Response From Vancouver Planted Expo |

Naturally Splendid Enterprises Ltd. ("Naturally Splendid") (TSX-V:NSP) (OTC PINK:NSPDF) (Frankfurt:50N), as previously announced, presented the Plantein™ line of plant-based entrees at the Planted Expo Vancouver on June 4 and June 5, 2022, at the Vancouver Convention Center

Planted Expo is Canada's largest plant-based event of the year, focused on consumers looking to add more plant-based choices to their daily diets. Naturally Splendid presented eight (8) Plantein™ plant-based entrees, including our plant-based; Burger; Crispy Burger; Crumbed Tenders; Sweet Chili Tenders; Nuggets; Schnitzel (cutlet); Garlic Kiev; and a Phishy Fillet.

Although the show is primarily for consumers, several local independent and retail chain stores also had representatives at the Expo. Many of these retail operations have reached out to Naturally Splendid inquiring about listing our products. In addition to the existing leads from the previous Food Expo, the sales team will actively follow up on these inquiries.

Naturally Splendid VP Mr. Bryan Carson states, "As we are actively working our sales efforts on FoodService and Retail nationally, we didn't want to lose sight of creating some local excitement about our products. The Greater Vancouver Region has over 2.5 million consumers, and this Expo is a low-cost way to target the plant-based consumer; as part of the show, we teamed up with Directfoods.com to get our products home-delivered. With everything being local and with Directfoods.com delivery, we reduce our packaging costs significantly. The response from attendees at Planted Expo has been exceptional. The Company has been receiving orders online since the show started on Saturday, and we look for growth opportunities for the business everywhere. We invite you to check out Planted Expo attendee responses for yourselves at https://youtu.be/BJUsq_QDfG8.

About Naturally Splendid Enterprises Ltd.

Naturally Splendid is a plant-based food manufacturing and technology company that produces and distributes nutritious and delicious plant-based commodity products.

Founded in 2010, the Company operates a Safe Quality Food Level 2 certified food manufacturing facility located just outside Vancouver, BC in Canada, focusing on producing an extensive range of plant-based entrees.

Naturally Splendid has an exclusive 10-year manufacturing and distribution agreement for Canada with a division of Australia's largest plant-based food manufacturer, Flexitarian Foods Pty. Ltd.

In addition to producing the Company's own branded products, Naturally Splendid provides contract manufacturing services and private labeling for a variety of nutritional plant-based food products destined for multiple distribution channels.

The Company has established healthy, functional foods under brands such as Natera Sport™, Natera Hemp Foods™, CHII™, Elevate Me™ and Woods Wild Bar™. The Company launched Natera Plant Based Foods, a line of delicious plant-based meat alternatives for the rapidly growing plant-based market segment.

Naturally Splendid maintains a relationship Plasm Pharmaceutical, a company that has been approved for conducting a phase 2 clinical trial approved by Health Canada for the treatment of COVID-19.

NSE has also developed proprietary technologies for the extraction of healthy omega 3 and 6 oils, as well as a protein concentrate from hemp.

For more information e-mail info@naturallysplendid.com or call Investor Relations at 604-570-0902 ext 101

On Behalf of the Board of Directors Mr. J. Craig Goodwin CEO, Director

Contact Information: Naturally Splendid Enterprises Ltd. (NSP - TSX Venture; NSPDF - OTCQB; 50N Frankfurt) #108-19100 Airport Way Pitt Meadows, BC, V3Y 0E2 Office: (604) 570-0902 Fax: (604) 465-1128 E-mail: info@naturallysplendid.com Website: www.naturallysplendid.com

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management's current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. Naturally Splendid cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond Naturally Splendid's control including, Naturally Splendid's ability to compete with large food and beverage companies; sales of any potential products developed will be profitable; sales of shelled hemp seed will continue at existing rates or increase; the ability to complete the sales of all bulk hemp seed purchase orders; and the risk that any of the potential applications may not receive all required regulatory or legal approval. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, Naturally Splendid undertakes no obligation to publicly update or revise forward-looking information.

NEITHER TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

SOURCE: Naturally Splendid Enterprises Ltd.

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The plant-based meat market is expected to grow at an impressive CAGR of 25.14 percent as consumers seek more plant-based options. The segment has the potential to grow by US$7.21 billion from 2015 to 2021. In 2019 alone, the plant-based meat market was valued at a significant US$3.77 billion. The high growth rate of this segment of the plant-based market presents an exciting opportunity for investors seeking to grow their capital.

A key geographic market in the plant-based category is North America, and Canada is a global leader in plant protein. The Government of Canada recently invested C$153 million into the Protein Industries SuperCluster, which seeks to increase the value of key Canadian crops such as canola, wheat and pulses. A significant opportunity for these crops revolves around the growing plant-based meat alternatives markets in North America, with further export opportunities in Asia and Europe. The Canadian government expects the investment to generate more than C$4.5 billion in GDP over the next 10 years.

Naturally Splendid Enterprises (TSXV:NSP, OTCQB:NSPDF, FSE:50N) is a Canadian-based company focused on manufacturing delicious plant-based products. Their feature plant-based line is marketed under the PlanteinTM trademark. This line is manufactured under a 10-year exclusive manufacturing and distribution agreement with Flexitarian Foods Pty. Ltd., a division of Australia’s largest plant-based manufacturer.

As a result of this agreement, Naturally Splendid offers the most extensive plant-based meat alternative choices than any other plant protein company in North America, including Beyond Meat (NASDAQ: BYND), Gardein (owned by Conagra NASDAQ: CAG) and Impossible Meat.

Over the years, Naturally Splendid has developed a number of retail brands covering various consumer channels that have been sold in thousands of retail locations across Canada and online. The Company’s feature plant-based line boasts a number of appetizers and entrees prepared for those looking to add more plant-based nutrition into their diets, whether they be vegans, vegetarians or the rapidly growing ‘flexitarian consumer.’

ProSnack Natural Foods, a 100% owned division of Naturally Splendid, manufactures plant-based appetizers and entrees in their 17,000 square foot Safe Quality Food (SQF) Certified food manufacturing facility located in Pitt Meadows, British Columbia in, Canada. The facility is capable of manufacturing a wide range of plant-based appetizers and entrees. While upgrading the Prosnack facility, the SQF Certification is temporarily on hold at the request of Company. SQF pre-certification inspection is expected in October 2022 with full certification expected Q2 2023. Previously the Company scored an 89/100 during their SQF certification process, indicating a high aptitude for manufacturing processes.

The facility is currently undergoing renovations to replicate the established, successful manufacturing processes that have made Plantein among Australia’s most popular plant-based entrees. Once completed in the latter part of 2022, the facility will have the capacity to produce 30 tons of plant-based products daily, or in dollar values, will have a manufacturing capacity of $45,000,000 CDN annually.

In addition to Naturally Splendid’s house brand, ‘Plantein,’ ProSnack will manufacture under Private Label agreements and manufacture for strategically selected companies, producing their proprietor formulations for plant-based products.

Flexitarian Foods has developed industry-disrupting IP in both product R&D as well as manufacturing. Rather than develop a ‘recipe’ for a single product, as most every other plant-based manufacturer does, Flexitarian Foods has perfected a system based on their IP for rapid product development. Flexitarian Food’s IP extends to manufacturing, and its success lies in using standardized equipment rather than custom manufactured equipment to process their plant-based foods.

