Vericel Announces Preliminary Fourth-Quarter and Full-Year 2020 Financial Results and Provides Business Updates

Record Quarterly and Full-Year Total Revenues

Fourth Quarter Revenue Growth of Approximately 15%

CAMBRIDGE, Mass., Jan. 11, 2021 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced preliminary unaudited financial results for the fourth quarter and year ended December 31, 2020, and provided business updates.

Preliminary Unaudited Fourth-Quarter and Full-Year 2020 Financial Results

Preliminary total net revenues for the fourth-quarter 2020 are expected to be in the range of $44.9-$45.4 million, with MACI® (autologous cultured chondrocytes on porcine collagen membrane) net revenue in the range of $34.4-$34.9 million, Epicel® (cultured epidermal autografts) net revenue of approximately $9.6 million, and NexoBrid® (concentrate of proteolytic enzymes enriched in bromelain) revenue of approximately $1 million related to the U.S. Biomedical Advanced Research and Development Authority’s (BARDA) procurement of NexoBrid for emergency response preparedness.  

Preliminary total net product revenues for the full-year 2020 are expected to be in the range of $123.9-$124.4 million, with MACI net revenue in the range of $94.1-$94.6 million, Epicel net revenue of approximately $27.5 million, and NexoBrid revenue of approximately $2.2 million related to the BARDA procurement.

Cash and investments increased by approximately $14.5 million in the fourth quarter. As of December 31, 2020, the company had approximately $100 million in cash and investments and no debt, compared to $79.0 million as of December 31, 2019.

Business Highlights and Updates

  • Record fourth-quarter and full-year total net revenues;
  • Record quarterly and full-year MACI implants and net revenue;
  • Record fourth-quarter and full-year Epicel grafts and net revenue, and the second highest quarterly Epicel grafts and revenue in history;
  • Received MACI biopsies from approximately 1,500 surgeons in 2020, up from approximately 1,400 surgeons in 2019;
  • Record quarterly high in the number of surgeons taking MACI biopsies in the fourth quarter; and
  • Double-digit growth in MACI biopsies in the fourth quarter, achieving a record quarterly high and a record monthly high in December.

“We delivered strong financial and operational results in the fourth quarter and for the full year, including record product volumes and revenue for both MACI and Epicel for the year,” said Nick Colangelo, President and CEO of Vericel.   “Epicel performance was very strong in the fourth quarter, with revenue growing over 60% for the quarter. MACI performance was in line with our expectations through mid-December. However, due to the recent surge in COVID-19 cases in the United States, the scheduling of MACI pipeline cases for the last two weeks of December slowed compared to historical trends and there was an increase in case cancellations during that period. We expect, based on our experience earlier this year, that the majority of those MACI cases, which represent approximately $2 million in revenue, will move forward in 2021.   Moreover, the underlying growth drivers for MACI were in line with our expectations, which we believe will drive strong revenue and profitability growth in 2021.”

The company will host a webcast and conference call to discuss its fourth quarter 2020 financial results and business highlights on February 24, 2020, at 8:30am Eastern Time. Webcast information can be found on the events and presentation section of the Investor Relations website at https://investors.vcel.com/events-presentations.

About Vericel Corporation

Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets. The company markets two cell therapy products in the United States. MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full-thickness burns greater than or equal to 30% of total body surface area. The company also holds an exclusive license for North American commercial rights to NexoBrid, a registration-stage biological orphan product for debridement of severe thermal burns.   For more information, please visit the company’s website at www.vcel.com.

Epicel® and MACI® are registered trademarks of Vericel Corporation. NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2021 Vericel Corporation. All rights reserved.

Preliminary and Unaudited Nature of Reported Results

Our revenue expectations for the fourth quarter and full year ended 2020, as well as our estimates concerning cash and investments are preliminary, unaudited and are subject to adjustment based on the completion of our ongoing internal control, review, and audit procedures.

Forward-Looking Statements

Vericel cautions you that all statements other than statements of historical fact included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Our actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.

Among the factors that may result in differences are the inherent uncertainties associated with our expectations concerning expected revenue results for the fourth quarter and full year ended 2020 and estimates of our cash and investments as of December 31, 2020. Vericel’s revenue expectations for the fourth quarter and full year ended 2020, as well as its estimates concerning cash and investments are preliminary, unaudited and are subject to adjustment during our ongoing internal review. Additional factors that could cause actual results to differ materially from those set forth in the forward-looking statements include, but are not limited to uncertainties associated with our expectations regarding future revenues, growth in revenues, market penetration for MACI and Epicel, growth in profit, gross margins and operating margins, the ability to achieve or sustain profitability, contributions to adjusted EBITDA, the expected target surgeon audience, potential fluctuations in sales and volumes and our results of operations over the course of the year, competitive developments, changes in third party coverage and reimbursement, our ability to supply or meet customer demand for our products, and the wide-ranging impacts of the COVID-19 pandemic on our business or the economy generally.

With respect to COVID-19, we are currently unable to reasonably estimate the specific extent, or duration, of the impact of the COVID-19 outbreak on our business, financial and operating results. We are also unable to predict how the outbreak will affect the pace with which state and local governments lift restrictions on the performance of elective surgical procedures or whether additional such restrictions may be imposed by states in the future, the availability of physicians and/or their treatment prioritizations or the impact of the outbreak on the overall healthcare infrastructure. Other disruptions or potential disruptions include restrictions on the ability of Company personnel to travel and access customers for training, promotion and case support, delays in product development efforts, and additional government-imposed quarantines and requirements to “shelter at home” or other incremental mitigation efforts that may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products. With respect to FDA’s review of the pending NexoBrid Biologics License Application, the COVID-19 pandemic may impact the FDA’s response time to regulatory submissions, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections, any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of NexoBrid. The total impact of these disruptions could have a material impact on the Company’s financial condition, cash flows and results of operations.

These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2020, Vericel’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 5, 2020, and in other filings with the SEC.  These forward-looking statements reflect our views as of the date hereof and Vericel does not assume and specifically disclaims any obligation to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

Investor Contacts:

Chad Rubin
Solebury Trout
[email protected]
+1 (646) 378-2947



500.com Entered into an Agreement to Acquire Bitcoin Mining Machines

PR Newswire

SHENZHEN, China, Jan. 11, 2021 /PRNewswire/ — 500.com Limited (NYSE: WBAI) (“500.com” or the “Company”), today announced that it has entered into a definitive purchase agreement (the “Agreement”) with certain non-U.S. persons (the “Sellers”) pursuant to which the Company expects to issue approximately US$14.4 million worth of its Class A ordinary shares as consideration to acquire bitcoin mining machines owned by the Sellers.

