Centene To Present At Cantor Global Healthcare Conference

On September 16, 2019 Centene Corporation (NYSE: CNC) reported it will present at the Cantor Global Healthcare Conference, to be held October 2-4, 2019, at the Intercontinental New York Barclay Hotel in New York City (Press release, CENTENE, SEP 16, 2019, View Source [SID1234539570]).

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Centene will present on Thursday, October 3rd, at 3:00 p.m. Eastern Daylight Time (EDT). A simultaneous live audio webcast is also available at: View Source

A webcast replay of this presentation will be available afterwards via the Company’s website at www.centene.com under the Investors section.

Lipocine to Participate in the Oppenheimer & Co. Fall Summit Focused on Specialty Pharma, Rare Disease & Gene Therapy

On September 16, 2019 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported that Dr. Mahesh Patel, Chairman, President and CEO, will participate in the Oppenheimer & Co. Fall Summit Focused on Specialty Pharma, Rare Disease & Gene Therapy, being held September 23-24, 2019 in New York City (Press release, Lipocine, SEP 16, 2019, View Source;co-fall-summit-focused-on-specialty-pharma-rare-disease–gene-therapy-300918042.html [SID1234539571]). Lipocine will be available to meet with investors in a one on one format. There will be no webcast presentation.

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Apellis Pharmaceuticals Announces Closing of Offering of Convertible Senior Notes

On September 16, 2019 Apellis Pharmaceuticals, Inc. (Nasdaq:APLS), a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, reported the closing of its offering of $220.0 million aggregate principal amount of 3.500% convertible senior notes due 2026 (the "notes") (Press release, Apellis Pharmaceuticals, SEP 16, 2019, View Source [SID1234539572]). The notes were sold in a private offering to qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Apellis also granted to the initial purchasers of the notes a 13-day option to purchase up to an additional $33.0 million aggregate principal amount of the notes, solely to cover over-allotments, if any.

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The notes are unsecured, senior obligations of Apellis, and bear interest at a rate of 3.500% per annum, payable semi-annually in arrears on March 15 and September 15 of each year, beginning on March 15, 2020. The notes will mature on September 15, 2026, unless earlier repurchased, redeemed or converted in accordance with their terms. Subject to certain conditions, on or after September 20, 2023, Apellis may redeem for cash all or a portion of the notes at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, if the last reported sale price of Apellis common stock has been at least 130% of the conversion price then in effect for a specified period of time ending on the trading day immediately before the date the notice of redemption is sent.

Holders of notes may require Apellis to repurchase their notes upon the occurrence of certain events that constitute a fundamental change under the indenture governing the notes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus any accrued and unpaid interest to, but excluding, the date of repurchase. In connection with certain corporate events or if Apellis calls any note for redemption, it will, under certain circumstances, be required to increase the conversion rate for holders who elect to convert their notes in connection with such corporate event or notice of redemption.

The notes are convertible into cash, shares of Apellis common stock, or a combination of cash and shares of Apellis common stock, at Apellis’ election. Prior to March 15, 2026, the notes are convertible only upon the occurrence of certain events and during certain periods, and thereafter, at any time until the second scheduled trading day immediately preceding the maturity date.

The conversion rate for the notes is initially 25.3405 shares of Apellis common stock per $1,000 principal amount of notes, which is equivalent to an initial conversion price of approximately $39.46 per share. This represents a premium of approximately 25.0% over the last reported sale price of $31.57 per share of Apellis common stock on The Nasdaq Global Select Market on September 11, 2019. The conversion rate is subject to adjustment upon the occurrence of certain events.

Apellis estimates that the net proceeds from the sale of the notes will be approximately $212.9 million (or approximately $244.9 million if the initial purchasers exercise in full their option to purchase additional notes), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Apellis. Apellis used approximately $28.4 million of the net proceeds from the offering of the notes to pay the cost of the capped call transactions described below. If the initial purchasers exercise their option to purchase additional notes, Apellis intends to use a portion of the net proceeds from the sale of the additional notes to pay the cost of additional capped call transactions.

