Market Newsdesk

QUEBEC CITY, May 03, 2021 (GLOBE NEWSWIRE) — (TSXV: HEO) – H₂O Innovation Inc. (“H₂O Innovation” or the “Corporation”) is pleased to announce its continued expansion in (“LATAM”), and increased efforts in the North American water reuse market, executing on several key objectives from the Corporation’s 3-Year Strategic Plan.

In line with the recently announced acquisition of Genesys Membrane Products S. L. (“GMP”), which added an office for the Corporation in Santiago, Chile, H₂O Innovation will strengthen existing and generate new relationships with original equipment manufacturers (“OEM”) in LATAM, a high growth potential market. With Piedmont having recently signed Pavax as a new distributor in Brazil, the Corporation’s Specialty Products pillar has now over 20 distributors in LATAM. A Key Account strategy is being implemented across all business lines and will improve market access for the Corporation’s OEM partners in LATAM.

In the United States, the Biden Administration has plans for a $110 B water infrastructure plan, a significant portion of which will likely go towards water reuse equipment improvements and upgrades. According to the President’s plan, $50 B will go for investments in programsto help communities build resilient land and water resources to tackle extreme weather events, including programs to provide funding for the western drought crisis by investing in water efficiency and recycling programs (Source: WateReuse Association). H₂O Innovation is capitalizing on the momentum from this to develop a new digital marketing strategy that focuses on its globally recognized expertise in water reuse.

Tying these two initiatives together, H₂O Innovation recently hired Alejandro Sturniolo to fulfill the role of Global Head of Water Reuse and Strategic Partnerships. He will lead the Corporation’s intention to become a global leader in these important markets. “We have known Alejandro for many years both professionally and as a friend, and we are excited to have the opportunity to bring him into the H₂O Innovation family. With his technical and commercial knowledge of the global water reuse market, and his experience with equipment and consumables in Latin America, he is perfectly positioned to help us grow in these strategic areas. Moreover, his vision and passion fit well with our strong company culture”, stated Frédéric Dugré, President and CEO of H₂O Innovation.

Alejandro has been involved in the water industry for the past 22 years and he currently serves as Vice-President and board member for the International Desalination Association (“IDA”) and Latin American Association of Desalination and Water Reuse (“ALADYR”), two important Water Industry associations. He successfully grew his own company, based in Argentina and Brazil, into one of the most recognized Water System Integrator in Latin America. Now based in Spain, he will help all H₂O Innovation business lines active internationally (mostly PWT, Genesys & Piedmont) to increase their sales with existing and new customers and distributors. In parallel, he will also spearhead H₂O Innovation global positioning as a leader in water reuse.

Prospective disclosures

Certain statements set forth in this press release regarding the activities of H₂O Innovation as well as other communications by the Corporation to the public that describe more generally management objectives, projections, estimates, expectations or forecasts may constitute forward-looking statements within the meaning of securities legislation. Forward-looking statements concern analysis and other information based on forecast future results, performance and achievements and the estimate of amounts that cannot yet be determined. Those forward-looking statements, based on the current expectations of management, involve a number of risks and uncertainties, known and unknown, which may result in actual and future results, performance, and achievements of the Company to be materially different than the said forward-looking statements. Information about the risk factors to which the Corporation is exposed is provided in the Annual Information Form dated September 23, 2020 available on SEDAR (www.sedar.com).

About H

₂

O Innovation 
Innovation is in our name, and it is what drives the organization. H₂O Innovation is a complete water solutions company focused on providing best-in-class technologies and services to its customers. The Corporation’s activities rely on three pillars: i) Water Technologies & Services (WTS) applies membrane technologies and engineering expertise to deliver equipment and services to municipal and industrial water, wastewater, and water reuse customers, ii) Specialty Products (SP) is a set of businesses that manufacture and supply a complete line of specialty chemicals, consumables and engineered products for the global water treatment industry, and iii) Operation & Maintenance (O&M) provides contract operations and associated services for water and wastewater treatment systems. Through innovation, we strive to simplify water. For more information, visit www.h2oinnovation.com.

