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Reports Q1 GAAP Earnings per Diluted Share of $3.01 versus a Loss per Diluted Share of $(7.86) in Q1 2020

Reports Q1 Adjusted Earnings per Diluted Share of $3.25 versus an Adjusted Loss per Diluted Share of $(3.33) in Q1 2020

SECAUCUS, N.J., May 20, 2021 (GLOBE NEWSWIRE) — The Children’s Place, Inc. (Nasdaq: PLCE), the largest pure-play children’s specialty apparel retailer in North America, today announced financial results for the first quarter ended May 1, 2021.

Jane Elfers, President and Chief Executive Officer announced, “We delivered outstanding first quarter results with gross margin, operating margin, and EPS all at record levels. Our Q1 2021 net sales of $435 million exceeded our pre-COVID Q1 2019 net sales of $412 million, despite having 261 or 27% fewer stores ending Q1 2021 versus Q1 2019.”

Ms. Elfers continued, “All key metrics across both our digital and stores channels exceeded expectations. Our top line results were driven by several factors, including double digit increases in AUR versus Q1 2020, resulting from strong product acceptance, higher price realization, reduced promotional activity, and unprecedented stimulus, as well as an acceleration in back-to-school sales, our ability to retain new digital customers we acquired during the pandemic, and a significant reactivation of store customers that we had temporarily lost during the government-mandated closure of all of our stores. Our record gross margin was driven by significantly higher merchandise margins versus Q1 2020 in both our digital and stores channels, significant occupancy savings from favorable lease negotiations and fewer stores, and meaningful e-commerce fulfillment optimization.”

Ms. Elfers continued, “We leveraged a very difficult period in 2020 to accelerate our strategic transformation and we are now well positioned for accelerated operating margin expansion in 2021 and beyond. The acceleration of our digital business, our highest operating margin channel, made possible by our pre-pandemic digital transformation investments, combined with the significant sales transfer rate we are achieving from our strategic decision to close 300, or a third, of our stores in less than 20 months, is resulting in an industry leading approximately 50% steady state annual digital penetration. Our long-standing fleet optimization strategy enables us to close the 300 stores, without financial penalty, and reset our occupancy costs. These occupancy cost reductions should continue to be a significant operating margin tailwind throughout 2021 and beyond. In addition, by aligning our overhead cost structure in 2020 to our digital first strategy, we have gained efficiencies and removed significant expense from our P&L, which will continue to benefit us in 2021 and beyond. We anticipate further operational efficiencies and sales opportunities when social distancing and other restrictions, such as limits on hours of operation, are further removed and we are able to return to normal operations in both our stores and distribution centers.”

Ms. Elfers concluded, “We are operating at a high level. We continue to navigate the extraordinary complexity of the pandemic while remaining firmly on offense. Our long-standing strategic plan has served us well. We are a stronger company today than we were prior to the pandemic and we look forward to continuing to deliver accelerated operating margin expansion for our shareholders in 2021 and beyond.”

First Quarter 2021 Results

Net sales increased $180.3 million, or 70.6%, to $435.5 million in the three months ended May 1, 2021, compared to $255.2 million in the three months ended May 2, 2020 primarily driven by strong customer response to our product assortment and the unprecedented level of stimulus payments from the recent government pandemic relief legislation.   Our fiscal 2021 first quarter net sales were negatively impacted by permanent and temporary store closures and the impact of reduced operating hours in our mall stores, as mandated by the mall owners.  Our fiscal 2020 first quarter sales were negatively impacted by the initial onset of the COVID-19 pandemic. Comparable retail sales were 83.0% for the quarter.

Gross profit increased $207.9 million to $188.2 million in the three months ended May 1, 2021, compared to a gross loss of ($19.7) million in the three months ended May 2, 2020. Adjusted gross profit increased $143.9 million to $189.2 million in the three months ended May 1, 2021, compared to $45.3 million in the comparable period last year, and leveraged 2,571 basis points to 43.4% of net sales.  The increase was primarily a result of the leverage of fixed expenses resulting from the increase in net sales, higher merchandise margins in both our digital and stores channels, and lower occupancy expenses due to rent abatements of $8 million, favorable lease negotiations, and permanent store closures.

Selling, general, and administrative expenses were $106.7 million in the three months ended May 1, 2021, compared to $98.5 million in the three months ended May 2, 2020. Adjusted SG&A was $104.1 million in the three months ended May 1, 2021, compared to $92.4 million in the comparable period last year, and leveraged 1,231 basis points to 23.9% of net sales, primarily as a result of the leverage of fixed expenses resulting from the increase in net sales, partially offset by higher incentive compensation accruals.

Operating income increased $239.1 million to $65.9 million in the three months ended May 1, 2021, compared to an operating loss of ($173.1) million in the three months ended May 2, 2020. Operating margin improved to 15.1%, compared to (67.8%) in the prior year period. Adjusted operating income increased $135.7 million to $70.7 million in the three months ended May 1, 2021, compared to an adjusted operating loss of ($64.9) million in the comparable period last year, and leveraged 4,168 basis points to 16.2% of net sales.

Net interest expense was $4.4 million in the three months ended May 1, 2021, compared to $1.8 million in the three months ended May 2, 2020.  The increase in interest expense was driven by a higher debt balance and the higher interest rate associated with our term loan.

Net income increased $160.0 million to $45.2 million, or $3.01 per diluted share, in the three months ended May 1, 2021, compared to net loss of $(114.8) million, or $(7.86) per diluted share, in the three months ended May 2, 2020. Adjusted net income increased $97.5 million to $48.7 million, or $3.25 per diluted share, compared to an adjusted net loss of $(48.7) million, or $(3.33) per diluted share, in the comparable period last year.

Non-GAAP Reconciliation

The Company’s results are reported in this press release on a GAAP and as adjusted, non-GAAP basis. Adjusted net income (loss), adjusted net income (loss) per diluted share, adjusted gross profit (loss), adjusted selling, general, and administrative expenses, and adjusted operating income (loss) are non-GAAP measures, and are not intended to replace GAAP financial information, and may be different from non-GAAP measures reported by other companies. The Company believes the income and expense items excluded as non-GAAP adjustments are not reflective of the performance of its core business, and that providing this supplemental disclosure to investors will facilitate comparisons of the past and present performance of its core business.

Beginning with the fourth quarter of fiscal 2020, the Company modified its reporting practices regarding the use of non-GAAP measures. As a result, the Company does not exclude (1) occupancy charges for rent at our stores when they were temporarily closed and (2) payroll and benefits for certain store employees during the period our stores were temporarily closed, net of a payroll tax credit benefit resulting from the Coronavirus Aid, Relief, and Economic Security Act (“CARES”). The presentation of adjusted net income (loss), adjusted net income (loss) per diluted share, adjusted gross profit (loss), adjusted selling, general, and administrative expenses, and adjusted operating income (loss) reflects these changes for prior periods. Reconciliation of Non-GAAP Financial Information to GAAP tables setting forth reconciliations reflecting the above modifications for quarters in fiscal 2020 were provided in our Form 8-K filed with the U.S. Securities and Exchange Commission on March 9, 2021.

The Company’s adjusted results exclude net expenses of approximately $1.6 million comprising certain items, which the Company believes are not reflective of the performance of its core business as a result of the COVID-19 pandemic, including incremental operating expenses, primarily incentive pay and personal protective equipment for our associates.

Additionally, the Company excluded net expenses of $3.2 million related to accelerated depreciation, contract termination costs, and restructuring costs, which were unrelated to the COVID-19 pandemic.

The total impact on income taxes for the above items was $1.3 million.

Store Update

As of May 1, 2021, the Company had 679 of 724 stores open to the public in the U.S., Canada, and Puerto Rico, with all of the temporarily closed stores located in Canada.

Consistent with the Company’s store fleet optimization initiative, the Company permanently closed 25 stores in the three months ended May 1, 2021.  The Company is planning to close an additional 98 stores in fiscal 2021 bringing total closures to our previously announced target of 300 closures.

The Company ended the quarter with 724 stores and square footage of 3.4 million, a decrease of 20.2% compared to the prior year.  Since the Company’s fleet optimization initiative was announced in 2013, it has permanently closed 474 stores.
  
Balance Sheet and Cash Flow
As of May 1, 2021, the Company had approximately $65.4 million of cash and cash equivalents and $196.9 million outstanding on its revolving credit facility.  Additionally, the Company used approximately $16.6 million in operating cash flow in the three months ended May 1, 2021.

