On March 20, 2020 STELLA PHARMA CORPORATION (Head office: Chuo-ku, Osaka City, President: Tomoyuki Asano) hereby reported that its drug for Boron Neutron Capture Therapy (BNCT [Note * 1 ]) Steboronine intravenous drip bag 9000mg/300mL (Generic name: Borofalan [10B]; hereinafter referred to as Steboronine) was approved by the Ministry of Health, Labour and Welfare of Japan for the treatment of locally unresectable recurrent or unresectable advanced head and neck cancer (Press release, Stella Chemifa, MAR 20, 2020, View Source [SID1234638634]).

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Head and neck cancer is a group of cancers that develop below the brain, ranging from the cranial base to the collarbone (such as the ear, nose, mouth, jaw and throat areas). The head and neck areas contain organs necessary for everyday activities, and therefore there is a need for the establishment of treatment that can both control the cancer and preserve such functions after the treatment. BNCT is a treatment in which the radiation destroys 10B-loaded cancer cells only, and is therefore expected to control the cancer while having less impact on peripheral normal tissues and their functions.

STELLA PHARMA CORPORATION conducted a Japanese phase II study (Note *2) with head and neck cancer patients in collaboration with Sumitomo Heavy Industries Ltd. (Head office: Shinagawaku, Tokyo; President: Shinji Shimomura), and filed for approval to manufacture and sell Steboronine based on the phase II results in October 2019. Steboronine was approved today by the Ministry of Health, Labour and Welfare of Japan as the world’s first boron drug for BNCT. Sumitomo Heavy Industries Ltd. obtained medical device approval for manufacturing and sales of an accelerator-based BNCT system on March 11, 2020 from the Ministry of Health, Labour and Welfare of Japan (Note *3). STELLA PHARMA CORPORATION has been developing Steboronine through industryacademia-government collaboration with support from Osaka Prefectural University (Location: Sakai City Naka-ku; President: Masahiro Tatsumisago), the Japan Science and Technology Agency, and the Japan Agency for Medical Research and Development, using the boron isotope enrichment technology (Note *4), established by our parent company STELLA CHEMIFA CORPORATION (Head office: Chuo-ku, Osaka City; Representative Director, President and Chief Executive Officer: Aki Hashimoto). In April 2017, the product was designated as a product subject to the "SAKIGAKE Designation System" by the Ministry of Health, Labour and Welfare. STELLA PHARMA CORPORATION will continue to work toward having Steboronine listed in the National Health Insurance drug price list and toward further development to expand the drug’s indications. STELLA PHARMA CORPORATION will continue to contribute to global medical care through the development of innovative pharmaceuticals and new treatment options for patients. Product Outline Product Name Steboronine intravenous drip bag 9000mg/300mL Generic Name Borofalan [10B] Indications Locally unresectable recurrent or unresectable advanced head and neck cancer Dosage & Administration For adult patients, administer Steboronine intravenously at 200 mg/kg/h as Borofalan(10B) for 2 hours, followed by neutron irradiation to the cancer lesion with continuous infusion at 100 mg/kg/h. SUPPLEMENTARY INFORMATION *1 Boron neutron capture therapy Boron-neutron capture therapy (BNCT) is a type of radiotherapy and a new way to treat cancer. Boron (10B) accumulates in cancer cells, when 10B compound is administered to patients and a neutron beam then is irradiated to the cancerous area from outside the body. The irradiated neutron-beam has very low-energy and has little effect on the human body. When the neutrons collides with the boron (10B) in the cancer cells, nuclear fission occurs so as to generate radiation (alpha-rays and 7Li-nuclei). BNCT is a treatment in which the radiation destroys cancer cells only. *2 Japanese phase II study A Japanese phase II study was conducted in 21 patients with locally unresectable recurrent squamous cell carcinoma of the head and neck or unresectable non-squamous cell carcinoma of the head and neck with the primary endpoint of tumor response (response rate) based on RECIST (Response Evaluation Criteria in Solid Tumors) v 1. 1. Overall response rate (95% CI) at 90 days after neutron irradiation was 71.4 (47.8-88.7) %. No dead or discontinued cases were observed during the primary endpoint evaluation period (90 days after neutron irradiation). *3 Medical devices for BNCT in combination with Steboronine  BNCT System NeuCureTM（Approval No.：30200BZX00084000）  BNCT dose calculation program NeuCureTM Dose Engine (Approval No. 30200BZX00083000) *4 Isotope enrichment technology for boron Naturally occurring boron contains 10B with a mass of 10 and 11B with a mass of 11. 10B contains only about 20%. Nuclear fission by neutrons used in the BNCT to destroy cancer cells is caused only by 10B, but not by 11B. Boron isotope enrichment technology is indispensable for BNCT. In Japan, STELLA CHEMIFA CORPORATION is the sole owner of boron isotope enrichment technology for separating and concentrating only 10B at high concentrations. STELLA PHARMA CORPORATION-Company Info STELLA PHARMA CORPORATION is committed to implementing its own corporate mission of "we shed new light on medical practice world-wide to save every irreplaceable life" as a principle of its corporate philosophy. In order to realize this corporate philosophy, we have been working to deliver BNCT to the market as a new treatment for incurable cancer since the founding of our company. We have decided to contribute to the prosperity and health of society through the development of innovative pharmaceuticals and new treatment options for cancer patients. For more information, please refer to the STELLA PHARMA website at View Source Precaution The information contained in this document is intended to disclose management information and is not for advertising or promotional purposes.

