Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage
biotechnology company developing next generation cancer and
infectious disease immunotherapies, today reported financial
results for the fourth quarter and full year ended December 31,
2020 and reviewed business highlights.
“Over this past year, we have demonstrated the
significant potential of our platform technologies and have
effectively transformed the profile of the company with the
addition of a second therapeutic focus, expanding our pipeline
programs by leveraging the distinct capabilities of Gritstone
EDGETM to identify key immune targets and our prime-boost vaccine
platform to elicit a robust immune response,” said Andrew Allen,
M.D., Ph.D., co-founder, president and chief executive officer of
Gritstone. “Our new infectious disease-focused collaborations with
leading institutions augment the ongoing GRANITE and SLATE Phase 2
studies in difficult-to-treat advanced cancers, for which we expect
to report data later this year. Additionally, we plan to initiate
clinical trials in earlier cancer disease settings, such as the
post-operative adjuvant context, where immunotherapy is typically
even more effective. Finally, from an operational standpoint, we
have strengthened our balance sheet with proceeds from partnerships
as well as a successful PIPE financing.”
Key Accomplishments
Oncology Programs
- Presented preliminary efficacy, immunogenicity, and safety data
up to dose level 3 (of 4) from the ongoing Phase 1 study evaluating
GRANITE (an individualized neoantigen immunotherapy) 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 and metastatic
non-small cell lung cancer (NSCLC) - 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 (a shared neoantigen immunotherapy) 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 TP53
mutation, 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
- Announced the selection of a bispecific antibody directed
against CT83, a cancer testis antigen prevalent in common solid
cancers with significant unmet need
Infectious Disease Programs
- Launched COVID-19 program (CORAL) to develop a
second-generation vaccine against SARS-CoV-2, the virus that causes
COVID-19, with potential for both prolonged protection and potency
against Spike mutants, in addition to other viral antigens outside
of Spike
- Received a grant from the Bill and Melinda Gates Foundation to
support the preclinical evaluation of the COVID-19 vaccine
- Entered into a clinical trial agreement with the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH), to support the conduct of the
Phase 1 CORAL clinical trial through the Infectious Diseases
Clinical Research Consortium (IDCRC)
- Executed a license agreement with the La Jolla Institute for
Immunology (LJI), one of the leading global organizations dedicated
to studying the immune system, to access validated SARS-CoV-2
epitopes that have been identified through LJI’s studies of
hundreds of patients recovering from COVID-19
- Established a collaboration with Gilead Sciences (Gilead) to
research and develop a vaccine-based immunotherapy as part of
Gilead’s efforts to find a curative treatment for human
immunodeficiency virus (HIV) infection
Balance Sheet Strengthening
- Completed a $125.0 million private investment in public equity
(PIPE) financing in December 2020 with a small syndicate of both
existing and new blue-chip life science investors
- In 2021, received $60 million in proceeds from the Gilead
collaboration, consisting of $30.0 million in upfront cash and
$30.0 million as an equity investment at a premium to market
price
Anticipated Upcoming
Milestones
- 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 v1 cohorts in the first half of
2021
- Initiate new Phase 2 clinical trial cohorts for GRANITE and
SLATE, including a cohort evaluating a SLATE v2 cassette optimized
for KRAS neoantigens for patients with NSCLC, in the first half of
2021
- Generate Phase 1 CORAL COVID-19 vaccine data in mid-2021
- Present data from Phase 2 GRANITE cohorts in advanced MSS-CRC
and gastric cancers in the second half of 2021
- Report data from SLATE v2 cassette in the first half of
2022
- Submit an Investigational New Drug (IND) application for the
CT83-directed bispecific antibody in mid-2022
Fourth Quarter and Full Year 2020
Financial ResultsFor the three and twelve months ended
December 31, 2020, Gritstone reported a net loss of $27.2 million
and $105.3 million, respectively. This compares to a net loss of
$27.7 million and $94.4 million, respectively, for the same periods
in 2019.
Collaboration revenue was $0.9 million for the
three months ended December 31, 2020, and $3.5 million for the full
year 2020, compared to $0.9 million for the three months ended
December 31, 2019, and $4.4 million for the full year 2019.
Total research and development expenses were
$22.8 million for the three months ended December 31, 2020, and
$88.6 million for the full year 2020, compared to $23.6 million and
$82.9 million, respectively, for the same periods in 2019. The
increase for the year ended December 31, 2020 was primarily due to
increases in personnel related expenses and expenses related to
in-house laboratory supplies and consumables and facilities
expenses.
General and administrative expenses were $5.6
million for the three months ended December 31, 2020, and $21.4
million for the full year 2020, compared to $5.6 million and $19.4
million, respectively, for the same periods in 2019. The increase
for the year ended December 31, 2020 was primarily due to increases
in personnel related costs and expenses for professional
services.
Cash, cash equivalents, marketable securities
and restricted cash were $172.1 million as of December 31, 2020,
compared to $128.8 million as of December 31, 2019. This excludes
$60 million in proceeds from the Gilead partnership, consisting of
$30 million upfront cash payment and $30 million equity investment,
which were received in the first quarter of 2021.
About Gritstone Gritstone Oncology, Inc.