On April 24, 2020, the Company amended its revolving credit facility to provide for an additional $35 million of availability under an accordion feature for one year, increasing availability to $360 million.  On April 23, 2021, the Company amended its revolving credit facility to extend the additional $35 million of availability for an additional year until April 23, 2022. 

Inventories as of May 1, 2021 were $417.8 million compared to inventories of $335.8 million, net of a COVID-19 pandemic related inventory reserve of $63.2 million, as of May 2, 2020.  The increase is primarily due to the absence of COVID-19 related inventory reserves in the current year as well as higher levels of back-to-school basics inventory.

Outlook

As a result of the continued volatility created by the COVID-19 pandemic, the Company is not providing EPS guidance.

Conference Call Information 

The Children’s Place will host a conference call Thursday, May 20, 2021 at 8:00 a.m. Eastern Time to discuss its first quarter fiscal 2021 results.

The call will be broadcast live at http://investor.childrensplace.com. An audio archive will be available on the Company’s website approximately one hour after the conclusion of the call. A conference call transcript will also be posted on our website.

About The Children’s Place
The Children’s Place is the largest pure-play children’s specialty apparel retailer in North America. The Company designs, contracts to manufacture, sells at retail and wholesale, and licenses to sell fashionable, high-quality merchandise predominantly at value prices, primarily under the proprietary “The Children’s Place”, “Place”, “Baby Place”, and “Gymboree” brand names. As of May 1, 2021, the Company had 724 stores in the United States, Canada, and Puerto Rico, online stores at www.childrensplace.com and www.gymboree.com, and the Company’s eight international franchise partners had 213 international points of distribution in 19 countries.

Forward Looking Statements

This press release contains or may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to statements relating to the Company’s strategic initiatives and adjusted net income per diluted share. Forward-looking statements typically are identified by use of terms such as “may,” “will,” “should,” “plan,” “project,” “expect,” “anticipate,” “estimate” and similar words, although some forward-looking statements are expressed differently. These forward-looking statements are based upon the Company’s current expectations and assumptions and are subject to various risks and uncertainties that could cause actual results and performance to differ materially. Some of these risks and uncertainties are described in the Company’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of its annual report on Form 10-K for the fiscal year ended January 30, 2021. Included among the risks and uncertainties that could cause actual results and performance to differ materially are the risk that the Company will be unsuccessful in gauging fashion trends and changing consumer preferences, the risks resulting from the highly competitive nature of the Company’s business and its dependence on consumer spending patterns, which may be affected by changes in economic conditions, the risks related to the COVID-19 pandemic, including the impact of the COVID-19 pandemic on our business or the economy in general (including decreased customer traffic, schools adopting remote and hybrid learning models, closures of businesses and other activities causing decreased demand for our products and negative impacts on our customers’ spending patterns due to decreased income or actual or perceived wealth, and the impact of the CARES Act and other legislation related to the COVID-19 pandemic, and any changes to the CARES Act or such other legislation), the risk that the Company’s strategic initiatives to increase sales and margin are delayed or do not result in anticipated improvements, the risk of delays, interruptions and disruptions in the Company’s global supply chain, including resulting from COVID-19 or other disease outbreaks, or foreign sources of supply in less developed countries, more politically unstable countries, or countries where vendors fail to comply with industry standards or ethical business practices, including the use of forced, indentured or child labor, the risk that the cost of raw materials or energy prices will increase beyond current expectations or that the Company is unable to offset cost increases through value engineering or price increases, various types of litigation, including class action litigations brought under consumer protection, employment, and privacy and information security laws and regulations, the imposition of regulations affecting the importation of foreign-produced merchandise, including duties and tariffs, and the uncertainty of weather patterns. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to release publicly any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Contact:  Investor Relations (201) 558-2400 ext. 14500

(Tables follow)

THE CHILDREN’S PLACE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
		First Quarter Ended
		May 1,				May 2,
			2021				2020
Net sales		$	435,481			$	255,207
Cost of sales			247,275				274,880
Gross profit (loss)			188,206				(19,673	)
Selling, general and administrative expenses			106,738				98,491
Asset impairment charges			–				37,091
Depreciation and amortization			15,561				17,888
Operating income (loss)			65,907				(173,143	)
Interest expense			(4,411	)			(1,840	)
Income (loss) before taxes			61,496				(174,983	)
Provision (benefit) for income taxes			16,291				(60,173	)
Net income (loss)		$	45,205			$	(114,810	)
Earnings (loss) per common share
Basic		$	3.08			$	(7.86	)
Diluted		$	3.01			$	(7.86	)
Weighted average common shares outstanding
Basic			14,670				14,611
Diluted			15,002				14,611

THE CHILDREN’S PLACE, INC.
RECONCILIATION OF NON-GAAP FINANCIAL INFORMATION TO GAAP
(In thousands, except per share amounts)
(Unaudited)
		First Quarter Ended
		May 1,				May 2,
			2021				2020
Net income (loss)		$	45,205			$	(114,810	)
Non-GAAP adjustments:
Incremental COVID-19 operating expenses			1,567				2,374
Accelerated depreciation			1,238				141
Fleet optimization			753				–
Contract termination costs			750				–
Restructuring costs			532				3,391
Inventory provision			–				63,247
Asset impairment charges			–				37,091
Accounts receivables			–				1,043
Gymboree integration costs			–				640
Legal reserve			–				302
Aggregate impact of Non-GAAP adjustments			4,840				108,229
Income tax effect (1)			(1,312	)			(28,663	)
Prior year uncertain tax positions (2)			–				–
Impact of CARES Act (3)			–				(13,477	)
Net impact of Non-GAAP adjustments			3,528				66,089
Adjusted net income (loss)		$	48,733			$	(48,721	)
GAAP net income (loss) per common share		$	3.01			$	(7.86	)
Adjusted net income (loss) per common share		$	3.25			$	(3.33	)
(1) The tax effects of the non-GAAP items are calculated based on the statutory rate of the jurisdiction in which the discrete item resides.
(2) Prior year tax related to uncertain tax positions.
(3) Primarily due to the impact of the CARES Act.
		First Quarter Ended
		May 1,				May 2,
			2021				2020
Operating income (loss)		$	65,907			$	(173,143	)
Non-GAAP adjustments:
Incremental COVID-19 operating expenses			1,567				2,374
Accelerated depreciation			1,238				141
Fleet optimization			753				–
Contract termination costs			750				–
Restructuring costs			532				3,391
Inventory provision			–				63,247
Asset impairment charges			–				37,091
Accounts receivables			–				1,043
Gymboree integration costs			–				640
Legal reserve			–				302
Aggregate impact of Non-GAAP adjustments			4,840				108,229
Adjusted operating income (loss)		$	70,747			$	(64,914	)

THE CHILDREN’S PLACE, INC.
RECONCILIATION OF NON-GAAP FINANCIAL INFORMATION TO GAAP
(In thousands, except per share amounts)
(Unaudited)
		First Quarter Ended
		May 1,				May 2,
			2021				2020
Gross profit (loss)		$	188,206			$	(19,673	)
Non-GAAP adjustments:
Incremental COVID-19 operating expenses			1,000				1,690
Inventory provision			–				63,247
Fleet optimization			–				–
Aggregate impact of Non-GAAP adjustments			1,000				64,937
Adjusted Gross profit (loss)		$	189,206			$	45,264
		First Quarter Ended
		May 1,				May 2,
			2021				2020
Selling, general and administrative expenses		$	106,738			$	98,491
Non-GAAP adjustments:
Fleet optimization			(753	)			–
Contract termination costs			(750	)			–
Incremental COVID-19 operating expenses			(567	)			(684	)
Restructuring costs			(532	)			(3,391	)
Accounts receivables			–				(1,043	)
Gymboree integration costs			–				(640	)
Legal reserve			–				(302	)
Aggregate impact of Non-GAAP adjustments			(2,602	)			(6,060	)
Adjusted Selling, general and administrative expenses		$	104,136			$	92,431

THE CHILDREN’S PLACE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
		May 1,			January 30,			May 2,
		2021			2021*			2020
Assets:
Cash and cash equivalents		$	65,376		$	63,548		$	71,751
Accounts receivable			42,619			39,534			37,173
Inventories			417,808			388,141			335,795
Other current assets			56,629			55,860			23,521
Total current assets			582,432			547,083			468,240
Property and equipment, net			172,090			181,801			212,011
Right-of-use assets			260,919			283,624			349,646
Tradenames, net			72,292			72,492			73,090
Other assets, net			45,969			55,127			81,949
Total assets		$	1,133,702		$	1,140,127		$	1,184,936
Liabilities and Stockholders’ Equity:
Revolving loan		$	196,893		$	169,778		$	234,554
Accounts payable			228,149			252,124			263,984
Current lease liabilities			129,070			174,585			150,463
Accrued expenses and other current liabilities			125,357			122,012			109,999
Total current liabilities			679,469			718,499			759,000
Long-term lease liabilities			195,435			214,173			281,839
Term loan			74,526			75,346			–
Other liabilities			39,263			38,732			39,062
Total liabilities			988,693			1,046,750			1,079,901
Stockholders’ equity			145,009			93,377			105,035
Total liabilities and stockholders’ equity		$	1,133,702		$	1,140,127		$	1,184,936
* Derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended January 30, 2021.

