On May 7, 2019 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported financial results and business highlights for the first quarter ended March 31, 2019 (Press release, Tocagen, MAY 7, 2019, View Source [SID1234535835]).
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"We had a strong start to the year with excellent progress on multiple fronts related to our Phase 3 Toca 5 trial of Toca 511 & Toca FC in patients with recurrent high grade glioma and potential commercial launch," said Marty Duvall, chief executive officer of Tocagen. "We ended the quarter well capitalized to fund operations into 2020 and look forward to the pending interim analysis of the Toca 5 trial this quarter and the final analysis by the end of the year."
First Quarter 2019 and Recent Highlights
Expanded leadership team: Fairooz Kabbinavar, M.D., FACP, was appointed senior vice president, clinical development, to oversee the advancement of Tocagen’s platform and lead product candidate, Toca 511 & Toca FC. Prior to joining Tocagen, Dr. Kabbinavar was principal medical director at Genentech where he led the development of cancer immunotherapy TECENTRIQ (atezolizumab) in small cell lung cancer as well as serving as the clinical lead for the head and neck cancer program. With this addition, Tocagen further adds to its leadership team’s deep biopharmaceutical R&D and commercialization experience, positioning the company for potential BLA filing and commercialization. Acting chief medical officer Lori A. Kunkel, M.D. has returned to the company’s board of directors.
Presented Toca 511 & Toca FC data: In April, Tocagen presented clinical and preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 and the 2019 American Association of Neurological Surgeons (AANS) Annual Meeting. New preclinical data demonstrated increased survival from the combination of Toca 511 & Toca FC with either temozolomide or cyclophosphamide. These results support the planned Phase 2/3 trial (NRG-BN006) evaluating Toca 511 & Toca FC in combination with standard of care, including temozolomide, in patients with newly diagnosed glioblastoma (GBM) to be conducted by NRG Oncology under its NCI-funded grant.
First Quarter 2019 Financial Results
Research and Development (R&D) Expenses: R&D expenses were $12.4 million for the quarter ended March 31, 2019, compared to $10.4 million for the quarter ended March 31, 2018. The R&D expenses in both periods were primarily driven by costs to support the Toca 5 trial and to support the manufacturing of drug product. The increase in 2019 reflects primarily higher manufacturing spend as compared to the same period in 2018.
General and Administrative (G&A) Expenses: G&A expenses were $4.4 million for the quarter ended March 31, 2019, compared to $2.4 million for the quarter ended March 31, 2018. The increase in G&A expenses was primarily due to higher personnel costs and contracted services to support the increased activity.
Net Loss: Net loss was $17.1 million, or $0.74 per common share (basic and diluted), for the quarter ended March 31, 2019, compared to a net loss of $12.9 million, or $0.65 per common share (basic and diluted), for the quarter ended March 31, 2018. The 2019 calculation is based on 23.0 million average common shares outstanding for the first quarter of 2019, compared to 19.9 million average common shares outstanding for the first quarter of 2018. Our average shares outstanding increased primarily as a result of selling 3.0 million shares in a public offering in December 2018.
Cash Position
Cash, cash equivalents and marketable securities were $80.1 million at March 31, 2019 compared to $96.1 million at December 31, 2018.
About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511 (vocimagene amiretrorepvec), and an investigational small molecule, Toca FC (flucytosine, extended-release). Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.