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

Source:

H₂O Innovation Inc.
www.h2oinnovation.com

Contact:
Marc Blanchet
+1 418-688-0170
[email protected]

VANCOUVER, British Columbia, May 03, 2021 (GLOBE NEWSWIRE) — Cypress Development Corp. (TSX-V:CYP) (OTCQB:CYDVF) (Frankfurt:C1Z1) (“Cypress” or “the Company”) is pleased to announce the appointment of Mr. Abraham (Braam) Jonker as Chief Financial Officer of the Company. Acting CFO James Pettit will continue to serve on the Board of Directors as a Non-Executive Director.

Mr. Jonker is an accomplished financial leader in the mining industry with almost 30 years of experience. He recently served as CFO of Nevada Copper Corp, where he led the corporate finance functions as the company transitioned to project developer and into initial start-up of production. Prior to his appointment as CFO, he also served as Interim CEO and Non-Executive Director of Nevada Copper. Mr. Jonker has played a pivotal role in several business recoveries and restructurings, was a key team member in management and at the board level in the strategic growth of a number of public companies and has participated, raised and overseen the raising of more than $750 million in the form of equity and debt instruments in the mining industry. He is a registered Chartered Accountant in British Columbia, (Canada), England, Wales and South Africa. He is also a member of the Chartered Institute of Management Accountants in the United Kingdom and holds a Masters degree in South African and International Tax from the Rand Afrikaans University, South Africa.

“We are pleased to welcome Braam to the Company” said Cypress CEO Bill Willoughby. “We are excited to have available his expertise in strategic and financial management and especially his recent accomplishments with a major mining project in Nevada. We look forward to his contributions as we move our Clayton Valley Lithium Project in Nevada towards a feasibility study. The Company also thanks Jim Pettit for his service as CFO and is looking forward to his continued guidance and involvement on the Board of Directors”.

About Cypress Development Corp.:

Cypress Development Corp. is a publicly traded exploration company focused on developing the Company’s 100%-owned Clayton Valley Lithium Project in Nevada. Exploration and development by Cypress discovered a world-class resource of lithium-bearing claystone adjacent to the Albemarle Silver Peak mine, North America’s only lithium brine operation. The size of the resource makes the Clayton Valley Project a premier source that has the potential to impact the supply of lithium for the fast-growing global energy storage battery market.

Clayton Valley Lithium Project, Nevada Claims Map:

https://www.cypressdevelopmentcorp.com/site/assets/files/3573/cyp_cypress_-_albemarle_properties_map.jpg

To find out more about Cypress Development Corp. (TSX-V: CYP), visit our website at www.cypressdevelopmentcorp.com.

CYPRESS DEVELOPMENT CORP.

“Dr. Bill Willoughby”

                                        
WILLIAM WILLOUGHBY, PhD., PE
Chief Executive Officer

For further information contact myself or:
Don Myers
Cypress Development Corp.
Director, Corporate Communications
Telephone: 604-639-3851
Toll Free: 800-567-8181
Facsimile: 604-687-3119
Email: [email protected]

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

This release includes certain statements that may be deemed to be “forward-looking statements”. All statements in this release, other than statements of historical facts, that address events or developments that management of the Company expects, are forward-looking statements. Although management believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results or developments may differ materially from those in the forward-looking statements. The Company undertakes no obligation to update these forward-looking statements if management’s beliefs, estimates or opinions, or other factors, should change. Factors that could cause actual results to differ materially from those in forward-looking statements, include market prices, exploration and development successes, continued availability of capital and financing, and general economic, market or business conditions. Please see the public filings of the Company at www.sedar.com for further information.

