Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology
company developing next generation cancer and infectious disease
immunotherapies, today reported financial results for the first
quarter ended March 31, 2021 and reviewed business highlights.
“The momentum we generated in the first quarter
-- with the launch of two novel programs in a new therapeutic
category of infectious disease, the execution of multiple
collaborations with notable government, private and nonprofit
institutions, and the continued advancement of our oncology
clinical programs – reflects the significant interest in our
innovative, antigen-directed clinical-stage immunotherapies,” said
Andrew Allen, M.D., Ph.D., co-founder, president and chief
executive officer of Gritstone. “We expect this activity level to
extend into the rest of the year. We are continuing patient dosing
and follow-up in our GRANITE program and will be submitting these
data for presentation at ESMO. Additionally, we expect to have data
from our CORAL COVID-19 program available later this year. Finally,
we will be initiating multiple clinical studies in oncology and
infectious disease in 2021.”
Key AccomplishmentsNeoantigen
Oncology Programs
- Continued enrolling and treating patients with advanced cancer
in single-arm Phase 2 expansion cohorts with GRANITE, an
individualized neoantigen immunotherapy, as a late-line therapy for
metastatic microsatellite stable colorectal cancer (MSS-CRC),
gastroesophageal (GEA) cancer and non-small cell lung cancer
(NSCLC)
- Continued enrolling and treating patients in single-arm Phase 2
expansion cohorts with version 1 (v1) of SLATE, a shared neoantigen
immunotherapy
Infectious Disease Programs
- Announced the launch of our CORAL COVID-19 program to develop a
second-generation vaccine against SARS-CoV-2, the virus that causes
COVID-19, with potential for both more durable protection and
broader immunity against Spike and additional non-Spike antigens,
compared with first-generation “Spike-only” vaccines which can be
impacted by emerging variants of concern in Spike sequence
- Began dosing volunteers in a Phase 1 CORAL clinical trial,
sponsored by the National Institute of Allergy and Infectious
Diseases (NIAID) and conducted through the Infectious Diseases
Clinical Research Consortium (IDCRC)
- Established a collaboration with Gilead Sciences (Gilead) to
develop a vaccine-based immunotherapy as part of Gilead’s efforts
to find a curative treatment for human immunodeficiency virus (HIV)
infection, and received $60 million in proceeds as a part of the
collaboration
Anticipated Remaining 2021
Milestones
- Submit an abstract to the European Society for Medical Oncology
(ESMO) conference in September 2021 to present GRANITE data,
including longer-term follow-up of late-stage, advanced disease
patients who remain in the Phase 1 study, in addition to
preliminary data from the Phase 2 cohorts in the same disease
context
- Advance the SLATE program by initiating a study with the
version two (v2) cassette optimized for KRAS neoantigens for
patients with NSCLC, and sharing data from SLATE v1 cohorts in the
third quarter of 2021
- Initiate a company-sponsored COVID-19 clinical study in the
third quarter of 2021, evaluating a novel vaccine containing Spike
and other SARS-CoV-2 epitopes as a boost after first generation
vaccination
- Share NIAID-IDCRC Phase 1 COVID-19 vaccine data in the third
quarter of 2021
- Share initial COVID-19 vaccine boost data in the fourth quarter
of 2021
- Initiate two randomized Phase 2 trials of GRANITE in
earlier-stage cancer patients in the second half of 2021
- Launch a new SLATE program, centered on an undisclosed shared
neoantigen, at the end of 2021
First Quarter 2021 Financial
ResultsFor the three months ended March 31, 2021,
Gritstone reported net income of $7.9 million, compared to a net
loss of $26.2 million for the three months ended March 31, 2020.
The increase in net income was due to an increase in license fee
revenue.
Collaboration and license revenue was $39.7
million for the three months ended March 31, 2021, compared to $1.3
million for the three months ended March 31, 2020. The increase was
due to the license revenue associated with the Gilead Collaboration
Agreement entered into in January 2021.
Total research and development expenses were
$24.9 million for the three months ended March 31, 2021, compared
to $22.5 million for the three months ended March 31, 2020. The
increase was primarily attributable to an increase in milestone and
license payments, as well as personnel-related expenses.
