Protech Home Medical Announces New Independent Board Member

Dr. Kevin A. Carter Appointed to Board of Directors

CINCINNATI, Dec. 09, 2020 (GLOBE NEWSWIRE) — Protech Home Medical Corp. (“Protech” or the “Company”) (TSXV: PTQ) (OTCQX: PTQQF) a U.S. based leader in the home medical equipment industry, focused on end-to-end respiratory care, announced today that Dr. Kevin A. Carter has joined the board of directors of the Company as an independent director.

Kevin A. Carter, DO, FAASM, is Board Certified in Sleep Medicine by the American Board of Family Medicine; he is also Board Certified in Family Medicine. Before establishing his current practice, Dr. Carter served as Medical Director at the Martin Army Sleep Medicine Center at Fort Benning, Georgia. Prior to this appointment, he served as a United States Army Field Surgeon, with service including deployment in Iraq. Currently, through the Carter Sleep Center, he offers full-spectrum sleep medicine evaluations, diagnosis, and treatments.

Dr. Carter holds the degree of Fellow by the American Academy of Sleep Medicine, a recognition that he has met the highest standards in the practice of sleep medicine.

Dr. Carter is a graduate of the Ohio University Heritage College of Osteopathic Medicine. He completed a Family Medicine residency at DeWitt Army Community Hospital and Sleep Medicine fellowship at Walter Reed Army Medical Center. He is also an active member of both the American Academy of Sleep Medicine and the American Academy of Family Physicians.

“The board is pleased to welcome Dr. Carter as our newest independent director, during such an important period of time in the Company’s history; Dr. Carter’s wealth of experience will be invaluable to us as we constantly seek to evolve our patient centric approach. Moreover, Dr. Carter’s expertise in Sleep Medicine will provide meaningful insights as we continue to grow and position our entire sleep business, in particular on the heels of our recent closing of the acquisition of Sleep, LLC,” commented Greg Crawford, CEO and Chairman of Protech. “This appointment reflects our commitment to building a strong and diverse board of directors to help the Company execute on its long-term growth strategy and continue to build shareholder value.”

Dr. Kevin A. Carter added, “I am excited to join the board of directors of a thriving at-home clinical respiratory company at such an important time. It is at-home providers focused on superior patient care like Protech, that do so much to assist hospital systems gain bed capacity by getting patients discharged to the home or treated in the home to begin with. During this chapter in our lives, it has never been so crucial to our healthcare system, and I truly believe this will have long lasting effects on the industry. Coupled with the demographics in the United States, there is no question the need for in-home healthcare will continue to surge for many years to come. Protech has the right infrastructure, team, and knowledge to seize the moment and I am proud to be associated with Protech, utilizing my skillset and background to help the company flourish.”

In connection with his appointment, Dr. Carter has been granted 200,000 incentive stock options exercisable at $1.54 per share vesting over a four year period and expiring on December 7, 2025. The options and underlying shares are subject to a four month hold.

The appointment of Dr. Carter expands the Company’s board of directors to four members, three of whom are independent.

ABOUT PROTECH HOME MEDICAL

The Company provides in-home monitoring and disease management services including end-to-end respiratory solutions for patients in the United States healthcare market. It seeks to continue to expand its offerings to include the management of several chronic disease states focusing on patients with heart or pulmonary disease, sleep disorders, reduced mobility and other chronic health conditions. The primary business objective of the Company is to create shareholder value by offering a broader range of services to patients in need of in-home monitoring and chronic disease management. The Company’s organic growth strategy is to increase annual revenue per patient by offering multiple services to the same patient, consolidating the patient’s services and making life easier for the patient.

The securities referred to in this news release have not been, nor will they be, registered under the United States ‎‎Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for t
he ‎account ‎or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration ‎requirements. ‎This news release does not constitute an offer for sale of securities, nor a solicitation for offers to ‎buy any securit
ies. ‎Any public offering of securities in the United States must be made by means of a prospectus ‎containing detailed ‎information about the company and management, as well as financial statements.‎

Neither the TSX Venture Exchange nor its
Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For further information please visit our website at www.protechhomemedical.com, or contact:

Cole Stevens
VP of Corporate Development
Protech Home Medical Corp.‎
‎859-300-6455‎
[email protected]

Gregory Crawford
Chief Executive Officer
Protech Home Medical Corp.‎
‎859-300-6455‎
[email protected]



C2C Gold Expands Newfoundland Holdings; Appoints Shawn Ryan as Technical Advisor

VANCOUVER, British Columbia, Dec. 09, 2020 (GLOBE NEWSWIRE) — C2C GOLD CORP. (CSE: CTOC; OTCQB: TAKUF) (formerly Taku Gold Corp.) is pleased to announce an expansion of its property holdings in the prolific Newfoundland Central Gold Belt as part of a strategic initiative to grow C2C into a leading company in Newfoundland’s rapidly emerging gold exploration boom. C2C has acquired, through staking, an additional 525 claims and now controls a total of 2,497 claims covering 624 sq km in the Central Newfoundland Gold Belt. The C2C properties are all road accessible and situated along the same prominent structural orogenic belt that is host to Marathon Gold’s Valentine project (estimated resources in all categories exceeding 4 million ounces gold)1, Canterra Minerals Corp.’s Wilding project, Great Atlantic Resources Corp.’s Golden Promise project and Sokoman Minerals Corp.’s Moosehead project.

The Company is also pleased to announce the appointment of Shawn Ryan, 2011 recipient of PDAC’s Prospector of the Year, as Technical Advisor to the Company.

The Company is hosting a live discussion on Thursday, December 10th at 11 AM PST with Technical Advisor, Shawn Ryan, and Executive Chair Janet Lee-Sheriff. Please log in and join the live discussion as they outline the exciting development in Newfoundland and C2C Gold’s growing position in the region:    https://attendee.gotowebinar.com/register/1313530878031715342.

To view C2C’s growing property holdings and overall activity in Newfoundland please view: https://bit.ly/2VBWnDx.

Shawn Ryan
, Technical Advisor

Shawn has over 20 years of experience prospecting gold across the Yukon and has been rapidly expanding his prospecting in Canada’s Newfoundland. A global leader in his field, his prospecting and specialization on advanced soil geochemical work led to the discovery of the millions of gold ounces including the Golden Saddle & Arc, Coffee, and QV gold resources. This success has also been recognized with Shawn winning the 2011 PDAC Prospector of the Year Award, 2010 Spud Huestis Award and the Yukon Prospector of the Year Award. Shawn continues to be an active participant with his technical teams, constantly improving efficiencies with his methodological exploration techniques.

C2C
Gold –
Newfoundland Properties

The company’s land package consists of three properties, Badger (1001 claims – 25,025 hectares), Millertown (908 claims – 22,700 hectares) and Barrens Lake (588 claims – 14,700 hectares). The new staking included the addition of claims to the Badger Lake project and the Barren Lake project. The expansion of these claim blocks covered adjacent prospective ground based with through-going regional-scale faulting and regionally anomalous gold in till geochemistry.

The C2C Gold projects are located within the Central Gold Belt within a northeast trending structure zone bounded by the Red Indian Line (RIL) fault zone on the north and the Valentine Lake fault zone to the south. These regionally extensive fault zones are deep crustal sutures which localize deformation and fluid flow and host orogenic-style gold bearing quartz veins and stockwork zones within the Central Gold Belt. Geologic mapping and aeromagnetic data show the complex architecture of faulting and folding characteristic of the Central Gold Belt. The host rocks are largely Early Cambrian to Late Ordovician Victoria Lake Supergroup consisting of calc-alkalic volcanic rocks that are intercalated with and overlain by volcanogenic sandstone and shale overlain by thick Caradocian graphitic shales. Regional till and lake sediment sampling programs by the Newfoundland and Labrador Geological Survey defined numerous gold-in-till anomalies that define the Central Gold Belt and are spatially related to this northeast trending structural zone.

The Badger, Millertown and Barrens Lake properties cover highly prospective ground in a newly emerging gold district. The projects are underexplored for their gold potential, given numerous gold-in-till anomalies, underlying favorable geology, structural elements, and regional tectonic setting in this emerging orogenic gold belt. C2C is compiling all available information towards designing a 2021 exploration program to evaluate these highly prospective new properties. The most recent exploration program took place in 2016-2017, when Torq Resources carried out infill till sampling on areas that overlap with portions of the current C2C property boundaries.

Companies working on active gold projects within this belt and the broader Exploits Subzone have noted the similarity in geological setting and character with both the Abitibi greenstone belts in Ontario and Quebec, Canada and the Bendigo-Fosterville deposits in Australia. Government reports enhanced by work completed by prospectors and public companies have shown, in many instances, gold-in-till anomalies are related to underlying gold-in-soil anomalies which are more directly linked to underlying bedrock gold occurrences.

Newfoundland Projects – Regional Overview

Newfoundland has long been known to have a large number of gold occurrences with relatively little modern exploration. Historical production from the Hope Brook, Nugget Pond, and Point Rousse projects have been typical of the island’s mines with relatively modest production from high grade deposits. More recently important significant drill intersections such as those at New Found Gold Corp. (22.3 g/t gold over 41.3 m)4 and those contributing to the growing resource at Marathon Gold Corp’s Valentine Deposit have raised the status of the area to that of a premier gold exploration jurisdiction. These continued positive results have given rise to extensive staking and expanded land holdings within Newfoundland’s Central Gold Belt giving rise to a modern-day gold rush.

Technical information in this news release has been approved by Jeff Cary, CPG, a consultant and “Qualified Person” as defined by National Instrument 43-101 – Standards of Disclosure for Mineral Projects.

About C2C Gold Corp.

C2C Gold Corp is a Canadian mineral exploration company focused on the acquisition and development of mineral projects in Newfoundland, Canada. The Company holds the Badger, Millertown, and Barrens Lake projects, which cumulatively cover an area of 624 km² with road access and proximity to communities and power lines.  All projects lie within the Central Newfoundland Gold Belt and provide a large land position in a top mineral exploration jurisdiction. Mineral development in Newfoundland has advanced significantly with increased exploration and development activities throughout the province. C2C also holds one of the largest land packages, with several prominent projects, within the prolific White Gold and Klondike districts in Canada’s Yukon.

