SAN DIEGO, May 23, 2017 /PRNewswire/ -- Tocagen Inc.
(Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy
company, today reported financial results for the first quarter
ended March 31, 2017 and business
highlights.
"Tocagen has made great strides in our mission to bring novel
and effective cancer-selective immunotherapies to patients, with an
initial focus on brain cancer. Key milestones achieved to date
include observing durable objective responses, extended overall
survival and a favorable safety profile for our lead product
candidate in patients with recurrent high grade glioma. These
milestones contributed to the completion of enrollment of the Phase
2 portion of our registrational trial and the FDA's granting of
Breakthrough Therapy Designation," said Marty Duvall, chief executive officer of
Tocagen. "Our upsized initial public offering substantially
increased our financial strength, which will help support the
advancement of our lead product, Toca 511 & Toca FC, our
ongoing study in metastatic cancer and our planned initiation of a
trial involving newly diagnosed patients with high grade
glioma."
First Quarter 2017 and Recent Corporate Progress
- Completed upsized initial public offering: In
April 2017, Tocagen completed its
initial public offering (IPO), including the underwriters' exercise
of their option to purchase an additional 1,275,000 shares at the
public offering price of $10.00 per
share. The underwriters' option brought the total number of shares
of common stock sold by Tocagen to 9,775,000 shares and increased
the amount of gross proceeds raised in the offering to
approximately $97.8 million, prior to
deducting the underwriting discount and estimated expenses of the
offering.
- Breakthrough therapy designation granted from FDA: 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
high grade glioma (HGG).
- Phase 2 trial fully enrolled: In February 2017, Tocagen completed patient
enrollment in the Phase 2 portion of Toca 5, a randomized,
international Phase 2/3 clinical trial of Toca 511 & Toca FC,
for the treatment of patients with recurrent brain cancer. Toca 5
is designed to serve as a potential registrational trial, and
top-line results from the Phase 2 portion are anticipated in the
first half of 2018. In the trial, patients with first or second
recurrence of glioblastoma or anaplastic astrocytoma who are
undergoing resection are randomized between a cancer-selective
virus and oral prodrug, Toca 511 & Toca FC, or standard of
care.
- Strengthened executive leadership team: In March 2017, Asha
Das, M.D., was promoted to senior vice president and chief
medical officer and Mark Foletta
joined Tocagen as executive vice president and chief financial
officer. Mr. Foletta succeeded Tom
Darcy, a company co-founder who retired in May 2017 and who continues to serve on Tocagen's
board of directors. In November 2016,
Marty Duvall joined Tocagen as chief
executive officer and a member of Tocagen's board of directors
while Harry Gruber, M.D., a company
co-founder who previously served as Tocagen's chief executive
officer, assumed the role of president, research and development,
and remains a member of Tocagen's board of directors.
- Expanded Orphan-Drug Designation: In May 2017, the FDA granted an expansion of the
Orphan-Drug Designation for Toca 511 & Toca FC to include the
treatment of malignant glioma, in addition to the previously
granted orphan designation for the treatment of glioblastoma
multiforme.
- Industry awards received: In April 2017, Tocagen was selected by Informa as a
winner of two Clinical and Research Excellence Awards (CARE), in
the categories of "Most Successful Early Phase Trial (Preclinical
& Phase I)" and "Excellence in Rare Disease Drug
Development."
Upcoming Milestones
- 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 newly diagnosed high grade glioma expected in
early 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.
First Quarter 2017 Financial Results
Cash Position: Cash, cash equivalents and marketable
securities were $28.9 million at
March 31, 2017, compared with
$31.2 million at December 31, 2016. In April 2017, Tocagen raised approximately
$97.8 million of gross proceeds in
the IPO.
Research and Development (R&D) Expenses: R&D
expenses were $6.6 million for the
quarter ended March 31, 2017,
compared to $6.5 million for the
quarter ended March 31, 2016. The
R&D expenses were primarily driven by continued increases in
clinical costs to support our ongoing Phase 2/3 clinical trial,
mostly offset by lower manufacturing costs in the first quarter of
2017.
