Capricor Collaborates with Lonza for the Development of CAP-1002, its Cell Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy and Other Indications

—Capricor to leverage Lonza’s expertise in technology transfer and development of cellular therapies to take CAP-1002 through potential product launch and commercial supply—

—The collaboration aims to expand Capricor’s manufacturing capacity for potential late-stage clinical trials and commercialization—

—Process development to take place in Lonza’s Houston (TX) center of excellence—

LOS ANGELES and BASEL, Switzerland, Jan. 12, 2021 (GLOBE NEWSWIRE) — Capricor Therapeutics, (NASDAQ: CAPR), a clinical-stage biotechnology company focused on the development of the first-in-class cell and exosome-based therapeutics for the treatment and prevention of serious diseases, and Lonza today announced that the companies have entered into an agreement for the development of CAP-1002, its leading clinical asset using allogeneic cardiosphere-derived cells (CDC) technology for the treatment of Duchenne Muscular Dystrophy (DMD) and complications arising from COVID-19.

“As we continue to expand our manufacturing efforts for CAP-1002, our lead cell therapy product candidate, this collaboration with Lonza provides us with a partner which has world-class expertise in technology transfer and an established track record of commercializing biologics,” said Linda Marbán, Chief Executive Officer of Capricor. “We are excited because this is an important step in our ability to potentially bring CAP-1002 closer to commercialization and allows us to bring this important therapy to patients with Duchenne muscular dystrophy as quickly as possible, if approved.”

CAP-1002 completed the positive HOPE-2 phase 2 clinical trial and has been granted orphan drug designation by the FDA for the treatment of DMD. CAP-1002 also received FDA acceptance of its IND application for a phase 2 clinical trial of CAP-1002 in patients with COVID-19 in August 2020, as announced by Capricor.

“Capricor’s lead candidate CAP-1002 is demonstrating efficacy in late-stage clinical studies to significantly benefit patients,” said Alberto Santagostino, SVP, Head of Cell and Gene Technologies, Lonza. “We will leverage our process development expertise and industrial manufacturing capabilities to enable Capricor to scale this therapy and make it available to patients globally, once approved for commercialization.”

The agreement aims to expand Capricor’s manufacturing capacity for potential late-stage clinical trials and commercialization. Operations will begin with a tech-transfer to Lonza’s Houston (TX) center of excellence, where Lonza will perform process development activities for late-clinical and commercial-scale GMP manufacturing of CAP-1002.

About Lonza

At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.

We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.

Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at www.lonza.com and follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell and exosome-based therapeutics for the treatment and prevention of diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy and COVID-19. Capricor is also investigating the field of extracellular vesicles and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. Capricor is now developing two potential vaccines for COVID-19 as part of its exosome platform. For more information, visit www.capricor.com and follow the Company on Facebook, Instagram and Twitter.

About CAP-1002

CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a type of cardiac cell therapy that has been shown in pre-clinical and clinical studies to exert potent immunomodulatory activity. It is being investigated for its potential to modify the immune system’s activity to encourage cellular regeneration. The cells function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair. CDCs have been the subject of over 100 peer-reviewed scientific publications and administered to over 200 human subjects across several clinical trials.

Lonza Contact Details

Dr. Sanna Fowler

Head of External Communications
Lonza Group Ltd
Tel +41 61 316 8929
[email protected] 

Dirk Oehlers

Investor Relations
Lonza Group Ltd
Tel +41 79 421 1609
[email protected] 

Capricor Contact Details

Media:

Caitlin Kasunich
KCSA Strategic Communications
[email protected]  
Tel 212.896.1241

Investor:

Joyce Allaire
LifeSci Advisors, LLC
[email protected]  
Tel 617.435.6602

Company:

AJ Bergmann, Chief Financial Officer
[email protected]  
310.358.3201

Additional Information and Disclaimer

Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.

Cautionary Note Regarding Forward-Looking Statements for Capricor

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; plans regarding process development and manufacturing; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, revenue projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the Securities and Exchange Commission on March 27, 2020 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 as filed with the Securities and Exchange Commission on November 13, 2020. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor’s exosome-based candidates have been approved for clinical investigation.



TOMI SteraMist Disinfection Receives Purchase Order From Vigilant Hose Company

FREDERICK, Md., Jan. 12, 2021 (GLOBE NEWSWIRE) — TOMI Environmental Solutions, Inc.® (“TOMI”, “the Company”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination, utilizing its premier Binary Ionization Technology Platform through its SteraMist products – a hydrogen peroxide-based mist and fog composed of ionized Hydrogen Peroxide (iHP™), announces that it has received a purchase order from Vigilant Hose Company, (“VHC”), in Emmitsburg, Maryland, which provides Fire/Rescue/EMS services to five counties across two states. Located in the same town that is home to the National Emergency Training Center (a subdivision of FEMA) where emergency professionals from all over the world come to further their training, VHC has the distinction of being the most visited Firehouse in the world.    

Vigilant Hose Company selected SteraMist technology to ensure the thorough cleaning and sterilization of its training facilities, equipment and vehicles, with the goal of protecting public health while continuing to provide first responder services to the community. Coronavirus has elevated disinfection protocols adopted by public facilities and is expected to evolve well beyond the pandemic, with further scrutiny placed on other harmful pathogens prevalent in medical environments such as MRSA, C. diff, and C. auris. With a second wave of COVID infection rates currently taking place alongside the influenza season, the ability to thoroughly disinfect public surfaces is paramount to ensuring continued access to the services provided by organizations like the Vigilant Hose Company.

Elissa J. Shane, COO of TOMI, stated, “We’re pleased that the Vigilant Hose Company has selected our products for the disinfection of the public areas and equipment within their essential operation. Our EPA-regulated SteraMist technology has the proven ability to disinfect and eliminate the COVID-19 virus when used in highly-trafficked, high-touch and enclosed areas within a facility or vehicle, making it the ideal solution for use throughout VHC as they continue their important public service work.”

Thomas R. Ward, President of the Vigilant Hose Company commented, “With the purchase of the TOMI SteraMist, VHC has added another tool to our arsenal in the fight against COVID-19. Our new surface disinfectant sprayer is the most powerful of its kind on the market to help fight and eliminate the Covid virus and other pathogens. We have already trained our members to use the device, so we are now prepared to sterilize our facilities and apparatus, including ambulances, on a regular basis. VHC’s commitment to the health and safety of our membership and the community continues to be at the forefront of everything that we do, and we believe the SteraMist system will meaningfully improve our ability to protect the health of our membership and the public.”     

