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Natural Grocers® Officially Introduces The good4u Meal Deal Program As Part Of Its Efforts To Fight Food Insecurity And Bring Nutritious Meals To Everyone

Program offers a menu of rotating healthy, simple, and affordable meal options to cook at home

PR Newswire

LAKEWOOD, Colo., Sept. 9, 2021 /PRNewswire/ — Showcasing that eating healthy does not need to be expensive and reflecting its Founding Principles to provide its communities with groceries that are healthy, high quality and affordable, Natural Grocers officially introduces the addition of its Natural Grocers good4uSM Meal Deal program. As part of its broader effort to fight food insecurity, the Natural Grocers good4u Meal Deals were introduced in April 2020 to provide customers with simple, affordable, and nutritious recipes for themselves and their families. The program has evolved into a mainstay for the organic and natural grocery retailer.

Natural Grocers officially introduces its good4u Meal Deal program, part of its broader effort to fight food insecurity.

“A lot of people think that healthy means expensive. But at Natural Grocers that is not true, and it has never been the case. We are committed to supporting the health and wellbeing of our communities with food and supplements at an Always Affordable Price℠. We always look for creative ways to give our customers even more value and avenues to support their health and wellbeing,” explained Natural Grocers’ Co-President, Kemper Isely.  “When the pandemic hit, we knew finances would get tighter for our communities and our goal was to help ensure that our customers could afford to feed their families with nutritious, satisfying meals that were easy to whip up in their kitchens. With the positive response the program has received, we decided to keep it as part of our good4u commitment to our communities.”

Members of {N}power®, Natural Grocers’ free loyalty program, can choose from a rotating selection of meals and price points, all of which include protein and only organic vegetables to maximize nutritional value. The program launch featured a whole chicken Meal Deal, accompanied by organic seasonal vegetables, which remains part of the rotating meal selections. The following Meals Deals are available at Natural Grocers now through October 31, 2021i:

  • Feed your family of four a Grilled Chicken Meal for under $13: Mary’s Free Range® and humanely raised whole chicken, with organic russet potatoes and seasonal vegetables:  organic zucchini through September 30, changing to organic carrots in October.
  • Feed your family of four a Burger Meal for under $12: Sustainably sourced and humanely raised Thousand HillsTM Grass Fed 80/20 Ground Beef, Rudi’s® hamburger buns or Canyon Bakehouse® gluten-free buns, organic red & green leaf lettuce, and organic beefsteak tomatoes. Customers can make it vegan for under $16 by replacing the ground beef with Beyond Meat® beef free burgers.
  • Feed your family of six a Frittata Meal for under $12: Natural Grocers Brand pasture raised organic eggs, Niman Ranch® pork breakfast sausage or Field Roast™ Apple & Maple plant-based breakfast sausage, and Organicgirl® baby spinach.
  • Feed your family of four a Chicken Drumstick Dinner for under $8: Mary’s Free Range and humanely raised chicken drumsticks, organic carrots and organic russet potatoes.
  • Feed your family of four a Sausage & Veggie Bake for under $10:  Pederson’s® kielbasa, fresh organic cauliflower and broccoli or Natural Grocers Brand frozen organic cauliflower florets and broccoli florets. Customers can make it vegan for under $13 by replacing the kielbasa with Beyond Sausage®, original or hot Italian.

Isely explains further, “To us, family means all of you, our customers. We deliberately chose the name “Feed Your Family” because of its significance to us – family extends beyond the traditional meaning of the word. We want to make it easy to feed the ones you love, whether they are your actual family, your friends, your neighbors, your pets, etc. All of our customers and good4u Crew members are part of our extended family and we have worked hard every day for the past 66 years to give “Our Family” the best food options at the best prices possible. Meal Deals are just another way we are able to do this. If you haven’t already, come join our family and have a delicious meal with your family – whoever they may be!”

Past Natural Grocers Good4u Meal Deals have included chili, lentil soup, tacos, enchiladas, quinoa bowls, with special editions for Mother’s Day brunch and Movie Night at Home. Select accompanying recipes can be found in Natural Grocers’ extensive recipe library.

Serving its Communities

Since Natural Grocers first opened its doors in 1955, it has had a successful track record of making healthy food more affordable and combating food insecurity in the communities it serves. In addition to the new Meal Deals program, the company is committed to helping community members gain access to nutritious food options:

  • Food Banks: In the early days, co-founder Margaret Isely kept a community food cabinet at the first store from which she would share the ingredients for a nutritious meal with families in need. Since then food bank fundraisers have become a lynchpin of company-wide programs throughout the year, including a 5-cent donation every time customers purchase a reusable bag or bring their own.
  • Loyalty Program: The {N}power program was recently updated, making it easier for members to earn reward points and take advantage of discounts, digital coupons, and other members-only features. The program also offers special pricing on popular items such as free-range eggs, avocados, whole chickens, almond butter, Natural Grocers Brand Vitamins & Supplements, and more. {N}power is free to join by filling out a quick form or by texting ‘organic’ to 72345ii.
  • Always Affordable Prices: As a Founding Principle, Natural Grocers has always worked diligently to provide the best possible pricing to help make a healthy and balanced lifestyle achievable for everyone. 
  • Natural Grocers Brand Products: Launched in 2018, the line now has more than 750 premium quality products, including a large pre-bagged Bulk Department and a recently expanded Natural Grocers Brand Vitamins & Supplements offering, which features a comprehensive range of more than 100 vitamins, herbs, minerals, and precision formulas. The in-house product line makes it possible for the company to offer these products at even more affordable prices.

About Natural Grocers by Vitamin Cottage

Natural Grocers by Vitamin Cottage, Inc. (NYSE: NGVC) is an expanding specialty retailer of natural and organic groceries, body care products, and dietary supplements. The products sold by Natural Grocers must meet strict quality guidelines and may not contain artificial colors, flavors, preservatives or sweeteners, or partially hydrogenated or hydrogenated oils. The Company sells only USDA certified organic produce and exclusively pasture-raised, non-confinement dairy products, and free-range eggs. Natural Grocers’ flexible smaller-store format allows it to offer affordable prices in a shopper-friendly, safe, and convenient retail environment. The Company also provides extensive free science-based Nutrition Education programs to help customers make informed health and nutrition choices. The Company, founded in 1955, has 161 stores in 20 states.

i
{N}power offers available to {N}power members only and are subject to program terms and conditions. Quantity limited to stock on hand; no rain checks. Pricing excludes tax and is subject to change without notice. We reserve the right to correct errors. Void where prohibited by law. Enter your phone number at checkout to redeem. This is a limited time offer: go to www.naturalgrocers.com/mealdeals for details.

ii Message and data rates may apply. See naturalgrocers.com/privacy for our Privacy Policy and naturalgrocers.com/terms for the {N}Power terms of use.

 

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SOURCE Natural Grocers by Vitamin Cottage, Inc.