THE CHILDREN’S PLACE, INC.
CONDENSED CONSOLIDATED CASH FLOWS
(In thousands)
(Unaudited)
		13 Weeks Ended				13 Weeks Ended
		May 1,				May 2,
			2021				2020
Net income (loss)		$	45,205			$	(114,810	)
Non-cash adjustments			58,914				29,331
Working capital			(120,682	)			45,028
Net cash used in operating activities			(16,563	)			(40,451	)
Net cash used in investing activities			(6,708	)			(5,612	)
Net cash provided by financing activities			24,450				49,187
Effect of exchange rate changes on cash			649				140
Net increase in cash and cash equivalents			1,828				3,264
Cash and cash equivalents, beginning of period			63,548				68,487
Cash and cash equivalents, end of period		$	65,376			$	71,751

NEW HAVEN, Conn., May 20, 2021 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ Peptide Drug Conjugate (PDC) tumor targeting platform, today announced that it has appointed pharmaceutical and financial services veteran Stephen Basso as Chief Financial Officer.

In this role, Basso will lead and optimize Cybrexa’s financial operations, including but not limited to managing investor relations, overseeing potential financing and engineering Cybrexa’s financial path to advancing the clinical development of its therapeutic candidates as the company seeks to expand addressable patient populations by targeting a broader scope of solid tumors.

“With our lead therapeutic candidate, CBX-12, currently in its Phase 1 trial, it is important that we continue charting this candidate’s development path,” said Per Hellsund, President and CEO of Cybrexa. “With decades of experience in strategic financial planning and analysis in the pharmaceutical industry, Stephen is both a proven talent and a timely addition to Cybrexa. We look forward to the doors that his financial and pharmaceutical expertise will no doubt unlock for the company, as we continue toward providing cancer patients with more treatment options.”

Basso brings more than 30 years of experience in the financial services industry and financial leadership in the pharmaceutical industry. Prior to joining Cybrexa, he served as Senior Vice President of Finance at Inozyme Pharma; Vice President, North America Commercial Finance, Global G&A at Alexion Pharmaceuticals; and Director, Financial Planning and Analysis at Pfizer. Basso holds a Master of Business Administration in finance from Boston College and a Bachelor of Science in business finance from Providence College.

About the alphalex™ Technology Platform

The Cybrexa alphalex™ technology platform – which consists of a pHLIP^® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP^® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP^® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com. 

About Cybrexa

Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.  

Contacts

Cybrexa Therapeutics
Lisa Rehm
Email: [email protected]

Investor Relations                                                                                
Stephanie Carrington
Tel: 646-277-1282
Email: [email protected]

Media Relations
Mark Corbae
Tel: 203-682-8288
Email: [email protected]

Kyle Evans
Tel: 201-421-5061
Email: [email protected]

OTTAWA and EDINBURGH, United Kingdom, May 20, 2021 (GLOBE NEWSWIRE) —

WHO:	CURO Compensation Limited (CURO), an industry leader in total compensation management and pay equity technology
WHAT:	Will deliver the webinar, “How to Prepare Your Team for a Compensation Management Software Implementation.”
WHEN:	Wednesday, May 26, 2021, at 10 a.m. ET.
WHERE:	To register, visit https://curomarketing.curocomp.com/webinar-how-to-prepare-your-team-for-a-compensation-management-software-implementation.
DETAILS:

An integral part of a company’s employee value proposition, compensation also represents the single largest profit and loss expense for most organizations. With shifting work models, the evolution of skills and a trend towards more personalized reward increasing compensation complexity, leading employers want to better understand how compensation management solutions provide the functionality needed to transform pay practices.

During this webinar, CURO co-founder and Senior Consultant Ruth Thomas will join Implementation Consultants Peter Moody and Naomi Kauffeldt to help attendees determine if compensation technology is right for their organization and how to prepare for the implementation process. Attendees will learn what factors impact organizational readiness and influence timelines, how to identify and engage key stakeholders, ways to set measures for success and understand ROI and more.

To register, visit https://curomarketing.curocomp.com/webinar-how-to-prepare-your-team-for-a-compensation-management-software-implementation.

About CURO Compensation

CURO Compensation (CURO) is an award-winning industry leader in total compensation management and pay equity technology. Empowering companies to maximize their talent investments, CURO helps employers make fair and appropriate compensation decisions based on real-time data. With CURO, employers can manage compensation processes with confidence, align employee pay with business success, analyze pay gaps and demonstrate a commitment to diversity, equity, inclusion and belonging across their workforce.

Founded in 2010, CURO solutions support organizations across North America, EMEA and APAC, with CURO Pay Equity recognized for innovating the rapidly growing DEIB technology market. For more information, visit curocomp.com.

Note to editors: Trademarks and registered trademarks referenced herein remain the property of their respective owners.

Media Contact: 
Kate Achille
The Devon Group for CURO 
[email protected]

IRVINE, Calif., May 20, 2021 (GLOBE NEWSWIRE) — Lantronix Inc. (NASDAQ: LTRX), a global provider of secure turnkey solutions for the Internet of Things (IoT) and Remote Environment Management (REM) offering Software as a Service (SaaS), connectivity services, engineering services and intelligent hardware, today announced that its Open-Q 820 µSOM was used in the development of the Whisper Hearing System. Created by San Francisco-based Whisper, the Whisper Hearing System is a learning hearing aid that gets better over time and uses artificial intelligence to process sound.

Click here to see the complete case study.

After seeing family members struggle with hearing loss, the co-founders of Whisper decided to reinvent the way hearing systems work by utilizing artificial intelligence, machine learning and powerful processing. Their goal was to use technology to help users hear better and to use machine learning to improve the system over time.

“Utilizing Lantronix Open-Q 820 µSOM, we were able to create the Whisper Hearing System, giving people with hearing loss a technologically advanced way to hear better,” said Shlomo Zippel, Co-Founder of Whisper.

Challenge: Reimagine Hearing Systems With Advanced Technology

Challenges in creating the Whisper hearing aids included:

• Reducing the latency between the actual sound and when it reaches the user’s ears so that speech is more intelligible, as even small delays make speech less understandable.
• Providing the processing power needed to extract speech from background noise
• Delivering big capabilities in a very small and portable form factor

Solution: Lantronix Open-Q 820 µSOM

Like a traditional hearing aid, the Whisper Hearing System has earpieces with tiny microphones. What makes it unique is the pocket-sized power and intelligence of the Whisper Brain, which is powered by the Lantronix Open-Q 820 µSOM. The Open-Q 820 provides Neural Network processing for sound as well as the low latencies required for speech intelligibility and the processing power to make it all work.

Lantronix’s Open-Q 820 µSOM is the world’s smallest production-ready, pre-certified micro computing module based on the Qualcomm® cutting-edge Snapdragon™ 820 processor. Designed for OEMs, its advanced technology and extensive range of peripherals provide the perfect platform for creating high-performance embedded and mobile devices.

Results: An Affordable Prototype and Speed to Market

Utilizing the Open-Q 820 µSOM enabled the Whisper designers to revolutionize hearing systems by using artificial intelligence, machine learning and wireless technology. The earpieces stay tiny since the Open-Q 820-based processing module is placed in the Whisper Brain, a small device about the size of a deck of cards that can be conveniently carried by the user.

Unlike traditional hearing aids, the Open-Q 820 µSOM’s unique architecture combines traditional powerful CPU cores with a unique advanced digital signaling processor, resulting in efficient power consumption while reducing sound delays and providing advanced separation of speech from background noise.

The Whisper App delivers regular software upgrades to give users the benefit of the very latest advances in hearing technology, delivering the only hearing system that actually learns and gets better over time.