For additional information:

Lori Walton, Chief Executive Officer
(604)757-7180
[email protected]
www.c2cgold.com

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
____________________

1 April 6, 2020 News Release – see N.I. 43-101 Technical Report and Pre-Feasibility Study on the Valentine Gold Project at marathon-gold.com

 



Dorman Announces More Than 530 New Products, Featuring Several OE FIX™ Upgrades

Highlights:

  • New OE FIX 4WD front differential actuator for more than 700,000 General Motors vehicles features upgraded rubber and mesh design to improve longevity and help prevent future failures.
  • New OE FIX intake manifold for more than 250,000 Hyundai and Kia vehicles has been reengineered to help reduce potential failure points in the factory design.
  • New OE FIX Power Band Clamp is first of several turbocharger boot clamps with patented curved profile designed to improve performance compared to traditional flat clamps.

COLMAR, Pa., Dec. 09, 2020 (GLOBE NEWSWIRE) — Dorman Products, Inc. (NASDAQ:DORM) is announcing today the release of more than 530 new replacement auto parts, giving repair shops and vehicle owners greater freedom to fix cars and trucks with innovative and trustworthy solutions.

This month Dorman is continuing to grow its line of OE FIX™ four-wheel-drive (4WD) components with a new 4WD front differential actuator (600-102XD) for more than 700,000 General Motors SUVs and pickup trucks like the Chevrolet Blazer and S10 and GMC Jimmy and Sonoma. The original equipment 4WD differential actuators on many of these vehicles may fail when the rubber diaphragm dry rots over time and creates vacuum leaks. Dorman’s team engineered a new compound material of nitrile rubber and polyester fiber mesh, which has been designed to outlast the original equipment material. This upgrade could help eliminate the need to replace the OEM version several times during the vehicle’s lifespan.

Another exclusive OE FIX this month is Dorman’s new upgraded intake manifold (615-472) for certain Hyundai Santa Fe, Kia Sedona and Kia Sorento model years, with more than a combined quarter-million vehicles in operation. The original equipment intake manifold on certain Hyundai and Kia vehicles may fail when the pivot linkage connecting the two variable-intake flapper valve shafts shears from fatigue. This Dorman OE FIX intake manifold has been reengineered for greater durability. The flapper valve shafts are made from thicker material for improved strength and the shafts are supported by additional bearings to reduce stress points that could lead to failure in the factory design.

Dorman is also releasing this month the first of several patented turbocharger intercooler hose clamps (55245), called Dorman Power Band Clamps. Typical flat-style clamps apply uneven force, which could cause pressure leaks and reduce vehicle performance. These Dorman OE FIX solutions have a curved profile that is designed to create a stronger seal to better protect turbo components. They also feature a low-profile spiral screw that takes less space than the original T-bolt clamp, and requires less torque for proper installation.

In addition to 130 other exclusive solutions this month, Dorman is now unveiling a new line of pre-programmed engine control modules (ECM) – also called engine control units (ECU) or powertrain control modules (PCM) – that are all remanufactured at Dorman’s advanced electronics facility in Lewisberry, Pennsylvania. With 37 ECMs now available, and a streamlined ordering system, it’s easier than ever to find and install the right unit.

These are just a few of Dorman’s featured new product releases this month. To sign up to receive all of Dorman’s new product announcements directly every month, sign up at DormanProducts.com/signup. To learn more about Dorman, take the Dorman Virtual Tour at DormanProducts.com/tour.

Note: Vehicle-in-Operation (VIO) information in this press release is based on Dorman’s analysis of third-party reports.

Contact: Steve Gisondi, Vice President of Marketing
Email: [email protected]

About Dorman Products

Dorman gives repair professionals and vehicle owners greater freedom to fix cars and trucks by focusing on solutions first. For over 100 years, we have been one of the automotive aftermarket industry’s pioneering problem solvers, releasing tens of thousands of replacement products engineered to save time and money and increase convenience and reliability.

Founded and headquartered in the United States, we are a global organization offering an always-evolving catalog of parts, covering both light duty and heavy duty vehicles, from chassis to body, from underhood to undercar, and from hardware to complex electronics. See our full offering and learn more at DormanProducts.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations that involve a number of known and unknown risks, uncertainties and other factors (many of which are outside of our control) which may cause actual events to be materially different from those expressed or implied by such forward-looking statements. For additional information concerning factors that could cause actual results to differ materially from the information contained in this press release, please see Dorman’s prior press releases and filings with the U.S. Securities and Exchange Commission (“SEC”), including Dorman’s most recent annual report on Form 10-K, its Form 10-Q for the quarter ended September 26, 2020 and its other SEC filings. Dorman is under no obligation to (and expressly disclaims any such obligation to) update any of the information in this press release if any forward-looking statement later turns out to be inaccurate whether as a result of new information, future events or otherwise.

Visit Dorman’s website at www.dormanproducts.com. The Investor Relations section of the website contains a significant amount of information about Dorman, including financial and other information for investors. Dorman encourages investors to visit its website to view new and updated information.

 



Ahana Announces General Availability of Managed Service for Presto on AWS; Delivers Combined Solution with Intel to Drive Adoption of Open Data Lakes Analytics

SAN MATEO, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) — Ahana, the self-service analytics company for Presto, announced today the General Availability of Ahana Cloud for Presto, the first cloud-native managed service focused on Presto on Amazon Web Services (AWS). Additionally, Ahana announced a go-to-market solution in collaboration with Intel via its participation in the Intel Disruptor Program to offer an Open Data Lake Analytics Accelerator Package for Ahana Cloud users that leverages Intel Optane on the cloud with AWS.


Ahana


Cloud for Presto
is the only easy-to-use, cloud-native managed service for Presto and is deployed within the user’s AWS account, giving customers complete control and visibility of clusters and their data. In addition to the platform’s use of Amazon Elastic Kubernetes Services (Amazon EKS) and a Pay-As-You-Go (PAYGO) pricing model in AWS Marketplace, the new release includes enhanced manageability, security and integrations via AWS Marketplace.

Ahana Cloud for Presto includes:

  • Easy-to-use Ahana SaaS Console for creation, deployment and management of multiple Presto clusters within a user’s AWS account bringing the compute to user’s data
  • Support for Amazon Simple Storage Service (Amazon S3), Amazon Relational Database (Amazon RDS) for MySQL, Amazon RDS for PostgreSQL and Amazon Elasticsearch
  • Click-button integration for user-managed Hive Metastores and Amazon Glue
  • Built-in hosted Hive Metastore that manages metadata for data stored in Amazon S3 data lakes
  • Pre-integrated and directly queryable Presto query log and integrations with Amazon CloudWatch
  • Cloud-native, highly scalable and available containerized environment deployed on Amazon EKS

“With Ahana Cloud being generally available, the power of Presto is now accessible to any data team of any size and skill level. By abstracting away the complexities of deployment, configuration and management, platform teams can now deploy ‘self-service’ Presto for open data lake analytics as well as analytics on a range of other data sources,” said Dipti Borkar, Cofounder and Chief Product Officer, Ahana. “Users are looking for analytics without being locked-in to proprietary data warehouses. This offering brings a SaaS open source analytics option to users with Presto at its core, using open formats and open interfaces.”

“As Ahana Cloud users, we saw from day one the value the platform brings to our engineering team,” said Kian Sheik, Data Engineer, ReferralExchange. “Within about an hour we were up and running Presto queries on our data, without having to worry about Presto under the covers. With out-of-the-box integrations with a Hive data catalog and no configurations needed, Ahana Cloud takes care of the intricacies of the system, allowing our team to focus on deriving actionable insights on our data.”

Ahana also announced its participation in the Intel Disruptor Program to drive the adoption of Open Data Lake Analytics. Together, Ahana and Intel will offer an Open Data Lake Analytics Accelerator Package, available for Ahana Cloud users that leverage Intel Optane on AWS. It includes special incentives and PAYGO pricing. An Open Data Lake Analytics approach is a technology stack that includes open source, open formats, open interfaces, and open cloud, a preferred approach for companies that want to avoid proprietary formats and technology lock-in that come with traditional data warehouses. The offering is aimed at improving joint customers’ experience of running Presto in the cloud to help power the next generation of analytics use cases.

“We look forward to working with Ahana and helping bring this compelling open data lake analytic solution to market,” said Arijit Bandyopadhyay, CTO of enterprise analytics & AI within Intel’s data platform group. “As more companies require data to be queried across many different data sources like Amazon S3, Amazon Redshift and Amazon RDS, Presto will become even more mission critical. Intel Optane coupled with the Ahana Cloud platform provides superior analytical performance and ease of use for Presto, enabling data-driven companies to query data in place for open data lake analytics.”

Availability and Pricing

Ahana Cloud for Presto is available in AWS Marketplace, with support for Microsoft Azure and Google Cloud to be added in the future. Ahana Cloud for Presto is elastically priced based on usage, with PAYGO and annual options via AWS Marketplace, starting from $0.25 per Ahana cloud credit.

The Ahana/Intel Open Data Lakes Accelerator Package is available today via an AWS Marketplace Private Offer.

Supporting R
esources

Tweet this: .@AhanaIO announces GA of #ManagedService for #Presto; Joins Intel Disruptor Program #cloudnative #opensource #analytics @prestodb https://bit.ly/2LiE6cL

About
Ahana

Ahana, the self-service analytics company for Presto, is the only company with a cloud-native managed service for Presto for Amazon Web Services that simplifies the deployment, management and integration of Presto and enables cloud and data platform teams to provide self-service, SQL analytics for their organization’s analysts and scientists. As the Presto market continues to grow exponentially, Ahana’s mission is to simplify interactive analytics as well as foster growth and evangelize the PrestoDB community. Ahana is a premier member of Linux Foundation’s Presto Foundation and actively contributes to the open source PrestoDB project. Founded in 2020, Ahana is headquartered in San Mateo, CA and operates as an all-remote company. Investors include GV, Lux Capital, and Leslie Ventures. Follow Ahana on LinkedIn, Twitter and PrestoDB Slack.

