On May 21, 2020 Boston Scientific Corporation (NYSE: BSX) reported the pricing of concurrent offerings of 25,550,000 shares of its common stock ("Common Stock") at a price to the public of $34.25 per share and 8,750,000 shares of its 5.50% Mandatory Convertible Preferred Stock, Series A ("Mandatory Convertible Preferred Stock") at a price to the public and liquidation preference of $100.00 per share (Press release, Boston Scientific, MAY 21, 2020, View Source [SID1234558385]). The underwriters have separate 30-day options to purchase up to an additional 3,832,500 shares of Common Stock and up to an additional 1,312,500 shares of Mandatory Convertible Preferred Stock. The offerings are expected to close on May 27, 2020, subject to customary closing conditions.

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 net proceeds from the Common Stock offering and the Mandatory Convertible Preferred Stock offering will be approximately $847.3 million and $847.3 million, respectively (or approximately $974.7 million and $974.6 million, respectively, if the underwriters exercise their options in full), in each case after deducting underwriting discounts and commissions and estimated offering expenses.

Boston Scientific intends to use a portion of the combined net proceeds from the offerings of $1,694.6 million (or $1,949.3 million if the underwriters for both offerings exercise their options in full) to repay in full the remaining $750.0 million outstanding under its $1.25 billion term loan credit facility maturing on April 20, 2021 and to pay related fees, expenses and premiums, after which it will be terminated. The remaining proceeds will be used for general corporate purposes, which may include refinancing or repayment of other outstanding indebtedness and funding potential future acquisitions and investments.

Unless earlier converted, each share of Mandatory Convertible Preferred Stock will automatically convert on June 1, 2023 (subject to postponement for certain market disruption events, the "mandatory conversion date") into between 2.3834 and 2.9197 shares of Boston Scientific’s Common Stock, subject to customary anti-dilution adjustments. The number of shares of Common Stock issuable upon conversion will be determined based on the average volume-weighted average price (VWAP) per share of Common Stock over the 20 consecutive trading day period beginning on, and including, the 21st scheduled trading day immediately preceding June 1, 2023.

Dividends on the Mandatory Convertible Preferred Stock will be payable on a cumulative basis when, as and if declared by Boston Scientific’s board of directors, at an annual rate of 5.50% on the liquidation preference of $100.00 per share. If declared, these dividends will be paid in cash, in shares of Common Stock or in a combination of cash and shares of Common Stock, at Boston Scientific’s election, subject to certain limitations, on March 1, June 1, September 1 and December 1 of each year, commencing on September 1, 2020 and continuing to, and including, June 1, 2023. Until Boston Scientific amends or terminates its existing credit agreements that contain a restriction on its ability to pay cash dividends on its capital stock, or such restrictions are no longer effective under the terms of such credit agreements, Boston Scientific will pay the relevant dividend in shares of its common stock.

The closing of each offering is not contingent upon the closing of the other offering.

J.P. Morgan, BofA Securities, Citigroup, Goldman Sachs & Co. LLC, Wells Fargo Securities, Morgan Stanley, Barclays and RBC Capital Markets are acting as joint book-running managers for the offerings.

The offerings are being made pursuant to an effective shelf registration statement on file with the U.S. Securities and Exchange Commission (the "SEC"). Each offering will be made by means of a prospectus and related preliminary prospectus supplement only. An electronic copy of each preliminary prospectus supplement, together with the accompanying prospectus, is available on the SEC’s website at www.sec.gov. Alternatively, copies of each preliminary prospectus supplement and accompanying prospectus relating to either offering or information concerning this offering may be obtained by contacting the joint book-running managers: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, Email: [email protected]; or BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, Email: [email protected].

Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the 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.

On May 21, 2020 I-Mab (NASDAQ: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders, and Genexine Inc. (KOSDAQ: 095700), a clinical-stage biotechnology company focused on developing innovative immunotherapeutics and novel long-acting biologics, reported that the China National Medical Products Administration (NMPA) has cleared the initiation of a Phase 2 clinical trial of TJ107/HyLeukin-7 (Efineptakin alfa), the novel long-acting recombinant human interleukin-7 (rhIL-7), in lymphopenic patients with newly-diagnosed glioblastoma multiforme (GBM) (Press release, I-Mab Biopharma, MAY 21, 2020, View Source [SID1234558384]). In addition, the two companies expanded their collaboration beyond the initial agreement to include development of TJ107/HyLeukin-7 for this indication.

