In a release issued under the same headline on May 5, 2022 by
Gritstone bio, Inc. (Nasdaq: GRTS), please note that two values in
the Condensed Consolidated Statements of Operations table and one
value in the Condensed Consolidated Balance Sheets table were
erroneously reported. The corrected release follows:
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage
biotechnology company that aims to develop the world’s most potent
vaccines, today reported financial results for the first quarter
ended March 31, 2022 and reviewed business highlights.
“Clinical data out of our cancer and viral disease vaccine
programs are expected to be flowing steadily through year-end and
over the next 18 months,” said Andrew Allen, M.D., Ph.D.,
Co-founder, President and Chief Executive Officer of Gritstone.
“Our individualized neoantigen vaccine candidate for solid tumors,
GRANITE, is now in a randomized Phase 2/3 trial in newly diagnosed
metastatic colorectal cancer, building on the exciting molecular
response/survival data shown at ESMO 2021 in end-stage colorectal
cancer patients. Multiple Phase 1 trials are ongoing in CORAL (2nd
generation COVID-19 vaccine program) with data from all studies
expected throughout 2H2022, and initial data from the Phase 2 study
of SLATE-KRAS (KRAS-specific ‘off-the-shelf’ vaccine candidate) is
also expected in 2H2022. Our recent presentations at AACR
underscore the unique capabilities of our novel self-amplifying
mRNA (samRNA) vector, which has demonstrated potency and dose
sparing potential along with a favorable safety and tolerability
profile in the clinic. The data we are generating with SARS-CoV-2
as the target are providing validation for the entire samRNA
platform and provide clear rationale to pursue additional viral
pathogens. We look forward to sharing more data and continuing to
demonstrate the value we are bringing to patients and all
stakeholders as the year progresses.”
Clinical Program Updates
Tumor-Specific Neoantigen (TSNA) Oncology
Programs
GRANITE – Individualized, TSNA-directed vaccine-based
immunotherapy using an adenoviral priming vector and samRNA
boost vector to deliver relevant neoantigens. Following success in
late-line studies, Gritstone intends to continue advancing GRANITE
through randomized, controlled trials and evaluate these candidates
in earlier lines of treatment, where immune responses may be
stronger and the potential benefits could be further
accentuated.
- In January, Gritstone announced
the first patient was enrolled for inclusion in GRANITE-CRC-1L, a
randomized, controlled Phase 2/3 trial evaluating GRANITE in
combination with immune checkpoint blockade for frontline
maintenance treatment of newly diagnosed patients with metastatic,
microsatellite-stable colorectal cancer (MSS-CRC). Preliminary data
(molecular response and progression-free survival) from the Phase 2
portion of the trial are expected in 2H2023.
- In March, Gritstone announced the
first patient was enrolled for inclusion in GRANITE-CRC-ADJUVANT, a
randomized, controlled Phase 2 trial in patients with high risk
MSS-CRC and stage II/III disease who are circulating tumor DNA
(ctDNA)+ after definitive surgery.
- In April, Gritstone shared two
poster presentations at the American Association for Cancer
Research (AACR) Annual Meeting:
- Poster 1238 further demonstrated
the correlation between patient survival and ctDNA in metastatic
CRC.
- Poster 4149 demonstrated lower
doses of samRNA drive superior neoantigen-specific CD8+ T cell
responses in cancer patients versus high doses in Phase 1/2 trials
for GRANITE and SLATE in patients with advanced solid tumors.
SLATE – “Off-the-shelf” shared neoantigen-directed vaccine-based
immunotherapy using an adenoviral priming vector and samRNA boost
vector to deliver a cassette of shared TSNA. Gritstone intends to
continue advancing its existing candidate, SLATE-KRAS, and has a
long-term objective of developing a suite of "off-the-shelf”
product candidates that target tumor-specific targets across a
number of patient populations and cancer types.
- In April, Gritstone
presented an oral presentation at AACR detailing how translational
immunology data and the company’s cassette design capabilities
enabled development of SLATE-KRAS, an optimized, KRAS-specific
version of SLATE that is now in Phase 2 study in patients with
advanced non-small cell lung cancer (NSCLC) and CRC.
- Early signals from
the ongoing Phase 2 study support the potential of SLATE-KRAS to
drive stronger CD8+ T cell responses to mutant KRAS than our
original candidate, SLATE v1.
- Initial data from
the ongoing Phase 2 study of SLATE-KRAS trial are expected in
2H2022.
