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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Glenmark Receives Orphan Drug Designation for GBR 1342, a Bispecific Antibody Candidate Under Evaluation for the Treatment of Multiple Myeloma

On September 16, 2019 Glenmark Pharmaceuticals (Glenmark), a research-led, integrated global pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its bispecific antibody candidate GBR 1342 for the treatment of patients with multiple myeloma who have received prior therapies (Press release, Glenmark, SEP 16, 2019, View Source [SID1234539569]). Derived from the company’s proprietary BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) technology, GBR 1342 is being investigated for the treatment of multiple myeloma. The candidate is one of five clinical-stage assets in the pipeline of Glenmark’s new innovation company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

GBR 1342 is designed to bind to both CD3 on T cells and CD38, an antigen known to be implicated in hematological malignancies, on target cells. This activates T cells and redirects them toward CD38+ tumor cells found in multiple myeloma. Once directed at the right target, the T cells help destroy the tumor cells.

A first-in-human, open-label, Phase 1 trial of GBR 1342 in multiple myeloma, is ongoing to assess the safety and tolerability of increasing doses of GBR 1342, and will also evaluate biomarkers, immunogenicity, and additional measures of disease activity.

"Patients who are struggling with diseases like multiple myeloma are seeking new treatment options and innovative approaches. We believe the focus of our new company is essential to these patients and to the healthcare system," said Alessandro Riva, MD, CEO of the new company. "As one of our first important pipeline milestones, we are excited that the FDA has recognized the potential for GBR 1342 to offer a significant advancement for patients with multiple myeloma."

Multiple myeloma is a rare blood disorder in which plasma cells in the bone marrow become malignant and replicate unchecked.1 The malignant plasma cells can displace normal blood cells in the body, leading to anemia and uncontrolled bleeding.1 It can also cause issues with bone density and strength, as well as lead to an increased risk of infection by lowering the body’s immune response.1

More than 32,000 new cases of multiple myeloma are expected to be diagnosed in 2019 in the U.S.2 During that same time, about 13,000 people are expected to die from the disease.2

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.

LIPAC Oncology and Huons Co. Announce Exclusive Licensing Agreement for TSD-001 in Korea

On September 16, 2019 LIPAC Oncology LLC and Huons Co., Ltd reported that they have entered into an exclusive licensing agreement to develop, manufacture and commercialize TSD-001 for all indications in Korea (Press release, Lipac Oncology, SEP 16, 2019, View Source [SID1234539568]). Huons is making an upfront payment and future milestone payments to LIPAC based on specific development, regulatory and commercial milestones. Huons will also make double-digit royalty payments based on sales.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TSD-001 is a proliposomal intravesical paclitaxel formulation (PLIP), currently in development for intravesical administration in the treatment of non-muscle invasive bladder cancer (NMIBC). NMIBC is a common and highly recurrent disease that can often be difficult to treat. If approved, TSD-001 would be the first chemotherapeutic agent approved by the U.S. Food and Drug Administration for this indication in almost two decades. Additional indications covered by the agreement include upper tract urothelial carcinoma, stage II/III ovarian cancer and peritoneal carcinoma.

"We are excited to potentially bring TSD-001 to patients living with bladder cancer in Korea," said Michael Oefelein, M.D., Chief Medical Officer of LIPAC. "Having treated bladder cancer for more than 23 years, it is very clear that new treatment options and more effective delivery systems could help improve both clinical outcomes and quality of life."

"This collaboration is the first of many we envisage under our global development strategy," said Will Robberts, President of LIPAC. "We believe that regional partnerships with strong companies such as Huons are essential to navigate the local subtleties of commercialization in countries outside of the United States."

The parties will form a Joint Development Committee to collaborate on the clinical development of TSD-001 in Korea and other partnering opportunities.

"We look forward to collaborating closely with LIPAC given their deep experience with TSD-001 and their proprietary proliposomal delivery platform," said Keyan UM, President and CEO of Huons. "We believe patients in Korea will benefit from a chemotherapy that targets the site of their disease."