Benefits of utilizing Lantronix’s Open-Q 820 µSOM Include:

• Accelerated timeline to deliver a prototype
• Reduced total cost of development
• Faster production and time-to-market
• FCC/IC and Canada Pre-certified

“We at Lantronix are proud to contribute to the development of the Whisper Hearing System that learns and adapts to the soundtrack of the user’s environment,” said Jonathan Shipman, VP of Strategy at Lantronix.

About Whisper

Established in 2017, Whisper is a team of artificial intelligence, hearing care, hardware, and software experts coming together to solve the challenge of providing better hearing. The team created the Whisper Hearing System so their parents, grandparents, friends and teammates can have a tomorrow that sounds even better than today. For more information visit https://whisper.ai/.

About Lantronix

Lantronix Inc. is a global provider of secure turnkey solutions for the Internet of Things (IoT) and Remote Environment Management (REM), offering Software as a Service (SaaS), connectivity services, engineering services and intelligent hardware. Lantronix enables its customers to provide reliable and secure IoT Intelligent Edge and OOBM solutions while accelerating time to market. Lantronix’s products and services dramatically simplify the creation, development, deployment and management of IoT projects while providing quality, reliability and security across hardware, software and solutions.

With three decades of proven experience in creating robust IoT technologies and OOBM solutions, Lantronix is an innovator in enabling its customers to build new business models, leverage greater efficiencies and realize the possibilities of the Internet of Things. Lantronix’s solutions are deployed inside millions of machines at data centers, offices and remote sites serving a wide range of industries, including energy, agriculture, medical, security, manufacturing, distribution, transportation, retail, financial, environmental and government.

Lantronix is headquartered in Irvine, Calif. For more information, visit www.lantronix.com.

Learn more at the Lantronix blog, www.lantronix.com/blog, featuring industry discussion and updates. To follow Lantronix on Twitter, please visit www.twitter.com/Lantronix. View our video library on YouTube at www.youtube.com/user/LantronixInc or connect with us on LinkedIn at www.linkedin.com/company/lantronix.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Any statements set forth in this news release that are not entirely historical and factual in nature, including without limitation statements related to our solutions, technologies and products as well as the use of our products in the development of Whisper’s Whisper Hearing System, are forward-looking statements. These forward-looking statements are based on our current expectations and are subject to substantial risks and uncertainties that could cause our actual results, future business, financial condition, or performance to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this news release. The potential risks and uncertainties include, but are not limited to, such factors as the effects of negative or worsening regional and worldwide economic conditions or market instability on our business, including effects on purchasing decisions by our customers; the impact of the COVID-19 outbreak on our employees, supply and distribution chains, and the global economy; cybersecurity risks; changes in applicable U.S. and foreign government laws, regulations, and tariffs; our ability to successfully implement our acquisitions strategy or integrate acquired companies; difficulties and costs of protecting patents and other proprietary rights; the level of our indebtedness, our ability to service our indebtedness and the restrictions in our debt agreements; and any additional factors included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2020, filed with the Securities and Exchange Commission (the “SEC”) on September 11, 2020, including in the section entitled “Risk Factors” in Item 1A of Part I of such report, as well as in our other public filings with the SEC. Additional risk factors may be identified from time to time in our future filings. The forward-looking statements included in this release speak only as of the date hereof, and we do not undertake any obligation to update these forward-looking statements to reflect subsequent events or circumstances.

© 2021 Lantronix, Inc. All rights reserved. Lantronix is a registered trademark, and EMG and ConsoleFlow are trademarks of Lantronix Inc. Other trademarks and trade names are those of their respective owners.

Lantronix Media Contact:

Gail Kathryn Miller
Corporate Marketing &
Communications Manager
[email protected]
949-453-7158

Lantronix Analyst and Investor Contact:

Jeremy Whitaker
Chief Financial Officer
[email protected]
949-450-7241

Lantronix Sales:

[email protected]

Americas +1 (800) 422-7055 (US and Canada) or +1 949-453-3990
Europe, Middle East and Africa +31 (0)76 52 36 744
Asia Pacific + 852 3428-2338
China + 86 21-6237-8868
Japan +81 (0) 50-1354-6201
India +91 994-551-2488

Initial Data from Ongoing Phase 1/2 Clinical Trial of NT219 in Adults with Advanced Solid Tumors and Head and Neck Cancer to be Highlighted

REHOVOT, Israel, May 20, 2021 (GLOBE NEWSWIRE) — Purple Biotech Ltd. (“Purple Biotech”, or the “Company”) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, announced today that it will present new data from the ongoing Phase 1/2 clinical trial of NT219 on Friday, June 4, 2021, at the 2021 ASCO Annual Meeting, which will be held virtually from June 4-8.

NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. The Phase 1/2 trial is evaluating NT219 as monotherapy treatment of advanced solid tumors, as well as in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent and/or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma.

“We are excited to present interim data from our ongoing Phase 1/2 clinical trial of NT219 as monotherapy for the treatment of solid tumors that has the potential to help people living with hard-to-treat cancers,” said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Purple Biotech. “We are excited to have clinical data for our NT219 program and we continue to expect the availability of further top-line data from the first part of this study in the second half of this year.”

Details of the presentation are as follows:

Title:  A Phase 1/2 study with open-label, dose escalation phase followed by single-arm expansion at the maximum tolerated dose to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 injection alone and in combination with Cetuximab in Adults with Advanced Solid Tumors and Head and Neck Cancer.

Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Location: ASCO Meeting Library

About Purple Biotech

Purple Biotech Ltd. is a clinical-stage company developing first-in-class therapies by overcoming tumor immune evasion and drug resistance. The Company’s oncology pipeline includes NT219 and CM24. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. The Company is currently advancing NT219 as a monotherapy treatment of solid tumors, followed by a dose escalation of NT219 in combination with cetuximab for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN) or colorectal adenocarcinoma in a Phase 1/2 study, and an expansion phase of NT219 at its recommended phase 2 level in combination with cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways. The Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in selected cancer indications in a Phase 1b study followed by a Phase 2 for the treatment of non-small cell lung cancer and pancreatic cancer. The Company has entered into a clinical collaboration agreement, as amended, with Bristol Myers Squibb for the planned Phase 1/2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab (Opdivo®) in patients with non-small cell lung cancer and in combination with nivolumab in addition to nab-paclitaxel (ABRAXANE®) in patients with pancreatic cancer. The Company is also the owner of Consensi®, an FDA-approved fixed-dose combination of celecoxib and amlodipine besylate, for the simultaneous treatment of osteoarthritis pain and hypertension that was approved by the FDA for marketing in the U.S. Consensi® is being sold in the U.S. by Burke Therapeutics, the marketing partner of the Company’s U.S. distributor, Coeptis Pharmaceuticals. The Company has also partnered to commercialize Consensi in China and South Korea. The Company’s corporate headquarters are located in Rehovot, Israel. For more information, please visit https://www.purple-biotech.com.

Forward-Looking Statements and Safe Harbor Statement

Certain statements in this press release that are forward-looking and not statements of historical fact are forward looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219 and CM24; the process by which early stage therapeutic candidates such as NT219 and CM24 could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2020 and in our other filings with the U.S. Securities and Exchange Commission (“SEC”), including our cautionary discussion of risks and uncertainties under “Risk Factors” in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC’s website, https://www.sec.gov.

Company Contact:

Gil Efron
Deputy CEO & Chief Financial Officer
[email protected]
+972-3-933-3121 ext. #105

Investors Relations Contact:

Chuck Padala
[email protected]
+1 646-627-8390

Media Contact:

Megan Humphreys
[email protected]
+1 412 398 1808

SUNRISE, Fla., May 20, 2021 (GLOBE NEWSWIRE) — Nano Dimension Ltd. (Nasdaq: NNDM), a leading Additively Manufactured Electronics (AME)/PE (Printed Electronics) provider, today announced financial results for the first quarter ended March 31, 2021. 

Nano Dimension reported revenues of $811,000 for the first quarter of 2021. The Company ended the quarter with a cash and deposits balance of $1,471,014,000 (including short and long-term unrestricted bank deposits), while net loss for the first quarter was $9,314,000.