The IP regarding product formulation creates the landscape to develop new plant-based SKUs in industry-leading time frames…typically 6-10 weeks for initial concept samples to be developed.

IP related to manufacturing provides a competitive pricing advantage due to the efficiency of the Company’s manufacturing processes. Flexitarian Food’s methodology based on their IP allows for rapid expansion to manufacturing capacity as capacity can be increased simply by adding additional equipment. This strategy lends itself to the opportunity to build multiple manufacturing facilities close to input sources and consumer bases, creating competitive advantages.

Initially, Naturally Splendid marketed its plant-based products under its Natera brand. The Company has since negotiated a 10-year licensing agreement to use the Plantein name in Canada. The licensing agreement has a 10-year extension, making this a 20-year agreement.

In August 2021, the company announced an exciting milestone in which NATERA’s plant-based chicken tenders and plant-based chicken nuggets will soon be available at 71 Denny’s Corporation (NASDAQ:DENN) restaurant locations across Canada. These items are currently being served in all Canadian Denny’s locations.

The Company has established relationships with Canada’s two largest food distributors, who in combination hold an estimated 85% market share.

Gordon Food Service (GFS) – Services Denny’s Canada account as well as others

Naturally Splendid’s initial foray into plant-based nutrition began over a decade ago and focused on hemp and the incredible nutritional profile the plant provided. The Company’s journey has included significant technological advances in hemp protein and the omegas contained in hemp, resulting in unique ingredients that may be incorporated into plant-based product formulations. Naturally Splendid is the owner of Chii Pure Hemp, an online store selling hemp seed and protein and manufactures nutritional bars and bites in their certified food manufacturing facility. This facility is now being retrofitted to manufacture a diverse range of plant-based appetizers and entrees. The Company’s previous technological advances in the area of micro-encapsulation of omegas and concentrating of plant proteins, has provided an opportunity to use these value-added ingredients in their own plant-based products. Additionally, these value-added ingredients have the potential to be marketed to other plant-based manufacturers creating new revenue stream. The opportunity within the plant-based market space has created new opportunities for these Company owned technologies and ingredients.

In addition to the Company’s plant-based appetizer and entree business, Naturally Splendid’s other plant-based brands include CHII, ElevateMe, NATERA Sport, and Pawsitive FX. CHII is one of Canada’s oldest hemp companies, established in 2019. The brand offers hemp seeds, oils, and proteins sold primarily online. Elevate Me, and Woods Wild Bars are the company’s bars offerings. These products are currently going through re-formulation to offer 100% plant-based nutrition. Pawsitive FX is the company’s foray into topical pet products, which feature 100% plant-based formulations.

ProSnack Natural Foods operates a 17,000 square foot Safe Quality Food (SQF) Certified Food Manufacturing facility in Pitt Meadows, British Columbia, Canada.

ProSnack Natural Foods facility is undergoing retrofitting and will manufacture the Plantein line of plant-based products upon commissioning. Upon retrofit completion, the facility will be capable of producing 30 tons of plant-based products per day, resulting in a manufacturing capacity in dollars of an estimated $40M CDN annually.

Additionally, and as importantly, Prosnack Natural Foods offers contract manufacturing for various clients, including private label programs.

Prior to retrofitting to manufacture plant-based entrees, Prosnack manufactured nutritional bars and bites for themselves under multiple ‘house brands’ and several well-known brands.

Naturally Splendid has secured the rights to use the Plantein name in Canada exclusively for an initial 10-year term with a 10-year renewal option.

Plantein originated in Australia and is manufactured by a division of the largest plant-based manufacturer in Australia.

The PlanteinTM line of plant-based foods includes alternatives for beef, chicken, pork, fish and seafood. The Company has over 40 commercially ready plant-based entrees and has launched eight (8) SKUs initially in foodservice and retail in Canada.

The eight (8) products available today are 100% vegan and include a plant-based Burger, Crispy Burger, Crumbed Tenders, Sweet Chili Tenders, Nuggets, Schnitzel, Garlic Kiev and Phishy Fillet.

Naturally Splendid has developed and owns several brands covering multiple categories, including CHII Pure Hemp, Elevate Me, Woods Wild Bar, NATERA Sport and Pawsitive FX focusing on plant-based ingredients.

CHII is one of Canada’s pioneering hemp companies, established in 1998. The brand offers hemp hearts, hemp oil and hemp seed protein through an online e-commerce platform. Chii hemp foods include hemp seed hearts, hemp protein powder and hemp seed oil.

The Company has developed, manufactured and distributed several nutritional bars and bites, including Elevate Me, Woods Wild Bar and KEY-TO-LIFE.

NATERA Sport also recently launched Procurc 30, an advanced curcumin-based supplement that Health Canada approved for phase two clinical trial as a potential treatment for Covid-19.

Pawsitive FX consists of three (3) all-natural balms for snout and paw health; Happy Paws, Strong Paws, Happy Snouts.Pawsitive FX as well as offers raw hemp oil for canine nutrition!

J. Craig Goodwin is a co-founder of Naturally Splendid. As CEO, Goodwin has been instrumental in the transition from a private company to a public company raising over CA$20,000,000 in the process. In addition to his role as CEO, Goodwin’s responsibilities included international business development where he oversaw the development of a South Korean project generating over C$7,000,000 in 2016.

Currently, Goodwin is developing business in South Korea, Japan, China, Germany and Australia to name a few. Previous to his appointment as CEO of Naturally Splendid, Goodwin accumulated over 30 years of sales and marketing experience including senior account executive for one of the largest outdoor advertising companies in the world, The Jim Pattison Sign Group. While with The Jim Pattison Sign Group, Craig was one of the most successful sales executives in Western Canada and received numerous awards for outstanding sales achievements.

In addition to sales and marketing, Goodwin has consulted for numerous public companies providing services including investor relations, raising venture capital and business development.

Bryan Carson’s vision of a company distributing healthy food choices is a driving force behind Naturally Splendid® and the foundations from which this company originated. For the past four years, Carson has overseen the operations of Naturally Splendid® including establishing supply channels, packaging and product development. Carson’s insight and vision have proved invaluable as part of the management team.

Carson created, operated and sold a successful retail store in Vancouver, B.C. His hands-on retail expertise from the conceptual planning stages through construction and launch is of great value in developing our relationship with major food distribution channels.

George Ragogna has over 30 years of experience in the Canadian financial services industry. Ragogna also has over 20 years of experience in a progressive leadership role specializing in strategic planning, corporate sales, workforce optimization and regulatory compliance. Ragogna successfully manages and supports a call center of over 550 employees, ensuring new and existing staff are trained and knowledgeable in the financial services industry and compliance processes.

Ragogna brings unique business acumen and strong technical skills that will strengthen the board at Naturally Splendid.

Larry Gilmour's professional career began in sales and marketing with internationally recognized brands such as Libby's (Libby, McNeil and Libby), Playtex Corp. and Black and Decker. Gilmour has also owned and operated chain grocery outlets including owner and operator of a Super Valu grocery store in Vancouver, B.C., for over five years. He has a successful track record of growing businesses with existing consumer bases.