TOMI™ Environmental Solutions, Inc.: Innovating for a safer world

®
 

TOMI™ Environmental Solutions, Inc. (NASDAQ:TOMZ) is a global decontamination and infection prevention company, providing environmental solutions for indoor surface disinfection through the manufacturing, sales and licensing of its premier Binary Ionization Technology® (BIT) platform. Invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, BIT solution utilizes a low percentage Hydrogen Peroxide as its only active ingredient to produce a fog of ionized Hydrogen Peroxide (iHP). Represented by the SteraMist® brand of products, iHP produces a germ-killing aerosol that works like a visual non-caustic gas.

TOMI products are designed to service a broad spectrum of commercial structures, including, but not limited to, hospitals and medical facilities, cruise ships, office buildings, hotel and motel rooms, schools, restaurants, meat and produce processing facilities, military barracks, police and fire departments, and athletic facilities. TOMI products and services have also been used in single-family homes and multi-unit residences.

TOMI develops training programs and application protocols for its clients and is a member in good standing with The American Biological Safety Association, The American Association of Tissue Banks, Association for Professionals in Infection Control and Epidemiology, Society for Healthcare Epidemiology of America, America Seed Trade Association, and The Restoration Industry Association.

For additional information, please visit http://www.tomimist.com/ or contact us at [email protected].

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

Certain written and oral statements made by us may constitute “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 (the “Reform Act”). Forward-looking statements are identified by such words and phrases as “we expect,” “expected to,” “estimates,” “estimated,” “current outlook,” “we look forward to,” “would equate to,” “projects,” “projections,” “projected to be,” “anticipates,” “anticipated,” “we believe,” “could be,” and other similar phrases. All statements addressing operating performance, events, or developments that we expect or anticipate will occur in the future, including statements relating to revenue growth, earnings, earnings-per-share growth, or similar projections, are forward-looking statements within the meaning of the Reform Act. They are forward-looking, and they should be evaluated in light of important risk factors that could cause our actual results to differ materially from our anticipated results. The information provided in this document is based upon the facts and circumstances known at this time. We undertake no obligation to update these forward-looking statements after the date of this release.

INVESTOR RELATIONS CONTACT

John Nesbett/Jennifer Belodeau
IMS Investor Relations
[email protected]



Jetson, The World’s Only Seasonal Probiotic Company, Launches Reformulated Immunity Product to Protect Against Illness during a Critical Sick Season

The winter formula features studied probiotic strains, as well as Vitamin C and Echinacea to limit the severity and duration of colds, bacterial infections and viral infections.

CHICAGO, Jan. 12, 2021 (GLOBE NEWSWIRE) — Jetson, creators of the world’s only seasonal probiotic, today announced the launch of re-formulated Immunity, the winter probiotic formula, specifically designed to boost the immune system and protect from illness. It uses scientifically studied bacterial strains clinically proven to strengthen immune response to viral respiratory illness and decrease inflammation, plus Vitamin C and Echinacea to supercharge the immune boosting power.

“For sure, this is the season to not take chances with the health of your immune system – Immune resiliency is critical for protection from bacteria, viruses, and other non-infectious exposures and we should do all we can,” said. Dr. Ilene Ruhoy, member of Jetson’s Gut Council. “Jetson’s Winter Probiotic, Immunity, has important probiotic strains to maintain gut membrane strength as well as critical vitamins and herbs for immune function. This probiotic, along with a healthy lifestyle, can help keep your immune system strong by ensuring gut integrity and motility and contributing to overall immune health.”

Jetson’s probiotics rotate seasonally, meaning they are constantly reformulated and informed by the latest scientific findings. This year’s version of Immunity contains:

Immunity can be taken in conjunction with other Jetson probiotics. For example, combining Immunity and Mood would provide a diverse dose of bacterial strains – plus Vitamin C, Echinacea and Vitamin D3 and B12 with just two pills.

“As the flu ramps up and COVID-19 persists, doctors are urgently warning that this is not the year to roll the dice and get the flu,” said George Chao, Jetson CEO. “Since 70% of the immune system lives in the gut, improving gut health is more important now than ever.”

Jetson’s probiotics are scientifically-backed and fresher than other probiotic brands, which tend to feature single-strain bacteria and use generic/commodity strains. Jetson also boasts the following unique differences:

  • More specialized strains: a year’s worth of Jetson’s seasonal probiotics provides 20 strains, which is above and beyond the one or two strains offered by market leaders.
  • Better gut absorption: Jetson’s strains are fresher and a proprietary capsule is specifically designed to survive stomach acid during digestion.
  • Seasonal formulations address the body’s unique needs throughout the year.
  • No-fuss monthly subscription option ensures you never forget to take care of your gut.
  • Transparency: Jetson discloses the specific strains used in each of its formulas. Visit wearejetson.com to learn more about the probiotic strains included in Immunity.

Jetson probiotics are gluten-free, Non-GMO, preservative-free, and allergen-free. They’re also free from soy, binders, and synthetic fillers. Jetson also offers a novel prebiotic, Gut Prep, a year-round add on to any Jetson probiotic.

To purchase Immunity, visit wearejetson.com. Jetson products are also available on Amazon and to ship to Canada.

Follow Jetson on Instagram @WeAreJetson, on Facebook @JetsonHealth and Youtube @WeAreJetson.

JETSON
Jetson is the world’s only seasonal probiotic. Founded by Stefan Weitz and Kiley Taslitz Anderson in June 2019, Jetson is dedicated to helping Americans get healthy through the gut. Delivered fresh each month, Jetson’s seasonal probiotics provide specific formulations tailored to address the body’s unique needs year-round for as little as $30 a month. Non-GMO, preservative-free, allergen-free, and gluten-free, Jetson’s individual seasonal probiotic products include Fit, Mood, Immunity, and Outside, as well as a prebiotic, Gut Prep. They have also recently launched a product line aimed at babies and kids, Jettie, and a probiotic specifically developed to support microbial balance in the gut during and after a course of antibiotics, Gut Recovery. The company was founded after Weitz was diagnosed with an incurable autoimmune disease — Multiple Sclerosis — and learned his overall health and quality of life was inextricably tied to the health of his gut. To keep it fresh and to purchase Jetson, please visit www.wearejetson.com.

