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Ninety Day Survival Outcomes in COVID-19 ARDS Trial of Remestemcel-L Presented at ISCT Meeting on Advances in Cell & Gene Therapies for Lung Diseases

NEW YORK, July 18, 2021 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, presented 90-day survival outcomes from the 222-patient randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS) at an invited presentation on July 17 to the International Society for Cell & Gene Therapy (ISCT) Scientific Signatures Series on Cell and Gene Therapies in Lung Diseases and Critical Illnesses. The results showed that two doses of remestemcel-L at days 3-5 conferred durable survival benefit through at least 90 days in the pre-specified subgroup of patients under age 65.

Key presentation findings were:

  • Remestemcel-L significantly reduced mortality by 48% at 90 days compared to controls in a pre-specified analysis of 123 treated patients under 65 years old, 26% vs 44%, Hazard Ratio (HR) 0.52, 95% CI (0.277, 0.964), p=0.038.1,2 This compares favourably with the 46% mortality reduction reported at 60 days (p=0.048)1,2 and indicates a durable treatment benefit in this patient population.
  • Remestemcel-L was even more effective when evaluated in an exploratory analysis in patients on dexamethasone as part of their standard of care, with 90-day mortality being reduced by 77% compared to controls under 65 who received dexamethasone, 14% vs 48%, HR 0.23, 95% CI (0.080, 0.681), p=0.00371,2
  • These survival benefits were accompanied by significant improvements relative to controls in pre-specified secondary endpoints of ventilator-free days, respiratory function as assessed by ARDS severity, and overall clinical improvement on a 7-point ordinal scale.
  • Despite a treatment-related improvement in respiratory function at day 7, there was no mortality reduction in the 97 treated patients over age 65, suggesting the need for more prolonged or higher dosing of anti-inflammatory therapy in these patients who may have a more exuberant inflammatory response associated with defective immune-mediated viral clearance mechanisms.

Recently published guidance to industry by the U.S. Food and Drug Administration (FDA)3 has recommended demonstration of mortality benefit for at least 60 days in critically ill patients. Mesoblast will be meeting shortly with the FDA to discuss the durable mortality reduction seen in patients under 65 years old who received remestemcel-L in this randomized controlled trial, and the regulatory pathway for remestemcel-L in this patient population.

Mesoblast entered into a license and collaboration agreement with Novartis for the development, manufacture, and commercialization of remestemcel-L, with an initial focus on the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19. The agreement remains subject to certain closing conditions, including time to analyze the results from this COVID-19 ARDS trial.

About the Trial of Remestemcel-L in Acute Respiratory Distress Syndrome (ARDS) due to COVID-19

The trial enrolled 222 mechanically ventilated COVID-19 patients with moderate/severe ARDS across the US, of whom 217 were randomized 1:1 and received either standard of care alone or standard of care plus 2 intravenous infusions of remestemcel-L at a dose of 2 million cells/kg 3-5 days apart. This was the same remestemcel-L dosing regimen used in the earlier compassionate use program where 11 of 12 patients were younger than 65 and 75% successfully came off ventilatory support.

The trial was halted in December 2020 after the Data Safety Monitoring Board (DSMB) performed a third interim analysis on the trial’s first 180 patients, noting that the trial was not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment. The trial was powered to achieve a primary endpoint of 43% reduction in mortality at 30 days for treatment with remestemcel-L on top of maximal care. The DSMB recommended that the trial complete with the enrolled 222 patients, and that all be followed-up as planned.

At follow-up through day 60, remestemcel-L showed a positive but non-significant trend in overall mortality reduction across the entire population of treated patients (n=217). In the pre-specified population of patients under age 65 (n=123), remestemcel-L reduced mortality through day 60 by 46%, but not in patients 65 or older (n=94). In an exploratory analysis through day 60, remestemcel-L reduced mortality by 75% and increased days alive off mechanical ventilation in patients under age 65 when combined with dexamethasone, in comparison with controls on dexamethasone.

About Mesoblast

Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2040 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has completed Phase 3 trials of rexlemestrocel-L for advanced chronic heart failure and chronic low back pain. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Footnotes

  1. All p-values are descriptive and not adjusted for multiplicity
  2. Hazard Ratios calculated using Cox regression proportional hazards model without adjustment; p-value from log rank test
  3. COVID-19: Developing Drugs and Biological Products for Treatment or Prevention – Guidance for Industry. U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER). February 2021

Forward-Looking Statements

This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. All statements other than statements of historical fact, including our intention to discuss a regulatory pathway with the FDA, are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions and variations thereof. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. The risks, uncertainties and other factors that may impact our forward-looking statements include, but are not limited to: the timing, progress and results of Mesoblast’s preclinical and clinical studies; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; whether the FDA agrees to a regulatory pathway; and the pricing and reimbursement of Mesoblast’s product candidates, if approved; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. Unless required by law, we do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For more information, please contact:


Corporate Communications / Investors
Media
Paul Hughes Sumit Media
T: +61 3 9639 6036 Grant Titmus
E: [email protected] T: +61 419 388 161
  E: grant@sumitmedia.com.au
   
  Kristen Bothwell
  T: +1 917 613 5434
  E: [email protected]



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Red Cat Holdings, Inc. Announces Pricing of Public Offering

PR Newswire

HUMACAO, Puerto Rico, July 18, 2021 /PRNewswire/ — Red Cat Holdings, Inc. (NASDAQ: RCAT) (“Red Cat” or the “Company”) a technology provider to the drone industry, today announced the pricing of its underwritten public offering of 13,333,334 shares of its common stock at a public offering price of $4.50 per share, for gross proceeds of approximately $60,000,000, before deducting underwriting discounts, commissions and offering expenses. In addition, the Company has granted the underwriters a 45 day option to purchase up to an additional 2,000,000 shares of common stock to cover over-allotments at the offering price, less the underwriting discount.

