Gritstone Oncology Reports Third Quarter 2018 Financial Results and Recent Business Highlights
November 14 2018 - 8:00AM
Successful Initial Public Offering
Raises $95.6 Million in Net Proceeds
Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage
biotechnology company developing the next generation of cancer
immunotherapies to fight multiple cancer types, today reported
recent business highlights and financial results for the third
quarter ended September 30, 2018.
“We are delighted to have completed a successful
initial public offering, which was the result of three years of
innovation and determination by our team,” said Andrew Allen, M.D.,
Ph.D., co-founder, president and chief executive officer of
Gritstone Oncology. “In addition to becoming a public company, we
are advancing our first product candidate, GRANITE-001, into
clinical development, and we have established collaborations with
two leading oncology companies – bluebird bio, Inc. (bluebird) and
Bristol-Myers Squibb (BMS). These collaborations validate the
scientific differentiation and clinical potential of our platform,
and also enable our technologies to more broadly fuel the
development of new investigational anti-cancer therapies.”
Recent Highlights
- In October 2018, the company completed its initial public
offering (IPO), raising $95.6 million in net proceeds, and
commenced trading on the Nasdaq Global Select Market under the
ticker symbol “GRTS.”
- The Food and Drug Administration (FDA) accepted the company’s
Investigational New Drug (IND) application for GRANITE-001, a
personalized immunotherapy using patient-specific neoantigens,
enabling the initiation of our Phase 1/2 clinical study
(GO-004).
- A collaboration with bluebird was established to develop novel
cancer cell therapies utilizing Gritstone’s proprietary
EDGE™ artificial intelligence platform to identify both
tumor-specific targets and therapeutically useful T cell receptors
against those targets.
- A clinical research collaboration was established with BMS to
evaluate Gritstone’s GRANITE-001 in combination with BMS’ immune
checkpoint inhibitors nivolumab and ipilimumab.
- Steve E. Krognes, an experienced financial and biotech
executive with more than 25 years of industry experience, was
appointed to the Board of Directors.
Anticipated Milestones Over the Next 15
Months
- Data demonstrating the predictive
power of the EDGE platform in the identification of neoantigens and
neoantigen-reactive T cells is in press at a peer-reviewed journal
and expected to be published in the near term.
- An IND application for the
initiation of a first-in-human study with SLATE-001, an
immunotherapy candidate using shared neoantigens for an
“off-the-shelf” therapy, is planned for submission in
mid-2019.
- Preliminary efficacy data from the
Phase 1 portion of GO-004 in patients with metastatic lung,
gastric, colorectal and bladder cancers is expected to be reported
in the second-half of 2019.
Third Quarter 2018 Financial
ResultsFor the three months ended September 30, 2018,
Gritstone reported a net loss of $18.6 million, compared to a net
loss of $9.5 million for the three months ended September 30,
2017.
Collaboration revenue was $0.1 million for the
three months ended September 30, 2018, with no collaboration
revenue recognized for the three months ended September 30, 2017.
The increase was due to revenue recognized under the Research
Collaboration and License Agreement with bluebird, which was
entered into in August 2018.
Total research and development expenses were
$15.6 million for the three months ended September 30, 2018,
compared to $8.1 million for the three months ended September 30,
2017. The increase was primarily attributable to an increase in
personnel-related expenses driven by increased headcount, as well
as an increase in outside services and consultants, in-house
laboratory supplies and consumables, and facilities-related
expenses.
General and administrative expenses were $3.1
million for the three months ended September 30, 2018, compared to
$1.4 million for the three months ended September 30, 2017. The
increase was primarily attributable to an increase in
personnel-related expenses driven by an increase in headcount and
an increase in legal and other outside professional services
required to support the company’s ongoing operations as a public
company.
Cash, cash equivalents, and marketable
securities were $77.4 million as of September 30, 2018, compared to
$39.0 million as of December 31, 2017. The increase was primarily
attributable to $30 million in cash received related to the
Research Collaboration and License Agreement and the Stock Purchase
Agreement with bluebird, offset by operating and investing cash
payments. The third quarter ending cash position does not include
the $95.6 million in net proceeds from the IPO, which was received
in the fourth quarter.
About Gritstone
OncologyGritstone Oncology (Nasdaq:GRTS), a clinical-stage
biotechnology company, is developing the next generation of cancer
immunotherapies to fight multiple cancer types. Gritstone develops
its products by leveraging two key pillars—first, a proprietary
machine learning-based platform, Gritstone EDGE™, which is designed
to predict, from a routine tumor biopsy, the tumor-specific
neoantigens (TSNA) that are presented on a patient’s tumor cells;
and second, the ability to develop and manufacture potent
immunotherapies utilizing patients’ TSNA to potentially drive the
patient’s immune system to specifically attack and destroy tumors.
The company’s lead product candidate, GRANITE-001, is a
personalized neoantigen-based immunotherapy beginning Phase 1
clinical testing. Gritstone’s second product candidate, SLATE-001,
is a shared neoantigen (“off-the-shelf”) immunotherapy which is
advancing towards the clinic. For more information, please visit
gritstoneoncology.com.
