Gritstone bio Reports Second Quarter 2023 Financial Results and Provides Corporate Updates
10 8월 2023 - 5:05AM
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology
company working to develop the world’s most potent vaccines, today
reported financial results for the second quarter ended June 30,
2023 and provided recent corporate and clinical updates.
“We are pleased with the pace at which our randomized GRANITE
Phase 2/3 trial is advancing. Completing enrollment for the Phase 2
portion underscores the enthusiasm for this trial, related to the
high unmet need for better treatments in common, immunologically
cold tumors, such as CRC,” said Andrew Allen, M.D., Ph.D.,
Co-founder, President, and Chief Executive Officer of Gritstone
bio. “Our partnership with Friends of Cancer Research on ctMoniTR,
a project to collate data across the industry to validate the use
of circulating tumor DNA (ctDNA) as an early predictor of treatment
outcomes, will help further define the emerging potential of ctDNA
as a superior method over radiology-based approaches to evaluate
early treatment effects of immunotherapy. Molecular response, or
reduction in ctDNA, is the primary efficacy endpoint for the Phase
2 portion of the GRANITE trial. GRANITE has the potential to be the
first neoantigen-based PCV to demonstrate efficacy in a randomized
study against a cold tumor, which would be a transformational
advance for the field. We look forward to sharing preliminary Phase
2 efficacy data in frontline MSS-CRC in the first quarter of
2024.”
Dr. Allen continued, “Additionally, the promising data we
continue to see from our CORAL (SARS-CoV-2 vaccine) program
highlights the differentiation and potential advantages of
self-amplifying mRNA (samRNA) over current vaccines against
infectious diseases. Our recent publication in Nature
Communications demonstrates the scientific rigor of our work to
date and the ability of our samRNA platform to drive potent and
durable immune responses. We believe our samRNA vaccine candidates
have demonstrated strong potential to serve as next-generation
vaccine solutions to COVID-19 and other infectious diseases.”
Corporate Update
- In August 2023, Gritstone announced it is partnering
with the Friends of Cancer Research
(Friends) in support of its ctDNA
for Monitoring Treatment Response (ctMoniTR) Project. The
ctMoniTR Project is a collaboration between industry, academia and
government to provide data to inform the application and adoption
of circulating tumor DNA (ctDNA) in drug development. Per the
agreement, Gritstone will be providing data to help inform the use
of change in ctDNA as an early indicator of long-term clinical
benefit in cancer patients.
Clinical Program Updates Tumor-Specific
Neoantigen Oncology Programs GRANITE - Individualized
neoantigen vaccine against cold tumors SLATE - “Off-the-shelf”
neoantigen vaccine program
- Enrollment is now complete in the Phase 2 portion of
the Phase 2/3 study, which is evaluating GRANITE as a maintenance
therapy in first-line metastatic microsatellite-stable colorectal
cancer (MSS-CRC). The company has met its target of 100
patients randomized. Preliminary efficacy data on approximately 50
patients who have completed at least 4 months of maintenance
treatment is expected in the first quarter of 2024.
- Gritstone delivered multiple presentations detailing
advances in neoantigen prediction capabilities and cancer vaccine
programs at the 2023 American Association for Cancer Research (AACR
2023, in April 2023).
- GRANITE (individualized neoantigen program) presentation:
Longitudinal analysis of participants in the GRANITE Phase 1/2
supports vaccine-elicited priming and boosting of antigen-specific
T cell populations associated with conversion of “cold” to “hot”
tumors and molecular responses.
- EDGE™ (Epitope Discovery for Genomes Platform) poster: Advances
in EDGE™ models (Gritstone’s AI-driven neoantigen prediction
platform) enable potential best-in-class prediction of class II
HLA-presented neoantigens that could drive CD4+ T cell
responses.
- SLATE (“off-the-shelf” neoantigen vaccine program) poster:
Description of a novel KRAS G12C class II epitope with evidence of
clinical benefit associated with vaccine-elicited T cell
response.
- The clinical trial collaboration with the National
Cancer Institute (NCI) to evaluate an autologous T cell therapy in
combination with Gritstone’s KRAS-directed vaccine candidate,
SLATE-KRAS, is ongoing. Under the terms of the
collaboration, Gritstone will provide the SLATE-KRAS vaccine as
requested by NCI. NCI will be responsible for conducting the
study.
- Gritstone expects to initiate a randomized Phase 2
clinical trial within SLATE (“off-the-shelf” neoantigen vaccine
program) in 2024.
Infectious Disease ProgramsCORAL –
Second-generation SARS-CoV-2 vaccine program that serves as
proof-of-concept for Gritstone’s infectious disease approach and
the potential application of samRNA in infectious diseases.
