Analyst Conference Summary

biotechnology

conference date: August 8, 2019 press release only
for quarter ending: June 30, 2019 (second quarter, Q2)

Forward-looking statements

Overview: clinical stage company with Phase 3 data readout in Q4, 2019.

Basic data (GAAP):

Revenue was $0, sequentially from $0, and from $0 in the year-earlier quarter.

Net income was negative $17.1 million, up from negative $16.1 million year-earlier.

Diluted EPS negative $0.72, up from negative $0.81 year-earlier.

Guidance:

none

Conference Highlights:

Marty Duvall, CEO of Tocagen, said "We are making excellent progress towards achieving our corporate objectives for the year. We are focused on providing the final analysis of our pivotal Phase 3 Toca 5 trial and preparing for a potential rolling BLA filing with FDA. The Toca 5 trial involving 403 patients with recurrent brain cancer will generate an extensive data set and holds promise to shape the treatment of these patients with a novel, multi-modality cancer-selective gene therapy in combination with surgery. We also continue to execute our life cycle strategy for Toca 511 and Toca FC with the submission to FDA of a draft protocol for the planned Phase 2/3 trial of Toca 511 and Toca FC in patients with newly diagnosed glioblastoma sponsored by NRG Oncology, which remains on track to activate by the end of 2019. In addition, we recently advanced plans to evaluate Toca 511 and Toca FC in non-CNS tumors with a trial for patients with non-muscle invasive bladder cancer, which is also expected to initiate by the end of the year."

In May 2019, Tocagen announced the Toca 5 Phase 3 clinical trial evaluating Toca 511 & Toca FC in recurrent high grade glioma (HGG) would continue without modification following a planned second interim analysis conducted by an Independent Data Monitoring Committee. [WM: causing the stock price to plummet, which is irrational]

The Phase 2/3 trial to be conducted by NRG Oncology (NRG-BN006) evaluating Toca 511 & Toca FC in combination with standard of care versus standard of care alone in patients with newly diagnosed GBM is proceeding towards initiation by year-end 2019.

Tocagen plans to initiate a Phase 1b trial, Toca 8, in non-muscle invasive bladder cancer (NMIBC) in the second half of 2019.

Cash ended at $68.3 million. [More will be needed for the launch if the data is positive]

Q&A:

none

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