Contact: Jetson Public Relations

Molly Antos
T: (847) 848-2090
[email protected]

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/685c7d35-19bf-4b50-994f-1bd263331e85 
https://www.globenewswire.com/NewsRoom/AttachmentNg/0b5b9bf9-41b2-4b91-8c5f-f807b18beb4d



Natera to Present New Colorectal Cancer Data at the 2021 ASCO GI Symposium

Oral presentation showcases the largest early-stage CRC cohort to date, further validating the serial use of Signatera™ for early recurrence detection and MRD assessment

PR Newswire

SAN CARLOS, Calif., Jan. 12, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced it will present new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, at the American Society of Clinical Oncology’s 2021 Gastrointestinal Cancers Symposium (ASCO GI), taking place January 15-17, 2021.

Natera will have one oral and one poster presentation, each describing the clinical performance of Signatera in patients with colorectal cancer (CRC).

Details about the presentations are as follows:

Abstract #11 | Oral Presentation | Presenter: Tenna V. Henriksen, MS | Jan. 16, 6:00 am PST

Circulating tumor DNA analysis for assessment of recurrence risk, benefit of adjuvant therapy, and early relapse detection after treatment in colorectal cancer patients

This multi-center study evaluates the prognostic value of longitudinal circulating tumor DNA (ctDNA) monitoring with Signatera in early-stage CRC. A cohort of 265 stage I-III CRC patients was followed for approximately three years (median of 28.4 months). Plasma samples were analyzed post-surgery, after adjuvant chemotherapy, and at regular intervals thereafter. The study demonstrates that Signatera detects recurrence early, with a median lead time of eight months before clinical or radiographic relapse; and compared to all other clinical and pathological risk factors, Signatera MRD status is the only significant risk factor in predicting recurrence.

“Our study is unique in that it is, to the best of our knowledge, the largest ctDNA study in early-stage CRC, with extremely mature follow-up,” said Claus Lindbjerg Andersen, PhD, Professor, Department of Molecular Medicine at Aarhus University and the study’s senior author. “Through this study, we are able to demonstrate that serial ctDNA testing can detect molecular residual disease a median of eight months ahead of clinical relapse, with significant potential to improve patient care.”

Abstract #102 | Poster Presentation | Principal Investigator: David Cunningham, MD | Jan. 15, 5:00 am PST

Minimal residual disease (MRD) detection with circulating tumor DNA (ctDNA) from personalized assays in stage II-III colorectal cancer patients in a U.K. multicenter prospective study (TRACC)

A prospective study on 122 patients with stage II-III CRC, who were monitored pre- and post-surgery using Signatera. Patients who were MRD-positive after surgery had a significantly higher rate of relapse than those who were MRD-negative. MRD detection rates increase with disease stage and risk features, and correlate with recurrence rates.

“We are delighted to share the results of these studies with the ASCO GI community,” said Alexey Aleshin, MD, Natera’s Senior Medical Director of Oncology. “These data build on our previous studies, providing yet another consistent proof point for the clinical performance of Signatera in CRC and demonstrating our commitment towards research and innovation in the MRD field.”

About Signatera


Signatera
 is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

About Natera


Natera
 is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women’s health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., [email protected] 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/natera-to-present-new-colorectal-cancer-data-at-the-2021-asco-gi-symposium-301206018.html

SOURCE Natera, Inc.

PagerDuty Strengthens Its Board of Directors With Appointment of Google VP Bonita Stewart

PagerDuty Strengthens Its Board of Directors With Appointment of Google VP Bonita Stewart

SAN FRANCISCO–(BUSINESS WIRE)–PagerDuty, Inc. (NYSE:PD), a global leader in digital operations management, today announced the appointment of Bonita Stewart to its Board of Directors. Stewart brings to the PagerDuty team more than 20 years of experience leading multi-billion dollar operations, accelerating digital technology adoption and driving digital transformation at scale.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210112005389/en/

Bonita Stewart (Photo: Business Wire)

Bonita Stewart (Photo: Business Wire)

Stewart currently serves as Vice President of Global Partnerships at Google, where she oversees the company’s global partnerships team for the largest US publishers across Search, Mobile Apps, Broadcast, Commerce, News, Telecommunications and Domains. The first African American woman appointed to a VP role at Google, Stewart brings decades of experience in marketing and technology, combined with a strong partner ecosystem background from major corporations in the IT and automotive fields. Stewart also offers significant public company board experience, having served on the Board of Directors of Pluralsight (NASDAQ:PS) since 2018 and Decker Outdoor Corporation (NYSE:DECK) since 2014. Prior to Google, Stewart served as Director of Interactive Communications, Chrysler Group (now known as Daimler AG), and during that time Chrysler Group was named Interactive Marketer of the Year by Ad Age. Prior to this she spent a decade in sales and marketing management positions at IBM.

“Bonita is a fantastic culture fit with our board and brings tremendous at-scale leadership experience to PagerDuty. Her experience building market presence and partner ecosystems, and scaling larger global operations make me proud to add her to our board,” said Jennifer Tejada, PagerDuty CEO. “A trailblazer in the industry, her decision to join our board is also an endorsement of our efforts to build a diverse business and create equal opportunity in tech and beyond.”

Named a Woman to Watch in Tech by Crain’s, Stewart has spent her career breaking barriers. She pioneered the concept of Howard West, a computer science immersion program for historically black colleges and universities (HBCUs), powered by Google. While with IBM, she founded One Moment in Time, introducing a new concept in women’s formal wear rentals with a view toward national franchising. Stewart received her BA with honors from Howard University and her MBA from Harvard Business School. In 2020, she co-authored, “A Blessing: Women of Color Teaming Up to Lead, Empower and Thrive.”

“PagerDuty leads the way in making life better for teams tasked with managing complex digital operations in real-time. The company’s focus on customer devotion, coupled with its progressive approach to building a balancing team at all levels aligns with my goal of moving the tech industry towards inclusion to drive better business outcomes,” said Stewart. “I believe we’re at the beginning of a new era in tech, and I look forward to joining Jennifer and her team as PagerDuty continues to lead by example.”

For more information, visit www.pagerduty.com.

About PagerDuty, Inc.

PagerDuty, Inc. (NYSE:PD) is a leader in digital operations management. In an always-on world, organizations of all sizes trust PagerDuty to help them deliver a perfect digital experience to their customers, every time. Teams use PagerDuty to identify issues and opportunities in real time and bring together the right people to fix problems faster and prevent them in the future. Notable customers include GE, Cisco, Genentech, Electronic Arts, Cox Automotive, Netflix, Shopify, Zoom, DoorDash, Lululemon and more. To learn more and try PagerDuty for free, visit www.pagerduty.com. Follow our blog and connect with us on Twitter, LinkedIn, YouTube and Facebook.