Gilmour joined Independent Pharmacist Inc. where he leveraged his sales, marketing and management skills to drive membership up significantly –– increasing sales tenfold from $2 million to $22 million over four years. When the business was sold, Gilmour built another business called Vancouver Wholesale Drugs. Gilmour was a partner and general manager of Vancouver Wholesale Drugs and oversaw a sales increase from $5 million to $70 million in just six years. Gilmour then returned to the grocery world purchasing an IGA grocery store in Vancouver, B.C., that he operated for over eight years. More recently, Gilmour has been advising business owners of small- to medium-sized businesses in infrastructure, financing, sales and marketing.

Kris Tarr's professional career has spanned almost three decades as an information technology and internet marketing consultant. Tarr has held several senior marketing management and IT executive positions, applying his decades of experience in technology, management and leadership to deliver business results for organizations in the high-tech, pharmaceutical, tourism, entertainment, online gaming and real estate sectors.

Tarr has worked for globally recognized organizations such as Coca-Cola, Disney and Nickelodeon. As a consultant, he has guided over a hundred small and medium-sized businesses, developing and implementing online and e-commerce strategies.

In Vancouver, Canada, Tarr focused on internet marketing with an emphasis on search engine optimization and social media automation for the online gaming industry. Tarr held a position as senior SEO strategist for Bodog which is a major online gaming brand. Tarr has also held the positions of ITSM (IT service management) head, chief technology officer and IT solutions provider at Oriental Game which is Asia's leading online gaming solutions provider.

Tarr has started numerous lucrative business ventures and has built and operated many successful search engines including a property management franchise. He co-founded Waveless Websystems Inc., where he developed e-commerce solutions for the home building industry, which led him to Southeast Asia to expand the company's software development team.

Naturally Splendid Enterprises Ltd. ("Naturally Splendid", "NSE" or "the Company") (FRANKFURT:50N) (TSXV:NSP) (OTC PINK:NSPDF) announces its audited financial results for the year ended December 31, 2021. All amounts are in Canadian dollars and are prepared in accordance with International Financial Reporting Standards

Naturally Splendid Chief Financial Officer Mr. George Ragogna states, "The company continues to focus on reducing operating overheads while we continue to re-purpose our existing certified food facility in Pitt Meadows, BC to optimize production of plant-based entrees. We have made positive strides for the Company in several areas including securing an exclusive ten (10) year manufacturing and distribution agreement for Canada with Flexitarian Foods Pty. Ltd, Australia's largest plant-based manufacturer. This 10-year exclusive manufacturing agreement can be extended for a further ten (10) year period.

The facility build-out will allow for the production of up to twenty (20) tons of plant-based entrees daily for the majority of our standard plant-based offerings, but as much as thirty (30) tons of plant-based production daily for certain products. This translates to a manufacturing capacity potential of over $30,000,000 CDN annually. Our manufacturing facility remains a cornerstone to the future of the Company as we expect to drive revenue from not only our Company branded products, but also through private label and contract manufacturing clients.

Ragogna continues, "The Company is focused on penetrating the plant-based market both in food service and retail channels. Initially, the Company focused on food service, developing a network of distributors that include national distribution partners such as Sysco Canada and Gordon Food Services (GFS). The Company recently engaged one of Canada's leading foodservice brokers, Tri-Elite Marketing to represent PlanteinTM across Canada. Food service was our initial focus, producing successes such as a national listing for our plant-based nuggets and tenders with Denny's Canada and Bar One restaurants".

The Company recently launched PlanteinTM, the Company's retail line of plant-based entrees. In this regard, the Company has secured exclusive rights for the PlanteinTM trademark for Canada from Flexitarian Foods. The term for licensing the PlanteinTM trademark is for ten (10) years with a ten (10) year renewal option, matching the term of the exclusive manufacturing and distribution agreement from Flexitarian Foods. Our initial PlanteinTM launch focuses on eight (8) plant-based entrees including a plant-based; Burger; Crispy Burger; Crumbed Tenders; Sweet Chili Tenders; Nuggets; Schnitzel (cutlet); Garlic Kiev; and the Phishy Fillet.

While we continue to progress with the build-out of our facility, our combination of brokers, distributors and internal sales staff continues to work towards increasing our sales in both food service and retail channels. All manufacturing equipment has been ordered, however, continued supply chain issues have delayed shipment of certain components of the manufacturing line which is pushing out the completion date of the facility. As such we have taken proactive measures with our strategic partners, Flexitarian Foods, and have ordered additional containers of product to support our aggressive sales strategy."

Company CEO Mr. Craig Goodwin states, "The Company recently attended three (3) significant industry tradeshows that have been on a hiatus for the past two (2) years due to the pandemic. Being able to sample our delicious entrees in tradeshow settings has made a huge difference, generating significant interest in our PlanteinTM line of plant-based offerings. Tradeshows attended include; Western Canada's largest natural, health and organics trade event, Canadian Health Food Association (CHFA) tradeshow; Grocery & Specialty Food West, Canada's leading western grocery trade fair; and the Planted Expo, Canada's largest plant-based consumer event of the year. These shows affirmed our belief that we have a winning product line and we have seen an increase in sales activity from retailers, food service outlets as well as consumers buying directly through the PlanteinTM website (www.plantein.ca).

Ragogna concludes, "The Company continues to make plant-based food manufacturing our priority. We firmly believe that the plant-based category has a bright future and as a manufacturer, we are well positioned to penetrate this market. Senior management is reviewing all operations and continues to create and execute a detailed strategic plan that focusses our attention on our core plant-based manufacturing business while reducing or eliminating operations that are not contributing to the growth of the Company".

During this reporting period, Covid-19 uncertainty negatively affected sales of existing product lines as well as impaired launches of new product lines. On March 11, 2020, the World Health Organization declared the outbreak of the novel coronavirus ("COVID-19") a global pandemic resulting in governments worldwide, including the Canadian government, to enact extensive measures in an effort to limit the spread of the virus. These measures, which include social distancing, travel restrictions, outright travel bans, and closures of non-essential businesses including restaurants, created a challenging period for the Company.Naturally Splendid recorded a net loss and comprehensive loss of $3,269,452 for the year ended December 31, 2021, compared with a net loss of $4,659,642 during the year ended December 31, 2020. The decrease in net loss and comprehensive loss was attributed to the decrease in selling and distribution expenses.

Gross profit margins increased by 3.4 percent of sales in the year ended December 31, 2021, compared with the year ended December 31, 2020. This is due to the increased profit margins in the new plant-based sales. The company's sales decreased by approximately $812,600 from the comparative period. During the year ended December 31, 2021, selling and distribution expenses decreased by approximately $560,000 largely due to a decrease in production (facility costs, quality assurance and lab testing) and production wages, which were offset by the government wage subsidy received during the year. Administrative expenses decreased by approximately $896,000 predominantly from corporate promotions and share-based payments. The decrease was attributed to a reduction in investor relations activity and the reduction of share-based payments.

Naturally Splendid recorded sales of $763,796 during the year ended December 31, 2021, compared with $1,576,408 for the year ended December 31, 2020.

The Company's sales decreased by approximately $813,000 from the comparative period. The Company had decreased sales in its private-label bars and bites business by approximately $790,000 and other branded products decreased by approximately $5,000. Branded hemp products decreased by approximately $65,000 and its new Natera Sport products decreased by approximately $149,000. The Company had sales of approximately $211,000 in its new Plant-based products.