Media Contact:
Beth Winkowski
Winkowski Public Relations, LLC
978-649-7189
[email protected] 



Delcath Systems Announces Pricing of Public Offering of Common Stock

NEW YORK, Dec. 09, 2020 (GLOBE NEWSWIRE) — Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, today announced the pricing of an underwritten public offering of 1,460,027 shares of its common stock at a public offering price of $13.25 per share. The gross proceeds of the offering to the Company are expected to be approximately $19.3 million, before deducting the underwriting discounts and commissions and other estimated offering expenses.

The closing of the offering is expected to occur on or about December 11, 2020, subject to the satisfaction of customary closing conditions.

Delcath intends to use the net proceeds from this offering for (i) the completion of its FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the “Focus Trial”), a global registration clinical trial that is investigating the primary endpoint of objective response rate, as well as other secondary and exploratory endpoints, in metastatic ocular melanoma, or mOM; (ii) preparation of the federal regulatory application for the HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system), or HEPZATO™, a drug/device combination product regulated as a drug, designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects; (iii) preparation for the commercial launch of HEPZATO; (iv) continued clinical development, including additional indications and expanded access trials in metastatic ocular melanoma; and (v) general corporate purposes, which may include capital expenditures and other operating expenses.

Canaccord Genuity and Roth Capital Partners are acting as joint book-running managers for the proposed offering.

A shelf registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on December 21, 2018. A preliminary prospectus supplement relating to the offering was filed with the SEC on December 8, 2020 and is available on the SEC’s website at http://www.sec.gov. The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website. Before investing in the offering, you should read the prospectus supplement and the accompanying prospectus in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the Company and the offering. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Canaccord Genuity LLC, Attention: Syndicate Department, 99 High Street, Suite 1200, Boston, MA 02110, by telephone at (617) 371-3900 or by email at [email protected] or Roth Capital Partners, LLC, 888 San Clemente, Newport Beach, CA 92660, Attention: Prospectus Department, or by telephone at (800) 678-9147.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Delcath Systems, Inc.

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product, HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system), is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. HEPZATO KIT has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system is marketed under the trade name Delcath CHEMOSAT® Hepatic Delivery System for Melphalan (CHEMOSAT) and has been CE Marked and used at major medical centers to treat a wide range of cancers of the liver. CHEMOSAT is being marketed under an exclusive licensing agreement with medac GmbH, a privately held multi-national pharmaceutical company headquartered in Germany that specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases.

Safe Harbor / Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the timing and results of the Company’s clinical trials, including without limitation the mOM and ICC clinical trial programs, our determination whether to continue the ICC clinical trial program or to focus on other alternative indications, and timely monitoring and treatment of patients in the global Phase 3 mOM clinical trial and the impact of the COVID-19 pandemic on the completion of our clinical trials; the impact of the presentations at major medical conferences and future clinical results consistent with the data presented; approval of Individual Funding Requests for reimbursement of the CHEMOSAT product; the impact, if any, of ZE reimbursement on potential CHEMOSAT product use and sales in Germany; clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK; the Company’s ability to successfully commercialize the HEPZATO KIT/CHEMOSAT system and the potential of the HEPZATO KIT/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver; our ability to obtain reimbursement for the CHEMOSAT system in various markets; approval of the current or future HEPZATO KIT/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets; actions by the FDA or foreign regulatory agencies; the Company’s ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same; uncertainties relating to the timing and results of research and development projects; and uncertainties regarding the Company’s ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

Contact:

Delcath Investor Relations

Email: [email protected]

Hayden IR

James Carbonara
(646)-755-7412
[email protected]



Wholesale Fashion Industry Demonstrates Resilience Through Digital Transformation

Newly released data from JOOR shows brands and retailers maintaining business continuity amidst ongoing pandemic

NEW YORK, Dec. 09, 2020 (GLOBE NEWSWIRE) — JOOR, the world’s leading digital wholesale platform for fashion, today released its growth figures for the second half of 2020. These data points illustrate how COVID-19 has ushered in an entirely new blueprint for wholesale by spurring brands and retailers to accelerate their digital transformation efforts.

Ongoing business disruption and shutdowns early in 2020 led brands and retailers to turn increasingly to virtual channels to conduct business as the year progressed. With over 8,600 brands and 200,000 curated retailers, JOOR’s platform activity represents the luxury fashion industry as a whole. Transaction data from the platform shows that business continues despite ongoing economic headwinds. Looking at the second half of 2020 compared to the same time period in 2019, both gross merchandise value (GMV) and average order value (AOV) passing through the JOOR platform increased 52% and 57% respectively. In addition, 4,000 new retailers placed orders in the second half of 2020 compared to the second half of 2019.

“The COVID-19 pandemic has upended the retail industry,” said Kristin Savilia, CEO of JOOR. “However, it has also served as a call to action for brands and retailers to find digital ways to work together. This is a new way of doing business that will continue even when in-person contact is possible again because it is convenient, sustainable and cost-effective.”

JOOR’s data shows that strong engagement is happening in the ecosystem. So far in 2020, 1.8 million new connections have been made on the JOOR platform between brands and curated retailers. Compared to the second half of 2019, brand profile visits increased by 362% and retailer logins rose by almost 50%. The top five retailers using JOOR as measured by year-to-date orders include Neiman Marcus, Nordstrom, Saks, Net-a-Porter and Mytheresa.

At the same time, small and medium-sized local retailers remain important in the retail ecosystem. The devastating impacts of the pandemic have made consumers conscious of supporting retailers in their own communities. Among JOOR’s 200,000 SMB retailers, transactions in the second half of 2020 rose 60% compared to the same period in 2019.

Virtual fashion shows, which were previously non-existent, gained significant traction in 2020. During the summer and fall fashion season, JOOR hosted 16 global events on its JOOR Passport platform, attracting more than 135,000 visitors from 128 countries. From a brand perspective, 1628 brands participated in a JOOR Passport event where they averaged 15 new connections per event and sold more than 470,000 items.

In October, McKinsey & Company published its own analysis that reflects the trends that emerge in JOOR’s data. They conclude that “these pandemic-induced patterns are likely to become permanent. Close to nine in ten decision makers say that new commercial and go-to-market sales practices will be a fixture throughout 2021 and possibly beyond.”

For more information, download JOOR’s whitepaper with comprehensive growth figures or visit JOOR.com.

About JOOR 

JOOR is the world’s industry-standard wholesale platform for fashion, that transacts over $1.5Bn in GMV every month. More than 8,600 brands and over 200,000 curated fashion retailers across 144 countries connect on the platform every day. With a commitment to fueling the advancement and growth of both brands and retailers, JOOR provides an ecosystem that combines dynamic virtual showrooms with collaborative tools including JOOR Passport, which centralizes the trade show experience across multiple fashion events. JOOR users have greater flexibility, visibility, performance and insights into their business. JOOR is headquartered in New York City and has offices in Los Angeles, Philadelphia, Paris, London, Milan, Madrid, Melbourne and Tokyo. For more information visit: JOOR.com.



Contact Information:
Gretchen Miller, [email protected]  

Vera Bradley Announces Third Quarter Fiscal 2021 Results

Company posts
third
quarter
GAAP EPS of $
0
.
2
6
per diluted share
, compared to $0.00 per diluted share last year, and non-GAAP EPS, excluding certain items, of $0.30 per diluted share, compared to $0.20 per diluted share last year

Company delivers gross margin rate improvement and
meaningful
leverage on expenses
for the quarter

Balance sheet remains strong
,
with cash, cash equivalents, and investments
of
$7
7.3
million

FORT WAYNE, Ind., Dec. 09, 2020 (GLOBE NEWSWIRE) — Vera Bradley, Inc. (Nasdaq: VRA) (the “Company”) today announced its financial results for the third quarter ended October 31, 2020.     

Chief Executive Officer Rob Wallstrom noted, “Our quarterly earnings once again significantly exceeded last year’s performance as well as our expectations.   We expanded our gross margin rate primarily through sales of cotton masks and controlled promotional activity, and we diligently managed our expenses, achieving meaningful expense leverage. Our multi-brand strategy is proving to be powerful.”

Wallstrom continued, “Customers are changing the way they shop, and we have responded. Our digital competencies are becoming increasingly important, especially in this quickly evolving environment. Somewhat fortuitously, last year, we acquired digitally-native Pura Vida and began working on critical Vera Bradley technology infrastructure and e-commerce site improvements necessary to position the Company for future success.

“Our consolidated e-commerce business was very strong in the third quarter, reflecting growth from both Vera Bradley and Pura Vida. Even as our stores were reopened during the third quarter, our Vera Bradley digital business rose nearly 50% over last year.   And, Pura Vida’s e-commerce year-over-year sales grew over 17% for the quarter, despite supply chain disruptions. E-commerce sales comprised over a third of total Company revenues for the quarter.”

“Our team demonstrated that by staying laser focused on the customer and by controlling what we can control, we can drive strong results and position ourselves to emerge a stronger and more resilient company, despite facing ongoing headwinds,” Wallstrom added. “Our results were achieved through the innovation, teamwork, and determination of our entire organization.”  

Wallstrom also added, “We are so thankful for all of our Associates and are especially grateful to those that have served on the front lines, making sure our customers have safe and exceptional experiences, day-in and day-out. We were once again thrilled to award a quarterly bonus of up to $500 (based on hours worked) to each distribution center, store, and customer service Associate for their continued contributions and devotion to Vera Bradley during this extraordinary time. Over the last two quarters, we have paid over $800,000 in well-deserved bonuses to our front-line Associates.”


Pura Vida Acquisition and Accounting

In the Company’s prior year second fiscal quarter (on July 16, 2019), Vera Bradley acquired a 75% interest in Creative Genius, Inc., which also operates under the name Pura Vida Bracelets (“Pura Vida”). Financial results for Pura Vida have been consolidated beginning July 17, 2019, the first full day following the acquisition.   The third quarters are comparable (with full quarters of Pura Vida performance); however, prior period nine-month numbers do not include Pura Vida results before the acquisition. Any reference to the results of “Vera Bradley” in this release is to results of the stand-alone Vera Bradley business (comprised of the Vera Bradley Direct and Indirect segments) and excludes Pura Vida. Any reference to the results of “Vera Bradley, Inc.” is to the combined results of Vera Bradley and Pura Vida.


