SAN DIEGO, Aug. 9, 2017 /PRNewswire/ -- Tocagen Inc.
(Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy
company, today reported financial results for the second quarter
ended June 30, 2017 and business
highlights.
"Tocagen is committed to bringing new treatment options to
cancer patients, with an initial focus on recurrent high grade
glioma," said Marty Duvall, chief
executive officer of Tocagen. "During the second quarter, we
completed our initial public offering and were granted PRIME
designation from the European Medicines Agency, both positioning us
well to advance the clinical development of Toca 511 and Toca
FC."
Second Quarter 2017 and Recent Corporate Progress
- Completed upsized initial public offering: In
April 2017, Tocagen completed its
initial public offering (IPO), raising approximately $97.8 million in gross proceeds.
- Complementary preclinical studies published in
Neuro-Oncology: In July 2017,
preclinical data from two independent research programs published,
which together showed that Toca 511 & Toca FC treatment
resulted in increased immune infiltrates in tumors and that
long-term survival and anti-tumor immune effects were T-cell
dependent and correlated with depletion of immune-suppressive
myeloid cells. The papers were published in the July issue of
Neuro-Oncology, featured on the cover of the journal and
highlighted in an editorial.
- PRIME designation granted from EMA: In July 2017, the European Medicines Agency (EMA)
granted Toca 511 PRIME (PRIority MEdicines) designation for the
treatment of patients with high grade glioma (HGG), a type of brain
tumor with significant unmet medical need.
Upcoming Milestones
- Toca 511 & Toca FC program update following interactions
with FDA under Tocagen's Breakthrough Therapy Designation expected
in the second half of 2017.
- Initiation of Phase 1b trial, called Toca 7, evaluating Toca
511 & Toca FC in patients with newly diagnosed high grade
glioma expected in the first half of 2018.
- Top-line results from the Phase 2 portion of the Phase 2/3 Toca
5 trial expected to be reported in the first half of 2018.
- Selection of second product candidate from Tocagen's retroviral
replicating vector platform expected in 2018.
Second Quarter 2017 Financial Results
Research and Development (R&D) Expenses: R&D
expenses were $6.6 million for the
quarter ended June 30, 2017, compared
to $6.5 million for the quarter ended
June 30, 2016. The R&D expenses
were primarily driven by continued increases in costs to support
the company's ongoing Phase 2/3 clinical trial.
General and Administrative (G&A)
Expenses: G&A expenses were $2.0 million for the quarter ended June 30, 2017, compared to $1.1 million for the quarter ended June 30, 2016. The increase in G&A expenses
was primarily due to higher costs to support increased operations
activity and costs associated with being a public company during
the second quarter of 2017, including a $0.5
million increase in stock-based compensation compared to the
same period in the prior year.
Net Loss: Net loss was $9.1
million, or $0.56 per common
share (basic and diluted), for the quarter ended June 30, 2017, compared to a net loss of
$8.0 million, or $3.66 per common share (basic and diluted), for
the quarter ended June 30, 2016. The
2017 calculation is based on 16.3 million average common shares
outstanding during the second quarter of 2017, compared to 2.2
million average common shares outstanding for the second quarter of
2016. The average common shares outstanding for the second quarter
of 2017 includes the issuance of 9.8 million common shares, as well
as the conversion of the convertible preferred stock and
convertible promissory notes into 7.8 million common shares, upon
the IPO in April 2017.
2017 Six-Month Results
R&D Expenses: R&D expenses were $13.3 million for the six months ended
June 30, 2017 compared to
$13.0 million for the six months
ended June 30, 2016. Similar to the
second quarter results, the R&D expenses primarily reflect
increased costs to support the ongoing Phase 2/3 clinical
trial.
G&A Expenses: G&A expenses were $4.0 million for the first six months ended
June 30, 2017 compared to
$2.2 million for the first six months
ended June 30, 2016, with the
increase primarily driven by higher costs to support increased
operations activity and costs associated with being a public
company, including a $0.7 million
increase in stock-based compensation compared to the same period in
the prior year.
Net Loss: Net loss for the first six months ended
June 30, 2017 was $18.1 million, or $1.95 per common share (basic and diluted),
compared to a net loss of $16.0
million, or $7.30 per common
share (basic and diluted), for the first six months ended
June 30, 2016. This calculation is
based on 9.3 million average common shares outstanding for the six
months ended June 30, 2017, compared
to 2.2 million average shares outstanding for the same period in
2016.