- In June 2023, interim results from the ongoing
CORAL-BOOST study (Phase 1 study evaluating the company’s
self-amplifying mRNA (samRNA) vaccine as a boost against COVID-19)
were published in Nature Communications. The results
demonstrate that Gritstone’s samRNA vaccine candidate boosted
immunity for at least 6 months in previously vaccinated older
adults and support our initial findings from a separate Phase 1
study in previously unvaccinated subjects (CORAL-CEPI).
- In April 2023, Gritstone presented new data from two
ongoing Phase 1 studies demonstrating persistence of high
neutralizing antibodies for at least 6 months following samRNA
vaccine across multiple settings and subject populations.
Both datasets were presented at the 33rd European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID 2023).
- CORAL-CEPI poster: Results from Part A of the CORAL-CEPI study
(total study n = 342), primary series samRNA vaccination shown to
elicit strong neutralizing antibody (nAb) responses that persist
for at least 6 months, including variant cross-reactive nAb, in
previously unvaccinated (“vaccine-naïve”) South African subjects.
Enrollment in CORAL-CEPI completed in February 2023.
- CORAL-BOOST poster: Results from cohorts 3 and 4 of the
CORAL-BOOST study showed the samRNA elicited robust nAbs, and that
these nAbs persisted for at least 6 months regardless of primary
series (adenovirus or mRNA). These results are generally consistent
with 6-month neutralizing antibody results from cohorts 1 and 2 of
the study, which evaluated samRNA as a boost following Vaxzevria
(adenovirus) only (August 2022).
- Enrollment in the CORAL-NIH trial completed in
2022. This study is sponsored and executed by NIAID.
- Gritstone expects to share additional data from the
CORAL-CEPI and CORAL-BOOST studies in Fall 2023.
HIV – Collaboration with Gilead under Gilead’s HIV Cure Program
to research and develop vaccine-based HIV immunotherapy
treatment.
- The collaboration with Gilead to research and develop a
vaccine-based HIV immunotherapy treatment remains active and
ongoing.
Second Quarter 2023 Financial Results
- Cash, cash equivalents, marketable securities and
restricted cash were $122.3 million as of June 30, 2023,
compared to $185.2 million as of December 31, 2022.
- Research and development expenses were $31.0
million for the three months ended June 30, 2023, compared to $27.3
million for the three months ended June 30, 2022. The increase of
$3.6 million was primarily due to increases of $1.0 million in
personnel-related expenses, $1.0 million in laboratory supplies,
and $2.5 million in facilities-related costs, offset by decreases
of $0.8 million in outside services, consisting primarily of
clinical trial and other chemistry, manufacturing and controls
("CMC") related expenses and $0.1 million in milestone and license
payments.
- General and administrative expenses were $6.7
million for the three months ended June 30, 2023, compared to $7.8
million for the three months ended June 30, 2022. The decrease of
$1.1 million was primarily due to decreases of $1.3 million in
outside services and $0.1 million in personnel-related expenses,
offset by an increase of $0.3 million in facilities-related
costs.
- Collaboration, license, and grant revenues
were $2.0 million for the three months ended June 30, 2023,
compared to $5.5 million for the three months ended June 30, 2022.
During the three months ended June 30, 2023, we recorded $0.1
million in collaboration revenue related to the Gilead
Collaboration Agreement, $0.3 million in collaboration revenue
related to the 2seventy Agreement, $1.1 million in grant revenue
from the CEPI Funding Agreement, and $0.5 million in grant revenue
from the Gates Foundation.
About Gritstone bioGritstone bio, Inc. (Nasdaq:
GRTS) is a clinical-stage biotechnology company that aims to
develop the world’s most potent vaccines. We leverage our
innovative vectors and payloads to train multiple arms of the
immune system to attack critical disease targets and have programs
in viral diseases and solid tumors. Independently and with our
partners, we are advancing a portfolio of product candidates with
the aim 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 our clinical and regulatory
development plans for our product candidates; our expectations
regarding the data to be derived in our ongoing and planned
clinical trials; the timing of commencement of our future
nonclinical studies, clinical trials and research and development
programs; our ability to discover, develop and advance product
candidates into, and successfully complete, clinical trials; and
our plans and strategy regarding maintaining existing and entering
into new collaborations and/or partnerships. 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’ clinical 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 9, 2023 and
any subsequent current and periodic reports filed with the
Securities and Exchange Commission.
Gritstone ContactsInvestors:George E.