Infectious Disease Programs
Gritstone’s infectious disease programs aim to deliver vaccine
candidates that drive both B cell and T cell immunity with the
potential to provide either a protective or therapeutic effect
across a broad array of viral diseases. This approach has
demonstrated the ability to generate robust CD8+ T cells and
neutralizing antibodies against SARS-CoV-2 in multiple preclinical
and clinical studies and is being evaluated against multiple other
pathogens in Gritstone-owned and partnered studies.
CORAL – Second-generation SARS-CoV-2 vaccine program delivering
both spike and highly conserved non-spike T cell epitopes (TCEs)
with a focus on the samRNA vector. This approach offers potential
for more durable clinical protection and broader immunity against
SARS-CoV-2 variants than first generation products by inducing
potent CD8+ T cells in addition to neutralizing antibody
responses.
- Gritstone is currently evaluating
five distinct SARS-CoV-2 product candidates across four different
clinical trials containing Spike plus additional non-Spike TCE
sequences (and also full-length nucleocapsid). These studies
include homologous and heterologous prime-boost regimens. All four
of these studies are ongoing, and initial data from all are
expected during the second half of 2022.
- The CORAL-BOOST study, a Phase 1 study evaluating a T cell
enhanced samRNA vaccine as a booster against SARS-CoV-2, is ongoing
in the United Kingdom. In January, Gritstone announced positive
clinical data from the first cohort and subsequently expanded the
study. The data, which demonstrated both strong neutralizing
antibody responses to Spike and robust CD8+ T cell responses,
provided human proof of concept of the samRNA vector in viral
diseases and the company’s approach to infectious disease.
- The CORAL-CEPI trial is ongoing in South Africa with support
from the Coalition for Epidemic Preparedness Innovations (CEPI) and
is evaluating T cell enhanced omicron- and beta-spike constructs in
virus-naïve, convalescent, and HIV+ patients.
- The CORAL-IMMUNOCOMPROMISED trial is ongoing in the United
Kingdom evaluating T cell enhanced samRNA and chimpanzee adenovirus
(ChAd) vaccines in B cell deficient subjects.
- The CORAL-NIH trial, which is being sponsored and executed by
the National Institute of Allergy and Infectious Disease (NIAID),
is ongoing in the United States evaluating T cell enhanced samRNA
and/or ChAd vaccines in previously vaccinated healthy
volunteers.
HIV – Collaboration with Gilead Sciences, Inc (Gilead) under
Gilead’s HIV Cure Program to research and develop vaccine-based HIV
immunotherapy treatment
- An investigational new drug
application (IND) was cleared in December 2021.
First Quarter 2022 Financial Results
Cash, cash equivalents, marketable securities and
restricted cash were $186.8 million as of March 31, 2022,
compared to $223.5 million as of December 31, 2021.
Research and development expenses were $28.2
million for the three months ended March 31, 2022, compared to
$24.9 million for the three months ended March 31, 2021. The
increase of $3.3 million for the three months ended March 31, 2022
compared to the three months ended March 31, 2021 was primarily due
to increases in personnel-related expenses, outside services, and
facilities related costs, offset by decreases in laboratory
supplies and milestone and license payments.
General and administrative expenses were $8.0
million for the three months ended March 31, 2022, compared to $6.9
million for the three months ended March 31, 2021. The increase of
$1.1 million was primarily attributable to increases in
personnel-related expenses and in facilities-related costs, offset
by a decrease in outside services.
Collaboration and license revenue was $4.7
million for the three months ended March 31, 2022, compared to
$39.7 million for the three months ended March 31, 2021. During the
three months ended March 31, 2022, we recognized $4.0 million in
collaboration revenue related to the 2seventy Agreement, $0.7
million in collaboration revenue related to the Gilead
Collaboration Agreement, $2.2 million in grant revenue from the
CEPI Funding Agreement, and $0.2 million in grant revenue from the
Gates Foundation. During the three months ended March 31, 2021, we
recorded $38.6 million in license revenue and $0.3 million in
collaboration revenue related to the Gilead Collaboration Agreement
and $0.7 million in collaboration revenue related to the 2seventy
Agreement.
About Gritstone Gritstone bio, Inc. (Nasdaq:
GRTS) is a clinical-stage biotechnology company that aims to create
the world’s most potent vaccines. Experts in vaccine design and
development, we leverage our innovative vectors and payloads to
train multiple arms of the immune system to attack critical disease
targets. Independently and with our collaborators, we are advancing
a portfolio of product candidates to treat and prevent viral
diseases and solid tumors in pursuit of improving patient outcomes
and eliminating disease. www.gritstonebio.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
5, 2022 and any current and periodic reports filed with the
Securities and Exchange Commission.
