SAN DIEGO, Nov. 8, 2018 /PRNewswire/ -- Tocagen Inc.
(Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy
company, today reported financial results and business highlights
for the third quarter ended September 30,
2018.
"We conclude the eventful third quarter of 2018 having met
important milestones, including early completion of enrollment and
the first interim analysis of our ongoing Phase 3 Toca 5 trial.
We've also further improved our balance sheet to advance our lead
program and execute against our goals," said Marty Duvall, chief executive officer of
Tocagen. "With the planned second interim and final analyses for
Toca 5 anticipated in 2019, we are preparing for a potential
rolling BLA submission and planning for commercial launch."
Third Quarter 2018 and Recent Highlights
- First interim analysis of Toca 5 Phase 3 trial: In
August 2018, Tocagen announced the
Toca 5 pivotal Phase 3 trial evaluating Toca 511 (vocimagene
amiretrorepvec) & Toca FC (extended-release flucytosine) in
patients with recurrent high grade glioma (rHGG) will continue
without modification following a pre-planned first interim analysis
of data. An Independent Data Monitoring Committee completed its
analysis at 50% of events occurring in the trial and recommended
the trial continue without modification. Tocagen estimates the
second interim analysis, at 75% of events in the trial, will occur
in the first half of 2019 and that the final analysis will occur by
the end of 2019.
- Completed Toca 5 enrollment: In September 2018, Tocagen completed the planned
enrollment of 380 patients in the ongoing Toca 5 Phase 3 trial
approximately three months ahead of schedule.
- Received milestone payment from ApolloBio: Completing
the Toca 5 enrollment triggered a milestone payment of $2 million from ApolloBio, Tocagen's licensee of
Toca 511 & Toca FC within the greater China region.
- Initiated commercial organization buildout: In
September 2018, Mohamed Ladha joined Tocagen as vice president,
head of commercial. Mr. Ladha will build, oversee and execute the
global commercial strategies for Tocagen's oncology products upon
regulatory approval in the United
States and other key markets.
- Presented Toca 6 data: Tocagen presented new clinical
data on Toca 511 & Toca FC in advanced solid tumors at the
International Cancer Immunotherapy Conference in late September.
Data showed favorable safety, vector deposition in "hot" and "cold"
tumors and immune changes consistent with preclinical and clinical
observations. Based on these data, Tocagen is now planning future
safety and efficacy trials in select tumor types.
- Publication of Toca 511 & Toca FC data: In
October 2018, two peer-reviewed
clinical data manuscripts appeared in print related to Toca 511
& Toca FC in rHGG. Data published by Timothy F. Cloughesy and co-authors in
Neuro-Oncology demonstrated multiyear durable responses
observed in rHGG patients treated in a Toca 511 & Toca FC Phase
1 trial. Data published by Daniel J.
Hogan and co-authors in Clinical Cancer Research
demonstrated Toca 511 & Toca FC treatment was not associated
with concerning integration sites and clonal expansion. These
manuscripts first published online May 12,
2018 and June 26, 2018,
respectively.
Third Quarter 2018 Financial Results
License Revenue: License revenue was $18.0 million for the quarter ended September 30, 2018, compared to less than
$0.1 million for the quarter ended
September 30, 2017. The 2018 revenue
was associated with a $16.0 million
upfront payment recognized under Tocagen's license agreement with
ApolloBio and a $2.0 million
development milestone earned upon completion of enrollment in the
Toca 5 clinical study.
Research and Development (R&D) Expenses: R&D
expenses were $12.3 million for the
quarter ended September 30, 2018,
compared to $7.6 million for the
quarter ended September 30, 2017. The
increase in R&D expenses in 2018 was primarily driven by higher
costs to support the expanded Toca 5 Phase 3 clinical study and
manufacturing activities related to Toca 511.
General and Administrative (G&A)
Expenses: G&A expenses were $4.3 million for the quarter ended September 30, 2018, compared to $2.2 million for the quarter ended September 30, 2017. The increase in G&A
expenses was primarily due to foreign non-income tax expense of
approximately $1 million paid under
Tocagen's license agreement with ApolloBio and an increase in
non-cash stock-based compensation expense.
Net Loss: Net loss was $0.4
million, or $0.02 per common
share (basic and diluted), for the quarter ended September 30, 2018, compared to a net loss of
$10.0 million, or $0.50 per common share (basic and diluted), for
the quarter ended September 30, 2017.
The reduction in net loss in 2018 was due to $18.0 million in revenue recognized under
Tocagen's license agreement with ApolloBio. Tocagen recognized
$1.5 million in income taxes for the
quarter ended September 30, 2018
related to the license agreement with ApolloBio. The 2018
calculation is based on 20.0 million average common shares
outstanding for the third quarter of 2018, compared to 19.8 million
average shares outstanding for the third quarter of 2017.
