On September 26, 2019 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI or the Company), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported the closing of its previously announced underwritten public offering and the exercise in full of the underwriters’ option to purchase additional shares (Press release, VBI Vaccines, SEP 26, 2019, View Source [SID1234539810]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by VBI, are US$40.3 million. 80,500,000 common shares at a public offering price of US$0.50 per share were issued and sold in this offering, which includes 10,500,000 shares issued upon the exercise of the underwriters’ option to purchase additional shares.

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Immediately following the closing of the underwritten public offering, the number of outstanding common shares of the Company is 178,257,199.

Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. acted as joint book-running managers, and National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (Nasdaq: NHLD), acted as lead manager for the underwritten public offering.

VBI intends to use the net proceeds from the offering to progress its pipeline programs including the completion of the global CONSTANT Phase 3 lot-to-lot consistency study, regulatory submissions, and pre-commercialization activities for Sci-B-Vac, a trivalent hepatitis B vaccine, and for the continued clinical development of VBI-1901, a vaccine immunotherapeutic candidate for recurrent glioblastoma (GBM); VBI-2601, an immunotherapeutic candidate for chronic hepatitis B infection; and VBI-1501, a cytomegalovirus (CMV) vaccine candidate. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement relating to the common shares was previously filed with the Securities and Exchange Commission (SEC) and declared effective on July 30, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering was filed with the SEC on September 18, 2019. A final prospectus supplement and accompanying prospectus, dated September 19, 2019, relating to the offering was filed with the SEC on September 20, 2019, and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, by e-mail at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004 or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On September 26, 2019 Flatiron Health reported 13 abstracts accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019, which will be held September 27 – October 1, 2019, in Barcelona, Spain (Press release, Flatiron Health, SEP 26, 2019, View Source [SID1234539827]). The research, spanning multiple tumor types and areas of study, utilized Flatiron’s high-quality, real-world oncology datasets. Collectively, these research presentations highlight the various applications of real-world evidence, enabling deep clinical insights to better understand the use of biomarkers, comparative effectiveness of therapies and outcomes in routine clinical care.

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Presentations include collaborator research by the U.S. Food & Drug Administration’s Oncology Center of Excellence, Huntsman Cancer Institute, Yale Cancer Center, Bayer, Bristol-Myers Squibb, Celgene, Merck, Pfizer, Roche/Genentech and Foundation Medicine.

The presentation schedule and links to abstracts can be found below.

Poster Discussion
Prevalence and prognostic effect of high tumor mutation burden (TMB-H) across multiple less common solid cancers using a real-world dataset
● First Author: Daniel Backenroth (Flatiron Health)
● Date/Time: September 29 — 08:45 – 09:45
● Presentation: #1877PD

Poster Sessions
Second-line (2L) real-world treatment (tx) patterns and outcomes in patients (pts) with advanced/metastatic non-small cell lung cancer (NSCLC) treated with first-line (1L) immuno-oncology (IO) monotherapy (mono tx)
● First Author: Denis Talbot (University of Oxford)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1497P

Real-world effectiveness of nivolumab monotherapy after prior systemic therapy in advanced non-small cell lung cancer (NSCLC) in the United States
● First Author: David D. Stenehjem (University of Minnesota)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1498P

Treatment patterns and outcomes for patients (pts) with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) in US clinical practice
● First Author: Matthew G. Krebs (The Christie NHS Foundation Trust)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1546P

Brain metastases, treatment patterns and outcomes in ROS1-positive NSCLC patients from US oncology community centers
● First Author: Matthew G. Krebs (The Christie NHS Foundation Trust)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1551P

Biomarker status as a mediator of age-related overall survival (OS) in advanced non-small cell lung cancer (aNSCLC)
● First Author: Aaron B. Cohen (Flatiron Health)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1558P

Comparison of real-world response rate (rwRR) to RECIST-based response rate in patients with advanced non-small cell lung cancer (aNSCLC)
● First Author: Xinran Ma (Flatiron Health)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1581P

Palbociclib plus an aromatase inhibitor as first-line therapy for metastatic breast cancer in US clinical practices: Real-world progression-free survival analysis
● First Author: Mylin Torres (Winship Cancer Institute, Emory University School of Medicine)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #327P

Comparative effectiveness of palbociclib plus letrozole vs letrozole for metastatic breast cancer in US real-world clinical practices
● First Author: Rachel M. Layman (Pfizer)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #329P