During the year ended December 31, 2021, selling and distribution expenses decreased by approximately $560,000 largely due to a decrease in production (facility costs, quality assurance, lab testing and reduced production) and production wages which were offset by the government wage subsidy received during the quarter. Administrative expenses decreased by approximately $896,000 mainly from share-based payments and corporate promotions. The decrease was attributed to a reductionin investor relationsactivity due to the pandemicand the reduction of corporate salaries from the government wage subsidy.

The cost of sales during the year ended December 31, 2021, and 2020, were $681,615 and $1,576,408 respectively. The company gross margin percentage was 10.8 percent of sales during the year ended December 31, 2021.

The company continued its sales mix with exports of bulk seeds and launching its new plant-based products. The bulk hemp seeds sold at a lower gross margin percentage than compared with the plant-based products and private label sales. The company will continue to focus on its higher-margin products and new commercial opportunities. Gross profits for the year ended December 31, 2021, were $82,181 (11 percent of sales) compared with $142,930 (7 percent of sales) for the year ended December 31, 2020.

For the Year Ended December 31, 2021

For the Year Ended December 31, 2020

Basic and Diluted Earnings (Loss)

About Naturally Splendid Enterprises Ltd.

Founded in 2010, NSE operates a food manufacturing facility just outside Vancouver, BC in Canada. The Company has established numerous healthy, functional foods under recognized brands such as Natera Sport™, Natera Hemp Foods, CHII, Elevate Me™ and Woods Wild Bar™, and most recently Natera Plant Based Foods, a line of delicious plant-based meat alternatives for the rapidly growing plant-based market segment. The Company has a myriad of new products and line extensions under development that are approaching launch. NSE, through its joint venture Plasm Pharmaceutical, has been approved for conducting a phase 2 clinical trial approved by Health Canada for treatment of COVID-19. NSE has also developed proprietary technologies for the extraction of high-demand, healthy omega 3 and 6 oils from hemp.

NSE contract manufacturers for healthy, functional food products and ingredients focusing on plant-based ingredients. The Company provides contract manufacturing services for many healthy food companies, private labeling a wide variety of nutritional food products destined for global healthy food markets.

For more information e-mail info@naturallysplendid.com or call Investor Relations at 604-570-0902 (ext. 101)

On Behalf of the Board of Directors

Mr. J. Craig Goodwin CEO, Director

Naturally Splendid Enterprises Ltd. (NSP - TSX Venture; NSPDF - OTCQB; 50N - Frankfurt) #108-19100 Airport Way Pitt Meadows, BC, V3Y 0E2 Office: (604) 570-0902 Fax: (604) 465-1128 E-mail : info@naturallysplendid.com Website: www.naturallysplendid.com

SOURCE: Naturally Splendid Enterprises Ltd.

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Naturally Splendid Enterprises Ltd. ("Naturally Splendid") (TSXV:NSP)(OTC PINK:NSPDF)(Frankfurt:50N) is pleased to announce we will be presenting the PlanteinTM line of plant-based entrees at the Planted Expo Vancouver on June 4 and June 5, 2022, at the Vancouver Convention Center

Planted Expo is Canada's largest plant-based event of the year, focused on consumers looking to add more plant-based choices to their daily diets. Planted Expo expects more than 15,000 plant-based enthusiasts to attend this two-day event.

Naturally Splendid will be featuring eight (8) PlanteinTM plant-based entrees, including a plant-based; Burger; Crispy Burger; Crumbed Tenders; Sweet Chili Tenders; Nuggets; Schnitzel (cutlet); Garlic Kiev; and a Phishy Fillet.

In June, Naturally Splendid presented the PlanteinTM line of plant-based entrees at the CHFA NOW tradeshow, Western Canada's largest natural, health and organics trade event and the Grocery & Specialty Food West (GSFW) trade show, Canada's leading western grocery trade fair, bringing together manufacturers and retailers from all over the country.

Building on the momentum gained from these twoprevious trade shows, Naturally Splendid is pleased to present the PlanteinTM line of plant-based entrees to the ever-growing consumer base choosing plant-based products.

A 2021 study conducted by Leger Research found that consumer demand for plant-based foods is growing in Canada and around the world. Recent data shows that two-thirds (67%) of Canadians consume plant-based foods frequently, and 31% of Canadians plan to eat more plant-based foods within the next year. https://www.plantbasedfoodscanada.ca/.

Naturally Splendid CEO Mr. Craig Goodwin states, "Canadians are choosing plant-based foods for a number of reasons. Consumer preferences demonstrate there are many factors culminating to encourage people to incorporate alternative protein options into their everyday diets including environmental sustainability, human health as well as animal welfare. Consumers are aware how simple, plant-based choices can have a positive impact on the well-being of our global community. However, we believe that a major driver growing plant-based sales is taste and consumer experience. In that regard, we believe our plant-based entrees are amongst the best tasting choices in the market today. We look forward to sharing our PlanteinTM entrees with thousands of consumers at the Planted Expo this upcoming weekend."

About Naturally Splendid Enterprises Ltd.

Naturally Splendid is a plant-based food manufacturing and technology company that produces and distributes nutritious and delicious plant-based commodity products.

Naturally Splendid has an exclusive 10-year manufacturing and distribution agreement for Canada with a division of Australia's largest plant-based food manufacturer, Flexitarian Foods Pty. Ltd.

Naturally Splendid maintains a relationship Plasm Pharmaceutical, a company that has been approved for conducting a phase 2 clinical trial approved by Health Canada for the treatment of COVID-19.

NSE has also developed proprietary technologies for the extraction of healthy omega 3 and 6 oils, as well as a protein concentrate from hemp.

For more information e-mail info@naturallysplendid.com or call Investor Relations at 604-673-9573.

On Behalf of the Board of Directors

Mr. J. Craig Goodwin CEO, Director

Naturally Splendid Enterprises Ltd. (NSP - TSX Venture; NSPDF - OTCQB; 50N Frankfurt) #108-19100 Airport Way Pitt Meadows, BC, V3Y 0E2 Office: (604) 570-0902 Fax: (604) 465-1128 E-mail: info@naturallysplendid.com Website: www.naturallysplendid.com

SOURCE: Naturally Splendid Enterprises Ltd.

News Provided by ACCESSWIRE via QuoteMedia

Naturally Splendid Enterprises Ltd. ("Naturally Splendid" or "NSE" or the "Company" ) (FRANKFURT:50N) (TSXV:NSP) (OTC PINK:NSPDF) today is providing a status update in accordance with its obligations under the alternative information guidelines set out in National Policy 12-203 - Management Cease Trade Orders ("NP 12-203"), which require the Company to provide bi-weekly updates until such time as the Company is current with its filing obligations under Canadian securities laws. As previously announced, the Company is subject to a management cease trade order ("MCTO") issued by the British Columbia Securities Commission. The MCTO prohibits the directors and executive officers of the Company from trading in or acquiring securities of the Company until two full business days after the Company files its audited financial statements for the year ended December 31, 2021 and the related management's discussion and analysis and certifications. The MCTO does not affect the ability of investors who are not insiders to trade in the securities of the Company

The Company advises that aside from the British Columbia Securities Commission granting the MCTO: (i) there have been no material changes to the information contained in the Company's April 14, 2022 news release; (ii) it intends to continue to comply with the alternative information guidelines of NP 12-203; and (iii) except as previously disclosed, there are no subsequent specified defaults (actual or anticipated) within the meaning of NP 12-203.

