FORM 10-Q

FOR THE QUARTER ENDED MARCH 31, 2020

TABLE OF CONTENTS

 

 

				Page
Part I	FINANCIAL INFORMATION			1
		Item 1.	Financial Statements (Unaudited)	1
			Condensed Consolidated Balance Sheets	1
			Condensed Consolidated Statements of Operations and Comprehensive Loss	2
			Condensed Consolidated Statements of Stockholders’ Equity	3
			Condensed Consolidated Statements of Cash Flows	4
			Notes to the Condensed Consolidated Financial Statements	6
		Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
		Item 3.	Quantitative and Qualitative Disclosures About Market Risk	27
		Item 4.	Controls and Procedures	28
Part II	OTHER INFORMATION			29
		Item 1.	Legal Proceedings	29
		Item 1A.	Risk Factors	29
		Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	30
		Item 3.	Defaults Upon Senior Securities	30
		Item 4.	Mine Safety Disclosures	30
		Item 5.	Other Information	30
		Item 6.	Exhibits	31
SIGNATURES				32

 

 

PART I FINANCIAL INFORMATION

 

Item 1.  Financial Statements

 

VAXART, INC. AND SUBSIDIARIES

 

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

VAXART, INC. AND SUBSIDIARIES

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

VAXART, INC. AND SUBSIDIARIES

 

Condensed Consolidated Statements of Stockholders’ Equity

For the Three Months Ended March 31, 2019 and 2020

(In thousands, except share amounts)

(Unaudited)

 

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

VAXART, INC. AND SUBSIDIARIES

 

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

VAXART, INC. AND SUBSIDIARIES

 

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

VAXART, INC. AND SUBSIDIARIES

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

 

 

 

 

 

 

 

Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements included in our Annual Report on Form 10-K filed with the SEC on March 19, 2020. This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “goal,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential” and similar expressions intended to identify forward-looking statements and reflect our beliefs and opinions on the relevant subject. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report on Form 10-Q, particularly in “Risk Factors.” The forward-looking statements included in this Quarterly Report on Form 10-Q are made only as of the date hereof. These statements are based upon information available to us as of the filing date of this Quarterly Report on Form 10-Q , and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

 

Company Overview and Background

 

We are a clinical-stage biotechnology company primarily focused on the development of oral recombinant vaccines based on our proprietary oral vaccine platform. Our oral vaccines are designed to generate broad and durable immune responses that may protect against a wide range of infectious diseases and may be useful for the treatment of chronic viral infections and cancer. Our vaccines are administered using a convenient room temperature-stable tablet, rather than by injection.

 

We are developing prophylactic vaccine candidates for several targets. These include SARS-CoV-2, a coronavirus currently causing an epidemic throughout the world; norovirus, a widespread cause of acute gastro-intestinal enteritis, for which three Phase 1 human studies have been completed, including a study with a bivalent norovirus vaccine which, as we announced in September, met its primary and secondary endpoints; seasonal influenza, for which our monovalent H1 influenza vaccine protected patients against H1 influenza infection in a recent Phase 2 challenge study; and respiratory syncytial virus, or RSV, a common cause of respiratory tract infections. In addition, we are developing our first therapeutic vaccine targeting cervical cancer and dysplasia caused by human papillomavirus, or HPV.

 

Merger with Aviragen

 

Vaxart Biosciences, Inc. was originally incorporated in California in March 2004, under the name West Coast Biologicals, Inc. and changed its name to Vaxart, Inc., or Private Vaxart, in July 2007, and reincorporated in the state of Delaware.  On February 13, 2018, Private Vaxart completed a reverse merger, or the Merger, with Aviragen Therapeutics, Inc., or Aviragen, pursuant to which Private Vaxart survived as a wholly owned subsidiary of Aviragen. Under the terms of the Merger, Aviragen changed its name to Vaxart, Inc. and Private Vaxart changed its name to Vaxart Biosciences, Inc.

 

Our Product Pipeline

The following table outlines the status of our oral vaccine development programs:

1.

Bivalent GI.1 - GII.4 Norovirus vaccine generated IgA ASC response rates of 78 – 86% for GI.1 and 90 – 93% for GII.4. Program on hold pending partnering process.

2.

Monovalent H1 flu vaccine completed phase 2 Proof of Concept efficacy study. Quadrivalent flu Phase 1 on hold pending partnering process.

3.

Janssen collaboration. Janssen has an option to negotiate an exclusive license.

4.

RSV program to be partnered with new antigen partner, pending which the program is on hold.

5.

HPV therapeutic pre-IND feedback received. Program presently on hold.