MONTRÉAL, May 03, 2021 (GLOBE NEWSWIRE) — Bombardier (TSX: BBD.B) today announced preliminary financial results and select operating metrics for the first quarter ended March 31, 2021.

First Quarter 2021 Preliminary Results and Select Operating Metrics

• Business jet revenues are expected to be $1.3 billion, an increase of 18% year-over-year.
• EBIT and adjusted EBITDA⁽¹⁾ from continuing operations are expected to be $19 million and $123 million, respectively.
• Free cash flow usage⁽¹⁾ from continuing operations is expected to be $405 million including ~$100 million of non-recurring cash items⁽²⁾. Cash flows from operating activities (continuing operations) expected to be $372 million and net additions to PP&E and intangible assets (continuing operations) expected to be $33 million.
• Expected pro-forma liquidity⁽³⁾ of $2.6 billion remaining after ~$2.4 billion expected to be deployed toward balance sheet deleveraging year-to-date.
• Business aircraft deliveries for the first quarter expected to be 26 units.
• Remains on track to deliver an expected 110-120 business aircrafts in 2021⁽⁴⁾.

“The preliminary financial results we are sharing today validate the actions we have taken to reposition our business and reflect the progress we are making on our strategic priorities,” said Éric Martel, President and Chief Executive Officer of Bombardier. “The first quarter was a strong start to the year, with our cost reduction initiatives beginning to contribute to the bottom line, continued progress of our Global 7500 learning curve and robust demand supporting significant year-over-year margin expansion. Looking ahead, our markets are continuing to show signs of improvement and our plans and financial performance for the year remain on track.”

The preliminary financial results and selected operating metrics included in this press release are based on information available as of May 3, 2021, and management’s initial review of operations for the first quarter ended March 31, 2021. As previously announced, the Corporation will disclose its final financial results on May 6, 2021.

Consent Solicitation

In a separate press release, Bombardier announced that it has launched consent solicitations with respect to its outstanding senior notes or debentures (with respect to any individual series, a “Consent Solicitation” and collectively, the “Consent Solicitations”). On April 22, 2021, Bombardier received a letter from counsel to a holder of 2034 Notes, claiming that the Corporation breached certain covenants under the indenture governing the 2034 Notes. The Corporation believes that these allegations are without merit and that the Corporation has not breached any covenant under the indenture. With the assistance of external advisors, the Corporation evaluated a range of options and determined that initiating the Consent Solicitations is the most expedient and efficient path to maintain value and protect the Corporation and its stakeholders.

Quarterly Conference Call

As previously announced, on May 6, 2021, at 8:00 a.m. EDT, Bombardier will hold a webcast/conference call intended for investors and financial analysts to review the Corporation’s financial results for the first quarter ended March 31, 2021.

A live webcast of the call and relevant financial charts will be available at https://ir.bombardier.com.
Stakeholders wishing to listen to the presentation and subsequent question-and-answer period by telephone may dial one of the following conference call numbers:

About Bombardier

Bombardier is a global leader in aviation, creating innovative and game-changing planes. Our products and services provide world-class experiences that set new standards in passenger comfort, energy efficiency, reliability and safety.

Headquartered in Montréal, Canada, Bombardier is present in more than 12 countries including its production/engineering sites and its customer support network. The Corporation supports a worldwide fleet of approximately 4,900 aircraft in service with a wide variety of multinational corporations, charter and fractional ownership providers, governments and private individuals.

News and information is available at bombardier.com or follow us on Twitter @Bombardier.

Bombardier, Global and Global 7500 are registered trademarks of Bombardier Inc. or its subsidiaries.

For information

CAUTION REGARDING NON-GAAP FINANCIAL MEASURES

This press release is based on expected reported earnings in accordance with IFRS and on the following non-GAAP financial measures:

Non-GAAP financial measures are mainly derived from the consolidated financial statements but do not have standardized meanings prescribed by IFRS. The exclusion of certain items from non-GAAP performance measures does not imply that these items are necessarily non-recurring. Other entities in our industry may define the above measures differently than we do. In those cases, it may be difficult to compare the performance of those entities to ours based on these similarly-named non-GAAP measures.