The Company continues to work towards completing the filing on or before the June 30, 2022, deadline and will continue to update its shareholders of the status of the Audited financials periodically.

About Naturally Splendid Enterprises Ltd.

Naturally Splendid is a plant-based food manufacturing and technology company that produces and distributes nutritious and delicious plant-based commodity products.

Naturally Splendid has an exclusive 10-year manufacturing and distribution agreement for Canada with a division of Australia's largest plant-based food manufacturer, Flexitarian Foods Pty. Ltd.

Naturally Splendid maintains a relationship Plasm Pharmaceutical, a company that has been approved for conducting a phase 2 clinical trial approved by Health Canada for the treatment of COVID-19.

NSE has also developed proprietary technologies for the extraction of healthy omega 3 and 6 oils, as well as a protein concentrate from hemp.

On Behalf of the Board of Directors

Mr. J. Craig Goodwin President, Director

Naturally Splendid Enterprises Ltd. (NSP - TSX Venture; NSPDF - OTCQB; 50N Frankfurt) #108-19100 Airport Way Pitt Meadows, BC, V3Y 0E2 Office: (604) 465-0548 Fax: (604) 465-1128 E-mail: info@naturallysplendid.com Website: www.naturallysplendid.com

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management's current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. Naturally Splendid cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond Naturally Splendid's control including, Naturally Splendid's ability to compete with large food and beverage companies; sales of any potential products developed will be profitable; sales of shelled hemp seed will continue at existing rates or increase; customers will complete on sales contracts; and the risk that any of the potential applications may not receive all required regulatory or legal approval. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, Naturally Splendid undertakes no obligation to publicly update or revise forward-looking information.

SOURCE: Naturally Splendid Enterprises Ltd.

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Naturally Splendid Enterprises Ltd. ("Naturally Splendid") (TSXV:NSP)(OTC PINK:NSPDF)(Frankfurt:50N) is pleased to announce the Company has executed a National Food Service Broker Agreement with Vancouver based Tri-Elite Marketing Ltd. (Tri-Elite), to market the Company's plant-based entrees, PlanteinTM, across Canada

Tri-Elite will focus on securing food service listings across Canada for the Company's extensive line of plant-based, meat alternative entrees. Tri-Elite will be participating with Naturally Splendid at the Canadian Health Food Association (CHFA) trade show this weekend, April 23rd and 24th, promoting the PlanteinTM line to its many existing clients and looking to make connections with new opportunities. Industry experts consider the CHFA trade shows the number one source of presenting new products to retailers doing business in Canada.

Tri-Elite Marketing Ltd. was founded in 2000 servicing western Canada initially. In 2003, current President Aggie Christopher, joined Tri-Elite as a partner bringing her extensive experience, relationships and distribution background to the company. In 2009 Aggie assumed full ownership of the company and its direction, expanding Company operations across Canada.

In 2018 Tri-Elite stepped into the national arena hiring territory managers for eastern Canada solidifying strong representation coast to coast. The Company has over twenty (20) full-time sales representatives across Canada dedicated to servicing Tri-Elite clients and expanding their distribution. The company has been built on hard work, loyalty, trust and finding the best sales candidates in each marketplace. Tri-Elite has been truly fortunate to have hired some of the best talents in the Food Service Industry and that has been the key to the success of the brands they represent and in turn, Tri-Elite's success.

Tri-Elite President Aggie Christopher states, "Tri-Elite Marketing is a partner for the future, with lofty targets and goals to provide premium service for our business partners supporting them to build their business and ultimately succeed. Consumers are demanding plant-based products more now than ever before and we believe this category will continue to grow. We deploy a very strategic game plan with goals to grow our vendor partner's business, while in turn continuing to build Tri-Elite Marketing to be the strongest and most focused brokerage company in Canada. We look forward to implementing the systems and processes we've developed over our decades of doing business that have proven to be successful and look forward to working with the Naturally Splendid team to make the PlanteinTM brand a sensation in Canada."

PlanteinTM is the brand name for Naturally Splendid's line of plant-based entrees (www.plantein.ca). Naturally Splendid has an exclusive manufacturing and distribution agreement for an extensive range of plant-based entrees with Flexitarian Foods Pty. Ltd., a division of Australia's largest plant-based manufacturer. The current roster of entrees that Naturally Splendid has initially launched under the PlanteinTM trademark, include a plant-based; Burger; Crunchy Burger; Crumbed Tenders; Sweet Chili Tenders; Nuggets; Schnitzel (cutlet); Garlic Kiev; and a Phishy Filet.

Naturally Splendid CEO Craig Goodwin comments, "We are very pleased that our initial PlanteinTM launch and subsequent rollout strategy is being supported by an organization as successful as Tri-Elite Marketing. Their understanding and achievements regarding product launches and national distribution will significantly benefit our sales and distribution strategies. We look forward to working with the Tri-Elite team with our most exciting product launch to date."

About Naturally Splendid Enterprises Ltd.

Naturally Splendid is a plant-based food manufacturing and technology company that produces and distributes nutritious and delicious plant-based commodity products.

Naturally Splendid has an exclusive 10-year manufacturing and distribution agreement for Canada with a division of Australia's largest plant-based food manufacturer, Flexitarian Foods Pty. Ltd.

Naturally Splendid maintains a relationship Plasm Pharmaceutical, a company that has been approved for conducting a phase 2 clinical trial approved by Health Canada for the treatment of COVID-19.

NSE has also developed proprietary technologies for the extraction of healthy omega 3 and 6 oils, as well as a protein concentrate from hemp.

For more information e-mail info@naturallysplendid.com or call Investor Relations at 604-570-0905 x 101.

On Behalf of the Board of Directors

Mr. J. Craig Goodwin CEO, Director

SOURCE: Naturally Splendid Enterprises Ltd.

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Naturally Splendid Enterprises Ltd. ("Naturally Splendid", "NSE" or "the Company") (FRANKFURT:50N)(TSXV:NSP)(OTC PINK:NSPDF) is pleased to announce that Mr. George Ragogna has been appointed Chief Financial Officer (CFO), replacing current Chief Financial Officer (CFO), Mr. Bryan Carson

Mr. Ragogna has over 30 years of experience in the Canadian financial services industry with over 20 years in a progressive leadership role specializing in; strategic planning, corporate sales, workforce optimization and regulatory compliance for the Co-operators Group Limited, a leading Canadian multi-line insurance and financial services co-operative with $56.4 billion in assets under management.

Prior to accepting the position of CFO for Naturally Splendid, Mr. Ragogna successfully managed the sales and service call center of over 550 employees for Co-operators Group Limited, ensuring new and existing staff were trained and knowledgeable in the financial services industry and compliance processes. Mr. Ragogna brings a unique business acumen and strong technical skills that will strengthen Naturally Splendid as the Company focuses on their core business.

Mr. Ragogna states, "I'm excited for the opportunity to support the organization in this next chapter as we transition ourselves into manufacturing our plant-based food entrees. This is a most exciting time as the plant-based protein product industry continues to grow. As a manufacturer, we will deploy innovative strategies to penetrate this expanding market as efficiently as possible and I look forward to implementing these strategies." Mr. Carson, a co-founder of Naturally Splendid, will retain his position of Vice President as well as his position as a Director of the Company. Mr. Ragogna remains a Director of the Company and Chairman of the Board as well as the position of CFO but will no longer be Chairman of the Audit Committee. The Chairman of the Audit Committee will be assigned to existing Director Mr. Larry Gilmour.

