Boston Scientific Prices $1.7 Billion of Senior Notes

On May 14, 2020 Boston Scientific Corporation (NYSE: BSX) reported the pricing of a public offering of $1.7 billion aggregate principal amount of its senior notes under the company’s shelf registration statement (Press release, Boston Scientific, MAY 14, 2020, View Source [SID1234558084]). The public offering consists of $500.0 million in aggregate principal amount of 1.900% notes due 2025 and $1.2 billion in aggregate principal amount of 2.650% notes due 2030.

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Boston Scientific expects to receive the net offering proceeds upon closing on May 18, 2020, subject to customary closing conditions. The company intends to use the net proceeds from this offering to (i) refinance $450.0 million of borrowings under its revolving credit facility and a portion of its pre-payable bank debt, including $750.0 million under its $1.0 billion term loan credit facility maturing in February 2021 and $500.0 million under its $1.25 billion term loan credit facility maturing in April 2021 and (ii) pay related fees, expenses and premiums.

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 qualification under the securities laws of any such state or jurisdiction. The offering is being made by means of a prospectus and related preliminary prospectus supplement only, copies of which or information concerning this offering may be obtained by contacting the joint book-running managers: Barclays Capital Inc., toll-free at (888) 603-5847; Citigroup Global Markets Inc., toll-free at (800) 831-9146, J.P. Morgan Securities LLC, toll-free at (212) 834-4533, or Wells Fargo Securities, LLC, toll-free at (800) 645-3751.

Neurocrine Biosciences to Present at the RBC Capital Markets 2020 Global Healthcare Conference

On May 14, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the RBC Capital Markets 2020 Global Healthcare Conference at 3:40 p.m. ET on Tuesday, May 19, 2020 (Press release, Neurocrine Biosciences, MAY 14, 2020, View Source [SID1234558083]). Kevin Gorman, Chief Executive Officer, will present at the conference .

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

Innovent Announces Key Results from a Number of Clinical Studies to Be Presented at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 14, 2020 Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic and other major diseases, reported that clinical data on its ORIENT-2 study of TYVYT (sintilimab injection), an innovative anti-PD-1 antibody co-developed with Eli Lilly and Company, in patients with advanced or metastatic esophageal squamous cell carcinoma will be presented by poster discussion, and six other clinical studies will be presented as posters or online publications at the 56th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Innovent Biologics, MAY 14, 2020, View Source [SID1234558082]).

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Poster Discussion

Title:
Sintilimab in Patients with Advanced or Metastatic Esophageal Squamous Cell Carcinoma Refractory to Previous Chemotherapy: A Randomized, Open-Label Phase 2 Study (ORIENT-2)
Abstract ID: 4511
Poster ID: 119
Session:
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
First Author:
Jianming Xu, MD (The Fifth Medical Center of PLA General Hospital)

Poster

Title:
Phase 1a Dose Escalation of IBI318, a First-in-Class Bispecific Anti-PD-1/PD-L1, in Patients with Advanced Tumors
Abstract ID: 3062
Poster ID: 126
Session:
Developmental Therapeutics-Immunotherapy
First Author:
Ruihua Xu, MD (Sun Yat-sen University Cancer Center)

Title:
Preliminary Results of Sintilimab Plus Different Dose of IBI305 (anti-VEGF Monoclonal Antibody) in Patients with Advanced Hepatocellular Carcinoma: A Phase 1b Study
Abstract ID: 3079
Poster ID: 143
Session:
Developmental Therapeutics-Immunotherapy
First Author:
Wen Zhang, MD (Cancer Hospital, Chinese Academy of Medical Sciences)

Title:
Sintilimab for Relapsed/Refractory Classical Hodgkin’s Lymphoma: Long-Term Follow-up on the Multicenter, Single-Arm Phase 2 ORIENT-1 Study
Abstract ID: 8034
Poster ID: 367
Session:
Hematologic Malignancies–Lymphoma and Chronic Lymphocytic Leukemia
First Author:
Hang Su, MD (The Fifth Medical Center of PLA General Hospital)

