LabCorp Prices $400,000,000 in 2.300% Senior Notes Due 2024 and $650,000,000 in 2.950% Senior Notes Due 2029

On November 18, 2019 LabCorp (NYSE: LH) reported that it has priced its offering of $1,050,000,000 in senior notes (Press release, LabCorp, NOV 18, 2019, View Source [SID1234552830]). The offering consists of two tranches: $400,000,000 aggregate principal amount of 2.300% Senior Notes due 2024 (the 2024 Notes) and $650,000,000 aggregate principal amount of 2.950% Senior Notes due 2029 (the 2029 Notes and, together with the 2024 Notes, the Notes). The Notes will bear interest from Nov. 25, 2019, payable semi-annually on June 1 and Dec. 1, commencing on June 1, 2020. The closing of the offering is expected to occur on Nov. 25, 2019, subject to the satisfaction of customary closing conditions. The Notes will be senior unsecured obligations and will rank equally with LabCorp’s existing and future senior unsecured debt. Concurrently with this offering, LabCorp is conducting a cash tender offer for up to $300,000,000 aggregate purchase price of its 4.625% Senior Notes due Nov. 15, 2020 (the Tender Offer).

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LabCorp intends to use the net proceeds of the Notes offering for general corporate purposes including (1) the purchase, redemption or repayment at maturity of its outstanding 2.625% Senior Notes due Feb. 1, 2020, (2) the concurrent Tender Offer, and (3) the repayment of some or all of the amounts outstanding under its term loan credit facilities.

The joint book-running managers for the offering are BofA Securities, US Bancorp, and Wells Fargo Securities. The offering will be made pursuant to an effective shelf registration statement on Form S-3 filed with the Securities and Exchange Commission. A copy of the prospectus and related prospectus supplement may be obtained without charge from the Securities and Exchange Commission. Alternatively, a copy of the prospectus and related prospectus supplement may be obtained from BofA Securities by calling toll-free 1-800-294-1322, from US Bancorp by calling toll-free 1-877-558-2607, or from Wells Fargo Securities by calling toll-free 1-800-645-3751.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the Notes or any other securities, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The offering of these securities may be made only by means of the prospectus supplement and the accompanying prospectus.

Entry into a Material Definitive Agreement.

On November 18, 2019, Phio Pharmaceuticals Corp. (the "Company") reported that it has entered into a Placement Agency Agreement (the "Placement Agency Agreement") with H.C. Wainwright & Co., LLC, as placement agent, pursuant to which the Company agreed to issue and sell, in a registered public offering of the Company (the "Offering"), 10,000,000 shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock") to certain investors (Filing, 8-K, Phio Pharmaceuticals, NOV 18, 2019, View Source [SID1234551513]). The offering price was $0.10 per share of Common Stock .

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Each purchaser in the Offering was required, as a condition to such purchase, to execute a subscription agreement pursuant to which they (i) agreed, effective until November 19, 2019, the record date of our next stockholder meeting, not to sell, dispose or otherwise transfer, directly or indirectly any shares of our Common Stock that they own or control as of the closing of this Offering and (ii) agreed to vote at our next stockholder meeting the shares of our Common Stock that they own or control as of the closing of this Offering in favor of an amendment of our articles of incorporation to undertake a reverse stock split of our Common Stock.

The Placement Agency Agreement contains customary representations and warranties, agreements and obligations, conditions to closing and termination provisions.

The net proceeds to the Company from the Offering is approximately $725,000, after deducting fees and expenses. The Company intends to use substantially all of the net proceeds of the Offering primarily for the development of the Company’s immuno-oncology program, for other research and development activities and for general working capital.

Pursuant to the Placement Agency Agreement, the Company agreed to pay the placement agent a cash fee of 7.5% and a management fee of 1.0% of the aggregate gross proceeds of the Offering We also agreed to pay the placement agent up to $40,000 for legal expenses and reimburse the placement agent up to $10,000 for clearing expenses. In addition, the Company, upon closing of the Offering, issued to the placement agent warrants to purchase up to 750,000 shares of Common Stock (the "Placement Agent Warrants"), or 7.5% of the aggregate number of shares of Common Stock sold in the Offering. The Placement Agent Warrants are immediately exercisable at a price of $0.125 per share of Common Stock, subject to adjustment in certain circumstances, may be exercised on a cashless basis under certain circumstances, and expire on November 19, 2024.

