SAN DIEGO, Oct. 29, 2015 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today reported financial results for the three and nine months ended September 30, 2015. Net loss for the third quarter of 2015 was $0.3 million, or $0.00 per share, compared with a net loss of $4.4 million, or $0.05 per share, for the third quarter of 2014. Revenues for the third quarter of 2015 were $5.0 million, compared with revenues of $3.4 million for the third quarter of 2014, reflecting increased revenues from Astellas Pharma Inc. for manufacturing services performed under our ASP0113 collaborative agreements. ASP0113 is Vical's therapeutic vaccine designed to prevent cytomegalovirus (CMV) disease and associated complications in transplant recipients.
Vical generated positive cash flow for the third quarter of 2015 of $0.2 million. The Company had cash and investments of $43.9 million at September 30, 2015 compared to $49.1 million at December 31, 2014. The Company is updating its 2015 full year cash burn guidance to a range of between $7 million and $9 million, a reduction in cash burn from its previous forecast of between $9 million and $12 million.
Program updates include:
ASP0113 CMV Vaccine
- Enrollment in the multinational Phase 3 registrational trial in approximately 500 hematopoietic cell transplant recipients is ongoing. Astellas has finalized the primary endpoint as a composite of overall mortality and CMV end organ disease and has decided to forego the adaptive trial design. Astellas is in active discussions with regulatory agencies to obtain their concurrence on the selected endpoint. Astellas expects enrollment in the trial to be completed by the third quarter of 2016, with the top-line data being available in the fourth quarter of 2017.
- Enrollment in the multinational Phase 2 trial in kidney transplant recipients is complete. The primary endpoint of this trial is the incidence of CMV viremia and the study is powered to show an approximately 50% reduction in CMV viremia at one year after transplantation. Top-line trial data are expected to be available in the third quarter of 2016.
- The subjects in the ongoing Phase 1/2 HSV-2 study will continue to be followed for a period of twelve months for safety and nine months for efficacy following their last dose. Vical expects that additional efficacy data will be available for analysis in December and will enable Vical to determine the next steps for the HSV-2 program by early next year.
- In August 2015, Vical's novel antifungal, VL-2397, received a qualified infectious disease product, or QIDP, designation from the FDA for the treatment of invasive aspergillosis. Vical is targeting initiation of a Phase 1 trial in the first half of 2016. This will be a randomized, double-blind study to determine the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VL-2397 administered by infusion in healthy volunteers.
Vical will conduct a conference call and webcast today, October 29, at noon Eastern Time, to discuss the Company's financial results and program updates with invited participants. The call and webcast are open on a listen-only basis to any interested parties. To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719) 325-2376 (preferred), or (888) 401-4669 (toll-free), and reference confirmation code 3993142. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 3993142. The call will also be available live and archived through the events page at www.vical.com. For further information, contact Vical's Investor Relations department by phone at (858) 646-1127 or by e-mail at firstname.lastname@example.org.
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. 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 net cash use guidance, as well as anticipated developments in independent and collaborative programs, including the timing of initiation, enrollment and announcement of data for clinical trials. Risks and uncertainties include whether Vical or others will continue development of ASP0113, Vical's HSV-2 vaccine, VL-2397 or any other independent or collaborative programs; whether Vical will achieve levels of revenues and control expenses to meet its financial projections; whether enrollment in on-going trials will continue at current rates; whether Vical or its collaboration partners will be able to obtain regulatory allowances or guidance necessary to proceed with proposed clinical trials or implement anticipated clinical trial designs; whether any product candidates will be shown to be safe and efficacious in clinical trials; whether Vical is able to continue its collaborative arrangements or enter into new ones; the timing of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; 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||Nine Months Ended|
|Statements of Operations||September 30,||September 30,|
|(in thousands, except per share amounts)||2015||2014||2015||2014|
|Contract revenue||$ 4,427||$ 3,004||$ 12,382||$ 9,073|
|License and royalty revenue||590||438||1,755||1,321|
|Research and development||2,128||3,180||8,222||7,705|
|Manufacturing and production||1,306||2,292||6,626||7,457|
|General and administrative||1,916||2,366||6,271||7,176|
|Total operating expenses||5,350||7,838||21,119||22,338|
|Loss from operations||(333)||(4,396)||(6,982)||(11,944)|
|Net investment and other income||33||32||99||85|
|Net loss||$ (300)||$ (4,364)||$ (6,883)||$ (11,859)|
|Basic and diluted net loss per share||$ (0.00)||$ (0.05)||$ (0.08)||$ (0.13)|
|Weighted average shares used in computing basic and diluted net loss per share||91,957||89,976||91,600||88,154|
|Balance Sheets||September 30,||December 31,|
|Cash, cash equivalents, and marketable securities, including restricted||$ 41,851||$ 47,152|
|Other current assets||5,769||4,178|
|Total current assets||47,620||51,330|
|Property and equipment, net||2,010||2,639|
|Total assets||$ 53,420||$ 57,979|
|Liabilities and stockholders' equity:|
|Current liabilities||$ 5,474||$ 5,201|
|Total liabilities and stockholders' equity||$ 53,420||$ 57,979|
CONTACT: Andrew Hopkins Anthony Ramos Vice President and Chief Accounting Officer (858) 646-1127 Website: www.vical.com