Title:
Sintilimab for Relapsed/Refractory (r/r) Extranodal NK/T Cell Lymphoma (ENKTL): Extended Follow-up on the Multicenter, Single-Arm Phase 2 Study (ORIENT-4)
Abstract ID: 8050
Poster ID: 383
Session:
Hematologic Malignancies–Lymphoma and Chronic Lymphocytic Leukemia
First Author:
Jianyong Li, MD, PhD (Jiangsu Province Hospital)

Online Publication

Title:
IBI310 Monotherapy or in Combination with Sintilimab in Patients with Advanced Melanoma: An Open-Label Phase 1a/1b Study
Abstract ID: 302489
First Author:
Bin Lian, MD (Beijing Cancer Hospital)

Title:
Transarterial Infusion Chemotherapy (TAI) Combined with Sintilimab in Locally Advanced, Potentially Resectable Hepatocellular Carcinoma (HCC)
Abstract ID: e16593
First Author:
Li Xu, MD (Sun Yat-sen University Cancer Center)

NantKwest and ImmunityBio to Initiate a Phase 2 Study of Immunotherapy for Metastatic Pancreatic Cancer

On May 14, 2020 NantKwest, Inc. (Nasdaq: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, a privately-held immunotherapy company, reported plans for a Phase 2, randomized, open-label study to evaluate the efficacy and safety of their combination immunotherapy: NantKwest’s PD-L1 t-haNK, ImmunityBio’s N-803, and aldoxorubicin HCI plus standard of care, versus standard-of-care chemotherapy for first- and second-line treatment of locally advanced or metastatic pancreatic cancer (Press release, NantKwest, MAY 14, 2020, View Source [SID1234558081]).

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Four metastatic pancreatic cancer patients have been treated with PD-L1 t-haNK and N-803 under single patient INDs, with two patients on treatment for an evaluable period. One patient reported ongoing, durable, complete response six months after treatment, and one observed response of stable disease. The Investigational New Drug (IND) application has received authorization from the U.S. Food and Drug Administration (FDA) with the study anticipated to begin in June 2020.

"Our results from expanded access use of PD-L1 t-haNK in combination with N-803 offer proof-of-concept that, together with these agents, the immune system may play a role to activate robust and durable responses in metastatic cancer patients who have failed all standard-of-care therapies," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. "Based on these encouraging data, we are moving forward with a randomized Phase 2 program that will evaluate our immunotherapy combination on top of standard of care, compared to standard of care alone, in first- and second-line treatment settings. This unique approach to orchestrating the innate and adaptive immune systems to induce immunogenic cell death may be an important new approach for pancreatic cancer patients—these being among the most challenging to treat with poor prognoses."

"Abraxane, a protein-based nanoparticle that activates macrophages, was our first evolution in making an impact on pancreatic cancer. With this addition of PD-L1 t-haNK and N-803, we are hopeful that we can proceed to the next step of long-term remission in this difficult to treat disease. Adding a natural killer cell with a checkpoint via PD-L1 t-haNK and activating memory T cells via N-803 will complete the ‘triangle offense’ we are orchestrating. The early results of complete response in one patient using the therapy on a compassionate use basis is encouraging and we are excited to initiate this trial involving other patients who suffer from pancreatic cancer," he said.

Study Details:

This Phase 2, randomized, two-cohort, open-label study will evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with PD-L1 t-haNK, N-803, and aldoxorubicin HCl in subjects with locally advanced or metastatic pancreatic cancer (QUILT-88). Each treatment setting, and first- and second-line or later maintenance, will be evaluated independently as Cohort A and Cohort B, respectively, with each Cohort having independent experimental and control arms. The study will initially enroll 268 subjects across both cohorts with the primary objective of comparative efficacy by progression free survival (PFS) per RECIST V1.1. Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).

