Gritstone Oncology Reports Third Quarter Financial Results and Recent Highlights
November 05 2020 - 9:01AM
Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage
biotechnology company developing the next generation of cancer
immunotherapies to fight multiple cancer types, today reported
financial results for the third quarter ended September 30, 2020
and reviewed business highlights.
“This year we have made important clinical and
scientific progress in advancing our two immunotherapies, GRANITE
and SLATE,” said Andrew Allen, M.D., Ph.D., co-founder, president
and chief executive officer of Gritstone Oncology. “Recently, we
began enrolling cancer patients in Phase 2 expansion cohorts for
both programs. These cohorts are designed to build upon the
evidence of clinical benefit seen in our Phase 1 studies, and we
are expanding at dose level four, the highest dose level studied in
Phase 1, which continues to be well-tolerated by patients. Our
clinical work has confirmed the differentiated ability of our
vaccine vectors to consistently drive robust CD8 T cell responses
specific to administered antigens. Our clinical work with SLATE has
demonstrated that certain antigens are immunodominant and can drive
focused immune responses. With our strategy to develop two versions
of an off-the-shelf cassette, we can be more specific to a
patient’s mutations and address this phenomenon prospectively,
ensuring that dominant neoantigens are not permitted to impair
immune responses to other neoantigens.”
Select
Accomplishments
- Presented preliminary efficacy, immunogenicity, and safety data
up to dose level 3 from the ongoing Phase 1 study evaluating
GRANITE in combination with immune checkpoint blockade for the
treatment of patients with advanced solid tumors, including
microsatellite stable colorectal cancer (MSS-CRC), gastroesophageal
(GEA) cancer, metastatic non-small cell lung cancer (NSCLC), and
bladder cancer • Demonstrated consistent,
strong neoantigen-specific CD8+ T cells generated in all patients
tested and evidence of clinical benefit, as well as a favorable
safety profile
- Presented the same data types from the Phase 1 study evaluating
SLATE in combination with immune checkpoint blockade for the
treatment of patients with metastatic NSCLC, pancreatic ductal
adenocarcinoma and MSS-CRC, as well as in patients with other solid
tumor types who have relevant mutation/human leukocyte antigen
(HLA) combinations • Induced CD8+ T cells
against multiple KRAS driver mutations, with the most pronounced
response against immunodominant neoantigens such as TP53mut, and
demonstrated a favorable safety profile
- Initiated single-arm Phase 2 expansion cohorts with GRANITE for
patients with MSS CRC who have progressed on FOLFOX/FOLFIRI therapy
and a second cohort for patients with GEA who have progressed on
chemotherapy
- Initiated single-arm Phase 2 expansion cohorts with SLATE v1 in
NSCLC patients with relevant KRAS mutations who have progressed on
prior immunotherapy, and patients with tumors where a relevant TP53
mutation exists
Anticipated Upcoming
Milestones
- Nominate a lead bispecific antibody development candidate
directed towards a novel solid tumor-specific HLA-peptide complex
by the end of 2020
- Present additional efficacy and safety data from the Phase 1
GRANITE study, including at the higher GRANITE dose level, in the
first half of 2021
- Present data from Phase 2 SLATE cohorts (v1 cassette) in the
first half of 2021
- Launch a SLATE v2 cassette into clinical trials in NSCLC
patients in the first half of 2021, optimized for KRAS neoantigens
(leveraging insights into immunodominance derived from v1
cassette)
- Present data from Phase 2 GRANITE cohorts in the second half of
2021
- Report data from SLATE v2 cassette in the second half of
2021
Third Quarter
2020 Financial ResultsFor the
three months ended September 30, 2020, Gritstone reported a net
loss of $26.1 million, compared to a net loss of $27.5 million for
the three months ended September 30, 2019.
Collaboration revenue was $0.8 million for the
three months ended September 30, 2020, compared to $1.0 million for
the three months ended September 30, 2019. Collaboration revenue
was due to the Research Collaboration and License Agreement with
bluebird bio Inc and another small collaboration agreement.
Total research and development expenses were
$22.1 million for the three months ended September 30, 2020,
compared to $24.9 million for the three months ended September 30,
2019. The decrease was primarily attributable to a decrease in
milestone and license payments and outside services and
consultants, offset by increases in manufacturing-related expenses,
lab supplies and research and development personnel.
General and administrative expenses were $5.0
million for the three months ended September 30, 2020, compared to
$4.6 million for the three months ended September 30, 2019. The
increase was primarily attributable to an increase in
personnel-related expenses.
Cash, cash equivalents, marketable securities
and restricted cash were $72.1 million as of September 30, 2020,
compared to $128.8 million as of December 31, 2019.