 

 

We are developing the following tablet vaccine candidates, which are based on our proprietary platform:

 

●

Coronavirus Vaccine. We are developing an oral tablet vaccine for coronavirus SARS-CoV-2. We have generated multiple vaccine candidates based on the published genome of SARS-CoV-2 and we are evaluating them in preclinical models for their ability to generate both mucosal and systemic immune responses. We believe the logistical advantages of an oral vaccine that is administered using a convenient room temperature-stable tablet could be of critical benefit when rolling out a major public health vaccination campaign.

 

According to the Center for Disease Control and Prevention, or CDC, in late 2019 an outbreak of COVID-19, caused by the virus SARS-CoV-2, began in Wuhan, China. The disease spread rapidly and person-to-person transmission has been widely documented. On January 20, 2020, state and local health departments in the United States, in collaboration with teams deployed from CDC, began identifying and monitoring all persons considered to have had close contact with patients with confirmed COVID-19. On March 6, 2020, President Trump signed an $8.3 billion emergency spending bill to confront the COVID-19 outbreak. The aims of these efforts were to ensure rapid evaluation and care of patients, limit further transmission, better understand risk factors for transmission and develop treatments. By May 9, 2020, more than 4 million COVID-19 cases had been identified in over 200 other countries and territories worldwide, including the United States, where over 1.3 million infections and 80,000 deaths have been reported. Stay-at-home orders or similar mandates have been issued in all 50 states and on March 27, 2020, President Trump signed a $2.2 trillion coronavirus relief bill to mitigate the financial and economic damage caused.

 

●

Norovirus Vaccine. We are developing an oral tablet vaccine for norovirus, a leading cause of acute gastroenteritis in the United States and Europe. Because norovirus infects the small intestine, we believe that our vaccine, which is designed to generate mucosal antibodies locally in the intestine in addition to systemic antibodies in the blood, will better protect against norovirus infection than an injectable vaccine. Clinical evidence that vaccines based on our platform technology can protect against infection is described under “Clinical Trial Update” in the “Seasonal Influenza Vaccine” section below. The program is currently on hold pending partnering discussions.

 

Norovirus is the leading cause of vomiting and diarrhea from acute gastroenteritis among people of all ages in the United States. Each year, on average, norovirus causes 19 to 21 million cases of acute gastroenteritis and contributes to 56,000 to 71,000 hospitalizations and 570 to 800 deaths, mostly among young children and older adults. Typical symptoms include dehydration, vomiting, diarrhea with abdominal cramps, and nausea. In a study by the CDC and Johns Hopkins University, published in 2016, the global economic impact of norovirus disease was estimated at $60 billion, $34 billion of which occurred in high income countries including the United States, Europe and Japan. An update by the lead authors estimated the burden in the U.S. alone to be $10.5 billion in 2018. Virtually all norovirus disease is caused by norovirus GI and GII genotypes, and we are developing a bivalent vaccine designed to protect against both. We anticipate the vaccine will be an annual, one-time administration ahead of the winter season when norovirus incidence is at its peak, similar to the influenza season.

 

Clinical Trial Update. In 2019, we completed the active phase of a Phase 1 clinical trial with our bivalent oral tablet vaccine for the GI.1 and GII.4 norovirus strains. Both the oral norovirus GI.1 and GII.4 vaccines were well tolerated, with no serious treatment-related adverse events reported. Most solicited and unsolicited adverse events were mild in severity, and there were no significant differences observed between the vaccine and placebo treatment groups.

 

Vaxart’s bivalent vaccine demonstrated robust immunogenicity, with an IgA ASC response rate of 78% for the GI.1 strain and 93% for the GII.4 strain for the bivalent cohort of the study, and 86% and 90%, respectively, for the two monovalent cohorts of the study. There was no interference observed in the bivalent arm of the study.

 

Following a review of the development strategy for norovirus, Vaxart has put all clinical development on hold pending a search for a partner to fund the program. If a partner is found, the next step in the clinical development program would most likely be a Phase 2 safety and dose confirmation study with Vaxart’s bivalent norovirus vaccine in subjects age 18 to 64. The study may be expanded to include subjects age 65 and over. A Phase 2 challenge study may also be considered, and could be conducted in parallel with, before or after the Phase 2 dose confirmation study. The Phase 2 dose confirmation study would be followed by a Phase 3 efficacy study in subjects age 18 and over, assuming FDA concurrence.

 

 

●

Seasonal Influenza Vaccine. Influenza is a major cause of morbidity and mortality in the U.S. and worldwide and, according to the CDC, only 49% of eligible U.S. citizens were vaccinated in 2018/2019, with particularly low vaccination rates among adults between ages 18 and 49. We believe our oral tablet vaccine has the potential to improve the protective efficacy of currently available influenza vaccines and increase flu vaccination rates.

