Market Newsdesk

 PRESS RELEASE

Immunocore presents phase 3 data comparing tebentafusp with investigator’s choice in the clinical trial plenary session at the

 American Association for Cancer Research 2021 Annual Meeting

Tebentafusp is the first investigational therapy to improve Overall Survival (OS) in patients with metastatic uveal melanoma

First positive Phase 3 clinical trial for any T cell receptor therapeutic and first for any bispecific in a solid tumor  

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 12 April 2021) Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, presented data from a phase 3 randomized trial comparing tebentafusp (IMCgp100) with investigator’s choice in first-line metastatic uveal melanoma (mUM) in the clinical trial plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2021.

Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM.  The OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Treatment-related adverse events were manageable and consistent with the proposed mechanism.

“This is the first investigational therapy to demonstrate improved OS in metastatic uveal melanoma,” said Bahija Jallal, Chief Executive Officer of Immunocore. “We believe these data demonstrate that tebentafusp has the potential to provide a meaningful difference in the treatment of metastatic uveal melanoma, a highly aggressive disease for which there is no effective standard of care.”

In a separate oral presentation on Monday April 12, Marcus O. Butler shared an analysis of previously treated uveal melanoma patients who had prolonged survival.

Two posters from the phase 2 IMCgp100-102 study are also available for on-demand viewing at the AACR website.  These analyses investigated the proposed mechanism of action (MoA), including inducing an increase in cytokines and T cell trafficking into the tumor.

Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Immunocore will be working with the FDA to complete submission of a BLA for tebentafusp in the third quarter of 2021.

The Company will host a conference call for industry, health and investment professionals on Tuesday, April 13^th at 7:30 am ET to discuss the phase 3 IMCgp100-202 trial. The webcast can be accessed directly through this link. A replay of the webcast will be made available shortly after the conclusion of the call and archived on the Investor Relations section of the Company’s website for at least 90 days.

PLENARY AND ORAL PRESENTATIONS

Title:
Phase 3 randomized trial comparing tebentafusp with investigator’s choice in first line metastatic uveal melanoma

• Date and Time: Plenary session presentation (CT002), Saturday April 10^th at 11:30am – 1:30pm ET
• Presenter: Jessica C. Hassel (PI), University Hospital Heidelberg, Heidelberg, Germany
• Abstract #:
  
  5342
  
• Session Title: Phase III Clinical Trials

Title:
Kinetics of radiographic response for tebentafusp (tebe) in previously treated metastatic uveal melanoma (mUM) patients (pts) achieving prolonged survival

• Date and Time: Oral presentation (CT038), Monday April 12^th at 1:30pm – 3:15pm ET
• Presenter: Marcus O. Butler (PI), Princess Margaret Cancer Centre, Toronto, ON, Canada
• Abstract #:
  
  5338
  
• Session Title: Disease-Oriented Innovative Clinical Research and Trials

POSTER PRESENTATIONS

Title: Tebentafusp induces transient systemic inflammation and modifies the micro-environment to sensitize uveal melanoma tumors to cytotoxic CD8 cells

• Poster #: 517
• Presenter: Marcus O. Butler (PI)

Title: Uveal melanoma study patients with low CD163:CD3 ratio in tumor biopsy and low serum IL-6 showed enhanced tumor shrinkage (TS) and overall survival (OS) on tebentafusp

• Poster #: 1673
• Presenter: Jessica Hassel (PI)

##

About Immunocore

Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore’s most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

About ImmTAC® Molecules

Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumours. 

About Tebentafusp

Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

About Uveal Melanoma

Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp, the design, progress, timing, scope and results of the Company’s clinical trials including IMCgp100-202, the anticipated timing of disclosure of results of clinical trials, plans for initiating future clinical trials and extension studies, the progress of the Company’s development programs including tebentafusp, the potential benefit of Breakthrough Therapy Designation or Orphan Drug Designation for tebentafusp, the timing of regulatory filings including estimates regarding the planned submission a BLA for tebentafusp, the likelihood of obtaining regulatory approval of any of the Company’s product candidates including tebentafusp, and the regulatory approval path for tebentafusp. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company’s control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.