Adjusted EBIT and adjusted EBITDA

Management uses adjusted EBIT and adjusted EBITDA for purposes of evaluating underlying business performance. Management believes these non-GAAP earnings measures in addition to IFRS measures provide users of this press release with enhanced understanding of our expected results and related trends and increases the transparency and clarity of the core expected results of our business. Adjusted EBIT and adjusted EBITDA exclude items that do not reflect our core performance or where their exclusion will assist users in understanding our expected results for the period. For these reasons, a significant number of users of this press release analyze our expected results based on these financial measures. Management believes these measures help users of this press release to better analyze results, enabling better comparability of our expected results from one period to another and with peers.

Free cash flow (usage)

Free cash flow is defined as cash flows from operating activities less net additions to PP&E and intangible assets. Management believes that this non-GAAP cash flow measure provides investors with an important perspective on the Corporation’s generation of cash available for shareholders, debt repayment, and acquisitions after making the capital investments required to support ongoing business operations and long-term value creation. This non-GAAP cash flow measure does not represent the residual cash flow available for discretionary expenditures as it excludes certain mandatory expenditures such as repayment of maturing debt. Management uses free cash flow as a measure to assess both business performance and overall liquidity generation.

Reconciliations of non-GAAP financial measures to the most comparable IFRS financial measures are provided in the table hereafter, except for the following reconciliation:

• free cash flow usage to cash flows from operating activities, which is provided above.

FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements, which may involve, but are not limited to: statements with respect to our objectives, anticipations and outlook or guidance in respect of various financial and global metrics and sources of contribution thereto, targets, goals, priorities, market and strategies, financial position, financial performance, market position, capabilities, competitive strengths, credit ratings, beliefs, prospects, plans, expectations, anticipations, estimates and intentions; general economic and business outlook, prospects and trends of an industry; customer value; expected demand for products and services; growth strategy; product development, including projected design, characteristics, capacity or performance; expected or scheduled entry-into-service of products and services, orders, deliveries, testing, lead times, certifications and execution of orders in general; competitive position; expectations regarding revenue and backlog mix; the expected impact of the legislative and regulatory environment and legal proceedings; strength of capital profile and balance sheet, creditworthiness, available liquidities and capital resources, expected financial requirements, and ongoing review of strategic and financial alternatives; the introduction of, productivity enhancements, operational efficiencies, cost reduction and restructuring initiatives, and anticipated costs, intended benefits and timing thereof; the anticipated business transition to growth cycle and cash generation; expectations, objectives and strategies regarding debt repayment, refinancing of maturities and interest cost reduction; expectations regarding availability of government assistance programs, compliance with restrictive debt covenants; expectations regarding the declaration and payment of dividends on our preferred shares; intentions and objectives for our programs, assets and operations; and the impact of the COVID-19 pandemic on the foregoing and the effectiveness of plans and measures we have implemented in response thereto; and expectations regarding gradual market and economic recovery in the aftermath of the COVID-19 pandemic.

Forward-looking statements can generally be identified by the use of forward-looking terminology such as “may”, “will”, “shall”, “can”, “expect”, “estimate”, “intend”, “anticipate”, “plan”, “foresee”, “believe”, “continue”, “maintain” or “align”, the negative of these terms, variations of them or similar terminology. Forward-looking statements are presented for the purpose of assisting investors and others in understanding certain key elements of our current objectives, strategic priorities, expectations, outlook and plans, and in obtaining a better understanding of our business and anticipated operating environment. Readers are cautioned that such information may not be appropriate for other purposes.