Carolyn Guss

[email protected]

Source: PagerDuty

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Software Technology Data Management

MEDIA:

Photo
Photo
Bonita Stewart (Photo: Business Wire)
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Global Sourcing Hits Record High in Q4, ISG Index™ Finds

Global Sourcing Hits Record High in Q4, ISG Index™ Finds

Global combined ACV reaches quarterly high of $16 billion in Q4, up 13%

ITO up 14%, propelling managed services to $7 billion-plus quarter

IaaS growth of 32% drives up as-a-service market by 24 percent, to record $8.8 billion

ISG sees robust growth for cloud-based services in 2021

STAMFORD, Conn.–(BUSINESS WIRE)–
Global demand for technology and business services reached a record high in the fourth quarter, as the sourcing industry continues to recover from its pandemic-related downturn, according to the latest state-of-the industry report from Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm.

Data from the ISG Index™, which measures commercial outsourcing contracts with annual contract value (ACV) of $5 million or more, show fourth-quarter ACV for the combined global market (both as-a-service and managed services) reached $16.0 billion, up 13 percent over last year and up 9 percent from the third quarter.

“Demand is picking up and deals are moving forward as businesses adjust to the pandemic and look ahead to the economy reopening more fully now that vaccines have arrived,” said Steve Hall, president of ISG. “But the recovery will be hit-or-miss in the short term because of how the virus has affected different countries and industries. Enterprises continue to focus on cost takeout and applying savings to digital initiatives. Agility, resiliency and transformation are common themes.”

In the fourth quarter, managed services ACV was $7.2 billion, the segment’s first quarter above $7 billion since the fourth quarter of 2019. Large deals in the manufacturing sector and in the DACH region produced better-than-expected growth of 3 percent. Within managed services, IT outsourcing (ITO) advanced 14 percent, to $5.7 billion, while business process outsourcing (BPO) slumped 27 percent, to $1.4 billion. A total of 455 contracts were signed in the quarter, up 6 percent over last year. That figure includes five mega deals (contracts with ACV of more than $100 million) totaling $1.7 billion.

Fourth-quarter ACV for cloud-based services (as-a-service) climbed 24 percent, to a record $8.8 billion, as enterprises signed larger and longer-term contracts with major technology providers. Much of the growth came from infrastructure-as-a-service (IaaS), up 32 percent, to a record $6.5 billion. Software-as-a-service (SaaS) rose 5 percent, to $2.3 billion.

2021 Forecast

ISG is forecasting the market for cloud-based services will grow 20 percent globally in 2021, and the market for managed services will grow 3 percent.

“2021 looks to be another year of robust growth for the hyperscalers, as they continue to push into the enterprise space with long-term agreements, especially in Europe,” said Hall. “Growing contract backlogs will provide a sustainable and steady source of revenue for many years down the line and enable the industry leaders to target underpenetrated markets.”

The managed services market, meanwhile, is in recovery mode, Hall said, and is likely to feel the continued impact of the pandemic in the first half. “Despite the great news on vaccines, optimism and spending are still being impacted by the pandemic. Lockdowns are hurting economies and companies are dealing with ongoing supply chain disruptions and spending caps.”

Full-Year Results

For 2020, the combined global market reached a record $59.8 billion, up 7 percent over the prior year. Full-year results were driven by a 17 percent increase in as-a-service ACV, to a record $33.2 billion. That beat ISG’s previous forecast of 15.5 percent growth for the year. As-a-service growth was paced by a 23 percent jump in IaaS, to a record $24.3 billion, while SaaS grew 4 percent, to a record $8.9 billion.

Managed services, at $26.6 billion, was down 4 percent, slightly better than the 6 percent decline ISG forecast last quarter, as large deals propped up the market in the fourth quarter. For the year, ITO was up 2 percent, to a record $21.4 billion, while BPO slid 23 percent, to $5.2 billion.

Americas

The Americas pulled back from a strong third quarter to generate $7.2 billion of ACV in the fourth quarter, up 4 percent over the prior year but down 11 percent sequentially. Managed services fell 17 percent, to $2.5 billion, with ITO slumping 32 percent, to $1.6 billion, even as BPO advanced 38 percent, to $858 million. It was the region’s softest quarter for managed services since the third quarter of 2016. As-a-service, meanwhile, jumped 21 percent, to a record $4.7 billion, on a 30 percent increase in IaaS, to $3.2 billion, and a 4 percent rise in SaaS, to $1.5 billion.

For the year, the Americas delivered a record $30.4 billion in combined market ACV, up 8 percent, with as-a-service up 18.5 percent, to a record $17.9 billion, and managed services down 4 percent, to $12.5 billion.

Europe, Middle East and Africa (EMEA)

EMEA delivered its best quarterly performance ever, with the combined market at a record $6.2 billion, up 18 percent. On the strength of five mega deals in EMEA, including contracts with Siemens and Daimler, managed services rose 14 percent, to $4.0 billion, with ITO soaring 55 percent, to $3.6 billion, offsetting a 66 percent slump in BPO, to only $400 million. As-a-service also grew strongly, up 25 percent, to a record $2.2 billion, with 34 percent growth in IaaS, to $1.6 billion, and 5 percent growth in SaaS, to $578 million.

Full-year combined ACV was a record $20.5 billion, up 7 percent, boosted by an as-a-service market that rose 15 percent, to a record $8.3 billion. Managed services grew 2 percent, to $12.1 billion.

Asia Pacific

Asia Pacific generated a record $2.6 billion in combined-market ACV in the fourth quarter, up 35 percent over the prior year. The region produced strong, double-digit growth across all segments. As-a-service was up 30 percent, to $1.9 billion, a new record, on 33 percent growth in IaaS, to a record $1.7 billion, and 12 percent growth in SaaS, to $257 million. Managed services, against a soft quarter a year ago, soared 55 percent, to $641 million, with ITO up 76 percent, to $473 million, and BPO up 16 percent, to $168 million.

For all of 2020, the combined market produced a record $9.0 billion of ACV, up 2 percent, boosted by a record $6.9 billion of as-a-service ACV, up 16 percent over the prior year. Managed services, however, slumped 27 percent, to $2.0 billion.