The shares of Common Stock sold in the Offering were offered and sold pursuant to a prospectus, dated April 6, 2018, and a prospectus supplement dated November 18, 2019, in connection with a takedown from the Company’s shelf registration statement on Form S-3 (File No. 333-224031), which was declared effective by the Securities and Exchange Commission on April 6, 2018. The Offering was made only by means of a prospectus forming a part of the effective registration statement.

The foregoing descriptions of the Placement Agency Agreement and the Placement Agent Warrants are not complete and are qualified in their entirety by reference to the full text of the Placement Agency Agreement and the forms of the Placement Agent Warrant, copies of which are filed as Exhibit 1.1 and Exhibit 4.1 to this Current Report on Form 8-K and hereby incorporated by reference herein. Attached as Exhibit 5.1 is an opinion of counsel regarding the due authorization of the Common Stock sold in the Offering.

Sangamo Therapeutics Announces Participation at the Jefferies 2019 London Healthcare Conference

On November 18, 2019 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that management will present at the Jefferies 2019 London Healthcare Conference on Thursday, November 21 at 4:40 p.m. GMT in London, UK (Press release, Sangamo Therapeutics, NOV 18, 2019, View Source [SID1234551476]).

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The presentation will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

Myovant Sciences to Host Webcast and Conference Call at 8:30 a.m. Eastern Time Tuesday, November 19 to Discuss Results from Phase 3 Study Evaluating Once-Daily, Oral Relugolix in Men with Advanced Prostate Cancer

On November 18, 2019 Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, reported it will hold a webcast and conference call beginning at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on Tuesday, November 19, 2019, to discuss results from the Phase 3 HERO study of once-daily, oral relugolix (120 mg) in men with advanced prostate cancer (Press release, Myovant Sciences, NOV 18, 2019, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-host-webcast-and-conference-call-830-am-1 [SID1234551475]).

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Webcast/Teleconference Details
To participate in the live conference call, please dial 1-800-532-3746 for domestic callers and +1-470-495-9166 for international callers. A live webcast of the conference call will also be available on the investor relations page of Myovant’s website at investors.myovant.com and will remain archived on Myovant’s website for at least 30 days.

Ascendis Pharma A/S Reports Third Quarter 2019 Financial Results

On November 18, 2019 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported financial results for the quarter ended September 30, 2019 (Press release, Ascendis Pharma, NOV 18, 2019, View Source [SID1234551454]).

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"Our achievements this year reflect our ability to bring a product from idea stage all the way through clinic, as we near the finish line for TransCon hGH and approach our planned regulatory filings in the United States (U.S.) and Europe," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "Our recent progress in the TransCon hGH program, including both in Europe and China, also support our strategy to establish global reach. The power of the TransCon technology is enabling us to build a leading fully integrated patient-focused biopharma company, and advance towards our ‘Vision 3×3’ goals."

He continued, "One of our driving values at Ascendis is patient focus. In response to the recent recall of NATPARA in the U.S., we recently expanded our TransCon PTH Phase 2 PaTH Forward Trial with a protocol addendum to help expedite participation of some of those patients affected by the recall. We believe the expanded trial will provide meaningful clinical data to help patients, both naïve to PTH and previously treated with PTH, and further demonstrate the value of our unique approach to product development."