Mr. Gilmour has been appointed Audit Committee Chairman. He has extensive sales and marketing expertise with internationally recognized brands such as: Libby's (Libby, McNeil and Libby); Playtex Corp.; and Black and Decker. Mr. Gilmour has also owned and operated chain grocery outlets including owner/operator of a Super Valu grocery store as well as owner/operator of an IGA grocery store, both of which were located in the Greater Vancouver Area of B.C.

Naturally Splendid CEO Mr. J. Craig Goodwin states, "Company co-founder Bryan Carson and I would like to welcome George to the Company as CFO. We have had the privilege of working with George in his role as Chairman of the Board. Having George step into the CFO role, with his 30 years of experience in the financial sector, is sure to be an asset for the Company. We look forward to supporting George in his new position".

About Naturally Splendid Enterprises Ltd.

Founded in 2010, NSE operates a food manufacturing facility just outside Vancouver, BC in Canada. The Company has established numerous healthy, functional foods under recognized brands such as Natera Sport™, Natera Hemp Foods, CHII, Elevate Me™ and Woods Wild Bar™, and most recently Natera Plant Based Foods, a line of delicious plant-based meat alternatives for the rapidly growing plant-based market segment. The Company has a myriad of new products and line extensions under development that are approaching launch. NSE, through an arrangement with Plasm Pharmaceutical, has been approved for conducting a phase 2 clinical trial approved by Health Canada for treatment of COVID-19. NSE has also developed proprietary technologies for the extraction of high-demand, healthy omega 3 and 6 oils from hemp.

For more information e-mail info@naturallysplendid.com or call Investor Relations at 604-465-0548 (ext. 105)

On Behalf of the Board of Directors Mr. J. Craig Goodwin CEO, Director

Naturally Splendid Enterprises Ltd. (NSP - TSX Venture; NSPDF - OTCQB; 50N - Frankfurt) #108-19100 Airport Way Pitt Meadows, BC, V3Y 0E2 Office: (604) 465-0548 Fax: (604) 465-1128 E-mail : info@naturallysplendid.com Website: www.naturallysplendid.com

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management's current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. Naturally Splendid cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond Naturally Splendid's control including, Naturally Splendid's ability to compete with large food and beverage companies; sales of any potential products developed will be profitable; sales of shelled hemp seed will continue at existing rates or increase; the ability to complete the sales of all bulk hemp seed purchase orders; and the risk that any of the potential applications may not receive all required regulatory or legal approval. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, Naturally Splendid undertakes no obligation to publicly update or revise forward-looking information.

SOURCE:Naturally Splendid Enterprises Ltd.

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The Gummy Project (CSE: GUMY) (FSE: 0OS2) (OTCQB: POTVF) ("GUMY" or the "Company") is pleased to announce the official launch of its new e-commerce site at www.shopgummies.com.

"The launch of our e-commerce site is a major milestone, making our product available across Canada for the first time," said Anthony Gindin, Chief Marketing Officer at GUMY. "This really marks our official launch into the Canadian market with e-commerce being a major component in our overall sales channel strategy. The site provides a vehicle for continued growth as well as a platform to share our story and fulfil our mandate to support endangered keystone species."

Both the Watermelon Sharks and Peachy Bees are now available for sale at www.shopgummies.com. Each bag contains 22 gummies with only two grams of sugar while being plant based, gluten free and non-GMO.

Shipping and fulfilment of online orders will commence on July 11, 2022.

"The initial feedback received on both the flavor formulations and the packaging has been tremendous and we are extremely excited that our gummies will now be available to consumers nationwide in Canada through our e-commerce platform," said Charlie Lamb, President and CEO of GUMY. "Our development team did a wonderful job building a website that not only looks fantastic but is also very user friendly."

We are a growing community of individuals and organizations who believe small contributions can add up to something big. We sell low sugar, plant based gummy products while raising money (and awareness) to support endangered keystone species. We are the only "better for you" candy company that is built to support our planet's most precious species and ecosystems, while educating our future generations on the steps we must take today, to ensure a viable tomorrow.

Charlie Lamb, President & CEO, Director Telephone: 1(236) 317-2812 - Toll free (877) 806-2633 E-mail: investors@shopgummies.com

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

Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding future financial position, business strategy, use of proceeds, corporate vision, proposed acquisitions, partnerships, joint-ventures and strategic alliances and co-operations, budgets, cost and plans and objectives of or involving the Company. Such forward-looking information reflects management's current beliefs and is based on information currently available to management. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "predicts", "intends", "targets", "aims", "anticipates", "may" or "believes" or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. A number of known and unknown risks, uncertainties and other factors may cause the actual results or performance to materially differ from any future results or performance expressed or implied by the forward-looking information. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company including, but not limited to, the impact of general economic conditions, industry conditions, risks relating to epidemics or pandemics such as COVID-19, including the impact of COVID-19 on the Company's business, financial condition, and results of operations. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. The Company does not assume any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by securities laws.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/129624

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Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-inflammatory and anti-fibrotic therapy for the treatment of cardiovascular diseases ("CVD"), announces the results from its Annual General Meeting of Shareholders (the "AGM") held virtually via live audio webcast, on June 28, 2022. Shareholders voted in favour of all management resolutions proposed in the Company's Information Circular.

Resolutions proposed and approved at the AGM were:

The results of the voting on the election of directors are as follows:

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-inflammatory and anti-fibrotic therapy for the treatment of CVD. The Company's lead product candidate, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation that is being clinically developed for use in cardiovascular medicine. CardiolRx™ is currently being evaluated in a Phase II/III multi-national, randomized, double-blind, placebo-controlled study (the "LANCER" trial). LANCER is designed to evaluate the efficacy and safety of CardiolRx™ as a cardioprotective therapy to reduce major cardiovascular and respiratory events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx™ has on key biomarkers associated with heart disease.

Cardiol has also received IND authorization from the FDA to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two orphan drug indications: (i) a Phase II multi-national, randomized, double-blind, placebo-controlled trial in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and the leading cause of sudden cardiac death in people less than 35 years of age; and (ii) a Phase II multicenter open-label pilot study in recurrent pericarditis (inflammation of the pericardium), which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations.

In addition, Cardiol is developing a subcutaneous formulation of cannabidiol for the treatment of inflammation and fibrosis associated with the development and progression of heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the U.S. exceeding $30 billion annually.

For more information about Cardiol Therapeutics, please visit cardiolrx.com.

Cautionary statement regarding forward-looking information:

This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward-looking information contained herein may include, but is not limited to, statements relating to the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of cardiovascular disease. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Information Form dated March 23, 2022, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.

For further information, please contact:

Trevor Burns, Investor Relations +1-289-910-0855 trevor.burns@cardiolrx.com

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The Gummy Project (CSE: GUMY) (FSE: 0OS2) (OTCQB: POTVF) ("GUMY" or the "Company") is pleased to announce that as of June 29, 2022 it has partnered with Stong's to launch its Watermelon Sharks and Peachy Bees into the Canadian retail market.

