Gritstone bio Reports First Quarter 2023 Financial Results and Provides Corporate Updates
12 May 2023 - 6:05AM
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 first quarter ended March 31,
2023 and provided recent corporate and clinical updates.
“Strategically prioritizing GRANITE underscores our conviction
in the program and focuses our near-term resources on the immense
opportunity that lies directly ahead of us: potentially being the
first to demonstrate efficacy of a neoantigen-based personalized
cancer vaccine in a randomized, controlled trial for MSS-CRC,” said
Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief
Executive Officer of Gritstone bio. “GRANITE is a potentially
transformative therapy that has already shown significant promise
in our published Phase 1/2 study in patients with metastatic
MSS-CRC, who had received two prior lines of chemotherapy. The high
demand seen to date for our ongoing Phase 2 is a testament to its
potential. Expanding the study from 80 to 100 patients not only
increases the statistical power of the study but also generates
more time-to-event data to help inform the Phase 3. We are thrilled
to have the momentum and capital to expand this study and take this
important step forward for patients with newly diagnosed metastatic
CRC, as well as those being treated for CRC in the adjuvant setting
and other cold tumors. We look forward to sharing preliminary Phase
2 efficacy data from approximately half of the 100 total patients
in the first quarter of 2024.”
Dr. Allen continued, “Along with the significant progress in
GRANITE, the data flowing from our CORAL program is highly
encouraging and provides early signals of the potential advantages
of self-amplifying mRNA (samRNA) over first-generation mRNA against
infectious disease. We recently observed durable neutralizing
antibody titers at 6 months following samRNA vaccination in over
100 vaccine-naïve subjects treated within our CORAL-CEPI trial,
where interim results were presented at ECCMID 2023.
Self-amplifying mRNA has several distinct characteristics including
prolonged and elevated antigen expression that suggest it could
play a key role in the induction of long-term, variant-proof immune
protection. We look forward to continuing to work with our
collaborators to demonstrate the full potential of our samRNA
platform against SARS-CoV-2 and other important viruses.”
Corporate Updates
GRANITE (individualized neoantigen vaccine against cold
tumors): Gritstone is focusing its resources to expand the
ongoing 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). As of May 10,
2023, the company had randomized 71 of the initially planned 80
total patients. The company plans to expand the study to randomize
100 patients in total. Enrollment of all 100 patients is expected
to complete in third quarter of 2023 and preliminary data on
approximately 50 of the 100 patients from the Phase 2 portion of
the study (circulating tumor DNA [ctDNA] and progression-free
survival data [evaluated by both RECIST and iRECIST criteria] on
patients completing at least 4 months of treatment) is expected in
the first quarter of 2024.
SLATE (“off-the-shelf” neoantigen vaccine
program): Given the strategic decision to focus on
GRANITE, the company is deferring the initiation of a randomized
Phase 2 clinical trial with SLATE until 2024. Previously, a
KRAS-dedicated version of SLATE demonstrated strong T cell
responses and an observed survival advantage among molecular
responders in Phase 1/2 studies of patients with MSS-CRC and
non-small cell lung cancer (NSCLC, press release announcing ESMO
2022 data available here). The company believes success in GRANITE
has the potential to further validate the company’s
neoantigen-based approach, which SLATE and GRANITE share, and that
SLATE is ready for application across solid tumor indications and
shared tumor neoantigen classes.
Infectious Disease: The company will continue
its ongoing clinical and preclinical infectious disease efforts as
planned, with the vast majority of these efforts being funded via
external collaborators. The Bill & Melinda Gates Foundation,
the Coalition for Epidemic Preparedness Innovations (CEPI) and the
National Institute of Allergy and Infectious Diseases (NIAID)
support the company’s CORAL program. Gilead Sciences, Inc. (Gilead)
is conducting a Phase 1 study as part of a collaboration with
Gritstone to research and develop a therapeutic vaccine against
HIV.
Clinical Program Updates Tumor-Specific
Neoantigen Oncology Programs (GRANITE and SLATE)
- In April 2023, Gritstone delivered multiple
presentations detailing advances in neoantigen prediction
capabilities and cancer vaccine programs at the 2023 American
Association for Cancer Research (AACR 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.
- In February 2023, Gritstone announced it had entered
into a clinical trial agreement with the National Cancer
Institute to evaluate an autologous T cell therapy
expressing a T cell receptor targeting mutated KRAS in combination
with Gritstone’s KRAS-directed vaccine candidate, SLATE-KRAS, in a
Phase 1 study led by Steven A. Rosenberg, M.D., Ph.D.
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 all studies to date, results have shown Gritstone’s
samRNA vaccine candidates to be well-tolerated and capable of
driving strong, durable and broad immunogenicity across several
subject populations and settings.
- 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 showed 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 show 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.
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.