General and Administrative (G&A)
Expenses: G&A expenses were $1.9 million for the quarter ended March 31, 2017, compared to $1.1 million for the quarter ended March 31, 2016. The increase in G&A expenses
was primarily due to higher costs to support the increased level of
clinical and finance activities during the first quarter of 2017.
Stock-based compensation also increased by $0.2 million in the first quarter of 2017
compared to the same period in the prior year.
Net Loss: Net loss was $9.1
million, or $4.11 per common
share (basic and diluted), for the quarter ended March 31, 2017, compared to a net loss of
$8.0 million, or $3.64 per common share (basic and diluted), for
the quarter ended March 31, 2016.
This calculation is based on 2.2 million common shares outstanding
during each period.
About Toca 511 & Toca FC
Tocagen's lead product candidate is a cancer-selective
immunotherapy comprised of an investigational biologic, Toca 511,
and an investigational small molecule, Toca FC, that are designed
to be used together. Toca 511 is an injectable retroviral
replicating vector (RRV) that encodes a prodrug activator
enzyme, cytosine deaminase (CD). CD is derived from yeast, and
humans do not naturally have this gene. Its selective delivery to
cancer cells means that the infected cancer cells selectively carry
the CD gene and produce CD protein. Toca FC is an investigational
orally administered prodrug, 5-fluorocytosine (5-FC) that is
inactive as an anti-cancer drug. In animal models, Tocagen has
shown that 5-FC is converted into the anticancer drug, 5-FU, at
high concentrations in Toca 511-infected cancer cells that are
producing CD protein. Together, the Toca 511 & Toca FC
combination directly kills cancer cells and immune-suppressive
myeloid cells resulting in activation of the immune system against
cancer.
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. Toca 511 & Toca FC
was granted Breakthrough Therapy Designation by the U.S. Food
and Drug Administration (FDA) for the treatment of recurrent
HGG. Tocagen has received grant support from leading
brain cancer foundations, including Accelerate Brain
Cancer Cure (ABC2), National Brain Tumor
Society (NBTS), American Brain Tumor
Association (ABTA), Musella Foundation and Voices
Against Brain Cancer (VABC).
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 and
updates from communications with the FDA and 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)
|
|
|
|
March
31,
2017
|
|
December
31,
2016
|
|
(unaudited)
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
$
28,885
|
|
$
31,245
|
Prepaid expenses and
other assets
|
5,409
|
|
4,106
|
Total
assets
|
$
34,294
|
|
$
35,351
|
|
|
|
|
Current
liabilities
|
$
16,075
|
|
$
14,382
|
Notes payable and
other long-term liabilities
|
8,711
|
|
10,435
|
Convertible
promissory notes payable and subscription liability
|
11,016
|
|
3,538
|
Convertible preferred
stock
|
131,413
|
|
131,413
|
Total stockholders'
deficit
|
(132,921)
|
|
(124,417)
|
Total liabilities,
convertible preferred stock and stockholders' deficit
|
$
34,294
|
|
$
35,351
|
TOCAGEN
INC.
CONDENSED
STATEMENTS OF OPERATIONS
(in thousands,
except share and per share data)
|
|
|
|
Three Months
Ended
March
31,
|
|
2017
|
|
2016
|
|
(unaudited)
|
|
|
|
|
License
revenue
|
$
11
|
|
$
14
|
Operating
expenses:
|
|
|
|
Research and
development
|
6,624
|
|
6,469
|
General and
administrative
|
1,940
|
|
1,111
|
Total operating
expenses
|
8,564
|
|
7,580
|
Loss from
operations
|
(8,553)
|
|
(7,566)
|
Other expense,
net
|
(520)
|
|
(440)
|
Net loss
|
$
(9,073)
|
|
$
(8,006)
|
Net loss per common
share, basic and diluted
|
$
(4.11)
|
|
$
(3.64)
|
Weighted-average
number of common shares outstanding, basic and diluted
|
2,207,747
|
|
2,198,080
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/tocagen-reports-first-quarter-2017-financial-and-business-results-300462699.html
SOURCE Tocagen Inc.