The Company expects to issue 11,882,860 newly-issued Class A ordinary shares valued at US$1.21 per share, corresponding to US$12.10 per American Depositary Share (“ADS”) (based on the ratio of ten ordinary shares per ADS), the closing trading price of the Company’s ADSs on January 8, 2021, the last trading day prior to the date of the Agreement, for a total consideration of approximately US$14.4 million to acquire bitcoin mining machines owned by the Sellers including such models as the S17, T17, M20s and S9. This transaction is subject to the completion of certain conditions precedent to the closing of the transaction, including the Sellers’ satisfactory completion of required closing conditions. There can be no assurance that the closing conditions will be satisfied, or that the proposed transaction will be consummated.

Assuming no delay to the timetable, this transaction is expected to close in the first quarter of 2021. Upon the consummation of the transaction, the Company plans to install all bitcoin mining machines acquired from the Sellers within four weeks. The Company expects to begin generating revenue from bitcoin mining in the first half of 2021. The total hash power capacity of the bitcoin mining machines acquired in this transaction is estimated to be approximately 918.5 PH/S.

About 500.com Limited

500.com Limited (NYSE: WBAI) is a leading online sports lottery service provider in China. The Company offers a comprehensive and integrated suite of online lottery services, information, user tools and virtual community venues to its users. 500.com was among the first companies to provide online lottery services in China, and is one of two entities that have been approved by the Ministry of Finance to provide online lottery sales services on behalf of the China Sports Lottery Administration Center, which is the government authority that is in charge of the issuance and sale of sports lottery products in China.

Safe Harbor Statements

This news release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “target,” “going forward,” “outlook” and similar statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond the Company’s control, which may cause the Company’s actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law.

For more information, please contact:

500.com Limited

[email protected] 
Ms. Danni Zheng
Phone: +86 755 8633 8005

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SOURCE 500.com Limited

Moen Launches Industry-First Smart Water Network to Provide Convenience and Security; Experience it at CES 2021

MOEN DELIVERS SMART WATER TECHNOLOGY FOR THE WHOLE HOME AND NEW INTEGRATED APP FOR AUTOMATED WATER SECURITY

PR Newswire

NORTH OLMSTED, Ohio, Jan. 11, 2021 /PRNewswire/ –Consumers can control nearly everything from their smartphone, including locks, doorbells, cameras, lights—all products that help make them feel safe, offer convenience, and provide peace of mind. But what about their water? Water damage is five times more likely than theft*, and water is one of the most used resources in our homes, making it pivotal for homeowners to simplify the way they manage it.

Safety continues to be one of the primary drivers for adoption of smart home solutions**, and Moen is changing the plumbing industry by giving consumers better control over the water that flows through their home, through enhanced water security, and convenient features and benefits with the Moen portfolio of whole-home smart water products and the new Moen App. 

Moen’s smart water products look beautiful, integrate seamlessly into the home, respond more intuitively, and empower homeowners to manage water in a way that improves their comfort, security, and conservation efforts—all while enabling them to live the connected lifestyle they desire. While homeowners go about their day, Moen’s products are working together in the background, 24/7, to monitor for potential water risks and leaks and can automatically take action to notify the user, shut off water and protect the home.

Smart Water Products Moen is Showcasing at CES Include:


CES 2021 Innovation Awards Best of Innovation Honoree
 – U by Moen Smart Faucet:
U by Moen Smart Faucet technology makes everyday interactions in the kitchen more convenient and efficient. U by Moen Smart Faucet offers completely touchless functionality and endless possibilities with intuitive voice-controlled technology to help homeowners complete tasks in the kitchen with precision—all through their smart speaker or existing smart home platform. The faucet also provides three additional ways to operate the faucet, including touchless sensor control, handle control, and through the Moen App to further simplify kitchen tasks.

Flo by Moen Smart Water Security System: 
Flo by Moen is a revolutionary, smart home water security system that features a suite of products to protect a home from water damage and leaks, 24/7. With the Moen App, consumers also get an unprecedented ability to control, conserve and monitor their home’s water from anywhere at any time. Products include:


NEW!

Flo by Moen Smart Sump Pump Monitor*** — a device that connects to homeowners’ current sump pump to help reduce the risk of flooding as a result of a failure by providing continuous monitoring and alerts when potential problems or unusual conditions are detected. The proactive monitoring allows homeowners to address and mitigate the risk of water damage around the clock.

Flo by Moen Smart Water Shutoff — a leak detection and water monitoring device that’s installed on the water lines going into the home and can automatically turn off the water to the home if a leak or risk are detected. The Smart Water Shutoff provides automated water security by continually monitoring water pressure, flow rate, and ambient temperature, while running daily Health Tests to check for potential leaks and other abnormalities. If the Shutoff senses a home has a leak or is at risk, it will alert the homeowner so they can take action through the app, or the device can be set to close the water valve automatically and help prevent catastrophic damage.

Flo by Moen Smart Water Detectors — a standalone water sensor that can be placed anywhere in a home to alert homeowners through the Moen App when and where it detects water outside of the pipes to help prevent water damage and loss due to a fixture malfunction or environmental factors.

For more information about new products from Moen, visit moen.com or call 1-800-BUY-MOEN (1-800-289-6636).

*Based on research from the

Insurance Information Institute


**
Parks Associates 2020 Report

***Not available in Canada

Amazon, Alexa and all related logos are trademarks of Amazon.com, Inc. or its affiliates

Apple HomeKit, Siri and all related logos are trademarks of Apple Inc. or its affiliates

Google and Google Home are trademarks of Google LLC.

A
BOUT MOEN
Moen is the #1 consumer faucet brand in North America, offering a vast array of stylish and innovative kitchen and bath faucets, showerheads, accessories, bath safety products, kitchen sinks, garbage disposals, leak detection products and connected home offerings for residential applications that give consumers more power than ever before to understand and control the water that flows through their homes. These thoughtful designs deliver an exceptional user experience and elevate the way people interact with water every day. In addition, Moen® Commercial offers superior-performing products that can deliver lower lifetime costs for today’s facilities.

Moen is part of Fortune Brands Home & Security, Inc. (NYSE: FBHS), which creates products and services that fulfill the dreams of home. Moen anchors the Global Plumbing Group (GPG), which also includes several brands under the House of Rohl® including Perrin & Rowe®, ROHL®, Riobel®, Shaws® and Victoria + Albert®. Fortune Brands’ other brands include Fiberon® composite decking and railing products, Master Lock® and Sentry® Safe security products, MasterBrand Cabinets® and Therma-Tru® entry door systems. Fortune Brands is part of the S&P 500 Index and a Fortune 500 Company. For more information, please visit www.FBHS.com.

