Vascular Biogenics Ltd. Announces Proposed Public Offering of Ordinary Shares and Pre-Funded Warrants

On April 8, 2021 Vascular Biogenics Ltd. ("VBL Therapeutics" or the "Company") (NASDAQ: VBLT), reported that it intends to offer and sell ordinary shares and, to certain investors in lieu thereof, pre-funded warrants to purchase ordinary shares in an underwritten public offering (Press release, VBL Therapeutics, APR 8, 2021, View Source [SID1234577739]). As part of this proposed offering, VBL Therapeutics expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the aggregate number of ordinary shares plus the ordinary shares underlying any pre-funded warrants that are sold in the offering, at the public offering price less the underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the securities in the offering are to be sold by VBL Therapeutics.

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VBL Therapeutics intends to use the net proceeds from the offering for working capital and other general corporate purposes.

Guggenheim Securities, LLC is acting as bookrunning manager for the proposed offering. Oppenheimer & Co. Inc. is also acting as a joint bookrunner.

The securities described may be offered by VBL Therapeutics pursuant to a shelf registration statement on Form F-3 (No. 333-251821), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). The securities may be offered only by means of a prospectus. A preliminary prospectus supplement relating to and describing the terms of the offering and a final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, by telephone at (212) 518-9544, or by email 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 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.

Extension of lock-up period in Gilead-Galapagos collaboration agreement

On April 8, 2021 Galapagos (Euronext & Nasdaq; GLPG) reported that Gilead and Galapagos signed an amendment to the share subscription agreement closed in 2019, extending the full lock-up of Gilead’s current shareholding in Galapagos to 2024 (Press release, Galapagos, APR 8, 2021, View Source [SID1234577774]).

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In August 2019, Gilead and Galapagos entered into a 10-year global transformative research and development collaboration, giving Gilead access to Galapagos’ innovative portfolio of compounds and drug discovery platform. As part of the transaction, Gilead made a $1.1B equity investment, increasing Gilead’s stake in Galapagos from approximately 12.3% to 22% of the issued and outstanding shares in Galapagos. In addition, Galapagos issued two warrants, allowing Gilead to further increase its ownership of Galapagos to up to 29.9% of the company’s issued and outstanding shares. Through the exercise of a first warrant, Gilead’s shareholding further increased to 25.1%. The most recent transparency notice received by Galapagos from Gilead indicates a 25.5% ownership position.

The amendment announced today stipulates that the full lock-up is extended: Gilead is now committed to a full lock-up of 5 years, retaining all of its 16,707,477 shares (currently 25.5%) until 22 August 2024. Previously, there was a full lock-up of 2 years, followed by a 3-year period during which the company would have held a minimum of 20% of outstanding shares. The lock-up restrictions are subject to certain exceptions as provided in the share subscription agreement.

Commenting on the amendment, Gilead CFO Andrew Dickinson said, "We remain strongly committed to our long-term collaboration. We continue to see significant value in Galapagos’ unique target discovery approach, and we support Galapagos, as the company works to deliver on this potential."

Bart Filius, COO and President of Galapagos, added, "The amendment announced today highlights Gilead’s commitment and support for our 10-year collaboration. We greatly benefit from Gilead’s scientific, developmental, and commercial know-how, and we look forward to continuing to work together as we push novel modes of action drugs forward, with the shared goal to help patients worldwide."

About the Gilead-Galapagos collaborations

In August 2019, Galapagos and Gilead entered into a 10-year global transformative research and development collaboration. Through this agreement, Gilead gained access to an innovative portfolio of compounds and a proven drug discovery platform. Gilead received an exclusive product license and option rights to develop and commercialize all current and future programs in all countries outside Europe.

Gilead and Galapagos also have a collaboration for the development and commercialization of filgotinib, originally signed in 2015, with a new agreement announced in December 2020. Through a phased transition including the transfer of filgotinib’s marketing authorization to Galapagos, the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021. Under the new operating model, Gilead retains commercial rights and remains marketing authorization holder for filgotinib outside of Europe, including in Japan.