 

Influenza is one of the most common global infectious diseases, causing mild to life-threatening illness and even death. An estimated 350 million cases of seasonal influenza occur annually worldwide, of which three to five million cases are considered severe, causing 290,000 to 650,000 deaths per year globally. During the flu season of 2018/2019 there were 34,200 flu related deaths in the U.S. alone, according to the CDC. Very young children and the elderly are at the greatest risk. In the United States, between 5% and 20% of the population contracts influenza, 226,000 people are hospitalized with complications of influenza, and between 3,000 and 49,000 people die from influenza and its complications each year, with up to 90% of the influenza-related deaths occurring in adults older than 65. The total economic burden of seasonal influenza has been estimated to be $87.1 billion, including medical costs which average $10.4 billion annually, while lost earnings due to illness and loss of life amount to $16.3 billion annually.

 

We believe our tablet vaccine candidate has the potential to address many of the limitations of current injectable egg-based influenza vaccines, because: our tablet vaccine candidates are designed to create broad and durable immune responses, which may provide more effective immunity and protect against additional strain variants; our vaccine is delivered as a room temperature-stable tablet, which we believe would provide a more convenient method of administration to enhance patient acceptance, and should simplify distribution and administration; and, by using recombinant methods, we believe our tablet vaccine may be manufactured more rapidly than vaccines manufactured using egg-based methods and should eliminate the risk of allergic reactions to egg protein.

 

Clinical Trial Update. In September 2018, we completed a $15.7 million contract with the U.S. Government through the Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority, or HHS BARDA, under which a Phase 2 challenge study of our H1N1 flu vaccine candidate was conducted. Previously, we had announced that, in healthy volunteers immunized and then experimentally infected with H1 influenza, our H1 influenza oral tablet vaccine reduced clinical disease by 39% relative to placebo, a result that was superior to that of Fluzone, the market-leading injectable quadrivalent influenza vaccine, which reduced clinical disease by only 27%. Our tablet vaccine also showed a favorable safety profile, indistinguishable from placebo.

 

On October 4, 2018, we presented data from the study demonstrating that our vaccine elicited a significant expansion of mucosal homing receptor plasmablasts to approximately 60% of all activated B cells, while Fluzone only maintained baseline levels of 20%. We believe these mucosal plasmablasts are a key indicator of a protective mucosal immune response and a unique feature of our vaccines. This data also provided evidence that our vaccines protect through mucosal immunity, the first line of defense against mucosal infections such as flu, norovirus, RSV and others, a potential key advantage over injectable vaccines for these indications.

 

At this time, we aim to finance development and commercialization of our seasonal quadrivalent influenza oral tablet vaccine through third-party collaboration and licensing arrangements and/or non-dilutive funding. In the future, we may also consider equity offerings and/or debt financings to fund the program. Pending a licensing, partnering or collaboration agreement, the seasonal flu program is currently on hold.

 

In addition to our conventional seasonal flu vaccine, we entered into a research collaboration agreement with Janssen Vaccines & Prevention B.V., or Janssen, to evaluate our proprietary oral vaccine platform for the Janssen universal influenza vaccine program. Under the agreement, we will produce non-GMP oral vaccine containing certain proprietary antigens from Janssen and test the product in a preclinical challenge model, with results expected in the first half of 2020. Upon completion of the study, Janssen will have an option to negotiate an exclusive worldwide license to our technology encompassing the Janssen antigens.

 

●

RSV Vaccine. RSV is a major respiratory pathogen with a significant burden of disease in the very young and in the elderly.

 

Based on the positive results of our cotton rat study, we believe our proprietary oral vaccine platform is the optimal vaccine delivery system for RSV, offering significant advantages over injectable vaccines. We will seek to develop a tablet RSV vaccine by licensing one or more RSV protein antigens that have demonstrated protection against RSV infection in clinical studies, or by partnering with a third party with RSV antigens that can be delivered with our platform. Pending a licensing, partnering or collaboration agreement, the RSV program is currently on hold.

 

●

HPV Therapeutic Vaccine. Our first therapeutic oral vaccine candidate targets HPV-16 and HPV-18, the two strains responsible for 70% of cervical cancers and precancerous cervical dysplasia.

 

Cervical cancer is the fourth most common cancer in women worldwide and in the United States with about 13,000 new cases diagnosed annually in the United States according to the National Cervical Cancer Coalition.

 

We have tested our HPV-16 vaccine candidate in two different HPV-16 solid tumor models in mice. The vaccine elicited T cell responses and promoted migration of the activated T cells into the tumors, leading to tumor cell killing. Mice that received our HPV-16 vaccine showed a significant reduction in volume of their established tumors.

 

In October 2018, we filed a pre-IND meeting request for our first therapeutic vaccine targeting HPV16 and HPV18 with the FDA, and we subsequently submitted a pre-IND briefing package. We received feedback from the FDA in January 2019. The program is currently on hold while the Company is focusing its efforts on the COVID-19 vaccine.
 