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SOURCE Moen

Globe Awards Gilat Multi-Million US Dollar Managed Service Contract for Significant Expansion of Cellular Backhaul Project

Gilat’s robust end-to-end solution will enable Globe to meet its goal of providing high-quality service throughout the Philippines

PETAH TIKVA, Israel, Jan. 11, 2021 (GLOBE NEWSWIRE) — Gilat Satellite Networks Ltd. (NASDAQ, TASE: GILT), a worldwide leader in satellite networking technology, solutions and services, announced today that Globe Telecom, Inc. (PSE: GLO) had awarded Gilat a multi-million US dollar managed service contract for significant project expansion for cellular backhaul over satellite. Gilat’s robust end-to-end solution will enable Globe to meet its goal of providing high-quality service throughout the Philippines.

Globe, the largest mobile network operator in the Philippines, chose Gilat’s solution to expand its’ nationwide coverage, as the demand for connectivity rapidly grows. Gilat’s cellular backhaul over satellite brings a quick solution compared to long and tedious efforts of laying out fiber, particularly in areas with challenging terrain.

Gilat, with its managed service expertise and technological advantage of its SkyEdge II-c platform for 2G, 3G, 4G and 5G, will provide Globe with a complete solution to provide its customers with the most resilient service. Gilat’s solution provides Globe with flexibility, to seamlessly and quickly relocate VSATs between sites.

“Over the past years, Gilat has been a reliable partner of Globe, supporting us with uncompromised quality that helps us serve our customers better. This backhaul technology will improve resiliency and increase dependability of our services attuned to providing the nation with a #First WorldNetwork,” said Ernest Cu, President and CEO of Globe.

“We are honoured to be of value to Globe and to continue to gain their trust. We strive to enable Globe to leverage Gilat’s expertise in delivering connectivity to the most challenging locations and stand committed to delivering the levels of service Globe requires, as we continue to evolve our solution and services to lead the industry with cellular backhaul over satellite,” said Abhay Kumar, Regional Vice President – APJ for Gilat. “We are very thankful to Globe for expanding their partnership with Gilat to address their strategic requirement of delivering significant cellular backhaul coverage in the Philippines.”

About Globe Telecom

Globe Telecom, Inc. is a leading full-service telecommunications company in the Philippines and publicly listed in the Philippine Stock Exchange with the stock symbol GLO. The company serves the telecommunications and technology needs of consumers and businesses across an entire suite of products and services including mobile, fixed, broadband, data connectivity, internet and managed services. It has major interests in financial technology, digital marketing solutions, venture capital funding for startups,  and virtual healthcare. In 2019, Globe became a signatory to the United Nations Global Compact, committing to implement universal sustainability principles.  Its principals are Ayala Corporation and Singtel, acknowledged industry leaders in the country and in the region. For more information visit www.globe.com.ph. Follow @enjoyglobe on Facebook, Twitter, Instagram and YouTube. 

About Gilat

Gilat Satellite Networks Ltd. (NASDAQ: GILT, TASE: GILT) is a leading global provider of satellite-based broadband communications. With 30 years of experience, we design and manufacture cutting-edge ground segment equipment, and provide comprehensive solutions and end-to-end services, powered by our innovative technology. Delivering high value competitive solutions, our portfolio comprises of a cloud based VSAT network platform, high-speed modems, high performance on-the-move antennas and high efficiency, high power Solid State Amplifiers (SSPA) and Block Upconverters (BUC).

Gilat’s comprehensive solutions support multiple applications with a full portfolio of products to address key applications including broadband access, cellular backhaul, enterprise, in-flight connectivity, maritime, trains, defense and public safety, all while meeting the most stringent service level requirements. Gilat controlling shareholders are the FIMI Private Equity Funds. For more information, please visit: www.gilat.com

Certain statements made herein that are not historical are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “estimate”, “project”, “intend”, “expect”, “believe” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties. Many factors could cause the actual results, performance or achievements of Gilat to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, among others, risks associated with the outbreak and global spread of the coronavirus (COVID-19) pandemic; changes in general economic and business conditions, inability to maintain market acceptance to Gilat’s products, inability to timely develop and introduce new technologies, products and applications, rapid changes in the market for Gilat’s products, loss of market share and pressure on prices resulting from competition, introduction of competing products by other companies, inability to manage growth and expansion, loss of key OEM partners, inability to attract and retain qualified personnel, inability to protect the Company’s proprietary technology and risks associated with Gilat’s international operations and its location in Israel. For additional information regarding these and other risks and uncertainties associated with Gilat’s business, reference is made to Gilat’s reports filed from time to time with the Securities and Exchange Commission. We undertake no obligation to update or revise any forward-looking statements for any reason.

Contact:

Gilat Satellite Networks
Doreet Oren, Director Corporate Communications
[email protected]

GK Investor and Public Relations
Ehud Helft, Managing Partner
[email protected]

 



Forma Therapeutics Reviews 2020 Highlights and Outlines Key 2021 Milestones

Forma Therapeutics Reviews 2020 Highlights and Outlines Key 2021 Milestones

Strong pipeline progress in 2020 positions company well for 2021

Established proof of concept in SCD for FT-4202

Potential transformative treatment profile for IDH1 inhibitor olutasidenib in R/R/ AML

Enrolling Phase 1 FT-7051 trial for prostate cancer – including patient with AR-v7 splice variants

Completed successful IPO and follow-on equity offering

WATERTOWN, Mass.–(BUSINESS WIRE)–Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today provided a review of corporate highlights from 2020 and outlined anticipated key clinical program milestones for 2021.

“While 2020 was marked by tremendous challenges due to the COVID-19 pandemic, Forma made important strides due to the courage of patients and the dedication of our employees. We reported promising results our from our clinical programs including FT-4202 in sickle cell disease, olutasidenib in both AML and glioma, and FT-7051 in prostate cancer, and also raised approximately $695 million in public equity offerings,” said Frank Lee, president and chief executive officer of Forma. “In this coming year, we anticipate continued progress, and look forward to advancing drug candidates that we believe have the potential to significantly impact patients living with rare hematologic diseases and cancers.”

Clinical Program Highlights and Milestones

PKR Program in Sickle Cell Disease (SCD):

FT-4202 is a novel investigational selective red blood cell pyruvate kinase R (PKR) activator Forma is actively evaluating in a multi-center, placebo-controlled Phase 1 trial in individuals with sickle cell disease ages 12 years and older.