About the ISG Index™

The ISG Index™ is recognized as the authoritative source for marketplace intelligence on the global technology and business services industry. For 73 consecutive quarters, it has detailed the latest industry data and trends for financial analysts, enterprise buyers, software and service providers, law firms, universities and the media. In 2016, the ISG Index was expanded to include coverage of the fast-growing as-a-service market, measuring the significant impact cloud-based services are having on digital business transformation. ISG also provides ongoing analysis of automation and other digital technologies in its quarterly ISG Index presentations.

The 4Q 2020 ISG Index was presented during a conference call and webcast today. To listen to an audio replay of the call and view presentation slides, visit this webpage.

For a snapshot of fourth-quarter and full-year 2020 ISG Index results, view this infographic.

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 700 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

Press Contacts:

Will Thoretz, ISG

+1 203 517 3119

[email protected]

Jim Baptiste, Matter Communications for ISG

+1 978 518 4527

[email protected]

KEYWORDS: Connecticut United States North America

INDUSTRY KEYWORDS: Technology Security Consulting Other Technology Professional Services Software Networks Internet Hardware Data Management

MEDIA:

Logo
Logo

Five Below, Inc. Announces Holiday Sales Results for Quarter-To-Date Through January 2, 2021

Net Sales Increased 21.1%; Comparable Sales Increased 10.1%

Strongest Holiday Comparable Sales Increase Since 2011

PHILADELPHIA, PA, Jan. 12, 2021 (GLOBE NEWSWIRE) — Five Below, Inc. (NASDAQ: FIVE) (“Five Below” or the “Company”) today announced net sales results for the quarter-to-date period from November 1, 2020 through January 2, 2021 (“Holiday Period”).

The Company announced that net sales for the Holiday Period increased by 21.1% to $722.3 million from $596.6 million in the comparable nine-week period from November 3, 2019 through January 4, 2020. Comparable sales for the Holiday Period increased by 10.1%.

Joel Anderson, President and CEO, said, “We are very pleased with our holiday sales performance, which surpassed our expectations. These strong results illustrate the broad appeal of our Wow offering at amazing values as well as the inherent flexibility of our model and merchandise offering. We featured extreme value products, as well as Wow gifts in our expanded Five Beyond offering, all of which resonated with customers. These sales results were accompanied by gross margins that were in line with our expectations and SG&A leverage that was stronger than planned.”

Mr. Anderson continued, “As we close out a very strong quarter and unprecedented year, I want to extend our deepest gratitude to our teams across the organization who executed with excellence while maintaining a focus on safety throughout our peak holiday season. We look forward to continuing our growth and to discussing our 2020 results and plans for 2021 on our year-end call in March.”

The Company is providing the following guidance for the fourth quarter and fiscal year 2020:

Fourth Quarter Fiscal 2020 Guidance

  • Net sales of $835 million to $840 million, or growth of 21.5% to 22.2%
  • Comparable sales increase of approximately 11.0%
  • Diluted income per common share of $2.08 to $2.12 on approximately 56.2 million estimated diluted weighted average shares outstanding

Full Year Fiscal 2020 Guidance

  • Net sales of $1.939 billion to $1.944 billion, or growth of 5.0% to 5.2%
  • Comparable sales decrease of approximately 6.5%
  • Diluted income per common share of $2.07 to $2.11 on approximately 56.2 million estimated diluted weighted average shares outstanding

As previously announced, management is scheduled to participate in a fireside chat today at 10:30 a.m. Eastern Time at the virtual ICR Conference 2021. The event will be webcast live at http://investor.fivebelow.com. An archived replay will be available two hours after the conclusion of the live event.

Forward-Looking Statements:

This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which reflect management’s current views, estimates, expectations and guidance regarding the Company’s industry, business strategy, goals and expectations concerning its market position, future operations, margins, profitability, capital expenditures, liquidity and capital resources and other financial and operating information. Investors can identify these statements by the fact that they use words such as “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future” and similar terms and phrases. The Company cannot assure investors that future developments affecting the Company will be those that it has anticipated. Actual results may differ materially from these expectations due to risks and uncertainties associated with the COVID-19 pandemic (including governmental restrictions and requirements, store closures and effects on customer demand or on our supply chain, our ability to keep our distribution centers and e-commerce fulfillment centers operational, our ability to effectively operate and remain open in some or all of our stores, and to open new stores and remodels), risks related to the Company’s strategy and expansion plans, risks related to the inability to successfully implement our online retail operations, including cyber security risks, risks related to our ability to select, obtain, distribute and market merchandise profitably, risks related to our reliance on merchandise manufactured outside of the United States, risks related to any legal proceedings that we may become subject to, the availability of suitable new store locations and the dependence on the volume of traffic to our stores, risks related to the Company’s continued retention of its executive officers, senior management and other key personnel, risks related to changes in consumer preferences and economic conditions, risks related to increased operating costs, including wage rates, risks related to extreme weather, pandemic outbreaks (in addition to COVID-19), global political events, war, terrorism or civil unrest (including any resulting store closures, damage, or loss of inventory), risks related to leasing, owning or building distribution centers, risks related to our ability to successfully manage inventory balance and inventory shrinkage, quality or safety concerns about the Company’s merchandise, increased competition from other retailers including online retailers, risks related to the seasonality of our business, risks related to our ability to protect our brand name and other intellectual property, risks related to customers’ payment methods, risks related to domestic and foreign trade restrictions including duties and tariffs affecting our domestic and foreign suppliers and increasing our costs, including, among others, the direct and indirect impact of recent and potential tariffs imposed and proposed by the United States on foreign imports, risks associated with the restrictions imposed by our indebtedness on our current and future operations, the impact of changes in tax legislation and accounting standards and risks associated with leasing substantial amounts of space. For further details and a discussion of these risks and uncertainties, see the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. If one or more of these risks or uncertainties materialize, or if any of the Company’s assumptions prove incorrect, the Company’s actual results may vary in material respects from those projected in these forward-looking statements. Any forward-looking statement made by the Company in this news release speaks only as of the date on which the Company makes it. Factors or events that could cause the Company’s actual results to differ may emerge from time to time, and it is not possible for the Company to predict all of them. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

About Five Below:

Five Below is a leading high-growth value retailer offering trend-right, high-quality products loved by tweens, teens and beyond. We know life is way better when you’re free to “let go & have fun” in an amazing experience filled with unlimited possibilities. With most items priced $1-$5, and some extreme value items priced beyond $5, we make it easy to say YES! to the newest, coolest stuff across 8 awesome Five Below worlds: Style, Room, Sports, Tech, Create, Party, Candy and Now. Founded in 2002 and headquartered in Philadelphia, Pennsylvania, Five Below today has over 1,000 stores in 38 states. For more information, please visit www.fivebelow.com!

