Market Newsdesk

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 03, 2021 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) today announces that it completed the rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (“NETs”).

Dr. Marek Kania, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said, “HUTCHMED is developing six novel oncology drug candidates internationally and this surufatinib NDA represents our first ever in the United States. Having successfully launched surufatinib in China early this year, we are now looking forward, subject to its approval, to being able to provide access to this important new therapeutic option for NETs patients in the U.S. and beyond. Our surufatinib NDA submission to the FDA was completed by our rapidly expanding international team of over 70 personnel based mainly in the U.S., working side by side with our discovery and development colleagues in China.”

The NDA is supported by data from two positive Phase III studies of surufatinib in NET in China (SANET-p¹ and SANET-ep²), and by data from a surufatinib study conducted in the U.S. in patients with pancreatic and extra-pancreatic NET. HUTCHMED previously announced that it had reached an agreement with the FDA during a pre-NDA meeting, whereby these studies may serve as the basis to support an NDA submission. Fast Track Designations granted in April 2020 by the FDA have permitted HUTCHMED to submit sections of the NDA on a rolling basis. Filing acceptance of the NDA is subject to the FDA’s review of the complete application. The data package will also be used to file a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) in 2021, based on scientific advice from the EMA’s Committee for Medicinal Products for Human Use.

HUTCHMED initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET and limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).

In addition to the two Fast Track Designations for surufatinib development in pancreatic and extra-pancreatic NET granted by the FDA in April 2020, Orphan Drug Designation for pancreatic NET was also granted in November 2019. 

About NETs

NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NETs are typically classified as pancreatic NET (“pNET”) or extra-pancreatic NET (“epNET”).

According to Frost & Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2020. Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 143,000 estimated patients living with NET in the U.S. in 2020.³ 

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

About Surufatinib Development

NETs in the U.S. and Europe: In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019. A U.S. FDA NDA rolling submission was initiated in December 2020, to be followed by a MAA submission to the EMA in Europe. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937).

epNETs in China: On December 30, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China (“NMPA”) for the treatment of epNET. Surufatinib is marketed in China under the brand name Sulanda^®. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of progression-free survival (“PFS”) at a preplanned interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO Congress and published in TheLancet Oncology in September 2020.⁴ Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment-related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).

pNETs in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pNET in China. It was terminated early as the pre-defined primary endpoint of PFS was met (clinicaltrials.gov identifier: NCT02589821) at a preplanned interim analysis, leading to a second NDA accepted by the NMPA in September 2020. The positive results of this study were presented at the 2020 ESMO Virtual Congress and published simultaneously in The Lancet Oncology⁵, demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.

Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier: NCT03873532).

Immunotherapy combinations: We have entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), Tuoyi^® (toripalimab) and Tyvyt^® (sintilimab), which are approved as monotherapies in China.

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM) (formerly Hutchison China MediTech Limited) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the submission of an NDA for surufatinib for the treatment of NET with the FDA and the timing of such submission, the therapeutic potential of surufatinib for the treatment of patients with NET and the further clinical development of surufatinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of surufatinib for the treatment of patients with NET in the U.S., China and other jurisdictions such as the E.U., its potential to gain expeditious approvals from regulatory authorities, the safety profile of surufatinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of capecitabine, tislelizumab, Tuoyi^®, and Tyvyt^® as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Investor Enquiries
Mark Lee, Senior Vice President	+852 2121 8200
Annie Cheng, Vice President	+1 (973) 567 3786
Media Enquiries
Americas – Brad Miles, Solebury Trout	+1 (917) 570 7340 (Mobile)  [email protected]
Europe – Ben Atwell / Alex Shaw, FTI Consulting	+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) [email protected]
Asia – Joseph Chi Lo / Zhou Yi, Brunswick	+852 9850 5033 (Mobile) / +852 9783 6894 (Mobile) [email protected]
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited	+44 (20) 7886 2500

_______________________________
_{¹Surufatinib in advanced neuroendocrine tumors – pancreatic.
²Surufatinib in advanced neuroendocrine tumors – extra-pancreatic (non-pancreatic).
³ According to Frost & Sullivan, in 2020, there were 19,000 newly diagnosed cases of NETs in the U.S. and an estimated 143,000 patients living with NETs. The current incidence to prevalence ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due to lower access to treatment options.
⁴ Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4.
⁵ Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30493-9. DOI: 10.1016/S1470-2045(20)30493-9.} 

PALM BEACH, Fla., May 03, 2021 (GLOBE NEWSWIRE) — BurgerFi International Inc. (Nasdaq: BFI, BFIIW), one of the nation’s fastest-growing premium fast-casual concepts, QSR’s 2020 Breakout Brand of the Year and recently voted USA Today’s 10Best Readers’ Choice Fast Casual Restaurant Top Better-Burger chain for 2021, has hired Henry Gonzalez as Chief Marketing Officer. Gonzalez holds over 25 years of experience with leading brands in marketing, account management, product development, category management, merchandising and promotions both domestically and internationally with B2C and B2B businesses. Gonzalez is another welcome addition to BurgerFi’s C-Suite and Executive Management Team, since the recent announcements of Chief Financial Officer, Michael Rabinovitch and Chief Operations Officer, Jim Esposito joining the company.

“While Henry’s been successful across several industries and categories, his tenacity, efforts give a unique perspective into the food industry is undeniable,” said Ophir Sternberg, Executive Chairman of BurgerFi. “For over 25 years, his experience in sales and marketing for leading QSR chains, food manufacturers and ad agencies has effectively trained him to understand how to develop collaborative relationships that drive sales and profit growth. We welcome him to BurgerFi’s leadership team where we know he’ll be instrumental in redefining our brand and value proposition.”

Gonzalez joins BurgerFi after serving as Founder of Bigger Slice Consulting, a marketing consulting practice focused on helping companies accelerate and sustain profitable growth by collaborating with them to define or refine their brand or value proposition, brand and product portfolio, strategic and tactical marketing plans, campaigns and communications. Prior to, he served as Chief Marketing Officer of Costa Farms, leading the marketing and category management teams developing new products, brands, merchandising and promotions to serve Walmart, Lowe’s, Home Depot, Ikea, Kroger and other top retailers.

