Nurix Therapeutics Announces Scientific Presentations on its BTK Program at the 61st American Society of Hematology Annual Meeting

On November 18, 2019 Nurix Therapeutics, Inc., a company developing novel therapies that control disease-causing proteins, reported an oral presentation on its wholly-owned, BTK degrader program for chronic lymphocytic leukemia will be delivered by the Company’s collaborators from the National Institutes of Health at the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) meeting (ASH) (Free ASH Whitepaper) (Press release, Nurix Therapeutics, NOV 18, 2019, View Source [SID1234551423]). A poster presentation will also be presented on the BTK degradation mechanism of action. ASH (Free ASH Whitepaper) is being held on December 7-10, 2019 at the Orange County Convention Center in Orlando, Fla.

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ORAL PRESENTATION DETAILS:
Title: Highly Potent BTK Degradation Induced by NRX0492 As a Therapeutic Strategy for CLL
Session: 605. Molecular Pharmacology, Drug Resistance—Lymphoid and Other Diseases I

Hematology Disease Topics & Pathways: Diseases, Leukemia, Biological, Therapies, CLL, immune cells, Lymphoid Malignancies, TKI

Presenter: Deyi Zhang, Laboratory of Lymphoid Malignancies, Hematology Branch, NHLBI, NIH, Bethesda, MD

Date: Saturday, December 7, 2019
Time: 1:15 p.m. EST
Location: W414AB, Level 4

POSTER PRESENTATION DETAILS:
Title: Targeted Protein Degradation of BTK As a Unique Therapeutic Approach for B Cell Malignancies
Session: 605. Molecular Pharmacology, Drug Resistance—Lymphoid and Other Diseases: Poster III

Hematology Disease Topics & Pathways: Diseases, Leukemia, Biological, Therapies, CLL, immune cells, Lymphoid Malignancies, TKI

Date: Monday, December 9, 2019
Time: 6:00 – 8:00 p.m. EST
Location: Hall B, Level 2

MorphoSys’s B-MIND trial of tafasitamab in DLBCL has successfully passed futility analysis

On November 18, 2019 MorphoSys AG (Prime Sector Segment, MDAX & TecDAX, NASDAQ: MOR) reported that the ongoing Phase 3 B-MIND study with the drug candidate tafasitamab has successfully passed the pre-planned, event-driven interim futility analysis (Press release, MorphoSys, NOV 18, 2019, View Source [SID1234551422]). The data was evaluated by an independent data control committee (IDMC). This recommended increasing the number of patients from the current 330 to 450. The B-MIND study compares the efficacy of the CD19 antibody tafasitamab in combination with bendamustine versus rituximab in combination with bendamustine in patients with relapsed or refractory diffuse large B-cell lymphoma (r / r DLBCL).

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As part of the futility interim analysis, the IDMC examined the data for the likelihood of a positive outcome of the study at the time of graduation. The IDMC evaluated the efficacy data in the entire patient population as well as in the biomarker-positive patient subpopulation. The biomarker, which describes patients with a low number of natural killer cells at baseline, was implemented as a co-primary endpoint in the first quarter of 2019 in a supplement to B-MIND. The IDMC’s recommendation to include more patients in the trials aims to increase the statistical power of the study in both the biomarker-positive patient subpopulation and the entire study population. The data from the analysis was not shared with MorphoSys.

Continuing the B-MIND study protocol, patient recruitment will be performed according to the original inclusion and exclusion criteria. This should further enable the comparison of efficacy in the whole as well as the biomarker-positive patient group. Topline results are expected to be available in the first quarter of 2022.