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Clearside Biomedical Expands XIPERE™ License Agreement with Arctic Vision to Include Australia, New Zealand, India and ASEAN Countries

– Increasing Global Awareness of Innovative Suprachoroidal Injection Platform –

ALPHARETTA, Ga., Sept. 09, 2021 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today it has agreed to expand the territories covered by its exclusive license agreement with Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies. As now amended, the licensed territory for XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) has been expanded from Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea to also include Australia, New Zealand, India and the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam).

“Over the past year, we have forged a strong relationship with Arctic Vision and have been impressed with their team’s speed and dedication to bringing needed ophthalmic treatments to a large and important global region,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer, Clearside Biomedical. “If approved, XIPERE will be the first therapy for macular edema associated with uveitis and will be the first approved therapeutic delivered into the suprachoroidal space. We are dedicated to providing global access to our clinically tested, non-surgical, repeatable micro-injection technology designed to unlock the potential clinical benefits of administering drugs into the suprachoroidal space.”

XIPERE, referred to as ARVN001 by Arctic Vision, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the suprachoroidal space (SCS®) using Clearside’s patented SCS Microinjector®. The product candidate is being investigated for the treatment of macular edema associated with uveitis. In the U.S., Clearside’s New Drug Application for XIPERE is under review by the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) action date of October 30, 2021. In China, Arctic Vision is planning to initiate a Phase 3 clinical trial of ARVN001 in the second half of 2021.

“We are very excited to expand the licensed territory of ARVN001 to two of the most important countries in the Pacific region,” said Eddy (Hoi Ti) Wu, Ph.D., Founder and CEO of Arctic Vision. “Building our commercial reach into the overseas market has always been a major strategic goal, and this amendment greatly accelerates the process. Beginning with ARVN001, we strive to bring innovative eyecare solutions to the greater pan-Asia market.”

Under the terms of the amended agreement, Clearside will receive a total of $3.0 million in upfront payments and is entitled to additional payments upon the achievement of certain regulatory and sales milestones in the newly added countries (including Australia, New Zealand, India and the ASEAN Countries). These financial terms for the new countries are in addition to the previously announced milestone payments for the achievement of specified events prior to and including receipt of approval of XIPERE in the United States and other development and ARVN001 approval and sales-based events in the original territory of Greater China and South Korea. Clearside is entitled to receive tiered royalties of 10% to 12% based on annual net sales of ARVN001 in all territories covered by the amended agreement.

Clearside is also partnered with an affiliate of Bausch Health, which holds the exclusive license for the commercialization and development of XIPERE in the United States and Canada. Clearside is currently in discussions with other potential partners regarding licensing the rights to commercialize and develop XIPERE in the European Union, the United Kingdom, South America and Mexico.

About Clearside Biomedical

Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications. For more information, please visit clearsidebio.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the potential approval of XIPERE by the FDA, the commercial potential of XIPERE and Arctic Vision’s clinical development of ARVN001 and potential launch in the licensed territories. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the U.S. Securities and Exchange Commission (SEC) on March 15, 2021, and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor and Media Contacts:

Jenny Kobin
Remy Bernarda
[email protected]
(678) 430-8206

Source: Clearside Biomedical, Inc.



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Flora Growth Expands Distribution, Will Launch Stardog Loungewear On E-Commerce Platform Zulily With Over 5 Million Active Customers

Flora Growth Expands Distribution, Will Launch Stardog Loungewear On E-Commerce Platform Zulily With Over 5 Million Active Customers

  • Flora Growth expands distribution of its Stardog Loungewear hemp textiles into the US
  • With annual sales of more than US$1.5 billion and 5 million active customers, online retailer Zulily curates personalized shopping experiences for the entire family
  • Stardog Loungewear will launch the campaign by offering its best-selling product, hemp shoes

MIAMI & TORONTO–(BUSINESS WIRE)–
Flora Growth Corp. (NASDAQ: FLGC) (“Flora” or the “Company”), a leading all-outdoor cultivator and manufacturer of global cannabis products and brands, is pleased to announce that its hemp textiles division has entered into a commercial agreement with American e-commerce company Zulily, LLC (“Zulily”) to launch a sales and marketing campaign across the US for its Stardog Loungewear (“Stardog”) product line. The brand and product launch through Zulily will initially feature Stardog’s best-selling product, hemp shoes, and is expected to kick off within the next month.

With annual sales of more than US$1.5 billion and 5 million active customers, online retailer Zulily helps moms around the world discover incredible deals and fresh styles for themselves, their families, and their homes. Zulily launches thousands of products with amazing value each day, curating personalized shopping experiences that include apparel and footwear for the whole family, toys, home décor, and so much more. Zulily’s app uses compelling video and imagery to bring more than 15,000 big name brands and boutique finds to life on mobile, including brands such as Callaway, Cuisinart, Disney, Hanes, New Balance, SOREL, UGG®, and Under Armour®.

Key highlights of the Zulily platform include:

  • Customers shop from all across the US and over 80 countries worldwide
  • Customers have a median household income of US$75,000
  • Over 90% of North American orders are placed by repeat customers
  • A majority of orders come from mobile devices

“In speaking with the category management team from Zulily, it was clear that they were looking to onboard special products with compelling values at attractive price points, differentiated by stories that inspire and excite consumers – this aptly describes Stardog and how we’ve executed mindfully building and scaling the brand, “ said Nicolás Vásquez, General Manager of Stardog Loungewear. “At Stardog, we are reframing our connection with nature by working with materials that can easily go back to where they came from. Growing the finest quality organic hemp fibers allows us to equip our tailors with the very best materials to design and handcraft our loungewear for consumers. Stardog is a shining example of the slow fashion movement that considers all aspects of the supply chain, aiming to respect people, the environment, and animals.”

“Conversations around corporate social responsibility and having a transparent supply chain are more prevalent today than ever before as consumers carefully consider how to spend their hard-earned dollars. When reviewing potential distribution partners to launch this campaign, it was evident to us that Zulily was able to effectively take consumers on a digital discovery journey that could accurately capture the story we’re trying to tell, make a personal connection, and provide us with the opportunity to expand this campaign into a larger initiative across our entire brand and product portfolio,” said Jason Warnock, Chief Revenue Officer of Flora Growth. “Stardog has an extremely passionate and engaged community in Colombia and we’re looking forward to working with the team at Zulily to help create the same demand and engagement we see at home. By taking a customer-centric approach and implementing a comprehensive marketing strategy coordinated across the entire customer journey, we believe that we’re effectively positioning Stardog to be as leading global hemp textile brand and look forward to announcing further distribution deals.”

About Flora Growth Corp.

Flora is a cannabis company that leverages natural, cost-effective cultivation practices to supply cannabis derivatives to its diverse business divisions of cosmetics, hemp textiles, and food and beverage. As the operator of one of the largest outdoor cultivation facilities, Flora strives to market a higher-quality premium product at below market prices. By prioritizing natural ingredients and value-chain sustainability across its portfolio, Flora creates premium products that help consumers restore and thrive. Visit www.floragrowth.ca or follow @floragrowthcorp on social for more information.