Summary of Financial Performance for the


Third


Quarter

Consolidated net revenues totaled $124.8 million for the current year third quarter compared to $127.5 million in the prior year third quarter.   

For the current year third quarter, Vera Bradley, Inc.’s consolidated net income totaled $8.9 million, or $0.26 per diluted share. These results included $1.4 million of net after tax charges related to intangible asset amortization. On a non-GAAP basis, excluding these items, Vera Bradley, Inc.’s consolidated third quarter net income totaled $10.2 million, or $0.30 per diluted share.

For the prior year third quarter, Vera Bradley, Inc. consolidated net income totaled $0.1 million, or $0.00 per diluted share. These results included $6.8 million of after tax charges comprised of $6.0 million related to purchase accounting adjustments for the Pura Vida acquisition (including inventory step-up amortization, intangible asset amortization, and accretion of the earn-out liability) and $0.8 million of expenses related to the re-platforming of Vera Bradley’s information technology systems (“Project Novus”). On a non-GAAP basis, excluding these charges, Vera Bradley, Inc. consolidated third quarter net income totaled $6.9 million, or $0.20 per diluted share.


Summary of Financial Performance for the


Nine


Months

Consolidated net revenues totaled $325.9 million for the current year nine months ended October 31, 2020 (which included $78.4 million of net revenues from Pura Vida), compared to $338.3 million of revenues in the prior year nine-month period ended November 2, 2019 ( which included $30.4 million of revenues from Pura Vida). Excluding Pura Vida, Vera Bradley net revenues totaled $247.5 million compared to $307.9 million in the prior year nine-month period.

For the current year nine months, Vera Bradley, Inc.’s consolidated net income totaled $0.8 million, or $0.02 per diluted share. These results included $10.2 million of net after tax charges, comprised of $4.1 million of intangible asset amortization, $2.7 million of impairment charges, $2.1 million of Project Novus expenses, $0.9 million of charges related to the cancellation of certain purchase orders as a result of the COVID-19 pandemic (“COVID-19” or the “pandemic”), a $0.2 million adjustment to the Pura Vida earn-out liability, and $0.2 million in certain department store exit costs resulting from COVID-19. On a non-GAAP basis, excluding these charges, Vera Bradley, Inc.’s consolidated net income for the current year nine months totaled $10.9 million, or $0.32 per diluted share. This non-GAAP performance included $0.13 of diluted earnings per share attributable to Pura Vida.

For the prior year nine-month period, Vera Bradley, Inc. consolidated net income totaled $3.6 million, or $0.10 per diluted share. These results included $10.3 million of after tax charges comprised of $9.0 million related to the purchase accounting adjustments for the Pura Vida acquisition (including inventory step-up amortization, intangible asset amortization, transaction costs, and accretion of the earn-out liability) and $1.3 million of expenses related to Project Novus. On a non-GAAP basis, excluding these charges, Vera Bradley, Inc. consolidated net income for the nine months totaled $13.8 million, or $0.40 per diluted share. This performance included $0.08 attributable to Pura Vida.


Non-GAAP Numbers

The current year non-GAAP third quarter income statement numbers referenced below exclude the previously outlined intangible asset amortization. The current year non-GAAP income statement numbers for the nine months referenced below exclude the previously outlined intangible asset amortization, impairment charges, Project Novus expenses, charges related to the cancellation of certain purchase orders resulting from COVID-19, an adjustment to the Pura Vida earn-out liability, and certain department store exit costs resulting from COVID-19. The prior year non-GAAP income statement numbers for the third quarter and nine months referenced below exclude the previously outlined Pura Vida acquisition-related charges and Project Novus expenses.  


Third


Quarter Details

Current year third quarter Vera Bradley Direct segment revenues totaled $78.2 million compared to $78.4 million in the prior year third quarter. E-commerce sales growth of 48.8% offset the 19.1% decline in comparable store sales for the quarter, as store traffic continues to be negatively impacted by the pandemic. The Company closed 10 full-line stores and opened six factory outlet stores in the last twelve months.

Vera Bradley Indirect segment revenues totaled $22.3 million compared to $24.1 million in the prior year third quarter, reflecting a reduction in orders primarily related to the pandemic and in the number of specialty and department store accounts.

Pura Vida segment revenues totaled $24.3 million compared to $25.0 million in the prior year third quarter. A 17.2% growth in e-commerce sales nearly offset a decline in sales to wholesale accounts, which were negatively affected by the pandemic.  

Third quarter consolidated gross profit totaled $73.8 million, or 59.1% of net revenues, compared to $67.9 million, or 53.2% in the prior year. On a non-GAAP basis, excluding inventory step-up amortization, gross profit totaled $74.1 million or 58.1% of net revenues in the prior year third quarter. The Company expanded its consolidated gross profit rate in the quarter primarily through sales of cotton masks and controlled promotional activity.     

Third quarter consolidated SG&A expense totaled $61.7 million, or 49.4% of net revenues, compared to $69.4 million, or 54.4% of net revenues, in the prior year. On a non-GAAP basis, excluding the previously discussed intangible asset amortization, consolidated SG&A expense totaled $59.4 million, or 47.6% of net revenues for the current year third quarter. On a non-GAAP basis, excluding intangible asset amortization, accretion of the earnout liability, and Project Novus expenses, prior year SG&A expense totaled $64.0 million, or 50.2% of net revenues.   Current year SG&A expenses were lower than the prior year due to both temporary and permanent expense reductions related to the pandemic.

The Company’s consolidated operating income totaled $12.2 million, or 9.7% of net revenues, compared to an operating loss of ($1.5) million, or (1.2%) of net revenues, in the prior year third quarter. On a non-GAAP basis, excluding the intangible asset amortization, current year consolidated operating income totaled $14.4 million, or 11.6%. This compares to prior year consolidated operating income of $10.1 million, or 7.9% of net revenues, on a non-GAAP basis, excluding the previously disclosed charges
related to purchase accounting adjustments for the Pura Vida acquisition (including inventory step-up amortization, intangible asset amortization, and accretion of the earn-out liability) and Project Novus expenses.

By segment:

  • Vera Bradley Direct operating income was $19.8 million, or 25.3% of Direct net revenues, for the third quarter, compared to $14.7 million, or 18.7% of Direct net revenues, in the prior year. On a non-GAAP basis, excluding a portion of the Vera Bradley Project Novus charges, prior year Direct operating income totaled $15.5 million, or 19.8% of Direct net revenues.
  • Vera Bradley Indirect operating income was $9.3 million, or 41.8% of Indirect net revenues, for the third quarter, compared to $9.3 million, or 38.7% of Indirect net revenues, in the prior year.
  • Pura Vida’s operating income was $0.4 million, or 1.7% of Pura Vida net revenues, in the current year, compared to an operating loss of $(4.5) million, or (17.9%) of Pura Vida net revenues, in the prior year. On a non-GAAP basis, excluding $2.3 million of intangible asset amortization, Pura Vida’s current operating income totaled $2.7 million, or 11.0% of Pura Vida net revenues, for the current year. On a non-GAAP basis, excluding the Pura Vida acquisition-related charges (inventory step-up amortization and intangible asset amortization), Pura Vida’s operating income was $4.2 million, or 16.7% of Pura Vida net revenues, for the prior year.


Details for


the


Nine


Months

Vera Bradley Direct segment revenues for the current year nine-month period totaled $196.2 million compared to $243.9 million in the prior year. The decline primarily resulted from the Company’s stores that were temporarily closed as a result of the pandemic for approximately half of the first and second quarters, partially offset by a 59.0% increase in e-commerce sales during the nine-month period.

Vera Bradley Indirect segment revenues for the nine months totaled $51.3 million compared to $64.0 million in the prior year, reflecting a reduction in orders primarily related to the pandemic and in the number of specialty and department store accounts.

Pura Vida segment revenues totaled $78.4 million compared to $30.4 million in the prior year, which represented a partial period from the date of acquisition.

Consolidated gross profit for the nine months totaled $187.6 million, or 57.6% of net revenues, compared to $185.7 million, or 54.9% of net revenues, in the prior year. On a non-GAAP basis, excluding charges for the cancellation of certain purchase orders resulting from COVID-19, current year gross profit totaled $189.0 million, or 58.0% of net revenues, compared to last year’s non-GAAP gross profit of $192.9 million, or 57.0 % of net revenues, which excluded inventory step-up amortization. The Company expanded its consolidated gross profit rate for the period primary through sales of cotton masks, product collaborations, careful inventory management, and tightly controlled promotional activity.

For the nine months, consolidated SG&A expense totaled $183.6 million, or 56.3% of net revenues, compared to $184.5 million, or 54.5% of net revenues, in the prior year. On a non-GAAP basis, excluding the previously outlined intangible asset amortization, impairment charges, Project Novus expenses, an adjustment to the Pura Vida earn-out liability, and certain department store exit costs, current year consolidated SG&A expense totaled $169.7 million, or 52.1% of net revenues. This compared to $175.3 million, or 51.8% of net revenues, in the prior year on a non-GAAP basis, excluding the previously discussed Pura Vida acquisition-related charges (including intangible asset amortization, transaction costs and accretion of earnout liability) and Project Novus expenses. On a non-GAAP basis, Pura Vida contributed $34.9 million of SG&A expenses in the current year and $13.8 million in the prior year nine months (representing a partial period from the date of acquisition).

For the nine months, the Company’s consolidated operating income totaled $4.1 million, or 1.3% of net revenues, compared to consolidated operating income of $2.2 million, or 0.7% of net revenues, in the prior year nine-month period. On a non-GAAP basis, excluding the previously disclosed charges (intangible asset amortization, impairment charges, Project Novus expenses, charges related to the cancellation of certain purchase orders, an adjustment to the Pura Vida earn-out liability, and certain department store exit costs), the Company’s consolidated operating income was $19.4 million, or 5.9% of net revenues. On a non-GAAP basis, excluding the previously disclosed charges (inventory step-up amortization, intangible asset amortization, Pura Vida transaction costs, accretion of earn-out liability, and Project Novus expenses), the Company’s consolidated operating income was $18.7 million, or 5.5% of net revenues, in the prior year.