Investor Contact:

Five Below, Inc.
Christiane Pelz
Vice President, Investor Relations
215-207-2658
[email protected]



Seanergy Maritime Holdings Corp. Announces Successful Completion of $179 million Financial Restructuring

  • Restructuring of $117 million of senior secured loan facilities and $62 million of junior loan facilities and convertible notes
  • No outstanding debt maturities before the fourth quarter of 2022
  • Reduction of interest rate and repayment instalments with positive impact on the cash break-even of the fleet
  • Relaxation of financial covenants allowing for additional financial flexibility, including payment of dividends
  • Aggregate debt reduction of $36 million in 2020
    through the restructuring arrangements and scheduled debt amortization

ATHENS, Greece, Jan. 12, 2021 (GLOBE NEWSWIRE) — Seanergy Maritime Holdings Corp. (“Seanergy” or the “Company”) (NASDAQ: SHIP) announced today that it has reached final agreements with certain of its senior lenders and junior lender, for the financial restructuring of a total of $179 million, consisting of four senior credit facilities (the “Senior Facilities”), three junior credit facilities (the “Jelco Loans”) and three junior convertible notes (the “Jelco Notes”). Following these agreements, the previously announced defaults and cross-defaults have been fully resolved.

Pursuant to the restructuring terms, approximately $87 million of debt maturities falling due in 2020 have been extended to future periods, between December 2022 and December 2024, providing Seanergy with a clean two-year runway. In addition, the rescheduling of the amortization payments under certain of the Senior Facilities and the reduction of the interest rate across the junior loans and notes are expected to have a positive impact on the cash break-even of the Company going forward. Moreover, the Company’s lenders have agreed to cancel or amend certain financial covenants and security maintenance provisions under the Senior Facilities allowing for additional financial flexibility, including payment of dividends.

Stamatis Tsantanis, the Company’s Chairman and Chief Executive Officer stated:

“We are very pleased to announce the successful conclusion of the restructuring discussions with certain of our lenders. The discussions extended since the first quarter of 2020 and were finally concluded in an amicable manner. The agreed solutions provide Seanergy with a solid financial standing going forward, allowing us to pursue our strategy to enhance corporate value and pave the way to improved shareholder returns.

Under the agreed restructuring, there are no imminent loan maturities or underlying defaults, our balance sheet has been delevered through the extinguishment of debt and accrued interest and our future cash flow is expected to improve through reduced interest expense and debt amortization payments in the next years. Our overall debt has seen an impressive year-over-year reduction of $36.0 million through the restructuring initiatives and the uninterrupted servicing of the scheduled amortization payments.

Despite the global challenges presented in 2020, we have delivered milestone transactions, including the prominent restructuring of our debt, fleet expansion and beneficial commercial agreements. Seanergy, as the only pure-play Capesize vessel owner listed in the US capital markets, is in a great position to capture what we believe is significant upside potential in a rising market.”

A summary of the various restructuring arrangements is presented below:


Alpha Bank SA (“Alpha Bank”) Extension and Amendments

As previously disclosed, we documented the agreement with Alpha Bank for the extension of two loan facilities secured by two of our Capesize vessels from March 17, 2020 and November 10, 2021, to December 31, 2022. The underlying terms remained substantially the same while in addition, certain corporate covenants and dividend restrictions were cancelled or relaxed. We are currently in compliance with all the terms of these facilities as amended.


Hamburg Commercial Bank AG (“HCOB”) Refinancing and Entrust Global Facility (“Entrust facility”)

As previously disclosed, we entered into a settlement agreement with HCOB for the facility secured by two of our Capesize vessels, under which the $29.1 million outstanding balance was settled for $23.5 million resulting in a $5.6 million debt extinguishment and an equivalent gain for Seanergy. The HCOB facility was refinanced by a new facility provided by certain nominees of Entrust Global and secured by the same vessels. The Entrust facility with an initial balance of $22.5 million, has a five-year term and reduced quarterly repayments that have positively impacted the break-even rates of the underlying vessels, as well as less restrictive financial covenants and value maintenance provisions. These developments resulted in a $6.6 million aggregate reduction in the Company’s debt. We are currently in compliance with all the terms of the Entrust facility.


UniCredit Bank AG (“UCB”) Extension and Amendments

The Company obtained credit committee approval for the extension of the maturity of the UCB facility secured by two of its Capesize vessels, by two years, from December 2020 to December 2022. Moreover, the approval provides for the cancellation of various financial covenants and value maintenance provisions. Most importantly, the lender has agreed to the reduction of the quarterly installments from $1.55 million to $1.2 million, on the basis of which, the all-in cash break-even of the underlying vessels has improved by approximately $1,900 per day. The agreement is subject to completion of definitive documentation.


Amsterdam Trade Bank (“ATB”) Amendments

The Company received credit committee approval from ATB concerning the amendment of the value maintenance provisions and of certain financial covenants under the ATB facility secured by one of our Capesize vessels. Such amendments will address potential non-compliance issues while providing for a uniform approach in the financial covenants across all of the Company’s senior loan facilities. The agreement is subject to completion of definitive documentation.


Jelco Loans and Notes Extensions and Amendments

On December 30, 2020 we entered into definitive documentation with Jelco Delta Holding Corp. (“Jelco”), the Company’s sole junior creditor, concerning $27.2 million of maturities falling due in 2020 and the settlement of accrued and unpaid interest through December 31, 2020. Jelco is a former affiliate of and related party to the Company and pursuant to this agreement, $6.5 million of principal indebtedness under one of the Jelco Loans was repaid, while all other maturities, including those of two Jelco Notes that were maturing in December 2022, were extended to December 2024. In addition, Jelco has agreed to the reduction of the applicable interest rate across all Jelco Loans and Jelco Notes to a fixed rate of 5.5% (previously floating based on LIBOR plus a spread ranging from 5% to 8.5%). Moreover, we have agreed to introduce two interim repayment instalments of $8.0 million each, payable in December 2022 and December 2023 and a semi-annual cash sweep mechanism capturing cash balances in excess of $25.0 million or time charter equivalent revenue of our Capesize fleet between $18,000 and $21,000, provided that such repayment obligations, together with all other prepayment obligations to Jelco, will not exceed $12 million in any calendar year. These arrangements will provide for the swift reduction of the Jelco debt to the extent the free cash flows of the Company permit.