CEO MESSAGE TO SHAREHOLDERS:

Mr. Yoav Stern, Chief Executive Officer of Nano Dimension, commented:

“Our business plan is proceeding on schedule but uniquely to Nano Dimension, as I have explained to our supportive investors and shareholders while we have raised the capital, to comprehend Nano Dimension’s short-term advancements, one should look at our quarterly performance through a magnifying glass that can trifurcate our reported results among three orthogonal axes¹ of intense yet temporarily perpendicular activities and developments:

• First axis– the sale efforts of our existing early bird machines (DragonFly LDM) which are slowly recovering from a long corona-related hibernation.
• The Second axis – our investment and expansion of our Product Development efforts, which are the main reason for the larger expense line, show a positive trend as we deploy capital as planned and promised, to accelerate R&D of material and printing technologies to advance the AME product line through the milestones of fitting market specifications.
• The Third axis is our M&A efforts. The two recent acquisitions, which have been “in process” for approximately 6 months, and the additional prospects we are working on since H2/2020, do not yet reflect positively on our financial statements.

On the First axis, as we have stated before, the effects of the pandemic, which include slow vaccination processes and recurring closures (especially in Europe), are still affecting our ability to sell new machines. Our technology is in its early adoption stage, and technologically forward-thinking prospective customers have not been allowed to make large capital equipment purchases under their current COVID-19 budgetary limitations. Additionally, due to COVID-related restrictions we cannot visit the facilities of most potential future customers, which severely limits our marketing and sales efforts.

“It is important to note that academic institutions are moving more quickly than private enterprise in overcoming COVID-related restrictions in making large purchases of capital equipment. In fact, we just announced the sale of a DragonFly LDM® to the University of Quebec in Canada. We are also very focused on building our sales and marketing organizations in the U.S., Europe and Asia so that we are prepared to ramp our sales efforts as pandemic-related restrictions are lifted. Our Sales and Marketing efforts are expressed in our P&L statements under the line: “Sales and marketing expenses,” which have more than tripled over the same period last year.

Our product development efforts on the Second axis are reflected in our P&L statements in the line: “Research and development expenses,” which have more than doubled in comparison to Q1/2020.

“The evolution on the Thirdaxis, our M&A activities, are manifested in the line “General and administrative expenses” in our P&L statements, which demonstrates more than tripled efforts, as we have recruited senior executive and business research personnel, in comparison to Q1/2020,” added Mr. Stern. “We see positive developments. After approximately 6 months of due diligence and negotiations, we have completed, at the end of April 2021, two exciting acquisitions:

• “DeepCube’s Deep Learning/Machine Learning technology will move us generations ahead of the competition with technology that will result in a much higher performance of our machines, based on self-learning, self-improvements and self-correcting algorithms.
• 
  NanoFabrica
  , is one of the most unique DLP Micro-3D-Printing machines (Digital Light Processing) developers in the world. We are in the process of making introductions of its technology in the form of TERA 250 3D-printers to our mutual vertical market segments (Defense, Aerospace, Aviation, Advance Medical and Industrial).

The much larger European and American companies which we are negotiating with, have been in a temporary acquisition-prohibitive status. Under the travel restrictions of the last year, we, as a buyer, refuse to close any transaction without physically visiting the facilities and undergoing a fully responsible and in-depth face-to-face due diligence process.

We have laid the groundwork to pursue a deeper due diligence and finalize those processes, as COVID travel and other restrictions are lifted with those companies. An acquisition of any one or more of the U.S. or European companies we are evaluating is expected to leapfrog Nano Dimension into a leading market position as we were aiming at over the last 2 quarters.”

“In summary,” Mr. Stern concluded, “Within a reasonable amount of time, all 3 of the axes are going to lose their orthogonality, and slowly merge into one direction. Product activity, M&A and Go-To-Market thrusts, being built now to deliver future synergy and complementarity, are planned to gradually merge, leverage off of each other and fuel a mutually accelerated growth. The companies we have acquired and plan to procure are analyzed based on their ability to amalgamate with the marketing channels of the products we develop and the market presence we build now for our early product lines. All 3 axes of activity will continue, but in parallel-overlapping routes rather than perpendicularly, integrated into a clear direction and mutual goals while quickening the growth.

Nano Dimension’s vision is to transform the electronics industry into an environmentally friendly and economically efficient additive manufacturing INDUSTRY 4.0: Enabling one-industrial-step process for the conversion of digital designs into functioning electronic devices, on demand, anytime, anywhere. We are in an incredibly strong financial position and have laid the foundation for substantial future growth.”

FINANCIAL RESULTS:




First Quarter 2021 Financial Results

●	Total revenues for the first quarter of 2021 were $811,000, compared to $1,971,000 in the fourth quarter of 2020, and $702,000 in the first quarter of 2020. The decrease is attributed to continuing delays in sales of DragonFly systems, which the Company primarily attributes to the impact of COVID-19.
●	Research and development (R&D) expenses for the first quarter of 2021 were $3,732,000, compared to $3,725,000 in the fourth quarter of 2020, and $1,702,000 in the first quarter of 2020. The increase compared to the first quarter of 2020 is attributed to an increase in payroll expenses and share-based payment expenses, as well as increase in materials expenses.
●	Sales and marketing (S&M) expenses for the first quarter of 2021 were $2,713,000, compared to $2,373,000 in the fourth quarter of 2020, and $819,000 in the first quarter of 2020. The increase compared to the fourth quarter of 2020 is attributed to an increase in share-based payment expenses and an increase in marketing expenses. The increase compared to the first quarter of 2020 is attributed to an increase in share-based payment expenses, an increase in payroll expenses due to an increase in the number of employees and an increase in marketing expenses.
●	General and administrative (G&A) expenses for the first quarter of 2021 were $3,425,000, compared to $3,539,000 in the fourth quarter of 2020, and $1,035,000 in the first quarter of 2020. The increase compared to the first quarter of 2020 is attributed to an increase in share-based payment expenses.
●	Net loss for the first quarter of 2021 was $9,314,000, or $0.05 per share, compared to $17,439,000, or $0.20 per share, in the fourth quarter of 2020, and $2,074,000, or $0.32 per share, in the first quarter of 2020.

Balance Sheet Highlights

●	Cash and cash equivalents, together with short and long-term bank deposits totaled $1,471,014,000 as of March 31, 2021, compared to $670,934,000 as of December 31, 2020. The increase compared to December 31, 2020, mainly reflects proceeds received from the sale of American Depositary Shares representing the Company’s ordinary shares.
●	Shareholders’ equity totaled $1,469,665,000 as of March 31, 2021, compared to $667,116,000 as of December 31, 2020.

Conference call information

The Company will host a conference call to discuss these financial results today, May 20, 2021, at 9:00 a.m. EDT (4:00 p.m. IDT). U.S. Dial-in Number: 1-866-744-5399, Israel Dial-in Number: 972-3-9180692. Please request the “Nano Dimension NNDM call” when prompted by the conference call operator.
For those unable to participate in the conference call, there will be a replay available from a link on Nano Dimension’s website at http://investors.nano-di.com/events-and-presentations.

About Nano Dimension

Nano Dimension (Nasdaq: NNDM) is a provider of intelligent machines for the fabrication of Additively Manufactured Electronics (AME). High fidelity active electronic and electromechanical subassemblies are integral enablers of autonomous intelligent drones, cars, satellites, smartphones, and in vivo medical devices. They necessitate iterative development, IP safety, fast time-to-market and device performance gains, thereby mandating AME for in-house, rapid prototyping and production. Nano Dimension machines serve cross-industry needs by depositing proprietary consumable conductive and dielectric materials simultaneously, while concurrently integrating in-situ capacitors, antennas, coils, transformers and electromechanical components, to function at unprecedented performance. Nano Dimension bridges the gap between PCB and semiconductor integrated circuits. A revolution at the click of a button: From CAD to a functional high-performance AME device in hours, solely at the cost of the consumable materials. For more information, please visit www.nano-di.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. Because such statements deal with future events and are based on Nano Dimension’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Nano Dimension could differ materially from those described in or implied by the statements in this press release. For example, Nano Dimension is using forward-looking statements when it discusses the expected impact of the COVID-19 pandemic and the recovery of sales, the expected benefits from investments in its sales and marketing organizations, advancement of the AMWE product line through milestones, the expected benefits from and continuation of M&A efforts, and expected market position and accelerated growth. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Nano Dimension’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 11, 2021, and in any subsequent filings with the SEC. Except as otherwise required by law, Nano Dimension undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Nano Dimension is not responsible for the contents of third party websites. 