Cash Position
Cash, cash equivalents and marketable securities were
$108.6 million at June 30, 2017 compared to $31.2 million at December
31, 2016. In April 2017,
Tocagen raised $97.8 million of gross
proceeds in the IPO.
About Toca 511 & Toca FC
Tocagen's lead product candidate is a two-part cancer-selective
immunotherapy comprised of an investigational biologic, Toca 511,
and an investigational small molecule, Toca FC. 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, only infected cancer cells carry
the CD gene and produce CD protein. Toca FC is an orally
administered prodrug, 5-fluorocytosine (5-FC), which is converted
into high concentrations of 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.
About Tocagen
Tocagen is a clinical-stage, cancer-selective gene therapy
company developing first-in-class, broadly applicable product
candidates designed to activate a patient's immune system against
their own cancer. Tocagen is developing its lead investigational
product candidate, Toca 511 & Toca FC, initially for the
treatment of recurrent high grade glioma (HGG), a disease with
significant unmet medical need. The U.S. Food and Drug
Administration (FDA) has granted Toca 511 & Toca FC
Breakthrough Therapy Designation for the treatment of recurrent HGG
and the European Medicines Agency (EMA) has granted Toca 511 PRIME
(PRIority MEdicines) designation for the treatment of HGG.
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 our cash
position, timing and success of our clinical trials and planned
clinical trials, timing of results from our clinical trials, timing
of updates from communications with the FDA and our plans regarding
selection of additional product candidates. 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 the United States and foreign countries; and
our estimates regarding expenses, future revenue and capital
requirements. These and other risks and uncertainties are described
more fully under the caption "Risk Factors" and elsewhere in
Tocagen's filings and reports with the United States Securities and
Exchange Commission. All forward-looking statements contained in
this press release speak only as of the date on which they were
made. Tocagen undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made.
TOCAGEN
INC.
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
|
|
|
June 30
,
|
|
|
December
31,
|
|
|
|
2017
|
|
|
2016
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
|
108,642
|
|
|
$
|
31,245
|
|
Prepaid expenses and
other assets
|
|
|
2,128
|
|
|
|
4,106
|
|
Total
assets
|
|
$
|
110,770
|
|
|
$
|
35,351
|
|
Current
liabilities
|
|
|
15,224
|
|
|
|
14,382
|
|
Notes payable and
other long-term liabilities
|
|
|
6,979
|
|
|
|
10,435
|
|
Convertible
promissory notes payable and subscription liability
|
|
|
-
|
|
|
|
3,538
|
|
Convertible preferred
stock
|
|
|
-
|
|
|
|
131,413
|
|
Total stockholders'
equity (deficit)
|
|
|
88,567
|
|
|
|
(124,417)
|
|
Total liabilities,
convertible preferred stock and stockholders' equity
|
|
$
|
110,770
|
|
|
$
|
35,351
|
|
TOCAGEN
INC.
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(in thousands,
except share and per share data)
|
|
|
|
Three Months
Ended
|
|
|
Six Months
Ended
|
|
|
|
June
30,
|
|
|
June
30,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
License
revenue
|
|
$
|
10
|
|
|
$
|
13
|
|
|
$
|
21
|
|
|
$
|
27
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
6,632
|
|
|
|
6,530
|
|
|
|
13,256
|
|
|
|
12,999
|
|
General and
administrative
|
|
|
2,030
|
|
|
|
1,103
|
|
|
|
3,970
|
|
|
|
2,214
|
|
Total operating
expenses
|
|
|
8,662
|
|
|
|
7,633
|
|
|
|
17,226
|
|
|
|
15,213
|
|
Loss from
operations
|
|
|
(8,652)
|
|
|
|
(7,620)
|
|
|
|
(17,205)
|
|
|
|
(15,186)
|
|
Other expense,
net
|
|
|
(414)
|
|
|
|
(422)
|
|
|
|
(934)
|
|
|
|
(862)
|
|
Net
loss
|
|
$
|
(9,066)
|
|
|
$
|
(8,042)
|
|
|
$
|
(18,139)
|
|
|
$
|
(16,048)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.56)
|
|
|
$
|
(3.66)
|
|
|
$
|
(1.95)
|
|
|
$
|
(7.30)
|
|
Weighted-average
number of common shares outstanding, basic and diluted
|
|
|
16,330,996
|
|
|
|
2,198,739
|
|
|
|
9,308,386
|
|
|
|
2,198,409
|
|
View original content with
multimedia:http://www.prnewswire.com/news-releases/tocagen-reports-second-quarter-2017-financial-and-business-results-300502314.html
SOURCE Tocagen Inc.