“Henry has a proven track record of working in fast-paced, competitive environments and masterfully integrating marketing and communications that not only moves the needle to drive short term business objectives but position brands for longer-term success. His extensive leadership experience in field and corporate marketing with Burger King collaborating with franchisee partners along with his agency, vendor partner and client experience make him uniquely qualified to collaborate with all stakeholders to help us unlock our brand’s potential to drive significant growth and profitability, said Julio Ramirez, CEO of BurgerFi. “He has been working with us as a contractor since the beginning of the year and has already made significant contributions. I am excited about the impact he’ll have leveraging his experience, passion and commitment to take our brand and our business to new heights as our CMO.”

For nearly a decade, Gonzalez worked at Crispin Porter + Bogusky, the preeminent ad agency of its time where he leveraged his experience working at Burger King to help lead Burger King’s US business during their tenure as Ad Age Client of the Decade. His agency experience also included leading teams working with top brands like MetLife, McDonald’s, Aspen Dental, Infiniti, Sam’s Club and others.

“I have been a huge fan of the brand as a consumer primarily because of the taste of the food and quality of the experience but also as a marketer because it’s so well positioned to capitalize on current trends. From a consumer standpoint, BurgerFi is the best kept secret in the fast casual space. I’m thrilled to collaborate with this talented team to bring a more consumer-focused and data driven approach to drive greater awareness, engagement, growth and profitability. We have a tremendous opportunity to highlight our points of differentiation and showcase how our brand is aligned with consumer expectations for fresh, all natural, great tasting food ordered and served conveniently across an array of platforms. Focusing on the consumer is how we’ll deliver on our mission to redeFine how the world eats burger by enriching lives through the best better burger experience.”

Gonzalez has a Bachelor of Science degree in Business Administration from the University of Florida. He believes in community service and actively supports organizations like Big Brothers Big Sisters as a Board Member, St. Hugh Grove Outreach Food Bank and Mission 22.

About BurgerFi International (Nasdaq: BFI, BFIIW) 
Established in 2011, BurgerFi is among the nation’s fastest-growing better burger concepts with approximately 120 BurgerFi restaurants domestically and internationally. The concept is chef-founded and is committed to serving fresh food of transparent quality. BurgerFi uses 100% American angus beef with no steroids, antibiotics, growth hormones, chemicals or additives. BurgerFi’s menu also includes high quality wagyu beef, antibiotic and cage-free chicken offerings, fresh, hand-cut sides and custard shakes and concretes. BurgerFi was voted the Top Better Burger chain in Fast Casual Restaurants in USA Today’s 10Best Readers’ Choice for 2021, named QSR Magazine’s Breakout Brand of the Year for 2020, placed as the Top Better Burger Chain in Fast Casual’s Top 100 Movers & Shakers list in 2021, was named “Best Burger Joint” by Consumer Reports and fellow public interest organizations in the 2019 Chain Reaction Study, listed as a “Top Restaurant Brand to Watch” by Nation’s Restaurant News in 2019, included in Inc. Magazine’s Fastest Growing Private Companies List, and ranked on Entrepreneur’s 2017 Franchise 500. To learn more about BurgerFi or to find a full list of locations, please visit www.burgerfi.com. Download the BurgerFi App on iOS or Android devices for rewards and  ‘Like’ BurgerFi on Facebook or follow @BurgerFi on Instagram and Twitter. 

BurgerFi® is a Registered Trademark of BurgerFi IP, LLC, a wholly-owned subsidiary of BurgerFi. 

Forward-Looking Statements 
This press release may contain “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 (the “Exchange Act”), including BurgerFi’s estimates of its future business outlook, prospects or financial results. Statements regarding BurgerFi’s objectives, expectations, intentions, beliefs or strategies, or statements containing words such as “believe,” “estimate,” “project,” “expect,” “intend,” “may,” “anticipate,” “plans,” “seeks,” “implies,” or similar expressions are intended to identify such forward-looking statements. It is important to note that BurgerFi’s actual results could differ materially from those in such forward-looking statements, and undue reliance should not be placed on such statements. Statements about the effects of the COVID-19 pandemic on our business, operations, financial performance and prospects may constitute forward-looking statements and are subject to the risk that the actual impacts may differ, possibly materially, from what is reflected in those forward-looking statements due to factors and future developments that are uncertain, unpredictable and in many cases beyond our control, including the scope and duration of the pandemic, actions taken by governmental authorities in response to the pandemic, and the direct and indirect impact of the pandemic. Among the important factors that could cause such actual results to differ materially are (i) the impact of any economic recessions in the U.S. and other parts of the world, (ii) fluctuations in the global economy, (iii) BurgerFi’s ability of maintaining its margins, (iv) changes in applicable accounting principles or interpretations of such principles, (v) delays in BurgerFi’s ability to develop new products and services and market acceptance of new products and services, (vi) rapid technological change, (vii) BurgerFi’s ability to attract and retain key management personnel, (viii) the existence of substantial competition, and (ix) other risk factors listed from time to time in BurgerFi’s  Exchange Act reports and other filings  with the Securities and Exchange Commission. All forward-looking statements included in this press release are made as of the date hereof, and BurgerFi undertakes no obligation to update any such forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Investor Relations Contact: 
Gateway Investor Relations 
Cody Slach or Cody Cree
(949) 574-3860 
[email protected] 

Company Contact: 
BurgerFi International Inc. 
Ashley Spitz, [email protected] 

Media Relations Contact: 
Quinn PR 
Laura Neroulias, [email protected] 

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ebfb7bd9-2f5d-4891-86c4-ca03ac8acadc

 

WEST PALM BEACH, Fla., May 03, 2021 (GLOBE NEWSWIRE) — Aidéo Technologies – a leader in AI-enabled automation technology for the healthcare industry – announced today that ONQ will use and re-sell the company’s auto-coding tool Gemini AutoCode™ to automate Revenue Cycle Management (RCM) for healthcare providers nationwide.