MacDougallGritstone bio, Inc.ir@gritstone.com
Media:Dan Budwick1AB(973) 271-6085dan@1abmedia.com
Gritstone bio,
Inc.Condensed Consolidated Balance Sheets
(Unaudited)(In thousands)
|
|
June 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
41,414 |
|
|
$ |
55,498 |
|
Marketable securities |
|
|
73,119 |
|
|
|
116,389 |
|
Restricted cash |
|
|
2,437 |
|
|
|
3,977 |
|
Prepaid
expenses and other current assets |
|
|
5,406 |
|
|
|
7,014 |
|
Total
current assets |
|
|
122,376 |
|
|
|
182,878 |
|
Long-term restricted cash |
|
|
5,290 |
|
|
|
5,290 |
|
Property
and equipment, net |
|
|
20,443 |
|
|
|
21,335 |
|
Lease
right-of-use assets |
|
|
71,985 |
|
|
|
17,481 |
|
Deposits
and other long-term assets |
|
|
2,529 |
|
|
|
9,739 |
|
Long-term marketable securities |
|
|
— |
|
|
|
4,031 |
|
Total
assets |
|
$ |
222,623 |
|
|
$ |
240,754 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts
payable |
|
$ |
4,925 |
|
|
$ |
8,694 |
|
Accrued
compensation |
|
|
6,036 |
|
|
|
8,215 |
|
Accrued
liabilities |
|
|
1,452 |
|
|
|
4,124 |
|
Accrued
research and development expenses |
|
|
2,042 |
|
|
|
3,343 |
|
Lease
liabilities, current portion |
|
|
4,838 |
|
|
|
5,294 |
|
Deferred
revenue, current portion |
|
|
2,818 |
|
|
|
5,131 |
|
Total
current liabilities |
|
|
22,111 |
|
|
|
34,801 |
|
Other
liabilities, noncurrent |
|
|
398 |
|
|
|
150 |
|
Lease
liabilities, net of current portion |
|
|
60,824 |
|
|
|
15,673 |
|
Debt,
noncurrent |
|
|
29,723 |
|
|
|
19,349 |
|
Total
liabilities |
|
|
113,056 |
|
|
|
69,973 |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common
stock |
|
|
22 |
|
|
|
22 |
|
Additional paid-in capital |
|
|
699,979 |
|
|
|
691,910 |
|
Accumulated other comprehensive loss |
|
|
(125 |
) |
|
|
(80 |
) |
Accumulated deficit |
|
|
(590,309 |
) |
|
|
(521,071 |
) |
Total
stockholders’ equity |
|
|
109,567 |
|
|
|
170,781 |
|
Total
liabilities and stockholders’ equity |
|
$ |
222,623 |
|
|
$ |
240,754 |
|
|
|
|
|
|
|
|
|
|
Gritstone bio,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive Loss (Unaudited)(In
thousands, except share and per share amounts)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenues |
|
$ |
400 |
|
|
$ |
2,761 |
|
|
$ |
941 |
|
|
$ |
7,506 |
|
Grant revenues |
|
|
1,555 |
|
|
|
2,710 |
|
|
|
3,456 |
|
|
|
5,156 |
|
Total revenues |
|
|
1,955 |
|
|
|
5,471 |
|
|
|
4,397 |
|
|
|
12,662 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
30,967 |
|
|
|
27,347 |
|
|
|
61,481 |
|
|
|
55,546 |
|
General and administrative |
|
|
6,716 |
|
|
|
7,792 |
|
|
|
13,461 |
|
|
|
15,747 |
|
Total operating expenses |
|
|
37,683 |
|
|
|
35,139 |
|
|
|
74,942 |
|
|
|
71,293 |
|
Loss
from operations |
|
|
(35,728 |
) |
|
|
(29,668 |
) |
|
|
(70,545 |
) |
|
|
(58,631 |
) |
Interest
income |
|
|
1,479 |
|
|
|
153 |
|
|
|
3,157 |
|
|
|
200 |
|
Interest
expense |
|
|
(985 |
) |
|
|
— |
|
|
|
(1,828 |
) |
|
|
— |
|
Other
expense |
|
|
(22 |
) |
|
|
— |
|
|
|
(22 |
) |
|
|
— |
|
Net
loss |
|
|
(35,256 |
) |
|
|
(29,515 |
) |
|
|
(69,238 |
) |
|
|
(58,431 |
) |
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on marketable securities |
|
|
(73 |
) |
|
|
(19 |
) |
|
|
(45 |
) |
|
|
(337 |
) |
Comprehensive loss |
|
$ |
(35,329 |
) |
|
$ |
(29,534 |
) |
|
$ |
(69,283 |
) |
|
$ |
(58,768 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.31 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.60 |
) |
|
$ |
(0.68 |
) |
Weighted-average number of shares used in computing net loss
per share, basic and diluted |
|
|
114,929,523 |
|
|
|
86,448,632 |
|
|
|
114,676,261 |
|
|
|
86,363,116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gritstone bio (NASDAQ:GRTS)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Gritstone bio (NASDAQ:GRTS)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024