  • In June 2020, encouraging ­single dose cohort data were reported at the 25th European Hematology Association (EHA) Annual Congress. Initial findings from Forma’s Phase 1 trial of FT-4202 in patients with SCD demonstrated a favorable tolerability profile and biologic effects, with evidence of pharmacodynamic activity.
  • In December 2020, clinical proof-of-concept data were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. Forma presented data from a multi-dose cohort of its Phase 1 trial of FT-4202 in patients with SCD, showing that 86% of patients dosed with 300 mg of FT-4202 for 14 days achieved a hemoglobin increase of greater than 1 g/dL from baseline. The observed reduction in hemolysis in conjunction with the biomarker analysis showing improved deformability and hydration of RBCs supports the hypothesis that pyruvate kinase activation may have an impact on vaso-occlusive crises (VOCs).
  • Additional clinical data anticipated from the ongoing Phase 1 randomized placebo-controlled trial in SCD patients. Data from the MAD2 600 mg cohort of the Phase 1 trial is expected to be reported in the first quarter of 2021, followed by results from the 12-week open-labelextension in the second quarter of 2021.
  • Expanding FT-4202 development program. Forma has initiated a global pivotal Phase 2/3 trial of FT-4202 in SCD patients, with plans to initiate a Phase 2 trial in thalassemia in the second half of 2021, and a pediatric SCD trial in the first half of 2022.

IDH1 Program in AML and Glioma:

Olutasidenib (FT-2102) is a selective inhibitor for cancers with IDH1 mutations Forma is evaluating for the treatment of acute myeloid leukemia (AML) and glioma. Olutasidenib is currently being studied in a registrational Phase 2 trial for relapsed/refractory (R/R) AML and an exploratory Phase 1 trial for glioma.

  • In May 2020, positive data for olutasidenib in glioma was announced at the American Society of Clinical Oncology (ASCO). Forma announced positive preliminary Phase 1 data for olutasidenib in refractory, enhancing glioma at ASCO 2020, suggesting the potential for response and prolonged disease control in relapsed/refractory IDH1-mutated glioma patients.
  • In October 2020, positive data for olutasidenib in a registrational trial for R/R AML was announced. Forma announced positive results from the planned interim analysis of the Phase 2 registration trial of olutasidenib in R/R AML patients with IDH1 gene mutations. Olutasidenib as a monotherapy demonstrated a favorable tolerability profile and achieved a composite complete remission (CR/CRh) rate of 33.3% (30% CR and 3% CRh), the primary efficacy endpoint. While a median duration of CR/CRh has not yet been reached, a sensitivity analysis indicated the median duration of CR/CRh to be 13.8 months. Further data analysis indicates an estimated 87% survival rate at 18 months in patients who respond to treatment with olutasidenib. Olutasidenib’s potential transformative treatment profile is based upon three key indicators: durability of response and increased survival for responders, favorable tolerability suggesting ability to combine with other therapies, and properties to support indication expansion to other IDH1 mutated cancers.
  • Forma has begun preparing for a new drug application for olutasidenib in R/R AML.

CPB/p300 Program in Prostate Cancer:

FT-7051 is a potent and selective CBP/p300 inhibitor Forma is evaluating for the treatment of metastatic prostate cancer resistant to androgen receptor (AR) signaling inhibitor therapy.

  • In April 2020, preclinical data on FT-6876 (a research compound related to FT-7051) in breast cancer was presented at the American Association for Cancer Research (AACR). Forma presented preclinical data that demonstrated antitumor activity of FT-6876 in AR-dependent breast cancer cell lines, suggesting that FT-6876 could serve as a treatment for patients with other AR-dependent tumors, such as prostate cancer.
  • Phase 1 underway in 2021. In December 2020, Forma initiated recruitment in a Phase 1 trial of FT-7051 in men with metastatic castration-resistant prostate cancer including those with AR-v7 splice variants. Dosing in this trial is anticipated to begin in early in the first quarter of 2021. Forma plans to disclose initial safety, tolerability and preliminary response data in the second half of 2021.

About Forma Therapeutics

Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding our beliefs and expectations regarding its: our business plans and objectives; future plans for FT-4202, FT-7051, and olutasidenib, including expectations regarding timing and success of the current ongoing clinical trials as well as planned future clinical trials, therapeutic potential and clinical benefits thereof, and upcoming milestones for our other product candidates; the planned timing and potential submission of new drug applications for olutasidenib in R/R AML, growth as a company and the anticipated contribution of our employees and the members of our board of directors to our operations and progress; presentation of additional data at upcoming scientific conferences, and other preclinical data in 2021; the potential commercial and collaboration opportunities, including potential future collaborators and parties, as well as value and market, for our product candidates; uses of capital, expenses and other 2021 financial results or in the future, and the potential impact of COVID-19 on patient retention, strategy, future operations, clinical trials or IND submissions. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical programs and other risks identified in our SEC filings, including those risks discussed under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

Media Contact:

Megan McGrath, +1 781-235-3060

MacDougall

[email protected]

Investor Contact:

Mario Corso, +1 781-366-5726

Forma Therapeutics

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

MEDIA:

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NFI Group Confirms 2020 Guidance, and Provides 2021 Guidance and 2025 Financial Targets at Investor Day

PR Newswire

WINNIPEG, MB, Jan. 11, 2021 /PRNewswire/ – (TSX: NFI) NFI Group Inc. (“NFI” or the “Company”), one of the world’s leading independent bus and coach manufacturers, today:

  • reaffirmed its financial guidance for 2020, including Adjusted EBITDA of $145 million to $155 million;
  • announced its financial guidance for 2021, including Adjusted EBITDA range of $220 million to $240 million, representing a potential improvement of over 50% from 2020 expectations; and
  • announced longer-term targets for 2025, including Adjusted EBITDA of $400 million to $450 million and a Return on Invested Capital (“ROIC”) target above 12%.

The Company will discuss these announcements at its Investor Day, happening today, January 11, 2021, from 8:30 – 11:30 a.m. EST. To join the Virtual Investor Day event visit nfigroup.com/investor-day-2021/.  All dollar amounts in this press release are expressed in U.S. dollars.

For Fiscal 2021, management anticipates revenue growth and enhanced profitability driven by market recovery, increased sales of zero-emission buses (“ZEBs”), geographic sales expansion and continued realization of fixed and variable cost reductions from its transformational “NFI Forward” initiative.


Fiscal 2021 Financial Guidance


2021 Financial Guidance


Revenue

$2.8 billion – $2.9 billion


ZEB (electric) as a percentage of manufacturing sales

20% – 25%


Adjusted EBITDA(1)

$220 million – $240 million


Cash Capital Expenditures – including NFI Forward

$50 million


Effective Tax Rate (“ETR”)

~31%


Seasonality

Year-over-year growth in
Revenue and Adjusted EBITDA in
Q2, Q3 and Q4, decline in Q1


(1) Adjusted EBITDA is not a recognized earnings measure and does not have a standardized meaning prescribed by IFRS. Therefore, it may not be comparable to similar measures presented by other issuers. See “Non-IFRS Measures” at the end of this press release.


