Market Newsdesk

Amryt Granted Orphan Drug Designation by the FDA for AP103

DUBLIN, Ireland, and Boston MA, December 23, 2020, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, is pleased to announce today that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation for AP103 for the treatment of Dystrophic Epidermolysis Bullosa (“DEB”).  AP103 is based on Amryt’s gene-therapy platform technology and offers a potential treatment for patients with DEB, a subset of EB.  
The FDA’s Office of Orphan Products Development (“OOPD”) grants orphan drug designation to support the development of medicines for rare diseases, that affect fewer than 200,000 people in the United States. Orphan drug designation may allow Amryt to be eligible for a seven-year period of U.S. Marketing exclusivity upon approval of AP103 and a waiver of the Prescription Drug User Fee Act (“PDUFA”) filing fees, subject to certain conditions.

AP103 is based on a new gene therapy delivery platform, in-licensed by Amryt in March 2018, that utilises a non-viral delivery vector, HPAE (Highly Branched Poly β-Amino Ester), designed to deliver the correct collagen VII gene into skin cells.

Joe Wiley, CEO of Amryt Pharma, commented: “Receiving an orphan drug designation from the FDA for our gene-therapy candidate, AP103, is a significant development for patients suffering from EB and provides additional momentum to our development pipeline.  Unlike other gene therapies that rely on viral vectors, AP103 is based on a novel polymer-based topical delivery platform, which we believe offers potential advantages in the gene-therapy field and has potential to be used in other genetic skin conditions.”

About Amryt

Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.  

Amryt’s commercial business comprises two orphan disease products.

Amryt’s lead development candidate, FILSUVEZ® (Oleogel-S10) is a potential treatment for the cutaneous manifestations of Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.  FILSUVEZ® has been selected as the brand name for the product. Amryt does not have regulatory approval for FILSUVEZ® to treat EB. In September and October 2020, Amryt reported positive results from its pivotal global Phase 3 trial in EB. The product has been granted Rare Pediatric Disease Designation and has also received a Fast Track Designation from the U.S. Food and Drug Administration.

Myalept® / Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. Metreleptin is also approved for lipodystrophy in Japan. Generalised and partial lipodystrophy are rare disorders characterised by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and are associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.

Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia (“HoFH”) in the US, Canada, Columbia, Argentina and Japan (under the trade name Juxtapid®) and in the EU and Brazil (under the trade name Lojuxta®). HoFH is a rare genetic disorder which impairs the body’s ability to remove low density lipoprotein (“LDL”) cholesterol (“bad” cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body from before birth – often ten times more than people without HoFH – and subsequent aggressive and premature cardiovascular disease.

In March 2018, Amryt in-licensed a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders.  For more information on Amryt, including products, please visit www.amrytpharma.com.

This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014.  The person making this notification on behalf of Amryt is Rory Nealon, CFO/COO and Company Secretary.

Forward-Looking Statements

This press release may contain forward-looking statements containing the words “expect”, “anticipate”, “intends”, “plan”, “estimate”, “aim”, “forecast”, “project” and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt’s present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond each of Amryt’s ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt’s ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management.

Contacts

Joe Wiley, CEO, +353 (1) 518 0200, [email protected]

Rory Nealon, CFO/COO, +353 (1) 518 0200, [email protected]

Edward Mansfield, Shore Capital, NOMAD, +44 (0) 207 468 7906, [email protected]

Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, [email protected]

Amber Fennell, Consilium Strategic Communications, +44 (0) 203 709 5700, [email protected]              

VANCOUVER, Dec. 22, 2020 (GLOBE NEWSWIRE) — BetterLife Pharma Inc. (“BetterLife” or the “Company”) CSE: BETR / OTCQB: BETRF / FRA: NPAU) an emerging biotech company, is pleased to announce that Patrick Kroupa and Justin Kirkland, two industry leaders in psychedelic therapeutics, have joined the Company. Mr. Kroupa and Mr. Kirkland will join the senior management team of BetterLife as Chief Psychedelics Officer and Chief Psychedelics Scientist, respectively. 

“BetterLife welcomes Patrick and Justin to our senior leadership team. Their experience in psychedelics in the fields of health and wellness will be valuable assets for Betterlife, helping solidify our place as leaders in this fast-growing industry” said Dr. Ahmad Doroudian, CEO of BetterLife.

“Psychedelic medicine offers the single greatest opportunity to positively impact mental health and well-being worldwide,” said Patrick Kroupa, “and BetterLife is uniquely positioned to make that happen. When you’re involved with a promising company that is aligned with your core beliefs and aspirations for humanity … that’s when good things happen.”

Justin Kirkland remarked “BetterLife believes that the mental health space is ready for transformation, and that innovation and investment will lead to a major disruption in how mental health is treated. I am extremely excited to join the BetterLife team and look forward to the opportunity to continue to educate and advance the global conversation on the promise of psychedelics.”