"This partnership represents another great step in our ongoing sales strategy and we're extremely proud to partner with Stong's, an iconic grocery store in Vancouver," said Charlie Lamb, President and CEO of GUMY. "Following our recent partnership announcements with Flair Airlines and Bard on the Beach, the upcoming launch of our ecommerce site on June 30 2022, and our distribution partnership with Dean's Dairy and Specialty Foods, consumers will soon be able to purchase our products at locations across Canada."

Stong's are Vancouver owned full-service grocery stores that have operated in the Vancouver area since 1931. Stong's has been "first to market" with numerous success stories over the years and are proud to forge early relationships with companies and their products. Stong's proudly supports its local community focusing on Children's Schools, Educational & Sports Programs as well as local Community Organizations & Festivals, through the donation of products and services for fundraising events.

"We are very happy to partner with a company like The Gummy Project. They align with a lot of the values we have at Stongs Market. This local company is doing a lot of great things with their brand. Great design, taste and happy to see that they donate a portion of their proceeds to their selected partners. Looking forward to our working relationship and feel that this product will take off in our store," said Robert Misa, Grocery Manager at Stong's Dunbar Street location.

Stong's is a full service retail grocery store, established in 1910 in Toronto by the Stong Brothers, Carson and Joseph. We are 100% BC owned and operated.

At Stong's Market, we offer a wide selection of products - far more than your average grocery store. We carry all major national brands as well as an extensive selection of unique, gourmet, natural and organic products. We pride ourselves on being local and in turn support local suppliers large and small. We have become the test market for many small suppliers looking to develop their product.

Charlie Lamb, President & CEO, Director Telephone: 1(236) 317-2812 - Toll free (877) 806-2633 E-mail: investors@shopgummies.com

Forward-Looking Statements Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding future financial position, business strategy, use of proceeds, corporate vision, proposed acquisitions, partnerships, joint-ventures and strategic alliances and co-operations, budgets, cost and plans and objectives of or involving the Company. Such forward-looking information reflects management's current beliefs and is based on information currently available to management. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "predicts", "intends", "targets", "aims", "anticipates", "may" or "believes" or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. A number of known and unknown risks, uncertainties and other factors may cause the actual results or performance to materially differ from any future results or performance expressed or implied by the forward-looking information. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company including, but not limited to, the impact of general economic conditions, industry conditions, risks relating to epidemics or pandemics such as COVID-19, including the impact of COVID-19 on the Company's business, financial condition, and results of operations. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. The Company does not assume any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by securities laws.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/129327

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First adjuvant Immunotherapy for patients at high risk of disease recurrence

Today, Bristol Myers Squibb Canada (BMS) announced Health Canada has issued a Notice of Compliance with Conditions (NOCc) for OPDIVO ® , as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. i OPDIVO ® is the first immuno-oncology treatment to bring benefit in the adjuvant setting of UC and represents a potential new standard of care for patients at high risk of disease recurrence. ii Unlike traditional cancer therapies that target the tumour directly, immuno-oncology activates the body's own immune system to help recognize and attack cancer cells. iii

"For years, patients with muscle-invasive urothelial carcinoma (MIUC) have lived with the unfortunate reality that, despite being diagnosed early enough to have their cancer removed, more than fifty percent face disease recurrence, with few safe and effective treatment options available to improve outcomes in these patients," said Dr. Wassim Kassouf , Professor, Department of Surgery (Urologic Oncology), McGill University . "The approval of OPDIVO ® is particularly important because clinicians now have an immunotherapy option to offer certain patients after surgery, that may reduce the risk of disease recurrence. This approval has the potential to significantly impact the way we treat MIUC in Canada ."

Bladder cancer begins when healthy cells in the bladder lining—most commonly urothelial cells—change and grow out of control, forming a mass called a tumor. Urothelial cells also line the renal pelvis and ureters. Cancer that develops in the renal pelvis and ureters is also considered a type of urothelial cancer and is referred to upper tract urothelial carcinoma (UTUC). iv Urothelial carcinoma of the bladder (UCB) is the most common malignancy of the urinary tract, v and the fifth most common cancer in Canada . vi Seventy-seven percent of new cases occur in males, making this the fourth most common cancer for Canadian men. vii

"We are pleased to see the approval of a new adjuvant treatment that has the potential to delay disease recurrence or prevent progression of disease. Through this positive decision, patients living with muscle-invasive urothelial carcinoma may have the opportunity for more quality time with their loved ones" said Michelle Colero , Executive Director, Bladder Cancer Canada. "This new treatment option addresses the challenging needs of patients after surgery, while they manage the fear of their cancer returning."

"We are pleased and proud to have OPDIVO ® now approved for the treatment of certain patients diagnosed with urothelial cancer in Canada ," said Troy André, General Manager, BMS Canada. "At BMS, we are committed to the pursuit of innovative therapies that can help improve patients' quality of life. This approval for OPDIVO ® gives us the opportunity to introduce a new post-surgery standard of care, building on our legacy as the first company to bring an immuno-oncology treatment to Canadian patients."

The Health Canada NOC/c was based on CheckMate-274 which is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial evaluating OPDIVO ® as an adjuvant treatment in patients who had undergone radical resection of urothelial carcinoma (UC) originating in the bladder or upper urinary tract and were at high risk of recurrence.

Treatment was provided up to one year, or until disease recurrence, toxicity, or withdrawal of consent occurred. The two primary endpoints of the trial were disease-free survival (DFS) among all the patients (intention-to-treat population) and among patients with a tumor programmed death ligand 1 (PD-L1) expression level of 1% or more. The key secondary endpoints include non-urothelial tract recurrence-free survival (NUTRFS), disease-specific survival (DSS) and overall survival (OS). i The trial met its primary endpoint of disease-free survival demonstrating that adjuvant OPDIVO ® offers patients a chance to delay or potentially prevent disease recurrence in all randomized patients (intention-to-treat population) and those with a tumor PD-L1 expression level of 1% or more. A positive association was observed between tumor PD-L1 expression and the magnitude of the treatment benefit. An improvement in overall survival has not yet been established.

Bristol Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol Myers Squibb Canada Co. employs close to 300 people across the country. For more information, please visit https://www.bms.com/ca/en .

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

i Health Canada issued a Notice of Compliance with Conditions which notes a positive association was observed between tumor PD-L1 expression and the magnitude of the treatment benefit, however an improvement in overall survival has not yet been established. ii Canadian Product Monograph. June 27, 2022. https://www.bms.com/assets/bms/ca/documents/productmonograph/OPDIVO_EN_PM.pdf iii Canadian Cancer Society. Immunotherapy. https://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/chemotherapy-and-other-drug-therapies/immunotherapy/?region=on . Accessed Apr 17, 2022. iv Cancer.Net. Bladder Cancer Guide. https://www.cancer.net/cancer-types/bladder-cancer/introduction . Accessed Apr 18, 2022. v Canadian Cancer Society. Cancerous tumours of the bladder. https://cancer.ca/en/cancer-information/cancer-types/bladder/what-is-bladder-cancer/cancerous-tumours#:~:text=Urothelial%20carcinoma,lining%20is%20called%20the%20urothelium ). Accessed Apr 17, 2022. vi Canadian Cancer Society. Cancer-specific stats 2021. https://cdn.cancer.ca/-/media/files/research/cancer-statistics/2021-statistics/2021_cancer-specific-stats.pdf?rev=bbadfd869b66415e97be9655a842858c&hash=3E552CE702E1BD7657E4E91FB7BA624B&_ga=2.111238148.1693575665.1650230785-493129280.1646783721 . Accessed Apr 17, 2022. vii Government of Canada. Bladder cancer in Canada. https://www.canada.ca/en/public-health/services/publications/diseases-conditions/bladder-cancer-canada.html . Accessed Apr 17, 2022.