The offering is expected to close on July 21, 2021, subject to satisfaction of customary closing conditions.

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.

The Company intends to use the net proceeds from the offering to provide funding for services, sales and marketing efforts for its Red Cat Drone Services, strategic acquisitions and related expenses, and general working capital. .

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-256216), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on May 17, 2021 and declared effective on June 14, 2021. The offering will be made only by means of a written prospectus. A prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. A final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and made available on the SEC’s website. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

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


About Red Cat Holdings, Inc.

Red Cat provides products, services and solutions to the drone industry. Spanning multiple industries and segments, the spectrum of companies in Red Cat’s portfolio provides diverse and comprehensive reach into multiple markets including: enterprise remote flight technology; SaaS solutions for secure flight data storage; consumer hardware and communication technology; and consumer e-commerce and lifestyle brands. For more information on Red Cat Holdings, Inc.  please visit the company’s website: https://www.redcatholdings.com/.


Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Red Cat Holdings, Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Red Cat Holdings, Inc. undertakes no duty to update such information except as required under applicable law.

For Investor Relations Inquiries:

Chad Kapper

Phone: (818) 906-4701

E-mail: [email protected]

 

 

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SOURCE Red Cat Holdings, Inc.

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Hyzon Motors signs Memorandum of Understanding with Superior Pak for the supply of up to 20 refuse collection vehicles in 2022

– Hyzon Motors partners with Superior Pak to develop hydrogen-powered refuse collection vehicles, initial supply of 5 trucks with expectation of orders for 15 more in 2022

– Refuse collection vehicles are particularly well-suited for hydrogen fuel cell technology due to their heavy, inefficient diesel consumption

PR Newswire

ROCHESTER, N.Y., July 18, 2021 /PRNewswire/ — Hyzon Motors Inc., through its wholly owned subsidiary Hyzon Motors Australia, is cleaning up garbage collection through a partnership with Superior Pak, a leading Australian manufacturer of waste handling equipment. This announcement comes ahead of Hyzon Motors’ first day of trading under the symbols “HYZN” and “HYZNW” on the Nasdaq Marketplace, scheduled for Monday, July 19.

Hyzon, a global supplier of zero-emission, hydrogen fuel-cell vehicles, announced today a Memorandum of Understanding to develop and supply 20 refuse collection vehicles (RCV) together with Superior Pak. The partnership will leverage Superior Pak’s 25 years of experience designing and engineering mobile waste collection and compaction equipment and Hyzon’s leading fuel cell technology.

The companies aim to deliver a zero-emissions, high-performance side lift garbage truck, capable of undertaking the 1500-2000 compactor lifts required during an 8-10 hour suburban working cycle.  The first 5 vehicles are expected to be delivered and operational in Q2 2022. 

Three of the first 5 vehicles are expected to be available from Hyzon under minimum 1 month demonstration loan arrangements in the Brisbane, Sydney and Melbourne areas associated with available hydrogen refueling facilities.  Orders are currently being accepted for the balance of 15 vehicles with expected demand from local governments as well as waste collection operators across Australia.

Superior Pak has already delivered over 3,000 compaction units for more than 50 municipalities in Australia and New Zealand, providing existing relationships from which to grow the distribution.

“Over 530 Australian municipalities manage waste collection for their residents, many of which have committed to net-zero emissions across their operations,” said Hyzon CEO Craig Knight. “Despite these commitments, few viable zero-emissions options exist.”

In fact, the vehicle developed by Hyzon and Superior Pak is expected to be the first clean RCV available in Australia to undertake full operational curb-side collection duties.

Refuse collection offers a particularly suitable application for hydrogen fuel cell technology to replace diesel, as the back-to-base model allows for a central refueling infrastructure. Operating the hydraulic lifts also demands significant power, which Hyzon’s high-density fuel cells can readily supply.

“Clean waste management is no longer an oxymoron,” said Rob Wrigley, Managing Director of Superior Pak. “The benefits to the environment, the communities and drivers is enormous, so we are determined to develop a reliable, accessible option within a year.”

Hydrogen vehicles, with their rapid torque, long-range, almost silent running and quick refueling – all while only emitting water vapor – are primed to take off in the garbage collection segment.

About Hyzon
Headquartered in Rochester, NY with US operations also in Chicago and Detroit, and international operations in the Netherlands, Singapore, Australia and China, Hyzon is a leader in hydrogen mobility. Hyzon is a pure-play hydrogen mobility company with an exclusive focus on hydrogen in the commercial vehicle market.  Utilizing its proven and proprietary hydrogen fuel cell technology, Hyzon aims to supply zero-emission heavy duty trucks and buses to customers in North America, Europe, and around the world. The company is contributing to the escalating adoption of hydrogen vehicles through its demonstrated technology advantage, leading fuel cell performance and history of rapid innovation. Visit www.hyzonmotors.com.

About Superior Pak
Superior Pak has supplied the waste industry with waste management equipment solutions since 1994. Superior Pak is an industry leader with the most comprehensive, innovative and industry proven range of waste management products available to the waste collection and management industry. With unparalleled expertise, Superior Pak continues to manufacture and provide industry-leading products, sales and after-market services throughout Australia and New Zealand with 25+ years of manufacturing and supply experience.

The cornerstones of the success and sustainability of the company are:

  • Constant improvement and innovation to develop industry leading products that are safe, reliable, and give Superior Pak’s customers the ability to perform their jobs as efficiently and stress-free as possible.
  • An unprecedented level of back-up service that keeps fleets operating smoothly and minimises downtime.

Superior Pak’s approach to innovation and product development begins with the end-users. The continuous communication and feedback systems the company has in place, ensures that Superior Pak’s engineering and manufacturing teams are developing products that are not only compliant with OH & S and industry standards, but meet and exceed client expectations. Super Pak understands that for its customers in the municipal and industrial waste collection markets, speed, performance and reliability are key factors in their own efficiency, profitability and ultimately their successful operation.

