SAN DIEGO, May 10, 2018 /PRNewswire/ -- Tocagen Inc.
(Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy
company, today reported financial results and business highlights
for the first quarter ended March 31,
2018.
"We are off to a strong start this year and are well positioned
to execute on our key priorities, including completing enrollment
in our Phase 3 trial in recurrent brain cancer by year end," said
Marty Duvall, chief executive
officer of Tocagen. "In parallel, we are working to expand Toca 511
& Toca FC into newly diagnosed brain cancer while exploring its
potential in other tumor types."
First Quarter 2018 and Recent Highlights
- Entered into a license agreement with ApolloBio: In
April 2018, Tocagen and ApolloBio
entered a license agreement to develop and commercialize Toca 511
& Toca FC within the greater China region. Tocagen is eligible to receive
up to $127 million in upfront
payment, development and commercial milestones, plus additional
double-digit tiered sales royalties. Upfront and near-term
development milestone payments total up to $20 million. More details are available in the
corresponding Form 8-K filed with the U.S. Securities and Exchange
Commission (SEC).
- Updated durable response data from Phase 1 recurrent high
grade glioma (rHGG) resection study: Updated durable response
data from the Phase 1 study involving patients with rHGG who
received Toca 511 & Toca FC at the time of surgical resection
were presented by trial investigators at the 2018 American Academy
of Neurology (AAN) Annual Meeting and 2018 American Association of
Neurological Surgeons (AANS) Annual Scientific Meeting. Tocagen
previously presented data from this study as of August 15, 2017. In the presentations at AAN and
AANS, updated data showed Toca 511 & Toca FC continue to
demonstrate a favorable safety profile and all study responders
remained alive and in complete response as of December 20, 2017. As of this cutoff date, the
median duration of durable response had not yet been reached, with
a median follow-up period of 37.4 months.
- Presented preliminary Toca 6 Phase 1 data: At the
American Association for Cancer Research (AACR) Annual Meeting
2018, research collaborators presented preliminary clinical data
that suggest the potential feasibility of intravenous (IV)
administration of Toca 511 from the ongoing Toca 6 Phase 1 trial of
Toca 511 & Toca FC in patients with advanced solid tumors.
Safety, tolerability and confirmation of vector deposition in
metastatic tumors was demonstrated in five patients with advanced
solid tumors who received Toca 511 intravenously. These data inform
Tocagen's plans to initiate additional studies evaluating the
efficacy of Toca 511 & Toca FC in patients with advanced
cancers.
First Quarter 2018 Financial Results
Research and Development (R&D) Expenses: R&D
expenses were $10.4 million for the
quarter ended March 31, 2018,
compared to $6.6 million for the
quarter ended March 31, 2017. The
increase in R&D expenses in 2018 was primarily driven by higher
costs to support the expanded Toca 5 trial and increased activities
in manufacturing of Toca 511 & Toca FC.
General and Administrative (G&A)
Expenses: G&A expenses were $2.4 million for the quarter ended March 31, 2018, compared to $1.9 million for the quarter ended March 31, 2017. The increase in G&A expenses
was primarily due to increased stock-based compensation expense and
costs associated with being a public company during the first
quarter of 2018.
Net Loss: Net loss was $12.9
million, or $0.65 per common
share (basic and diluted), for the quarter ended March 31, 2018, compared to a net loss of
$9.1 million, or $4.11 per common share (basic and diluted), for
the quarter ended March 31, 2017. The
2018 calculation is based on 19.9 million average common shares
outstanding for the first quarter of 2018, compared to 2.2 million
average common shares outstanding for the first quarter of
2017.
Cash Position and Guidance
Cash, cash equivalents and marketable securities were
$74.0 million at March 31, 2018 compared to $88.7 million at December
31, 2017. Subsequent to the close of the first quarter 2018,
Tocagen signed a license agreement with ApolloBio and expects to
receive $16 million by early in the
third quarter of 2018, according to the terms of the licensing
agreement. Tocagen reiterates its annual guidance and continues to
estimate the total cash used in 2018 to fund operations, capital
expenditures and debt amortization will not exceed $50 million.
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
(vocimagene amiretrorepvec) 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, infected cancer cells carry the CD gene and produce CD.
Toca FC is an orally administered, extended-release formulation of
the prodrug, 5-fluorocytosine (5-FC), which is converted into an
anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD.
5-FU kills cancer cells and immune-suppressive myeloid cells in the
tumor microenvironment resulting in anti-cancer immune activation
and subsequent tumor killing.
About Tocagen Inc.
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's lead investigational product candidate,
Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3
trial for recurrent high grade glioma (rHGG), 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 rHGG and the
European Medicines Agency (EMA) has granted Toca 511 PRIME
(PRIority MEdicines) designation for the treatment of glioma. For
more information about Tocagen, visit www.tocagen.com.
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
enrollment, timing and success of our clinical trials and planned
clinical trials, expectations regarding our preclinical development
activities, plans related to development of our current and future
product candidates in additional indications, and expectations
regarding near term payments from our partner in the greater
China region. 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; the ability of our China partner to receive the necessary
government approvals to make the required payments to us;
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,
|
|
|
December
31,
|
|
|
|
2018
|
|
|
2017
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
|
73,998
|
|
|
$
|
88,725
|
|
Prepaid expenses and
other assets
|
|
|
4,741
|
|
|
|
3,348
|
|
Total
assets
|
|
$
|
78,739
|
|
|
$
|
92,073
|
|
Current
liabilities
|
|
|
16,902
|
|
|
|
17,330
|
|
Notes payable and
other long-term liabilities
|
|
|
2,159
|
|
|
|
3,661
|
|
Total stockholders'
equity
|
|
|
59,678
|
|
|
|
71,082
|
|
Total liabilities and
stockholders' equity
|
|
$
|
78,739
|
|
|
$
|
92,073
|
|
TOCAGEN
INC.
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(in thousands,
except share and per share data)
|
|
|
|
|
Three Months
Ended
|
|
|
|
|
March
31,
|
|
|
|
|
2018
|
|
2017
|
|
|
|
|
(unaudited)
|
|
|
License
revenue
|
|
$
|
9
|
|
$
|
11
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
10,436
|
|
|
6,624
|
|
|
General and
administrative
|
|
|
2,419
|
|
|
1,940
|
|
|
Total operating
expenses
|
|
|
12,855
|
|
|
8,564
|
|
|
Loss from
operations
|
|
|
(12,846)
|
|
|
(8,553)
|
|
|
Other expense,
net
|
|
|
(34)
|
|
|
(520)
|
|
|
Net loss
|
|
$
|
(12,880)
|
|
$
|
(9,073)
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.65)
|
|
$
|
(4.11)
|
|
|
Weighted-average
number of common shares outstanding, basic and diluted
|
|
|
19,905,871
|
|
|
2,207,747
|
|
|
|
|
|
|
|
|
|
|
|
Media Contact:
Monica May
Canale Communications
(619) 849-5383
monica@canalecomm.com
Investor Contact:
Elizabeth Broder
Endurance Advisors
(646) 206-1246
ebroder@enduranceadvisors.com
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SOURCE Tocagen Inc.