By their nature, forward-looking statements require management to make assumptions and are subject to important known and unknown risks and uncertainties, which may cause our actual results in future periods to differ materially from forecast results set forth in forward-looking statements. While management considers these assumptions to be reasonable and appropriate based on information currently available, there is risk that they may not be accurate. The assumptions underlying the forward-looking statements made in this press release include the following material assumptions: the deployment of the proceeds from the sale of the Transportation business to Alstom on terms allowing the Corporation, when combined to other financing sources and free cash flow generation, to repay or otherwise manage its various maturities for the next three years; growth of the business aviation market and increase of the Corporation’s share of such market; proper identification of recurring cost savings and executing on our cost reduction plan; optimization of our real estate portfolio, including through the sale or other transaction in respect of real estate assets on favorable terms; and access to working capital facilities on market terms. Given the impact of the changing circumstances surrounding the COVID-19 pandemic and the related response from the Corporation, governments (federal, provincial and municipal), regulatory authorities, businesses, suppliers, customers, counterparties and third-party service providers, there is inherently more uncertainty associated with the Corporation’s assumptions as compared to prior years.

Certain factors that could cause actual results to differ materially from those anticipated in the forward-looking statements include, but are not limited to, risks associated with general economic conditions, risks associated with our business environment (such as risks associated with the financial condition of business aircraft customers; trade policy; increased competition; political instability and force majeure events or global climate change), operational risks (such as risks related to developing new products and services; development of new business; order backlog; the transition to a pure-play business aviation company; the certification of products and services; the execution of orders; pressures on cash flows and capital expenditures based on seasonality and cyclicality; execution of our strategy, productivity enhancements, operational efficiencies, restructuring and cost reduction initiatives; doing business with partners; product performance warranty and casualty claim losses; regulatory and legal proceedings; environmental, health and safety risks; dependence on certain customers, contracts and suppliers; supply chain risks; human resources; reliance on information systems; reliance on and protection of intellectual property rights; reputation risks; risk management; tax matters; and adequacy of insurance coverage), financing risks (such as risks related to liquidity and access to capital markets; retirement benefit plan risk; exposure to credit risk; substantial debt and interest payment requirements; restrictive debt covenants; reliance on debt management and interest cost reduction strategies; and reliance on government support), market risks (such as foreign currency fluctuations; changing interest rates; increases in commodity prices; and inflation rate fluctuations). Any one or more of the foregoing factors may be exacerbated by the ongoing COVID-19 outbreak and may have a significantly more severe impact on the Corporation’s business, results of operations and financial condition than in the absence of such outbreak. As a result of the current COVID-19 pandemic, additional factors that could cause actual results to differ materially from those anticipated in the forward-looking statements include, but are not limited to: risks related to the impact and effects of the COVID-19 pandemic on economic conditions and financial markets and the resulting impact on our business, operations, capital resources, liquidity, financial condition, margins, prospects and results; uncertainty regarding the magnitude and length of economic disruption as a result of the COVID-19 outbreak and the resulting effects on the demand environment for our products and services; uncertainty regarding market and economic recovery in the aftermath of the COVID-19 pandemic; emergency measures and restrictions imposed by public health authorities or governments, fiscal and monetary policy responses by governments and financial institutions; disruptions to global supply chain, customers, workforce, counterparties and third-party service providers; further disruptions to operations, orders and deliveries; technology, privacy, cyber security and reputational risks; and other unforeseen adverse events.

Readers are cautioned that the foregoing list of factors that may affect future growth, results and performance is not exhaustive and undue reliance should not be placed on forward-looking statements. Other risks and uncertainties not presently known to us or that we presently believe are not material could also cause actual results or events to differ materially from those expressed or implied in our forward-looking statements. The forward-looking statements set forth herein reflect management’s expectations as at the date of this press release and are subject to change after such date. Unless otherwise required by applicable securities laws, we expressly disclaim any intention, and assume no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. The forward-looking statements contained in this press release are expressly qualified by this cautionary statement.