Surpassing traditional Computer Assisted Coding (CAC) tools, Gemini AutoCode™ delivers a People Assisted Coding (PAC) solution that uses artificial intelligence and machine learning to continuously improve with each interaction and assign the correct codes without human intervention. Designed to provide production coding using technology, Gemini AutoCode™ easily integrates with electronic medical records and can accurately interpret and code more than 40,000 clinical encounters per hour.

“We’re committed to helping the healthcare industry through digital innovation, and Aidéo Technologies helps us deliver the most powerful solutions to providers,” said Jack McBride, CEO of ONQ. “Aidéo’s team has expertise in AI and a deep understanding of RCM; we are looking forward to making the most of this partnership.”

Gemini AutoCode™ uses AI, a proprietary Natural Language Processing engine and machine learning to interpret structured and unstructured clinical data, so unlike CAC solutions, Aidéo Technologies’ software application assigns the appropriate procedure and diagnosis codes based on free-form notes with accuracy that matches or exceeds human coders.

“Gemini AutoCode™ delivers measurable impact with seamless integration into any practice, so it’s a wonderful tool for ONQ’s clients,” said Rob Gontarek, President and CEO of Aidéo Technologies. “Our technology pairs well with theirs, and the results promise to be revolutionary for the healthcare billing industry.”

About Aidéo Technologies 
Aidéo Technologies (www.aideo-tech.com) provides software automation tools using artificial intelligence, robotics and machine learning to the healthcare industry. Established in 2009, the company has development centers in West Palm Beach, Fla., and Silicon Valley.

About ONQ: One of the fastest-growing businesses in the healthcare billing support industry, ONQ (www.onqoc.com) provides automation solutions, global labor outsourcing and patient call center services from its facilities in Santiago, Panama.

Contact:
Laura Krejca
Senior Director, Client Service
[email protected]

Reaffirms commitment to maintaining CN’s U.S. headquarters in Kansas City and ongoing investment in local communities

Proposed combination will provide the ability for customers to choose the best route and carrier options for their needs

MONTREAL, May 03, 2021 (GLOBE NEWSWIRE) — CN (TSX: CNR, NYSE: CNI) today issued an open letter to the Kansas City Southern (NYSE: KSU) (“KCS”) community regarding CN’s superior proposal to combine with KCS. The letter outlines why a combined CN-KCS represents the best solution for all stakeholders and sets the record straight on the merits of CN’s proposal.

The following is a copy of the letter:

To the KCS Community,

At CN, we believe how you get there is just as important as reaching your destination. On the railroad, that means getting our customers’ freight from origin to destination safely, cost-effectively and reliably, with respect for the environment and the communities we serve. In business, it means dealing fairly and honestly, with respect for people and processes.

We are in a spirited contest with Canadian Pacific (CP) to acquire Kansas City Southern (KCS). We believe we have a better bid than CP, that we can be a better partner to KCS and all of its stakeholders, and that a combined CN-KCS represents the best solution for shippers and the North American economy.

We also believe that the people who pay to move freight on our rails should have a say in what happens here. That is why we asked our industry regulator – the Surface Transportation Board – to apply a higher “enhanced competition” standard of regulatory review to our proposed transaction instead of the lower pre-2001 standard CP asked for.

We want to know what customers think, and we are confident they will like what they hear. Since launching our bid, more than 600 customers, suppliers, port operators, elected officials and other key stakeholders have written letters to the STB in support of a CN-KCS combination.

Finally, we believe facts matter, and that good processes lead to proper outcomes. And that is why we feel compelled to set the record straight on some of the so-called “truths” that CP has been promoting in an effort to muddy the water on our clearly superior bid. So here are some facts:

• With more choices comes more competition, lower costs and better service. A CN-KCS combination will offer customers more connections and more choices, with new access points and gateway options. This includes an additional 22 Class 1 gateways, 5 ports and 10 barge terminals for the supply chain of KCS customers. A combined CP-KCS offers none of this.
• CN will preserve all existing route choices. We are committed to preserving routing options by keeping current gateways open and providing bottleneck protections. This empowers customers to choose the best route and carrier options for their needs.
• CN is creating new shipping options. CP wants you to believe that a combined CN-KCS would impair competition in north-south shipping. This plainly isn’t true. A combined CN-KCS would compete with multiple Class 1 railroads operating no less than six other north-south routes, not to mention Mississippi River barge traffic and the biggest freight carriers of all – truck traffic along Interstates 35 and 55.
• CN is committed to Kansas City Southern – and to Kansas City. We have great respect for KCS’s people, culture and history. We are committed to maintaining CN’s U.S. headquarters in Kansas City, investing in the communities we serve and working with KCS’s talented management team to create good new jobs up and down the line.
• CN has committed to implementing appropriate arrangements with its customers and the STB to address any competitive concerns, including those that might arise from the fact that 1% of a combined CN-KCS’s tracks would overlap. At CN, we focus on solutions.
• CN has put forward an identical voting trust structure to CP to ensure KCS remains independent until regulators have approved whichever transaction KCS ultimately chooses to pursue. We are confident the STB will approve both voting trusts and put them on level ground so that KCS shareholders can realize the best value for their shares.

These are the facts. You can also read more about this important transaction and our superior proposal at www.ConnectedContinent.com.

CN has been a part of the fabric of the American industrial heartland for decades, with the highly successful acquisitions and integrations of Wisconsin Central, Illinois Central, the EJ&E and other iconic U.S. railroads. We hope we can count on your support so that CN and KCS together can embark on the next phase of the process towards creating the premier railway for the 21^st century.

Respectfully,

JJ Ruest CEO CN

Rob Reilly COO CN

For more information about CN’s superior proposal to combine with KCS, please visit www.ConnectedContinent.com.