CONTACT: 
Immunocore
Debra Nielsen, Head of Communications
T: +1 (610) 368-8602
E: [email protected]
Follow on Twitter: @Immunocore

Consilium Strategic Communications (corporate and financial)

Mary-Jane Elliott/ Chris Welsh/ Sukaina Virji/Jessica Hodgson
T: +44 (0)203 709 5700
E: [email protected]

Investor Relations  
Clayton Robertson, Head of Investor Relations
T: +1 215-384-4781
E: [email protected]

PHILADELPHIA, PA, April 12, 2021 (GLOBE NEWSWIRE) — FTAC Athena Acquisition Corp. (NASDAQ:FTAAU) (the “Company”), a blank-check company formed for the purpose of acquiring or merging with one or more technology and financial services technology companies, today announced that the holders of the Company’s units may elect to separately trade the Class A ordinary shares and warrants underlying the units commencing on April 16, 2021. Those units not separated will continue to trade on the NASDAQ Capital Market under the symbol “FTAAU” and the Class A ordinary shares and warrants are expected to trade under the symbols “FTAA” and “FTAAW”, respectively. No fractional warrants will be issued upon separation of the units and only whole warrants will trade.

Cantor Fitzgerald & Co. served as the sole book-running manager for the offering. 

A registration statement relating to the units and the underlying securities was declared effective by the Securities and Exchange Commission on February 22, 2021. This press release shall not constitute an offer to sell or the 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.

The offering is being made only by means of a prospectus, copies of which may be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 5th Floor, New York, New York 10022, email: [email protected]. Copies of the registration statement can be accessed for free through the SEC’s website at www.sec.gov.

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s registration statement and prospectus for the offering filed with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law.

Contact Information:

Amanda Abrams
[email protected]
(215) 701-9693

SANTA PAULA, Calif., April 12, 2021 (GLOBE NEWSWIRE) — Calavo Growers, Inc. (“Calavo”) (“Company”) (Nasdaq-GS: CVGW), a global leader in the avocado and value-added fresh food industries, today reminded shareholders that due to continued public health concerns related to the spread of COVID-19, the Company will provide its shareholders with the capability to attend its 2021 annual shareholder meeting virtually. The meeting will consist only of the formal business portion and the Company is offering the virtual alternative as a way for shareholders to have essentially the same meeting experience without attending in person.

The annual meeting will be held at 1:00 pm Pacific Time on April 21, 2021. Holders of record at the close of business on February 22, 2021 will be entitled to participate, submit questions and vote at the annual meeting by following the instructions available on the virtual meeting website at www.virtualshareholdermeeting.com/CVGW2021 and using the 16-digit control number included in their proxy materials.

Non-shareholders may attend the annual meeting as a guest but will not have the option to vote any shares or ask questions during the virtual meeting.

Cumulative Voting

Note that cumulative voting for directors will not be allowed via the live webcast. Shareholders who wish to vote cumulatively for directors should provide proxy instructions before the Annual Meeting at www.proxyvote.com. Shareholders will be able to vote cumulatively for directors in person at the Annual Meeting, but there will be no difference in the tallying of cumulative votes for directors provided through instructing a proxy in advance at www.proxyvote.com compared to voting in person at the Annual Meeting. Shareholders need not attend the Annual Meeting in person simply to vote cumulatively for directors.

Whether or not a shareholder plans to access the live call or webcast of the Annual Meeting, the Company urges all shareholders to vote and submit their proxies in advance of the Annual Meeting using one of the methods described in its proxy materials.

Shareholders are encouraged to read the Company’s proxy statement carefully. All information included in the proxy statement remains unchanged except with respect to the matters set forth herein.

About Calavo Growers, Inc.

Calavo Growers, Inc. is a global avocado-industry leader and provider of value-added fresh food serving retail grocery, foodservice, club stores, mass merchandisers, food distributors and wholesalers worldwide. The Company’s Fresh segment procures and markets fresh avocados and select other fresh produce, including tomatoes and papayas. The Renaissance Food Group (RFG) segment creates, markets and distributes a portfolio of healthy, fresh foods, including fresh-cut fruit, fresh-cut vegetables and prepared foods. The Foods segment manufactures and distributes guacamole and salsa. Founded in 1924, Calavo’s fresh food products are sold under the respected Calavo brand name as well as Garden Highway, Chef Essentials and several private label and store brands.