Use of trastuzumab emtansine (T-DM1; K) after pertuzumab + trastuzumab (PH) in patients with HER2-positive metastatic breast cancer (mBC): Challenges in assessing effectiveness of treatment sequencing in the real world (RW)
● First Author: Thibaut Sanglier (Roche)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #356P

Co-occurrence of NTRK fusions with other genomic biomarkers in cancer patients
● First Author: Xiaolong Jiao (Bayer)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #102P

Association of programmed cell death 1 (PD-1) inhibitor therapy with overall survival (OS) in stage IV melanoma treated with targeted therapies
● First Author: Aracelis Z. Torres (Flatiron Health)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #1290P

Comparative-effectiveness of pembrolizumab vs nivolumab for patients with metastatic melanoma
● First Author: Justin Moser (Huntsman Cancer Institute)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #1346P

On September 26th, 2019 Peptomyc S.L., a biotech company specialized in the development of protein and peptide therapeutics for cancer treatment, reported it has appointed Manuela Niewel, M.D., as Chief Medical Officer (CMO) (Press release, Peptomyc, SEP 26, 2019, View Source [SID1234555332]). Dr. Niewel will assume responsibility for leading Peptomyc’s overall clinical development, regulatory and medical affairs activities.

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«We are very excited to have Manuela joining us and we warmly welcome her to Peptomyc. With her compassion for patients, her expertise in drug development in oncology and her clear leadership skills, she will definitely be a very strong asset in our team,» saidLaura Soucek, co-founder and CEO of Peptomyc.

Dr Niewel is an MD educated oncologist, who has focused nearly her entire career within the Oncology space, from first in men through registration of oncology drugs. She started as a resident within Oncology hospitals in Germany, working very closely with cancer patients. She then moved into the industry to focus her work within the Clinical Development setting. She joins Peptomyc from Rigontec, a start-up biotech acquired by Merck Sharp & Dohme in October 2017 for up to 464 M€ (shorturl.at/yKY03), where she served as Senior Vice President for Clinical Development since 2015, bringing their compound very quickly and successfully into the clinic. Dr. Niewel also acted as a clinical development consultant for several biotech companies and held Senior Medical Director positions at Chiltern International and Pharmanet, and led Clinical Research groups at PFK Oncology Services, Nycomed and Synthelabo Research. She obtained her M.D. diploma and doctoral degree at the University Munich and her Diploma in Pharmaceutical Medicine at DGPharMed Munich, Germany.

"As an oncologist and drug developer, I am very excited at having the opportunity to lead the clinical development of Omomyc, which acts against a target still considered undruggable" said Manuela Niewel, who also added: "I am very pleased about being part of this dedicated and dynamic team focused on advancing a promising treatment option for many underserved patients".

Dr. Niewel joins Peptomyc at a crucial time, as the company is preparing for a phase

I/II clinical study with its first-in-class anti-MYC lead compound, OMO103. "We are convinced that Manuela’s deep experience in innovative drug development and valuable input to our clinical development plan and regulatory strategy will contribute to the successful implementation of our clinical trials in 2020", adds Marie-Eve Beaulieu, co-founder and CSO of the company.

Peptomyc is currently completing its pre-clinical safety studies with OMO103, its first-in-class peptide compound against MYC, an oncoprotein deregulated in most –if not all- types of cancer. OMO103 has demonstrated its anti-tumor activity in multiple types of mouse models of cancer. The company’s prime focus areas are Non-Small-Cell Lung Cancer and Triple Negative Breast Cancer, but Peptomyc’s products could in the future apply to many more indications that still represent significant unmet needs within the oncology field.

About Peptomyc

Peptomyc is a spin-off from VHIO – the Vall d’Hebron Institute of Oncology – and ICREA – the Catalan Institute of Research and Advanced Studies -, in Barcelona, Spain.

It develops peptide therapeutics for the treatment of cancer patients. Its lead compound, OMO103, is a cell penetrating peptide against MYC, one of the most-wanted targets in cancer therapy, for which no inhibitor is available in the clinic yet. Phase I/II clinical trials testing safety and efficacy of OMO103 are planned to begin in 2020, with a specific focus on Non-Small-Cell Lung Cancer and Triple Negative Breast Cancer patients. Peptomyc counts on the support of private funding by Alta Life Sciences, Healthequity and business angels, and public grants (such as a recent SME Instrument Phase II by the European Commission, or the ENISA loan, from the Spanish Government’s Ministry of Industry, Commerce and Tourism).