The
 guidance provided above is driven by numerous expectations and assumptions including, but not limited to, the following:


  • Revenue: Growth is expected to be driven by the Company’s solid backlog, new order growth from the anticipated recovery within North American public transit markets and the United Kingdom transit market, combined with an expected increase in sales activity in Asia Pacific and European markets. In addition, management believes there is potential for improvement in private coach aftermarket parts sales.

  • ZEB sales: Growth in ZEB sales is based on the Company’s backlog and expected new orders from increased market demand for zero-emission vehicles.

  • Adjusted EBITDA:
    Adjusted EBITDA growth is based on expected revenue growth, anticipated margins from vehicles in the Company’s current backlog and anticipated new orders, expected increases in the sales of ZEBs and cost reductions from the NFI Forward initiative. NFI expects to realize approximately $29 million of savings in 2021 from NFI Forward and to reach cumulative savings of approximately $47 million since the inception of the program in the third quarter of 2020. The lower end of the Adjusted EBITDA range is based on scenarios where production is negatively impacted by slower market recovery, limited ongoing impacts of COVID-19 and delays in achieving cost reductions from the NFI Forward initiative.

  • Cash Capital Expenditures:
    Fiscal 2020 cash capital expenditures are expected to be allocated between maintenance and NFI Forward projects, based on approximately a seventy/thirty percent split.

  • ETR: The Effective Tax Rate is based on current tax rates in the jurisdictions in which NFI operates, anticipated financial results, the Company’s corporate structure and the assumption that there will not be significant changes in applicable tax rates in 2021.

  • COVID-19:
    We have assumed that the impact of COVID-19 on the Company’s business in 2021 will be significantly lower than in 2020, including no significant idling of any of the Company’s facilities, increased buying activity from customers and limited supply disruptions. The overall impact of COVID-19 is expected to reduce steadily through the end of 2021.


Longer-Term Financial Targets

The Company is also providing longer-term financial targets based on management’s market and operations expectations up to fiscal 2025.


2025 Financial Targets


Revenue

$3.9 billion – $4.1 billion


ZEB (electric) revenue as a percentage of manufacturing sales

35% – 40%


Adjusted EBITDA

$400 million – $450 million


ROIC(2)

>12%


(2) ROIC is not a recognized earnings measure and does not have a standardized meaning prescribed by IFRS. Therefore, it may not be comparable to similar measures presented by other issuers. See “Non-IFRS Measures” at the end of this press release.


The
 financial targets set out above are based on the Company’s long-term operating plan and represent performance targets that management is seeking to achieve. They are driven by numerous expectations and assumptions including, but not limited to, the following:


  • Revenue: Growth is expected to be driven by the expected recovery in NFI’s core markets, combined with anticipated international sales expansion, increased sales of ZEBs, market share gains and an increase in deliveries of ARBOC’s low-floor cutaway and medium-duty products.

  • ZEB sales: Growth in ZEB sales as a percentage of manufacturing sales is based on NFI expanding its market leading share of ZEB sales, and from review of customers capital and fleet renewal plans that suggest there will be a significant increase in their demand for electric vehicles.

  • Adjusted EBITDA: Adjusted EBITDA growth is based on the expected revenue growth referred to above, margin expectations on future sales and the realization of the full amount of the expected cost savings from the NFI Forward initiative by 2023, resulting in NFI operating with a lower fixed cost base.

  • ROIC: Target is driven by the factors noted above combined with the expectation that there will not be significant changes in tax rates from current levels.

  • COVID-19: Management has assumed that the impact of COVID-19 on the Company’s business will significantly reduce at an accelerating pace through 2021 and 2022, with 2023 and thereafter being unaffected.

  • The targets exclude any impacts from any future acquisitions during 2021 to 2025.

“Today’s guidance and longer-term targets reflect the fact that NFI is on the path to recovery, with solid improvement expected in 2021 as a transition to significant growth expected through 2025,” said Paul Soubry, President and Chief Executive Officer. “We see a tremendous opportunity for NFI to drive profitable growth through market recovery, geographic expansion and increased sales of zero-emission buses. We also expect to realize upon the benefits of a lower cost base from the completion of our NFI Forward initiative.”

“While the pandemic continues to impact our customers and our businesses around the world, we’ve been very encouraged to see governments step up their commitment to support essential service agencies and operators through increased funding to support operations and capital for eco-friendly, transit buses,” Soubry added. “We look forward to hosting our analysts, investors and other stakeholders at today’s virtual Investor Day where we will discuss our outlook and showcase how NFI’s industry leading green products and services will drive the evolution to a cleaner, zero-emission future – or what we call the ZEvolution.”

The above tables outline guidance for selected Fiscal 2021 consolidated financial metrics and longer-term targets for Fiscal 2025. This guidance and these targets take into consideration management’s current outlook and the Company’s anticipated Fiscal 2020 results and are based on the assumptions and expectations noted in this release. The purpose of the financial guidance and targets is to assist investors, shareholders and others in understanding certain financial metrics relating to expected Fiscal 2021 financial results and the longer-term 2025 targets in order to assist in the evaluation of the performance of our business.  The information may not be appropriate for any other purposes. Information about our guidance and targets, including the various assumptions and expectations underlying them, is forward looking and should be read in conjunction with the “Forward-looking Statements” contained  at the end of this press release and the related disclosure and information about various economic, competitive and regulatory assumptions, factors and risks in the Company’s other disclosure documents that may cause actual future financial and operating results to differ from management’s current expectations. There can be no assurance that such guidance or financial targets will be met and actual performance may differ materially.

About NFI Group

Leveraging 450 years of combined experience, NFI is leading the battery-electric transition of mass mobility around the world. With zero-emission buses and coaches, infrastructure, and technology, NFI meets today’s urban demands for scalable smart mobility solutions. Together, NFI is enabling more livable cities through connected, clean, and sustainable transportation.

NFI is a leading independent global bus manufacturer providing a comprehensive suite of mass transportation solutions under brands: New Flyer® (heavy-duty transit buses), Alexander Dennis Limited (single and double-deck buses), Plaxton (motor coaches), MCI® (motor coaches), ARBOC® (low-floor cutaway and medium-duty buses), and NFI Parts™. NFI vehicles incorporate the widest range of drive systems available including: clean diesel, natural gas, diesel-electric hybrid, and zero-emission electric (trolley, battery, and fuel cell). In total, NFI now supports over 105,000 buses and coaches currently in service around the world.

NFI common shares are traded on the Toronto Stock Exchange under the symbol NFI. Further information is available at www.nfigroup.com, www.newflyer.com, www.mcicoach.com, www.arbocsv.com, www.nfi.parts, and www.alexander-dennis.com.

