1234553777]). Previously, Dr. Basson was Global Head of Translational Medicine (Cardiovascular and Metabolism) at Novartis for 10 years, where he led the team developing new global programs to translate basic findings into novel therapeutics.

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"As a highly-regarded scientist and drug developer, Craig’s experience in global translational medicine is uniquely suited to Boston Pharmaceuticals as we continue to evolve our pipeline," said Robert Armstrong, Ph.D., Chief Executive Officer and Co-Founder of Boston Pharmaceuticals. "His proven track record for innovation and drug development will support our mission of addressing unmet medical needs for larger patient populations."

"Boston Pharmaceuticals’ strategy of following the data and selectively advancing a portfolio of high value candidates into differentiated therapeutics excites me," said Dr. Basson. "I am thrilled to join Boston Pharmaceuticals at this time of important growth for the company and look forward to leveraging my experience to accelerate the development of the pipeline and to continuing to bring novel medicines to patients in need."

Dr. Basson was previously Global Head of Translational Medicine for the Cardiovascular and Metabolic Therapeutic Areas at Novartis Institutes for Biomedical Research. At Novartis, he co-led the Cardiovascular Metabolism (CVM) Disease Area Decision Board, oversaw the leadership of early clinical portfolio through Proof of Concept (PoC) and supported late phase clinical programs by indication expansion PoC studies and specialized clinical pharmacology and profiling studies. He has been involved in the development of a number of important and novel medicines for patients with cardiovascular disease, diabetes, and metabolic disorders.

Prior to Novartis, Dr. Basson was a Professor of Cardiology and Internal Medicine at Cornell University Medical College. He obtained an M.Sc. in Physiological Sciences at the University of Oxford and completed an M.D. and Ph.D. at Yale University. Dr. Basson serves as a scientific advisor to variousfor-profit and nonprofit organizations.