Forward-Looking Statements 
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of present or historical fact included in this press release are forward-looking statements. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Except as otherwise required by applicable law, Hyzon disclaims any duty to update any forward –looking statements, all of which are expressly qualified by the statements in this section, to reflect events or circumstances after the date of this press release. Hyzon cautions you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of Hyzon, including risks and uncertainties described in the “Risk Factors” section of Exhibit 99.3 of Hyzon’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 9, 2021, the “Risk Factors” section of Hyzon’s definitive proxy statement on Schedule 14A filed with the SEC on June 21, 2021, and other documents filed by Hyzon from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements, such as risks related to the ability to convert non-binding memoranda of understanding into binding orders or sales (including because of the current or prospective financial resources of the counterparties to Hyzon’s non-binding memoranda of understanding and letters of intent), or the ability to identify additional potential customers and convert them to paying customers. Hyzon gives no assurance that Hyzon will achieve its expectations.

 

Media contacts

Hyzon Motors

For U.S., Europe and Asia media: 
Caroline Curran
Hill+Knowlton Strategies
+1 256-653-5811
[email protected] 

For Australasian media:
Fraser Beattie
Cannings Purple
+61 421 505 557
[email protected] 

For investors:
Caldwell Bailey
ICR, Inc.
[email protected] 

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SOURCE HYZON Motors

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iQiyi to Hold Second Content Showcase and Industry Panel Discussion With The Justin Poy Agency in North America

TORONTO, July 17, 2021 (GLOBE NEWSWIRE) — iQiyi, (Chinese: 爱奇艺; pinyin: Ài qí yì), the global streaming leader of Asian entertainment, will be holding its second North American Content Showcase on July 20, 2021 at 1:00 PM EST (10:00 AM PST) to update all North American agencies and clients on the latest streaming programming on iQiyi North America. Following the content showcase, there will be an industry panel discussion on, “Strengthening brands in the Age of Streaming Content”. Audiences from all over North America will hear from Justin Poy, President of The Justin Poy Agency — the exclusive ad agency for iQiyi North America in Canada as well as Ariel Tsai from PingPong Digital, a multicultural ad agency in the United States. To register for this unique Content Showcase, PLEASE REGISTER HERE: https://cutt.ly/9maiKo7

“iQiyi presents such a fantastic opportunity for brands in North America that want to reach the Asian market, to align themselves with programming that reinforces their brand’s mandate and image. North America, and Canada in particular, has been ripe for a mature Asian media platform — and now it’s here”, says Justin Poy, President of The Justin Poy Agency.

iQiyi is currently one of the largest online video sites in Asia, with over 115.6 million mobile Daily Average Users who spent 8.4 billion hours per month watching video content on the platform through all devices in 2020. Furthermore, iQiyi is also one of the largest creator of original Asian content, which has won many awards both domestically and internationally. From Story of Yanxi Palace to The Bad Kids, iQiyi constantly takes Asian storytelling to new heights, and will continue to bring premium pan-Asian content that international and regional users will love in the future.

This year’s most-anticipated Korean action-adventure mystery thriller Jirisan starring Jun Ji-hyun and Ju Ji-hoon is an iQiyi International original and exclusive K-Drama series. Jirisan is a suspenseful drama that tells the story of climbers in the vast secret land of Jirisan. Its all-star cast also includes Sung Dong-il ( The Cursed ) and Oh Jung-se ( It’s Okay to Not Be Okay ), amongst many others.

In the short-running dramas category, iQiyi’s “LIGHT ON Theatre”, a content library comprised of suspense and crime series, was a huge hit last year and introduced many new users to the international platform. Shows in the content franchise include popular dramas such as Kidnapping Game, The Bad Kids and Sisyphus. The Bad Kids, won the Best Creative Award at last year’s Busan International Film Festival. The show was also named by key Hollywood Entertainment Magazine “Variety” one of The Best International TV Series of 2020.

“We don’t want to just sell ads on our platform, but rather, offer an opportunity for advertisers to uniquely integrate their brands with our wide range of superb content. We think iQiyi offers our partners in North America a branding opportunity that no other Asian media can offer”, affirms Leo Geng Senior Vice President of iQiyi.

JPA has implemented a dedicated team to handle iQiyi sales in Canada. It is offering customized packages as well as sponsorships for exciting popular exclusive iQIYI content. For iQiyi advertising inquiries, please contact: Nicole Zhang, Sales Manager/The Justin Poy Agency at [email protected] or call: +1 (437) 986-6183.

To register for this unique Content Showcase, PLEASE REGISTER HERE: https://cutt.ly/9maiKo7

The Justin Poy Agency (JPA), a div. of JUSTIN POY MEDIA INC. is an award-winning Toronto based advertising agency established in 1993. The Agency specializes in multicultural advertising and has full in-house production capabilities including multilingual copywriting, video production and post-production facilities, and a full creative team onsite for some of the fastest turnaround times in the industry. JPA is now working as exclusive media representative for IQIYI North America in Canada.

iQiyi International Headquartered in Singapore, iQIYI International is an on-demand video streaming service providing beloved pan-Asian entertainment to international viewers. Offering both ad-supported and VIP subscription services, iQIYI International delivers premium drama series, movies, variety shows, and anime; with local languages and subtitles; powered by cutting-edge technology. iQIYI International is owned by iQIYI, Inc. (Nasdaq: IQ).



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Herbalife Nutrition and Proactive Sports Performance Debut New Elite Training Facility

PR Newswire

LOS ANGELES, July 17, 2021 /PRNewswire/ — Premier global nutrition company, Herbalife Nutrition, along with Proactive Sports Performance hosted a grand opening today of a new multi-million-dollar elite training facility, “Proactive Fueled by Herbalife Nutrition,” located in Westlake Village, California.

Professional and amateur athletes, together with company executives gathered to try out the equipment at the 17,000 square foot multi-sport training center which provides a high tech, personalized experience for athletes, including access to physical conditioning, sports rehabilitation, personalized nutrition management and the Herbalife24 sports performance testing lab.

