Tocagen (TOCA) and Forte Biosciences merge; trade as Forte Biosciences (FBRX)

Tocagen Inc. (Nasdaq: TOCA), and Forte Biosciences, Inc., a privately held clinical-stage biopharmaceutical company developing a live biotherapeutic for the treatment of inflammatory skin diseases, announced today that they have entered into a definitive agreement under which Tocagen will merge with Forte in an all-stock transaction.

The merged company will focus on advancing Forte's clinical program in inflammatory skin diseases, including atopic dermatitis. The combined company operates under the name Forte Biosciences and trades on the Nasdaq Capital Market under the ticker symbol FBRX.

• https://www.fortebiorx.com/home/default.aspx
• Paul Wagner, CEO

Paul Wagner, CEO

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Tocagen was a struggling brain cancer biotech whose huge Phase III failure triggered mass layoffs at the company.

Forte Biosciences is a biotech tackling atopic dermatitis and other inflammatory skin diseases.

Three years years ago, Tocagen went public and raised $85 million on the promise of a two-part therapy for glioblastoma. Part 1 used a vector to attack cancer cells and deliver the gene for an enzyme and Part 2 was a prodrug that converts into an anti-cancer drug. It was an intriguing approach to a deadly indication that has evaded most previous attempts, but in September, in its biggest test, the two-part therapy showed all but no signs of working.

In fact, patients on the control arm lived a month longer on average than patients on the drug arm, 12.2 vs 11.1. That computed to a hazard ratio of 1.06 and a p-value of 0.62. The company’s stock dropped 81% on the announcement, and a month later they cut 65% of their workforce, leaving the San Diego-based biotech with just 30 employees.

Tocagen (TOCA) : late-stage trial of cancer treatment misses primary endpoint

** charts after earnings **

Shares of Tocagen Inc. plummeted 82% on heavy volume toward a record low Thursday, after the gene company said a late-stage trial of its brain cancer treatment failed to meet its primary endpoint of survival compared with standard of care treatment. Trading volume of 975,000 shares ahead of the open was already more than triple the full-day average of about 253,000 shares. The company said all secondary endpoints of the phase 3 trial evaluating Toca 511 and Toca FC in patients with recurrent high grade glioma undergoing resection showed no meaningful difference between the arms of the trial. The company said further analysis of the trial data is underway. The stock is on track to open below the $1 mark, below the previous record low close of $3.00. It had already tumbled 49.1% year to date through Wednesday.

Tocagen (TOCA) began trading on the Nasdaq on Thur 13 Apr 2017

Tocagen is focused on cancer gene therapies that are designed to use a patient's immune system against their own cancer, according to its prospectus.
Tocagen Inc. said Monday it plans to 7.25 million shares in its initial public offering, priced at $10 to $12 a share, to raise $79.8 million at the midpoint of the range.
The company priced its IPO at $10.00 per share, at the low end of an initial estimated $10.00 to $12.00 per share range. The company now has a market cap of approximately $187M.

• Sector: Healthcare
• Industry: Biotechnology
• Full Time Employees: 85
• http://www.tocagen.com

The San Diego, CA-based firm develops gene therapies based on retroviral replicating vectors (RRVs) that are designed to selectively deliver therapeutic genes to cancer cells and persist therein.

Its lead product candidate is Breakthrough Therapy- and Fast Track-tagged Toca 511 & Toca FC for the treatment of high-grade glioma (brain cancer). Top-line data from a Phase 2 clinical trial are expected in H1 2018. Toca 511 (vocimagene amiretrorepvec) is the RRV and Toca FC is an orally administered extended-release formulation of the prodrug 5-fluorocytosine (5-FC) which readily crosses the blood-brain barrier. It is converted into the chemo agent 5-FU by an enzyme called cytosine deaminase (CD). The company says 5-FU delivered this way has a dual mechanism of action, killing cancer cells and boosting the immune system by killing immunosuppressive cells.

In November 2015, Tocagen initiated the Phase 2 portion of a randomized, controlled Phase 2/3 clinical trial of Toca 511 & Toca FC in patients with recurrent HGG, which is designed to serve as a potential registrational trial. The company completed enrollment of the Phase 2 portion with 187 patients in February 2017 and plan to report top-line results in the first half of 2018. In February 2017, the U.S. Food and Drug Administration (FDA) granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of patients with recurrent HGG.

2016 Financials ($M): Operating Expenses: 31.7 (+37.8%); Net Loss: (33.4) (-44.6%); Cash Burn: (29.5) (-40.5%).