About CN

CN is a world-class transportation leader and trade-enabler. Essential to the economy, to the customers, and to the communities it serves, CN safely transports more than 300 million tons of natural resources, manufactured products, and finished goods throughout North America every year. As the only railroad connecting Canada’s Eastern and Western coasts with the U.S. South through a 19,500-mile rail network, CN and its affiliates have been contributing to community prosperity and sustainable trade since 1919. CN is committed to programs supporting social responsibility and environmental stewardship.

Forward Looking Statements

Certain statements included in this news release constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and under Canadian securities laws, including statements based on management’s assessment and assumptions and publicly available information with respect to KCS, regarding the proposed transaction between CN and KCS, the expected benefits of the proposed transaction and future opportunities for the combined company. By their nature, forward-looking statements involve risks, uncertainties and assumptions. CN cautions that its assumptions may not materialize and that current economic conditions render such assumptions, although reasonable at the time they were made, subject to greater uncertainty. Forward-looking statements may be identified by the use of terminology such as “believes,” “expects,” “anticipates,” “assumes,” “outlook,” “plans,” “targets,” or other similar words.

Forward-looking statements are not guarantees of future performance and involve risks, uncertainties and other factors which may cause actual results, performance or achievements of CN, or the combined company, to be materially different from the outlook or any future results, performance or achievements implied by such statements. Accordingly, readers are advised not to place undue reliance on forward-looking statements. Important risk factors that could affect the forward-looking statements in this news release include, but are not limited to: the outcome of any possible transaction between CN and KCS, including the possibility that a transaction will not be agreed to or that the terms of any definitive agreement will be materially different from those described; uncertainties as to whether KCS will cooperate with CN regarding the proposed transaction; the parties’ ability to consummate the proposed transaction; the conditions to the completion of the proposed transaction; that the regulatory approvals required for the proposed transaction may not be obtained on the terms expected or on the anticipated schedule or at all; CN’s indebtedness, including the substantial indebtedness CN expects to incur and assume in connection with the proposed transaction and the need to generate sufficient cash flows to service and repay such debt; CN’s ability to meet expectations regarding the timing, completion and accounting and tax treatments of the proposed transaction; the possibility that CN may be unable to achieve expected synergies and operating efficiencies within the expected time-frames or at all and to successfully integrate KCS’ operations with those of CN; that such integration may be more difficult, time-consuming or costly than expected; that operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers or suppliers) may be greater than expected following the proposed transaction or the public announcement of the proposed transaction; the retention of certain key employees of KCS may be difficult; the duration and effects of the COVID-19 pandemic, general economic and business conditions, particularly in the context of the COVID-19 pandemic; industry competition; inflation, currency and interest rate fluctuations; changes in fuel prices; legislative and/or regulatory developments; compliance with environmental laws and regulations; actions by regulators; the adverse impact of any termination or revocation by the Mexican government of KCS de México, S.A. de C.V.’s Concession; increases in maintenance and operating costs; security threats; reliance on technology and related cybersecurity risk; trade restrictions or other changes to international trade arrangements; transportation of hazardous materials; various events which could disrupt operations, including illegal blockades of rail networks, and natural events such as severe weather, droughts, fires, floods and earthquakes; climate change; labor negotiations and disruptions; environmental claims; uncertainties of investigations, proceedings or other types of claims and litigation; risks and liabilities arising from derailments; timing and completion of capital programs; and other risks detailed from time to time in reports filed by CN with securities regulators in Canada and the United States. Reference should also be made to Management’s Discussion and Analysis in CN’s annual and interim reports, Annual Information Form and Form 40-F, filed with Canadian and U.S. securities regulators and available on CN’s website, for a description of major risk factors relating to CN.

Forward-looking statements reflect information as of the date on which they are made. CN assumes no obligation to update or revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, unless required by applicable securities laws. In the event CN does update any forward-looking statement, no inference should be made that CN will make additional updates with respect to that statement, related matters, or any other forward-looking statement.

No Offer or Solicitation

This news release does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Additional Information and Where to Find It

This news release relates to a proposal which CN has made for an acquisition of KCS. In furtherance of this proposal and subject to future developments, CN (and, if a negotiated transaction is agreed, KCS) may file one or more registration statements, proxy statements, tender offer statements or other documents with the U.S. Securities and Exchange Commission (“SEC”) or applicable securities regulators in Canada. This news release is not a substitute for any proxy statement, registration statement, tender offer statement, prospectus or other document CN and/or KCS may file with the SEC or applicable securities regulators in Canada in connection with the proposed transactions.

INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT(S), REGISTRATION STATEMENT(S), TENDER OFFER STATEMENT, PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC OR APPLICABLE SECURITIES REGULATORS IN CANADA CAREFULLY IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT CN, KCS AND THE PROPOSED TRANSACTIONS. Any definitive proxy statement(s), registration statement or prospectus(es) and other documents filed by CN and KCS (if and when available) will be mailed to stockholders of CN and/or KCS, as applicable. Investors and security holders will be able to obtain copies of these documents (if and when available) and other documents filed with the SEC and applicable securities regulators in Canada by CN free of charge through at www.sec.gov and www.sedar.com. Copies of the documents filed by CN (if and when available) will also be made available free of charge by accessing CN’s website at www.CN.ca.

Participants

This news release is neither a solicitation of a proxy nor a substitute for any proxy statement or other filings that may be made with the SEC and applicable securities regulators in Canada. Nonetheless, CN and its directors and executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed transactions. Information about CN’s executive officers and directors is available in its 2021 Management Information Circular, dated March 9, 2021, as well as its 2020 Annual Report on Form 40-F filed with the SEC on February 1, 2021, in each case available on its website at www.CN.ca/investors/ and at www.sec.gov and www.sedar.com. Additional information regarding the interests of such potential participants will be included in one or more registration statements, proxy statements, tender offer statements or other documents filed with the SEC and applicable securities regulators in Canada if and when they become available. These documents (if and when available) may be obtained free of charge from the SEC’s website at www.sec.gov and www.sedar.com, as applicable.