On September 26, 2019, AbbVie Inc. ("AbbVie") reported sale of €1.4 billion aggregate principal amount of its senior notes, consisting of €750 million aggregate principal amount of 0.750% senior notes due 2027 and €650 million aggregate principal amount of 1.250% senior notes due 2031 (collectively, the "Notes") (Filing, 8-K, AbbVie, SEP 26, 2019, View Source [SID1234539811]). The offering of the Notes was made pursuant to a Prospectus Supplement, dated September 17, 2019 and filed with the Securities and Exchange Commission (the "SEC") on September 19, 2019 (the "Prospectus Supplement"), and the Prospectus dated September 13, 2018, filed as part of the shelf registration statement (File No. 333-227316) that became effective under the Securities Act of 1933, as amended, when filed with the SEC on September 13, 2018.

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The Notes are governed by an indenture, dated November 8, 2012 (the "Base Indenture"), by and between AbbVie and U.S. Bank National Association, as trustee (in such capacity, the "Trustee"), as supplemented by Supplemental Indenture No. 6, dated September 26, 2019 (the "Supplemental Indenture"), among AbbVie, the Trustee, Elavon Financial Services DAC, UK Branch, as paying agent (the "Paying Agent"), and U.S. Bank National Association, as transfer agent and registrar (in such capacity, the "Transfer Agent" and the "Registrar"). In connection with the issuance and sale of the Notes, AbbVie, the Trustee, the Paying Agent, the Transfer Agent and the Registrar also entered into an agency agreement, dated September 26, 2019 (the "Agency Agreement").

The Notes will mature on November 18 of the applicable year. The Notes are unsecured, unsubordinated obligations of AbbVie and will rank equally in right of payment with all of AbbVie’s existing and future unsecured, unsubordinated indebtedness, liabilities and other obligations.

As previously disclosed, AbbVie intends to use the net proceeds from the offering of the Notes, together with cash on hand, (i) to redeem, satisfy and discharge or repay at maturity all of its 0.375% senior notes due 2019 in an aggregate outstanding principal amount of €1.4 billion, and to pay any premium and accrued interest in respect thereof, and/or (ii) for general corporate purposes.

Please refer to the Prospectus Supplement for additional information regarding the offering of the Notes and the terms and conditions of the Notes. The foregoing summary of the Notes does not purport to be complete and is qualified in its entirety by reference to the full text of (i) the Base Indenture attached as Exhibit 4.1 hereto; (ii) the Supplemental Indenture attached as Exhibit 4.2 hereto; (iii) the Agency Agreement attached as Exhibit 4.3 hereto; and (iv) the forms of the Notes attached as Exhibits 4.4 and 4.5 hereto.

On September 26, 2019 ZielBio, Inc., an early-stage biotechnology company that identifies novel high value disease targets and develops therapeutic interventions to improve patient outcomes, reported that it has closed a $25.1 million Series A financing round (Press release, ZielBio, SEP 26, 2019, View Source [SID1234539828]). The round is led by Morningside Venture Investments and Partners Innovation Fund (PIF). ZielBio’s lead candidate ZB131 is a proprietary humanized monoclonal antibody against cell surface plectin (CSP), a target that is highly expressed on the plasma membrane of multiple types of cancer cells, including ovarian, pancreatic, lung and colorectal. The funding will enable the company to conduct further research to prioritize potential cancer applications, validate additional targets and initiate a planned phase 1 clinical trial with ZB131. "We are excited to partner with Morningside and PIF whose resources and drug development experience will greatly accelerate ZB131 development," noted Kimberly Kelly, PhD, President and Chief Science Officer at ZielBio.

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"Since its first discovery by ZielBio founder Dr. Kimberly Kelly at Massachusetts General Hospital, we have been encouraged by the unique role that cell surface plectin plays in proliferation, migration and cell survival and its potential as a drug target for a range of difficult to treat cancers," said PIF Partner Meredith Fisher, PhD. "Extensive pre-clinical laboratory and animal research has demonstrated that ZB131 has a high affinity to bind to CSP, inducing growth arrest and necrosis of targeted tumor cells."

"Despite the incredible progress being made in immuno-oncology, current therapies have limits and there remains a profound need for new targets and options for many deadly cancers," said Jason Dinges, JD, PhD, Investment Advisor at Morningside Technology Advisory. "ZB131 has shown potentially superior immune activation to current checkpoint inhibitors and greater direct tumor cell killing than EGFR inhibitors."

In connection with the financing, Drs. Dinges and Fisher have joined Dr. Kelly on the ZielBio Board of Directors.