Contact: Financial Profiles, Inc.
Lisa Mueller, Senior Vice President
(310) 622-8231
[email protected]

This communication may be deemed to be solicitation material in respect of the 2021 annual meeting of shareholders (the “Annual Meeting”) of Calavo Growers, Inc., a California corporation (the “Company”). On March 1, 2021, the Company filed a definitive proxy statement with the Securities and Exchange Commission (the “Commission”) in connection with the Annual Meeting. SHAREHOLDERS ARE URGED TO READ CAREFULLY AND IN THEIR ENTIRETY THE PROXY STATEMENT AND ANY OTHER SOLICITING MATERIALS THAT ARE FILED WITH THE COMMISSION WHEN THEY BECOME AVAILABLE BECAUSE THESE DOCUMENTS CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY AND THE PROPOSALS TO BE VOTED UPON. The Company’s proxy statement and any other solicitation materials filed by the Company with the Commission can be obtained free of charge at the Commission’s website at www.sec.gov and at the investor relations section of the Company’s website at ir.calavo.com. Shareholders may also write to the Company at the following email address to request copies of these materials: [email protected]. The Company, its directors and certain of its officers will be participants in the solicitation of proxies from shareholders in respect of the Annual Meeting. Detailed information regarding the identity of participants, and their respective interests in the Company by security holdings or otherwise, are set forth in the definitive proxy statement for the Annual Meeting. The contents of the websites referenced above are not deemed to be incorporated by reference into the proxy statement.

TEMPE, Ariz., April 12, 2021 (GLOBE NEWSWIRE) — Align Technology, Inc. (Nasdaq: ALGN), a leading global medical device company engaged in the design and manufacture of the Invisalign system, iTero intraoral scanners, and exocad CAD/CAM services for orthodontic and restorative dentistry, today announced its support to expand access to vaccinations by U.S. dentists.

As seen over the last year, managing health care resources during a pandemic or other health crisis is a complex mix of preparation and execution, with access to responsible care being a key consideration. Federal, state, and local public health officials and health care providers have worked to balance access to COVID-19 testing and healthcare while also meeting other health needs – both routine and unexpected – that continue even during a pandemic. As the number of people vaccinated against COVID-19 increases across the U.S., it is important to review and build on lessons learned in order to optimize responsiveness for future events. One of those lessons is the potential value of using networks of existing, trusted, community-level health care providers when rolling out vaccination plans.

“Since the start of the pandemic, Align’s customers – primarily dentists and orthodontists across the country – have been at the forefront of their profession and healthcare, in general, using social media and virtual appointment and treatment monitoring tools to stay connected with and communicate public health and safety protocols to their patients,” said Julie Coletti, Align Technology senior vice president, chief legal and regulatory officer. “As essential health care providers of ongoing health care services, they have earned their patients’ trust by staying current with the latest health and safety protocols and public health requirements to safely and responsibly treat their patients.”

As trusted, highly qualified health care professionals, dentists can expand the number of care providers that offer immunizations. According to the American Dental Association, 9 percent of Americans (31 million people) see a dentist every year, but do not see a physician¹. This is a significant statistic to be considered as part of any future plans for vaccine administration.

Dentists Provide Experienced Care

Before completing dental school and becoming licensed, dentists are professionally trained to administer intraoral and extraoral injections into nerve tissue for local anesthesia – which is arguably more difficult to effectively administer than a vaccine injected into the shoulder muscle. Further, many states permit dentists to administer dermal fillers, Botox^® injections, and to start IVs for procedures requiring sedation.

Building on Pandemic Policies

A majority of states have established the foundation for dentist-provided vaccinations by affirmatively permitting dentists to administer COVID-19 vaccinations. On March 16, 2021, the U.S. Department of Health and Human Services amended an emergency declaration under the Public Readiness and Emergency Preparedness Act to authorize additional providers, including dentists and dental students, to vaccinate patients for COVID-19 nationwide regardless of state laws that prevent dentists from doing so.³

Align believes that these recent pandemic-related policies should be the start of additional integration of dentists to vaccinate against other diseases. For example, augmenting the role of the dental profession in routine immunization of oral health related diseases such as Human Papillomavirus (HPV) would increase society’s access to future immunizations.² Such steps would establish a more robust vaccine program by expanding access at a community level through trusted and competent dentists.

¹ ADA Health Policy Institute, “Could Dentists Relieve Physician Shortages, Manage Chronic Disease?”, David Leader, D.M.D., M.P.H.; Marko Vujicic, Ph.D.; Brittany Harrison, M.A.; http://www.ada.org/~/media/ADA/Science%20and%20Research/HPI/Files/HPIBrief_1218_1.pdf

² North Carolina Oral Health Collaborative (NCOHC), “Dentists’ Role in Vaccination: An Opportunity for Public Health Impact”, Zachary Brian, DMD, MHA, https://oralhealthnc.org/dentists-role-in-vaccination-an-opportunity-for-public-health-impact/

³ https://www.federalregister.gov/documents/2021/03/16/2021-05401/seventh-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for

About Align Technology, Inc.


