On May 3, 2018 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended March 31, 2018. Net loss for the first quarter of 2018 was $6.3 million, or $0.29 per share, compared with a net loss of $2.8 million, or $0.25 per share, for the first quarter of 2017 (Press release, Vical, MAY 3, 2018, View Source [SID1234526014]). Revenues for the first quarter of 2018 were $0.7 million, compared with revenues of $3.2 million for the first quarter of 2017, reflecting revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements.

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Vical had cash and investments of $58.3 million at March 31, 2018. The Company’s cash burn for the first quarter of 2018 was $4.6 million, which was consistent with the Company’s full year 2018 guidance of between $20 million and $24 million.

Program updates include:

VCL-HB01 HSV-2 Therapeutic Vaccine

Vical expects to announce top-line results from a Phase 2 study of its HSV-2 therapeutic vaccine during the second quarter of 2018. The last subject in the study has now completed nine months of surveillance; the primary endpoint of annualized recurrence rate will be calculated based on recurrences that are both clinically- and virologically-confirmed. This endpoint provides important information on the number of genital lesion recurrences over time in this chronic disease setting and is clinically meaningful for both patients and treating physicians. The Phase 2 study is being conducted in HSV-2 seropositive healthy adult subjects, 18 to 50 years of age who are randomized 2:1 to receive either vaccine or placebo.
VL-2397 Antifungal Drug

During the first quarter of 2018, Vical initiated a Phase 2 trial comparing VL‑2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (ClinicalTrials.gov Identifier: NCT03327727). The Company intends to conduct the trial in approximately 40 major cancer and transplantation centers in North America, Europe and Asia. The FDA has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis for patients with limited treatment options. The FDA has also granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL‑2397 for the treatment of invasive aspergillosis. Only one new class of antifungal therapy has been approved in the last 30 years. VL-2397 has a novel mechanism of antifungal action and could be the first therapeutic in a new class of antifungals. VL-2397 was isolated from a leaf litter fungus in a Malaysian national park, and was in‑licensed from Astellas in 2015.
Hepatitis B Virus (HBV) Therapeutic Drug

The Company is pursuing preclinical development of a novel treatment for chronic HBV infection based on its DNA and lipid-delivery technologies. The initial aim of this program will be to demonstrate proof of concept for inhibiting HBV infection in an in vivo model. This preclinical development effort is being conducted in collaboration with Vical’s partner, AnGes, Inc. of Osaka, Japan.
Vical will conduct a conference call and webcast today, May 3, at noon Eastern Time, to discuss the Company’s financial results and program updates. 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 (323)794-2567 (preferred), or (888)278-8469 (toll-free), and reference confirmation code 1443635. 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 1443635. The webcast 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 [email protected].