 

Anti-Virals

 

●

Through the Merger, we acquired two royalty earning products, Relenza and Inavir. We also acquired three Phase 2 clinical stage antiviral compounds, which we have discontinued.

 

●

Relenza and Inavir are antivirals for the treatment of influenza that are marketed by GlaxoSmithKline, plc, or GSK, and Daiichi Sankyo Company, Limited, or Daiichi Sankyo, respectively. We have earned royalties on the net sales of Relenza and Inavir in Japan. The last patent for Relenza expired in July 2019 and the last patent for Inavir expires in December 2029. Sales of these antivirals vary significantly from quarter to quarter due to the seasonality of flu, and from one year to the next depending on the intensity of the flu season and competition from other antivirals such as Tamiflu. Importantly, on February 23, 2018, Xofluza, a new drug to treat influenza developed by Shionogi, was approved in Japan. The drug has gained significant market share, substantially reducing sales of Inavir.

 

Financial Operations Overview

 

Revenue

 

Revenue from Customer Service Contracts

 

We are earning revenue from a fixed price service contract, as amended, for a total of $617,000, which we expect to complete by June 30, 2020, subject to unforeseen delays.

 

Royalty Revenue

 

We earn royalty revenue on sales of Inavir and, until the patent expired, Relenza, both treatments for influenza, from our licensees, Daiichi Sankyo and GSK, respectively, under royalty agreements with expiry dates in December 2029 and July 2019, respectively, based on fixed percentages of net sales of these drugs.

 

Non-Cash Royalty Revenue Related to the Sale of Future Royalties

 

In April 2016, Aviragen sold certain royalty rights related to Inavir in the Japanese market for $20.0 million to HealthCare Royalty Partners III, L.P., or HCRP. At the time of the Merger, the fair value of the estimated future benefit to HCRP was $15.9 million, which we recorded as a liability that we are amortizing using the effective interest method over the remaining estimated life of the arrangement. Even though we did not retain the related royalties under the transaction, as the amounts are remitted to HCRP, we will continue to record revenue related to these royalties until the amount of the associated liability and related interest is fully amortized.

 

Research and Development Expenses

 

Research and development expenses represent costs incurred to conduct research, including the development of our tablet vaccine platform, and the manufacturing, preclinical and clinical development activities of our tablet vaccine candidates. We recognize all research and development costs as they are incurred. Research and development expenses consist primarily of the following:

 

●

employee-related expenses, which include salaries, benefits and stock-based compensation;

●

expenses incurred under agreements with contract research organizations, or CROs, that conduct clinical trials on our behalf;

●

manufacturing materials, analytical and release testing services required for our production of vaccine candidates used primarily in clinical trials;

●

process development expenses incurred internally and externally to improve the efficiency and yield of the bulk vaccine and tablet manufacturing activities;

●

laboratory supplies and vendor expenses related to its preclinical research activities;

●

consultant expenses for services supporting our clinical, regulatory and manufacturing activities; and

●

facilities, depreciation and allocated overhead expenses.

 

We do not allocate our internal expenses to specific programs. Our employees and other internal resources are not directly tied to any one research program and are typically deployed across multiple projects. Internal research and development expenses are presented as one total.

 

We incur significant external costs for manufacturing our tablet vaccine candidates, and for CROs that conduct clinical trials on our behalf. We capture these expenses for each vaccine program. We do not allocate external costs incurred on preclinical research or process development to specific programs.

 

 

The following table shows our research and development expenses for the three months ended March 31, 2020 and 2019, identifying external costs that were incurred in each of our vaccine programs and, separately, on preclinical research and process development:

 

		Three Months Ended March 31,
		2020				2019
		(in thousands)
External program costs:
Norovirus program		$	112			$	865
RSV and HPV programs			—				13
Teslexivir and vapendavir programs			7				17
Preclinical research and process development			121				53
Total external costs			240				948
Internal costs			1,302				2,881
		$	1,542			$	3,829

 

Our preclinical research activities in the three months ended March 31, 2020, related principally to COVID-19 and to our customer service contract, whereas in the three months ended March 31, 2019, they related principally to norovirus.

 

We expect that research and development expenses will be lower in 2020 than in 2019 since we ceased internal manufacturing as part of our restructuring in December 2019 and we expect that a substantial proportion of our research and development costs in the future will be funded by partnering or collaboration agreements. We expect that the total costs of research and development related to our product candidates will increase significantly over the next several years as we advance our tablet vaccine candidates into and through clinical trials, pursue regulatory approval of our tablet vaccine candidates and prepare for a possible commercial launch, all of which will also require a significant investment in manufacturing and inventory related costs. Since we believe that a significant portion of such costs will be borne by partners and collaborators, we do not expect the costs borne by us will increase significantly, if at all.