Pancreatic cancer kills an estimated 47,000 people annually; it is the fourth leading cause of cancer-related death in the U.S., and 57,600 new cases are expected in 2020. Less than 5% of these patients will live for more than five years after diagnosis, and the median survival prognosis is 5 to 8 months.

Applied DNA Reports 2020 Fiscal Second Quarter Financial Results

On May 14, 2020 Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, reported consolidated financial results for the fiscal second quarter and the six months ended March 31, 2020 (Press release, Applied DNA Sciences, MAY 14, 2020, View Source [SID1234558080]).

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"Continued execution on our strategic priorities in our second fiscal quarter resulted in an expansion of our linear DNA story to include COVID-19 vaccine candidate and diagnostic kit programs and the addition of new development customers. These new development customers, several of which are leaders in the field of gene and redirected-cell therapies, demonstrate broadening interest and adoption of our proprietary linear DNA approach to preclinical biotherapeutics and diagnostics development and further validate linear DNA as a viable alternative for plasmid DNA," stated Dr. James A. Hayward, president and CEO of Applied DNA.

"Most of our activities during the quarter were devoted to our COVID-19 development programs that serve to also elevate the profile of our PCR-based LinearDNA platform to the biopharma industry as a powerful, large-scale tool for the rapid manufacture of DNA-based therapeutics," continued Dr. Hayward. "The global focus on the pandemic and the speed with which vaccine candidates are being developed are laying bare the limitations of modern vaccine development that are almost-exclusively reliant on plasmid-based technologies that are often slow and require much more downstream processing. Because our linear DNA approach does not require bacterial fermentation and has the added advantage of essentially no risk of contamination by genes for antibiotic resistance and other genetic contaminants, we believe our platform is well suited for such DNA-based therapeutics as engineered T cells, gene therapies, RNAi, and vaccines, such as for COVID-19 or future emerging infectious diseases. One new development customer, a global Top-20 pharmaceutical manufacturer, is evaluating the full scope of our platform to potentially serve as a foundational tool for their future genetic therapy pipeline. As the industry comes to terms with the limitations of plasmid-based technologies in terms of production speed and risk, we believe this will set the stage for a paradigm shift towards the rapid manufacturing of linear DNA vaccines with our LinearDNA platform as the accelerator."

Concluded Dr. Hayward, "Looking ahead, we remain focused on driving interest and building demand for our linear DNA approach across certain highly-regulated markets, such as drug development, that we believe offer a path to higher and more recurring revenue. Takis Biotech ("Takis") has initiated preclinical animal trials of our LinearDNA version of their vaccine candidates that we believe will demonstrate similar, robust immune responses to their plasmid-based constructs, but with the added advantage of speed and scalability to manufacture for global use. Concurrently, we are preparing for the possibility for Takis to progress to human trials this fall by readying our facility for compliance with the FDA’s cGMP regulations that govern the quality of biologics for human use. We have also developed our Linea COVID-19 high-throughput and high-sensitivity SARS-CoV-2 detection kit to enable mass-testing that can be a crucial tool in the toolbox of health systems and governments in the fight to further ‘flatten the curve’. Having received Emergency Use Authorization from the FDA today, we are now focused on the commercialization of our kit to assist frontline workers leading the charge against the pandemic. Pharmaceutical molecular tagging is another target market and one where the FDA has granted us entry into its Emerging Technology Program that gives us a path to drive the industry’s adoption of our authentication technologies and mitigate participation of counterfeit and adulterated drugs in the legitimate pharmaceutical supply chain. We will continue to build our business development pipeline and execute on our strategy to advance and prove the capabilities of linear DNA to drug developers and the broader pharmaceutical industry."

