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Tocagen Reports Third Quarter 2017 Financial and Business Results
"Recent operational highlights include the acceleration of Toca 511 & Toca FC development into a pivotal Phase 3 trial and the presentation of updated Phase 1 data in patients with recurrent high-grade glioma at the recent AACR-NCI-EORTC meeting," said
Third Quarter 2017 and Recent Corporate Progress
- Toca 5 trial accelerated into Phase 3: On
October 26, 2017 ,Tocagen announced that based on communications with theU.S. Food and Drug Administration (FDA ) under Breakthrough Therapy Designation,Tocagen accelerated Toca 511 & Toca FC clinical development by modifying the original two-step trial design (Phase 2 followed by a Phase 3) into a seamless, pivotal trial, known as the Toca 5 trial. - Updated Phase 1 data presented: Research collaborators presented at the
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics onOctober 27, 2017 , updated durable complete response data from the Phase 1 trial of Toca 511 & Toca FC in patients with high-grade glioma (HGG). Two previously announced partial responders converted to complete responses, bringing the total number of complete responses to six. The median duration of response has not been reached after nearly three years of follow up. - Grant to support development of products for orphan diseases awarded: As previously announced, the
FDA awardedTocagen a$2 million grant, payable over four years, to support the Toca 5 trial. More details on the grant awarded through the Orphan Products Clinical Trials Grants Program are available at FDA.gov. - PRIME designation granted from EMA: In
July 2017 , theEuropean Medicines Agency (EMA) granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of patients with HGG.
Third Quarter 2017 Financial Results
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Net Loss: Net loss was
2017 Nine-Month Results
R&D Expenses: R&D expenses were
G&A Expenses: G&A expenses were
Net Loss: Net loss for the first nine months ended
Cash Position
Cash, cash equivalents and marketable securities were
About Toca 511 & Toca FC
About
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our business plans and objectives, expectations regarding the timing and success of our clinical trials and planned clinical trials. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost and timing of our product candidate development activities and planned clinical trials; our ability to execute on our strategy; regulatory developments in
TOCAGEN INC. CONDENSED BALANCE SHEETS (in thousands) |
||||||||
September 30, |
December 31, |
|||||||
2017 |
2016 |
|||||||
(unaudited) |
||||||||
Cash, cash equivalents and marketable securities |
$ |
99,573 |
$ |
31,245 |
||||
Prepaid expenses and other assets |
2,597 |
4,106 |
||||||
Total assets |
$ |
102,170 |
$ |
35,351 |
||||
Current liabilities |
16,738 |
14,382 |
||||||
Notes payable and other long-term liabilities |
5,317 |
10,435 |
||||||
Convertible promissory notes payable and subscription liability |
- |
3,538 |
||||||
Convertible preferred stock |
- |
131,413 |
||||||
Total stockholders' equity (deficit) |
80,115 |
(124,417) |
||||||
Total liabilities, convertible preferred stock and stockholders' equity (deficit) |
$ |
102,170 |
$ |
35,351 |
TOCAGEN INC. CONDENSED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
September 30, |
September 30, |
|||||||||||||||
2017 |
2016 |
2017 |
2016 |
|||||||||||||
(unaudited) |
(unaudited) |
|||||||||||||||
License revenue |
$ |
10 |
$ |
11 |
$ |
31 |
$ |
38 |
||||||||
Operating expenses: |
||||||||||||||||
Research and development |
7,563 |
7,586 |
20,819 |
20,585 |
||||||||||||
General and administrative |
2,184 |
956 |
6,154 |
3,170 |
||||||||||||
Total operating expenses |
9,747 |
8,542 |
26,973 |
23,755 |
||||||||||||
Loss from operations |
(9,737) |
(8,531) |
(26,942) |
(23,717) |
||||||||||||
Other expense, net |
(216) |
(469) |
(1,150) |
(1,331) |
||||||||||||
Net loss |
$ |
(9,953) |
$ |
(9,000) |
$ |
(28,092) |
$ |
(25,048) |
||||||||
Net loss per common share, basic and diluted |
$ |
(0.50) |
$ |
(4.09) |
$ |
(2.19) |
$ |
(11.39) |
||||||||
Weighted-average number of common shares outstanding, basic and diluted |
19,809,449 |
2,200,509 |
12,847,206 |
2,199,114 |
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SOURCE
Media Contact: Monica May, Canale Communications, (619) 849-5383, monica@canalecomm.com; Investor Contact: Elizabeth Broder, The Trout Group, (646) 378-2945, ebroder@troutgroup.com