 

The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for our tablet vaccine candidates. The probability of successful commercialization of our tablet vaccine candidates may be affected by numerous factors, including clinical data obtained in future trials, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our tablet vaccine candidates.

 

General and Administrative Expense

 

General and administrative expenses consist of personnel costs, allocated expenses and expenses for outside professional services, including legal, audit, accounting, public relations, market research and other consulting services. Personnel costs consist of salaries, benefits and stock-based compensation. Allocated expenses consist of rent, depreciation and other facilities related expenses.

 

 

Results of Operations

 

The following table presents selected items in the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2020 and 2019:

 

		Three Months Ended March 31,
		2020				2019
		(in thousands)
Revenue:
Revenue from customer service contracts		$	99			$	—
Royalty revenue			2,769				3,659
Non-cash royalty revenue related to sale of future royalties			34				1,748
Total revenue			2,902				5,407
Operating expenses:
Research and development			1,542				3,829
General and administrative			1,990				2,026
Restructuring costs			64				—
Total operating expenses			3,596				5,855
Operating loss			(694	)			(448	)
Other income and (expenses):
Interest income			41				5
Interest expense			—				(107	)
Non-cash interest expense related to sale of future royalties			(491	)			(544	)
Foreign exchange gain, net			—				5
Total other income and (expenses)			(450	)			(641	)
Net loss before income taxes			(1,144	)			(1,089	)
Provision for income taxes			153				250
Net loss		$	(1,297	)		$	(1,339	)

 

Revenue from Customer Service Contracts

 

The following table presents our revenue from customer service contracts for the three months ended March 31, 2020 and 2019, respectively:

 

Three Months Ended March 31,
2020				2019				% Change
(dollars in thousands)
$	99			$	—				N/A

 

In the three months ended March 31, 2020, we earned revenue from customer service contracts of $99,000. This revenue was recognized from a fixed price contract executed in July 2019, as amended, for a total of $617,000, which we expect to be completed by June 30, 2020, subject to unforeseen delays, enabling us to recognize the remaining $112,000 as revenue. There were no comparable contracts in the three months ended March 31, 2019.

 

 

Royalty Revenue

 

The following table presents our royalty revenue for the three months ended March 31, 2020 and 2019, respectively:

 

Three Months Ended March 31,
2020				2019				% Change
(dollars in thousands)
$	2,769			$	3,659				(24	)%

 

For the three months ended March 31, 2020, royalty revenue decreased by $890,000, or 24%, compared to the three months ended March 31, 2019. Royalty revenue is earned on sales of Inavir and, until the patent expired in July 2019, Relenza, both treatments for influenza, which were acquired in the Merger and is based on fixed percentages of net sales of these drugs in the period. The decrease in 2020 is principally due to the absence of Relenza royalty revenue.

 

Non-cash Royalty Revenue Related to Sale of Future Royalties

 

The following table presents our non-cash royalty revenue related to sale of future royalties for the three months ended March 31, 2020 and 2019, respectively:

 

Three Months Ended March 31,
2020				2019				% Change
(dollars in thousands)
$	34			$	1,748				(98	%)

 

For the three months ended March 31, 2020, royalty revenue related to sale of future royalties was $34,000, compared to $1.7 million in the three months ended March 31, 2019. The decrease is due to a ceiling of $3.3 million that may be earned in years ending on March 31, and we recorded almost all of this in the nine months ended December 31, 2019.

 

Research and Development

 

The following table presents our research and development expenses for the three months ended March 31, 2020 and 2019, respectively:

 

Three Months Ended March 31,
2020				2019				% Change
(dollars in thousands)
$	1,542			$	3,829				(60	)%

 

For the three months ended March 31, 2020, research and development expenses decreased by $2.3 million, or 60%, compared to the three months ended March 31, 2019. The decrease in the 2020 period is principally due to a reduction in personnel costs after we ceased internal manufacturing as part of our December 2019 restructuring, and decreases in manufacturing costs, principally related to the norovirus vaccine, in the cost of norovirus clinical trials, in expenses for depreciation and for amortization of intangible assets acquired in the Merger and in facilities costs. We expect that research and development expenses will continue to be lower in 2020 as compared to 2019 since (i) we ceased internal manufacturing as part of our restructuring in December 2019 and (ii) we expect that a substantial portion of our research and development costs in the future will be funded by partnering or collaboration agreements. 