For more information visit www.IAmHerbalifeNutrition.com, or www.ProactiveSP.com

About Herbalife Nutrition Ltd.

Herbalife Nutrition (NYSE: HLF) is a global company that has been changing people’s lives with great nutrition products and a proven business opportunity for its independent distributors since 1980. The Company offers high-quality, science-backed products, sold in over 90 countries by entrepreneurial distributors who provide one-on-one coaching and a supportive community that inspires their customers to embrace a healthier, more active lifestyle. Through the Company’s global campaign to eradicate hunger, Herbalife Nutrition is also committed to bringing nutrition and education to communities around the world.

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SOURCE Herbalife Nutrition (NYSE: HLF)

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ATHIRA SHAREHOLDERS: August 24, 2021 Filing Deadline in Class Action – Contact Lieff Cabraser

ATHIRA SHAREHOLDERS: August 24, 2021 Filing Deadline in Class Action – Contact Lieff Cabraser

SAN FRANCISCO–(BUSINESS WIRE)–
The law firm of Lieff Cabraser Heimann & Bernstein, LLP announces that class action litigation has been filed on behalf of investors who purchased or otherwise acquired the securities of Athira Pharma, Inc. (“Athira” or the “Company”) (Nasdaq: ATHA) between September 18, 2020 and June 17, 2021 (the “Class Period”), including Athira common stock purchased pursuant or traceable to the registration statement and prospectus issued in connection with the Company’s initial public offering (“IPO”) in September 2020.

If you purchased or otherwise acquired Athira securities during the Class Period and/or in the IPO, you may move the Court for appointment as lead plaintiff by no later than August 24, 2021. A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation. Your share of any recovery in the actions will not be affected by your decision of whether to seek appointment as lead plaintiff. You may retain Lieff Cabraser, or other attorneys, as your counsel in the action.

Athira investors who wish to learn more about the litigation and how to seek appointment as lead plaintiff should click here or contact Sharon M. Lee of Lieff Cabraser toll-free at 1-800-541-7358.

Background on the Athira Securities Class Litigation

Athira, headquartered in Bothell, Washington, is a clinical-stage biopharmaceutical company focused on the development of molecular technology in the treatment of neurological diseases, including Alzheimer’s disease. In September 2020, Athira completed its IPO by issuing and selling approximately 13 million shares of common stock at $17.00 per share, for net proceeds of approximately $186 million.

The actions allege that, throughout the Class Period, defendants made materially false and misleading statements and/or omitted to state material adverse facts regarding the Company’s business, operations, and prospects. Specifically, the actions allege that defendants failed to disclose to investors that the doctoral research conducted by Athira’s Chief Executive Officer and President, defendant Leen Kawas contained improperly altered images and constituted potential research misconduct. Kawas’s research reportedly was foundational to Athira’s efforts to develop treatments for Alzheimer’s disease and cited in a patent licensed by Athira.

On June 17, 2021, after markets closed, Athira announced that Kawas was placed on temporary leave pending an investigation by a special committee into “actions stemming from doctoral research Dr. Kawas conducted while at Washington State University.” The same day, the scientific publication STAT reported that the investigation involves allegedly altered images appearing in four papers for which Kawas was the lead author. According to STAT, Kawas’s research papers “are foundational to Athira’s efforts to treat Alzheimer’s” and her “doctoral work laid the biological groundwork that Athira continues to use in their approach to treating Alzheimer’s.” According to an investment analyst, the investigation could have “clear negative implications for how we/investors view the asset, and/or management credibility.” On this news, the price of Athira common stock fell $7.09 per share, or 38.9%, from a closing price of $18.24 on June 17, 2021, to close at $11.15 per share on June 18, 2021, on heavy trading volume.

About Lieff Cabraser

Lieff Cabraser Heimann & Bernstein, LLP, with offices in San Francisco, New York, Nashville, and Munich is an internationally recognized law firm committed to advancing the rights of investors and promoting corporate responsibility worldwide.

The National Law Journal has recognized Lieff Cabraser as one of the nation’s top plaintiffs’ law firms for fourteen years. In compiling the list, the National Law Journal examines recent verdicts and settlements and looked for firms “representing the best qualities of the plaintiffs’ bar and that demonstrated unusual dedication and creativity.” Law360 has selected Lieff Cabraser as one of the Top 50 law firms nationwide for litigation, highlighting our firm’s “laser focus” and noting that our firm routinely finds itself “facing off against some of the largest and strongest defense law firms in the world.” Benchmark Litigation has named Lieff Cabraser one of the “Top 10 Plaintiffs’ Firms in America.”

For more information about Lieff Cabraser and the firm’s representation of investors, please visit https://www.lieffcabraser.com/.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Sharon M. Lee

Lieff Cabraser Heimann & Bernstein, LLP

Telephone: 1-800-541-7358

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Legal Professional Services

MEDIA:

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Four-Year Biktarvy® Data Presented at IAS 2021 Demonstrate High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults

Four-Year Biktarvy® Data Presented at IAS 2021 Demonstrate High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults

– 99% of Participants Achieved and Maintained an Undetectable Viral Load With Biktarvy in Pooled Analysis of 192-Week Data From Open-Label Extension Period of Two Phase 3 Trials in Treatment-Naïve Adults –

– 72-Week Data From the BRAAVE Study Demonstrate 99% of Black Adults Who Are Virologically Suppressed and Switched to Biktarvy From a Standard Regimen Achieved and Maintained an Undetectable Viral Load –

FOSTER CITY, Calif.–(BUSINESS WIRE)–
Gilead Sciences, Inc. (Nasdaq: GILD) today announced a pooled analysis of a 48-week open-label extension of two Phase 3 studies (Study 1489 and Study 1490) shows 99% of participants who initiated treatment with Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) maintained an undetectable viral load (HIV-1 RNA <50 copies/mL) through four years of follow-up (Week 192, n=476/480, missing=excluded). In the 48-week open-label extension, there were zero cases of treatment-emergent resistance to any components of Biktarvy in participants treated with Biktarvy. These findings, along with long-term data from Phase 3 studies in virologically suppressed Black Americans and virologically suppressed people living with HIV aged 65 and older, demonstrated Biktarvy sustains efficacy with a high barrier to resistance across a range of people living with HIV, inclusive of their treatment history, gender, race or age. These data were presented at the 11th International AIDS Society (IAS) Conference on HIV Science.