(Nasdaq: GRTS), a clinical-stage biotechnology company, is
developing the next generation of immunotherapies against multiple
cancer types and infectious diseases. Gritstone develops its
products by leveraging two key pillars—first, a proprietary machine
learning-based platform, Gritstone EDGETM, which is designed to
predict antigens that are presented on the surface of cells, such
as tumor or virally-infected cells, that can be seen by the immune
system; and, second, the ability to develop and manufacture potent
immunotherapies utilizing these antigens to potentially drive the
patient’s immune system to specifically attack and destroy
disease-causing cells. The company’s lead oncology programs include
an individualized neoantigen-based immunotherapy, GRANITE, and an
“off-the-shelf” shared neoantigen-based immunotherapy, SLATE, which
are being evaluated in clinical studies. The company also has a
bispecific antibody (BiSAb) program for solid tumors in lead
optimization. Within its infectious disease pipeline, Gritstone is
advancing CORAL, a COVID-19 program to develop a second-generation
vaccine, with support from departments within the National
Institutes of Health (NIH), the Bill & Melinda Gates
Foundation, as well as a license agreement with La Jolla Institute
for Immunology. Additionally, the company has a global
collaboration for the development of a therapeutic HIV vaccine with
Gilead Sciences. 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 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. 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 Annual Report on Form 10-K filed on March
11, 2021 and any 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 Consolidated Statements of
Operations |
(In thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
December 31, |
|
December 31, |
|
|
|
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
Collaboration |
$ |
917 |
|
|
$ |
884 |
|
|
$ |
3,462 |
|
|
$ |
4,365 |
|
Contribution |
|
431 |
|
|
|
- |
|
|
|
575 |
|
|
|
- |
|
Total revenue |
|
1,348 |
|
|
|
884 |
|
|
|
4,037 |
|
|
|
4,365 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
22,845 |
|
|
|
23,582 |
|
|
|
88,643 |
|
|
|
82,896 |
|
General and administrative |
|
5,650 |
|
|
|
5,615 |
|
|
|
21,411 |
|
|
|
19,409 |
|
Total operating expenses |
|
28,495 |
|
|
|
29,197 |
|
|
|
110,054 |
|
|
|
102,305 |
|
Loss from operations |
|
(27,147 |
) |
|
|
(28,313 |
) |
|
|
(106,017 |
) |
|
|
(97,940 |
) |
Interest and other income, net |
|
(20 |
) |
|
|
609 |
|
|
|
703 |
|
|
|
3,507 |
|
Net loss |
$ |
(27,167 |
) |
|
$ |
(27,704 |
) |
|
$ |
(105,314 |
) |
|
$ |
(94,433 |
) |
Net loss per common share, basic and diluted |
$ |
(0.69 |
) |
|
$ |
(0.77 |
) |
|
$ |
(2.79 |
) |
|
$ |
(2.81 |
) |
Shares used to compute for net loss per common share,
basic and diluted |
|
39,364,507 |
|
|
|
35,906,917 |
|
|
|
37,792,365 |
|
|
|
33,554,823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gritstone Oncology, Inc. |
Condensed Consolidated Balance Sheets |
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2020 |
|
December 31, 2019 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
$ |
170,056 |
|
|
$ |
57,408 |
|
Marketable securities |
|
|
|
|
|
1,002 |
|
|
|
70,368 |
|
Prepaid expenses and other current assets |
|
|
|
|
|
4,332 |
|
|
|
3,497 |
|
Total current assets |
|
|
|
|
|
175,390 |
|
|
|
131,273 |
|
Property and equipment, net |
|
|
|
|
|
22,105 |
|
|
|
26,911 |
|
Operating lease right-of-use assets |
|
|
|
|
|
21,344 |
|
|
|
23,427 |
|
Deposits and other long-term
assets |
|
|
|
|
|
2,728 |
|
|
|
2,778 |
|
Total assets |
|
|
|
|
$ |
221,567 |
|
|
$ |
184,389 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
$ |
9,578 |
|
|
$ |
4,621 |
|
Accrued compensation |
|
|
|
|
|
6,331 |
|
|
|
4,598 |
|
Accrued liabilities |
|
|
|
|
|
677 |
|
|
|
1,041 |
|
Accrued research and development |
|
|
|
|
|
1,053 |
|
|
|
1,779 |
|
Lease liabilities, current portion |
|
|
|
|
|
5,874 |
|
|
|
2,505 |
|
Deferred revenue, current portion |
|
|
|
|
|
3,475 |
|
|
|
4,956 |
|
Total current liabilities |
|
|
|
|
|
26,988 |
|
|
|
19,500 |
|
Other non-current liabilities |
|
|
|
|
|
395 |
|
|
|
- |
|
Lease liabilities, net of current portion |
|
|
|
|
|
19,225 |
|
|
|
20,985 |
|
Deferred revenue, net of current portion |
|
|
|
|
|
8,220 |
|
|
|
9,560 |
|
Total liabilities |
|
|
|
|
|
54,828 |
|
|
|
50,045 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
Common stock |
|
|
|
|
|
18 |
|
|
|
17 |
|
Additional paid-in capital |
|
|
|
|
|
493,023 |
|
|
|
355,291 |
|
Accumulated other comprehensive loss |
|
|
|
|
|
- |
|
|
|
24 |
|
Accumulated deficit |
|
|
|
|
|
(326,302 |
) |
|
|
(220,988 |
) |
Total stockholders' equity |
|
|
|
|
|
166,739 |
|
|
|
134,344 |
|
Total liabilities and stockholders' equity |
|
|
|
|
$ |
221,567 |
|
|
$ |
184,389 |
|
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