By segment:

  • Vera Bradley Direct operating income was $31.6 million, or 16.1% of net revenues, compared to $45.2 million, or 18.5% of Direct net revenues, in the prior year. On a non-GAAP basis, excluding impairment charges, a portion of the charges for the cancellation of purchase orders, and a portion of Project Novus expenses, the current year Direct operating income was $38.5 million, or 19.6% of Direct net revenues. On a non-GAAP basis, excluding a portion of the Vera Bradley Project Novus expenses, prior year Direct operating income was $46.3 million, or 19.0% of Direct net revenues.
  • Vera Bradley Indirect operating income was $18.6 million, or 36.2% of Indirect net revenues, compared to $24.2 million, or 37.8% of net revenues, in the prior year. On a non-GAAP basis, excluding certain department store exit costs and a portion of the charges for the cancellation of purchase orders, current year Indirect operating income totaled $19.0 million, or 37.0% of Indirect net revenues.
  • Pura Vida’s operating income was $4.0 million, or 5.2% of Pura Vida net revenues, for the current year, compared to an operating loss of ($5.0) million, or (16.5%) of Pura Vida net revenues, in the prior year. On a non-GAAP basis, excluding the intangible asset amortization, Pura Vida’s operating income was $11.0 million, or 14.1% of Pura Vida net revenues, for the current year. On a non-GAAP basis, excluding the Pura Vida acquisition-related charges (inventory step-up amortization and intangible asset amortization), Pura Vida’s operating income was $5.1 million, or 16.7% of Pura Vida net revenues, for the prior year (representing a partial period from the date of acquisition).


Balance Sheet

Net capital spending for the third quarter and nine months totaled $0.9 million and $5.2 million, respectively. Capital expenditures are expected to total between $6 and $7 million for the year.

Cash, cash equivalents, and investments as of October 31, 2020 totaled $77.3 million compared to $48.8 million at the end of last year’s third quarter. The Company had $30.0 million of borrowings outstanding on its $75.0 million ABL credit facility at quarter end.

Quarter-end inventory was $141.6 million, compared to $134.0 million at the end of the third quarter last year. Current year third quarter inventory was higher than the prior year primarily due to receipts accelerated into the third quarter from the fourth quarter. Management expects year-over-year inventory to be relatively flat at fiscal year end.

During the first quarter of this fiscal year, the Company’s board of directors temporarily suspended share repurchases due to the pandemic, so no purchases have been made since that time. At the end of the third quarter, the Company had approximately $32.9 million remaining under its $50.0 million share repurchase authorization. The Board of Directors has extended the plan authorization through December 11, 2021.


Forward-Looking Guidance

The continued uncertainties surrounding COVID-19 make fourth quarter financial performance extremely difficult to predict. As a result, the Company is not providing forward-looking guidance.


Disclosure Regarding Non-GAAP Measures

The Company’s management does not, nor does it suggest that investors should, consider the supplemental non-GAAP financial measures in isolation from, or as a substitute for, financial information prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). Further, the non-GAAP measures utilized by the Company may be unique to the Company, as they may be different from non-GAAP measures used by other companies.

The Company believes that the non-GAAP measures presented in this earnings release, including gross profit; selling, general, and administrative expenses; operating income; net income; net income attributable and available to Vera Bradley, Inc.; and diluted net income per share available to Vera Bradley, Inc. common shareholders, along with the associated percentages of net revenues, are helpful to investors because they allow for a more direct comparison of the Company’s year-over-year performance and are consistent with management’s evaluation of business performance. A reconciliation of the non-GAAP measures to the most directly comparable GAAP measures can be found in the Company’s supplemental schedules included in this earnings release.


Call Information

A conference call to discuss results for the third quarter is scheduled for today, Wednesday, December 9, 2020, at 9:30 a.m. Eastern Time. A broadcast of the call will be available via Vera Bradley’s Investor Relations section of its website, www.verabradley.com. Alternatively, interested parties may dial into the call at (800) 458-4121, and enter the access code 6506855. A replay will be available shortly after the conclusion of the call and remain available through September 16, 2020. To access the recording, listeners should dial (844) 512-2921, and enter the access code 6506855.


About Vera Bradley, Inc.

Vera Bradley, Inc. operates two unique lifestyle brands – Vera Bradley and Pura Vida. Vera Bradley and Pura Vida are complementary businesses, both with devoted, emotionally-connected, and multi-generational female customer bases; alignment as causal, comfortable, affordable, and fun brands; positioning as “gifting” and socially-connected brands; strong, entrepreneurial cultures; a keen focus on community, charity, and social consciousness; multi-channel distribution strategies; and talented leadership teams aligned and committed to the long-term success of their brands.

Vera Bradley, based in Fort Wayne, Indiana, is a leading designer of women’s handbags, luggage and other travel items, fashion and home accessories, and unique gifts.  Founded in 1982 by friends Barbara Bradley Baekgaard and Patricia R. Miller, the brand is known for its innovative designs, iconic patterns, and brilliant colors that inspire and connect women unlike any other brand in the global marketplace.

In July 2019, Vera Bradley, Inc. acquired a 75% interest in Creative Genius, Inc., which also operates under the name Pura Vida Bracelets (“Pura Vida”). Pura Vida, based in La Jolla, California, is a rapidly growing, digitally native, and highly engaging lifestyle brand founded in 2010 by friends Paul Goodman and Griffin Thall. Pura Vida has a differentiated and expanding offering of bracelets, jewelry, and other lifestyle accessories.

The Company has three reportable segments: Vera Bradley Direct (“VB Direct”), Vera Bradley Indirect (“VB Indirect”), and Pura Vida. The VB Direct business consists of sales of Vera Bradley products through Vera Bradley full-line and factory outlet stores in the United States, verabradley.com, the Vera Bradley online outlet site, and the Vera Bradley annual outlet sale in Fort Wayne, Indiana. The VB Indirect business consists of sales of Vera Bradley products to approximately 2,000 specialty retail locations throughout the United States, as well as select department stores, national accounts, third party e-commerce sites, and third-party inventory liquidators, and royalties recognized through licensing agreements related to the Vera Bradley brand. The Pura Vida segment consists of sales of Pura Vida products through the Pura Vida websites, www.puravidabracelets.com, www.puravidabracelets.eu, and www.puravidabracelets.ca, and through the distribution of its products to wholesale retailers.


Website Information

We routinely post important information for investors on our website www.verabradley.com in the “Investor Relations” section. We intend to use this webpage as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, our webpage is not incorporated by reference into, and is not a part of, this document.

Investors and other interested parties may also access the Company’s most recent Corporate Responsibility and Sustainability Report outlining its ESG (Environmental, Social, and Governance) initiatives at https://www.verabradley.com/us/static/customerservice/corporateresponsibility.


Vera Bradley Safe Harbor Statement

Certain statements in this release are “forward-looking statements” made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the Company’s current expectations or beliefs concerning future events and are subject to various risks and uncertainties that may cause actual results to differ materially from those that we expected, including: possible adverse changes in general economic conditions and their impact on consumer confidence and spending; possible inability to predict and respond in a timely manner to changes in consumer demand; possible loss of key management or design associates or inability to attract and retain the talent required for our business; possible inability to maintain and enhance our brand; possible inability to successfully implement Vision 20/20 long-term strategic plan; possible inability to successfully open new stores, close targeted stores, and/or operate current stores as planned; incremental tariffs or adverse changes in the cost of raw materials and labor used to manufacture our products; possible adverse effects resulting from a significant disruption in our distribution facilities; or business disruption caused by COVID-19. Risks, uncertainties, and assumptions also include the possibility that Pura Vida acquisition benefits may not materialize as expected; that Pura Vida’s business may not perform as expected; and that the Company is unable to successfully implement integration strategies related to the acquisition. More information on potential factors that could affect the Company’s financial results is included from time to time in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s public reports filed with the SEC, including the Company’s Form 10-K for the fiscal year ended February 1, 2020. We undertake no obligation to publicly update or revise any forward-looking statement. Financial schedules are attached to this release.

CONTACTS:
Investors:
Julia Bentley, VP of Investor Relations and Communications
[email protected]
(260) 207-5116

Media:           
[email protected]
877-708-VERA (8372)

        

Vera Bradley, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
           
  October 31,
2020
  February 1,
2020
  November 2,
2019
Assets          
Current assets:          
Cash and cash equivalents $ 75,765     $ 49,917     $ 25,999  
Short-term investments   1,068       8,977       9,410  
Accounts receivable, net   36,027       24,290       26,960  
Inventories   141,588       123,606       133,964  
Income taxes receivable   3,545       1,043       3,705  
Prepaid expenses and other current assets   13,859       10,956       11,305  
Total current assets   271,852       218,789       211,343  
           
Operating right-of-use assets   97,534       114,790       116,571  
Property, plant, and equipment, net   66,376       73,027       75,561  
Intangible assets, net   49,318       56,305       58,772  
Goodwill   44,254       44,254       44,604  
Long-term investments   478       14,912       13,437  
Deferred income taxes   4,972       7,656       7,905  
Other assets   6,390       5,328       3,833  
Total assets $ 541,174     $ 535,061     $ 532,026  
           
Liabilities, Redeemable Noncontrolling Interest, and Shareholders’ Equity          
Current liabilities:          
Accounts payable $ 27,136     $ 20,235     $ 24,751  
Accrued employment costs   12,970       11,412       9,299  
Short-term operating lease liabilities   24,543       21,347       22,162  
Earn-out liability         18,448       21,901  
Other accrued liabilities   14,297       13,850       14,889  
Income taxes payable   251       2,113       884  
Total current liabilities   79,197       87,405       93,886  
           
Long-term operating lease liabilities   97,849       113,775       115,706  
Long-term debt   30,000              
Other long-term liabilities   154       62       53  
Total liabilities   207,200       201,242       209,645  
           