Contacts:

Media Canada Mathieu Gaudreault CN Media Relations & Public Affairs (514) 249-4735 [email protected] Longview Communications & Public Affairs Martin Cej (403) 512-5730 [email protected] United States Brunswick Group Jonathan Doorley / Rebecca Kral (917) 459-0419 / (917) 818-9002 [email protected] [email protected]

Investment Community Paul Butcher Vice-President Investor Relations (514) 399-0052 [email protected]

• 
  Revenue Increased 92% Sequentially – 11% Above Analyst Consensus
  
• 
  XBAW Filter Shipments Up Over 100% Sequentially  
  
• 
  Growing Customer Activity in 5G Mobile, WiFi, Infrastructure and Other Markets
  
• 
  New Plan to Accelerate Fab Expansion and Boost Capacity by an Additional 2X by CYE 2021 to Approximately 500 Million Filters Per Year
  
• 
  Company to Host Investor Update Call Today at 8:00 am EDT
  

Charlotte, N.C., May 03, 2021 (GLOBE NEWSWIRE) — Akoustis Technologies, Inc. (NASDAQ: AKTS) (“Akoustis” or the “Company”), an integrated device manufacturer (IDM) of patented bulk acoustic wave (BAW) high-band RF filters for mobile and other wireless applications, announced today record revenue of $2.5 million for the 2021 fiscal third quarter ended March 31, 2021, 11% above analyst consensus. Quarterly revenue increased over $1.0 million sequentially, an increase of 92% from the previous December quarter. The Company exited the March quarter with $90.4 million of cash.

The Company will host an investor call to provide a business update and outlook, followed by a Q & A session this morning at 8:00 a.m. EDT. The call-in numbers are 877-407-3982 (domestic) or +01 201-493-6780 (international). The conference call will be webcast live on the Company’s website and will be available for playback at the following URL: https://ir.akoustis.com/ir-calendar.

Jeff Shealy, founder and CEO of Akoustis, commented, “We continued to build momentum in the March quarter, and we are in the best position in our history to deliver on significant opportunities across multiple BAW filter markets and to deliver substantial revenue and earnings growth moving forward.” Mr. Shealy continued, “We are actively delivering volume production of our WiFi 6 tandem filter solution, delivering initial samples of our new 5G mobile filter solutions, shipping multiple 5G small cell XBAW^® filter solutions, and we are entering the final stage of qualification with our WiFi 6E coexistence XBAW^® filter solutions. We currently see WiFi 6E as one of our most compelling near-to-intermediate term market opportunities, while the 5G mobile handset filter market remains our largest potential intermediate-to-long term market opportunity by both unit volume and revenue.”

Akoustis is actively delivering volume production of its WiFi 6 tandem filter solutions, shipping multiple 5G small cell XBAW^® filter solutions, delivering initial designs of its new 5G mobile filter solutions to multiple customers and is now entering the market with its new WiFi 6E coexistence XBAW^® filter solutions.

Given the rapidly growing sales funnel activity as well as ongoing interaction with customers regarding expected ramps in both 5G mobile and WiFi 6E in calendar 2022, the Company plans to increase the annual production capacity at its New York fab by the end of calendar 2021 to approximately 500 million filters per year.

Recent Business Highlights

• XBAW filter unit shipments up over 100% sequentially
• Shipped first XBAW^® filter sample to RF front-end module customer for evaluation and characterization
• Completed design and released to fab new XBAW^® 5G mobile filter for tier-1 RF component customer
• Completed the process flow for our chip-scale-package (CSP) for XBAW^® filters, aimed at the emerging 5G mobile and WiFi device markets
• Continued engagement with first 5G mobile customer and executed against open purchase orders
• Introduced new 5 GHz WiFi 6E coexistence filter solution with 5.6 GHz and 6.6 GHz XBAW^® filter modules
• Shipped volume order for 5.5 GHz and 6.5 GHz WiFi 6E filters with new tier-1 customer
• Announced inclusion on multiple WiFi 6E reference designs from two tier-1 SoC makers
• Continued commercial production for tier-1 consumer focused tri-band WiFi 6 product, which is currently available for sale in both online and retail box stores
• Achieved robust sampling of WiFi 6E filters to tier-1 and tier-2 OEMs, ODMs and SoC customers
• Awarded new design win for XBAW^® filter from new CBRS customer
• Continued DARPA direct-to-phase II (DP2) contract to advance design and manufacturing of XBAW^® technology for filters and other sensors
• Retired the entire $25 million principal amount of convertible debt, resulting in a largely debt free balance sheet.
• Expanded XBAW^® patent portfolio to 47 issued and licensed patents plus 78 patents pending, with 9 new patent issuances in the current calendar year

Akoustis currently has 15 commercial XBAW filters in its product catalog, and recently introduced 5.6 GHz and 6.6 GHz WiFi 6E coexistence filter modules, which when qualified, will bring the number of catalog products to 17. Current product catalog filters include a 5.6 GHz WiFi filter, a 5.2 GHz WiFi filter, a 5.5 GHz WiFi-6E filter, a 6.5 GHz WiFi 6E filter, three small cell 5G network infrastructure filters including two Band n77 filters and one Band n79 filter, a 3.8 GHz filter and five S-Band filters for defense phased-array radar applications, a 3.6 GHz filter for the CBRS 5G infrastructure market and a C-Band filter for the unmanned aircraft systems (UAS) market. The Company is also developing several new filters for the sub-7 GHz bands targeting 5G mobile device, network infrastructure, WiFi CPE and defense markets.