Cautionary Statement Concerning Forward-Looking Statements

This document contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: Flora’s supply chain strategy; the size of markets for cannabis and cannabis products; our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this document and other statements made from time to time by us or our representatives may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, or the forward-looking events discussed in this document and other statements made from time to time by us or our representatives not occurring, except as may be required by applicable law.

Investor Relations:

Evan Veryard

[email protected]

Public Relations:

Cassandra Dowell

+1 (858) 264-6600

[email protected]

KEYWORDS: Florida United States North America Canada

INDUSTRY KEYWORDS: Textiles Specialty Manufacturing Food/Beverage Alternative Medicine Fashion Health Cosmetics Retail Online Retail

MEDIA:

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Nabriva and Vizient Enter into Agreement to Make XENLETA® (lefamulin) Available to Vizient’s Pharmacy Network Program

– Expands access to XENLETA for hospitalized patients with Community Acquired Bacterial Pneumonia (CABP)

DUBLIN, Ireland and FORT WASHINGTON, Pa., Sept. 09, 2021 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced that it has entered into an agreement with Vizient to offer XENLETA, which treats community-acquired bacterial pneumonia (CABP), as a contracted product to Vizient’s Pharmacy Network Program. Vizient provides expertise, analytics and advisory services, as well as a contract portfolio that represents more than $110 billion in annual purchasing volume, to improve patient outcomes and lower costs.

Nabriva CEO Ted Schroeder commented, “We are excited by Vizient’s decision to enter into an agreement to make XENLETA available to their Hospital Pharmacy Network, enabling access across Vizient member hospitals, which make up more than half of U.S. hospitals. Based on data from the Healthcare Cost and Utilization Project, it is estimated approximately 3 million adults are diagnosed with CABP in the hospital setting annually. Importantly, many of these patients may be at increased risk for adverse effects associated with respiratory fluoroquinolone or reside in areas with a high (>25%) prevalence of macrolide resistance. We are enthusiastic about the opportunity to provide clinicians a short-course, IV and oral monotherapy treatment option that addresses these unmet medical needs for their CABP patients.”

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about the ability of Nabriva Therapeutics to raise awareness of XENLETA and SIVEXTRO, drive prescription demand growth and drive top-line sales growth, the potential benefits to patients of SIVEXTRO and XENLETA, the market opportunity for SIVEXTRO and XENLETA, the availability of SIVEXTRO through major U.S. specialty wholesalers, the impact on Nabriva Therapeutics’ reported revenue from anticipated sales of SIVEXTRO, the sufficiency of its cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutic’s ability to comply with its obligations under its loan agreement with Hercules, Nabriva Therapeutic’s ability to maintain the conditions under the distribution agreement to exclusively distribute and promote SIVEXTRO, including its ability to maintain a commercial infrastructure sufficient to promote and distribute SIVEXTRO, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the SEC. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments may cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.

CONTACTS:

For Investors

Kim Anderson
Nabriva Therapeutics plc
[email protected]

For Media

Andrea Greif
Ogilvy
[email protected]
914-772-3027



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Precision BioSciences Outlines Clinical Development Strategy for In Vivo Gene Editing Pipeline

Precision BioSciences Outlines Clinical Development Strategy for In Vivo Gene Editing Pipeline

– Accelerated Clinical Development Expected to Enable Three Investigational New Drug/Clinical Trial Applications Within Next Three Years, Including for Familial Hypercholesterolemia as early as 2022, Primary Hyperoxaluria Type 1 in 2023, and Chronic Hepatitis B in 2024

– Announced Licensing and Collaboration Agreement with iECURE to Advance PCSK9 Knockout Program for Familial Hypercholesterolemia Through Phase 1; iECURE Also Receives License to Develop Four ARCUS-Based Gene Insertion Programs

– Featured Preclinical Data Demonstrating Precision and Versatility of ARCUS Editing Platform, Including First Presentation of ARCUS-Mediated Gene Insertion in Non-Human Primates

– Gene Editing Event Broadcast at 8:00 am ET Includes Presentation by James M. Wilson, M.D., Ph.D., Professor in the Departments of Medicine and Pediatrics, Perelman School of Medicine, University of Pennsylvania and Chief Scientific Advisor of iECURE

DURHAM, N.C.–(BUSINESS WIRE)–
Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, today provided strategic business updates on its in vivo gene editing pipeline during the Company’s first gene editing R&D event.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210909005318/en/

“Gene editing promises to fundamentally reshape the treatment landscape across numerous therapeutic categories. Today’s in vivo gene editing R&D event showcases the power of our ARCUS genome editing platform – including key demonstrations of capabilities, such as gene insertion and mitochondrial DNA gene editing – which offers distinct advantages in this emerging field,” commented Matt Kane, CEO and co-founder of Precision BioSciences. “We are excited to announce a new collaboration with iECURE which we expect to help us expedite clinical validation of the ARCUS platform for both gene knockout and gene insertion.”

“Today, we are excited to share additional data highlighting the precision and versatility of our ARCUS platform, which is designed to enable safe, specific and efficient gene editing. Since ARCUS can be delivered via AAV or LNP, it has potential utility in treating diseases in the liver as well as many genetic diseases that affect tissues beyond the liver. In addition, the unique enzymology of ARCUS enables it to make complex gene insertion and gene repair edits more efficiently than other editing platforms,” said Derek Jantz, Ph.D., Chief Scientific Officer and co-founder of Precision. “We believe these unique attributes of ARCUS support its differentiation for in vivo use and its potential to treat a broader range of genetic diseases than other editing technologies. We are very excited about our near-term pipeline and expect ARCUS to deliver on its full promise as we take on more challenging programs.”

Precision expects that three of its preclinical programs will advance to investigational new drug (IND)/clinical trial application (CTA) in the next three years:

  • As part of an agreement to expedite development, iECURE expects to advance Precision’s PBGENE-PCSK9 candidate for familial hypercholesterolemia (FH) through Phase 1 clinical studies with CTA filing expected as early as 2022.
  • Precision has initiated IND-enabling activities and expects to submit an IND application for PBGENE-PH1 for primary hyperoxaluria type 1 (PH1) in 2023.
  • Precision will pursue clinical development of its PBGENE-HBV candidate for chronic hepatitis B virus (HBV) and expects to submit an IND/CTA in 2024.

Announced today in a separate release, Precision BioSciences has signed a license and collaboration agreement with iECURE, a mutation-agnostic in vivo gene editing company striving to cure devastating diseases with high unmet need, co-founded by James M. Wilson, M.D., Ph.D. Using Precision’s PCSK9-directed ARCUS nuclease, iECURE plans to advance Precision’s PBGENE-PCSK9 candidate into a Phase 1 study in FH and gain access to Precision’s PCSK9-directed ARCUS nuclease to develop four other pre-specified gene insertion therapies for genetic diseases, focusing initially on liver diseases. Precision will retain rights to PBGENE-PCSK9, including for FH and all products developed for genetic indications except those licensed to iECURE. In return for its license grant, Precision will receive an equity stake in iECURE and is eligible to receive milestone and royalty payments on sales of iECURE products developed with ARCUS.