Fiscal Second Quarter 2020 Financial Results:

Revenues decreased 29% for the second quarter of fiscal 2020 to $552 thousand, compared with $778 thousand reported in the same period of the prior fiscal year and decreased 13% from $634 for the first quarter of fiscal 2020. This decrease in revenues year over year is due to a decrease of $305 thousand in service revenues, offset by an increase of $79 thousand in product revenues. The decrease in service revenues is primarily attributable to a decrease from a government contract award that ended during the second half of fiscal 2019 and a decline in precommercial feasibility projects in both textiles and cannabis. The increase in product revenues was primarily related to an increase in biopharmaceutical revenues during the quarter ended March 31, 2020.
Total operating expenses decreased to $3.1 million for the second fiscal quarter of 2020, compared with $3.3 million in the prior fiscal year’s second quarter. This decrease is attributable to a decrease in professional fees of approximately $183 thousand due to reduced legal fees. To a lesser extent, the decrease relates to a reduction of approximately $64 thousand in travel fees as result of travel restrictions associated with COVID-19. This decrease was offset by an increase in research and development expenses of $52 thousand.
Net loss for the quarter ended March 31, 2020 was $3.0 million, or $0.79 per share, compared with a net loss of $2.7 million, or $3.22 per share, for the quarter ended March 31, 2019, an increase of 10%, and a net loss of $2.7 million, or $1.12 per share, for the quarter ended December 31, 2019.
Excluding non-cash expenses, Adjusted EBITDA was negative $2.6 million and a negative $2.3 million for the quarters ended March 31, 2020 and 2019, respectively. See below for information regarding non-GAAP measures.
Cash was $8.7 million at March 31, 2020 that includes the exercise of warrants associated with the November 15, 2019 underwritten public offering ("the offering") totaling approximately $2.8 million in net proceeds. Subsequent to March 31, 2020 the Company received a further $2.9 million of net proceeds through the exercise of warrants associated with the offering. There is a total of approximately 1.5 million warrants outstanding from the offering at May 14, 2020.
Six Months Ended March 31, 2020 Financial Results:

Revenues decreased 29% for the first half of fiscal 2020 to $1.2 million, compared with $1.7 million reported in the same period of the prior fiscal year. This decrease in revenue year over year is due to a decrease of $472 thousand in service revenues and a decrease of $5 thousand in product revenues. The decrease in service revenues is primarily attributable to a decrease from a government contract award that ended during the second half of fiscal 2019.
Total operating expenses decreased to $6.1 million for the six months ended March 31, 2020, compared with $7.2 million in the prior fiscal year’s first six months. This decrease is primarily attributable to decreases in payroll of approximately $272 thousand, attributable to headcount reductions, a decrease in stock-based compensation expense of approximately $262 thousand as well as decreases in legal and professional fees of $139 thousand, consulting fees of $121 thousand, reduced travel expenses of $110 thousand and research and development of $93 thousand.
Net loss for the six-month period ended March 31, 2020 was $5.6 million, or $1.76 per share, compared with a net loss of $5.9 million, or $6.51 per share, for the six months ended March 31, 2019, an improvement of 5%.
Excluding non-cash expenses, Adjusted EBITDA was negative $5.0 million and a negative $4.9 million for the six months ended March 31, 2020 and 2019, respectively. See below for information regarding non-GAAP measures.
Select Quarterly Operational Highlights:

Applied DNA progressed its COVID-19 development program that spans both vaccine development and clinical diagnostic kit development:

On May 14, 2020, Applied DNA announced that it had received Emergency Use Authorization for its COVID-19 diagnostic Assay kit from the U.S. FDA. Clinical laboratories in the United States certified under Clinical Laboratory Improvement Amendments can immediately begin ordering and using the Linea COVID-19 assay kit to detect SARS-CoV-2, the virus that causes COVID-19;
On May 5, 2020, the Company announced that it had applied to the U.S. Food and Drug Administration for Emergency Use Authorization for its COVID-19 diagnostic kit, Linea COVID-19, a RT-PCR-based, high-sensitivity and high-throughput COVID-19 diagnostic test;
On May 4, 2020, Applied DNA and its COVID-19 development partner, Takis, announced that the first injections of their DNA vaccine candidates against the Spike protein (‘S’ gene) of the SARS-CoV-2 virus that causes the COVID-19 disease, have produced neutralizing antibodies in test animals. The studies were completed at the renowned Lazzaro Spallanzani ("Spallanzani") National Institute for Infectious Diseases in Rome. These initial results were obtained using plasmids (the templates for LinearDNA) to baseline results; Applied DNA’s linear DNA dose-response trials begin in the week of May 4, 2020;
On April 21, 2020, the Company signed an agreement with Stony Brook University Hospital to validate and implement the Company’s COVID-19 diagnostic test; Linea COVID-19. The diagnostic test targets the SARS-CoV-2 Spike (S) gene, which is also the subject of the Company’s COVID-19 vaccine development program.;
On April 15, 2020, Applied DNA announced that it had shipped five linear DNA versions of COVID-19 vaccine candidates to its drug development partner, Takis, to support the immediate start of preclinical animal testing. Shipment of the vaccine candidates follows Takis’ receipt of approval from Italy’s Ministry of Health to begin preclinical testing. Concurrent with Takis’ animal trials, Applied DNA is preparing for cGMP production of selected vaccine candidate(s) to support human trials scheduled to begin this fall; and
On March 24, the Company announced that it had filed a provisional patent application with the U.S. Patent and Trademark Office for a diagnostic assay for COVID-19.
The Company’s LinearDNA platform for preclinical biotherapeutic (gene and redirected-cell therapies) and diagnostic applications development continued to shift towards broader adoption:

On March 26, the Company announced that it had shipped CAR T amplicons proprietary to a new development customer, the biologics subsidiary of a U.S.-based, global biopharmaceutical company, for use in evaluating the use of linear DNA; and
On March 20, Applied DNA announced the signing of a research agreement with a new development customer, a global Top-20 pharmaceutical manufacturer, to evaluate the full scope of the Company’s linear DNA platform to potentially improve the efficacy and safety of the customer’s CAR T therapy pipeline. The research agreement includes the Company’s patented technologies to maximize protein expression and unique linear DNA anti-CD19 CAR T construct for the treatment of acute lymphocytic leukemia.
The Company’s DNA tagging business for supply chain security continued to build awareness and adoption:

On February 24, the Company announced the receipt of international patents on its Beacon secure optical molecular market technologies in China, Canada, and the U.S., each a key market for brand protection and assurance for Applied DNA;
On February 20, Applied DNA received Pareve kosher certification for products within its SigNature and CertainT brands from Orthodox Union, the world’s largest and most widely recognized international kosher certification agency. Certification supports the Company’s business development efforts in the food, pharmaceutical, and dietary supplements markets to maximize adoption of its molecular-based tagging platform;
On February 19, the Company entered the dietary supplements market with a multi-year contract with Nutrition21, a trusted developer and supplier of novel and clinically substantiated branded ingredients for the nutritional supplement industry. Under the terms of the contract, the application of Applied DNA’s CertainT platform to Nutrition21’s leading sports supplement, Nitrosigine, offers Nutrition21 the certainty of its ingredients all the way through to their customers’ finished products and onto retail shelves and online stores. Separately, the two companies signed an additional agreement to enable Nutrition21 to represent the CertainT platform throughout Nutrition21’s extensive network in the dietary supplement market.
Fiscal Second Quarter 2020 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal second quarter-end 2020 results on Thursday, May 14, 2020 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

Participant Toll Free:1-844-887-9402
Participant Toll: 1-412-317-6798
Please ask to be joined to the Applied DNA Sciences call
Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through May 21, 2020):

Participant Toll Free: 1-877-344-7529
Participant Toll: 1-412-317-0088
Participant Passcode: 10141899
Webcast replay: View Source
For those unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under the ‘Events and Presentations’ section of the company’s Investor Relations web site: View Source