“Four decades after the virus was first reported, it is imperative to commit to driving scientific innovation to meet the needs of people living in today’s world. Globally, the number of older adults with HIV is increasing and communities of color, especially Black adults, continue to be disproportionately affected by HIV while underrepresented in HIV clinical trials,” said Professor Chloe Orkin, MBBCH, FRCP, Lead for HIV Research at Queen Mary University of London. “To help end the global HIV epidemic, effective treatment needs to be acceptable and accessible to everyone. The long-term data reinforce the durability of Biktarvy and highlight its potential role in helping to meet the treatment needs of a diverse group of people living with HIV.”

Gilead presented additional Biktarvy data at IAS 2021, including findings from the BRAAVE 2020 Study, a Phase 3 clinical trial designed with community input to evaluate the specific treatment responses of virologically suppressed adults living with HIV who self-identified as Black or African American following a switch to Biktarvy from a variety of regimens. A total of 495 study participants were randomly allocated and treated in a 2:1 ratio to either switch to open-label Biktarvy for up to 72 weeks (n=330) or to stay on a standard regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent for 24 weeks with a delayed switch to Biktarvy for up to 48 weeks (n=165).

At 72 weeks, 99% of participants (n=246/248, missing=excluded) who switched to Biktarvy at the start of the study maintained an undetectable viral load regardless of age or sex at birth. These results provide further evidence that Biktarvy is an effective and durable treatment option for Black adults who are virologically suppressed, including those with a history of treatment failure or pre-existing resistance.

Gilead also presented long-term data from a Phase 3b open-label trial enrolling people living with HIV aged 65 and older who switched to Biktarvy (n=86) from either Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) or a tenofovir disoproxil fumarate (TDF)-based regimen. The analysis showed that 100% of participants (n=68/68, missing=excluded) and 74% of participants (n=64/86) in the snapshot analysis of the Intention to Treat-Exposed (ITT-E) population having HIV-1 RNA <50 copies/mL maintained high rates of virologic suppression at Week 96 with no virologic failures or emergent resistance through 96 weeks. The COVID-19 pandemic impacted in-person visits during the study, with 11 participants unable to be assessed after 84 weeks due to restrictions. There were two participants (2.3%) with Grade 3-4 study drug-related AEs, 11 participants (13%) with Grade 3-4 laboratory abnormalities and three participants (3.5%) with drug-related adverse events (AEs) leading to study drug discontinuation. These results reinforce Biktarvy as an effective and generally well-tolerated treatment option with a high barrier to resistance in the growing population of older people living with HIV.

Results from a Phase 3 study (Study 1844) demonstrated the safety and non-inferior efficacy of switching to Biktarvy in those replacing their existing treatment regimen. In Study 1844, participants (n=563) who were virologically suppressed (HIV-1 RNA <50 copies/mL) on a regimen containing abacavir, dolutegravir, and lamivudine (600/50/300mg) (ABC/DTG/3TC) were randomly allocated and treated in a 1:1 ratio to stay on their existing regimen of ABC/DTG/3TC (n=281) or switch to Biktarvy (n=282) in a blinded manner. The primary endpoint was the proportion of patients with HIV RNA ≥50 copies/mL at Week 48. Study participants were randomly allocated through 48 weeks, after which point participants electing to continue in the study enter an open-label extension receiving Biktarvy. At the point of the last study visit, 98% (n=535/545) of those who switched to Biktarvy maintained virologic suppression for a median duration of two years, including those with pre-existing resistance or who experienced viral “blips.” In participants treated with Biktarvy, there were no cases of treatment failure with resistance to any component of Biktarvy.

“A clinical research program that aims to address the differentiated unmet needs of people living with HIV can help inform long-term treatment strategies and is central to Gilead’s mission to help end the HIV epidemic,” said Frank Duff, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “The four-year data presented at IAS demonstrate the robust and durable efficacy and safety profile of Biktarvy as a treatment option for a diverse range of people living with HIV.”

The use of Biktarvy in individuals with known resistance to the components of Biktarvy is investigational; this use is not approved by the U.S. Food and Drug Administration (FDA), and the safety and efficacy of Biktarvy for this use has not been established. Please see below for the U.S. Indication and Important Safety Information for Biktarvy.

Biktarvy does not cure HIV or AIDS.

About Studies 1489 and 1490

Study 1489 and Study 1490 are Phase 3, double-blind, active-controlled studies. For 144 weeks, treatment-naïve participants were blinded to receive either Biktarvy (n=634) or a dolutegravir-containing triple therapy (n=640). Treatment outcomes were assessed at Week 144 and showed participants in both groups achieved an undetectable viral load with no treatment-emergent resistance. Beyond Week 144, participants were able to receive Biktarvy in an active OLE Phase for up to 96 weeks. Study 1489 and Study 1490 are ongoing.

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies /mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Biktarvy.

U.S. Important Safety Information for Biktarvy

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of Biktarvy.Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Biktarvy. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

  • Coadministration: Do not use Biktarvy with dofetilide or rifampin.