NANO DIMENSION INVESTOR RELATIONS CONTACT

Yael Sandler, CFO | [email protected] 

Unaudited Consolidated Statements of Financial Position as at

		March 31,									December 31,
		2020					2021				2020(*)
(In thousands of USD)		(Unaudited)					(Unaudited)
Assets
Cash and cash equivalents			4,509					1,099, 057				585,338
Bank deposits			–					296,844				85,596
Restricted deposits			31					61				62
Trade receivables			1,482					999				713
Other receivables			609					972				1,126
Inventory			3,679					3,164				3,314
Total current assets			10,310					1,401, 09 7				676,149
Bank deposits			–					75,113				–
Restricted deposits			366					391				406
Property plant and equipment, net			4,604					5,422				5,092
Right of use asset			2,459					4,103				3,169
Intangible assets			5,019					4,24 3				4,440
Total non-current assets			12,448					89,272				13,107
Total assets			22,758					1,490, 36 9				689,256
Liabilities
Trade payables			756					1,654				776
Other payables			3,447					5, 449				5,910
Total current liabilities			4,203					7 , 103				6,686
Liability in respect of government grants			937					754				850
Lease liability			1,834					3,277				2,618
Liability in respect of warrants and rights of purchase			464					9,570				11,986
Total non-current liabilities			3,235					13,601				15,454
Total liabilities			7,438					20, 704				22,140
Equity
Share capital			12,219					375,594				257,225
Share premium and capital reserves			65,216					1,211,920				518,426
Treasury shares			(1,509)					(1,509)				(1,509)
Presentation currency translation reserve			1,431					1,431				1,431
Accumulated loss			(62,037)					( 117, 771)				(108,457)
Total equity			15,320					1,4 69 , 665				667,116
Total liabilities and equity			22,758					1,490, 369				689,256

(*) The December 31, 2020 balances were derived from the Company’s audited annual financial statements.

  

Unaudited Consolidated Statements of Profit or Loss and Other Comprehensive Income


(In thousands of USD, except per share amounts) 
  

	For the Three-Month Period Ended March 31,						For the Year ended December 31,
	2020			2021			2020(*)
Revenues	702			811			3,399
Cost of revenues	415			352			1,563
Cost of revenues – amortization of intangible	193			197			771
Total cost of revenues	608			549			2,334
Gross profit	94			262			1,065
Research and development expenses, net	1,702			3, 732			9,878
Sales and marketing expenses	819			2, 713			6,597
General and administrative expenses	1,035			3, 425			20,287
Operating loss	(3,462	)		( 9, 608	)		(35,697	)
Finance income	1,426			818			446
Finance expense	38			524			13,243
Total comprehensive loss	(2,074	)		( 9, 314	)		(48,494	)
Basic loss per share (after 1:50 reverse split effective June 29, 2020)	(0.32	)		( 0. 0 5	)		(1.13	)

(*) The December 31, 2020 balances were derived from the Company’s audited annual financial statements.

Consolidated Statements of Changes in Equity (Unaudited)


(In thousands of USD)

		Share capital				Share premium and capital reserves					Treasury shares				Presentation currency translation reserve				Accumulated loss				Total equity
For the Three months ended March   31 , 2021 :
Balance as of January 1, 2021			257,225				518,426					(1,509	)			1,431				(108,457	)			667,116
Issuance of ordinary shares, net			114,024				682,322					—				—				—				796,346
Exercise of warrants and options			4,345				(1,415	)				—				—				—				2,930
Share-based payments			—				12,587					—				—				—				12,587
Net loss			—				—					—				—				(9,314	)			(9,314	)
Balance as of March 31, 2021			375,594				1,211,920					(1,509	)			1,431				( 11 7 , 771	)			1, 469, 665

---

¹ An orthogonal classification is one in which no item is a member of more than one group, that is, the classifications are mutually exclusive. Independent variables that affect a particular variable are said to be orthogonal if they are uncorrelated.

REDWOOD CITY, Calif., May 20, 2021 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced the addition of Davelyn Hood, MD, to its leadership team as Director, Scientific and Patient Affairs. In her new role, Dr. Hood will be a key member of the team in furthering the development of RZ358, Rezolute’s monoclonal antibody currently being evaluated in a Phase 2b clinical trial to treat congenital hyperinsulinism, a rare disease that is the most common cause of persistent low blood sugars in children.

“Dr. Hood is an ideal addition to our team, as her professional expertise, combined with her first-hand understanding of the patient experience, will be invaluable in guiding the RZ358 clinical program,” said Brian Roberts, MD, Head of Clinical Development at Rezolute.

Dr. Hood is a long-standing member of Congenital Hyperinsulinism International (CHI), where she has led international collaboration and communication efforts around ensuring increased access to treatment. In addition to over a decade of experience working on initiatives related to congenital hyperinsulinism, Dr. Hood has also served in various scientific and leadership capacities, including the President of the Board of Directors and Principal Investigator for the patient reported Hyperinsulinism Global Registry, aimed at consolidating patient data for research purposes.

“I am honored to be joining the talented team at Rezolute and to support the development of RZ358,” said Dr. Hood. “Being a parent to a child with congenital hyperinsulinism makes the management of the disease and the search for better therapies very personal for me. I am looking forward to highlighting the unique needs of the CHI patient population and applying my medical and advocacy experience in advancing the RZ358 clinical program.”

About RZ358

RZ358 is an intravenously administered human monoclonal antibody that binds to a unique site (allosteric) on the insulin receptor throughout the body, such as in the liver, fat, and muscle. The antibody modifies insulin’s binding and signaling to maintain glucose levels in a normal range which counteracts the effects of elevated insulin in the body. Therefore, we believe that RZ358 is ideally suited as a potential therapy for conditions characterized by excessive insulin levels, and it is being developed to treat the hyperinsulinism and low blood sugar characteristic of diseases such as congenital HI. As RZ358 acts downstream from the beta cells, it has the potential to be universally effective at treating congenital HI caused by any of the underlying genetic defects.

RZ358 received Orphan Drug Designation in the United States and European Union as well as Pediatric Rare Disease Designation in the US. Rezolute is currently evaluating RZ358 in the RIZE trial, a Phase 2b clinical trial in patients with congenital hyperinsulinism.

About Rezolute, Inc.

Rezolute is advancing novel therapies for diseases caused by chronic glucose imbalance. The Company’s lead clinical asset, RZ358, is in Phase 2b development for treatment of congenital hyperinsulinism (CHI), a rare pediatric endocrine disorder. The Company is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema. For more information, visit www.rezolutebio.com or follow us on Twitter.

Forward-Looking Statements

This release, like many written and oral communications presented by Rezolute, Inc. and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “seek,” “strive,” “try,” or future or conditional verbs such as “could,” “may,” “should,” “will,” “would,” or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.

Media and Investor Contact

Argot Partners
[email protected]
212-600-1902

Global WholeHealth Partners Corp (GWHP: OTC) is bringing the testing to you, to your school or to your work.  8k filed on 05/14/2021.

Global will be using this CLIA WAIVED Lab to test for COVID 19 Antigen, Antibody, and the other 15 tests that are CLIA WAIVED that Global carries.

San Clemente, CA, May 20, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Global WholeHealth Partners Corp. (OTC: GWHP) offers one of the largest lines of COVID 19 tests. Global WholeHealth Partners Corp (OTC: GWHP) states that the Antibody IgG/IgM tests that they offer are capable of detecting all the current identified SARS-CoV-2 viruses.  The strains identified in the United Kingdom (B.1.1.7), South Africa (B.1.351), and Brazil (P.1) strain contains multiple mutations, most reflected in the S gene, which encodes the spike protein. Global understands the need to be ahead of the virus to conquer the virus.

Global WholeHealth Partners recognizes that there is a crucial need for faster testing and faster results when it comes to fighting the COVID. Global WholeHealth Partners knows that the quicker the test results can be reviewed by a Front-Line Healthcare Worker, the quicker we can stop the spread of this disease.

Global WholeHealth Partners Corp. provides cutting edge technology using In-vitro Diagnostic (IVD) Real-Time PCR Machines for detection of SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood. It has led the fight against vector borne terminal diseases such as Ebola, ZIKA, Dengue, Malaria, Influenza and Tuberculosis, Corona Viruses, and among other vector borne diseases, with an FDA Certificate of Exportability (2260-11-2019).  The company was founded on March 7, 2013 and is headquartered in San Clemente, CA.