2018 Nine-Month Results
License Revenue: License revenue was $18.0 million for the nine months ended
September 30, 2018, compared to less
than $0.1 million for the nine months
ended September 30, 2017. The 2018
revenue was associated with a $16.0
million upfront payment recognized under Tocagen's license
agreement with ApolloBio and a $2.0
million development milestone earned upon completion of
enrollment in the Toca 5 clinical study.
R&D Expenses: R&D expenses were $35.5 million for the nine months ended
September 30, 2018 compared to
$20.8 million for the nine months
ended September 30, 2017. Similar to
the third quarter results, the R&D expenses primarily reflect
increased costs to support the expanded Toca 5 Phase 3 clinical
study, manufacturing activities related to Toca 511 & Toca FC
and personnel and related costs due to increased headcount.
G&A Expenses: G&A expenses were $9.3 million for the nine months ended
September 30, 2018 compared to
$6.2 million for the nine months
ended September 30, 2017. Similar to
the third quarter results, the G&A expenses primarily reflect
the foreign non-income tax expense paid under Tocagen's license
agreement with ApolloBio and an increase in non-cash stock-based
compensation expense.
Net Loss: Net loss for the nine months ended September 30, 2018 was $29.4 million, or $1.47 per common share (basic and diluted),
compared to a net loss of $28.1
million, or $2.19 per common
share (basic and diluted), for the nine months ended September 30, 2017. This calculation is based on
19.9 million average common shares outstanding for the nine months
ended September 30, 2018, compared to
12.8 million average shares outstanding for the same period in
2017.
Cash Position and Guidance
Cash, cash equivalents and
marketable securities were $79.8
million at September 30, 2018
compared to $88.7 million at
December 31, 2017. Tocagen refined
its annual cash burn guidance and estimates the total cash used in
2018 to fund operations and capital expenditures will be
approximately $50 million, resulting
in a year-end cash balance of approximately $70 million, up from approximately $40 million implied in guidance provided in
January 2018.
About Toca 511 & Toca FC
Tocagen's lead product
candidate is a two-part cancer-selective immunotherapy comprising
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. Toca FC is an orally administered 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 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's lead investigational product candidate,
Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3
trial (Toca 5) for recurrent high grade glioma (HGG), a disease
with significant unmet medical need. The U.S. Food and Drug
Administration awarded Tocagen an orphan drug grant for the
Toca 5 trial and has granted Toca 511 & Toca FC Breakthrough
Therapy Designation for the treatment of recurrent HGG. The
European Medicines Agency 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 timing and success of our clinical
trials and planned clinical trials, expectations regarding our
preclinical research and development activities, expectations
regarding our use of cash and cash on hand at the end of the year,
and plans related to development of our current and future product
candidates in additional indications. 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)
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
2018
|
|
2017
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
|
79,849
|
|
$
|
88,725
|
|
|
Prepaid expenses and
other assets
|
|
|
10,504
|
|
|
3,348
|
|
|
Total
assets
|
|
$
|
90,353
|
|
$
|
92,073
|
|
|
Current
liabilities
|
|
|
14,594
|
|
|
17,330
|
|
|
Notes payable and
other long-term liabilities
|
|
|
28,092
|
|
|
3,661
|
|
|
Total stockholders'
equity
|
|
|
47,667
|
|
|
71,082
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
90,353
|
|
$
|
92,073
|
|
|
TOCAGEN
INC.
|
|
CONDENSED
STATEMENTS OF OPERATIONS
|
|
(in thousands,
except share and per share data)
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
(unaudited)
|
|
(unaudited)
|
|
License
revenue
|
$
|
18,009
|
|
$
|
10
|
|
$
|
18,027
|
|
$
|
31
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
12,262
|
|
|
7,563
|
|
|
35,461
|
|
|
20,819
|
|
General and
administrative
|
|
4,320
|
|
|
2,184
|
|
|
9,311
|
|
|
6,153
|
|
Total operating
expenses
|
|
16,582
|
|
|
9,747
|
|
|
44,772
|
|
|
26,972
|
|
Income (loss) from
operations
|
|
1,427
|
|
|
(9,737)
|
|
|
(26,745)
|
|
|
(26,941)
|
|
Other expense,
net
|
|
(1,810)
|
|
|
(216)
|
|
|
(2,607)
|
|
|
(1,151)
|
|
Net loss
|
$
|
(383)
|
|
$
|
(9,953)
|
|
$
|
(29,352)
|
|
$
|
(28,092)
|
|
Net loss per common
share, basic and diluted
|
$
|
(0.02)
|
|
$
|
(0.50)
|
|
$
|
(1.47)
|
|
$
|
(2.19)
|
|
Weighted-average
number of common shares outstanding, basic and diluted
|
|
19,951,262
|
|
|
19,809,449
|
|
|
19,926,662
|
|
|
12,847,206
|
Media Contact:
Pam Lord
Canale Communications
(619) 849-6003
pam@canalecomm.com
Investor Contact:
Elizabeth
Broder
Endurance Advisors
ebroder@enduranceadvisors.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/tocagen-reports-third-quarter-2018-financial-and-business-results-300746231.html
SOURCE Tocagen Inc.