Warnings and precautions

  • Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during Biktarvy therapy and monitor for adverse reactions.
  • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
  • New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate Biktarvy in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Biktarvy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating Biktarvy and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue Biktarvy if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through Week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

  • Prescribing information: Consult the full prescribing information for Biktarvy for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
  • Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of Biktarvy. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of Biktarvy. Biktarvy can increase the concentration of drugs that are substrates of OCT2 or MATE1.
  • Drugs affecting renal function: Coadministration of Biktarvy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Dosage and administration

  • Dosage: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food.
  • Renal impairment: Not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history.
  • Hepatic impairment: Not recommended in patients with severe hepatic impairment.
  • Prior to or when initiating: Test patients for HBV infection.
  • Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

Pregnancy and lactation

  • Pregnancy: There is insufficient human data on the use of Biktarvy during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using Biktarvy during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a U.S. reference population.
  • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

About Gilead Sciences

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.

For more than 30 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 once-daily oral antiretroviral tablet 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 operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

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 possibility of unfavorable results from ongoing and additional clinical trials involving Biktarvy; and Gilead’s ability to receive FDA and other regulatory approvals for additional indications for Biktarvy, and the risk that any such approvals, if granted, may have significant limitations on its use. 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, 2021, 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 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.

U.S. Prescribing Information for Biktarvy and Genvoya, including BOXED WARNINGS,are available at www.gilead.com.

Biktarvy, Genvoya, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

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.

Jacquie Ross, Investors

+1 (408) 656-8793

Brian Plummer, Media

+1 (202) 309-5207

Rhiannon Bid, Media (Europe)

+44 (0) 7824 530 487

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Research Hospitals Clinical Trials Biotechnology AIDS Health Pharmaceutical Science Oncology

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New Phase 3 Data Support the Sustained, Long-Acting Efficacy of Lenacapavir, Gilead’s Investigational HIV-1 Capsid Inhibitor

New Phase 3 Data Support the Sustained, Long-Acting Efficacy of Lenacapavir, Gilead’s Investigational HIV-1 Capsid Inhibitor

– Week 26 Data From the CAPELLA Trial Show Lenacapavir Leads to High Rates of Virologic Suppression in Heavily Treatment-Experienced People Living With Multi-Drug Resistant HIV –

FOSTER CITY, Calif.–(BUSINESS WIRE)–
Gilead Sciences, Inc. (Nasdaq: GILD) today announced new results from the ongoing Phase 2/3 CAPELLA trial evaluating lenacapavir, the company’s investigational, long-acting HIV-1 capsid inhibitor, in heavily treatment-experienced people living with multi-drug resistant HIV. The findings demonstrate that lenacapavir, administered subcutaneously every six months in combination with other antiretrovirals, achieved high rates of virologic suppression at Week 26 in people living with HIV whose virus was no longer effectively responding to therapy. In this patient population of high unmet medical need, 81% (n=29/36) of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at Week 26. The data were presented at the 11th International AIDS Society (IAS) Conference on HIV Science.

These data support the ongoing evaluation of lenacapavir for the treatment of HIV-1 infection and form the basis of the New Drug Application (NDA) that the company recently submitted seeking U.S. Food & Drug Administration (FDA) approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals. If approved, lenacapavir would be the first capsid inhibitor and the only HIV-1 treatment option administered every six months.

“Despite the advances in treating HIV infection, there remains an unmet need for treatment options for people who struggle with multi-drug resistance. As a physician, it’s frustrating to have limited options for these patients who are at greater risk of progressing to AIDS,” said Jean-Michel Molina, MD, University of Paris, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals. “The CAPELLA results are exciting as they demonstrate that an undetectable viral load is achievable in a patient population that has typically had challenges with viral suppression over the course of their journey living with HIV. New, long-acting options in development, like lenacapavir, are critical to changing the clinical landscape, and I’m encouraged that lenacapavir can potentially help improve clinical outcomes.”

Lenacapavir is being developed in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with multi-drug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations. Lenacapavir is a potentially first-in-class capsid inhibitor without overlapping resistance with any currently approved antiretroviral therapy (ART). Lenacapavir is designed to inhibit HIV replication by interfering with multiple, essential steps of the viral lifecycle, including capsid-mediated uptake of HIV-1 proviral DNA, virus assembly and release, and capsid core formation. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.

“Lenacapavir is a breakthrough innovation in HIV research. If approved, it has the potential to become a cornerstone of future long-acting HIV regimens,” said Frank Duff, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “Scientific advances are a key to helping end the HIV epidemic. Our researchers are committed to addressing the unmet needs of people living with HIV, including the exploration of different dosing intervals that may coincide with regularly scheduled visits with healthcare providers.”

In addition to 81% of CAPELLA participants achieving an undetectable viral load at Week 26, participants achieved a mean increase in CD4 count of 81 cells/µL. In the data presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021), the CAPELLA trial achieved its primary endpoint by demonstrating that a significantly higher proportion of participants randomly allocated to receive lenacapavir (n=24) achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those randomly allocated to receive placebo (n=12) during the 14-day functional monotherapy period (88% vs. 17%, p<0.0001). Those who received lenacapavir achieved a statistically significantly greater mean decrease in viral load than those who received placebo during the functional monotherapy period (-1.93 log10 copies/mL vs. -0.29 log10 copies/mL, p<0.0001).

Lenacapavir was generally well tolerated, with no adverse events (AEs) leading to study drug discontinuation and no serious adverse events related to lenacapavir. The most common adverse events observed to date in the CAPELLA study were injection site reactions, which were mostly mild in severity. The most common injection site reactions were injection site swelling (26%) and erythema (24%). Four participants experienced treatment-emergent lenacapavir resistance and three of these four participants later re-suppressed while continuing lenacapavir in addition to their optimized background regimen. One participant did not re-suppress.