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—second, 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 individualized
neoantigen-based immunotherapy, GRANITE, and its “off the shelf”
shared neoantigen-based immunotherapy, SLATE, are being evaluated
in clinical studies. Novel tumor-specific antigens can also provide
targets for bispecific antibody (BiSAb) therapeutics for solid
tumors, and Gritstone’s BiSAb program is currently in lead
optimization. For more information, please visit
gritstoneoncology.com.
Gritstone Forward-Looking
StatementsThis press release contains
forward-looking statements, including, but not limited to,
statements related to the potential of Gritstone’s therapeutic
programs; the advancements in the Company’s ongoing clinical
trials; the timing of data announcements related to ongoing
clinical trials and the initiation of future clinical trials,
including the timing thereof. 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
programs’ early stage of development, the process of designing and
conducting preclinical and clinical trials, the regulatory approval
processes, the timing of regulatory filings, the challenges
associated with manufacturing drug products, Gritstone’s ability to
successfully establish, 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 most recent
Quarterly Report on Form 10-Q filed on November 5, 2020 and any
current and periodic reports filed with the Securities and Exchange
Commission.
ContactsMedia:Dan Budwick1AB(973)
271-6085dan@1abmedia.com
Investors:Alexandra Santos Wheelhouse Life Science Advisors(510)
871-6161asantos@wheelhouselsa.com
Gritstone Oncology, Inc. |
Condensed Consolidated Statements of
Operations |
(Unaudited) |
(In thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
|
|
|
|
|
|
|
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
Collaboration |
|
$ |
795 |
|
$ |
984 |
|
$ |
2,544 |
|
$ |
3,481 |
Contribution |
|
144 |
|
- |
|
144 |
|
- |
Total revenue |
|
939 |
|
984 |
|
2,688 |
|
3,481 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
22,050 |
|
24,886 |
|
65,807 |
|
59,314 |
General and administrative |
|
5,031 |
|
4,582 |
|
15,751 |
|
13,794 |
Total operating expenses |
|
27,081 |
|
29,468 |
|
81,558 |
|
73,108 |
Loss from operations |
|
(26,142) |
|
(28,484) |
|
(78,870) |
|
(69,627) |
Interest and other income, net |
|
69 |
|
936 |
|
723 |
|
2,898 |
Net loss |
|
$ |
(26,073) |
|
$ |
(27,548) |
|
$ |
(78,147) |
|
$ |
(66,729) |
Net loss per common share, basic and diluted |
|
$ |
(0.69) |
|
$ |
(0.77) |
|
$ |
(2.10) |
|
$ |
(2.04) |
Shares used to compute for net loss per common share,
basic and diluted |
|
37,750,145 |
|
35,690,600 |
|
37,268,318 |
|
32,762,176 |
Gritstone Oncology, Inc. |
Condensed Consolidated Balance Sheets |
(Unaudited) |
(In thousands) |
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
|
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
57,648 |
|
$ |
57,408 |
Marketable securities |
12,897 |
|
70,368 |
Prepaid expenses and other current assets |
3,202 |
|
3,497 |
Total current assets |
73,747 |
|
131,273 |
Property and equipment, net |
23,306 |
|
26,911 |
Operating lease right-of-use assets |
22,706 |
|
23,427 |
Deposits and other long-term
assets |
2,749 |
|
2,778 |
Long-term marketable
securities |
- |
|
- |
Total assets |
$ |
122,508 |
|
$ |
184,389 |
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
3,284 |
|
$ |
4,621 |
Accrued compensation |
4,910 |
|
4,598 |
Accrued liabilities |
665 |
|
1,041 |
Accrued research and development |
2,557 |
|
1,779 |
Lease liabilities, current portion |
5,069 |
|
2,505 |
Deferred revenue, current portion |
5,528 |
|
4,956 |
Total current liabilities |
22,013 |
|
19,500 |
Other non-current liabilities |
634 |
|
- |
Lease liabilities, net of current portion |
20,791 |
|
20,985 |
Deferred revenue, net of current portion |
7,086 |
|
9,560 |
Total liabilities |
50,524 |
|
50,045 |
Commitments and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Convertible preferred stock |
- |
|
- |
Common stock |
17 |
|
17 |
Additional paid-in capital |
371,097 |
|
355,291 |
Accumulated other comprehensive loss |
5 |
|
24 |
Accumulated deficit |
(299,135) |
|
(220,988) |
Total stockholders' equity |
71,984 |
|
134,344 |
Total liabilities and stockholders' equity |
$ |
122,508 |
|
$ |
184,389 |
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