GWHP develops, manufactures, and markets in vitro diagnostic (IVD) tests for OTC, or consumer-use as well as professional rapid diagnostic point-of-care (POC) test kits for hospitals, physicians’ offices, and medical clinics in the US and abroad. Notably, The Company offers 56 products FDA approved and many are Approved for OTC use, and 15 POC products approved by the CLIA WAIVED FDA.

Media Contact:

Name: Charles Strongo,

CEO, Global WholeHealth Partners Corp.

Email: [email protected]

www.gwhpcorp.com

Forward-Looking Statements

This press release contains “forward-looking statements.”  Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

VANCOUVER, British Columbia, May 20, 2021 (GLOBE NEWSWIRE) — American Lithium Corp. (“American Lithium” or the “Company”) (TSX-V:LI | OTCQB:LIACF | Frankfurt:5LA1) is pleased to announce positive lithium results from mapping and sampling of two new outcrop target areas in the Quelcaya region 6 kilometres (km) west of the Falchani lithium deposit in the Macusani Plateau in southeastern Peru. The Company is also pleased to provide an update on upcoming exploration and development plans for these new areas and for the existing Falchani Lithium and Macusani Uranium Projects (“Falchani” and “Macusani”).

Highlights:

• Two new high priority, drill-ready lithium target areas have been identified west of Falchani through mapping and surface sampling.
• Drilling now being planned to test these targets and focus on the discovery of new lithium deposits.
• In-fill and expansion drilling to begin at Falchani and focus on resource re-classification (upgrading resource categories) and resource expansion.
  • Expansion drilling to begin at Macusani to expand existing uranium resources and test for new deposits.
• Permitting process, including environmental and community permitting, underway with goal of launching the above drill programs late June to coincide with the end of the local rainy season.

Simon Clarke, Chief Executive Officer & Director of American Lithium stated, “We are very excited with the new lithium and uranium exploration targets generated by our Peruvian team and are pleased with the progress made on permitting required to reactivate exploration and development. Drilling is expected to commence shortly. Having our own diamond drills provides maximum flexibility while enabling us to control and minimize drilling costs. We anticipate running three drill rigs simultaneously.”

Dr. Laurence Stefan, President, Chief Operating Officer & Director of American Lithium added, “The newly discovered lithium target areas expand our exploration drill target inventory separately from the large Falchani Lithium deposit. In addition, the work we have planned at both the Falchani and Macusani Projects should enable us to expand and re-classify our existing resources at both Projects. We are optimistic that the planned drill programs will further enhance both the lithium and uranium potential of the entire Macusani Plateau region for the benefit of all stakeholders. Our pioneering work in Peru in the field of green energy metals will help strengthen the country’s status as a prime mining jurisdiction.”

Outcrop Mapping and Sampling Results Details

In Q3-Q4 2020 and Q1 of 2021, while adhering to strict national and local COVID-19 regulations and with the support of local communities, Plateau’s Peruvian technical team completed surface exploration work consisting of prospecting, mapping and outcrop sampling west of the Falchani Lithium Deposit in the south-central portion of the Company’s project area. This work resulted in the discovery of two new areas of outcropping and sub-cropping volcanic-related lithium mineralization.

A total of 64 grab and trench samples were collected from surface outcrop or subcrop buried under thin soil cover from 2 separate areas located near Quelcaya Village, 6 km west of the Falchani Lithium project area (for location map follow link: Quelcaya Area Location Map). Samples were collected and analyzed for a variety of volcanic rock types and returned highly variable lithium grades ranging from 88 parts per million (ppm) Li to 2,700 ppm Li. The selected nature of such sampling does not necessarily reflect potential lithium contents expected from future drill testing, but do indicate the presence of lithium mineralization in new areas in a similar volcanic-related setting but in different rock units and rock types than at Falchani.

The results of the mapping and sampling work with lithium geochemical analyses for selected samples displayed, along with interpreted provisional cross-sections for the Sapanuta 3 and Clark-Dyke Zones are summarized in the three figures linked in this release. Outcrop descriptions and structural measurements were used to interpret the local geology and produce maps and sections. The cross-sections are provisional and will be used to guide the drill targeting, which will more accurately establish the subsurface geology.

Sapanuta 3 Zone


The Sapanuta 3 Zone consists of shallow dipping, highly weathered volcaniclastic tuffs very similar to those found at Falchani, but with lithium grades ranging between 1,056-1,758 ppm Li. The tuff unit is exposed in outcrop and appears to be intruded or cored by a small subvolcanic intrusive exposed downslope, and in part, is overlain by thin Macusani rhyolite. The extensive surface weathering / alteration in this area may be responsible for the lower Li grades observed in surface grab samples compared to Falchani, but it is interpreted that this new tuff unit may have the potential to host similar grades and thickness as Falchani in the subsurface, however this will ultimately be confirmed through drilling. For further details follow link: Sapanuta Interpreted Cross Section C-C’.

Clark-Dykes Zone


The Clark-Dykes Zone consists of a shallow dipping subvolcanic intrusive sill/dyke unit with lithium grades ranging from 704-2,700 ppm Li. The sill/dyke unit underlies a thin volcaniclastic tuff with lower Li grades than the Li-rich tuff hosting Falchani-style mineralization. It is interpreted that the sill/dyke unit appears to terminate in a subvolcanic intrusion downslope to the southwest. The footwall rocks underlying the Li-rich sill/dyke unit are rhyolite. While different in style to Falchani, the crystalline nature of the host sill/dyke unit suggests that upgrading should be possible through simple rejection of coarser crystalline mineral phases (quartz and feldspars that can represent up to 50% by volume of the rock) through screening and/or flotation. This processing work and initial leach testing work is currently being planned alongside initial drill testing. For further details follow link: Clark Dykes Interpreted Cross Section D-D’.

Samples were collected using geological hammers with samples of 3-6 kilograms (kg) placed in sealed bags for shipping to analytical labs in Lima. Sample site map coordinates are recorded using hand-help GPS, outcrop descriptions and any structural measurements are recorded, and samples described and photographed by Company geologists.

Quality Assurance, Quality Control and Data Verification

Outcrop grab samples are collected from exposed outcrop, with samples placed in sealed bags and shipped to Certimin’s sample analytical laboratory in Lima for sample preparation, processing and ICP-MS/OES multi-element analysis. Certimin is an ISO 9000 certified assay laboratory. The selected grab samples are not necessarily representative of the grades of mineralization hosted on the property. The Company’s Qualified Person, Mr. Ted O’Connor, has verified the data disclosed, including prospecting and outcrop sampling procedures and analytical data. The program is designed to include a comprehensive analytical quality assurance and control routine comprising the systematic use of Company inserted standards, blanks and field duplicate samples and internal laboratory standards.

Falchani and Macusani Drill Programs

Drill rigs will also be mobilized to Falchani and Macusani. At Falchani, drilling will focus on in-fill and expansion drilling with a focus on the re-classification (upgrading resource categories) and expansion of existing resources. At Macusani drilling will focus on newly prospected/mineralized areas extending from several existing deposits and on new areas where sampling has identified surface uranium mineralization (Please refer to Plateau Energy news release dated January 26, 2021 for details).

Option Grant

The Company also announces the granting, subject to regulatory acceptance, of an aggregate of 7,050,000 incentive stock options to certain officers, directors and consultants of the Company (the “Options”). The Options have a term of 5 years and are exercisable at a price of $2.17 per common share.

Qualified Person

Mr. Ted O’Connor, P.Geo., a Director of American Lithium, and a Qualified Person as defined by National Instrument 43-101 Standards of Disclosure for Mineral Projects, has reviewed and approved the scientific and technical information contained in this news release.

Ab
out American Lithium

American Lithium is actively engaged in the acquisition, exploration and development of lithium projects within mining-friendly jurisdictions throughout the Americas. The company is currently focused on enabling the shift to the new energy paradigm through the continued exploration and development of its strategically located TLC lithium claystone project in the richly mineralized Esmeralda lithium district in Nevada as well as continuing to advance its Falchani lithium and Macusani uranium development projects in southeastern Peru. Both Falchani and Macusani have been through preliminary economic assessments, exhibit strong additional exploration potential and are situated near significant infrastructure.

Please watch our informative project update videos and related background information at https://www.americanlithiumcorp.com

For more information, please contact the Company at [email protected] or visit our website at www.americanlithiumcorp.com. Follow us on Facebook, Twitter and LinkedIn.

On behalf of the Board of Directors of American Lithium Corp.