Align Technology designs, manufactures and offers the Invisalign^® system, the most advanced clear aligner system in the world, iTero^® intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 200 thousand doctor customers, and is key to accessing Align’s 500 million consumer market opportunity worldwide. Align has helped doctors treat over 9.6 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero systems and services, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Align Technology Madelyn Homick 408-470-1180 [email protected]

Zeno Group Sarah Johnson 828-551-4201 [email protected]

HIGH POINT, N.C., April 12, 2021 (GLOBE NEWSWIRE) — vTv Therapeutics Inc. (Nasdaq: VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced that results from the JDRF-supported SimpliciT-1 Study will be presented at A Scientific Symposium: In celebration of the 100th anniversary of the University of Toronto’s discovery of insulin (Insulin100) held virtually, April 15 & 16, 2021.

The presentation titled “The SimpliciT-1 Study: Hepatoselective Glucokinase Activation Via TTP399 For The Treatment Of Type 1 Diabetes Mellitus” was awarded first place in the symposium’s Post Doc – Clinical Category and earned the opportunity to be presented to the world’s leading experts on type 1 diabetes. Dr. Klara Klein, MD, PhD, Division of Endocrinology and Metabolism at the University of North Carolina at Chapel Hill, and Sub-Principal Investigator of the SimpliciT-1 study, will present the data in a 15 minute presentation on April 15th in a session held from 1:10-1:25pm ET. Registration is available here.

The Insulin100 symposium, chaired by Dr. Daniel Drucker of the University of Toronto, celebrates the 100th anniversary of the life-saving discovery of insulin and aims to provide comprehensive updates on the latest advances in diabetes treatment and management.

“We are pleased that vTv’s research in type 1 diabetes is being recognized by the diabetes community,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “We are dedicated to advancing TTP399 and believe that it has the potential to be a new treatment option for type 1 diabetes that improves patients’ lives.”

vTv is currently conducting a mechanistic study exploring the effects of TTP399 on ketone body formation during a period of insulin withdrawal in people with type 1 diabetes and is planning a pivotal trial that will be initiated later this year.

About the SimpliciT-1 Study

The SimpliciT-1 Study was a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of TTP399 as an adjunct to insulin therapy in adults with T1D. The Phase 2 study was conducted in two parts under a treat-to-target protocol to evaluate the safety and efficacy of TTP399 in T1D patients over 12 weeks of daily dosing following a multi-week insulin optimization and placebo run-in period.

Results from the study showed that treatment with 800mg of TTP399 demonstrated statistically significant reductions in HbA1c, as previously announced. Importantly, it also resulted in a clinically relevant (~40%) reduction in the frequency of severe or symptomatic hypoglycemia, as compared to placebo. TTP399 exhibited a favorable safety profile, with abnormal serum and urine ketones detected less frequently in participants in the TTP399 group than in the placebo group. These data suggest the potential of TTP399 to lower HbA1c and reduce hypoglycemia without increasing the risk of ketosis and should be further evaluated as an adjunctive therapy for the treatment of type 1 diabetes.

About vTv Therapeutics

vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and inflammatory disorders, including psoriasis. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), renal disease, and primary mitochondrial myopathy. For more information, please visit www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics.

Forward-Looking Statements

This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.

Contacts

Investors:

Corey Davis
LifeSci Advisors
[email protected]

or

Media:

[email protected] 

Source: vTv Therapeutics Inc. 

LEXINGTON, Mass., April 12, 2021 (GLOBE NEWSWIRE) — Mimecast Limited (NASDAQ: MIME), a leading email security and cyber resilience company, today announced it will issue a press release reporting financial results for the fourth quarter and full year 2021 ended March 31, 2021, before the market open on May 11, 2021.

Mimecast will host a conference call to discuss these financial results for investors and analysts at 8:00 am EDT (UTC-05:00) on May 11, 2021. The call will be webcast live on the investor relations section of the Company’s website investors.mimecast.com. An archive of the call will be available approximately two hours after the live call has ended.