Non-IFRS Measures

References to “Adjusted EBITDA” are to earnings before interest, income taxes, depreciation and amortization after adjusting for the effects of certain non-recurring and/or non-operations related items that do not reflect the current ongoing cash operations of the Company as described in the Company’s disclosure documents available on SEDAR at www.sedar.com.  References to “ROIC” are to net operating profit after taxes (calculated as Adjusted EBITDA less depreciation of plant and equipment, depreciation of right-of-use assets and income taxes at a rate of 31%) divided by average invested capital for the last twelve month period (calculated as to shareholders’ equity plus long-term debt, obligations under leases, other long-term liabilities and derivative financial instrument liabilities less cash).

Management believes Adjusted EBITDA and ROIC are useful measures in evaluating the performance of the Company. However, Adjusted EBITDA and ROIC are not recognized earnings measures under IFRS and do not have standardized meanings prescribed by IFRS. Readers of this press release are cautioned that Adjusted EBITDA or ROIC should not be construed as an alternative to net earnings or loss or cash flows from operating activities determined in accordance with IFRS as an indicator of NFI’s performance. Historical reconciliations of net earnings to Adjusted EBITDA has been provided in the Company’s disclosure documents available on SEDAR at www.sedar.com. NFI’s method of calculating Adjusted EBITDA and ROIC may differ materially from the methods used by other issuers and, accordingly, may not be comparable to similarly titled measures used by other issuers.

Forward-Looking Statements

Certain statements in this press release are “forward-looking statements”, which reflect the expectations of management regarding the Company’s future growth, financial performance and results of operations and the Company’s strategic initiatives, plans, business prospects and opportunities, including the duration, impact of and recovery from the COVID-19 pandemic. The words “believes”, “views”, “anticipates”, “plans”, “expects”, “intends”, “projects”, “forecasts”, “estimates”, “guidance” and “targets”, “may”, “will” and similar expressions are intended to identify forward looking statements. These forward-looking statements reflect management’s current expectations regarding future events (including the recovery of the Company’s markets and the expected benefits to be obtained through its “NFI Forward” initiative) and the Company’s financial and operating performance and speak only as of the date of this press release.  Forward-looking statements involve significant risks and uncertainties, should not be read as guarantees of future events, performance or results, and will not necessarily be accurate indications of whether or not or the times at or by which such performance or results will be achieved.

A number of factors that may cause actual results to differ materially from the results discussed in the forward-looking statements include: the Company may not be able to achieve its targets for sales growth, funding may not continue to be available to the Company’s customers at current levels or at all; the Company’s business is affected by economic factors and adverse developments in economic conditions could have an adverse effect on the for the Company’s products and the results of its operations; currency fluctuations could adversely affect the Company’s financial results or competitive position; interest rates could change substantially, materially impacting the Company’s revenue and profitability; an active, liquid trading market for the Company’s common shares (the “Shares”) may cease to exist, which may limit the ability of shareholders to trade Shares; the market price for the Shares may be volatile; if securities or industry analysts do not publish research or reports about the Company and its business, if they adversely change their recommendations regarding the Shares or if the Company’s results of operations do not meet their expectations, the Share price and trading volume could decline; in addition, if securities or industry analysts publish inaccurate or unfavorable research about the Company or its business, the Share price and trading volume of the Shares could decline; competition in the industry and entrance of new competitors; current requirements under “Buy America” regulations may change and/or become more onerous or suppliers’ “Buy America” content may change; failure of the Company to comply with the U.S. Disadvantaged Business Enterprise (“DBE”) program requirements or the failure to have its DBE goals approved by the U.S. Federal Transit Administration; absence of fixed term customer contracts, exercise of options and customer suspension or termination for convenience; local content bidding preferences in the United States may create a competitive disadvantage; uncertainty resulting from the exit of the UK from the European Union; requirements under Canadian content policies may change and/or become more onerous; operational risk resulting from inadequate or failed internal processes, people and/or systems or from external events, including fiduciary breaches, regulatory compliance failures, legal disputes, business disruption, pandemics, floods, technology failures, processing errors, business integration, damage to physical assets, employee safety and insurance coverage; international operations subject the Company to additional risks and costs and may cause profitability to decline; dependence on limited sources or unique sources of supply; dependence on supply of engines that comply with emission regulations; a disruption, termination or alteration of the supply of vehicle chassis or other critical components from third-party suppliers could materially adversely affect the sales of certain of the Company’s products; the Company’s profitability can be adversely affected by increases in raw material and component costs; the Company may incur material losses and costs as a result of product warranty costs, recalls and remediation of transit buses and motor coaches; production delays may result in liquidated damages under the Company’s contracts with its customers; catastrophic events may lead to production curtailments or shutdowns; the Company may not be able to successfully renegotiate collective bargaining agreements when they expire and may be adversely affected by labour disruptions and shortages of labour; the Company’s operations are subject to risks and hazards that may result in monetary losses and liabilities not covered by insurance or which exceed its insurance coverage; the Company may be adversely affected by rising insurance costs; the Company may not be able to maintain performance bonds or letters of credit required by its contracts or obtain performance bonds and letters of credit required for new contracts; the Company is subject to litigation in the ordinary course of business and may incur material losses and costs as a result of product liability claims; the Company may have difficulty selling pre-owned coaches and realizing expected resale values; the Company may incur costs in connection with regulations relating to axle weight restrictions and vehicle lengths; the Company may be subject to claims and liabilities under environmental, health and safety laws; dependence on management information systems and cyber security risks; the Company’s ability to execute its strategy and conduct operations is dependent upon its ability to attract, train and retain qualified personnel, including its ability to retain and attract executives, senior management and key employees; the Company may be exposed to liabilities under applicable anti-corruption laws and any determination that it violated these laws could have a material adverse effect on its business; the Company’s risk management policies and procedures may not be fully effective in achieving their intended purposes; internal controls over financial reporting, no matter how well designed, have inherent limitations; there are inherent limitations to the effectiveness of any system of disclosure controls and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures; ability to successfully execute strategic plans and maintain profitability; development of competitive or disruptive products, services or technology; development and testing of new products or model variants; acquisition risk; reliance on third-party manufacturers; third-party distribution/dealer agreements; availability to the Company of future financing; the Company may not be able to generate the necessary amount of cash to service its existing debt, which may require the Company to refinance its debt; the restrictive covenants in the credit facilities could impact the Company’s business and affect its ability to pursue its business strategies; payment of dividends is not guaranteed; a significant amount of

the Company’s cash is distributed, which may restrict potential growth; the Company is dependent on its subsidiaries for all cash available for distributions; future sales or the possibility of future sales of a substantial number of Shares may impact the price of the Shares and could

result in dilution; if the Company is required to write down goodwill or other intangible assets, its financial condition and operating results would be negatively affected; income tax risk due to the Company’s operations being complex and income tax interpretations, regulations and legislation that pertain to its activities are subject to continual change; investment eligibility and Canadian federal income tax risks; certain U.S. tax rules may limit the ability of NF Holdings and its U.S. subsidiaries (the “NF Group”) to deduct interest expense for U.S. federal income tax purposes and may increase the NF Group’s tax liability and certain financing transactions could be characterized as “hybrid transactions” for U.S. tax purposes, which could increase the NF Group’s tax liability.