MISSISSAUGA, Ontario, May 03, 2021 (GLOBE NEWSWIRE) — BioSyent Inc. (“BioSyent”, TSX Venture: RX) is pleased to announce that for the sixth consecutive year, FeraMAX^® has been named the #1 recommended iron supplement brand in a national survey of Canadian physicians and pharmacists.

The 2021 OTC Recommendations Survey was conducted by EnsembleIQ, Research, Insights and Innovation team and the following publications and websites: Pharmacy Practice + Business, The Medical Post, Profession Santé, CanadianHealthcareNetwork.ca and ProfessionSanté.ca. This annual survey was conducted online between October 2020 and January 2021 with Canadian retail pharmacists and physicians. In total, 1,812 surveys were completed by pharmacists (including 647 Québec pharmacists) and 657 surveys were completed by physicians (including 268 Québec physicians).

FeraMAX^® was named by both pharmacists and physicians surveyed (in both Québec and all Canada) as the most recommended iron supplement brand to Canadian patients.

Last year, BioSyent Pharma Inc. launched FeraMAX^® Pd Therapeutic 150, the first product under a patented formulation made with a homogeneous polysaccharide, Polydextrose, linked to ferric (Fe³⁺) elemental iron to form the proprietary Polydextrose Iron Complex (“PDIC”).

“We are delighted with the continued vote of confidence by healthcare professionals in FeraMAX^® as their trusted choice for iron deficient patients,” remarked Mr. René Goehrum, President and CEO of BioSyent. “This recognition is especially meaningful in an environment fraught with the complexities of changed healthcare practices during the COVID-19 pandemic. We express our appreciation to healthcare professionals and patients and we look forward to strengthening our partnership with ongoing innovation and commitment to the overall iron health of Canadian patients.”

About FeraMAX

^®

FeraMAX^® Pd Therapeutic 150 is an oral iron supplement indicated for the treatment of iron deficiency anemia. This is a patented formulation and the only Polydextrose Iron Complex (PDIC) in Canada. It offers several benefits compared to conventional iron salt supplements and is well-tolerated.   FeraMAX^® is Vegan Certified and provides an iron therapy option for vegans, vegetarians, and patients with other dietary restrictions. FeraMAX^® Pd Therapeutic 150 is also recognized by the Society of Obstetricians and Gynaecologists of Canada, for demonstrated scientific evidence of safety and efficacy. FeraMAX^® Powder (Polysaccharide-Iron Complex) is available in a pleasant tasting, dissolvable powder for pediatric patients.

For more information on FeraMAX^®, please visit www.feramax.com.

About BioSyent Inc.

Listed on the TSX Venture Exchange under the trading symbol “RX”, BioSyent is a profitable growth-oriented specialty pharmaceutical company focused on in-licensing or acquiring innovative pharmaceutical and other healthcare products that have been successfully developed, are safe and effective, and have a proven track record of improving the lives of patients. BioSyent supports the healthcare professionals that treat these patients by marketing its products through its community, specialty and international business units.

As of the date of this press release, the Company has 12,706,275 common shares outstanding.

For a direct market quote for the TSX Venture Exchange and other Company financial information please visit www.tmxmoney.com.

For further information please contact:

Mr. René C. Goehrum
President and CEO
BioSyent Inc.
E-Mail: [email protected]
Phone: 905-206-0013
Web: www.biosyent.com

This press release may contain information or statements that are forward-looking.  The contents herein represent our judgment, as at the release date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking information or statements.  Potential risks may include, but are not limited to, those associated with clinical trials, product development, future revenue, operations, profitability and obtaining regulatory approvals.
 

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.

• Vaxart to advance three oral tablet COVID-19 vaccine candidates to the clinic: VXA-CoV2-1 (includes both the S and the N proteins) into Phase II and two S-only constructs into Phase I/II
  
• Four clinical trials of the oral norovirus vaccine candidate to be initiated in 2021
• Cash, cash equivalents, and marketable securities of $177.3 million as of March 31, 2021
  

SOUTH SAN FRANCISCO, Calif., May 03, 2021 (GLOBE NEWSWIRE) — Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company developing oral vaccines that are administered by room-temperature stable tablet rather than by injection, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update. As part of this update, the Company announced that it plans to initiate several clinical and pre-clinical COVID-19 vaccine studies as it continues the development of its multivariant COVID-19 vaccine candidate portfolio.