"We are delighted with the IDMC’s recommendation and see it as an important step in the clinical development of tafasitamab," said Drs. Malte Peters, Chief Development Officer of MorphoSys. "DLBCL is a difficult-to-treat disease with a high unmet medical need, so new treatment options are urgently needed, and we are well on our way to approving our BLA approval application for tafasitamab in combination with lenalidomide, regardless of B-MIND positive clinical trial results L-MIND and Re-MIND by the end of 2019. "

About B-MIND
The pivotal Phase 2/3 B-MIND trial is investigating tafasitamab in combination with the chemotherapeutic agent bendamustine in patients with relapsed or refractory diffuse large B-cell lymphoma (R / R DLBCL) who are not eligible for high-dose chemotherapy and subsequent chemotherapy Autologous stem cell transplantation compared to the combination of the anti-CD20 antibody rituximab plus bendamustine A low number of natural killer cells in the peripheral blood at baseline was implemented as a biomarker in coordination with the FDA in the first quarter of 2019. A pre-planned, event-driven futility interim analysis in the B-MIND study took place in November 2019 and resulted in an increase in patient count to 450 (out of 330).

About CD19 and tafasitamab (MOR208)
CD19 is broadly and homogeneously expressed in several malignant B-cell diseases including DLBCL and CLL. It has been shown that CD19 participates in the B cell receptor (BCR) signaling pathway, which is considered to be important for B cell survival and makes CD19 a potential target in B cell disease.
Tafasitamab (MOR208) is a humanized Fc-modified monoclonal antibody against CD19. The Fc modification of tafasitamab should lead to a significant increase in antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus improving a key mechanism of tumor cell killing. Tafasitamab has been studied in preclinical models to induce direct apoptosis by binding to CD19, which is considered to be a critical component for B cell receptor (BCR) signaling.
In addition to B-MIND, MorphoSys is investigating tafasitamab as a therapeutic option in B-cell malignancies in a series of ongoing combination trials. The open-label Phase 2 combination trial (L-MIND trial) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed / refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) in Question come. Based on preliminary data from L-MIND, the FDA granted the status of breakthrough therapy for tafasitamab plus lenalidomide in this patient population in October 2017.
Re-MIND, the real world data trial in a control group treated with lenalidomide monotherapy, reached its primary endpoint in October 2019 and demonstrated clinical superiority of the tafasitamab / lenalidomide combination compared to lenalidomide alone. In addition, tafasitamab is currently being studied in patients with relapsed / refractory CLL / SLL following the discontinuation of previous bron-tyrosine kinase inhibitor therapy (eg ibrutinib) in combination with idelalisib or venetoclax.

LIPOCINE ANNOUNCES CLOSING OF PUBLIC OFFERING OF COMMON STOCK AND WARRANTS

On November 18, 2019 Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported the closing of a public offering of (i) 10,450,000 Class A Units, each consisting of shares of its common stock and common warrants to purchase its common stock and (ii) 1,550,000 Class B Units consisting of pre-funded warrants and warrants to purchase its common stock, at a price of $0.50 per Class A Unit and $0.4999 per Class B Unit, for total gross proceeds to the Company of approximately $6.0 million, before deducting placement agent fees and other estimated offering expenses (Press release, Lipocine, NOV 18, 2019, View Source [SID1234551421]). The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

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Roth Capital Partners acted as sole agent for the public offering.

The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-220942) (including a prospectus) previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the offering will be filed with the SEC.

A copy of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained by contacting Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, (800) 678-9147. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus are also available free of charge on the website of the SEC at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

LABCORP ANNOUNCES PROPOSED SALE OF SENIOR NOTES

On November 18, 2019 LabCorp (NYSE: LH) reported that it plans to offer, subject to market and other conditions, senior notes that are expected to be issued in two tranches (the Notes) (Press release, LabCorp, NOV 18, 2019, View Source [SID1234551420]). The Notes will be senior unsecured obligations and will rank equally with LabCorp’s existing and future senior unsecured debt.

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LabCorp intends to use the net proceeds of the Notes offering for general corporate purposes that may include (1) the purchase, redemption or repayment at maturity of its outstanding 2.625% Senior Notes due Feb. 1, 2020, (2) the purchase of up to $300 million aggregate purchase price of its 4.625% Senior Notes, due Nov. 15, 2020 in a 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 announcement 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, Halozyme Therapeutics, Inc. (the "Company," "we," "us" or "our") reported that completed its sale of $400.0 million in aggregate principal amount of 1.25% Convertible Senior Notes due 2024 (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") (Filing, 8-K, Halozyme, NOV 18, 2019, View Source [SID1234551418]). The Convertible Notes were issued under an indenture, dated as of November 18, 2019, (the "Indenture") between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee (the "Trustee"). In addition, the initial purchasers of the Convertible Notes (the "Initial Purchasers") exercised their option to purchase an additional $60.0 million in aggregate principal amount of the Convertible Notes. The offer and sale of the Convertible Notes and the shares of common stock issuable upon conversion of the Convertible Notes have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and the Convertible Notes and such shares may not be offered or sold absent registration or an applicable exemption from registration requirements, or in a transaction not subject to, such registration requirements.