 

General and Administrative

 

The following table presents our general and administrative expenses for the three months ended March 31, 2020 and 2019, respectively:

 

Three Months Ended March 31,
2020				2019				% Change
(dollars in thousands)
$	1,990			$	2,026				(2	)%

 

For the three months ended March 31, 2020, general and administrative expenses decreased by $36,000, or 2%, compared to the three months ended March 31, 2019. We expect general and administrative costs will remain at a similar level for the remainder of 2020.

 

 

Restructuring Costs

 

The following table presents our restructuring costs for the three months ended March 31, 2020 and 2019, respectively:

 

Three Months Ended March 31,
2020				2019				% Change
(dollars in thousands)
$	64			$	—				N/A

 

We approved a reduction-in-force during the year ended December 31, 2019, for which we accrued severance and benefits charges, the maximum amount potentially payable under a manufacturing work order which we suspended, impairment charges against property and equipment and right-of-use assets formerly used for manufacturing from which no future benefits will be derived, and incurred legal fees and accretion costs in connection with the restructuring. Our costs in the three months ended March 31, 2020, were for legal fees and for accretion related to the manufacturing premises.

 

We expect to record further charges in 2020 for legal fees, broker commissions and accretion related to the manufacturing premises and, potentially, further impairment of a right-of-use asset if we are unable to sublease our manufacturing premises for as much as we are presently paying, or if subleasing takes longer than expected. We also expect to reverse part of the charge related to the suspended manufacturing work order following negotiations with the vendor.

 

Other Income and (Expenses)

 

The following table presents our non-operating income and expenses for the three months ended March 31, 2020 and 2019, respectively:

 

Three Months Ended March 31,
2020				2019				% Change
(dollars in thousands)
$	(450	)		$	(641	)			(30	)%

 

For the three months ended March 31, 2020, we recorded net non-operating expenses of $450,000, a 30% decrease from the $641,000 recorded in the three months ended March 31, 2019. The decrease was principally due to the absence of interest expense in the 2020 period, principally due to the repayment of a loan from Oxford Finance LLC in November 2019.

 

Provision for Income Taxes

 

The following table presents our provision for income taxes for the three months ended March 31, 2020 and 2019, respectively:

 

Three Months Ended March 31,
2020				2019				% Change
(dollars in thousands)
$	153			$	250				(39	)%

 

The provision for income taxes comprises $153,000 and $250,000 in the three months ended March 31, 2020 and 2019, respectively. The majority of the charge, $140,000 in 2020 and $236,000 in 2019, represents withholding tax on royalty revenue earned on sales of Inavir in Japan, which is potentially recoverable as a foreign tax credit but expensed because we record a 100% valuation allowance against our deferred tax assets. The decrease arose because of Inavir royalties, including the portion that we pass through to HCRP, in the first calendar quarter fell from $4.7 million in 2019 to $2.8 million in 2020. The remainder of the charge, $13,000 in 2020 and $14,000 in 2019, relates to foreign taxes payable on intercompany interest.

 

Liquidity and Capital Resources

 

From its inception until the Merger, Private Vaxart’s operations were financed primarily by net proceeds of $38.9 million and $29.4 million from the sale of convertible preferred stock and the issuance of convertible promissory notes, respectively, all of which were converted into Aviragen common stock in the Merger, and $4.9 million from the issuance of secured promissory notes to Oxford Finance, of which the remaining balance of $2.5 million as of September 30, 2019, was repaid in full on November 4, 2019. Vaxart gained $25.5 million in cash from Aviragen in the Merger, of which $4.9 million was used to pay Aviragen’s Merger-related costs. Since the Merger, through March 31, 2020, we have received net proceeds of $39.3 million from the sale of common stock, pre-funded warrants and common stock warrants and the exercise of pre-funded warrants and common stock warrants from equity financings in March, April and September 2019 and March 2020.

 

As of March 31, 2020, we had $29.9 million of cash and cash equivalents. We believe our existing funds, along with our projected revenue and further proceeds from the exercise of common stock warrants and options, are sufficient to fund us well into 2021 and possibly beyond. To continue operations thereafter, we expect that we will need to raise further capital, through the sale of additional securities or otherwise. Our operating needs include the planned costs to operate our business, including amounts required to fund working capital and capital expenditures. As of March 31, 2020, we had no commitments for capital expenditures. Our future capital requirements and the adequacy of our available funds will depend on many factors, most notably our ability to successfully commercialize our products and services.

 

 

We plan to fund a significant portion of our ongoing operations through partnering and collaboration agreements which, while reducing our risks and extending our cash runway, will also reduce our share of eventual revenues, if any, from our vaccine product candidates. We may be able to fund certain activities with assistance from government programs including HHS BARDA. We may also need fund our operations through equity and/or debt financing. The sale of additional equity would result in additional dilution to our stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market vaccine candidates that we would otherwise prefer to develop and market ourselves. Any of these actions could harm our business, results of operations and prospects.

