November 5, 2008
Vical Reports Third Quarter 2008 Financial Results and Continued Progress in Product Development Programs
SAN DIEGO, Nov. 5 /PRNewswire-FirstCall/ -- Vical Incorporated today reported financial results for the quarter ended September 30, 2008. Revenues for the third quarter of 2008 were $0.8 million, compared with revenues of $0.4 million for the third quarter of 2007. The net loss for the third quarter of 2008 was $9.8 million or $0.24 per share, compared with $9.2 million or $0.24 per share for the third quarter of 2007.
Revenues for the first nine months of 2008 were $5.3 million, compared with revenues of $4.7 million for the first nine months of 2007. The net loss for the first nine months of 2008 was $27.9 million, or $0.70 per share, compared with a net loss of $27.0 million, or $0.69 per share, for the first nine months of 2007.
Vical had cash and investments of $49 million at September 30, 2008. The company's third quarter 2008 financial results were consistent with its projection for a full year net loss of $32 million to $37 million and a net cash burn of $27 million to $32 million.
During the third quarter, Vical achieved the milestone of enrolling the 80th stem cell transplant recipient in the company's Phase 2 cytomegalovirus (CMV) vaccine trial. The company expects to announce during the fourth quarter the results of an interim analysis in this trial on those subjects who were enrolled by the end of March.
H5N1 Pandemic Influenza Vaccines
Vical and AnGes MG, Inc., signed a non-binding Letter of Intent in October indicating their mutual interest in licensing the development and marketing rights for Vical's Vaxfectin(R)-formulated H5N1 pandemic influenza DNA vaccines in Japan to AnGes. Vical reported in July that the company's pandemic influenza DNA vaccines achieved potentially protective levels of antibody responses (H5 hemagglutination inhibition, or HI, titers of at least 40 and at least a four-fold increase from baseline) in at least 50% and up to 67% of evaluable subjects in the higher dose cohorts in a 100-subject Phase 1 trial. Expanded data presented in October showed that in the highest dose cohorts, responses peaked by Day 56 and were sustained in 80% to 100% of the responders through the end of the study at Day 182.
In addition to the successful initial human application of the Vaxfectin(R) adjuvant in the H5N1 pandemic influenza vaccine program, Vaxfectin(R)-formulated DNA vaccines have been well-tolerated and have demonstrated significant immune responses in multiple animal models, including nonhuman primates. Vaxfectin(R) has also demonstrated a dose-sparing effect (the ability to achieve the same vaccine effectiveness with lower vaccine doses) with the commercial seasonal influenza and government-stockpiled H5N1 pandemic influenza vaccines. Vaxfectin(R) may have potential applications as an adjuvant for other protein-based vaccines against infectious diseases and cancer as well. The Vaxfectin(R) adjuvant is currently being evaluated by potential partners for a variety of additional vaccine applications, and continued progress was reported over the past few months, including:
-- New mouse data with Vaxfectin(R)-formulated seasonal influenza vaccines demonstrating the ability to adjust the ratio of Vaxfectin(R) to vaccine and drive substantial increases in either antibody or T-cell responses, without reducing the other type of response, compared with unformulated vaccine;
-- A mouse study demonstrating a 100-fold increase in antigen-specific CD8+ T-cell responses with a Vaxfectin(R)-formulated cancer vaccine compared with unformulated vaccine;
-- A research collaboration with the Karolinska Institutet and the Swedish Institute for Infectious Disease Control to evaluate a Vaxfectin(R)-formulated preventive DNA vaccine against HIV in a Phase 1 human clinical trial as part of a prime-boost regimen; and
-- Publication in the August issue of "Clinical and Vaccine Immunology" of results demonstrating long-term protection against measles challenge in juvenile and infant nonhuman primates with a Vaxfectin(R)-formulated DNA vaccine.
Vical will conduct a conference call and webcast to discuss the financial results and program updates with invited analysts and institutional investors today, November 5, at noon Eastern Time. 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 (800) 817-4887, or (913) 312-1277 for international participants, and reference confirmation code 3255394. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (888) 203-1112, or (719) 457-0820 for international participants, and enter replay passcode 3255394. The call also will be available live and archived through the events page at http://www.vical.com/. For further information, contact Vical's Investor Relations department by phone at (858) 646-1127 or by e-mail at [email protected]
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at http://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 full-year net loss and net cash burn projections, as well as statements about the company's pandemic influenza and CMV vaccine programs, the company's Vaxfectin(R) adjuvant, and other independent and collaborative programs. Risks and uncertainties include whether Vical or others will continue development of the CMV vaccine, the pandemic influenza vaccine, the Vaxfectin(R) adjuvant, or any other independent or collaborative programs; whether Vical will announce results of the Phase 2 CMV vaccine interim analysis in the fourth quarter, if at all; whether Vical will be able to complete a mutually satisfactory definitive agreement with AnGes; whether preliminary H5N1 DNA vaccine Phase 1 clinical trial results will be confirmed upon further analysis or in larger studies; whether Vaxfectin(R) or other results in animal studies can be duplicated in human clinical trials; whether nonclinical results will advance to human clinical testing, and if so, whether such testing will be successful; whether commercial partners or collaborators will pursue additional Vaxfectin(R) applications; whether the company will achieve levels of revenues and control expenses to meet projected financial performance; whether any product candidates will be shown to be safe and efficacious in clinical trials; the timing of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; the dependence of the company on its collaborative partners; 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.
Contacts: Alan R. Engbring Executive Director, Investor Relations (858) 646-1127 Website: http://www.vical.com/ Jill M. Church Vice President and Chief Financial Officer VICAL INCORPORATED Selected Condensed Financial Information (Unaudited) Statements of Operations Three Months Ended Nine Months Ended (in thousands, except per Sept. 30, Sept. 30, share amounts) 2008 2007 2008 2007 Revenues: Contract and grant revenue $711 $164 $1,604 $3,994 License and royalty revenue 133 211 3,727 747 Total revenues 844 375 5,331 4,741 Operating expenses: Research and development 6,226 5,580 19,284 17,314 Manufacturing and production 2,716 2,871 8,772 11,034 General and administrative 2,087 2,192 6,439 6,825 Total operating expenses 11,029 10,643 34,495 35,173 Loss from operations (10,185) (10,268) (29,164) (30,432) Net investment income 360 1,029 1,292 3,399 Net loss $(9,825) $(9,239) $(27,872) $(27,033) Basic and diluted net loss per share $(0.24) $(0.24) $(0.70) $(0.69) Weighted average shares used to calculate basic and diluted net loss per share 40,349 39,193 39,688 39,189 Balance Sheets September 30, December 31, (in thousands) 2008 2007 Assets: Cash, cash equivalents, and marketable securities $43,022 $71,489 Other current assets 1,649 1,261 Total current assets 44,671 72,750 Marketable securities 6,000 - Property and equipment, net 11,146 12,287 Other assets 4,948 5,548 Total assets $66,765 $90,585 Liabilities and stockholders' equity: Current liabilities $7,522 $8,108 Long-term obligations 2,480 2,565 Stockholders' equity 56,763 79,912 Total liabilities and stockholders' equity $66,765 $90,585
CONTACT: Alan R. Engbring, Executive Director, Investor Relations, orJill M. Church, Vice President and Chief Financial Officer, both of VicalIncorporated, +1-858-646-1127
Web site: http://www.vical.com/