Corporate Highlights & Progress

Completed the last subject visit for the long-term clinical database for TransCon hGH, paving the way for the company’s planned Biologics License Application to the U.S. Food and Drug Administration in the first half of 2020 and the Marketing Authorisation Application to the European Medicines Agency in the second half of 2020. TransCon hGH is a long-acting prodrug of human growth hormone (hGH) in phase 3 development as a once-weekly therapy for pediatric growth hormone deficiency (GHD).
Completed the manufacturing of drug product Process Performance Qualification (PPQ) batches required to support the planned regulatory filings in 2020 for TransCon hGH. The company is now finalizing the associated analytics and preparing qualification reports.
Advanced the TransCon hGH program in Greater China with VISEN Pharmaceuticals, who initiated a phase 3 trial for TransCon hGH in pediatric GHD.
Received Orphan Designation from the European Commission for TransCon hGH, which is provided to therapies aimed at treating, preventing or diagnosing a disease that is life-threatening or chronically debilitating, affects no more than five in 10,000 persons in the European Union and which may provide significant additional benefit over existing therapies.
Announced a protocol addendum in the U.S. designed to expedite enrollment of subjects previously treated with NATPARA in the TransCon PTH PaTH Forward Trial, a global phase 2 trial evaluating the safety, tolerability and efficacy of TransCon PTH in adult subjects with hypoparathyroidism (HP). TransCon PTH is an investigational long-acting prodrug of PTH in development as a potential once-daily replacement therapy for HP, designed to provide physiologic levels of PTH for 24 hours a day, seven days a week. Under the addendum, patients previously treated with NATPARA in the U.S. will now have an expedited pathway to enroll in PaTH Forward. As a result, the company expects to exceed targeted enrollment of 40 subjects, and plans to report top-line data from the expanded trial in first quarter of 2020. The goal of PaTH Forward is to evaluate TransCon PTH control of serum and urinary calcium, and identify a titration regimen for complete withdrawal of standard of care (i.e., active vitamin D and calcium supplements).
Initiated the ACcomplisH Trial, a global, phase 2, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of TransCon CNP, a long-acting prodrug of C-type natriuretic peptide (CNP), at escalating doses in children with achondroplasia (ACH). TransCon CNP is designed to provide continuous exposure to CNP at therapeutic levels with once-weekly dosing.
Presented preclinical data for TransCon TLR7/8 Agonist, a product candidate in development for oncology, at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting. TransCon TLR7/8 Agonist is prodrug of resiquimod, a small molecule with immune-activating and anti-tumor properties that is transiently conjugated to a hydrogel carrier via a TransCon linker. Administered as an intratumoral injection, TransCon TLR7/8 Agonist delivered sustained local release of resiquimod over weeks directly to the tumor site and demonstrated potent anti-tumor activity as a monotherapy, as well as in combination with interleukin-2 (IL-2).
Ended the third quarter of 2019 with cash and cash equivalents of €658.7 million.
Third Quarter 2019 Financial Results

For the third quarter, Ascendis Pharma reported a net loss of €25.1 million, or €0.53 per share (basic and diluted) compared to a net loss of €34.0 million, or €0.81 per share (basic and diluted) for the same period in 2018.

Revenue for the third quarter was €2.2 million compared to €20 thousand in the same quarter of 2018. The increase relates to our November 2018 strategic investment in VISEN Pharmaceuticals.

Research and development (R&D) costs for the third quarter were €46.3 million compared to €31.5 million during the same period in 2018. Higher R&D costs in 2019 reflect an increase in personnel-related costs to support development and manufacturing of TransCon hGH, TransCon PTH and TransCon CNP, increasing clinical trial costs for the PaTH Forward Trial and the ACcomplish Trial, as well as increased costs for other research programs, including oncology.

General and administrative expenses for the third quarter were €10.0 million compared to €6.8 million during the same period in 2018. The increase is primarily due to higher personnel-related costs and other increasing costs of expanding the company and preparing to become a commercial organization.

As of September 30, 2019, Ascendis Pharma had cash and cash equivalents of €658.7 million compared to €690.4 million as of June 30, 2019. As of September 30, 2019, Ascendis Pharma had 47,739,647 ordinary shares outstanding.

Conference Call and Webcast information

Ascendis Pharma will host a conference call and webcast today at 4:30 p.m. ET to discuss its third quarter 2019 financial results. Details include:

Date Monday, November 18, 2019
Time 4:30 p.m. ET
Dial In (U.S.) 844-290-3904
Dial In (International) 574-990-1036
Access Code 5897398
A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.