Apellis intends to use the remainder of the net proceeds from the sale of the notes to fund clinical development of APL-2, including preparation of a New Drug Application submission, to support the potential commercialization of APL-2, including the build-out of a commercial infrastructure and sales force, conduct research activities, repay in full the amount owed under a promissory note and for working capital and other general corporate purposes.

In connection with the pricing of the notes, Apellis entered into capped call transactions with an affiliate of one of the initial purchasers of the notes and another financial institution (the "option counterparties"). The capped call transactions are expected generally to reduce the potential dilutive effect on Apellis common stock upon any conversion of notes and/or offset any cash payments Apellis is required to make in excess of the principal amount of converted notes, as the case may be, with such reduction and/or offset subject to a cap based on the cap price. The cap price of the capped call transactions is initially $63.14 per share of Apellis common stock, representing a premium of 100% above the last reported sale price of $31.57 per share of Apellis common stock on The Nasdaq Global Select Market on September 11, 2019, and is subject to certain adjustments under the terms of the capped call transactions. If the initial purchasers exercise their option to purchase additional notes, Apellis expects to enter into additional capped call transactions with the option counterparties.

In connection with establishing their initial hedge of the capped call transactions, the option counterparties have advised Apellis that they and/or their respective affiliates expect to purchase shares of Apellis common stock and/or enter into various derivative transactions with respect to Apellis common stock concurrently with or shortly after the pricing of the notes, and, if applicable, the exercise by the initial purchasers of their option to purchase additional notes. This activity could increase (or reduce the size of any decrease in) the market price of Apellis common stock or the notes at that time.

In addition, the option counterparties have advised Apellis that they and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Apellis common stock and/or purchasing or selling Apellis common stock or other securities of Apellis in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so during any observation period related to a conversion of notes or following any purchase of notes by Apellis upon any fundamental change purchase date or otherwise). This activity could also cause or avoid an increase or a decrease in the market price of Apellis common stock or the notes, which could affect noteholders’ ability to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that noteholders will receive upon conversion of such notes.

The notes were sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes, if any, have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction, and the notes and any such shares may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. The offering of the notes was made only by means of a private offering memorandum.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy the notes, nor shall there be any sale of, the notes in any state or jurisdiction in which such offer, solicitation or sale would be unlawful under the securities laws of any such state or jurisdiction.

Genprex is Defining a New Immunogene Therapy that Could Change the Course of Cancer

On September 16, 2019 Genprex, a clinical-stage gene therapy company developing potentially life-changing technologies for cancer patients, reported raising the standard in cancer treatment by developing what it calls an "immunogene therapy," which harnesses the power of immunotherapy’s immunomodulation through the delivery of a gene therapy (Press release, Genprex, SEP 16, 2019, https://www.genprex.com/news/genprex-is-defining-a-new-immunogene-therapy-that-could-change-the-course-of-cancer/ [SID1234551276]).

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Gene therapies and immunotherapies are two different types of treatment. Simply put, gene therapies insert a gene into a patient’s cells1while immunotherapies boost the body’s natural defenses to fight diseases, such as cancer.2 Genprex’s cancer fighting drug candidate for non-small cell lung cancer (NSCLC), Oncoprex immunogene therapy, is a gene therapy that also has immunomodulatory effects.

Oncoprex classifies as a gene therapy because it consists of a tumor suppressor gene that is injected intravenously and can specifically target cancer cells. As a gene therapy, Oncoprex works to fight off cancer by interrupting cell signaling pathways that cause replication and proliferation of cancer cells. It also stimulates apoptosis, or the death of cancer cells.