Presentations from Precision’s in vivo Gene Editing R&D event will highlight the Company’s clinical development strategy and updates on the following wholly-owned and partnered preclinical programs using ARCUS-mediated editing:

Featured Preclinical Data

  • ARCUS for Gene Insertion into the PCSK9 locus: Due to the unique type of cut made by ARCUS nucleases, we believe ARCUS may be better suited for gene insertion than CRISPR-based gene editing tools. In non-human primates (NHPs), ARCUS was observed to be more efficient than CRISPR at inserting a Factor IX transgene into the PCSK9 locus. The Factor IX transgene is responsible for making the coagulation Factor IX protein associated with hemophilia B bleeding disorder.

“Research conducted by the Gene Therapy Program has shown ARCUS is capable of precise edits that can be applied broadly across genetic diseases in a mutation-dependent manner,” said Dr. James M. Wilson. “Additionally, as reported today, ARCUS has demonstrated highly efficient gene insertion with a PCSK9-directed nuclease that will be foundational to iECURE in addressing rare genetic diseases, as well as long-term durability reflecting its curative potential with a single administration. Taken together, these findings continue to support what we have learned over years of collaborating with Precision: that the unique properties of ARCUS are differentiated versus other tools in this field.”

  • ARCUS for Chronic HBV (PBGENE-HBV): Current standard-of-care treatments for HBV suppress viral replication, but often do not clear the virus, leaving covalently closed circular DNA (cccDNA) and integrated HBV genomes that enable viral persistence. Precision’s gene editing program for HBV applies ARCUS to knockout this persistent cccDNA and potentially further reduce viral persistence.

New preclinical data to be presented today, and data previously presented at the American Society of Gene & Cell Therapy Annual Meeting, show that ARCUS efficiently targeted and degraded HBV cccDNA in HBV-infected primary human hepatocytes and reduced expression of HBV S-antigen (HBsAg) by as much as 95%. Similar levels of HBsAg reduction were observed in a newly developed mouse model of HBV infection following administration of ARCUS mRNA using lipid nanoparticle (LNP) delivery. Precision will pursue clinical development of its PBGENE-HBV candidate using LNP delivery and expects to submit an IND in 2024.

  • ARCUS for Mitochondrial Genome Editing: Mitochondrial diseases frequently are caused by pathogenic mutations in the mitochondrial genome that reduce the ability of mitochondria to convert food and oxygen into energy to sustain life and support organ function. Mitochondrial diseases affect approximately 1 in 5,000 individuals.

Recent preclinical studies used mitochondrial-targeted ARCUS (mitoARCUS) to selectively eliminate mutant mitochondrial genomes that cause disease in cell and animal models. In work conducted by Precision BioSciences, a hybrid cell model with a mixture of wild-type (healthy) and mutant mitochondrial genomes, a single treatment with mitoARCUS mRNA converted the cells to >99% wild-type. Work led by Carlos T. Moraes, Ph.D., Esther Lichtenstein Professor in Neurology at the University of Miami Miller School of Medicine and in a mouse model of mitochondrial disease and published online in Nature Communications on May 28, 2021, found that mitoARCUS delivered by AAV effectively targeted and depleted mutant mitochondrial genomes in multiple tissues. No editing of potential nuclear off-target sites could be detected, and liver and skeletal muscle showed robust elimination of mutant mtDNA with concomitant restoration of markers of mitochondrial function.

  • ARCUS for FH (PBGENE-PCSK9): Precision’s gene editing program for FH seeks to knockout expression of the PCSK9 gene. As published by Wang et al. in Molecular Therapy in June 2021, “Long-term Stable Reduction of Low-density Lipoprotein in Nonhuman Primates Following In Vivo Genome Editing,” PBGENE-PCSK9 is supported by extensive NHP data over a three-year period, which demonstrates a long-term, stable edit accompanied by up to an 82% reduction from baseline in PCSK9 levels and up to a 62% reduction in LDL levels.

Data will be presented on the clinical nuclease which is expected to be delivered by AAVrh79 in a Phase 1 clinical study to be conducted by iECURE.

  • ARCUS for PH1 (PBGENE-PH1): Precision’s gene editing program for PH1 applies ARCUS to knockout the well-characterized HAO1 gene to prevent the production of a toxic metabolite called oxalate that causes extremely severe and potentially fatal kidney stone accumulation in patients.

NHP data supporting this approach has shown, on average, a 98.0% reduction in HAO1 mRNA and a 97.9% reduction in the encoded protein after a single administration of an AAV vector encoding ARCUS. Compared to published results with siRNAs targeting HAO1, Precision’s approach appeared to provide an improved metabolic profile with the potential for long-term benefit from a single dose. Precision has initiated IND-enabling activities and expects to submit an IND application for this program in 2023 using LNP delivery.

  • ARCUS for Duchenne Muscular Dystrophy (DMD) (PBGENE-DMD): ARCUS genome editing has previously been shown to increase expression of a shortened version of dystrophin in cultured myoblasts from a DMD patient. The approach uses two ARCUS nucleases delivered by a single AAV to simultaneously cut and delete a large segment of the dystrophin gene that encodes exons 45 through 55 of dystrophin – a region of the gene that accounts for more than 50% of DMD-causing mutations.

In November 2020, Precision and Lilly announced an exclusive license agreement to utilize ARCUS genome editing for the research and development of up to six potential in vivo targets for genetic disorders. The collaboration initially included three gene targets, with the lead program targeting the dystrophin gene responsible for DMD (PBGENE-DMD). In addition, Precision will use ARCUS for one liver-directed target (PBGENE-LLY2) and one CNS-directed target (PBGENE-LLY3).

Dr. Jantz continued, “The versatility of our platform offers us the optionality to pursue numerous therapeutic applications through strategic partnerships, enabling us to capture more of the value of the ARCUS technology and accelerate key programs. For example, in addition to rapidly advancing PBGENE-PCSK9 to the clinic, iECURE will provide critical validation of ARCUS’ gene-insertion capabilities. Lilly will help us research ARCUS-mediated editing in muscle and CNS. Even as we aggressively invest in wholly-owned programs, we will continue to leverage collaborations that enable us to explore novel applications of ARCUS and reach patients quicker.”

The Company’s balance of cash and cash equivalents is approximately $167 million as of August 31, 2021. The Company continues to expect that existing cash and cash equivalents will be sufficient to fund planned operations into 2023.

Call and Webcast Information

Precision’s gene editing R&D event is being held today, September 9, 2021, at 8:00 a.m. ET. The dial-in conference call numbers for domestic and international callers are (866) 970-2058 and (873) 415-0216, respectively. The conference ID number for the call is 6376435. Participants may also access the live webcast, including slides, available in the Investors and Media section under Events and Presentations. An archived replay of the webcast will be available on Precision’s website for one year following the presentation.

About ARCUS

ARCUS® is a proprietary genome editing technology discovered and developed by scientists at Precision BioSciences. It uses sequence-specific DNA-cutting enzymes, or nucleases, that are designed to either insert (knock in), remove (knockout), or repair DNA of living cells and organisms. ARCUS is based on a naturally occurring genome editing enzyme, I-CreI, that evolved in the algae Chlamydomonas reinhardtii to make highly specific cuts in cellular DNA. Precision’s platform and products are protected by a comprehensive portfolio including more than 80 patents to date.