Gilead presented additional lenacapavir clinical development program data at the conference. Phase 2 data from CALIBRATE, an ongoing, open-label, active-controlled trial in treatment-naïve people with HIV-1 infection showed lenacapavir, given subcutaneously or orally, in combination with oral daily emtricitabine/tenofovir alafenamide (F/TAF) led to high rates of viral suppression by Week 28 (94%; n=147/157). Specifically, in the pooled subcutaneous lenacapavir + F/TAF arms, 93% (n=98/105) achieved an undetectable viral load (<50 copies/mL). In the oral lenacapavir + F/TAF arm, 94% (n=49/52) achieved an undetectable viral load (<50 copies/mL). These results support the ongoing evaluation and further development of lenacapavir in combination with other long-acting partner agents for the treatment of HIV-1 infection and will support Gilead’s long-acting oral and injectable development program.

Lenacapavir was generally well tolerated. The most common AEs observed to date in the CALIBRATE study among those who received subcutaneous lenacapavir were injection site reactions, which were generally mild in severity. The most common injection site reactions were injection site swelling (18%) and erythema (17%). Importantly, there were no serious AEs related to study drug. Two participants discontinued due to AEs (both due to mild injection site induration). One participant had treatment-emergent resistance to study drugs.

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.

About CAPELLA (NCT04150068)

CAPELLA is a Phase 2/3, double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of Gilead’s investigational, long-acting HIV-1 capsid inhibitor lenacapavir administered every six months as a subcutaneous injection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. CAPELLA includes men and women living with HIV-1 and is being conducted at research centers in North America, Europe and Asia.

In CAPELLA, 36 participants with multi-class HIV-1 drug resistance and a detectable viral load while on a failing regimen were randomly allocated to receive oral lenacapavir or placebo in a 2:1 ratio for 14 days, in addition to continuing their failing regimen (functional monotherapy). An additional 36 participants were enrolled in a separate treatment cohort. Both cohorts are part of the ongoing maintenance period of the study evaluating the safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen. The primary endpoint was the proportion of participants randomly allocated to receive lenacapavir or placebo for 14 days, in addition to continuing their failing regimen, achieving ≥0.5 log10 copies/mL reduction from baseline in HIV-1 RNA at the end of the functional monotherapy period.

Following the 14-day functional monotherapy period, participants randomly allocated to receive lenacapavir or placebo, in addition to continuing their failing regimen, started open-label lenacapavir and an optimized background regimen, while those enrolled in a separate treatment cohort received open-label lenacapavir and an optimized background regimen on Day 1. This ongoing maintenance period of the study is evaluating the additional trial endpoints of safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen.

For further information, please see https://clinicaltrials.gov/ct2/show/NCT04150068.

About CALIBRATE (NCT04143594)

CALIBRATE is an ongoing, phase 2, open-label, active-controlled study in treatment-naïve people with HIV-1 infection designed to evaluate the efficacy and safety profile of lenacapavir-containing regimens. CALIBRATE includes men and women living with HIV-1 and is being conducted at research centers in North America, Puerto Rico and the Dominican Republic.

In CALIBRATE, 182 participants were randomly allocated (2:2:2:1) into one of the four treatment groups. The first and second groups received subcutaneous lenacapavir every 26 weeks following an oral lead-in period together with oral daily emtricitabine/tenofovir alafenamide (F/TAF); at Week 28, those achieving HIV-1 RNA viral load <50 copies/mL switched their F/TAF to oral daily TAF or bictegravir, while continuing lenacapavir. The third group received oral daily lenacapavir with F/TAF. The fourth group received oral daily bictegravir/F/TAF (B/F/TAF). The primary endpoint of the study is the proportion of participants achieving a viral load of <50 c/mL at Week 54. Lenacapavir was generally well tolerated, with no study drug-related serious AEs. The most common AEs observed were injection site reactions, which were generally mild in severity.

For further information, please see https://clinicaltrials.gov/ct2/show/NCT04143594.

About Lenacapavir

Lenacapavir is a potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. 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.

The safety and efficacy of lenacapavir are being evaluated in multiple ongoing clinical studies. Data presented at AIDS 2020 from a Phase 1 study support further evaluation of lenacapavir administered subcutaneously every six months for both HIV-1 treatment and prevention. During June 2021, the company initiated the first of its two planned prevention trials evaluating the use of lenacapavir as an injectable PrEP option administered every six months among cisgender men, gender non-binary individuals and persons of trans experience who have sex with men. The prevention trial among cisgender adolescent girls and young women is projected to commence later this summer.

About Gilead Sciences

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.

For more than 30 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 once-daily oral antiretroviral tablet 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 operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

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 or complete clinical trials or studies involving lenacapavir within currently anticipated timelines or at all; the possibility of unfavorable results from ongoing or additional clinical trials or studies involving lenacapavir; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including FDA approval of lenacapavir for the treatment of HIV-1 infection in HTE people with MDR HIV-1 infection, and the risk that any such approvals may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and that, 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, 2021, 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 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.

Jacquie Ross, Investors

+1 (650) 358-1054

Brian Plummer, Media

+1 (202) 309-5207

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: AIDS Health Infectious Diseases Hospitals Clinical Trials Pharmaceutical Biotechnology

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Shareholder Alert: Ademi LLP investigates whether Reliant Bancorp, Inc. has obtained a Fair Price in its transaction with United Community Banks, Inc.

PR Newswire

MILWAUKEE, July 17, 2021 /PRNewswire/ — Ademi LLP is investigating Reliant (NASDAQCM: RBNC) for possible breaches of fiduciary duty and other violations of law in its transaction with United.

Click here to learn how to join the action: https://www.ademilaw.com/case/reliant-bancorp-inc or call Guri Ademi toll-free at 866-264-3995.  There is no cost or obligation to you.

Ademi LLP alleges Reliant’s financial outlook is excellent and yet Reliant shareholders will receive only 0.9842 shares of United common stock for each share of Reliant common stock outstanding or $30.58 per share of Reliant common stock, based on United’s closing stock price of $31.07 on July 13, 2021. The merger agreement unreasonably limits competing bids for Reliant by prohibiting solicitation of further bids, and imposing a termination penalty if Reliant accepts a superior bid. Reliant insiders will receive millions of dollars as part of change of control arrangements. We are investigating the conduct of Reliant’s board of directors, and whether they are (i) fulfilling their fiduciary duties to all shareholders, and (ii) obtaining a fair and reasonable price for Reliant.

