On October 29, 2018 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended September 30, 2018 (Press release, Vical, OCT 29, 2018, View Source [SID1234530293]). Net loss for the third quarter of 2018 was $1.5 million, or $0.07 per share, compared with a net loss of $3.1 million, or $0.27 per share, for the third quarter of 2017. Revenues for the third quarter of 2018 were $0.1 million, compared with revenues of $3.2 million for the third quarter of 2017, reflecting a reduction in revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements. Net loss for the third quarter of 2018 included a gain of $2.3 million related to the sale of the Company’s manufacturing assets and $0.7 million received from Astellas to cover close down costs related to the ASP0113 program.
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Vical had cash, cash equivalents, marketable securities and long-term investments of $52.7 million at September 30, 2018. The Company’s cash burn for the third quarter of 2018 was $1.6 million. The Company is updating its 2018 full year cash burn guidance to a range of between $15 million and $18 million, a reduction in cash burn from its previous forecast of between $20 million and $24 million. The Company anticipates ending 2018 with a minimum of $45 million in cash, cash equivalents, marketable securities and long-term investments.
Vical recently 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. There is no set timetable for the review process and there can be no assurance that the process will result in a transaction.
Program updates include:
VL-2397 Antifungal Candidate
The multinational Phase 2 registration 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 is ongoing (ClinicalTrials.gov Identifier: NCT03327727). Vical expects to conduct the trial in approximately 40 major cancer and transplantation centers in North America, Europe and Asia. Centers are now open for enrollment in the US, Canada, Belgium, Germany, and will open shortly in South Korea. 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. VL-2397 has a novel mechanism of antifungal action and could be the first therapeutic in a new class of antifungals.
VR-CHB01 Hepatitis B Virus (HBV) Therapeutic Candidate
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. The Company expects to complete the initial stage of preclinical development in the fourth quarter of 2018