Mimecast: Relentless protection. Resilient world.™

Mimecast (NASDAQ: MIME) was born in 2003 with a focus on delivering relentless protection. Each day, we take on cyber disruption for our tens of thousands of customers around the globe; always putting them first, and never giving up on tackling their biggest security challenges together. We are the company that built an intentional and scalable design ideology that solves the number one cyberattack vector – email. We continuously invest to thoughtfully integrate brand protection, security awareness training, web security, compliance and other essential capabilities. Mimecast is here to help protect large and small organizations from malicious activity, human error and technology failure; and to lead the movement toward building a more resilient world. Learn more about us at www.mimecast.com.

Mimecast social media resources:

LinkedIn: Mimecast
Facebook: Mimecast
Twitter: @Mimecast
Blog: Cyber Resilience Insights

Press Contact

Tim Hamilton
[email protected] 
617 393 7122

Investor Contact

Robert Sanders
[email protected] 
617-393-7074

John Thero to Retire as President and CEO on August 1, 2021

Board Appoints Karim Mikhail, Current SVP and Head of Commercial for Europe, as Successor

DUBLIN, Ireland and BRIDGEWATER, N.J., April 12, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that John F. Thero, 60, has informed the board of directors of his plan to retire as president and chief executive officer, effective August 1, 2021. He will also step down from the board at that time. The board has appointed Karim Mikhail, 50, Amarin’s senior vice president and head of commercial for Europe, to succeed Mr. Thero as the company’s next president and chief executive officer. Mr. Mikhail will join the board upon his effective date. Mr. Thero will continue to provide his guidance and expertise to the company in an advisory capacity through the end of 2021.

Mr. Mikhail joined Amarin in 2020 from THEODON, a global commercial strategy consultancy he founded in 2018. Prior to this, Mr. Mikhail spent more than 20 years at Merck, where from 2014 to 2018 he served as global commercial leader for Merck’s $4 billion lipid franchise, overseeing P&L and leading the worldwide launch of ezetimibe with the IMPROVE-IT study indication. In this role, he was responsible for reversing the business’ decline in the U.S. market and globally, accelerating revenue by an additional $380 million through the launch of ATOZET and driving EBITDA growth through international expansion. Prior to that, Mr. Mikhail led the successful commercial launch of dozens of products, including ezetimibe and various molecules in diabetes, hypertension, immunology, and oncology, and served as Merck’s chief marketing officer for Europe, Middle East and Africa and chief operating officer for emerging markets. At Amarin, Mr. Mikhail has been responsible for preparing commercialization of the company’s lead product in Europe, for which regulatory approval was received on March 30, 2021.

Dr. Lars Ekman, Chairman of Amarin’s Board of Directors, commented, “After 12 years at Amarin, and the last seven as CEO, John has decided now is the right time to announce his retirement. We owe enormous gratitude to John as under his leadership roles, with the support of the entire Amarin team, the company has completed multiple successful clinical trials, launched its lead product VASCEPA^® (icosapent ethyl) in the United States, and has initiated its international expansion plans, including commercialization in Europe following the recent marketing authorization of VAZKEPA from the European Commission. John and the entire board have taken a thoughtful approach to succession planning designed to ensure that Amarin is best positioned to both continue its progress in the United States and accelerate its growth trajectory globally. The board has been increasingly impressed with Karim’s strategic and operational capabilities, and his clear passion for VASCEPA and vision for continuing Amarin’s progress worldwide make him the clear choice to succeed John. We look forward to an exciting new chapter for the highly capable Amarin team under Karim’s leadership.”

“While announcing my retirement is a bittersweet moment for me, I have every confidence in Amarin and its outstanding employees who are dedicated to the patients and shareholders we serve,” said Mr. Thero. “2021 is a pivotal year for Amarin as we continue to develop markets for our important drug, VASCEPA. As the first-and–only drug approved by each of the U.S. FDA, European Commission, and Health Canada for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy, we are proud of our role in ushering in a new era in cardiovascular care. With our unique therapeutic solution and deep bench of internal talent, I believe that now is an ideal time to transition leadership to Karim as we work to realize Amarin’s full potential. Since Karim joined Amarin last year, he has proven himself to be an invaluable member of the leadership team and a true partner to me as we prepare for the commercialization of VAZKEPA in Europe. I am excited to continue working closely with him and the board to facilitate a successful transition over the coming months.”