Factors relating to the global COVID-19 pandemic include: the magnitude and duration of the global, national and regional economic and social disruption being caused as a result of the pandemic; the impact of national, regional and local governmental laws, regulations and “shelter in place” or similar orders relating to the pandemic which may materially adversely impact the Company’s ability to continue operations; partial or complete closures of one, more or all of the Company’s facilities and work locations or the reduction of production rates (including due to government mandates and to protect the health and safety of the Company’s employees or as a result of employees being unable to come to work due to COVID-19 infections with respect to them or their family members); production rates may be further decreased as a result of the pandemic; supply delays and shortages of parts and components and disruption to labour supply as a result of the pandemic; the pandemic will likely adversely affect operations of customers and reduce and delay, for an unknown period, customers’ purchases of the Company’s products; the anticipated recovery of the Company’s markets in the future may be delayed or increase in demand may be lower than expected as a result of the continuing effects of the pandemic; the Company’s ability to obtain access to additional capital if required; and the Company’s financial performance and condition, obligations, cash flow and liquidity and its ability to maintain compliance with the covenants under  its credit facilities, which may also negatively impact the ability of the Company to pay dividends. There can be no assurance that the Company will be able to maintain sufficient liquidity for an extended period, obtain future satisfactory covenant relief under its credit facilities, if required, or access to additional capital or access to government financial support or as to when production operations will return to previous production rates. There is also no assurance that governments will provide continued or adequate stimulus funding during or after the pandemic for public transit agencies to purchase transit vehicles or that public or private demand for the Company’s vehicles will return to pre-pandemic levels in the anticipated period of time. The Company cautions that due to the dynamic, fluid and highly unpredictable nature of the pandemic and its impact on global and local economies, businesses and individuals, it is impossible to predict the severity of the impact on the Company’s business, operating performance, financial condition and ability to generate sufficient cash flow and maintain adequate liquidity and any material adverse effects could very well be rapid, unexpected and may continue for an extended and unknown period of time.

Factors relating to the Company’s “NFI Forward” initiative include: the Company’s ability to successfully execute the initiative and to generate the planned savings in the expected time frame or at all; management may have overestimated the amount of savings and production efficiencies that can be generated or may have underestimated the amount of costs to be expended; the implementation of the initiative may take longer than planned to achieve the expected savings; further restructuring and cost-cutting may be required in order to achieve the objectives of the initiative; the estimated amount of savings generated under the initiative may not be sufficient to achieve the planned benefits; combining business units and/or reducing the number of production or parts facilities may not achieve the efficiencies anticipated; and the impact of the continuing global COVID-19 pandemic. There can be no assurance that the Company will be able to achieve the anticipated financial and operational benefits, cost savings or other benefits of the initiative.

The Company cautions that the foregoing factors are not exhaustive of all potential risks. These factors and other risks and uncertainties are discussed in the Company’s press releases, Annual Information Form and materials filed with the Canadian securities regulatory authorities which are available on SEDAR at www.sedar.com.  Due to the potential impact of these and other factors, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by applicable law.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/nfi-group-confirms-2020-guidance-and-provides-2021-guidance-and-2025-financial-targets-at-investor-day-301204865.html

SOURCE NFI Group Inc.

REGENXBIO to Present at the 39th Annual J.P. Morgan Healthcare Conference

PR Newswire

ROCKVILLE, Md., Jan. 11, 2021 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 11:40 a.m. ET. The conference will be held in a virtual meeting format.

A webcast of the presentation can be accessed in the Investors section of REGENXBIO’s website at www.regenxbio.com. An archived replay of the webcast will be available in the Investors section of REGENXBIO’s website for approximately 30 days following the presentation.

About REGENXBIO Inc.

REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO’s NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.

Contacts:

Tricia Truehart

Investor Relations and Corporate Communications
347-926-7709
[email protected]

Investors:
Eleanor Barisser, 212-600-1902
[email protected]

Media:
David Rosen, 212-600-1902
[email protected]

Cision View original content:http://www.prnewswire.com/news-releases/regenxbio-to-present-at-the-39th-annual-jp-morgan-healthcare-conference-301203628.html

SOURCE REGENXBIO Inc.

Sol-Gel Technologies to Present at Upcoming 2021 Solebury Trout Virtual Investor Conference and H.C. Wainwright BioConnect Conference

NESS ZIONA, Israel, Jan. 11, 2021 (GLOBE NEWSWIRE) — Sol-Gel Technologies (NASDAQ: SLGL), (“Sol-Gel”), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that the company will present an overview of the Company and provide a business update at the following virtual investor conferences.

Solebury Trout 2021 Virtual Investor Conference
     
Speaker:   Dr. Alon Seri-Levy, Chief Executive Officer
Date:   January 11-15, 2020
Access:   Available on demand at the following Link
     
H.C. Wainwright BioConnect 2021 Virtual Conference
     
Speakers:   Gilad Mamlok, Chief Financial Officer
Date:   January 11-14, 2020 
Access:   Available on demand to conference participants.

About Sol-Gel Technologies

Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel leverages its proprietary microencapsulation technology platform for the development of Twyneo (benzoyl peroxide and tretinoin) cream, under investigation for the treatment of acne vulgaris, and Epsolay®, under investigation for the treatment of papulopustular rosacea. The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, under investigation for the treatment of palmoplantar keratoderma, and preclinical assets tapinarof and roflumilast. For additional information, please visit www.sol-gel.com.

For further information, please contact:

Sol-Gel Contact:
Gilad Mamlok
Chief Financial Officer
+972-8-9313433

Investor Contact:
Michael Levitan
Solebury Trout
+1-646-378-2920
[email protected]

Source: Sol-Gel Technologies Ltd.



Helius Medical Technologies, Inc. Submits Response to U.S. FDA in Pursuit of De Novo Classification and Clearance of the PoNS™ Device for the Treatment of Gait Deficit Due to Symptoms of Multiple Sclerosis

Submits formal response to the U.S. Food and Drug Administration’s request for additional information

NEWTOWN, Pa., Jan. 11, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has submitted its formal response to the U.S. Food and Drug Administration’s (the “FDA” or “Agency”) request for additional information.

The FDA’s request for additional information was related to the Company’s request for de novo classification and clearance of the Portable Neuromodulation Stimulator (PoNS™) device as a potential treatment for gait deficit due to symptoms of Multiple Sclerosis (“MS”), to be used as an adjunct to a supervised therapeutic exercise program in patients over 18 years of age.