On March 20, 2020 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that on March 17, 2020 the U.S. Patent and Trademark Office ("USPTO") issued a Certificate to extend the duration of U.S. patent 6,409,990 for an additional five years through May 12, 2025 (Press release, Navidea Biopharmaceuticals, MAR 20, 2020, View Source [SID1234555723]). This Certificate was based on the U.S. Food and Drug Administration’s ("FDA") recommendation for a five-year extension under the Hatch-Waxman Act for patent term lost in regulatory review.

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This patent claims and protects Lymphoseek (technetium [Tc 99m] tilmanocept) and has been exclusively licensed with varying geographical and medical indication coverages to Cardinal Health and Navidea. Allowance of this patent extension will permit Cardinal Health and Navidea to extend their exclusive rights to manufacture and commercialize Lymphoseek until the end of the extended patent term in 2025.

"I am pleased the USPTO has taken positive action and extended the Lymphoseek patent until May 12, 2025," said Jed Latkin, CEO of Navidea. "This is an exciting time for Navidea as this extension is just the first of several IP related announcements that we expect to have over the next several quarters."

On March 19, 2020 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the year ended December 31, 2019, and provided a corporate update (Press release, VBL Therapeutics, MAR 19, 2020, View Source [SID1234555698]).

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"We are excited to advance our clinical program for VB-111 in ovarian cancer towards an important interim analysis, while collaborating with the National Cancer Institute and top US neuro-oncology centers in externally-sponsored studies of VB-111 for colon cancer and recurrent GBM," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer continues to enroll patients as planned and we expect the readout from an important interim analysis by the end of the first quarter. VBL made significant advancement during 2019 on all fronts. We now look forward to 2020 as a potential turn around year for the company, with three parallel clinical trials for VB-111 and upcoming results from our MOSPD2 programs for inflammation and oncology."

Amos Ron, Chief Financial Officer of VBL Therapeutics stated, "We had more than $37 million in cash, cash equivalents and restricted bank deposits at December 31, 2019. This is expected to provide us with sufficient resources to continue to develop VB-111 and other product candidates and to fund our operating expenses and capital expenditure requirements into the third quarter of 2021."

Fourth Quarter and Key Corporate Highlights:

VB-111 program in ovarian cancer – The OVAL Phase 3 potential-registration study of VB-111 in ovarian cancer continues as planned towards the important interim analysis in 1Q 2020. This analysis will focus on CA-125 response rate, which will be analyzed according to GCIG strict criteria in 60 evaluable patients. The data will help to inform whether the positive outcome observed with VB-111 in the Phase 2 study in ovarian cancer is being replicated in the OVAL Phase 3 trial.
Results from a Phase 1/2 clinical trial of VB-111 in the treatment of patients with recurrent platinum resistant ovarian cancer were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Data demonstrated a median overall survival (OS) of 498 days in the VB-111 therapeutic-dose arm, versus 172.5 days in the low-dose arm (p=0.03). 58% of evaluable patients treated with the therapeutic dose of VB-111 had a GCIG CA-125 response. In comparison, in the AURELIA trial, the GCIG CA-125 response rate was 31.8% with bevacizumab and chemotherapy, and only 11.6% with chemotherapy alone.
VB-111 for colon cancer – In February 2020, we announced the launch of a Phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo), an immune checkpoint inhibitor, in the treatment of metastatic colorectal cancer, under a Cooperative Research and Development Agreement (CRADA) between VBL and the U.S. National Cancer Institute (NCI). NCI will serve as the IND sponsor for this study (ClinicalTrials.gov Identifier: NCT04166383).
VB-111 program in recurrent glioblastoma (rGBM) – VBL announced the publication of clinical data from the Phase 2 and GLOBE Phase 3 studies of VB-111 in rGBM in two manuscripts published in December 2019 in the peer-reviewed journal Neuro-Oncology, the official journal of the Society for Neuro-Oncology.
Study results attribute the contradictory outcomes between the Phase 2 and Phase 3 trials to the lack of VB-111 monotherapy priming in the GLOBE Phase 3 study, providing clinical, mechanistic and radiographic support for this hypothesis.
With the understanding that study regimen may be a key factor for VB-111 activity in rGBM, a new study, under U.S. IND sponsorship by Dana-Farber Cancer Institute, in collaboration with a group of leading U.S. neuro-oncology investigators, will assess neo-adjuvant and adjuvant treatment with VB-111 in rGBM patients undergoing a second surgery. Launch of this study is expected in the first half of 2020.
VB-111 GMP Facility – VBL’s new gene therapy pharmaceutical grade manufacturing facility in Modiin, Israel, was certified by the European Union (EU) Qualified Person (QP) as being in compliance with EU Good Manufacturing Practices (GMP). The facility has also been certified by the Israeli Ministry of Health as being in compliance with the Israeli law and regulations of GMP. These important steps are expected to support future commercialization of VB-111, if approved.
MOSPD2 bi-specific mAbs for cancer – We are developing bi-specific antibodies designed to kill tumor cells, based on MOSPD2 as a novel target whose expression is induced in multiple tumors. We previously presented preclinical proof-of-concept for this approach using a BiTE antibody, and are currently advancing our lead bi-specific antibody candidate towards an IND filing. New data from this program were accepted for presentation in a late breaking abstract session at the 2020 American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
MOSPD2 mAb program for inflammation – VBL continues to advance the development of lead MOSPD2 antibodies for immune-inflammatory indications, with potential for MS, RA and NASH. The Company signed a service agreement with Thermo Fisher Scientific, one of the leading vendors in the antibody field, for production of lead candidate VB-601 for toxicology and clinical development. A pre-IND submission for VB-601 is expected in 2Q 2020. New data on MOSPD2 as a target for inflammatory digestive disorders were accepted for presentation at EASL’s annual International Liver Congress, ILC 2020, and Digestive Disease Week (DDW) conferences later this year. Our abstract for DDW was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction.
Lecinoxoids platform – VBL executed a strategic exclusive option to license agreement with one of the world-leading European animal health companies for the development of VBL’s proprietary anti-inflammatory molecule, VB-201, for veterinary use. VBL received an undisclosed up-front payment. Upon exercise of the license option, VBL expects to receive additional milestones and royalties, which have the potential to exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans.
Fiscal Year Ended December 31, 2019 Financial Results:

Cash Position: At December 31, 2019, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposit of $37.0 million and working capital of $29.1 million. VBL expects that its cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into 3Q 2021.
Revenues: Revenues related to VBL’s collaboration in Japan and with an animal health company amounted to $0.6 million in the year ended December 31, 2019.
R&D Expenses: Research and development expenses, net, after government grants, for the year ended December 31, 2019, were approximately $15.5 million, compared to approximately $15.9 million in the same period in 2018.
G&A Expenses: General, administrative and marketing expenses for the year ended December 31, 2019, were $4.9 million, compared to $5.6 million for the same period in 2018.
Comprehensive Loss: VBL reported a net loss for year ended December 31, 2019, of $19.5 million, or ($0.54) per share, compared to a net loss of $20.4 million, or ($0.62) per share, in the year ended December 31, 2018.
For further details on VBL’s financials, please refer to Form 20-F filed with the SEC.

Conference Call:
Thursday, March 19th @ 8:30am Eastern Time
From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13699636
Webcast: View Source

On March 19, 2020 Abbott (NYSE: ABT) reported that it will announce its first-quarter 2020 financial results on Thursday, April 16, 2020, before the market opens (Press release, Abbott, MAR 19, 2020, View Source [SID1234555702]).

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The announcement will be followed by a live webcast of the earnings conference call at 8:00 a.m. Central time (9:00 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On March 19, 2020 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported results for the fourth quarter and full year 2019 and provided a corporate and clinical update (Press release, AmpliPhi Biosciences, MAR 19, 2020, View Source [SID1234555703]).

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Key Fourth Quarter and Subsequent Period Highlights:

·Entered into a $25 million securities purchase agreement pursuant to which Innoviva, Inc. ("Innoviva") will purchase approximately 8.7 million shares of Armata common stock at $2.87 per share and warrants to purchase an additional approximately 8.7 million shares with an exercise price of $2.87 per share.

·Announced the closing of the first tranche of the Innoviva securities purchase agreement, issuing 993,139 common shares and warrants to purchase 993,139 common shares in exchange for gross proceeds of approximately $2.8 million. The Company obtained voting agreements from shareholders representing approximately 55% of its outstanding shares that have agreed to vote in favor of the financing at the special shareholder meeting now scheduled for March 26, 2020. Following approval at the meeting, the second tranche of $22.2 million will be received by Armata.

