PCI Biotech to present at RNA Therapeutics Virtual Conference

On January 22, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that it will present at the 12th Annual RNA Therapeutics Virtual Conference, a UK based online event taking place February 10-11, 2021 (Press release, PCI Biotech, JAN 22, 2021, View Source [SID1234585156]). The 2021 conference is set to explore the latest developments in RNA delivery agents and RNA-based therapeutics with the latest case studies on advanced mRNA technologies, oligonucleotide delivery, therapeutic applications and future trends and innovations. PCI Biotech is also a sponsor of the event.

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On Wednesday, February 10, 2021 at 13:10pm (CET), Dr. Anders Høgset, CSO, will present an overview of PCI Biotech’s proprietary platform technology, focusing on the delivery of RNA molecules, including the most recent data on the use of the fimaNAc delivery technology in the exciting field of RNA based therapies. The presentation slides will be made available through a separate press release around the timing of the presentation and the full presentation will be made available on PCI Biotech’s website (www.pcibiotech.com) under "Scientific publications & presentations" after the event.

Herantis Pharma Strengthens Management Team with New CMO

On January 22, 2021 Herantis Pharma Plc ("Herantis"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative biologic and gene therapies, reported the full-time appointment of Magnus Sjögren, MD, PhD as Chief Medical Officer (Press release, Herantis Pharma, JAN 22, 2021, View Source,c3272253 [SID1234577478]). Dr. Sjögren will assume the role of Chief Medical Officer effective as of 1st of May 2021.

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"We are delighted to add Magnus Sjögren to our management team. He brings an impressive skill set strongly complementary to our focus therapeutic areas at Herantis and a distinguished CV, making him our top choice for CMO. Dr. Sjögren joins at a key time for the company as we continue to advance and accelerate our neurological and lymphatic programs," said Craig Cook, CEO of Herantis Pharma. "This is such an exciting time for the company and his very successful track record in clinical research and translational medicine in neuroscience and other diseases will be a real asset for Herantis Pharma."

Dr Sjogren is a neuroscience expert with a focus on neurodegenerative diseases, and in addition has experience in other areas relevant to Herantis’ programs including oncology and inflammation. He has held several senior executive and scientific positions at major pharmaceutical and biotechnology companies, including Chief Medical Officer at DiaGenic, Vice President Global Exploratory Development at UCB Pharma, Global Head of Translational Medicine in Schering-Plough and Senior Clinical Research Director at AstraZeneca. He is highly knowledgeable on Herantis’ compounds, having consulted to the company for several years in our key programs. He is an Associate Professor at Gothenburg University, a Research Lecturer at Copenhagen University, a trained psychiatrist, and the author of more than 135 scientific publications. He received his Doctor of Medicine from Linköping University in Sweden, his PhD in clinical psychiatry, and his postdoc in clinical neuroscience from the University of Gothenburg, Sweden.

"Herantis represents truly novel clinical stage research in disease modifying therapies, using novel biological and gene therapy approaches. I am thrilled to be given the opportunity to oversee the clinical development of Herantis’ compelling pipeline programs in neurodegenerative and lymphatic diseases and very much look forward to working with the whole Herantis team as we advance our portfolio to provide innovative treatments that can make a real difference for patients," commented Dr. Sjögren, CMO of Herantis Pharma.

Zealand Pharma announces update to 2020 financial guidance

On January 22, 2021 Zealand Pharma A/S ("Zealand") (Nasdaq: ZEAL), (CVR-no. 20 04 50 78), a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, reported an update to the financial guidance for 2020 (based on preliminary and unaudited numbers) (Press release, Zealand Pharmaceuticals, JAN 22, 2021, View Source [SID1234576935]).

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Zealand expects increased general operating expense guidance by approximately 5-10% (total operating expenses of DKK 1,050 million to 1,100 million).

Zealand will announce the detailed and audited financial results, and expects to provide outlook for 2021, in the 2020 Annual Report to be released on 11 March 2021.

Dose-escalation study initiated

On January 22, 2021 Hamlet Pharma reported the inclusion of patients in the dose escalation study of bladder cancer in Prague (Press release, HAMLET Pharma, JAN 22, 2021, View Source;utm_medium=rss&utm_campaign=dose-escalation-study-initiated [SID1234574600]). The study will examine the efficacy and safety of our drug candidate Alpha1H at higher doses than used in the previously communicated clinical study.

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In preparation for Phase III trials, it is essential to optimize the treatment dose for patient safety and efficacy. As previously communicated, Alpha1H has shown clear efficacy as a standalone therapeutic agent in bladder cancer patients and is under continuous active development. Hamlet Pharma now initiates the dose-escalation program involving five times and ten times higher doses than those used in the previous part of the trial. The clinic in Prague has recruited the first patients into the study and several more patients have been identified as potential candidates for the dose-escalation study as well as for the combination part, which will be conducted in parallel. The team working with the clinical study is experienced and highly motivated to continue the investigations of Alpha1H, in order to define its potential new treatment of bladder cancer.

The Food and Drug Administration has declared bladder cancer a great unmet medical need, as very few new treatments are available for this patient group. Hamlet Pharma is committed to improving the treatment options, using Alpha1H alone and/or in combination with chemotherapeutic drugs. We feel confident that the recruitment of patients now will proceed, despite the COVID-19 pandemic. The staff is taking all necessary precautions for a safe recruitment and treatment of patients during the study.

"Continuing the clinical program and reaching patients in need of new therapies is our highest priority", says Catharina Svanborg, Chairman and Founder of Hamlet Pharma.

"Extensive clinical trial experience in the Hamlet Pharma team explains the efficient progression of the clinical trial program", says Mats Persson, CEO of Hamlet Pharma.

Pascal Amends Warrant Terms of Non-brokered Private Placement

On January 22, 2021 Pascal Biosciences, Inc. ("Pascal" or the "Company") (TSXV: PAS) (OTC:BIMUF), a biotechnology company that specializes in cancer drug discovery and development, reported that it has amended the terms of the non-brokered private placement (the "Private Placement") previously announced on November 2, 2020, and amended on January 19, 2021 (Press release, Pascal Biosciences, JAN 22, 2021, View Source [SID1234574297]) . The new terms provide for issuance of up to 7,500,000 Units at a price of $0.10 per unit (each a "Unit") for gross proceeds of up to $750,000.00. Each Unit will consist of one common share and one common share purchase warrant (each a "Warrant"). Each Warrant will entitle the holder to purchase one additional common share of the Company at a price of $0.15 for a period of twenty-four months from the date of closing, subject to an acceleration clause which the Company may exercise once the Units are free of resale restrictions and if the Company’s shares are trading at or above a volume weighted average price of $0.40 for 10 consecutive trading days. The Warrants will expire upon 30 days from the date the Company provides notice in writing to the Warrant holders via a news release. Proceeds of the Private Placement may be subject to a 7% finder’s fees.

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Certain directors and officers of the Company intend to acquire the Units under the Private Placement. Any such participation would be considered to be a "related party transaction" as defined under Multilateral Instrument 61 -101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The transaction will be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 as neither the fair market value of any shares issued to, or the consideration paid by such persons, will exceed 25% of the Company’s market capitalization.

The proceeds from the sale of Units will be added to working capital in furtherance of the Company’s business. The securities to be issued under the placement will be subject to a four-month hold period and the Private Placement is subject to the acceptance of the TSX Venture Exchange.