Patrick Kroupa joining as Chief Psychedelics Officer

Patrick Kroupa, president of Transcend Biodynamics LLC, will be joining the management team at BetterLife as Chief Psychedelic Officer. Mr. Kroupa has over 20 years experience working with a wide spectrum of psychedelic compounds to address mental health and drug dependence disorders. Patrick brings a tremendous breadth of experience utilizing cutting-edge molecular advancements to enhance the positive outcomes of unaddressed patient populations.

Justin Kirkland joining as Chief Psychedelics Scientist

Justin Kirkland is a chemist with experience in natural products, small molecules, peptide synthesis, analytical chemistry, and drug formulations for improved bioavailability. Mr. Kirkland has earned a BS in Agronomy and an MS in Biology, and attended medical school in Belize at the Central American Health Sciences University. He was recently awarded a U.S. patent for the improved synthesis of the ergoline, 2-bromo-LSD.  

About BetterLife Pharma Inc.

BetterLife Pharma Inc. is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drug delivery platform technologies. BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV), and/or to directly inhibit tumours to treat specific types of cancer.

For further information please visit www.abetterlifepharma.com.

About Transcend Biodynamics LLC

Transcend is a research focused biotechnology company creating and clinically validating an evolving IP portfolio of novel molecules and drug delivery mechanisms for clinical trials and commercialization. Transcend is focused on developing second generation psychedelic compounds, peptides, pro-drugs, and nutraceuticals to address unmet needs within mental health, wellness and anti-aging industries.

Contact Information:

Ahmad Doroudian, Chief Executive Officer
Email: [email protected]
Phone: 604-221-0595

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

COPENHAGEN, Denmark, Dec. 23, 2020 (GLOBE NEWSWIRE) — Evaxion Biotech, a clinical-stage biotechnology company developing AI-driven immunotherapies, announces today the dosing of the first patient in a Phase I/IIa clinical trial of its adjuvant immunotherapy EVX-02, in combination with checkpoint inhibitors in patients with advanced melanoma.

The open label, multi-center study will assess the safety, tolerability, pharmacodynamic response and efficacy of EVX-02 with checkpoint inhibitors in patients who have had a complete resection of Stage IIIB/IIIC/IIID or Stage IV melanoma and are at high risk of recurrence. The study is planned to take place at five clinical centers in Australia, targeting recruitment of a total of 46 patients. Early data read out from this Phase I/IIa is expected in H1 2021.

Lars Wegner, CEO of Evaxion Biotech, said: “We are very excited to start this Phase I/IIa study with EVX-02 further demonstrating the potential of Evaxion’s integrated PIONEER™ artificial intelligence platform to accelerate the discovery and development of a new generation of patient-specific cancer immunotherapies. We believe that the computational power behind the discovery of this compound shows that EVX-02 may have the potential to make a difference in malignant melanoma, which accounts for 1% of skin tumors and causes of 60% mortality due to skin cancers.”

EVX-02 is a personalized cancer immunotherapy designed based on the unique tumor genetic fingerprint of each individual patient and consists of patient-specific cancer neoepitopes incorporated into a DNA plasmid. The mutanome immunotherapy is devised by PIONEER, Evaxion’s computational platform which has been shown to be capable of identifying cancer neoepitopes from matched tumor-normal DNA sequencing data and ranking of the neoepitopes according to their predicted capability in stimulating a T-cell response.

The aim of EVX-02 is to promote T cell priming and expansion of effector cells for direct tumor killing. When administered, EVX-02 is taken up by antigen presenting cells and the neoepitopes are then expressed and displayed on the cell surface, thus triggering a neoepitope-specific immune response targeting the cancer cells.

About Evaxion

Evaxion Biotech A/S is a clinical stage AI-immunology™ platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer and infectious diseases. Based on its proprietary and scalable AI-immunology core technology, Evaxion is developing a broad pipeline of novel product candidates which currently includes three patient-specific cancer immunotherapies, two of which are in Phase I/IIa clinical development. In addition, Evaxion is advancing a portfolio of vaccines to prevent bacterial and viral infections with one program currently in preclinical development against S. aureus (including Methicillin-resistant S. aureus) induced skin and soft tissue infections.

For more information
Evaxion Biotech				LifeSci Advisors LLC
Glenn S. Vraniak				Mary-Ann Chang
Chief Financial Officer				Managing Director
[email protected]				[email protected]
t: +1 (513) 476-2669				+44 7483 284 853

December 23, 2020

SBM Offshore reports a contractual lease extension for FPSO Espirito Santo in Brazil and expects a potential increase in the lease duration for FPSOs in Guyana. SBM Offshore will present an updated pro-forma backlog, taking into account the most recent developments, along with its Full Year 2020 Earnings.