“The Helius team is very excited to announce the timely submission of our response to the FDA’s request for additional information,” said Dane Andreeff, Interim President and Chief Executive Officer of Helius. “The achievement of this important milestone was made possible by the diligent efforts of our regulatory and clinical affairs team, and I would like to thank them for their hard work and dedication in recent months.”

Mr. Andreeff continued: “Looking ahead, we expect that the FDA’s receipt of our response will enable the FDA to resume its review of our request for de novo classification and clearance. We remain committed to our goal of bringing our PoNS technology to the aid of U.S. patients suffering with gait deficit due to MS-related symptoms as expeditiously as possible, and hope to receive the FDA’s decision on our request for de novo classification and clearance during the first half of this year.”

Additional Background Information:

Helius submitted its request for de novo classification and clearance of the PoNS device for the treatment of gait deficit due to symptoms from MS on August 4, 2020, following the receipt of Breakthrough Designation by FDA in early May. On October 19, 2020, the Company announced the receipt of the FDA’s request for additional information, which was received approximately 75 days following the submission date and placed the FDA’s review on hold until receipt by the FDA of the requested information.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for de novo classification and clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ is currently not commercially available in the United States, the European Union or Australia.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Jack Powell
[email protected]

Cautionary Disclaimer Statement: 

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “look forward,” “will,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future growth and operational progress, clinical and regulatory development plans for the PoNS device, and potential regulatory clearance of the PoNS device, including expected timing for the FDA to resume its review of our request for de novo classification and clearance and expected timing for receipt of the FDA’s decision on such request.

These statements involve substantial known and unknown risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the clinical development process and FDA regulatory submission and approval process, including that the Company’s request for de novo classification and clearance may be declined by the FDA, that the FDA is not required to and may not respond to the Company’s request in the timeframe indicated by its de novo review goals or in the time the Company expects, whether the Company’s response will be satisfactory to the FDA, whether the FDA will require additional information, whether the Company will be able to provide it in a timely manner and whether such additional information will be satisfactory to the FDA, uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, uncertainties associated with future clinical trials and other development activities, and other risks detailed from time to time in the filings made by the Company with securities regulators, including the risks and uncertainties described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release. 



DS Smith Partners With Brrr Box to Deliver First Commercial, Sustainable Cooler Alternative to Styrofoam

DS Smith Partners With Brrr Box to Deliver First Commercial, Sustainable Cooler Alternative to Styrofoam

Packaging giant’s temperature, moisture-resistant Greencoat technology makes Brrr Box a 100% recyclable, biodegradable cooler

ATLANTA–(BUSINESS WIRE)–
DS Smith, the leading sustainable packaging company, has joined forces with Vig Pak LLC to introduce Brrr Box, a patented, 100% recyclable, biodegradable cooler that incorporates some of the most modern technologies available in corrugated cardboard packaging.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210111005132/en/

Brrr Box is a 100% recyclable, biodegradable cooler. (Photo: DS Smith)

Brrr Box is a 100% recyclable, biodegradable cooler. (Photo: DS Smith)

Named “The Official Cooler of Planet Earth,” Brrr Box uses DS Smith’s proprietary Greencoat corrugated moisture-resistant and FDA food contact-safe material to coat its sustainable alternative to Styrofoam.

Unlike typical plastic foam coolers, Greencoat is biodegradable, made of sustainable and renewable fiber that reduces waste to landfills and carbon emissions.

“Greencoat was launched 13 years ago as a revolutionary product created to survive the harsh poultry shipping supply-chain and has since been adopted by a number of other markets. Brrr Box is a natural extension of the product line that’s ideal for consumers looking for an eco-friendly, durable way to transport ice and cold beverages without the negative impact of Styrofoam,” said Melanie Galloway, sales, marketing and innovation director at DS Smith Packaging North America.

She announced the partnership today with Brrr Box co-founder and President Ed Battle.

Battle said the Brrr Box is an innovative corrugated beverage cooler solution being used by a major U.S. convenience store chain to replace Styrofoam coolers.

“The chain was looking for a disposable cooler that performed as well as Styrofoam, first and foremost,” he said. “They are also conscious of precious floor space in stores, and Brrr Box is shipped and displayed flat, so they can carry more inventory in a much smaller footprint. And, frankly, they wanted an environmentally friendly alternative as well. Brrr Box is the only product that does that.”

Battle said it’s not a single-use cooler. It opens and closes with one hand, assembles in about 5 seconds, holds a dozen 12-ounce beverages and 10 pounds of ice and can keep contents cold for up to 8 hours.

“It’s a multi-use cooler if treated properly. And the best part is instead of those Styrofoam coolers going back into the waste stream, this goes back into the circular economy and is fully curbside recyclable,” he said.

Galloway said Greencoat uses a patented process applied completely in-house. The technology combines impregnation and coating on the paper to provide durability and long-lasting moisture protection and temperature resistance.

For retailers looking to provide an eco-friendly alternative to Styrofoam, Brrr Box offers many benefits, including:

  • 100% recyclable and biodegradable.
  • Ships and merchandises flat.
  • Accepts high-impact graphic printing.
  • Reduces freight, warehousing and merchandising space.
  • Compatible with corporate green initiatives and reduces carbon footprint.
  • Opens and closes with one hand and assembles in about 5 seconds.
  • Cooler holds a dozen 12-ounce beverages and 10 pounds of ice. Can keep contents cold for up to 8 hours.
  • Made in the United States.

DS Smith’s purpose is to ‘Redefine Packaging for a Changing World’, and as part of its recently launched “Now and Next Sustainability Strategy” and commitment to a circular economy, by 2030 the company will use packaging and recycling to replace problem plastics, reduce customer carbon and eliminate consumer packaging waste.

About DS Smith

DS Smith is a leading provider of corrugated packaging worldwide, supported by recycling and papermaking operations. A member of the FTSE 100, DS Smith focuses on creating innovative and sustainable packaging solutions, using a closed-loop recycling model – in which paper and corrugated is collected, recycled and then used again to make packaging materials. North American operations are headquartered in Atlanta, with 13 manufacturing, paper and recycling facilities, totaling more than 2,000 employees. Using the combined expertise of its divisions – including Packaging, Recycling, Paper – DS Smith works with customers to develop solutions that reduce complexity and deliver results throughout the supply chain.

Mindy Myrick, Head of Corporate Affairs

[email protected] / +1 410-251-9570

Caroline Curran, Hill+Knowlton Strategies

[email protected] / +1 256-653-5811

KEYWORDS: United States North America Georgia

INDUSTRY KEYWORDS: Supply Chain Management Packaging Retail Environment Logistics/Supply Chain Management Transport Manufacturing

MEDIA:

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Brrr Box is a 100% recyclable, biodegradable cooler. (Photo: DS Smith)