Gilead and Galapagos continue to investigate the potential for filgotinib to support patients living with Inflammatory Bowel Disease (IBD). Gilead will retain operational responsibility for the current trials in Crohn’s disease while Galapagos will assume operational responsibility for ongoing trials in ulcerative colitis (UC). Filgotinib in UC has been filed in Europe and a global Phase 3 program is ongoing in Crohn’s Disease. More information about clinical trials can be accessed at www.clinicaltrials.gov.

Luoqi Biotechnology received tens of millions of yuan in Series A+ financing!

On April 8, 2021 Luoqi Biotechnology reported the completion of Series A+ financing of tens of millions of yuan (Press release, Novamab, APR 8, 2021, View Source [SID1234637753]). This round of financing was led by Hongyun Fund, a partnership between Huatai Zijin and Alibaba Health, and was followed by Daoyuan Capital. , Haoyue Capital continues to serve as the exclusive financial advisor.

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This round of financing will continue to be used for IND filing and clinical development of two inhaled nanobody asthma treatments, as well as preclinical development of other respiratory and autoimmune disease pipelines. In addition, Luoqi is also about to build a 500L GMP Pichia pastoris production plant that can meet clinical phase II sample preparation. In the next 1-2 years, three products will enter the clinical research stage.

Dr. Wan Yakun, founder and general manager of Luoqi Biotech, said "Luoqi Biotechnology is a nanobody biopharmaceutical R&D company focusing on the entire industry chain. It is committed to the industrialization of innovative biopharmaceutical achievements and the research and development of targeted new drugs. It has established a complete nanobody new drug development system, integrating early screening and research and development of nanobodies. The late-stage process development of candidate drugs is effectively combined to form a systematic and complete R&D system, which is at the leading level in the industry domestically and even internationally. Thank you very much to investors for their high recognition of our team and projects! The success of this round of financing provides a strong guarantee for the rapid advancement of the company’s new drug projects. We will continue to delve into the field of respiratory and autoimmune diseases and accelerate the development of corresponding products."

Ms. Cao Qun, Chairman of Huatai Zijin said the founding team of Luoqi Biotech has rich R&D experience and international vision in the field of nanobodies. Based on the in-depth understanding of the advantages of nanobody drugs, the team develops innovative drug delivery methods for large market space indications, improves the accessibility and medication compliance of antibody drugs, and benefits patients at home and abroad. We are firmly optimistic about the future development of the nanobody industry and the company’s unique potential to become a domestic leader in this field. Huatai Zijin will adhere to the investment philosophy of "grow together with entrepreneurs" and rely on its own resources to continue to support the company’s development.

Mr. Zhang Dafeng, Chairman of Daoyuan Capital, said Luoqi Biotech has a leading position in the field of domestic nanobodies. It has systematically established the core competitive Pichia pastoris CMC platform and nanobody rapid screening platform. In order to give full play to the compliance of nanobody delivery methods, the production of low Characteristics such as cost and ease of engineering transformation have laid a good foundation. We are full of expectations for the innovative drug projects currently developed by Luoqi Biotech and hope to be approved for marketing as soon as possible to meet the clinical needs of patients and reduce the cost burden of patients.

Biofrontera announces preliminary revenue for Q1 2021

On April 8, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary, unaudited revenue for the first quarter 2021 (Press release, Biofrontera, APR 8, 2021, View Source [SID1234577724]).

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The Company’s preliminary unaudited revenue for the period January 1 to March 31, 2021 amounts to approximately EUR 5.6 million compared to EUR 6.5 million in the same period last year, a decline of 14%.

Preliminary revenues from product sales in the US were around EUR 3.9 million, compared to EUR 4.2 million in Q1 2020, which corresponds to a decline of 6%. In Germany, revenues from product sales amounted to approximately EUR 1.4 million, compared to EUR 1.3 million in Q1 2020, a gain of 7%. In the rest of Europe, the Company generated product sales of around EUR 0.3 million, compared to EUR 0.8 million in the same period last year, a decline of 69%.