Mr. Mikhail stated, “I joined Amarin last year because I was inspired by the company’s entrepreneurial spirit in addressing such a large unmet medical need and the potential to set a new standard of cardiovascular care. I am honored to take on this new role. We have an unparalleled product with outstanding evidence, positive efficacy and safety profile, and tremendous momentum with our near-term European launch plans and expected commercial approval in China near the end of 2021. Amarin’s team is first rate and I am excited to build upon the strong commercial progress in the United States. I look forward to working with John, the board and the entire Amarin team as we capture the significant growth opportunities ahead.”

About Karim Mikhail

Mr. Mikhail, 50, joined Amarin in July 2020, and currently serves as senior vice president and head of commercial for Europe where he has responsibility for the company’s commercialization of VAZKEPA in Europe. He was previously with Merck for 22 years, in seven different countries, spanning three continents, where he held positions of increasing responsibility, including as global commercial leader for Merck’s $4 billion lipid franchise and chief marketing officer for Europe, Middle East and Africa and chief operating officer for emerging markets. Mr. Mikhail led THEODON, a global commercial strategy consultancy he founded in 2018.

Mr. Mikhail is a pharmacist by training and holds a master’s degree in biopharmaceutical marketing and management from the graduate school of business in Paris, École Supérieure de Commerce de Paris (ESCP).

About Amarin

Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland as well as commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.

About Cardiovascular Risk

Cardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.¹ And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds.

Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.² Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.^3,4,5

About REDUCE-IT^®

REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).

REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.⁶ The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.⁷ The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.⁸ These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.

About VASCEPA^® (icosapent ethyl) Capsules

VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.

Indications and Limitation of Use (in the United States)

VASCEPA is indicated:

• As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
  • established cardiovascular disease or
  • diabetes mellitus and two or more additional risk factors for cardiovascular disease.
• As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information

• VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
• VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
• It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
• VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
• Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
• Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
• Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
• Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.

Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:

Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with 
Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT

	VASCEPA		Placebo		VASCEPA vs Placebo
	N = 4089 n (%)	Incidence Rate (per 100 patient years)	N = 4090 n (%)	Incidence Rate (per 100 patient years)	Hazard Ratio (95% CI)
Primary composite endpoint
Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE)	705 (17.2)	4.3	901 (22.0)	5.7	0.75 (0.68, 0.83)
Key secondary composite endpoint
Cardiovascular death, myocardial infarction, stroke (3-point MACE)	459 (11.2)	2.7	606 (14.8)	3.7	0.74 (0.65, 0.83)
Other secondary endpoints
Fatal or non-fatal myocardial infarction	250 (6.1)	1.5	355 (8.7)	2.1	0.69 (0.58, 0.81)
Emergent or urgent coronary revascularization	216 (5.3)	1.3	321 (7.8)	1.9	0.65 (0.55, 0.78)
Cardiovascular death [1]	174 (4.3)	1.0	213 (5.2)	1.2	0.80 (0.66, 0.98)
Hospitalization for unstable angina [2]	108 (2.6)	0.6	157 (3.8)	0.9	0.68 (0.53, 0.87)
Fatal or non-fatal stroke	98 (2.4)	0.6	134 (3.3)	0.8	0.72 (0.55, 0.93)
[1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality. [2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization.

FULL U.S. FDA-APPROVED VASCEPA

PRESCRIBING INFORMATION

CAN BE FOUND AT

WWW.VASCEPA.COM

.

Forward-Looking Statements

This press release contains forward-looking statements, including statements about expectations for continued company progress in the United States and accelerated growth trajectory globally, anticipated regulatory approvals and related timing and a smooth management transition. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties that may individually or together impact the matters herein and cause actual results, events and performance to differ materially from such forward looking statements. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: events that could impact future regulatory assessment, such as delays due to COVID-19 restrictions, later arising data, regulatory reviews and pricing assessments, and the successful implementation of commercialization plans or other information, uncertainties associated with litigation generally and patent litigation specifically; Amarin’s ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; and uncertainties associated generally with research and development and regulatory submissions, reviews, action dates and approvals. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent annual report on Form 10-K. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate.

Availability of Other Information About Amarin

Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Amarin Contact Information

Investor Inquiries:

Investor Relations
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
[email protected] (investor inquiries)

Solebury Trout
[email protected]

Media Inquiries:

Communications
Amarin Corporation plc
In U.S.: +1 (908) 892-2028
[email protected] (media inquiries)

AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending registration in the United States.

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¹ American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139–e596.
² Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.
³ Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.
⁴ Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs,
and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular
risk. J Am Heart Assoc. 2018;7(15):e008740.
⁵ Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease – New insights from
epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
⁶ Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.
⁷ Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.
⁸ Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.