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Pivotal ZUMA-5 Study Demonstrates Overall Response Rate of 91% and a Complete Response rate of 77% in Patients Who Received Yescarta After Three or More Lines of Therapy –

– Kite's Third Approved Cell Therapy Indication in Europe –

Kite, a Gilead Company (Nasdaq: GILD), today announces that the European Commission (EC) has approved its CAR T-cell therapy Yescarta ® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. Yescarta has maintained orphan medicinal product designation in this indication.

"Patients with advanced relapsed or refractory follicular lymphoma have a high need for new treatment options," said Christi Shaw, CEO, Kite. "This is the third approved indication for a Kite cell therapy in Europe, and we are pleased to enable more patients with different lymphomas greater access to this treatment innovation."

Follicular lymphoma is a form of non-Hodgkin lymphoma in which tumors grow slowly but can become more aggressive over time. FL is the second most common type of lymphoma globally and accounts for approximately 22% of all lymphomas diagnosed worldwide. In Europe, approximately 27,000 new cases are diagnosed each year.

"Follicular lymphoma that has relapsed multiple times is a difficult-to-treat disease with an especially poor prognosis as only 20% of patients are still alive at five years after their second relapse," said Ibrahim Yakoub-Agha, MD, PhD, Head of the Hematopoietic Cell Transplantation and Cellular Therapy Unit, Lille University Hospital. "Ninety-one percent of patients in the ZUMA-5 study responded to axicabtagene ciloleucel after three or more prior lines of therapy, and more than half of these were still in response two years later. This sign of durable remission is critical for patients who need options that can deliver long-term benefit."

"Follicular lymphoma is often misunderstood as easy to treat or non life-threatening, even when it has reached a significantly advanced stage," said Nicola Mendelsohn, Founder and Chair of the Follicular Lymphoma Foundation (FLF). "For patients with later-line relapsed or refractory disease, it is often very aggressive. Axicabtagene ciloleucel represents an important advance for a patient population in Europe with limited treatment options."

The approval is supported by data from the pivotal, single-arm Phase 2 ZUMA-5 international study in patients with relapsed or refractory FL who had received at least two prior lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. Among patients who had received three or more lines of prior therapy (n=75), the overall response rate (ORR) was 91%, and the complete response (CR) rate was 77% at the 24-month analysis. The median duration of response (DoR) was 38.6 months, and the proportion of responders still in response at Month 24 was 56%.

Among all evaluable patients within ZUMA-5 (n=119), safety observations were consistent with the known safety profile for Yescarta. Grade ≥3 cytokine release syndrome (CRS) occurred in 6% of patients and neurologic events occurred 16% of patients. Most CRS cases (99%) of any grade resolved by the time of data cut-off and 60% of neurologic events were resolved within three weeks. The most significant and frequently occurring adverse events were CRS (77%), infections (59%) and encephalopathy (47%). For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management), please refer to the EU Summary of Product Characteristics (SmPC).

Additional data were shared separately during an oral presentation at the 2021 American Society of Hematology Meeting .

FL is a form of indolent non-Hodgkin lymphoma (iNHL) in which malignant tumors slowly grow but can become more aggressive over time, especially if they relapse. FL is the most common form of indolent non-Hodgkin lymphoma and the second most common type of lymphoma globally. It accounts for approximately 22% of all lymphomas diagnosed worldwide. Currently, there are limited options for the treatment of relapsed or refractory FL after two or more lines of therapy.

ZUMA-5 is an ongoing, single-arm, open-label, international, multicentre trial evaluating 122 patients (≥18 years old) with relapsed or refractory follicular lymphoma (FL), who received at least two prior lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. The primary endpoint was ORR, and secondary endpoints included CR rate, ORR and CR in patients who had received three or more lines of prior therapy, DoR, overall survival, progression-free survival and incidence of adverse events.

Please see full US Prescribing Information , including BOXED WARNING and Medication Guide.

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and the median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1- 133 days) and the median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL.

The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41), and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in a higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset of and decrease the duration of CRS.

Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained in the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL; ≥ Grade 3 infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

Secondary malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with an unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting.

The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with an unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with an unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kite's singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit www.kitepharma.com . Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Kite and Gilead to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yescarta; the risk that physicians may not see the benefits of prescribing Yescarta for the treatment of FL; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Yescarta including BOXED WARNING , is available at www.kitepharma.com and www.gilead.com .

Kite, the Kite logo, Yescarta, and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220628005521/en/

Jacquie Ross, Investors investor_relations@gilead.com

Anna Padula, Media apadula@kitepharma.com

News Provided by Business Wire via QuoteMedia

NDA Resubmission Addresses Issues Related to Vial Compatibility –

– If Approved, Lenacapavir Would be the First and the Only HIV-1 Treatment Option Administered Twice-Yearly –

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.

Gilead resubmitted the NDA in response to the FDA Complete Response Letter (CRL) issued in February 2022, which cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir in borosilicate vials as the reason for the FDA action. The NDA resubmission contains comprehensive CMC data to support the compatibility of lenacapavir with an alternative vial type made from aluminosilicate glass. In addition, the NDA is supported by extensive pre-clinical and earlier clinical research data as well as data from the Phase 2/3 CAPELLA study, which evaluated the antiviral activity of lenacapavir administered every six months as a subcutaneous injection, in combination with other antiretroviral(s), in heavily treatment-experienced people with multi-drug resistant HIV-1 infection.

Once accepted by the FDA, a new Prescription Drug User Fee Act (PDUFA) date will be established.

"There are people with HIV who have severely limited treatment options due to resistance to multiple antiretroviral therapy classes," said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. "We are committed to addressing unmet needs and recognize the urgency for filling the critical treatment gap for people with multi-drug resistant HIV whose virus is no longer effectively responding to their current therapy."

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.

Lenacapavir is Gilead's potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment of HIV-1 infection. The safety, efficacy and dosing of Gilead's investigational, long-acting HIV-1 capsid inhibitor lenacapavir are being evaluated in multiple ongoing clinical studies. Lenacapavir's multi-stage mechanism of action is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting therapy options for people living with or at risk for HIV-1. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes. If approved, lenacapavir would be the only HIV-1 treatment option administered twice-yearly.

For 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 11 HIV medications , including the first single-tablet regimen to treat HIV and the first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS.

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress and complete clinical trials involving lenacapavir in the anticipated timelines or at all; the possibility of unfavorable results from ongoing and additional clinical trials involving lenacapavir; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the FDA may not approve the NDA for lenacapavir for the treatment of HIV-1 infection in HTE people with MDR HIV-1 infection in a timely manner or at all; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and as a result, lenacapavir may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.

For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter ( @Gilead Sciences ) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220627005599/en/

Jacquie Ross, Investors investor_relations@gilead.com

Brian Plummer, Media brian.plummer@gilead.com

News Provided by Business Wire via QuoteMedia

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