Moreover, Seanergy and Jelco have agreed to the settlement of all accrued and unpaid interest through December 31, 2020 and other fees payable to Jelco in an aggregate amount of approximately $5.6 million, through a private placement of units consisting of one common share (or one pre-funded warrant in lieu of one common share) and one warrant to purchase one common share for a fixed price of $0.70. The issuance of these common shares and warrants closed on January 8, 2021. Each unit was issued at a price of $0.70, in line with the pricing of the Company’s public offering that closed in August 2020 and represents a 39% premium compared to the closing price of the Company’s shares on the date of signing of the agreement. The terms of the warrants and pre-funded warrants are substantially the same as those of the Class E warrants and pre-funded warrants issued in the Company’s public offering in August 2020. The Company has also granted an option to Jelco to convert up to $3.0 million of principal indebtedness under one of the Jelco Loans at the same terms and pricing. Seanergy has also agreed to amend the conversion price of the Jelco Notes to $1.20 per share, which represents an approximately 139 % premium compared to the closing price of the Company’s shares on the date of signing of the agreement. As part of the transaction, Jelco waived any and all past breaches or events of default under the Jelco Loans and Jelco Notes.

The acquisition of shares by Jelco is subject to a standstill undertaking and 9.99% beneficial ownership blockers, precluding the acquisition of the Company’s shares, including through the exercise of warrants or the conversion of the Jelco Notes to the extent that it would result in Jelco or its affiliates beneficially owning, including control over the voting or disposition of, more than 9.99% of the outstanding common shares of the Company after giving effect to the acquisition. The Company has granted customary registration rights with respect to all shares issued or issuable to Jelco as a result of this transaction, including the shares underlying the Jelco Notes, and has undertaken to file a registration statement covering the resale of these shares.

About Seanergy Maritime Holdings Corp.

Seanergy Maritime Holdings Corp. is the only pure-play Capesize ship-owner publicly listed in the US. Seanergy provides marine dry bulk transportation services through a fleet of 11 Capesize vessels with an average age of about 12 years and aggregate cargo carrying capacity of approximately 1,926,117 dwt. The Company is incorporated in the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP”, its Class A warrants under “SHIPW” and its Class B warrants under “SHIPZ”.

Please visit our company website at: www.seanergymaritime.com

Forward-Looking Statements

This press release contains forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as “may”, “should”, “expects”, “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of the Company. Actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the Company’s operating or financial results; the Company’s ability to continue as a going concern; the Company’s liquidity, including its ability to service its indebtedness; competitive factors in the market in which the Company operates; shipping industry trends, including charter rates, vessel values and factors affecting vessel supply and demand; future, pending or recent acquisitions and dispositions, business strategy, areas of possible expansion or contraction, and expected capital spending or operating expenses; risks associated with operations outside the United States; risks associated with the length and severity of the ongoing novel coronavirus (COVID-19) outbreak, including its effects on demand for dry bulk products and the transportation thereof; and other factors listed from time to time in the Company’s filings with the SEC, its most recent annual report on Form 20-F. The Company’s filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, 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.

For further information please contact:

Capital Link, Inc.
Daniela Guerrero
230 Park Avenue Suite 1536
New York, NY 10169
Tel: (212) 661-7566
E-mail: [email protected]



TMX Group Equity Financing Statistics – December 2020

Canada NewsWire


Toronto Stock Exchange, TSX Venture Exchange

TORONTO, Jan. 12, 2021 /CNW/ – TMX Group today announced its financing activity on Toronto Stock Exchange (TSX) and TSX Venture Exchange (TSXV) for December 2020.

TSX welcomed 10 new issuers in December 2020, compared with 11 in the previous month and three in December 2019. The new listings were four exchange traded funds, two closed end funds, one life sciences company, one technology company, one oil & gas company and one mining company. Total financings raised in December 2020 decreased 34% compared to the previous month, and decreased 65% compared to December 2019. The total number of financings in December 2020 was 53, compared with 39 the previous month and 52 in December 2019.

For additional data relating to the number of transactions billed for TSX, please click on the following link: https://www.tmx.com/resource/en/440 

TSXV welcomed eight new issuers in December 2020, compared with four in the previous month and 12 in December 2019. The new listings were three capital pool companies, four mining companies and one financial services company. Total financings raised in December 2020 increased 136% compared to the previous month, and were up 145% compared to December 2019. There were 177 financings in December 2020, compared with 115 in the previous month and 146 in December 2019.

TMX Group consolidated trading statistics for December 2020 can be viewed at www.tmx.com.


Toronto Stock Exchange


December 2020


November 2020


December 2019

Issuers Listed

1,642

1,643

1,572

New Issuers Listed

10

11

3

IPOs                                                                

8

7

1

Graduates from TSXV

2

3

0

Issues Listed                                                  

2,293

2,296

2,222

IPO Financings Raised                                  

$339,028,246

$117,959,988

$172,500,000

Secondary Financings Raised

$3,479,516,201

$5,710,255,105

$3,039,232,705

Supplemental Financings Raised

$47,308,800

$22,656,848

$7,961,638,100

Total Financings Raised

$3,865,853,247

$5,850,871,941

$11,173,370,805

Total Number of Financings                        

53

39

52

Market Cap Listed Issues                            

$3,398,550,102,622

$3,320,596,311,218

$3,196,015,391,388


Year-to-date Statistics


2020


2019


% change

New Issuers Listed                                        

170

134

+26.9

IPOs

140

106

+32.1

Graduates from TSXV

20

21

-4.8

IPO Financings Raised                                  

$6,759,887,738

$1,579,564,320

+328.0

Secondary Financings Raised

$27,199,147,749

$19,846,208,282

+37.0

Supplemental Financings Raised

$2,220,900,538

$13,388,164,546

-83.4

Total Financings Raised

$36,179,936,025

$34,813,937,148

+3.9

Total Number of Financings

533

511

+4.3

Market Cap Listed Issues

$3,398,550,102,622

$3,196,015,391,388

+6.3


TSX Venture Exchange

**


December 2020


November 2020


December 2019

Issuers Listed                                                 

1,889

1,900

1,939

New Issuers Listed

8

4

12

IPOs                                           

5

2

10

Graduates to TSX

2

3

0

Issues Listed

1,974

1,986

2,027

IPO Financings Raised                                  

$12,042,642

$680,000

$37,539,650

Secondary Financings Raised (1)