Gritstone Forward-Looking
Statements This press release contains forward-looking
statements, including but not limited to statements related to the
expected timing for preliminary efficacy data from the Phase 1
portion of GO-004, the planned submission of an IND for SLATE-001
and expectations with regard to certain publications regardin the
EDGE platform. Such forward-looking statements involve substantial
risks and uncertainties that could cause Gritstone’s research and
clinical development programs, future results, performance or
achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the drug development process, including Gritstone’s early stage of
development, the process of designing and conducting clinical
trials, the regulatory approval processes, the timing of regulatory
filings, the challenges associated with manufacturing drug
products, Grtistone’s ability to successfully protect and defend
its intellectual property and other matters that could affect the
sufficiency of existing cash to fund operations. Gritstone
undertakes no obligation to update or revise any forward-looking
statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of the company in general, see Gritstone’s
recently filed Registration Statement on Form S-1 and any
subsequent current and periodic reports filed with the Securities
and Exchange Commission.
ContactsMedia:Dan Budwick1AB(973)
271-6085dan@1abmedia.com
Investors:Alexandra SantosWheelhouse Life Science Advisors(510)
871-6161asantos@wheelhouselsa.com
Gritstone Oncology, Inc. |
|
Condensed Statements of
Operations |
|
(Unaudited) |
|
(In thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue |
|
$ |
96 |
|
|
$ |
- |
|
|
$ |
96 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
15,622 |
|
|
|
8,084 |
|
|
|
39,712 |
|
|
|
19,939 |
|
|
General
and administrative |
|
|
3,088 |
|
|
|
1,404 |
|
|
|
7,940 |
|
|
|
4,244 |
|
|
Total
operating expenses |
|
|
18,710 |
|
|
|
9,488 |
|
|
|
47,652 |
|
|
|
24,183 |
|
|
Loss
from operations |
|
|
(18,614 |
) |
|
|
(9,488 |
) |
|
|
(47,556 |
) |
|
|
(24,183 |
) |
|
Interest
and other income, net |
|
|
26 |
|
|
|
37 |
|
|
|
120 |
|
|
|
175 |
|
|
Net
loss |
|
$ |
(18,588 |
) |
|
$ |
(9,451 |
) |
|
$ |
(47,436 |
) |
|
$ |
(24,008 |
) |
|
Net loss
per common share, basic and diluted |
|
$ |
(7.60 |
) |
|
$ |
(4.59 |
) |
|
$ |
(20.27 |
) |
|
$ |
(12.27 |
) |
|
Shares
used to compute for net income (loss) per common share, basic and
diluted |
|
|
2,445,547 |
|
|
|
2,057,040 |
|
|
|
2,339,705 |
|
|
|
1,957,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gritstone Oncology, Inc. |
|
Condensed Balance Sheets |
|
(Unaudited) |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2018 |
|
December 31,
2017 |
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
|
|
|
|
$ |
65,936 |
|
|
$ |
39,007 |
|
|
Marketable securities |
|
|
|
|
|
|
11,486 |
|
|
|
46,946 |
|
|
Prepaid
expenses and other current assets |
|
|
|
|
|
|
6,728 |
|
|
|
2,526 |
|
|
Total
current assets |
|
|
|
|
|
|
84,150 |
|
|
|
88,479 |
|
|
Property
and equipment, net |
|
|
|
|
|
|
27,012 |
|
|
|
27,211 |
|
|
Deposits and other
long-term assets |
|
|
|
|
|
|
2,039 |
|
|
|
1,610 |
|
|
Total
assets |
|
|
|
|
|
$ |
113,201 |
|
|
$ |
117,300 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
|
Accounts
payable |
|
|
|
|
|
$ |
3,874 |
|
|
$ |
3,935 |
|
|
Accrued
compensation |
|
|
|
|
|
|
2,400 |
|
|
|
2,227 |
|
|
Accrued
liabilities |
|
|
|
|
|
|
2,238 |
|
|
|
1,490 |
|
|
Deverred
revenue, current portion |
|
|
|
|
|
|
5,210 |
|
|
|
- |
|
|
Total
current liabilities |
|
|
|
|
|
|
13,722 |
|
|
|
7,652 |
|
|
Deferred
rent, net of current portion |
|
|
|
|
|
|
1,567 |
|
|
|
1,749 |
|
|
Other
non-current liabilities |
|
|
|
|
|
|
25 |
|
|
|
96 |
|
|
Lease
financing obligation, net of current portion |
|
|
|
|
|
|
10,502 |
|
|
|
10,521 |
|
|
Deferred
revenue, net of current portion |
|
|
|
|
|
|
14,694 |
|
|
|
- |
|
|
Total
liabilities |
|
|
|
|
|
|
40,510 |
|
|
|
20,018 |
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
|
Convertible preferred stock |
|
|
|
|
|
|
177,872 |
|
|
|
156,937 |
|
|
Common
stock |
|
|
|
|
|
|
2 |
|
|
|
1 |
|
|
Additional paid-in capital |
|
|
|
|
|
|
3,885 |
|
|
|
2,045 |
|
|
Accumulated other comprehensive loss |
|
|
|
|
|
|
(5 |
) |
|
|
(74 |
) |
|
Accumulated deficit |
|
|
|
|
|
|
(109,063 |
) |
|
|
(61,627 |
) |
|
Total
stockholders' equity |
|
|
|
|
|
|
72,691 |
|
|
|
97,282 |
|
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
$ |
113,201 |
|
|
$ |
117,300 |
|
|
|
|
|
|
|
|
|
|
|
|
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