 

Our future funding requirements will depend on many factors, including the following:

 

●

the timing and costs of our planned preclinical studies for our product candidates;

 

●

the timing and costs of our planned clinical trials of our product candidates;

 

●

our manufacturing capabilities, including the availability of contract manufacturing organizations to supply our product candidates at reasonable cost;

 

●

the amount and timing of royalties received on sales of Inavir;

 

●

the number and characteristics of product candidates that we pursue;

 

●

the outcome, timing and costs of seeking regulatory approvals;

 

●

revenue received from commercial sales of our future products, which will be subject to receipt of regulatory approval;

 

●

the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;

 

●

the amount and timing of any payments that may be required in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other intellectual property rights; and

 

●

the extent to which we in-license or acquire other products and technologies.

 

In addition, the COVID-19 pandemic may negatively impact our operations, including possible effects on its financial condition, ability to access the capital markets on attractive terms or at all, liquidity, operations, suppliers, industry, and workforce. The Company will continue to evaluate the impact that these events could have on the operations, financial position, and the results of operations and cash flows during fiscal year 2020 and beyond.

 

Cash Flows

 

The following table summarizes our cash flows for the periods indicated:

 

		Three Months Ended March 31,
		2020				2019
		(in thousands)
Net cash used in operating activities		$	(3,208	)		$	(4,653	)
Net cash used in investing activities			(1	)			(552	)
Net cash provided by financing activities			19,542				2,123
Net increase (decrease) in cash and cash equivalents		$	16,333			$	(3,082	)

 

Net Cash Used in Operating Activities

 

Vaxart experienced negative cash flow from operating activities for the three months ended March 31, 2020 and 2019, in the amounts of $3.2 million and $4.7 million, respectively. The cash used in operating activities in the three months ended March 31, 2020, was due to cash used to fund a net loss of $1.3 million, adjustments for net non-cash income related to depreciation and amortization, stock-based compensation, non-cash interest expense related to sale of future royalties and non-cash revenue related to sale of future royalties totaling $1.6 million and an increase in working capital of $309,000. The cash used in operating activities in the three months ended March 31, 2019, was due to cash used to fund a net loss of $1.3 million and an increase in working capital of $3.8 million, partially offset by net non-cash expenses related to depreciation and amortization, stock-based compensation, non-cash interest expense, non-cash interest expense related to sale of future royalties and non-cash revenue related to sale of future royalties totaling $459,000.

 

 

Net Cash Used in Investing Activities

 

We used $4,000 and $552,000 to purchase property and equipment in the three months ended March 31, 2020 and 2019, respectively. We received cash of $3,000 for the sale of equipment in the three months ended March 31, 2020.

 

Net Cash Provided by Financing Activities

 

We received $9.2 million from the sale of common stock and warrants in a registered direct offering and $10.3 million from the exercise of common stock warrants in the three months ended March 31, 2020. We received $2.5 million in the three months ended March 31, 2019, from the sale of common stock in a registered direct offering, partially offset by the repayment of principal of $417,000 on the secured promissory note payable to Oxford Finance LLC.

 

Critical Accounting Policies and Estimates

 

Our management’s discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments. We base our estimates on historical experience and on various assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially from these estimates. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

 

Accrued Research and Development Expenses

 

We record accrued expenses for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of clinical and contract formulation and contract manufacturing activities. We record the estimated costs of research and development activities based upon the estimated amount of services provided and include the costs incurred but not yet invoiced within accrued liabilities in the condensed consolidated balance sheets and within research and development expense in the condensed consolidated statement of operations and comprehensive loss. These costs can be a significant component our research and development expenses.

 

We estimate the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates.

 

Intangible Assets

 

Intangible assets acquired in the Merger were recorded at their estimated fair values of $20.3 million for developed technology related to Inavir which is being amortized on a straight-line basis over the estimated period of future royalties of 11.75 years and $1.8 million for the developed technology related to Relenza which was fully amortized over the remaining royalty period of 1.3 years. These valuations were prepared by an independent third party based on estimated discounted cash flows based on probability-weighted future development expenditures and revenue streams, which are highly subjective.

 

Off-Balance Sheet Arrangements

 

We had no off-balance sheet arrangements in the periods presented.

 

Recent Accounting Pronouncements

 

See the “Recent Accounting Pronouncements” in Note 2 to the Condensed Consolidated Financial Statements in Part I, Item 1 for information related to the issuance of new accounting standards in the first quarter of 2020, none of which had a material impact on our condensed consolidated financial statements.

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable.

 

 

 

Item 4.  Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our President and Chief Executive Officer (who serves as our principal executive officer and principal financial officer), has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, our management has concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2020.

