SAN DIEGO, May 7, 2019 /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,
2019.
"We had a strong start to the year with excellent progress on
multiple fronts related to our Phase 3 Toca 5 trial of Toca 511
& Toca FC in patients with recurrent high grade glioma and
potential commercial launch," said Marty
Duvall, chief executive officer of Tocagen. "We ended the
quarter well capitalized to fund operations into 2020 and look
forward to the pending interim analysis of the Toca 5 trial this
quarter and the final analysis by the end of the year."
First Quarter 2019 and Recent Highlights
- Expanded leadership team: Fairooz Kabbinavar, M.D.,
FACP, was appointed senior vice president, clinical development, to
oversee the advancement of Tocagen's platform and lead product
candidate, Toca 511 & Toca FC. Prior to joining Tocagen, Dr.
Kabbinavar was principal medical director at Genentech where he led
the development of cancer immunotherapy TECENTRIQ® (atezolizumab)
in small cell lung cancer and served as the clinical lead for the
head and neck cancer program. With this addition, Tocagen further
adds to its leadership team's deep biopharmaceutical R&D and
commercialization experience, positioning the company for potential
BLA filing and commercialization. Acting chief medical officer
Lori A. Kunkel, M.D. has returned to
the company's board of directors.
- Presented Toca 511 & Toca FC data: In April, Tocagen
presented clinical and preclinical data at the American Association
for Cancer Research (AACR) Annual Meeting 2019 and the 2019
American Association of Neurological Surgeons (AANS) Annual
Meeting. New preclinical data demonstrated increased survival from
the combination of Toca 511 & Toca FC with either temozolomide
or cyclophosphamide. These results support the planned Phase 2/3
trial (NRG-BN006) evaluating Toca 511 & Toca FC in combination
with standard of care, including temozolomide, in patients with
newly diagnosed glioblastoma (GBM) to be conducted by NRG Oncology
under its NCI-funded grant.
First Quarter 2019 Financial Results
Research and Development (R&D) Expenses: R&D
expenses were $12.4 million for the
quarter ended March 31, 2019,
compared to $10.4 million for the
quarter ended March 31, 2018. The
R&D expenses in both periods were primarily driven by costs to
support the Toca 5 trial and manufacturing of drug product. The
increase in 2019 reflects primarily higher manufacturing spend as
compared to the same period in 2018.
General and Administrative (G&A)
Expenses: G&A expenses were $4.4 million for the quarter ended March 31, 2019, compared to $2.4 million for the quarter ended March 31, 2018. The increase in G&A expenses
was primarily due to higher personnel costs and contracted services
to support the increased activity.
Net Loss: Net loss was $17.1
million, or $0.74 per common
share (basic and diluted), for the quarter ended March 31, 2019, compared to a net loss of
$12.9 million, or $0.65 per common share (basic and diluted), for
the quarter ended March 31, 2018. The
2019 calculation is based on 23.0 million average common shares
outstanding for the first quarter of 2019, compared to 19.9 million
average common shares outstanding for the first quarter of 2018.
Our average shares outstanding increased primarily as a result of
selling 3.0 million shares in a public offering in December
2018.
Cash Position
Cash, cash equivalents and marketable securities were $80.1 million at March 31,
2019 compared to $96.1 million
at December 31, 2018.
About Toca 511 & Toca FC
Tocagen's lead product candidate is a two-part
cancer-selective immunotherapy comprising an investigational
biologic, Toca 511 (vocimagene amiretrorepvec), and an
investigational small molecule, Toca FC (flucytosine,
extended-release). 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, 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.
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 results of our and our collaborator's clinical trials
and planned clinical trials, expectations regarding the timing of
regulatory submissions and reviews, expectations regarding our
preclinical research and development activities, expectations
regarding our use of cash in 2019, 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)
|
|
|
|
|
|
|
|
|
March
31,
|
|
|
December
31,
|
|
|
2019
|
|
|
2018
|
|
|
(unaudited)
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
|
80,123
|
|
|
$
|
96,086
|
Prepaid expenses and
other assets
|
|
|
14,605
|
|
|
|
6,995
|
Total
assets
|
|
$
|
94,728
|
|
|
$
|
103,081
|
Current
liabilities
|
|
|
16,177
|
|
|
|
16,534
|
Notes payable and
other long-term liabilities
|
|
|
33,697
|
|
|
|
28,402
|
Total
stockholders' equity
|
|
|
44,854
|
|
|
|
58,145
|
Total liabilities and
stockholders' equity
|
|
$
|
94,728
|
|
|
$
|
103,081
|
TOCAGEN
INC.
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(in thousands,
except share and per share data)
|
|
|
|
Three Months
Ended
|
|
|
March
31,
|
|
|
2019
|
|
2018
|
|
|
(unaudited)
|
License
revenue
|
|
$
|
9
|
|
$
|
9
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
|
12,434
|
|
|
10,436
|
General and
administrative
|
|
|
4,446
|
|
|
2,419
|
Total operating
expenses
|
|
|
16,880
|
|
|
12,855
|
Loss from
operations
|
|
|
(16,871)
|
|
|
(12,846)
|
Other expense,
net
|
|
|
(213)
|
|
|
(34)
|
Net loss
|
|
$
|
(17,084)
|
|
$
|
(12,880)
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.74)
|
|
$
|
(0.65)
|
Weighted-average
number of common shares outstanding, basic and diluted
|
|
|
23,040,951
|
|
|
19,905,871
|
Media Contact:
Pam Lord
Canale Communications
(619) 849-6003
pam@canalecomm.com
Investor Contact:
Pete Rahmer
Endurance Advisors
(415) 515-9763
prahmer@enduranceadvisors.com
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SOURCE Tocagen Inc.