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The Company received net proceeds from the offering of approximately $446.9 million. The Company plans to use up to $200.0 million of the net proceeds from the offering to repurchase shares of the Company’s common stock, including approximately $143.1 million to repurchase approximately 8.1 million shares of its common stock concurrently with the offering in privately negotiated transactions effected through one or more of the Initial Purchasers or an affiliate thereof and $50 million to repurchase approximately 2.1 million shares of its common stock, pursuant to and subject to adjustment as provided in the ASR Agreement as described below.

The Company used approximately $26.1 million of the net proceeds from the offering to repay all outstanding amounts under its loan agreement with Oxford Finance and Silicon Valley Bank and intends to use the remainder of the net proceeds for general corporate purposes, including additional share repurchases subsequent to the offering and working capital.

The Convertible Notes will pay interest semi-annually in arrears on June 1st and December 1st of each year, beginning on June 1, 2020, at an annual rate of 1.25% and will be convertible into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election, based on the applicable conversion rate at such time. The Convertible Notes are general unsecured obligations of the Company and will rank senior in right of payment to all of the Company’s indebtedness that is expressly subordinated in right of payment to the Convertible Notes, will rank equally in right of payment with all of the Company’s existing and future liabilities that are not so subordinated, will be effectively junior to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness and will be structurally subordinated to all indebtedness and other liabilities (including trade payables) of the Company’s current or future subsidiaries.

Holders may convert their Convertible Notes at their option only in the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on March 31, 2020, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive business days immediately after any five consecutive trading day period (such five consecutive trading day period, the "measurement period") in which the trading price per $1,000 principal amount of notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of Company’s common stock on such trading day and the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on Company’s common stock, as described in the offering memorandum; (4) if we call such notes for redemption; and (5) at any time from, and including, June 1, 2024 until the close of business on the scheduled trading day immediately before the maturity date. The Convertible Notes will be convertible, regardless of the foregoing circumstances, at any time from, and including, June 1, 2024 until the close of business on the scheduled trading day immediately preceding the maturity date.

Upon conversion, the Company will pay or deliver, as applicable, cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. The initial conversion rate for the Convertible Notes will be 41.9208 shares of common stock per $1,000 in principal amount of Convertible Notes, equivalent to a conversion price of approximately $23.85 per share of our common stock. The conversion rate is subject to adjustment as described in the Indenture.

Subject to certain exceptions, holders may require the Company to repurchase, for cash, all or any portion thereof in an authorized denomination of their Convertible Notes upon a "Fundamental Change" (as defined in the Indenture) at a price equal to 100% of the principal amount of the Convertible Notes being repurchased plus any accrued and unpaid interest, if any, up to, but excluding, the "Fundamental Change Repurchase Date" (as

defined in the Indenture). In addition, upon a "Make-Whole Fundamental Change" (as defined in the Indenture) prior to the maturity date of the Convertible Notes, the Company will, in certain circumstances, increase the conversion rate for a specified period of time. The Company may not redeem the Convertible Notes prior to December 1, 2022 and on or before the 40th scheduled trading day immediately before the maturity date.

The Indenture includes customary covenants, and sets forth certain events of default after which the Convertible Notes may be declared immediately due and payable and sets forth certain types of bankruptcy or insolvency events of default involving the Company or certain of its subsidiaries after which the Convertible Notes become automatically due and payable.

The foregoing description of the Indenture and Convertible Notes is qualified in its entirety by reference to the text of the Indenture and the Form of Convertible Note, copies of which are attached as Exhibits 4.1 and 4.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.