SAN DIEGO, Feb. 19, 2019 (GLOBE NEWSWIRE) -- Vical Incorporated (VICL) today announced that it has decided to discontinue the Phase 2 clinical trial of VL‑2397 that was initiated in the first quarter of 2018. The decision was based on the Company’s decision to conserve its cash resources while it pursues its strategic alternative review process, as well as low patient accrual rates. The Phase 2 clinical trial was evaluating VL-2397 as a potential first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant.
“While we believe in the potential benefits of VL-2397, we have made a strategic decision to discontinue our current development activities and conserve cash,” stated Vijay Samant, chief executive officer at Vical. “We want to thank the study investigators and their patients who participated in the trial for their support.”
In the third quarter of 2018, Vical announced plans to explore a range of strategic options to enhance shareholder value. The Company retained MTS Health Partners, L.P. to assist in the strategic review process. Given the decision announced today, the Company will focus on concluding the strategic review process.
Vical also plans to undertake a restructuring, including an appropriate reduction in staff. As a result, the Company will incur a restructuring related charge in the first quarter of 2019.
Fourth Quarter 2018 Financial and Operating Results
Vical also reported financial results for the three months ended December 31, 2018. Net loss for the fourth quarter of 2018 was $3.6 million, or $0.17 per share, compared with a net loss of $3.7 million, or $0.21 per share, for the fourth quarter of 2017. Revenues for the fourth quarter of 2018 were $0.1 million, compared with revenues of $4.0 million for the fourth quarter of 2017, reflecting revenues from Astellas Pharma Inc. for services performed under the prior ASP0113 collaborative agreements. Vical had cash and investments of $50.5 million at December 31, 2018. The Company’s net cash burn for 2018 was $12.4 million. The Company will not provide additional cash guidance until the strategic review process is complete.
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases. Additional information on Vical is available at www.vical.com.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include plans to complete a restructuring and the estimated impact on cash resources, as well as Vical’s plans to complete its review of strategic alternatives and the potential benefits of a strategic transaction. Risks and uncertainties include whether the termination of VL-2397 development and the planned restructuring will have the intended impact of conserving cash resources, Vical’s ability to identify potential strategic transactions and to complete any transaction that it pursues; whether Vical will be able to realize the expected benefits of any transaction; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
|Selected Condensed Financial Information (Unaudited)|
|Three Months Ended||Twelve Months Ended|
|Statements of Operations||December 31,||December 31,|
|(in thousands, except per share amounts)||2018||2017||2018||2017|
|License and royalty revenue||10||10||40||418|
|Research and development||2,558||4,448||12,327||14,391|
|Manufacturing and production||-||1,790||1,436||6,479|
|General and administrative||1,517||1,596||7,505||6,335|
|Total operating expenses||4,075||7,834||21,268||27,205|
|Loss from operations||(3,951)||(3,881)||(19,646)||(13,386)|
|Net investment and other income||346||153||3,392||426|
|Basic and diluted net loss per share||$||(0.17)||$||(0.21)||$||(0.74)||$||(1.01)|
|Weighted average shares used in computing|
|basic and diluted net loss per share||21,844||17,778||21,842||12,888|
|Balance Sheets||December 31,||December 31,|
|Cash, cash equivalents, and marketable|
|securities, including restricted||$||48,071||$||60,691|
|Other current assets||1,128||15,626|
|Total current assets||49,199||76,317|
|Property and equipment, net||100||606|
|Liabilities and stockholders' equity:|
|Total liabilities and stockholders' equity||$||52,344||$||80,494|
Contacts: Andrew Hopkins Anthony Ramos
(858) 646-1127 Vice President and Chief Financial Officer