Redeemable noncontrolling interest   29,146       30,049       30,333  
Shareholders’ equity:          
Additional paid-in-capital   103,282       100,357       98,450  
Retained earnings   308,598       307,414       295,386  
Accumulated other comprehensive income   8       158       96  
Treasury stock   (107,060 )     (104,159 )     (101,884 )
Total shareholders’ equity of Vera Bradley, Inc.   304,828       303,770       292,048  
Total liabilities, redeemable noncontrolling interest, and shareholders’ equity $ 541,174     $ 535,061     $ 532,026  

Vera Bradley, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
               
               
  Thirteen Weeks Ended   Thirty-Nine Weeks Ended
  October 31,
2020
  November 2,
2019
  October 31,
2020
  November 2,
2019
               
Net revenues $ 124,849   $ 127,501     $ 325,903   $ 338,289  
Cost of sales   51,018     59,631       138,263     152,618  
Gross profit   73,831     67,870       187,640     185,671  
Selling, general, and administrative expenses   61,703     69,423       183,640     184,465  
Other income   36     77       89     1,021  
Operating income (loss)   12,164     (1,476 )     4,089     2,227  
Interest expense (income), net   298     (133 )     855     (955 )
Income (loss) before income taxes   11,866     (1,343 )     3,234     3,182  
Income tax expense (benefit)   2,892     (361 )     1,470     851  
Net income (loss)   8,974     (982 )     1,764     2,331  
Less: Net income (loss) attributable to redeemable noncontrolling interest   100     (1,121 )     1,011     (1,257 )
Net income attributable to Vera Bradley, Inc. $ 8,874   $ 139     $ 753   $ 3,588  
               
Basic weighted-average shares outstanding   33,411     33,907       33,382     34,104  
Diluted weighted-average shares outstanding   33,977     34,114       33,789     34,355  
               
Basic net income per share available to Vera Bradley, Inc. common shareholders $ 0.27   $ 0.00     $ 0.02   $ 0.11  
Diluted net income per share available to Vera Bradley, Inc. common shareholders $ 0.26   $ 0.00     $ 0.02   $ 0.10  
               

Vera Bradley, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited) 
        
  Thirty-Nine Weeks Ended


  October 31,
2020



  November 2,
2019



Cash flows from operating activities          
Net income $ 1,764     $ 2,331  
Adjustments to reconcile net income to net cash provided by (used in) operating activities:          
Depreciation of property, plant, and equipment 10,808     13,856  
Impairment charges 3,806      
Amortization of operating right-of-use assets 16,051     16,359  
Amortization of intangible assets 6,987     2,884  
Provision for doubtful accounts 1,559     97  
Stock-based compensation 3,487     4,032  
Deferred income taxes 2,684     (1,113 )
Loss (gain) on investments 13     (178 )
Adjustment of earn-out liability 229     1,803  
Amortization of step-up in inventory basis     7,230  
Other non-cash (gain) charges, net (22 )   157  
Changes in assets and liabilities:          
Accounts receivable (14,289 )   (3,620 )
Inventories (17,982 )   (21,970 )
Prepaid expenses and other assets (3,965 )   (3,331 )
Accounts payable 7,222     4,146  
Income taxes (4,364 )   (4,175 )
Operating lease liabilities, net (14,331 )   (18,727 )
Accrued and other liabilities 1,973     (9,016 )
Net cash provided by (used in) operating activities 1,630     (9,235 )
           
Cash flows from investing activities          
Purchases of property, plant, and equipment (5,178 )   (11,425 )
Purchases of investments (851 )   (13,762 )
Proceeds from maturities and sales of investments 23,031     34,209  
Cash received (paid) for business acquisition, net of cash acquired 993     (76,032 )
Net cash provided by (used in) investing activities 17,995     (67,010 )
           
Cash flows from financing activities          
Tax withholdings for equity compensation (562 )   (1,154 )
Repurchase of common stock (3,077 )   (9,143 )
Distributions to redeemable noncontrolling interest (1,483 )   (951 )
Borrowings under asset-based revolving credit agreement 60,000      
Repayment of borrowings under asset-based revolving credit agreement (30,000 )    
Payment of contingent consideration for business acquisition (18,677 )    
Net cash provided by (used in) financing activities 6,201     (11,248 )
Effect of exchange rate changes on cash and cash equivalents 22     (1 )
           
Net increase (decrease) in cash and cash equivalents $ 25,848     $ (87,494 )
Cash and cash equivalents, beginning of period 49,917     113,493  
Cash and cash equivalents, end of period $ 75,765     $ 25,999  
           
Supplemental disclosure of cash flow information          
Cash paid for income taxes, net $ 3,152     $ 6,166  
Supplemental disclosure of non-cash activity          
Non-cash operating, investing, and financing activities          
Repurchase of common stock          
Expenditures incurred but not yet paid as of October 31, 2020 and November 2, 2019 $     $ 99  
Expenditures incurred but not yet paid as of February 1, 2020 and February 2, 2019 $ 176     $ 197  
Purchases of property, plant, and equipment          
Expenditures incurred but not yet paid as of October 31, 2020 and November 2, 2019 $ 538     $ 391  
Expenditures incurred but not yet paid as of February 1, 2020 and February 2, 2019 $ 559     $ 1,065  
Contingent consideration related to business acquisition $     $ 20,098  

 
Vera Bradley, Inc.
Third Quarter Fiscal 2021
GAAP to Non-GAAP Reconciliation Thirteen Weeks Ended October 31, 2020
(in thousands, except per share amounts)
(unaudited)
  Thirteen Weeks Ended
  As Reported   Other Items   Non-GAAP
(Excluding Items)
Gross profit $ 73,831     $     $ 73,831  
Selling, general, and administrative expenses   61,703       2,273   1   59,430  
Operating income (loss)   12,164       (2,273 )     14,437  
Income (loss) before income taxes   11,866       (2,273 )     14,139  
Income tax expense (benefit)   2,892       (336 ) 2   3,228  
Net income (loss)   8,974       (1,937 )     10,911  
Less: Net income (loss) attributable to redeemable noncontrolling interest   100       (568 )     668  
Net income (loss) attributable to Vera Bradley, Inc.   8,874       (1,369 )     10,243  
Diluted net income (loss) per share available to Vera Bradley, Inc. common shareholders $ 0.26     $ (0.04 )   $ 0.30  
           
Vera Bradley Direct segment operating income $ 19,777     $     $ 19,777  
Vera Bradley Indirect segment operating income $ 9,342     $     $ 9,342  
Pura Vida segment operating income (loss) $ 402     $ (2,273 ) 1 $ 2,675  
Unallocated corporate expenses $ (17,357 )   $     $ (17,357 )
           
1Related to the amortization of definite-lived intangible assets
2Related to the tax impact of the charges mentioned above

 
Vera Bradley, Inc.
Third Quarter Fiscal 2020
GAAP to Non-GAAP Reconciliation Thirteen Weeks Ended November 2, 2019
(in thousands, except per share amounts)
(unaudited)
  Thirteen Weeks Ended
  As Reported   Other Items   Non-GAAP
(Excluding Items)
Gross profit (loss) $ 67,870     $ (6,197 ) 1 $ 74,067  
Selling, general, and administrative expenses   69,423       5,405   2   64,018  
Operating (loss) income   (1,476 )     (11,602 )     10,126  
(Loss) income before income taxes   (1,343 )     (11,602 )     10,259  
Income tax (benefit) expense   (361 )     (2,661 ) 3   2,300  
Net (loss) income   (982 )     (8,941 )     7,959  
Less: Net (loss) income attributable to redeemable noncontrolling interest   (1,121 )     (2,167 )     1,046  
Net income (loss) attributable to Vera Bradley, Inc.   139       (6,774 )     6,913  
Diluted net income (loss) per share attributable to Vera Bradley, Inc. $ 0.00     $ (0.20 )   $ 0.20  
           
Vera Bradley Direct segment operating income (loss) $ 14,675     $ (814 ) 4 $ 15,489  
Vera Bradley Indirect segment operating income $ 9,324     $     $ 9,324  
Pura Vida segment operating (loss) income $ (4,483 )   $ (8,666 ) 5 $ 4,183  
Unallocated corporate expenses $ (20,992 )   $ (2,122 ) 6 $ (18,870 )
      
1Related to a purchase accounting adjustment for the amortization of the step-up in inventory basis associated with the acquisition of Pura Vida  
2Items include $2,469 for the amortization of definite-lived intangible assets and $1,803 for the accretion of the earn-out liability associated with the acquisition of Pura Vida and $1,133 for technology-related re-platforming charges including certain professional fees and accelerated depreciation
3Related to the tax impact of the charges mentioned above     
4Related to technology re-platforming charges     
5Related to the purchase accounting adjustments for the Pura Vida acquisition, including the amortization of the step-up in inventory basis  
and the amortization of definite-lived intangible assets     
6Related to $1,803 for the accretion of the earn-out liability associated with the acquisition of Pura Vida and $319 for technology re-platforming charges 

 
Vera Bradley, Inc.
GAAP to Non-GAAP Reconciliation Thirty-Nine Weeks Ended October 31, 2020
(in thousands, except per share amounts)
(unaudited)
  Thirty-Nine Weeks Ended
  As Reported   Other Items   Non-GAAP
(Excluding Items)
Gross profit (loss) $ 187,640     $ (1,320 ) 1 $ 188,960  
Selling, general, and administrative expenses   183,640       13,973   2   169,667  
Operating income (loss)   4,089       (15,293 )     19,382  
Income (loss) before income taxes   3,234       (15,293 )     18,527  
Income tax expense (benefit)   1,470       (3,389 ) 3   4,859  
Net income (loss)   1,764       (11,904 )     13,668  
Less: Net income (loss) attributable to redeemable noncontrolling interest   1,011       (1,746 )     2,757  
Net income (loss) attributable to Vera Bradley, Inc.   753       (10,158 )     10,911  
Diluted net income (loss) per share available to Vera Bradley, Inc. common shareholders $ 0.02     $ (0.30 )   $ 0.32  
           