About Precision BioSciences, Inc.

Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company’s pipeline consists of multiple “off-the-shelf” CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.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 contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the further development and potential of our ARCUS platform, the clinical development and timeline of PBGENE-PCSK9, PBGENE-PH1 and PBGENEHBV, our agreement with iECURE and the potential clinical development and benefits thereunder, our agreement with Lilly and the potential clinical development and benefits thereunder, and our expected use of cash and cash equivalents. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “mission,” “goal,” “may,” “will,” “would,” “should,” “could,” “target,” “potential,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments and effects of restrictions thereunder; risks associated with raising additional capital; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; our or our collaborators’ ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ development of product candidates; our or our collaborators’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; our or our collaborators’ ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to obtain an adequate supply of T cells from qualified donors; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; the rate and degree of market acceptance of any of our product candidates; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate key executives and personnel; market and economic conditions; effects of system failures and security breaches; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events effects of the outbreak of COVID-19, or any pandemic, epidemic or outbreak of an infectious disease; insurance expenses and exposure to uninsured liabilities; effects of tax rules; risks related to ownership of our common stock and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors & Media page of our website at investor.precisionbiosciences.com.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Investor Contact:

Alex Kelly

Chief Financial Officer

[email protected]

Media Contact:

Maurissa Messier

Senior Director, Corporate Communications

[email protected]

KEYWORDS: North Carolina United States North America

INDUSTRY KEYWORDS: Health Genetics Research Pharmaceutical Science Biotechnology

MEDIA:

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Precision BioSciences and iECURE Announce License and Collaboration Agreement to Develop ARCUS-Based Gene Editing Therapies

Precision BioSciences and iECURE Announce License and Collaboration Agreement to Develop ARCUS-Based Gene Editing Therapies

iECURE to License Precision’s PCSK9-Directed ARCUS Nuclease and Pursue Four Gene Insertion Programs Focused on Liver Diseases; Precision Retains Rights Across All Indications Except Those Licensed to iECURE

iECURE Expects to File a Clinical Trial Application as Early as 2022 for Precision’s PBGENE-PCSK9 Candidate for Familial Hypercholesterolemia

Preclinical Data for ARCUS-Mediated Gene Insertion to be Presented Today by iECURE Chief Scientific Advisor, James M. Wilson, M.D., Ph.D. at Precision’s Gene Editing R&D Event

DURHAM, N.C. & PHILADELPHIA–(BUSINESS WIRE)–
Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical-stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, and iECURE, a mutation-agnostic in vivo gene editing company striving to cure devastating diseases with high unmet need, today announced a license and collaboration agreement under which iECURE plans to advance Precision’s PBGENE-PCSK9 candidate into Phase 1 studies and gain access to Precision’s PCSK9-directed ARCUS nuclease to develop additional gene editing therapies for genetic diseases, initially targeting liver diseases.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210909005309/en/

Under the terms of the agreement, iECURE plans to file a clinical trial application as early as 2022 to advance the PBGENE-PCSK9 clinical candidate through Phase 1 clinical studies for the treatment of familial hypercholesterolemia (FH). Precision will retain rights to PBGENE-PCSK9, including all products developed for genetic indications with increased risk of severe cardiovascular events such as FH. In return, Precision has granted iECURE a license to use its PCSK9-directed ARCUS nuclease to insert genes into the well-characterized PCSK9 locus to develop treatments for four other pre-specified rare genetic diseases. Precision will receive an equity stake in iECURE and is eligible to receive milestone and royalty payments on sales of iECURE products developed with ARCUS.

“We are excited to continue working with Jim Wilson under this new in vivo gene editing license and collaboration agreement with iECURE, as iECURE looks to rapidly advance our PBGENE-PCSK9 candidate, file for a clinical trial application in 2022, and use our PCSK9-directed ARCUS nuclease, and its knock-in capabilities, to pursue new treatments for rare genetic diseases,” said Derek Jantz, Ph.D., Chief Scientific Officer and Co-Founder of Precision BioSciences. “Through this collaboration we expect to gain important clinical validation for in vivo gene editing with ARCUS, while retaining rights to this PCSK9-directed nuclease, which we believe offers a safe harbor locus for DNA gene editing knock-in without deleterious effects when the PCSK9 gene is disrupted.”

“We founded iECURE with the aim of focusing on genetic diseases with significant unmet need that we could target in a mutation-agnostic manner. After evaluating different gene editing technologies and platforms, we believe gene editing with ARCUS, including use of the uniquely designed ARCUS nuclease as a gene insertion tool targeting the PCSK9 gene will help us rapidly advance several candidates to the clinic with the potential to deliver on the promise of highly efficient, specific, and safe gene insertion,” said Joe Truitt, Chief Executive Officer of iECURE. “We are excited to partner with Precision on this key pillar of our gene editing strategy, to advance this work for rare genetic diseases.”

James M. Wilson, M.D., Ph.D., Chief Scientific Advisor of iECURE and Professor in the Departments of Medicine and Pediatrics, Perelman School of Medicine, University of Pennsylvania, Director, Gene Therapy Program, will present new non-human primate data demonstrating ARCUS-mediated gene addition today, September 9, 2021 during the Precision BioSciences gene editing R&D event. Dr. Wilson and his team have demonstrated in non-human primates that it is possible to use ARCUS to insert new genes stably into the PCSK9 locus, which could be used as a potential approach for treating multiple genetic diseases with a single therapeutic strategy.

About ARCUS

ARCUS® is a proprietary genome editing technology discovered and developed by scientists at Precision BioSciences. It uses sequence-specific DNA-cutting enzymes, or nucleases, that are designed to either insert (knock in), remove (knockout), or repair DNA of living cells and organisms. ARCUS is based on a naturally occurring genome editing enzyme, I-CreI, that evolved in the algae Chlamydomonas reinhardtii to make highly specific cuts in cellular DNA. Precision’s platform and products are protected by a comprehensive portfolio including more than 80 patents to date.

About Precision BioSciences, Inc.

Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company’s pipeline consists of multiple “off-the-shelf” CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences please visit www.precisionbiosciences.com.

About iECURE

iECURE is an in vivo gene editing company striving to cure liver disorders with high unmet need. We are advancing our pipeline in close partnership with the world-class translational engine at the University of Pennsylvania’s Gene Therapy Program. Using in vivo editing, our methods focus on inserting functioning genes into patients’ genomes, which offers long-term, stable expression of those genes. With our team’s proven track record, reversing the course of these devastating disorders is now hopefully within reach.

Financial disclosure: The University of Pennsylvania and Dr. James Wilson hold equity interests in iECURE, receive significant sponsored research support from the company, and will be entitled to receive licensing revenues from iECURE based on successful technology development and commercialization of the licensed technology.