Gritstone ContactsMedia:Dan Budwick1AB(973)
271-6085dan@1abmedia.comInvestors:George E. MacDougallDirector,
Investor Relations & Corp CommsGritstone bio,
Inc.IR@gritstone.com
Gritstone bio,
Inc. Condensed
Consolidated Statements of
Operations(Unaudited)(In thousands,
except share and per share amounts)
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
|
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license
revenues |
|
$ |
4,745 |
|
|
$ |
39,693 |
|
Grant revenues |
|
|
2,446 |
|
|
|
- |
|
Total revenues |
|
|
7,191 |
|
|
|
39,693 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
28,199 |
|
|
|
24,856 |
|
General and administrative |
|
|
7,955 |
|
|
|
6,941 |
|
Total operating expenses |
|
|
36,154 |
|
|
|
31,797 |
|
Income (loss) from
operations |
|
$ |
(28,963 |
) |
|
$ |
7,896 |
|
Interest income, net |
|
$ |
47 |
|
|
$ |
27 |
|
Net income (loss) |
|
$ |
(28,916 |
) |
|
$ |
7,923 |
|
Net income (loss) per common
share, basic |
|
$ |
(0.34 |
) |
|
$ |
0.10 |
|
Weighted-average number of
shares used in computing net income (loss) per share, basic |
|
|
86,277,599 |
|
|
|
75,987,372 |
|
Net income (loss) per share,
diluted |
|
$ |
(0.34 |
) |
|
$ |
0.10 |
|
Weighted-average number of
shares used in computing net income (loss) per share, diluted |
|
|
86,277,599 |
|
|
|
77,464,356 |
|
Gritstone bio,
Inc.Condensed Consolidated Balance
Sheets(Unaudited)(In thousands)
|
March 31,2022 |
|
December 31,2021 |
|
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
69,158 |
|
|
$ |
93,287 |
|
Marketable securities |
|
103,004 |
|
|
|
108,346 |
|
Restricted cash |
|
9,395 |
|
|
|
11,285 |
|
Prepaid expenses and other current assets |
|
10,946 |
|
|
|
7,672 |
|
Total current assets |
|
192,503 |
|
|
|
220,590 |
|
Restricted cash |
|
5,290 |
|
|
|
6,005 |
|
Property and equipment, net |
|
22,283 |
|
|
|
21,622 |
|
Lease right-of-use assets |
|
21,832 |
|
|
|
22,920 |
|
Deposits and other long-term
assets |
|
1,564 |
|
|
|
2,352 |
|
Long-term marketable
securities |
|
- |
|
|
|
4,617 |
|
Total assets |
$ |
243,472 |
|
|
$ |
278,106 |
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
5,641 |
|
|
$ |
4,230 |
|
Accrued compensation |
|
4,285 |
|
|
|
6,925 |
|
Accrued liabilities |
|
1,350 |
|
|
|
411 |
|
Accrued research and development |
|
3,601 |
|
|
|
3,706 |
|
Lease liabilities, current portion |
|
6,886 |
|
|
|
7,483 |
|
Deferred revenue, current portion |
|
12,324 |
|
|
|
17,201 |
|
Total current liabilities |
|
34,087 |
|
|
|
39,956 |
|
Other non-current
liabilities |
|
|
|
|
|
|
|
Lease liabilities, net of current
portion |
|
18,989 |
|
|
|
18,936 |
|
Deferred revenue, net of current
portion |
|
1,505 |
|
|
|
3,128 |
|
Total liabilities |
|
54,281 |
|
|
|
62,020 |
|
Commitments and
contingencies |
|
|
|
Convertible preferred stock |
|
- |
|
|
|
- |
|
Common stock |
|
20 |
|
|
|
20 |
|
Additional paid-in capital |
|
619,862 |
|
|
|
617,523 |
|
Accumulated other comprehensive loss |
|
(391 |
) |
|
|
(73 |
) |
Accumulated deficit |
|
(430,300 |
) |
|
|
(401,384 |
) |
Total stockholders' equity |
|
189,191 |
|
|
|
216,086 |
|
Total liabilities and
stockholders' equity |
$ |
243,472 |
|
|
$ |
278,106 |
|
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