$370,556,898

$178,438,865

$68,437,121

Supplemental Financings Raised

$576,022,238

$226,992,108

$285,273,400

Total Financings Raised

$958,621,778

$406,110,973

$391,250,171

Total Number of Financings                        

177

115

146

Market Cap Listed Issues

$78,362,951,154

$66,919,901,885

$45,351,401,011


Year-to-date Statistics


2020


2019


% Change

New Issuers Listed                      

63

89

-29.2

IPOs

39

73

-46.6

Graduates to TSX

20

21

-4.8

IPO Financings Raised                                  

$213,018,283

$91,031,359

+134.0

Secondary Financings Raised (1)

$1,879,583,265

$1,100,135,241

+70.9

Supplemental Financings Raised

$4,570,886,951

$3,044,907,302

+50.1

Total Financings Raised

$6,663,488,499

$4,236,073,902

+57.3

Total Number of Financings                        

1,717

1,372

+25.1

Market Cap Listed Issues

$78,362,951,154

$45,351,401,011

+72.8


**Includes NEX (not applicable to New Issuers Listed, IPOs and IPO Financings Raised)

(1)     
Secondary financings include prospectus offerings on both a  treasury and secondary basis

TMX Group does not guarantee either the completeness or the accuracy of this information. The information contained in this media release is provided for informational purposes only and you agree not to rely upon the information contained in this media release for any trading, business, or financial purposes.  By using this media release, you expressly agree to the condition that TMX Group assumes no liability or responsibility for any errors or inaccuracies in this media release.

TMX Group welcomes the following companies that listed during December 2020:


Toronto Stock Exchange


Issuer Name


Company Symbol

CI Galaxy Bitcoin Fund

BTCG.UN & BTCG.U

Haivision Systems Inc.

HAI

Horizons Tactical Absolute Return Bond ETF

HARB

K92 Mining Inc.

KNT

MindBeacon Holdings Inc.

MBCN

Pipestone Energy Corp.

PIPE

TD Morningstar ESG Canada Equity Index ETF

TMEC

TD Morningstar ESG International Equity Index ETF

TMEI

TD Morningstar ESG U.S. Equity Index ETF

TMEU

The Ether Fund

QETH.U


TSX Venture Exchange


Issuer Name


Company Symbol

Cross Border Capital I Inc.

CBX.P

Cuspis Capital II Ltd.

CCII.P

E2Gold Inc.

ETU

EFH Holdings Inc.

EFH

Element 29 Resources Inc.

ECU

Empress Royalty Corp.

EMPR

Jabbo Capital Corp.

JAB.P

Tempus Resources Ltd.

TMRR


About TMX Group (TSX:X)

TMX Group operates global markets, and builds digital communities and analytic solutions that facilitate the funding, growth and success of businesses, traders and investors. TMX Group’s key operations include Toronto Stock Exchange, TSX Venture Exchange, TSX Alpha Exchange, The Canadian Depository for Securities, Montréal Exchange, Canadian Derivatives Clearing Corporation, and Trayport which provide listing markets, trading markets, clearing facilities, depository services, technology solutions, data products and other services to the global financial community. TMX Group is headquartered in Toronto and operates offices across North America (Montréal, Calgary, Vancouver and New York), as well as in key international markets including London and Singapore. For more information about TMX Group, visit our website at www.tmx.com. Follow TMX Group on Twitter: @TMXGroup.

SOURCE TMX Group Limited

Recombinetics Inc. Announces Neurofibromatosis Type 1 Research Collaboration with AstraZeneca

PR Newswire

EAGAN, Minn., Jan. 12, 2021 /PRNewswire/ —  Recombinetics Inc., a leading gene editing company with platform technology applied to biomedicine and animal agriculture, today announced a research collaboration with AstraZeneca(LSE/STO/Nasdaq: AZN)  in a first of its kind study to inform the knowledge base of Neurofibromatosis Type 1 (NF1).

NF1 is a pediatric disease that affects 1 in 3,000 births. NF1 patients suffer from a variety of manifestations including learning disabilities, scoliosis, and are predisposed to tumor development. In April 2020, selumetinib became the first FDA approved therapy for NF1 patients for the treatment of symptomatic, inoperable plexiform neurofibromas. 

Surrogen, a subsidiary of Recombinetics Inc., has developed several large animal models of neurofibromatoses that exhibit the clinical features seen in patients with these diseases. In particular, Surrogen’s NF1 minipig displays café-au-lait macules, a diagnostic marker of NF1.  In addition, the model also develops both optic pathway glioma and cutaneous neurofibromas, both of which are manifestations of the disease that have been challenging to study preclinically, until now.  

Surrogen’s NF1 minipig platform presents an exceptional opportunity to better understand this disease and pilot much needed treatments and cures to the millions of people throughout the world suffering  from this disease.  

Together, AstraZeneca and Recombinetics Inc. will now undertake a study to assess selumetinib for the treatment of cutaneous neurofibromas, using Surrogen’s NF1 preclinical platform. The results of this study will provide key insights into whether selumetinib can also be used as an effective treatment for cutaneous neurofibromas, which occur in nearly all NF1 patients.

 “Bringing new therapies to the clinic that are poised to have a meaningful impact on patient lives is the most important thing we can do,” says Dr. Adrienne Watson, Recombinetics Inc. Vice President of Research and Development, “Utilizing a preclinical model that most closely resembles the patient population is critical to these efforts.”

According to Recombinetics’ CEO, Mark Platt, “Dr. Watson and her team have shown incredible skill, dedication, and focus in bringing this powerful genetic model to bear in the fight to treat and cure NF1.  It is an honor to partner with AstraZeneca to combine our efforts and make a difference for NF1 patients and their families.”

About Recombinetics

Founded in 2008, Recombinetics Inc. is a recognized global leader in the development, deployment, and commercialization of genetically engineered animals.  Its four subsidiaries, Regenevida, Surrogen, Makana, and Acceligen, have delivered hundreds of animals to enable drug, device and therapeutic discovery, generate transplantable cells, tissues and organs, and provide improved health, well-being and productivity of agricultural animals.

Contact:
Nikki Rockstroh
[email protected]


https://recombinetics.com/

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SOURCE Recombinetics, Inc.