Precision’s Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company’s agreement with iECURE to develop and commercialize gene editing therapies using the Company’s PCSK9-directed ARCUS nuclease for cardiovascular and rare genetic diseases, the timing of clinical trials and results therefrom, any future milestones or royalty payments thereunder, the development and commercial potential of ARCUS-mediated gene addition and the potential value of iECURE equity. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “mission,” “goal,” “may,” “will,” “would,” “should,” “could,” “target,” “potential,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments and effects of restrictions thereunder; risks associated with raising additional capital; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; our or our collaborators’ ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ development of product candidates; our or our collaborators’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; our or our collaborators’ ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to obtain an adequate supply of T cells from qualified donors; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators’ ability to enroll patients; changes in interim “top line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; the rate and degree of market acceptance of any of our product candidates; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate key executives and personnel; market and economic conditions; effects of system failures and security breaches; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events effects of the outbreak of COVID-19, or any pandemic, epidemic or outbreak of an infectious disease; insurance expenses and exposure to uninsured liabilities; effects of tax rules; risks related to ownership of our common stock; and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors & Media page of our website at investor.precisionbiosciences.com.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Precision BioSciences Investor Contact:

Alex Kelly

Chief Financial Officer

[email protected]

Precision BioSciences Media Contact:

Maurissa Messier

Senior Director, Corporate Communications

[email protected]

iECURE Contact:

Danielle Cantey

Canale Communications for iECURE

[email protected]

KEYWORDS: United States North America North Carolina Pennsylvania

INDUSTRY KEYWORDS: Health Genetics General Health Research Science Pharmaceutical Biotechnology

MEDIA:

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Innoviz Technologies Sets September 2021 Conference Schedule and Corporate Open House for October 6th

PR Newswire

TEL AVIV, Israel, Sept. 9, 2021 /PRNewswire/ — Innoviz Technologies, a technology leader of high-performance, solid-state LiDAR sensors and perception software, today announced its financial conference schedule for September 2021 and open house on October 6th, 2021 at its corporate headquarters in Rosh Ha’Ayin, Israel.

Innoviz_Technologies_Logo

Cowen Global Transportation and Sustainable Mobility Conference
Fireside Chat Presentation on Friday, September 10 at 8:40 a.m. Eastern time
Webcast: Link


Citi Small/Mid-Cap & Growth Conference
One-on-one meetings on Friday, September 17

Evercore ISI AutoTech & AI Forum
Fireside Chat Presentation on Wednesday, September 22 at 1:15 p.m. Eastern Time
Webcast: Link

Jefferies Israel Innovation Summit
Fireside Chat Presentation on Thursday, September 30 at 2:40 p.m. Eastern time
Webcast: Link

To schedule a one-on-one meeting or receive additional information, please contact your conference representative or Innoviz’s investor relations team at [email protected].

Corporate Open House

Innoviz will host an open house for investors at its corporate headquarters in Rosh Ha’Ayin, Israel on Wednesday, October 6, 2021 from 9:00am to 12:00pmIsrael time. Attendees will have an opportunity to meet management, demo Innoviz’s state-of-the-art LiDAR technology, tour the company’s innovation garage and participate in a demo ride. To attend the in-person event, please RSVP by emailing Maya Lustig at [email protected].

About Innoviz Technologies

Innoviz is a leading provider of technology that will put autonomous vehicles on roads. Innoviz’s LiDAR technology can “see” better than a human driver and meets the automotive industry’s strict expectations for performance, safety and price. Selected by BMW for its fully autonomous car program, Innoviz’s technology will be deployed in BMW’s consumer vehicles. Innoviz is backed by top-tier strategic partners and investors, including SoftBank Ventures Asia, Samsung, Magna International, Aptiv, Magma Venture Partners, and others. For more information, visit www.innoviz.tech.

Join the discussion:
Facebook, LinkedIn, YouTube, Twitter

Innoviz Technologies

[email protected] 

Investor Contact
Maya Lustig                                                          Gateway Investor Relations
Innoviz Technologies                                            Cody Slach or Matt Glover
+972 54 677 8100                                                 (949) 574-3860
[email protected]                              [email protected]


Forward Looking Statements

This announcement contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the services offered by Innoviz, the anticipated technological capability of Innoviz’s products, the markets in which Innoviz operates and Innoviz’s projected revenue and other future financial and operational results. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this announcement, including but not limited to, the ability to implement business plans, forecasts, and other expectations, the ability to identify and realize additional opportunities, and potential changes and developments in the highly competitive LiDAR technology and related industries. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in Innoviz’s annual report on Form 20-F filed with the SEC on April 21, 2021 and other documents filed by Innoviz from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Innoviz assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Innoviz gives no assurance that it will achieve its expectations.

 

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Alkermes Announces Launch of 4th Annual Alkermes Pathways Research Awards® Program

— Competitive Grant Program to Offer Individual Grants of Up to $100,000 per Project —

— Application Period to Run From Sept. 13, 2021 Through Nov. 12, 2021 —

PR Newswire

DUBLIN, Sept. 9, 2021 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced that it will begin accepting applications for its annual Alkermes Pathways Research Awards® program on Sept. 13, 2021. This competitive grant program is designed to support the next generation of researchers working on the front lines to advance understanding and awareness of disease states in the field of neuroscience. In its fourth year, the program will offer grants to early-career investigators who have demonstrated a commitment to helping people living with schizophrenia, bipolar disorder, alcohol use disorder (AUD) or opioid use disorder (OUD). The application period will run through Nov. 12, 2021.

“As a leader in developing treatments for serious mental illness and addiction, Alkermes is committed to supporting and advancing research that has the potential to drive meaningful change for people living with these complex diseases,” said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. “Now in its fourth year, the Pathways program has a track record of assisting early-career investigators working on important research projects across a variety of topics who share our commitment to these patient communities.”  

The 4th annual Alkermes Pathways Research Awards program will offer grants in amounts of up to $100,000 per project. To qualify, early-career investigators must be M.D.s, Ph.D.s, or equivalent, who are within five years of their initial academic appointment or are current post-doctoral fellows, and who are affiliated with a medical or research institution within the United States. Applicants will be evaluated by an independent review committee comprised of specialists in psychiatry, neurobiology, pharmacology, and behavioral science from academic research centers.

The Pathways program began in 2018 and has since provided funding to 16 researchers across the United States. Award recipients have undertaken important, mentor-supported research to help advance the field of neuroscience. For more information on the Alkermes Pathways Research Awards program, including full eligibility criteria and how to apply for the 4th annual edition of the program,  visit www.PathwaysResearchAwards.com.


About Alkermes plc

Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Alkermes Pathways Research Awards® is a registered service mark of Alkermes, Inc. The Alkermes Pathways Research Awards logo is a service mark of Alkermes, Inc.