“The recent results of a poll we commissioned suggested that as many as 19 million more Americans would decide to get vaccinated against COVID-19 if the vaccine was administered as a pill instead of a needle injection — a number we expect to be much higher worldwide, particularly given the distribution advantages of a room-temperature stable tablet. That alone could potentially make a significant global impact,” said Andrei Floroiu, Chief Executive Officer of Vaxart.

“Additionally, we expect our vaccine to have a different profile – on safety, tolerability, and immunogenicity – than those of injectable vaccines,” added Floroiu. “Our vaccines employ a novel mechanism of action — validated by clinical results against flu — that is very different than those of injectable vaccines, thus offering the potential to complement, if not replace, injectable vaccines.”

Recent Business Highlights:

Clinical and Pre-Clinical:

COVID-19

• Vaxart announced the results from its VXA-CoV2-1 Phase I clinical trial in 35 subjects:
  • Generally well-tolerated with no severe adverse events reported.
  • Triggered multiple immune responses against SARS-CoV2 antigens, including:
    • Inducing a high percentage of responding CD8+ T cells against both Spike (S) and Nucleoprotein (N) proteins, which may provide long-lasting cross-reactive protection against current and future strains of the virus due to the vaccine’s more conserved target.
    • An increase in proinflammatory Th1 cytokines, which are responsible for orchestrating the immune response to viral infection.
  • As previously announced, later today Vaxart will provide new data comparing the T-cell responses induced by its VXA-CoV2-1 vaccine with those of other vaccines. The Company will also present new mucosal antibody data and review the recent Phase 1 clinical results that suggest VXA-CoV2-1 is potentially protective against new and future COVID-19 strains due to the vaccine’s more conserved target.
• Next steps
  • Pre-clinical studies:
    • Several studies with our S and N and S-only constructs in multiple animal models are ongoing or will begin soon, testing attributes of our vaccine candidates such as impact on infection, illness, shedding, transmission, and cross-variant protection.
  • Clinical studies:
    • A Phase II trial of VXA-CoV2-1, our vaccine encoding both the S and the N proteins, is expected to start mid-year 2021 instead of 2Q. The delay is due to manufacturing issues at the Baltimore contract manufacturing facility, the same facility where other COVID-19 vaccine manufacturers have also reported issues.
    • Manufacturing of our vaccines is currently underway at the Company’s other manufacturing partner, and at our own GMP facility. We are also evaluating additional manufacturing partners both in the U.S. and abroad.
    • Phase I/II studies of two S-only vaccine constructs targeting different variants are planned to begin in 3Q 2021.
    • Boosting studies with previously vaccinated or infected subjects are also planned for 2H 2021.
    • Trials in India and Latin America are expected to initiate in 2021.

Norovirus:

Norovirus is a highly infectious illness that affects around 20 million Americans annually, and it has an annual economic impact of approximately $10.5 billion in the United States. Vaxart plans to progress its oral norovirus vaccine program with the initiation of four clinical trials in 2021:

• A booster dose in a subset of subjects who participated in the prior Phase 1b bivalent study will assess the safety, tolerability and immunogenicity of this dose approximately 18 months after initial dosing. Dosing is completed, and results will be reported by mid-year 2021.
• A booster ranging trial designed to assess the safety, tolerability, immunogenicity, and efficacy of 2-dose vaccination schedule (4, 8, and 12 weeks apart) started recently.
• An age escalation trial in subjects over 65 years old designed to assess the safety, tolerability, immunogenicity, and efficacy of 2 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) planned to start in 3Q 2021.
• A Phase 2 challenge study is planned to start later this year.