General and administrative expenses were $6.9
million for the three months ended March 31, 2021, compared to $5.5
million for the three months ended March 31, 2020. The increase was
primarily attributable to an increase in outside professional
services.
Cash, cash equivalents, marketable securities
and restricted cash were $199.0 million as of March 31, 2021
compared to $172.1 million as of December 31, 2020.
About Gritstone Gritstone bio, 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. 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
gritstone.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. 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 May
6, 2021 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 bio,
Inc.Condensed Consolidated Statements of
Operations(Unaudited)(In thousands,
except share and per share data)
|
Three Months Ended |
|
March 31, |
|
|
|
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
Revenue: |
|
|
|
Collaboration and license revenues |
$ |
39,693 |
|
$ |
1,262 |
|
Total revenue |
|
39,693 |
|
|
1,262 |
|
Operating expenses: |
|
|
|
Research and development |
|
24,856 |
|
|
22,468 |
|
General and administrative |
|
6,941 |
|
|
5,465 |
|
Total operating expenses |
|
31,797 |
|
|
27,933 |
|
Income (loss) from operations |
|
7,896 |
- |
|
(26,671 |
) |
Interest and other income, net |
$ |
27 |
|
$ |
465 |
|
Net income (loss) |
$ |
7,923 |
|
$ |
(26,206 |
) |
Net income (loss) per common share, basic |
$ |
0.10 |
|
$ |
(0.71 |
) |
Shares used to compute for net income (loss) per common share,
basic and diluted |
|
75,987,372 |
|
|
36,798,562 |
|
Net income (loss) per common share, diluted |
$ |
0.10 |
|
$ |
(0.71 |
) |
Shares used to compute for net income (loss) per common share,
basic and diluted |
|
77,464,356 |
|
|
36,798,562 |
|
Gritstone bio,
Inc.Condensed Consolidated Balance
Sheets(Unaudited)(In thousands)
|
March 31,2021 |
|
December 31,2020 |
|
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
108,505 |
|
|
$ |
170,056 |
|
Marketable securities |
|
89,501 |
|
|
|
1,002 |
|
Prepaid expenses and other current assets |
|
4,507 |
|
|
|
4,332 |
|
Total current assets |
|
202,513 |
|
|
|
175,390 |
|
Property and equipment, net |
|
21,693 |
|
|
|
22,105 |
|
Operating lease right-of-use assets |
|
19,997 |
|
|
|
21,344 |
|
Deposits and other long-term assets |
|
2,736 |
|
|
|
2,728 |
|
Total assets |
$ |
246,939 |
|
|
$ |
221,567 |
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
6,368 |
|
|
$ |
9,578 |
|
Accrued compensation |
|
3,821 |
|
|
|
6,331 |
|
Accrued liabilities |
|
571 |
|
|
|
677 |
|
Accrued research and development |
|
1,558 |
|
|
|
1,053 |
|
Lease liabilities, current portion |
|
6,075 |
|
|
|
5,874 |
|
Deferred revenue, current portion |
|
3,386 |
|
|
|
3,475 |
|
Total current liabilities |
|
21,779 |
|
|
|
26,988 |
|
Other non-current liabilities |
|
395 |
|
|
|
395 |
|
Lease liabilities, net of current portion |
|
17,619 |
|
|
|
19,225 |
|
Deferred revenue, net of current portion |
|
7,795 |
|
|
|
8,220 |
|
Total liabilities |
|
47,588 |
|
|
|
54,828 |
|
Commitments and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Convertible preferred stock |
|
- |
|
|
|
- |
|
Common stock |
|
18 |
|
|
|
18 |
|
Additional paid-in capital |
|
517,715 |
|
|
|
493,023 |
|
Accumulated other comprehensive loss |
|
(3 |
) |
|
|
- |
|
Accumulated deficit |
|
(318,379 |
) |
|
|
(326,302 |
) |
Total stockholders' equity |
|
199,351 |
|
|
|
166,739 |
|
Total liabilities and stockholders' equity |
$ |
246,939 |
|
|
$ |
221,567 |
|
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