Alkermes Contacts: 
For Investors: Sandy Coombs,   +1 781 609 6377
For Media:  Gretchen Murphy,  +1 781 609 6419

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NuVasive Simplify Cervical Disc Data Published In International Journal Of Spine Surgery

Peer-reviewed data results from multi-center FDA Investigational Device Exemption study reiterate disc’s superiority to ACDF

PR Newswire

SAN DIEGO, Sept. 9, 2021 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify® Cervical Disc one-level U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study data was recently published in the International Journal of Spine Surgery. The data was utilized in the device’s FDA pre-market application for one-level indication approval in September 2020.

The peer-reviewed study reiterates that the Simplify Cervical Disc has a significantly greater success rate at the 24-month follow up compared to anterior cervical discectomy and fusion (ACDF) when used in treatment for one-level cervical total disc replacement (cTDR).1 Findings from this study include:

  • Mean Neck Disability Index (NDI), a patient-reported measure for disability related to cervical spinal disorders, was significantly lower for patients who underwent a cTDR with the Simplify Cervical Disc compared to ACDF;
  • Range of motion significantly increased for cTDR patients treated with the Simplify Cervical Disc at three months and was maintained throughout follow ups; and
  • Facet joint degeneration assessment by MRI showed little change from pre- to post-operation in the cTDR patients. This is the first time 24-month follow up MRI scans were used in an IDE study for cTDR.2 The Simplify Cervical Disc allows for enhanced visualization through MRI postoperatively compared to alternative devices, a key imaging modality in spine.

“This recent peer-reviewed publication validates the strong clinical data behind the Simplify Cervical Disc and why this is the most clinically effective technology in the cTDR procedure segment,” said Kyle Malone, vice president of Clinical, Medical, and Regulatory Affairs at NuVasive. “As we continue to pursue Simplify Cervical Disc clinical data, we are encouraged by these results to support our commitment to outcome-driven innovation in spine surgery that benefits surgeons, hospitals, and—most importantly—patients.”

The Simplify Cervical Disc is part of the NuVasive C360™ portfolio, which offers comprehensive, procedurally integrated solutions for the cervical spine across ACDF, posterior cervical fusion, and cTDR procedures. The device is designed with key performance functions that include a radiologic design, anatomic disc heights, and physiologic motion. Overall, the Simplify Cervical Disc demonstrates clinical superiority to ACDF3 and has the highest overall clinical success rate compared to any other approved cervical disc at both one- and two-levels.2 It is one of three devices approved for use in two-level cTDR procedures.2

“I am excited to see this study published on the Simplify Cervical Disc’s one-level FDA trial,” said Richard Guyer, MD, orthopedic spine surgeon and co-founder of the Texas Back Institute in Plano, Texas. “Not only were the disc’s results excellent for the cTDR procedure compared to fusion, but it also breaks new ground in cervical technology by offering a combination of smaller, more anatomic disc heights, reproducing a spine’s natural motion, and being entirely MRI compatible unlike other cTDR implants.”

This data will also be presented by Dr. Guyer at the following industry conferences with recognition in the best paper section for each respective meeting:

  • North American Spine Society 36th Annual Meeting on Wednesday, September 29, 2021
  • Cervical Spine Research Society 49th Annual Meeting on Saturday, December 4, 2021


About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company’s less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company’s comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.


Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons and hospitals, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products, the Company’s ability to adequately manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. 

__________________________

1 Guyer RD, Coric D, Nunley PD, et al. Single-level cervical disc replacement using a PEEK-on-ceramic implant: results of a multicenter FDA IDE trial with 24-month follow-up. Int J Spine Surg 2021;15(4):633-44.

2 Data on file. Based on review of publicly available materials at the time of this release.

3 Simplify Cervical Artificial Disc – P200022

 

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SOURCE NuVasive, Inc.

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Toyota Corolla Cross: All-New Body Style Adds Utility, Fun

— U.S.-Assembled Corolla Cross Adds a Versatile New Family Member to the Best-Selling Nameplate in the Industry

— Hits the Sweet Spot with Small Crossover Drivability and Large Crossover Functionality

— Available in AWD with over eight inches of ground clearance

— Value-Priced Corolla Cross Lineup Arrives in Dealerships in October

PR Newswire

PLANO, Texas, Sept. 9, 2021 /PRNewswire/ — Fresh off the sale of the record-setting 50-millionth Corolla, the best-selling car of all time welcomes a versatile new family member with the introduction of the 2022 Toyota Corolla Cross. Value-priced and packed with features not typically found in a small crossover, Corolla Cross hits the sweet spot with the engaging driving experience of a small car and the functionality of a larger crossover. The 2022 Toyota Corolla Cross, based on the ever-popular Corolla sedan, is coming to dealerships this October with a starting MSRP of $22,195 for the front-wheel drive base grade. And a bump up to all-wheel drive will be available for an extra $1,300.

The all-new 2022 Corolla Cross will be assembled in the U.S. at the new Mazda Toyota Manufacturing plant in Huntsville, Alabama – a brand new facility that will have the capacity to produce up to 150,000 Corolla Cross vehicles per year.

“For over 50 years, Corolla has been synonymous with dependability, fuel efficiency, safety and value,” said Lisa Materazzo, group vice president of Toyota Marketing.  “With the all-new Corolla Cross, we are building upon that foundation and offering even more versatility and creature comforts to make everything from a daily commute to a weekend escape more memorable.”

Available in front-wheel drive (FWD) and all-wheel drive (AWD), the compact SUV maximizes the inherent potential of the high-strength TNGA-C platform and a 169-horsepower 2.0-liter Dynamic Force Engine. This enables the Corolla Cross to achieve high-quality performance, a comfortable ride and outstanding spaciousness. What’s more, the surprising cargo capacity gives it the versatility to accommodate life’s adventures.


Well Appointed, Yet Powerful

Offered in three grades – L, LE and XLE – the versatile design of the Corolla Cross is spacious, modern, powerful and high quality. From an engineering perspective, it offers an approachable exterior as well as a higher line-of-sight thanks to the revised TNGA-C platform. Key design cues include a distinctive black grille flanked by LED lighting with black body accents – giving the entry SUV a confident appearance. And from the rear, the stylish design elements continue, with an integrated rear spoiler and LED lighting. Wheel options range from 17-inch steel on L to 18-inch alloy on XLE.

For exterior color options, the 2022 Corolla Cross is offered in:

  • Wind Chill Pearl ($425 extra-color cost)
  • Celestite
  • Sonic Silver
  • Jet Black
  • Barcelona Red Metallic
  • Cypress
  • Blue Crush Metallic

Inside, Corolla Cross’ spacious interior offers many of the same desirable features as its sedan and hatchback siblings. The all-new model can be outfitted with a power moonroof, as well as either single- or dual-zone automatic climate control, with all grades featuring standard heating and air conditioning vents for rear seat passengers.

For interior color options, the 2022 Corolla Cross is offered in:

  • L: Fabric-trimmed seats in Light Gray
  • LE: Fabric-trimmed seats in Light Gray or Black
  • XLE: SofTex®-trimmed seats in Macadamia/Mocha or Black

A 10-way power-adjustable driver’s seat with lumbar and heated front seats, standard on XLE, put the driver in a comfortable and commanding position.