“Simon Clarke”

CEO & Director

Tel: 604 428 6128

For further information, please contact:

American Lithium Corp.
Email: [email protected]
Website: www.americanlithiumcorp.com

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

Cautionary Statement Regarding Forward Looking Information

This news release contains certain forward-looking information and forward-looking statements (collectively “forward-looking statements”) within the meaning of applicable securities legislation. All statements, other than statements of historical fact, are forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements regarding the plans, objectives and advancement of the TLC, Falchani and Macusani Projects (the “Projects”), exploration drilling plans, in-fill and expansion drilling plans, results of exploration and development plans, expansion of resources and testing of new deposits, environmental and social community permitting, and any other statements regarding the business plans, expectations and objectives of American Lithium. Forward-looking statements are frequently identified by such words as “may”, “will”, “plan”, “expect”, “anticipate”, “estimate”, “intend”, “indicate”, “scheduled”, “target”, “goal”, “potential”, “subject”, “efforts”, “option” and similar words, or the negative connotations thereof, referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management are not, and cannot be, a guarantee of future results or events. Although American Lithium believes that the current opinions and expectations reflected in such forward-looking statements are reasonable based on information available at the time, undue reliance should not be placed on forward-looking statements since American Lithium can provide no assurance that such opinions and expectations will prove to be correct.  All forward-looking statements are inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including risks, uncertainties and assumptions related to: American Lithium’s ability to achieve its stated goals, including the anticipated benefits of the acquisition of Plateau Energy Metals Inc. (“Plateau”); the estimated costs associated with the advancement of the Projects; risks and uncertainties relating to the COVID-19 pandemic and the extent and manner to which measures taken by governments and their agencies, American Lithium or others to attempt to reduce the spread of COVID-19 could affect American Lithium, which could have a material adverse impact on many aspects of American Lithium’s businesses including but not limited to: the ability to access mineral properties for indeterminate amounts of time, the health of the employees or consultants resulting in delays or diminished capacity, social or political instability in Peru which in turn could impact American Lithium’s ability to maintain the continuity of its business operating requirements, may result in the reduced availability or failures of various local administration and critical infrastructure, reduced demand for the American Lithium’s potential products, availability of materials, global travel restrictions, and the availability of insurance and the associated costs; risks related to the certainty of title to the properties of American Lithium, including the status of the “Precautionary Measures” filed by American Lithium’s subsidiary Macusani Yellowcake S.A.C. (“Macusani”), the outcome of the administrative process, the judicial process, and any and all future remedies pursued by American Lithium and its subsidiary Macusani to resolve the title for 32 of its concessions; risks regarding the ongoing Ontario Securities Commission regulatory proceedings; the ongoing ability to work cooperatively with stakeholders, including but not limited to local communities and all levels of government; the potential for delays in exploration or development activities due to the COVID-19 pandemic; the interpretation of drill results, the geology, grade and continuity of mineral deposits; the possibility that any future exploration, development or mining results will not be consistent with our expectations; risks that permits will not be obtained as planned or delays in obtaining permits; mining and development risks, including risks related to accidents, equipment breakdowns, labour disputes (including work stoppages, strikes and loss of personnel) or other unanticipated difficulties with or interruptions in exploration and development; risks related to commodity price and foreign exchange rate fluctuations; risks related to foreign operations; the cyclical nature of the industry in which American Lithium operates; risks related to failure to obtain adequate financing on a timely basis and on acceptable terms or delays in obtaining governmental approvals; risks related to environmental regulation and liability; political and regulatory risks associated with mining and exploration; risks related to the uncertain global economic environment and the effects upon the global market generally, and due to the COVID-19 pandemic measures taken to reduce the spread of COVID-19, any of which could continue to negatively affect global financial markets, including the trading price of American Lithium’s shares and could negatively affect American Lithium’s ability to raise capital and may also result in additional and unknown risks or liabilities to American Lithium. Other risks and uncertainties related to prospects, properties and business strategy of American Lithium are identified in the “Risks and Uncertainties” section of Plateau’s Management’s Discussion and Analysis filed on January 19, 2021, in the “Risk Factors” section of American Lithium’s Management’s Discussion and Analysis filed on January 29, 2021, and in recent securities filings available at

www.sedar.com

. Actual events or results may differ materially from those projected in the forward-looking statements. American Lithium undertakes no obligation to update forward-looking statements except as required by applicable securities laws. Investors should not place undue reliance on forward-looking statements.

Cautionary Note Regarding Macusani Concessions

Thirty-two of the 151 concessions held by American Lithium’s subsidiary Macusani, are currently subject to Administrative and Judicial processes (together, the “Processes”) in Peru to overturn resolutions issued by INGEMMET and the Mining Council of MINEM in February 2019 and July 2019, respectively, which declared Macusani’s title to 32 of the concessions invalid due to late receipt of the annual validity payments. In November 2019, Macusani applied for injunctive relief on 32 concessions in a Court in Lima, Peru and was successful in obtaining such an injunction on 17 of the concessions including three of the four concessions included in the Macusani Uranium Project PEA. The grant of the Precautionary Measure (Medida Cautelar) has restored the title, rights and validity of those 17 concessions to Macusani until a final decision is obtained at the last stage of the judicial process. A Precautionary Measure application was made at the same time for the remaining 15 concessions and was ultimately granted by a Court in Lima, Peru on March 2, 2021 which has also restored the title, rights and validity of those 15 remaining concessions to Macusani, with the result being that all 32 concessions are now protected by Precautionary Measure (Medida Cautelar) until a final decision on this matter is obtained at the last stage of the judicial process. A final date for the last stage of the judicial process has not yet been set. If American Lithium’s subsidiary Macusani does not obtain a successful resolution of the Processes, its title to the concessions could be revoked.

 

BOSTON, May 20, 2021 (GLOBE NEWSWIRE) — Atea Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of next-generation therapeutics for severe viral infections, today announced the appointment of Jerome Adams, M.D., M.P.H., to its Board of Directors. Dr. Adams most recently served as Surgeon General of the United States and brings a wide range of experience spanning clinical practice, clinical research, public health, and government agency leadership.

“We are honored to welcome Dr. Adams to our Board of Directors, as his unique experience as Surgeon General during the COVID-19 pandemic will undoubtedly help guide Atea as we continue to advance our antiviral pipeline, including our global Phase 3 MORNINGSKY trial of AT-527 for the treatment of COVID-19,” said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals.

“As a result of the COVID-19 pandemic, the focus of citizens and governments throughout the world on public health and infectious diseases is extremely high. With AT-527, Atea has the potential to bring an easily administered oral antiviral to help in the fight against this global public health crisis. I am looking forward to lending my expertise to help advance this important program, while also supporting Atea in the development of its broader antiviral pipeline for severe viral diseases,” commented Dr. Adams.

Dr. Adams served as the 20^th Surgeon General of the United States from 2017 to 2021, where he focused on the opioid epidemic and was a member of the COVID-19 Task Force. Prior to that, he served as the State Health Commissioner for Indiana from 2014 to 2017, where he presided over Indiana’s efforts to deal with state-wide, unprecedented HIV outbreak. Before beginning his public service in 2014, Dr. Adams was a practicing anesthesiologist and Associate Professor in the Department of Anesthesiology at Indiana University. Earlier in his career, Dr. Adams was a Clinical Research Assistant at Eli Lilly and Company. He has served in leadership positions at a number of professional organizations, including the American Medical Association, the Indiana State Medical Association, and the Indiana Society of Anesthesiologists.

Dr. Adams received a B.S. in Biochemistry and B.A. in Psychology from the University of Maryland and holds an M.P.H. from the University of California, Berkeley, and an M.D. from Indiana University School of Medicine.

About Atea Pharmaceuticals

Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential of our product candidates, in particular AT-527, and expectations regarding our pipeline. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: uncertainty around and costs associated with the development of AT-527 as a potential treatment for COVID-19 and our other product candidates; dependence on management, directors and other key personnel; the impact of the COVID-19 pandemic on our business; our limited operating history and significant losses since inception; our need for substantial additional funding; our ability to use our net operating loss carryforwards; our dependence on the success of our most advanced product candidates; risks related to the regulatory approval process; risks associated with the clinical development process; risks related to healthcare laws and other legal compliance matters; risks related to potential commercialization; risks related to manufacturing and our dependence on third parties; risks relating to intellectual property; our ability to maintain effective internal control over financial reporting and the significant costs as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in our most recent Quarterly Report on Form 10-Q, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Contacts

Jonae Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
[email protected]

Will O’Connor
Stern Investor Relations
212-362-1200
[email protected]