Vera Bradley Direct segment operating income (loss) $ 31,634     $ (6,842 ) 4 $ 38,476  
Vera Bradley Indirect segment operating income (loss) $ 18,575     $ (387 ) 5 $ 18,962  
Pura Vida segment operating income (loss) $ 4,046     $ (6,987 ) 6 $ 11,033  
Unallocated corporate expenses $ (50,166 )   $ (1,077 ) 7 $ (49,089 )
      
1Related to charges for the cancellation of certain purchase orders as a result of COVID-19
2Items include $6,987 for the amortization of definite-lived intangible assets; $3,806 for store impairment charges; $2,738 for technology-related re-platforming charges including certain professional fees and accelerated depreciation; $229 for an adjustment upon payment of the earn-out liability; and $213 in certain department store exit costs as a result of COVID-19
3Related to the tax impact of the charges mentioned above
4Related to $3,806 for impairment charges; $1,146 for an allocation of charges for the cancellation of purchase orders; and $1,890 for technology re-platforming charges
5Related to $213 in certain department store exit costs and $174 for an allocation of charges for the cancellation of purchase orders
6Related to the amortization of definite-lived intangible assets
7Related to $848 for technology re-platforming charges and $229 for an adjustment upon payment of the earn-out liability

Vera Bradley, Inc.
GAAP to Non-GAAP Reconciliation Thirty-Nine Weeks Ended November 2, 2019
(in thousands, except per share amounts)
(unaudited)
  Thirty-Nine Weeks Ended
  As Reported   Other Items   Non-GAAP
(Excluding Items)
Gross profit (loss) $ 185,671     $ (7,230 ) 1 $ 192,901  
Selling, general, and administrative expenses   184,465       9,205   2   175,260  
Operating income (loss)   2,227       (16,435 )     18,662  
Income (loss) before income taxes   3,182       (16,435 )     19,617  
Income tax expense (benefit)   851       (3,646 ) 3   4,497  
Net income (loss)   2,331       (12,789 )     15,120  
Less: Net (loss) income attributable to redeemable noncontrolling interest   (1,257 )     (2,529 )     1,272  
Net income (loss) attributable to Vera Bradley, Inc.   3,588       (10,260 )     13,848  
Diluted net income (loss) per share attributable to Vera Bradley, Inc. $ 0.10     $ (0.30 )   $ 0.40  
           
Vera Bradley Direct segment operating income (loss) $ 45,172     $ (1,147 ) 4 $ 46,319  
Vera Bradley Indirect segment operating income $ 24,193     $     $ 24,193  
Pura Vida segment operating (loss) income $ (5,025 )   $ (10,114 ) 5 $ 5,089  
Unallocated corporate expenses $ (62,113 )   $ (5,174 ) 6 $ (56,939 )
      
1Related to a purchase accounting adjustment for the amortization of the step-up in inventory basis associated with the acquisition of Pura Vida  
2Items include $2,884 for the amortization of definite-lived intangible assets, $2,721 for transaction costs and $1,803 for the accretion of the earn-out liability associated with the acquisition of Pura Vida and $1,797 for technology-related re-platforming charges including certain professional fees and accelerated depreciation  
3Related to the tax impact of the charges mentioned above     
4Related to technology re-platforming charges     
5Related to the purchase accounting adjustments for the Pura Vida acquisition, including the amortization of the step-up in inventory basis and the amortization of definite-lived intangible assets       
6Related to $2,721 for Pura Vida transaction costs; $1,803 for the accretion of the earn-out liability associated with the Pura Vida acquisition; and $650 for technology re-platforming charges

 



Prothena Reports Positive 9 Month Results from Phase 1 Long-term Extension Study of PRX004, the First Investigational Anti-Amyloid Immunotherapy for the Treatment of ATTR Amyloidosis

  • Slowing of
    neuropathy
    progression
    for all 7 evaluable patients
    ,
    evidenced by
    a
    +1.29
    point mean change in NIS
    ,
    was
    more favorable than expected
    progression
    of +9.2
    points
  • Improvement in neuropathy for 3 of these 7 evaluable patients demonstrated by a mean change in NIS of 3.33 points
  • I
    mprovement
    in cardiac function for
    all
    7 evaluable patients
    demonstrated
    by
    a
    decrease in
    global longitudinal strain (GLS)
  • Investor conference call and webcast
    scheduled
    today at
    8
    :30
    A
    M ET

DUBLIN, Ireland, Dec. 09, 2020 (GLOBE NEWSWIRE) — Prothena Corporation plc (NASDAQ:PRTA) today reported positive results from the Phase 1 study of PRX004, the first anti-amyloid immunotherapy designed to deplete amyloid to demonstrate efficacy in ATTR amyloidosis. In the first report of clinical results with this depleter mechanism of action, PRX004 showed favorable results as demonstrated by slowing of neuropathy progression for all 7 evaluable patients at 9 months, including improvement in neuropathy in 3 of the 7 patients, and improved cardiac systolic function for all 7 patients. In this Phase 1 study, PRX004 was found to be generally safe and well tolerated across all dose levels. Prothena management will host a webcast to discuss the Phase 1 results today at 8:30 AM ET and will be joined by Dr. Ole Suhr, Senior Professor, Department of Public Health and Clinical Medicine, Umeå University, gastroenterologist and internist who was a principal investigator in the study, and Dr. Daniel Lenihan, Director, Cardio-Oncology Center of Excellence Advanced Heart Failure, Clinical Research Cardiovascular Division, Washington University in St. Louis.

As previously reported, the long-term extension portion of the Phase 1 study was disrupted by the COVID-19 pandemic. As a result, 7 patients received all infusions through 9 months and were considered evaluable for efficacy. For all of the evaluable patients, slowing of neuropathy progression was demonstrated by a mean change from baseline in Neuropathy Impairment Score (NIS) of +1.29 points at 9 months. This compares favorably to a calculated mean change in NIS of +9.2 points at 9 months in untreated and placebo-treated patients with hereditary ATTR peripheral neuropathy (hATTR-PN) based on analysis of published historical data. In addition, the change in NIS for each of these evaluable patients was more favorable than the published historical data. In this highly progressive disease, it was encouraging to see 3 of 7 patients demonstrate improvement in neuropathy with a mean change in NIS of –3.33 points at 9 months. These positive results were observed in patients with or without concomitant use of stabilizer therapy. PRX004 also demonstrated improvement in cardiac systolic function in each of the 7 evaluable patients, with a mean change in GLS of –1.21% at 9 months (centrally read). For the 3 patients who improved on NIS, GLS improvement was more pronounced, with a mean change of –1.51% at 9 months. Taken together, these positive clinical findings suggest PRX004’s depleter mechanism of action can result in benefits in both neuropathy and cardiac function.

“We are pleased to see evidence of both a slowing of disease progression as well as a rapid improvement in neuropathy after only 9 months of treatment with PRX004. In this progressive disease, the more favorable than expected change in NIS for all 7 patients is an encouraging finding, as is PRX004’s favorable safety and tolerability profile,” stated Radhika Tripuraneni, MD, MPH Chief Development Officer and ATTR Program Head, Prothena. “The improvement on GLS, a key measure of cardiac systolic function, in all evaluable patients was even more pronounced in the 3 patients who improved on NIS. These results demonstrate the potential of PRX004’s depleter mechanism of action as uniquely suited for patients at high risk of early mortality due to amyloid deposition in vital organs. We look forward to advancing PRX004 in 2021 to address this high unmet medical need.”

“Given the expected clinical progression in patients with ATTR, this first report of clinical results for PRX004 are particularly encouraging,” stated Ole Suhr, MD. “These consistent results on neuropathy and cardiac assessments demonstrate the potential of this novel depleter mechanism to provide a new treatment paradigm that is highly needed to treat this deadly disease, especially for patients with more advanced ATTR cardiomyopathy, where amyloid removal is needed to improve heart function.”

PRX004 Phase 1 Study

The Phase 1, open-label, multicenter dose-escalation study (NCT03336580) enrolled 21 patients with hereditary ATTR Amyloidosis (hATTR) to receive PRX004 intravenously once every 28 days for up to 3 infusions in the dose escalation phase of the study. Patients were enrolled into 1 of the following 6 PRX004 dose cohorts: 0.1, 0.3, 1, 3, 10, and 30 mg/kg, starting with the lowest dose. Eligible patients who completed dose-escalation were provided the opportunity to enroll in the long-term extension (LTE) portion of the study. All 21 patients enrolled in the Phase 1 study successfully completed dose-escalation and 17 patients subsequently enrolled in the LTE.

In order to inform dose selection, a pharmacokinetic/pharmacodynamic (PK/PD) model was developed and subsequently confirmed by observed reductions in free non-native TTR (transthyretin) in plasma of patients following PRX004 administration. Based on this model, dose levels ≥3 mg/kg were predicted to saturate (occupy ≥90%) amyloid deposits. Therefore, cohorts 4, 5 and 6 were considered equivalent, and efficacy was assessed in these patients and pooled. Out of 12 patients, 7 from cohorts 4 (n=3), 5 (n=3), and 6 (n=1) received all infusions through 9 months and were therefore considered evaluable for efficacy. The remaining 5 patients did not meet these criteria due to COVID-19 pandemic-related disruptions.

PRX004 demonstrated a PK profile consistent with an lgG1 monoclonal antibody and exposures increased proportionally with dose.

Monthly intravenous (IV) infusions of PRX004 were generally safe and well tolerated at all dose levels tested, with 233 separate infusions and up to 17 infusions per patient in the study. No drug-related serious adverse events (SAEs), drug-related ≥grade 3 adverse events, deaths or dose-limiting toxicities were reported. The most frequent treatment-emergent AEs (≥10%) were fall, anemia, upper respiratory tract infection, back pain, constipation, diarrhea and insomnia. No clinically relevant anti-drug antibodies were observed. Consistent with the proposed mechanism of action, PRX004 administration did not impact levels of native, normal tetrameric TTR.