Third Fiscal Quarter Financial Performance

		For the Three Months Ended March 31, 2021				For the Three Months Ended March 31, 2020				For the Nine Months Ended March 31, 2021				For the Nine Months Ended March 31, 2020
Revenue
Revenue with customers		$	2,517			$	363			$	4,461			$	1,424
Cost of revenue			2,973				217				7,224				1,340
Gross profit (loss)			(456	)			146				(2,763	)			84
Operating expenses
Research and development			5,225				5,769				17,171				15,736
General and administrative expenses			3,395				2,589				9,683				8,158
Total operating expenses			8,620				8,358				26,854				23,894
Loss from operations			(9,076	)			(8,212	)			(29,617	)			(23,810	)
Other (expense) income
Interest (expense) income			(2,027	)			(1,162	)			(5,162	)			(3,259	)
Rental income			—				54				—				164
Change in fair value of contingent real estate liability			—				480				—				446
Change in fair value of derivative liabilities			928				1,066				744				396
Total other (expense) income			(1,099	)			438				(4,418	)			(2,253	)
Net loss		$	(10,175	)		$	(7,774	)		$	(34,035	)		$	(26,063	)
Net loss per common share – basic and diluted		$	(0.22	)		$	(0.21	)		$	(0.83	)		$	(0.80	)
Weighted average common shares outstanding – basic and diluted			45,620,610				36,236,779				41,047,723				32,659,339

Akoustis Technologies, Inc.

Condensed Consolidated Balance Sheets
(In thousands, except share data)
(Unaudited)

		March 31,				June 30,
		2021				2020
Assets
Assets:
Cash and cash equivalents		$	90,392			$	44,308
Accounts receivable			1,620				351
Inventory			1,446				136
Other current assets			1,572				1,408
Total current assets			95,030				46,203
Property and equipment, net			28,755				23,605
Intangibles, net			579				544
Operating lease right-of-use asset, net			531				699
Restricted cash			—				100
Other assets			282				282
Total Assets		$	125,177			$	71,433
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses		$	5,163			$	5,899
Deferred revenue			123				—
Operating lease liability – current			260				231
Short term loans payable			1,218				—
Total current liabilities			6,764				6,130
Long-term Liabilities:
Convertible notes payable, net			—				21,628
Operating lease liability – non-current			274				472
Long term loans payable			392				1,591
Other long-term liabilities			117				117
Total long-term liabilities			783				23,808
Total Liabilities			7,547				29,938
Stockholders’ Equity
Preferred stock, par value $0.001: 5,000,000 shares authorized; none issued and outstanding			—				—
Common stock, $0.001 par value; 100,000,000 shares authorized; 50,374,194 and 37,990,380 shares issued and outstanding at March 31, 2021 and June 30, 2020, respectively			50				38
Additional paid in capital			255,230				145,072
Accumulated deficit			(137,650	)			(103,615	)
Total Stockholders’ Equity			117,630				41,495
Total Liabilities and Stockholders’ Equity		$	125,177			$	71,433

The following Non-GAAP measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP. These non-GAAP measures exclude significant expenses that are required by GAAP to be recorded in the Company’s financial statements and are subject to inherent limitations. Please see reconciliations to comparable GAAP measures below and descriptions of these non-GAAP measures under “Non-GAAP Measures.”

Below, Non-GAAP Operating Loss and Non-GAAP Net Loss for the three months ending March 31, 2021 and 2020 were as follows:

Akoustis Technologies, Inc.
Unaudited Reconciliations of Non-GAAP Financial Measures
	Three Months Ended
	March 31, 2021	March 31, 2020
(in thousands)
GAAP operating loss	$                          (9,076)	$                         (8,212)
Common stock issued for services	1,991	1,803
Non-GAAP operating loss	$                          (7,085)	$                         (6,409)
	Three Months Ended
	March 31, 2021	March 31, 2020
(in thousands)
GAAP net loss	$                        (10,175)	$                         (7,774)
Change in fair value of contingent real estate liability	–	(480)
Change in fair value of derivative liabilities	(928)	(1,066)
Debt discount amortization	2,059	842
Common stock issued for services	1,991	1,803
Non-GAAP net loss	$                          (7,054)	$                         (6,674)
Weighted average common shares outstanding – basic and diluted	45,620,610	36,263,779
Non-GAAP net loss per common share – basic and diluted	$                             (0.15)	$                           (0.18)
	Nine Months Ended
	March 31, 2021	March 31, 2020
(in thousands)
GAAP operating loss	$                        (29,617)	$                       (23,810)
Common stock issued for services	6,084	5,108
Non-GAAP operating loss	$                        (23,534)	$                       (18,702)
	Nine Months Ended
	March 31, 2021	March 31, 2020
(in thousands)
GAAP net loss	$                        (34,035)	$                       (26,063)
Change in fair value of contingent real estate liability	–	$                            (446)
Change in fair value of derivative liabilities	(744)	$                            (396)
Debt discount amortization	4,405	$                           2,333
Common stock issued for services	6,084	$                           5,108
Non-GAAP net loss	$                        (24,290)	$                       (19,464)
Weighted average common shares outstanding – basic and diluted	41,047,723	32,659,339
Non-GAAP net loss per common share – basic and diluted	$                             (0.59)	$                           (0.60)

Non-GAAP Measures

We regularly review a number of metrics, including Non-GAAP Operating Loss and Non-GAAP Net Loss, which are not financial measures calculated in accordance with generally accepted accounting principles in the United States (“GAAP”). Non-GAAP Operating Loss represents operating loss before common stock issued for services. Non-GAAP Net Loss represents net loss before change in fair value of contingent real estate liability, change in fair value of derivative liabilities, debt discount amortization and common stock issued for services. The Company believes these non-GAAP measures provide useful information to management, investors and financial analysts regarding certain financial and business trends relating to the Company’s financial condition and results of operations. We use these non-GAAP measures to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions.

About Akoustis Technologies, Inc.

Akoustis^® (http://www.akoustis.com/) is a high-tech BAW RF filter solutions company that is pioneering next-generation materials science and MEMS wafer manufacturing to address the market requirements for improved RF filters – targeting higher bandwidth, higher operating frequencies and higher output power compared to incumbent polycrystalline BAW technology deployed today. The Company utilizes its proprietary XBAW^® manufacturing process to produce bulk acoustic wave RF filters for mobile and other wireless markets, which facilitate signal acquisition and accelerate band performance between the antenna and digital back end. Superior performance is driven by the significant advances of high-purity, single-crystal and associated piezoelectric materials and the resonator-filter process technology which drives electro-mechanical coupling and translates to wide filter bandwidth. 