While sales in Germany remained relatively stable over the quarter compared to the previous year, revenues in the USA for the months of January and February 2021 were well below those of the previous year due to the pandemic. Starting in the second half of March last year, our sales were significantly impacted by the pandemic, and this is where we already saw a significant upturn this year in the USA compared to last year. In March 2021, our sales in the USA increased by around 46% year-on-year, indicating a significant recovery of the situation in the USA, presumably also due to the high vaccination rates.

Cardiff Oncology to Host Key Opinion Leader Webinar on Onvansertib for the Treatment of KRAS-Mutated Metastatic Colorectal Cancer

On April 8, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, reported that it will host a key opinion leader (KOL) webinar on onvansertib for the treatment of KRAS-mutated metastatic colorectal cancer on Monday, April 12, 2021 at 11 a.m. Eastern Time (Press release, Cardiff Oncology, APR 8, 2021, View Source [SID1234577725]).

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The webinar will feature presentations by KOLs Daniel H. Ahn, D.O., M.S. (Mayo Clinic Arizona), and Manish R. Sharma, M.D. (START Midwest), who will discuss the current treatment landscape and unmet medical need in KRAS-mutated metastatic colorectal cancer (mCRC), as well as the ongoing Phase 1b/2 clinical trial and observations from the Expanded Access Program evaluating onvansertib in combination with FOLFIRI/Avastin in KRAS-mutated mCRC.
During the webinar, Cardiff Oncology’s CEO, Mark Erlander, Ph.D., will give a corporate update and outlook for the year. Dr. Erlander and Drs. Ahn and Sharma will be available to answer questions following the conclusion of the formal presentations.

About the KOLs
Daniel H. Ahn, D.O, M.S. is a GI Medical Oncologist and Assistant Professor in the Division of Hematology/Medical Oncology at the Mayo Clinic. He conducts clinical and translational research focused on developing anti-cancer agents for patients with gastrointestinal cancers. Dr. Ahn collaborates extensively with various scientists and industry partners to design and execute innovative clinical trials, including many first-in-human studies. He is the Lead for the GI Oncology Translational Research Disease Working Group at Mayo Clinic Arizona. He also serves on the Board of Directors for the Mayo Clinic-supported cancer research consortium Academic and Community Cancer Research United (ACCRU) and is an Alliance for Clinical Trials in Oncology GI Committee member, a National Cancer Institute (NCI)-supported cooperative research group.
Dr. Ahn’s research includes a large focus on the incorporation of agents that target the multiple facets of cancer, including genetic and epigenetic drivers, as well as the feeding microenvironment and the immune milieu. His research has also led to the launch of a number of clinical trials, including recent studies investigating novel agents targeting DNA repair mechanisms, sequencing treatment strategies in colorectal cancer as well as various targeted therapies in advanced colorectal cancer.

Manish R. Sharma, M.D. is the Associate Director of Clinical Research at START Midwest and is a medical oncologist in Grand Rapids, Michigan. He graduated with honors from the University of Michigan Medical School in 2004. He completed his residency in Internal Medicine at the University of California – San Francisco, where he also served as chief resident. He completed a combined fellowship training in Hematology/Oncology and Clinical Pharmacology & Pharmacogenomics at the University of Chicago.
He subsequently spent six years on the faculty as an Assistant Professor of Medicine at the University of Chicago, where he had a Career Development Award from the National Institutes of Health and was very involved in the teaching and mentorship of trainees. Dr. Sharma developed expertise in oncology drug development, gastrointestinal cancers, clinical pharmacology, pharmacogenomics, and pharmacometrics. He is board certified in Medical Oncology and Clinical Pharmacology.
Dr. Sharma joined START Midwest and Cancer & Hematology Centers of Western Michigan in 2018. Throughout his clinical oncology practice, Dr. Sharma has specialized in the treatment of gastrointestinal cancers. His clinical research interests include early phase drug development and clinical pharmacology trials for patients with advanced solid tumors. He has been the principal investigator on more than 25 phase I clinical trials involving immunotherapies, targeted therapies, chemotherapy, antibody-drug conjugates, drug-drug interactions, and food effect. He has co-authored more than 20 peer-reviewed papers related to oncology drug development and has served as a reviewer for many oncology and clinical pharmacology journals.