Oncoprex also works as an immunotherapy because it modulates the body’s immune response against cancer. The TUSC2 gene, which is the active agent in Oncoprex, has been shown to upregulate Natural Killer cells, or NK cells. These NK cells are known for their ability to kill tumor cells.3TUSC2 has also been shown to downregulate PD-L1, or programmed cell death ligand-1, receptors. These receptors, which are also known as immune checkpoint proteins, can sometimes help cancer evade detection. TUSC2 works to downregulate, or suppress them, which helps the body’s immune system to fight against the cancer.

Genprex’s immunogene therapy is unlike the approved targeted gene therapies and immunotherapies available today. Because Oncoprex is a gene therapy with immunotherapy characteristics, it is poised and positioned to help NSCLC patients who cannot benefit from today’s treatment options.

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

References:

(2019). What is gene therapy?. [online] U.S. National Library of Medicine. Available at: View Source [Accessed 5 Sep. 2019].
Cancer.org. (2019). Cancer Immunotherapy. [online] Available at: View Source [Accessed 5 Sep. 2019].
Eissmann, P. (2019). Natural Killer Cells | British Society for Immunology. [online] Immunology.org. Available at: View Source [Accessed 5 Sep. 2019].

Karyopharm Enters Into Royalty Agreement with Healthcare Royalty Partners for up to $150 Million

On September 16, 2019 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, reported its entry into a royalty agreement with HealthCare Royalty Partners (HCR) for up to $150 million to support the ongoing development and commercialization of XPOVIOTM (selinexor), the Company’s first-in-class, oral SINE compound, which is currently marketed in the U.S. for the treatment of patients with heavily pretreated multiple myeloma (Press release, Karyopharm, SEP 16, 2019, View Source [SID1234539509]). Selinexor is also in late-stage clinical development for the treatment of patients with relapsed or refractory multiple myeloma who have had one to three prior lines of therapy and for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

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Under the terms of the agreement, Karyopharm will receive $75 million at closing this month and is eligible to receive an additional $75 million upon the achievement of future regulatory and commercial milestones and subject to approval by both parties. In exchange for the amount received at the initial closing, HCR will receive a tiered royalty in the mid-single digits based on worldwide net revenues of XPOVIO and any other future products. Karyopharm expects that the $75 million initially received from HCR under this royalty agreement, combined with its existing cash, cash equivalents and investments, together with the cash expected to be generated from product sales, will be sufficient to fund its operations into the middle of 2021.

"This non-dilutive financing provides Karyopharm with immediate and substantial capital to support the ongoing commercialization of XPOVIO in patients with heavily pretreated multiple myeloma, and further the development of selinexor in future high unmet need indications," said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "We are delighted to have the support and confidence of HealthCare Royalty Partners, a premier partner known for its strategic investments in promising healthcare companies and assets."

Clarke Futch, Managing Partner and Chairman of the Investment Committee of HealthCare Royalty Partners stated: "Based on our extensive due diligence, we believe XPOVIO’s strong commercial prospects and upside potential creates an attractive investment profile for HCR. The Karyopharm leadership team has deep expertise in bringing innovative drugs to market for the treatment of high unmet need cancers, and we are pleased to be partnering with them during this transformative time in the Company’s evolution."

XPOVIO received accelerated approval from the U.S. Food and Drug Administration (FDA) on July 3, 2019 for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. A Marketing Authorization Application (MAA) seeking conditional approval for selinexor is currently under review by the European Medicines Agency and Karyopharm expects to receive a decision on the MAA by early 2020.

Morgan Stanley & Co. LLC acted as sole structuring agent, and Goodwin Procter LLP acted as special transaction counsel, to Karyopharm on the transaction.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. In addition to receiving accelerated FDA approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody, Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor. Selinexor is also being studied in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In 2018, Karyopharm reported positive top-line results from the Phase 2b SADAL study evaluating selinexor in patients with relapsed or refractory DLBCL after at least two prior multi-agent therapies and who are ineligible for transplantation, including high dose chemotherapy with stem cell rescue. Selinexor has received Fast Track designation from the FDA for the patient population evaluated in the SADAL study. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in liposarcoma (SEAL), in recurrent gliomas (KING) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.