If you own Reliant common stock and wish to obtain additional information, please contact Guri Ademi either at [email protected] or toll-free: 866-264-3995, or https://www.ademilaw.com/case/reliant-bancorp-inc.                       

We specialize in shareholder litigation involving buyouts, mergers, and individual shareholder rights throughout the country. For more information, please feel free to call us. Attorney advertising. Prior results do not guarantee similar outcomes.

Contacts

Ademi LLP
Guri Ademi
Toll Free: (866) 264-3995
Fax: (414) 482-8001

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ECMOHO Announces Strategic Cooperation Agreement with South Korean ChongKunDang Group to Establish Distribution of High-End Health Foods

SHANGHAI, China, July 16, 2021 (GLOBE NEWSWIRE) — ECMOHO Limited (Nasdaq: MOHO) (“ECMOHO” or the “Company”), a leading integrated solutions provider in the health and wellness market in China, is pleased today to announce a strategic cooperation agreement with well-known South Korean pharmaceutical company, ChongKunDang Group (hereafter referred to as “CKD”), in providing global marketing and multichannel sales for one-stop retail solutions for CKD’s health products in China. With advanced equipment and cutting-edge technology as its foundation, CKD will be able to provide Chinese consumers with high-quality, diversified healthcare products, including probiotics, via ECMOHO’s established and extensive domestic distribution channels.

ECMOHO, as a leading online retail service provider of health products in China, has cooperated with well-known domestic and foreign healthcare brands such as Harbin Pharmaceutical, ONLLY, Jiangzhong Pharmaceutical, Bayer, and Puritan’s Pride, among others. Given ECMOHO’s extensive experience in customer data collection and analysis, new product trend research, and digital marketing and promotion in the domestic health food market, the new partnership will provide CKD with an in-depth analysis of various user groups, including China’s Generation Z. Since the beginning of 2021, ECMOHO has expanded to new social media platforms, such as TikTok and Kuaishou, and involved key opinion leaders (KOLs) and key opinion consumer (KOC) resources to promote and distribute professional content and empower its business partners to achieve more efficient and rapid growth in the China market.

CKD was founded in 1941 and is one of South Korea’s longest standing pharmaceutical companies, with nearly a century-long history. Its probiotic brand LACTO-FIT has maintained a leading position in the South Korean probiotic market since its debut, and has won the Korean national “Functional Health Food Award” for 3 consecutive years. Upon debuting in the Chinese market in May 2020, LACTO-FIT won the praise of Chinese consumers and saw sales soar to RMB 100 million, creating a supply of high-end health products that meet consumer demands for high quality, effective health foods.

Ms. Zoe Wang, Chairman and CEO of ECMOHO, commented: “With China’s booming domestic health food industry, ECMOHO provides invaluable sales and marketing services for CKD’s many brands via channels such as Tmall, JD, Koala, TikTok, and Kuaishou, which cover many categories of nutrition and healthcare products. The partnership will be mutually beneficial, as ECMOHO and CKD work together to introduce high-quality health products to Chinese consumers.”

“With the rise in living standards, Chinese consumers are demanding better health products, leading to growth and expansion of many health industries. Among them, probiotics has been relatively popular in recent years, which involves daily supplements, health foods, medicines, and even pet products,” continued Ms. Zoe Wang.

Mr. Li Xin CFO of ECMOHO, added: “Due to an acceleration in the pace of work and life and increases in physical and mental pressures, consumers have turned to probiotics for improving immunity and digestion, in particular to help with nutrient absorption and reducing intestinal inflammation. Probiotics also help with indigestion and congenital lactase deficiency, and have other obvious health benefits. Data shows the probiotic market in China is growing at 10-15% per year; in 2015 it was RMB 48.6 billion, in 2020 it reached RMB 84.9 billion. However, the demand for probiotics has become increasingly personalized and the market lacks sufficient high-end products with improved efficacy and quality that fully meet the needs of many consumers.”

ECMOHO’s cooperation with CKD was chosen after thorough consideration and in-depth analysis of the health food industry, and having proposed a new development strategy. As the demand for low- and medium-end health foods plateaus, introduction of high-quality products will be the driver of consumer demand. Meanwhile, ECMOHO will also develop customized probiotic products to meet the needs of different consumer groups with diverse health conditions.

ECMOHO’s full-scale, extensive domestic marketing network, built up over 10 years, will help ensure CKD’s high-end probiotic products can quickly reach Chinese consumers from all cities and regions, including those in domestic low-tier cities, as well as attract young consumers through novel tastes and diverse product offerings. ECMOHO’s nearly 11 million paying users is expected to help drive the demand for CKD’s high-quality probiotic products. CKD, through continued research and development technology in probiotics, will ensure the continued improvement of its products’ efficacy and quality, creating significant advantages in the Chinese high-end health food market.

About ECMOHO Ltd.

ECMOHO is a leading integrated solutions provider in the health and wellness market in China. The company curates and sells the best global brands and quality products to Chinese health-conscious consumers. Our technology, network and expertise in marketing and distribution empower us to connect families with advanced health supplements, nutrition and food items, personal care products, household healthcare equipment and other wellness products. Through over ten years of operation, ECMOHO has established an ecosystem of trusted products and relationships to provide customized solutions which promote health regeneration, impart therapeutic benefits, and increase longevity to our devoted consumers to sustain health. For more information, please visit http://ir.ecmoho.com/

For investor and media inquiries, please contact:
ECMOHO Ltd.
Investor Relations
Email: [email protected]


Forward-Looking Statements 


This press release contains statements, which may constitute “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of the Company, and members of its management as well as the assumptions on which such statements are based. When the Company uses words such as “may,” “will,” “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results.

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