Vaxart Announces Third Quarter 2019 Financial Results and Provides Corporate Update
- Oral Bivalent Norovirus Vaccine Meets Primary and Secondary Endpoints in Phase 1b Study -
“The positive topline results from the Phase 1b clinical trial were a major milestone for the norovirus program,” said
The CDC estimates that norovirus causes
Recent Corporate Highlights:
- Vaxart’s Tableted Oral Bivalent Norovirus Vaccine Meets Primary and Secondary Endpoints in Phase 1b Study
- The study met all primary endpoints for safety and demonstrated robust immunogenicity with response rates of 90 – 93% for norovirus GII.4 and 78 – 86% for norovirus GI.1 as measured by IgA Antibody Secreting Cells (ASC), a key marker for mucosal immunity and a potential correlate of protection for norovirus disease.
- Manufacturing of Norovirus GI.1 and GII.4 vaccines is proceeding as planned at Lonza and the initiation of the Phase 2 Bivalent Norovirus study is on target for 2020.
- Research collaboration with Janssen’s Universal Influenza Vaccine Program is proceeding with results expected in 2020.
- Priced an underwritten public offering which closed in September. As of
September 30, 2019, the aggregate gross proceeds were $9.0 million. Vaxartpresented a corporate overview and update to investors and strategic partners at the H.C. Wainwright 21st Annual Global Investment Conference, in New York City.
- Scientific meeting presentations:
- IDWeek – Washington, DC, Presentation Title: Oral Norovirus Vaccination in Humans Induces Plasmablast B Cell Expansion and Follicular T Cell Activation Comparable to Natural Infection
- 7th International Calicivirus Conference – Sydney,
Australia, Presentation Title: Oral Vaccine to Prevent Norovirus Infection Induces Mucosal Homing Plasmablasts and T Follicular Cells in Humans
- 10th International Vaccines for Enteric Diseases Conference (VED 2019) – Lausanne,
Switzerland, Presentation Title: Progress on the Development of an Oral, Bivalent Norovirus Vaccine
Financial Results for the Three Months Ended
Vaxartreported a net loss of $5.3 millionfor the third quarter of 2019 compared to $6.5 millionfor the third quarter of 2018. The principal reason for the decrease was a reduction in research and development expenditure. Vaxartended the quarter with cash and cash equivalents of $19.6 millioncompared to $16.3 millionat June 30, 2019. The increase was primarily due to the $8.1 millionnet proceeds from equity financing, mostly from the underwritten offering in September 2019, partially offset by cash used in operations.
- Revenue for the quarter was
$454,000compared to $281,000in the third quarter of 2018. The increase was mostly due to non-cash royalty revenue related to the sale of future royalties.
- Research and development expenses were
$3.7 millionfor the quarter compared to $4.4 millionfor the third quarter of 2018. The decrease was mainly due to the absence of clinical trials costs for teslexivir and a reduction in amortization of intangibles, partially offset by higher clinical trial and manufacturing costs incurred in the Company’s norovirus program.
- General and administrative expenses were
$1.5 millionfor the quarter compared to $1.7 millionfor the third quarter of 2018. The decrease was mainly due to lower audit and accounting costs.
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “believe,” “could,” “potential,” “will” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to the Vaxart’s ability to develop and commercialize its product candidates and clinical results and trial data; Vaxart’s plans to start a phase 2 study with its bivalent norovirus vaccine in 2020; Vaxart’s expectations with respect to its collaboration with Janssen and the timing of expected results in 2020; Vaxart’s intention to continue its efforts to advance its oral tablet vaccines for seasonal influenza, RSV and HPV; the ability of
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Condensed Consolidated Balance Sheets
|September 30, 2019||December 31, 2018|
|Cash and cash equivalents||$||19,558||$||11,506|
|Prepaid and other assets||1,282||1,446|
|Property and equipment, net||1,469||1,066|
|Right-of-use assets, net||2,301||—|
|Intangible assets, net||17,526||19,413|
|Liabilities and stockholders’ equity|
|Accrued and other liabilities||1,621||1,675|
|Liability related to sale of future royalties||16,154||17,741|
|Secured promissory note||2,454||3,611|
|Operating lease liabilities||2,514||—|
|Total liabilities and stockholders’ equity||$||42,695||$||35,227|
(1) Derived from the audited consolidated financial statements of
Condensed Consolidated Statements of Operations
|Three Months Ended September 30,||Nine Months Ended September 30,|
|(in thousands, except share and per share amounts)|
|Research and development||3,713||4,381||11,249||12,801|
|General and administrative||1,455||1,674||4,856||5,455|
|Total operating expenses||5,168||6,161||16,105||19,962|
|Loss from operations||(4,714||)||(5,880||)||(10,159||)||(17,570||)|
|Bargain purchase gain||—||—||—||6,660|
|Other income and (expenses), net||(515||)||(668||)||(1,783||)||(2,166||)|
|Provision for income taxes||(31||)||—||(294||)||(29||)|
|Net loss attributable to common stockholders||$||(5,260||)||$||(6,548||)||$||(12,236||)||$||(13,444||)|
|Net loss per share, basic and diluted||$||(0.32||)||$||(0.92||)||$||(0.96||)||$||(2.23||)|
|Shares used in computing net loss per share, basic and diluted||16,249,032||7,141,189||12,748,665||6,038,001|
Source: Vaxart, Inc.