Akoustis plans to service the fast growing multi-billion-dollar RF filter market using its integrated device manufacturer (IDM) business model. The Company owns and operates a 120,000 sq. ft. ISO-9001:2015 registered commercial wafer-manufacturing facility located in Canandaigua, NY, which includes a class 100 / class 1000 cleanroom facility – tooled for 150-mm diameter wafers – for the design, development, fabrication and packaging of RF filters, MEMS and other semiconductor devices. Akoustis Technologies, Inc. is headquartered in the Piedmont technology corridor near Charlotte, North Carolina.

Forward-Looking Statements

This document includes “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements about our estimates, expectations, beliefs, intentions, plans or strategies for the future (including our possible future results of operations, business strategies, competitive position, potential growth opportunities, potential market opportunities and the effects of competition), and the assumptions underlying such statements. Forward-looking statements include all statements that are not historical facts and typically are identified by use of terms such as “may,” “might,” “would,” “will,” “should,” “could,” “project,” “expect,” “plan,” “strategy,” “aim,” “anticipate,” “attempt,” “develop,” “help,” “believe,” “think,” “estimate,” “predict,” “intend,” “forecast,” “seek,” “potential,” “possible,” “continue,” “future,” and similar words (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Forward-looking statements are neither historical facts nor assurances of future results, performance, events or circumstances. Instead, these forward-looking statements are based on management’s current beliefs, expectations and assumptions and are subject to risks and uncertainties. Factors that could cause actual results to differ materially from those currently anticipated include, without limitation, risks relating to our ability to obtain adequate financing and sustain our status as a going concern; our limited operating history; our inability to generate revenues or achieve profitability;  the results of our research and development activities; our inability to achieve acceptance of our products in the market; the impact of a pandemic or epidemic or a natural disaster, including the COVID-19 pandemic, on our operations, financial condition and the worldwide economy, including its impact on our ability to access the capital markets; general economic conditions, including upturns and downturns in the industry; shortages in supplies needed to manufacture our products, or needed by our customers to manufacture devices incorporating our products; our limited number of patents; failure to obtain, maintain, and enforce our intellectual property rights; our inability to attract and retain qualified personnel; our reliance on third parties to complete certain processes in connection with the manufacture of our products; product quality and defects; existing or increased competition; our ability to successfully manufacture, market and sell products based on our technologies; our ability meet the required specifications of customers and achieve qualification of our products for commercial manufacturing in a timely manner; our ability to successfully scale our New York wafer fabrication facility and related operations while maintaining quality control and assurance and avoiding delays in output; the rate and degree of market acceptance of any of our products; our ability to achieve design wins from current and future customers; contracting with customers and other parties with greater bargaining power and agreeing to terms and conditions that may adversely affect our business; risks related to doing business in foreign countries, including China; any security breaches, cyber-attacks or other disruptions compromising our proprietary information and exposing us to liability; our failure to innovate or adapt to new or emerging technologies; our failure to comply with regulatory requirements; results of any arbitration or litigation that may arise; stock volatility and illiquidity; dilution caused by any future issuance of common stock or securities that are convertible into or exercisable for common stock; our failure to implement our business plans or strategies; and our ability to maintain effective internal control over financial reporting. These and other risks and uncertainties are described in more detail in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the Company’s most recent Annual Report on Form 10-K and in subsequently filed Quarterly Reports on Form 10-Q. Considering these risks, uncertainties and assumptions, the forward-looking statements regarding future events and circumstances discussed in this document may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements included in this document speak only as of the date hereof and, except as required by law, we undertake no obligation to update publicly or privately any forward-looking statements, whether written or oral, for any reason after the date of this document to conform these statements to new information, actual results or to changes in our expectations.

Contact:

COMPANY:
Tom Sepenzis
Akoustis Technologies
VP of Corporate Development & IR
(980) 689-4961
[email protected]

The Del Mar Consulting Group, Inc.
Robert B. Prag, President
(858) 794-9500
[email protected]

WILMINGTON, N.C., May 03, 2021 (GLOBE NEWSWIRE) — LGI Homes, Inc. (NASDAQ: LGIH) announced its newest community in the greater Wilmington area, Harrison Cove, in Hampstead.

Ideally located between I-40 and US-17, Harrison Cove is just a short commute from world-class beaches and the entertainment of downtown Wilmington. Minutes from home, residents can relax at either Wrightsville Beach or Topsail Beach. Downtown Wilmington provides homeowners with the ideal day of shopping and dining in a picturesque setting at the famous Wilmington Riverwalk.

At Harrison Cove, LGI Homes offers an assortment of one and two-story, single-family homes. These four spacious floor plans range in size from 1,317 square feet to 2,358 square feet. With up to four bedrooms and two-and-a-half baths, these new homes showcase design features that today’s homebuyers are searching for. In every new home at Harrison cove, buyers will enjoy open floor plans, modern kitchens, private master suites, spacious walk-in closets, large family rooms and lush front yard landscaping.

Homeowners at Harrison Cove will enjoy move-in ready homes equipped with LGI’s CompleteHome™ package. This package showcases an incredible assortment of included upgrades such as a chef-ready kitchen with energy-efficient Whirlpool^® kitchen appliances, sprawling granite countertops, an undermount kitchen sink, a USB outlet in the kitchen and 36” upper cabinets with crown molding that provide ample storage space.

Quick move-in opportunities and attractive financing options are available to qualified buyers at Harrison Cove. Pricing for these new homes starts in the $260s. To accommodate homebuyers during this time, the Harrison Cove information center is open for tours by appointment only and is in compliance with Centers for Disease Control and Prevention (CDC) and local safety guidelines. Interested buyers are encouraged to call (844) 899-1659 ext 635 to schedule a tour.

About LGI Homes, Inc.