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 affirmation was provided by NMPA in response to a pre-IND request to support the clinical development plans for TJ107/HyLeukin-7 as a potential treatment for GBM. Per the clearance, I-Mab and Genexine are able to initiate a phase 2 clinical study in China without additional IND application submission required.

"There’s a critical need to bring innovative therapies for patients suffering from GBM, an aggressive brain cancer with a particularly grim prognosis. I-Mab and Genexine appreciate the NMPA’s accelerated assessment and giving the greenlight to initiate a Phase 2 clinical trial of TJ107/Hyleukin-7 for GBM," said Dr. Joan Shen, CEO of I-Mab. "I-Mab’s expanded collaboration with Genexine speaks volume of our productive partnership and excellent progress made to date, which bring us a step closer to deliver on our promise to help patients in need."

Under the terms of the expanded collaboration, I-Mab will be mainly responsible for conducting the Phase 2 GBM clinical trial in China, and Genexine will share the development strategies, data and costs for success of this clinical trial. Financial terms are not disclosed.

"Standard of care in treating GBM induces long-lasting lymphopenia in most patients. As a potential treatment for patients suffering from this devastating cancer, TJ107/HyLeukin-7 has demonstrated to effectively induce T cells, especially naïve and memory T cells, and correct lymphopenia in patients with late stage solid tumors," said Dr. Jung Won Woo, Executive Vice President, CDO, Genexine. "We are delighted to deepen our partnership with I-Mab to develop a potential novel therapy."

The restoring ability of T cell deficiency of TJ107/HyLeukin-7 in a Phase 1b study (NCT03478995) by Genexine was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting in 2019. The study was on 21 terminal patients with solid tumor, and showed that TJ107/HyLeukin-7 was well tolerated without dose limiting toxicity and cytokine release syndrome. Dose-dependent increase of absolute lymphocyte counts and T cell subsets (not Treg) were also observed. The findings suggested that TJ107/HyLeukin-7 can be an excellent combination partner for chemo-radiation, cancer vaccines and immune checkpoint inhibitors such as anti-PD-1/PD-L1 antibodies, by increasing T lymphocytes and thereby contributing to enhanced anti-tumor effects.

By leveraging the results of Genexine’s ongoing clinical trials in South Korea, I-Mab is currently conducting a Phase 1b trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and determine recommended Phase 2 dose (RP2D) of TJ107/HyLeukin-7 in Chinese subjects with advanced solid tumors (NCT04001075).

According to the data released by GLOBOCAN 2018 by International Agency for Research on Cancer, WHO, new cases of brain and nervous system cancers reached 76,494 in China, approximately 17% of which was GBM[1]. The annual incidence rate of GBM in China is 5 to 8 per 100,000 person-year.

[1] Ostrom Q T, Gittleman H, Liao P, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 2010–2014[J]. Neuro-oncology, 2017, 19(suppl_5): v1-v88.

About TJ107/HyLeukin-7

TJ107/HyLeukin-7 (Efineptakin alfa) is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. It emerged from Genexine’s proprietary hyFc platform for discovering of long-acting biologics. I-Mab has acquired exclusive rights from Genexine to develop and commercialize TJ107/ HyLeukin in Greater China. TJ107/HyLeukin-7 may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. TJ107/HyLeukin-7 has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.

On May 21, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, is scheduled to present at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 at 3:30 p.m. Eastern Time (Press release, Veracyte, MAY 21, 2020, View Source [SID1234558382]).

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 link to the live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On May 21, 2020 Incyte (Nasdaq:INCY) reported that it will present at the Goldman Sachs 41st Annual Global Healthcare Conference (held virtually) on Tuesday, June 9, 2020 at 8:00 a.m. ET (Press release, Incyte, MAY 21, 2020, View Source [SID1234558381]).

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 presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

On May 21, 2020 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of oncology mono- and combination therapies, reported the initiation of the Phase 2 portion of the Phase 1/2 clinical trial for APL-101 based on completion of the Phase 1 and approval from the study’s safety review committee to advance the trial (Press release, Apollomics, MAY 21, 2020, View Source [SID1234558380]). APL-101 is a novel, orally administered, highly selective Type 1b class of c-MET inhibitor, an enzyme which has been shown to function abnormally in many malignant tumors.