·In connection with the financing transaction, appointed Sarah Schlesinger, M.D. and Odysseas Kostas, M.D. to its Board of Directors, both of whom also serve on the Board of Innoviva.

·Continued to advance development of its lead program, a Pseudomonas aeruginosa phage product candidate AP-PA02, toward submission of an Investigational New Drug application (IND) seeking regulatory approval to initiate a first-in-human clinical trial this year. GMP production of the product candidate has been completed at the Company’s Marina del Rey facility.

·Announced that the Company has been awarded up to $5 million in a development award grant from the Cystic Fibrosis Foundation to help fund the Pseudomonas aeruginosa phage development.

·Expanded the Board of Directors with the appointment of research and development veteran Todd C. Peterson, Ph.D., and strengthened its clinical team with the appointment of Heather Dale Jones, M.D., as Vice President, Clinical Development.

"During the fourth quarter, we continued to efficiently advance development of our lead phage candidate programs, most notably AP-PA02 for Pseudomonas aeruginosa," said Todd R. Patrick, Chief Executive Officer of Armata. "Pseudomonas aeruginosa is an increasingly multi-drug resistant bacteria that causes severe acute and chronic infections and is particularly problematic for cystic fibrosis patients. This promising therapeutic is just one example of the potent and highly targeted phage candidates that are emerging from our proprietary manufacturing and screening capabilities, and we are eager to initiate formal clinical development with our first-in-human study in 2020."

"The securities purchase agreement that we recently entered into with Innoviva significantly strengthened our financial position and, upon closing of the second and final tranche, will provide us with the resources necessary to achieve significant and potentially value-creating development milestones this year and next. We look forward to a successful year." Mr. Patrick concluded.

Anticipated 2020 Milestones:

·Close the second tranche of the previously announced securities purchase agreement with Innoviva

·File an IND and initiate a clinical trial evaluating the safety and tolerability of AP-PA02 in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa

·Obtain third party, non-dilutive funding to advance its Staphylococcus aureus phage candidate, AP-SA02, into clinical trials

·Continue to screen pathogens against the Company’s proprietary phage library to identify additional high-quality bacteriophage product candidates and expand the pipeline

Fourth Quarter Financial Results

Research and Development. Research and development expenses for the three months ended December 31, 2019 were $1.7 million as compared to $2.0 million for the comparable period in 2018.

General and Administrative. General and administrative expenses for the three months ended December 31, 2019 were $2.1 million as compared to approximately $0.8 million for the comparable period in 2018. The increase was due to expenses resulting from the merger of C3J Therapeutics, Inc. and AmpliPhi Biosciences Corp. (the "Merger").

Loss from Operations. Loss from operations for the three months ended December 31, 2019 was $4.4 million as compared to $2.8 million for the comparable period in 2018.

Full Year 2019 Financial Results

Research and Development. Research and development expenses for the year ended December 31, 2019 were $9.8 million as compared to $8.4 million for the comparable period in 2018. The net increase of $1.4 million was primarily related to a $0.9 million increase in non-cash stock-based compensation expense, a $0.7 million increase in personnel expenses resulting from the Merger, a $0.5 million increase in laboratory supplies, a $0.4 million increase for outside services, a $0.2 million increase of rent and utilities expenses, offset by a $1.3 million of tax rebate from the Australian tax authorities.

General and Administrative. General and administrative expenses for the year ended December 31, 2019 were $9.3 million as compared to $2.5 million in the comparable period in 2018. The increase of $6.8 million was primarily due to a $3.3 million increase in non-cash stock-based compensation expense, a $2.1 million increase in professional fees (legal, audit and investment banking) primarily associated with the Merger, a $0.4 million increase in personnel-related expenses, and $0.5 million increase in insurance costs.

Loss from Operations. Loss from operations for the year ended December 31, 2019 was $19.8 million as compared to $17.7 million for the comparable period in 2018. The increase was due to an increase in non-cash stock-based compensation and additional operating costs in connection with the Merger.

Cash and Equivalents. As of December 31, 2019, Armata held $6.0 million of unrestricted cash and cash equivalents as compared to $9.7 million as of December 31, 2018. Subsequent to the end of the fourth quarter, the Company announced that it had entered into a $25 million private placement securities agreement with Innoviva. The first tranche, in which Armata issued 993,139 common shares and warrants to purchase an additional 993,139 common shares in exchange for gross proceeds of approximately $2.8 million, closed in February.

The audit opinion included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 contains a going concern explanatory paragraph.

As of March 17, 2020, there were approximately 10.9 million shares of common stock outstanding.