In back, storage space can be maxed out thanks to the 60/40-split folding rear seats that come standard on all grades, while XLE models also include a center armrest with two additional cupholders. To make access to the roomy cargo area even more convenient, the Corolla Cross has an available power liftgate with height adjustability.

Available accessories, including a roof rack with crossbars, an activity mount for carrying items such as bicycles, a tow hitch and all-weather floormats keep you equipped for any adventure.


Small But Mighty

The Corolla Cross is equipped with the mighty Dynamic Force four cylinder, 2.0-liter DOHC 16-valve with Dual Variable Valve Timing with intelligence (VVT-i) engine. That means a punchy 169 horsepower engine paired with CVT with a physical first gear provides a truly engaging driving experience, all while delivering exceptional efficiency.

Corolla Cross’ suspension also plays a role here, as it’s fully independent for all-wheel-drive models, while front-wheel-drive vehicles feature a brand-new torsion beam system in the rear.

Additionally, every Corolla Cross is capable of towing up to 1,500 lbs. (enough to pull a trailer with a personal watercraft for a day of fun on the lake).

For those who choose AWD, Toyota’s clever Dynamic Torque Control system directs up to 50% of power to the rear wheels when it’s needed – and disengages completely when it’s not. This feature helps Corolla Cross maintain great fuel economy – another strong suit for this powertrain – with an estimated 32 combined MPG for the FWD model and an estimated 30 combined MPG for the AWD model.


Connectivity for the Long Drive

However, passengers choose to listen to music or connect with their worlds, the 2022 Corolla Cross is ready with the latest multimedia systems. A 7-inch multimedia touchscreen comes on the L grade, while LE and XLE feature an 8-inch touchscreen.

The vast range of in-car entertainment and connected functionalities, including standard compatibility for Apple CarPlay and Android Auto, will be sure to keep passengers engaged. Mobile devices will stay topped off through wireless charging (standard on LE and XLE), or through the conveniently located USB media port. LE and XLE grades offer two USB charging ports for rear seat passengers, welcoming all devices along for the drive!

The available Audio Plus multimedia with Remote Connect and a nine-speaker JBL® sound system is the perfect complement to a road trip playlist. And when it’s time to turn on the tunes, Amazon Alexa connectivity keeps Amazon’s digital assistant just a question away. Other connected features include a standard three-month SiriusXM Platinum subscription to more than 300 channels accessible throughout the country.

XLE owners can get key info at a glance, courtesy of an available 7-inch Multi-Information Display with various vehicle and systems info to choose from.


Exceptional Toyota Value, Naturally

Toyota’s typical outstanding value is clearly evident throughout the lineup, from the entry-level Corolla Cross L grade all the way up to the top-of-the-line XLE grade. All trims are offered in both FWD and AWD.

Standard features include the following.

L Grade:

  • 7″ Multimedia Display
  • 4.2″ MID
  • Apple CarPlay®, Android Auto™ and Amazon Alexa
  • SiriusXM® trial
  • Rear HVAC Vents
  • TSS 2.0
  • Remote Keyless Entry
  • Two USB ports
  • LED headlights and taillights
  • 17″ Steel wheels with silver wheel covers

LE Grade – L features plus:

  • 8″ Multimedia display
  • Qi-wireless charging
  • Blind Spot Monitor with Rear Cross-Traffic Alert
  • 17″ alloy wheels
  • Roof rails
  • Smart Key with Push Button Start
  • Leather wrapped steering wheel
  • Auto climate control
  • Three USB ports
  • Color-keyed heated power outside mirrors with turn signals

XLE Grade – LE features plus:

  • 18″ alloy wheels
  • 7″ MID
  • SofTex®-trimmed seats
  • 10-way power driver seat with lumbar
  • Heated front seats
  • LED DRLs and fog lights
  • Rear Cross-Traffic Brake
  • Front and Rear Parking Assist with Automatic Braking
  • Dual zone climate control
  • Rear folding armrest with two cup holders
  • Leather shift knob
  • Tonneau cover

Options:

  • LE :
    • Audio Plus with JBL® 9-speaker system
    • Moonroof package
      • Moonroof
      • Tonneau cover
  • XLE:
    • Audio Plus with JBL® 9-speaker system
    • Convenience Package
      • Moonroof
      • Power rear liftgate
    • Adaptive Front Lighting System with auto-leveling


Safety

True to Toyota form, modern safety is key for Corolla Cross. That’s why all grades come standard with both the Toyota Safety Sense suite of advanced active safety systems, as well as Toyota’s signature STAR Safety System. Blind Spot Monitor and Rear Cross-Traffic Alert come standard on LE and XLE, while Front and Rear Parking Assist with Automatic Braking is standard on XLE. All grades come standard with nine airbags throughout the cabin to help protect occupants.

Toyota Safety Sense 2.0 is a comprehensive active safety system that includes:

  • Pre-Collision System with Pedestrian and Cyclist Detection (PCS with PD)
  • Lane Departure Alert (LDA) with Steering Assist
  • Lane Tracing Assist (LTA)
  • Road Sign Assist (RSA)
  • Full-Speed Range Dynamic Radar Cruise Control (DRCC)
  • Automatic High Beams (AHB)

The Toyota STAR Safety System includes:

  • Enhanced Vehicle Stability Control (Enhanced VSC)
  • Traction Control (TRAC)
  • Anti-lock Brake System (ABS)
  • Electronic Brake-force Distribution (EBD)
  • Brake Assist (BA)
  • Smart Stop Technology (SST)


2022 Corolla Cross Pricing*


Grade


FWD MSRP MY22


AWD MSRP MY22

Corolla Cross L

$22,195

$23,495

Corolla Cross LE

$24,545

$25,845

Corolla Cross XLE

$26,325

$27,625

*MSRP does not include delivery, processing and handling (DPH) of $1,215.


Limited Warranty

Toyota’s 36-month/36,000 mile basic new-vehicle warranty applies to all components other than normal wear and maintenance items. Additional 60-month warranties cover the powertrain for 60,000 miles and against perforation from corrosion for 60 months with no mileage limitation.

The 2022 Corolla Cross also comes standard with ToyotaCare, a complimentary plan covering normal factory-scheduled maintenance, for two years or 25,000 miles, whichever comes first, and two years of Roadside Assistance, regardless of mileage.



About Toyota

Toyota (NYSE:TM) has been a part of the cultural fabric in North America for more than 60 years, and is committed to advancing sustainable, next-generation mobility through our Toyota and Lexus brands plus our 1,800 dealerships.

Toyota has created a tremendous value chain and directly employs more than 47,000 in North America. The company has contributed world-class design, engineering, and assembly of more than 40 million cars and trucks at our 14 manufacturing plants, 15 including our joint venture in Alabama that begins production in 2021.

Through its Start Your Impossible campaign, Toyota highlights the way it partners with community, civic, academic and governmental organizations to address our society’s most pressing mobility challenges. We believe that when people are free to move, anything is possible. For more information about Toyota, visit

www.toyotanewsroom.com

.

Media Contacts
Nicky Hamila
469-292-3596
[email protected]

 

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SOURCE Toyota