Headquartered in The Woodlands, Texas, LGI Homes, Inc. engages in the design, construction and sale of homes in Texas, Arizona, Florida, Georgia, New Mexico, Colorado, North Carolina, South Carolina, Washington, Tennessee, Minnesota, Oklahoma, Alabama, California, Oregon, Nevada, West Virginia, Virginia and Pennsylvania. Since 2018, LGI Homes has been ranked as the 10th largest residential builder in the United States based on units closed. The Company has a notable legacy of more than 18 years of homebuilding operations, over which time it has closed more than 45,000 homes. For more information about the Company and its new home developments, please visit the Company’s website at www.lgihomes.com.

MEDIA CONTACT:

Rachel Eaton

(281) 362-8998 ext. 2560

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0333c679-dbb6-4a3c-99db-01ac96b11be6

Omaha, NE , May 03, 2021 (GLOBE NEWSWIRE) — FitLife Brands Begins Trading on the OTCQX Market

OMAHA, NE – May 3, 2021 — FitLife Brands, Inc. (“FitLife” or the “Company”) (OTCQX: FTLF), a provider of innovative and proprietary nutritional supplements for health-conscious consumers marketed under the brand names NDS Nutrition, PMD, SirenLabs, Nutrology, CoreActive, Metis Nutrition, iSatori, Energize, and BioGenetic Laboratories, today announced that its common stock has been approved for trading on the OTCQX retaining its current symbol, FTLF, effective as of the opening of trading on Monday, May 3, 2021.

To qualify for the OTCQX Market, companies must meet high financial standards, follow best practice corporate governance, demonstrate compliance with US securities laws, be current in their disclosure, and have a professional third-party sponsor introduction. In conjunction with trading on OTCQX, the Company today filed an investor presentation on Form 8K with the Securities and Exchange Commission. The presentation provides additional information about the Company’s strategy and operations.

Dayton Judd, FitLife’s Chairman and CEO, commented, “We anticipate that our upgrading from the Pink Market to the OTCQX will raise our visibility in the investment community, improve the liquidity of our common stock, and broaden our investor base. We appreciate the support of our shareholders and look forward to welcoming new investors to the FitLife Brands family.”

About FitLife Brands

FitLife Brands is a developer and marketer of innovative and proprietary nutritional supplements for health-conscious consumers. FitLife markets over 130 different dietary supplements to promote sports nutrition, improved performance, weight loss and general health primarily through domestic and international GNC® franchise locations as well as through more than 17,000 additional domestic retail locations and, increasingly, online. FitLife is headquartered in Omaha, Nebraska. For more information please visit our websites at www.fitlifebrands.com and www.nutrologyonline.com.

Forward-Looking Statement
s

Statements in this release that are forward looking involve known and unknown risks and uncertainties, which may cause the Company’s actual results in future periods to be materially different from any future performance that may be suggested in this news release. Such factors may include, but are not limited to, the ability to of the Company to continue to grow revenue, and the Company’s ability to continue to achieve positive cash flow given the Company’s existing and anticipated operating and other costs. Many of these risks and uncertainties are beyond the Company’s control. Reference is made to the discussion of risk factors detailed in the Company’s filings with the Securities and Exchange Commission including its reports on Form 10-K and 10-Q. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the dates on which they are made.

[email protected]

SAN FRANCISCO, May 03, 2021 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) will announce its first quarter 2021 financial results on Monday, May 10 after the market close. FibroGen will also conduct a conference call on that day at 5:00 p.m. ET (2:00 p.m. PT) with the investment community to further detail the company’s corporate and financial performance.

Conference Call and Audio Webcast

Interested parties may access a live audio webcast of the conference call via the FibroGen website at https://fibrogen.gcs-web.com/events-and-presentations/events. It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Dial-In Information

Live (U.S./Canada): (877) 658-9081
Live (International): (602) 563-8732
Confirmation number: 2036817  

A replay of the webcast and investor presentation will be available shortly after the call for a period of 30 days. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international), and use passcode 2036817.

About FibroGen

FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For more information, please visit www.fibrogen.com.

Contacts:

FibroGen, Inc.

Investors:

Michael Tung, M.D.
Corporate Strategy / Investor Relations
1.415.978.1434
[email protected] 

Media:

Jennifer Harrington
+1.610.574.9196
[email protected] 

NEW YORK and VIENNA, Austria, May 03, 2021 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that it will release first quarter 2021 financial results before the market opens on Wednesday, May 12, 2021.

The Company will not be conducting a conference call in conjunction with this earnings release.

About HOOKIPA

HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body’s immune system.

HOOKIPA’s proprietary arenavirus-based technologies, non-replicating and replicating, induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA’s viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy not used in combination, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.

HOOKIPA is building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens. The lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.

HOOKIPA’s non-replicating prophylactic Cytomegalovirus (CMV) vaccine candidate, HB-101, is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based functional cures for HIV and chronic Hepatitis B infections.

Find out more about HOOKIPA online at www.hookipapharma.com.

For further information, please contact:
Media	Investors
Nina Waibel	Matt Beck
Senior Director – Communications	Executive Director – Investor Relations
[email protected]	[email protected]

NEW HAVEN, Conn., May 03, 2021 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced it will host a conference call and webcast on Monday, May 10, 2021 at 8:30 AM Eastern Time to discuss its first quarter 2021 operating and financial results.

Conference Call & Webcast Details

Date/Time: Monday, May 10, 2021, 8:30 AM Eastern Time
Domestic: 877-407-2985
International: 201-378-4915

The webcast will be accessible* under “Events” on the News & Media page of the Company’s website at www.bioxceltherapeutics.com.

Replay

Domestic: 877-660-6853
International: 201-612-7415
Conference ID: 13719370

*Replay available through at least May 24, 2021

BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BioXcel’s two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.

Contact Information:

BioXcel Therapeutics, Inc.
www.bioxceltherapeutics.com

Investor Relations:
Mary Coleman
BioXcel Therapeutics, VP of Investment Relations
[email protected]
1.475.238.6837

John Graziano
Solebury Trout
[email protected]
1.646.378.2942

Media:

Julia Deutsch
Solebury Trout
[email protected]
1.646.378.2967