 

Changes in Internal Control over Financial Reporting

 

Inherent Limitations on Effectiveness of Controls

 

Our management, including our President and Chief Executive Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within Vaxart have been detected.

 

 

PART II OTHER INFORMATION

 

 

Item 1.  Legal Proceedings

 

From time to time we may be involved in claims arising in connection with our business. Based on information currently available, we believe that the amount, or range, of reasonably possible losses in connection with any pending actions against us in excess of established reserves, in the aggregate, not to be material to our consolidated financial condition or cash flows. However, losses may be material to our operating results for any particular future period, depending on the level of income for such period.

 

Item 1A.  Risk Factors

 

You should consider the risks and uncertainties described under Item 1A of Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which we filed with the Securities and Exchange Commission on March 19, 2020, together with all other information contained or incorporated by reference in this Quarterly Report on Form 10-Q when evaluating our business and our prospects. Except as disclosed below, there are no material changes from the risk factors set forth in Part I, Item 1A, in our Annual Report on Form 10-K for the year ended December 31, 2019.

 

The COVID-19 coronavirus could adversely impact our preclinical studies and clinical trials.

 

Since the initial report of a novel strain of coronavirus, COVID-19, in China in December 2019, the COVID-19 coronavirus has spread to multiple countries, including the United States.  We have active and planned preclinical studies and clinical trial sites in the United States. As the COVID-19 coronavirus continues to spread around the globe, we will likely experience disruptions that could severely impact our planned preclinical studies and clinical trials, including our preclinical studies for our SARS-CoV-2 vaccine and our clinical trials for our vaccine candidate for the GI.1 and GII.4 norovirus strains. Effects on our preclinical study and clinical trial programs include, but are not limited to:

 

●

delays in procuring subjects in our preclinical studies;

 

●

delays or difficulties in enrolling patients in our clinical trials;

 

●

delays or difficulties in preclinical and clinical site initiation, including difficulties in establishing appropriate and safe social distancing and other safeguards at preclinical and clinical sites;

 

●

diversion of healthcare resources away from the conduct of preclinical and  clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

 

●

interruption of key preclinical study and clinical trial activities, such as preclinical and clinical trial site monitoring, due to limitations on freight and travel imposed or recommended by federal or state governments, employers and others;

 

●

limitations in employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families, delays or difficulties in conducting site visits and other required travel, and the desire of employees to avoid contact with large groups of people; and

 

●

delays in receiving approval from local regulatory authorities to initiate or continue our planned preclinical studies and clinical trials.

 

The global outbreak of COVID-19 continues to rapidly evolve. The extent to which COVID-19 may impact our preclinical studies and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

 

 

 

Item 2.     Unregistered Sales of Equity Securities and Use of Proceeds

 

Not applicable.

 

 

Item 3.     Defaults Upon Senior Securities

 

Not applicable.

 

 

Item 4.     Mine Safety Disclosures

 

Not applicable.

 

 

Item 5.     Other Information

 

Not applicable.

 

 

 

 

Item 6.  Exhibits

 

				Incorporated by Reference
Exhibit Number	Description of Document			Schedule/Form	File Number	Exhibit	Filing Date
4.1	Form of Common Stock Warrant (March 2020)			Form 8-K	001-35285	4.1	March 2, 2020
4.2	Form of Placement Agent Warrant (March 2020)			Form 8-K	001-35285	4.2	March 2, 2020
10.1	Form of Securities Purchase Agreement, dated February 27, 2020, by and among Vaxart, Inc. and the Purchasers named therein			Form 8-K	001-35285	10.1	March 2, 2020
10.2 *	Offer Letter, dated May 1, 2006, by and between the Company and Dr. Sean Tucker
10.3 *	Offer Letter, dated March 26, 2018, by and between the Company and Margaret Echerd
10.4 *	Letter dated December 27, 2018, from the Company to Margaret Echerd
31.1 *	Certification of Principal Executive and Financial Officer pursuant to Exchange Act Rule, 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1 *§	Certification of Principal Executive and Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101 *	The following financial information from the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2020, formatted in Extensible Business Reporting Language (XBRL): (i) the Condensed Consolidated Balance Sheets as of March 31, 2020 and December 31, 2019, (ii) the Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2020 and 2019, (iii) the Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2019 and 2020, (iv) the Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2020 and 2019, and (iv) Notes to the Condensed Consolidated Financial Statements
*	Filed herewith
§	In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release Nos. 33-8238 and 34-47986, Final Rule: Management’s Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, the certification furnished in Exhibit 32.1 hereto is deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Exchange Act. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

		VAXART, INC.
Dated: May 12, 2020		By:  /s/ WOUTER W. LATOUR, M.D.
		Wouter W. Latour, M.D.
		President and Chief Executive Officer
		(Principal Executive Officer and Principal Financial Officer)