Vaxart also released data from a poll it commissioned, which surveyed 1,500 subjects and found that as many as an additional 19 million Americans would decide to get vaccinated against COVID-19 if they had an oral tablet option.

• The poll suggested as many as an additional 4 million Black, 3 million rural, 2 million Hispanic and 1.5 million Asian Americans would take a pill COVID-19 vaccine.
• 7 in 10 said they would prefer taking a vaccine pill rather than getting injected with a vaccine.

Corporate:

• Vaxart appointed David Wheadon, M.D., to its Board of Directors. Dr. Wheadon is a health policy leader and physician with more than three decades of global experience in the pharmaceutical industry coordinating the interests of public companies, trade groups, and regulators.
• Rajesh Kapoor, Ph.D., joined Vaxart as the SVP Quality. Dr. Kapoor brings 30 years of domestic and international experience with small and large companies covering aseptic and non-aseptic Quality Operations encompassing vaccines, biologics, drugs, APIs, clinical Quality Assurance, and radiopharmaceuticals.

Cash, Cash Equivalents, and Marketable Securities Balance:

• Vaxart ended the quarter with cash, cash equivalents, and available-for-sale debt securities of $177.3 million, compared to $126.9 million as of December 31, 2020. The increase was primarily due to receipts of $65.7 million from the Company’s $250 million at-the-market facility entered into in October 2020 and $1.9 million from the exercise of warrants and options, partially offset by $16.6 million of cash used in operations and $0.6 million spent on property and equipment.

Financial Results for the Three Months Ended March 31, 2021:

• Vaxart reported a net loss of $16.0 million for the first quarter of 2021 compared to $1.3 million for the first quarter of 2020. Net loss per share for the first quarter of 2021 was $0.14, compared to a net loss of $0.02 in the first quarter of 2020. The increase in net loss per share was due to the increase in net loss partially offset by the increase in the weighted average number of shares outstanding.
• Revenue for the first quarter of 2021 was $506,000 compared to $2.9 million in the first quarter of 2020. The decrease was principally due to a reduction in royalty revenue related to Inavir sales in Japan as a result of abnormally low incidences of seasonal influenza.
• Research and development expenses were $10.1 million for the first quarter of 2021 compared to $1.5 million for the first quarter of 2020. The increase was mainly due to manufacturing and clinical trial expenses related to the COVID-19 and norovirus vaccine candidates.
• General and administrative expenses were $5.9 million for the first quarter of 2021 compared to $2.0 million for the first quarter of 2020. The increase was mainly due to higher legal and insurance expenses, and an increase in headcount and related costs.

About Vaxart

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication. Vaxart has filed broad domestic and international patents covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan,” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates and clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations relating to Vaxart’s relationship with Emergent BioSolutions, Inc., Kindred Biosciences and Attwill Medical Solutions Sterilflow, LP, including their ability to produce cGMP vaccines and the timing thereof; Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for coronaviruses such as SARS, MERS and SARS-CoV-2; expectations regarding Vaxart’s ability to develop effective vaccines against new and emerging variant strains; expectations regarding the timing and nature of future developments and announcements, including those related to trials and studies; the potential applicability of results seen in our preclinical studies or trials to those that may be seen in humans or clinical trials; the expected role of mucosal immunity in blocking transmission of COVID-19; and Vaxart’s expectations with respect to the effectiveness of its product candidates, including Vaxart’s potential role in mitigating the impact of COVID-19. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners’ control, including the ongoing COVID-19 pandemic; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to resolve pending legal matters; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

Vaxart, Inc.

Condensed Consolidated Balance Sheets

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(1) Derived from the audited consolidated financial statements of Vaxart, Inc. for the year ended December 31, 2020, included on the Form 10-K filed with the Securities and Exchange Commission on February 25, 2021

Vaxart, Inc.

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