About ATTR Amyloidosis

Transthyretin amyloidosis (ATTR amyloidosis) is a rare, progressive and fatal disease characterized by deposition of abnormal, non-native forms of TTR protein (amyloid) in vital organs. ATTR amyloidosis can be hereditary (hATTR) when caused by a mutation in the TTR gene, or wild-type (wtATTR) when it occurs sporadically. Patients can experience a spectrum of clinical manifestations due to deposition of amyloid that can affect multiple organs, most commonly the heart and/or nervous system. It is estimated that between 400,000 to 1.4 million patients suffer from ATTR-cardiomyopathy (ATTR-CM). Within this population, between 130,000 to 490,000 patients are estimated to be moderate-to-advanced and categorized as New York Heart Association Class III and IV. TTR protein is produced primarily in the liver, pancreas and choroid plexus and in its native tetrameric form serves as a carrier for thyroxin and retinol binding protein (a transporter for vitamin A) and has been proposed to have neuroprotective effects.

About PRX004 and Depleter Mechanism of Action

PRX004 is an investigational humanized monoclonal antibody designed to deplete amyloid associated with disease pathology that underlies hereditary and wild type ATTR amyloidosis (hATTR and wtATTR, respectively), without affecting the native, normal tetrameric form of the protein.

It is generally accepted that at the time of diagnosis, affected organs in ATTR patients contain extracellular amyloid deposits. These deposits, together with prefibrillar species, are believed to cause organ dysfunction. PRX004 has been shown in preclinical studies to promote clearance of insoluble amyloid fibrils through antibody-mediated phagocytosis and inhibit amyloid formation. This depleter mechanism of action has the potential to provide benefit for ATTR patients at high risk for early mortality due to amyloid deposition in vital organs.

Conference Call Details

Prothena management will discuss results from the Phase 1 study of PRX004 during an audio webcast and conference call today, at 8:30AM ET. The webcast will be made available on the Company’s website at www.prothena.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay will be available on the Company’s website for at least 90 days.

To access the call via dial-in, please dial (877) 887-5215 (U.S. and Canada toll free) or (315) 625-3069 (international) five minutes prior to the start time and refer to conference ID number 3038486. A replay of the call will be available until December 23, 2020 via dial-in at (855) 859-2056 (U.S. and Canada toll free) or (404) 537-3406 (international), Conference ID Number 3038486.

About Prothena

Prothena Corporation plc is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s partnered programs include prasinezumab (PRX002/RG7935), in collaboration with Roche for the potential treatment of Parkinson’s disease and other related synucleinopathies, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD) or other neurodegenerative diseases. Prothena’s wholly-owned programs include PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta). For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.

Forward-looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential and proposed mechanisms of action of PRX004;
the design and capabilities of our misTTR assay for hereditary ATTR
;
and advancing PRX004 into late-stage clinical development. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the effects on our business of the worldwide COVID-19 pandemic and the risks, uncertainties and other factors described in the “Risk Factors” sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 3, 2020, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Prothena undertakes no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in Prothena’s expectations.

Contacts:

Media

Ellen Rose, Head of Communications
650-922-2405, [email protected]

Investors

Jennifer Zibuda, Director, Investor Relations & Communications
650-837-8535, [email protected]

 



NETSOL Technologies Signs Multi-Million-Dollar Contract with Global Tier One Auto Captive in China to Upgrade to Next-Gen NFS Ascent® Platform

CALABASAS, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) — NETSOL Technologies, Inc. (NasdaqNTWK), a global business services and enterprise application solutions, has signed an agreement with a global automotive financial services company in China to upgrade from the Company’s legacy NFS system to its premier, next-generation Ascent® platform. The multi-year, multi-million-dollar agreement includes licensing, support and services revenues components, which will be recognized respectively over the life of the contract.

The longtime NETSOL customer provides automotive installment loans, credit loans, interest subsidies and other services and mainly conducts business domestically in China. NETSOL’s NFS Ascent® platform was chosen for its unrivaled capabilities and proven track record for success both in Asia-Pacific (APAC) and across the globe.

“After having worked with this significant customer over the years through our legacy NFS offering, we appreciate the vote of confidence this major renewal means for the quality of service we have provided in that time,” said President of NETSOL China Hui Liang. “This upgrade to NFS Ascent is also further market validation for our next-gen solution in our largest historical market. With an over 75% share in the Chinese auto finance and leasing space, NETSOL has become the preferred industry business partner for companies in China.

“Thanks to the flexible architecture we’ve built into both our legacy and next-gen platforms, our teams will be able to migrate valuable data from the current system as well as integrate additional third-party data sources into the new platform with high fidelity and without issue. To further expedite this transition process, our deployment will be carried out in three-phases over the coming months by our teams at home in Lahore and across the APAC region.”

About NETSOL Technologies

NETSOL Technologies, Inc. (NASDAQ:NTWK) is a worldwide provider of IT and enterprise software solutions primarily serving the global finance and leasing industry. The company’s suite of applications is backed by 40 years of domain expertise and supported by a committed team of more than 1300 professionals placed in eight strategically located support and delivery centers throughout the world. NFS, LeasePak, LeaseSoft or NFS Ascent – help companies transform their finance and leasing operations, providing a fully automated asset-based finance solution covering the complete finance and leasing lifecycle.


Forward-Looking Statements


This press release may contain forward-looking statements relating to the development of the Company’s products and services and future operation results, including statements regarding the Company that are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words “expects,” “anticipates,” variations of such words, and similar expressions, identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, but their absence does not mean that the statement is not forward-looking. These statements are not guarantees of future performance and are subject to certain risks,
uncertainties, and assumptions that are difficult to predict. Factors that could affect the Company’s actual results include the progress and costs of the development of products and services and the timing of the market acceptance. The subject Companies expressly disclaim any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based.

Investor Relations Contact:

Matt Glover and Tom Colton

Gateway Investor Relations
949-574-3860
[email protected]



ImmunoGenesis: Acquisition Strengthens “Cold” Tumor Targeting Pipeline


  • ImmunoGenesis acquires rights to evofosfamide; Phase 2 clinical testing in combination with checkpoint blockade is planned for 2021


    .

  • Evofosfamide is


    the


    only


    known


    reducer of solid tumor hypoxia, a driver of therapeutic resistance in immunologically “cold” tumors such as pancreatic & prostate cancer.

HOUSTON, Dec. 09, 2020 (GLOBE NEWSWIRE) — ImmunoGenesis, Inc., a clinical-stage biotechnology company developing therapeutics to catalyze effective immune responses in immunologically cold cancers such as prostate, colorectal and pancreatic cancer, today announced that it has acquired the rights to the hypoxia-reducing agent evofosfamide. The company plans to initiate a Phase 2 clinical trial in 2021 investigating evofosfamide in combination with both CTLA-4 and PD-1 blockade in patients with castration-resistant prostate cancer (CRPC), pancreatic ductal adenocarcinoma (PDAC) and HPV-negative head and neck cancer (HNSCC).

Evofosfamide, a 2-nitroimidazole prodrug of the cytotoxin bromo-isophosphoramide mustard (Br-IPM), was originally developed as a hypoxia-activated prodrug. Dr. Michael A. Curran, founder of ImmunoGenesis, discovered that evofosfamide can reduce hypoxia in solid tumors. Dr. Curran demonstrated in pre-clinical models that evofosfamide could restore T cell function and synergize with checkpoint inhibition.

Based on Dr. Curran’s work as Associate Professor of Immunology at The University of Texas MD Anderson Cancer Center, ImmunoGenesis is developing evofosfamide as a hypoxia-reversal agent (HRA) which could synergize with checkpoint blockade to drive efficacy in tumor types where checkpoint blockade monotherapy is ineffective. Dr. Curran’s financial relationship with ImmunoGenesis is managed and monitored by the MD Anderson Conflict of Interest Committee.

The planned Phase 2 trial is supported by data from a Phase 1 trial, both led by David S. Hong, M.D., Professor of Investigational Cancer Therapeutics at MD Anderson. The Phase 1 study investigated evofosfamide in combination with the CTLA-4 inhibitor, ipilimumab, in four tumor types where hypoxia is believed to be a major source of immune resistance. The combination treatment drove an overall response rate of 17 percent and a disease control rate of 83 percent across four different dose levels in 21 heavily pre-treated patients.

“Overcoming resistance to immunotherapy in immunologically cold tumors will likely require a multi-faceted approach to address diverse mechanisms of host immune suppression,” said Dr. Curran, “Evofosfamide is the first drug to demonstrate success in reversing hostile tumor metabolism through reduction of hypoxia. Restoration of tumor oxygen supply facilitates T cell infiltration and persistence allowing these otherwise poorly immune checkpoint sensitive cancers to become therapeutically sensitized.”

In addition to the clinical efficacy demonstrated in the Phase 1 trial, a clear biomarker picture has emerged. Pre-existing immune gene signatures predicted response to therapy, while hypermetabolic tumors predicted progression. Responders also showed improved cellular signatures of anti-tumor immunity.

“Our vision at ImmunoGenesis is to develop a pipeline of drugs that synergize to address the critical ingredients necessary for effective immunity against the particularly difficult-to-treat cold tumors, including the generation of sufficient anti-tumor T cells, the protection and expansion of those cells in the tumor, and finally the reduction in hostile tumor metabolism,” said James Barlow, ImmunoGenesis President and CEO. “Coupled with the PD-L1/PD-L2 dual specific antibody and STING agonist the company previously licensed from Dr. Curran’s lab, the addition of evofosfamide creates an integrated suite of molecules with extraordinary potential to address the unmet therapeutic need in cold cancers.”

About ImmunoGenesis, Inc.

ImmunoGenesis is a clinical-stage biotechnology company developing therapeutics to catalyze effective immune responses in immunologically “cold” cancers such as prostate, colorectal, and pancreatic cancer. These tumor types represent more than half of all cancers, and current immunotherapies have shown limited to no efficacy here. As a result, there is a high unmet need for efficacious therapies.

www.immunogenesis.com

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “will,” “could,” “believe,” “plan,” “expect,” “target,” “continue,” “to,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements regarding the development and/or effectiveness of evofosfamide and the ability of evofosfamide to achieve the desired results whether as a monotherapy or in combination with other therapies. We may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.

ImmunoGenesis Contact

Bill Tanner
Chief Financial Officer
203-517-8577
[email protected]