SBM Offshore signed an agreement with its client Shell for a five years’ extension for the lease and operate contracts of the FPSO Espirito Santo located in Brazil. The end of the contractual lease and operate period was extended from December 2023 to December 2028. SBM Offshore is the majority owner of the lease and operating companies related to FPSO Espirito Santo with 51% equity ownership, together with MISC Berhad with 49% equity ownership.

ExxonMobil affiliate Esso Exploration and Production Guyana Limited, has also initiated discussions with SBM Offshore about potentially extending the lease and operate durations for FPSOs in Guyana.

Corporate
Profile

The Company’s main activities are the design, supply, installation, operation and the life extension of floating production solutions for the offshore energy industry over the full lifecycle. The Company is market leading in leased floating production systems, with multiple units currently in operation.

As of December 31, 2019, the Company employs approximately 4,450 people worldwide spread over offices in our key markets, operational shore bases and the offshore fleet of vessels.

SBM Offshore N.V. is a listed holding company headquartered in Amsterdam, the Netherlands. It holds direct and indirect interests in other companies.

Where references are made to SBM Offshore N.V. and /or its subsidiaries in general, or where no useful purpose is served by identifying the particular company or companies “SBM Offshore” or “the Company” are sometimes used for convenience.

For further information, please visit our website at www.sbmoffshore.com.

The Management Board
Amsterdam, the Netherlands, December 23, 2020

Financial Calendar	Date	Year
Full Year 2020 Earnings – Press Release	February 11	2021
Annual General Meeting of Shareholders	April 7	2021
Trading Update 1Q 2021 – Press Release	May 12	2021
Half Year 2021 Earnings – Press Release	August 5	2021
Trading Update 3Q 2021 – Press Release	November 11	2021

For further information, please contact:

Investor Relations

Bert-Jaap Dijkstra
Group Treasurer and IR

Telephone:	+31 (0) 20 236 3222
Mobile:	+31 (0) 6 21 14 10 17
E-mail:	[email protected]
Website:	www.sbmoffshore.com

Media Relations

Vincent Kempkes
Group Communications Director

Telephone:	+31 (0) 20 236 3170
Mobile:	+31 (0) 6 25 68 71 67
E-mail:	[email protected]
Website:	www.sbmoffshore.com

Disclaimer

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. Some of the statements contained in this release that are not historical facts are statements of future expectations and other forward-looking statements based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those in such statements. Such forward-looking statements are subject to various risks and uncertainties, which may cause actual results and performance of the Company’s business to differ materially and adversely from the forward-looking statements. Certain such forward-looking statements can be identified by the use of forward-looking terminology such as “believes”, “may”, “will”, “should”, “would be”, “expects” or “anticipates” or similar expressions, or the negative thereof, or other variations thereof, or comparable terminology, or by discussions of strategy, plans, or intentions. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this release as anticipated, believed, or expected. SBM Offshore NV does not intend, and does not assume any obligation, to update any industry information or forward-looking statements set forth in this release to reflect subsequent events or circumstances. Nothing in this press release shall be deemed an offer to sell, or a solicitation of an offer to buy, any securities.

Attachment

• Update on Lease and Operate backlog

New York, Dec. 23, 2020 (GLOBE NEWSWIRE) — Viveon Health Acquisition Corp. (the “Company” or “Viveon Health”) announced today that it priced its initial public offering of 17,500,000 units at $10.00 per unit. The units are expected to trade on the NYSE American (“NYSE American”) under the ticker symbol “VHAQU” beginning December 23, 2020. Each unit consists of one share of common stock, one redeemable warrant with each warrant entitling the holder thereof to purchase one half-share of common stock at a price of $11.50 per full share, and one right to receive one-twentieth of one share of common stock upon the consummation of an initial business combination. Once the securities comprising the units begin separate trading, the shares of common stock, redeemable warrants, and rights are expected to be listed on the NYSE American under the symbols “VHAQ,” “VHAQW,” and “VHAQR,” respectively.

The offering is expected to close on December 28, 2020, subject to customary closing conditions. 

Chardan acted as sole book running manager in the offering. The underwriters have been granted a 45-day option to purchase up to an additional 2,625,000 units offered by the Company to cover over-allotments, if any, at the initial public offering price.

A registration statement relating to these securities was declared effective by the Securities and Exchange
Commission on December 22, 2020. The offering is being made only by means of a prospectus, copies of which may be obtained by contacting Chardan, 17 State Street, 21st floor, New York, New York 10004 or by calling (646) 465-9001. Copies of the registration statement can be accessed through the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or 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 jurisdiction.

About Viveon Health Acquisition Corp.

Viveon Health Acquisition Corp. is a blank check company, also commonly referred to as a special purpose acquisition company, or SPAC, formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. It is the Company’s intention to pursue prospective targets that are focused on the regenerative medicine, spine and orthopedic industry in the United States and other developed countries.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements,” including with respect to the IPO and search for an initial business combination. Forward looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based, except as required by law.

Contact

Rom Papadopoulos
CFO, Viveon Health Acquisition Corp.
404-861-5393
[email protected]