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 APL-101 Phase 1/2 clinical trial is an international multicenter, open-label study evaluating the safety, pharmacokinetics, and preliminary efficacy of APL-101. The Phase 2 portion of the study, titled SPARTA, will evaluate activity in non-small cell lung cancer (NSCLC) with a mutation that leads to MET exon 14 skipping, and across tumor types (pan-cancer) with MET amplification or fusions.

"Advancing APL-101 into our Phase 2 SPARTA trial is a major milestone for Apollomics as we strive to combat NSCLC MET exon 14 skipping and MET dysregulated tumors with precision," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer. "The incidence of MET dysregulations presents a critical need to identify patients who can benefit most from a targeted treatment, like APL-101, in order to optimize patient care. Over the past several years, we have established numerous partnerships with leading biopharma companies, and we continue to progress our robust research and development pipeline globally."

SPARTA will enroll patients into multiple cohorts. In NSCLC, the trial will evaluate both c-MET inhibitor naïve and experienced patients with mutations that lead to MET exon 14 skipping. Two cohorts will enroll patients with solid tumors with MET amplifications and fusions, including glioblastoma multiforme, the most aggressive form of brain cancer. The primary objective of SPARTA is to assess efficacy by overall response rate (ORR) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) or relevant evaluation criteria per tumor type. Secondary objectives include the incidence and severity of adverse events and additional efficacy measurements including time to progression, progression free survival, and overall survival.

"MET is dysregulated in several tumor types in addition to non-small cell lung cancer allowing for the possibility of broad applicability for a targeted treatment. Based on the tolerability data from the Phase 1 portion of SPARTA, and the emerging data observed in MET dysregulated NSCLC from a parallel ongoing Chinese Phase 1 trial, we are encouraged by the potential of APL-101. We look forward to further evaluation of APL-101 in the Phase 2 setting," added Mark Awad, M.D., Ph.D., SPARTA Principal Investigator, Assistant Professor of Medicine at Harvard Medical School and Clinical Director of the Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute.

The Phase 1 portion of the study was completed in April 2020. In the study, APL-101 was generally safe and well-tolerated with no reported dose limiting toxicities, and the recommended Phase 2 dose was determined to be 200 mg twice daily (BID). Apollomics expects to present the results of the Phase 1 portion of the study at an upcoming medical meeting.

About c-MET Dysregulations

Dysregulation of the c-MET tyrosine kinase receptor is implicated in the development of tumor malignancy and can arise through several mechanisms, including gene fusion and amplification, overexpression of the receptor and/or its ligand hepatocyte growth factor (HGF), and the acquisition of activating mutations. One type of the activating mutations cause exon 14 to be skipped due to aberrant splicing of MET mRNA. MET exon 14 skipping occurs in approximately 3% of NSCLC and has been demonstrated to be an oncogenic driver, raising the possibility that tumors with these specific mutations will be largely sensitive to c-MET inhibitors.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is a disease in which malignant cancer cells form in the tissues of the lung. In 2017, there were an estimated 558,000 people living with lung and bronchus cancer in the United States, with new cases estimated to be over 228,000 in 2020. Lung cancer is also one of the more deadly cancers with a relative 5-year survival rate of around 20%. NSCLC is the most common type of lung cancer with about 80% to 85% of lung cancers falling into this category.

About APL-101

APL-101 is a novel small molecule kinase inhibitor that targets c-MET. It is a Type 1b class highly selective c-MET inhibitor. APL-101 has demonstrated strong tumor inhibitory effect in a variety of preclinical c-MET dysregulated human gastric, hepatic, pancreatic and lung cancer xenograft animal models and patient-derived xenograft models (PDX). In Phase 1 clinical trials, APL-101 (PLB1001) demonstrated a generally well-tolerated safety profile with preliminary evidence of clinical activity in NSCLC subjects harboring a mutation that leads to MET exon 14 skipping and in secondary glioblastoma multiforme (sGBM) patients harboring MET fusion and/or exon 14 skipping with evidence of brain penetration. In China, APL-101 is referred to as PLB1001 where it is being developed by Apollomics’ partner Beijing Pearl Biotechnology Co. Ltd. Details on the Phase 1/2 SPARTA clinical trial can be found on clinicaltrials.gov: NCT03175224. Apollomics is actively assessing the potential of investigating APL-101 in combination with novel therapies and in a variety of tumor types in addition to developing APL-101 as single-agent cancer therapy. APL-101 is currently under clinical investigation and not approved for any use anywhere in the world.