- In February 2023, results from a preclinical study
conducted in collaboration with Gilead were presented at Conference
on Retroviruses and Opportunistic Infections (CROI) 2023.
The first data disclosed from the Gritstone-Gilead HIV Cure
collaboration, results showed that simian immunodeficiency virus
(SIV) Chimpanzee Adenovirus (ChAd) and self-amplifying mRNA
(samRNA) vaccines induced a strong and broad CD8+ T cell immune
response, which was significantly enhanced in combination with
immune modulators.
First Quarter 2023 Financial Results
- Cash, cash equivalents, marketable securities and
restricted cash were $153.2 million as of March 31, 2023,
compared to $185.2 million as of December 31, 2022.
- Research and development expenses were $30.5
million for the three months ended March 31, 2023 compared to $28.2
million for the three months ended March 31, 2022. The increase of
$2.3 million was primarily due to increases of $1.5 million in
personnel-related expenses, $0.3 million in outside services, $0.7
million in facilities related costs, and $0.8 million in laboratory
supplies, offset by a decrease of $1.0 million in milestone and
license payments.
- General and administrative expenses were $6.7
million for the three months ended March 31, 2023 compared to $8.0
million for the three months ended March 31, 2022. The decrease of
$1.3 million was primarily attributable to decreases of $1.1
million in outside services and $0.2 million in facilities-related
costs.
- Collaboration, license, and grant revenues
were $2.4 million for the three months ended March 31, 2023
compared to $7.2 million for the three months ended March 31, 2022.
During the three months ended March 31, 2023, we recorded $0.1
million in collaboration revenue related to our collaboration with
Gilead, $0.4 million in collaboration revenue related to our
collaboration with 2seventy bio, Inc., $1.5 million in grant
revenue from CEPI, and $0.4 million in grant revenue from the Gates
Foundation. During the three months ended March 31, 2022, we
recognized $4.0 million in collaboration revenue related to our
collaboration with 2seventy bio, $0.7 million in collaboration
revenue related to our collaboration with Gilead, $2.2 million in
grant revenue from CEPI, and $0.2 million in grant revenue from the
Gates Foundation.
Webcast DetailsA webcast to discuss
first quarter 2023 results will be held at 4:30pm ET today (May
11):Conference call: 1-888-999-6281Conference ID:
1754341Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1612896&tp_key=c6c637ac24
An archived replay will be accessible at
https://ir.gritstonebio.com/investors/events for 30 days following
the event.
About Gritstone bioGritstone is working to
create 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.
MacDougallDirector, Investor Relations & Corporate
CommunicationsGritstone bio, Inc.ir@gritstone.com
Media:Dan Budwick1AB(973) 271-6085dan@1abmedia.com
|
Gritstone bio, Inc.Condensed Consolidated
Balance Sheets (unaudited)(In thousands) |
|
|
March 31, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
47,128 |
|
|
$ |
55,498 |
|
Marketable securities |
|
98,680 |
|
|
|
116,389 |
|
Restricted cash |
|
2,077 |
|
|
|
3,977 |
|
Prepaid expenses and other current assets |
|
6,880 |
|
|
|
7,014 |
|
Total current assets |
|
154,765 |
|
|
|
182,878 |
|
Long-term restricted cash |
|
5,290 |
|
|
|
5,290 |
|
Property and equipment,
net |
|
20,365 |
|
|
|
21,335 |
|
Lease right-of-use assets |
|
15,615 |
|
|
|
17,481 |
|
Deposits and other long-term
assets |
|
13,917 |
|
|
|
9,739 |
|
Long-term marketable
securities |
|
— |
|
|
|
4,031 |
|
Total assets |
$ |
209,952 |
|
|
$ |
240,754 |
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
5,975 |
|
|
$ |
8,694 |
|
Accrued compensation |
|
4,697 |
|
|
|
8,215 |
|
Accrued liabilities |
|
3,123 |
|
|
|
4,124 |
|
Accrued research and development expenses |
|
3,448 |
|
|
|
3,343 |
|
Lease liabilities, current portion |
|
4,628 |
|
|
|
5,294 |
|
Deferred revenue, current portion |
|
2,801 |
|
|
|
5,131 |
|
Total current liabilities |
|
24,672 |
|
|
|
34,801 |
|
Other liabilities,
noncurrent |
|
251 |
|
|
|
150 |
|
Lease liabilities, net of
current portion |
|
14,575 |
|
|
|
15,673 |
|
Debt, noncurrent |
|
29,576 |
|
|
|
19,349 |
|
Total liabilities |
|
69,074 |
|
|
|
69,973 |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock |
|
— |
|
|
|
— |
|
Common stock |
|
22 |
|
|
|
22 |
|
Additional paid-in capital |
|
695,961 |
|
|
|
691,910 |
|
Accumulated other comprehensive loss |
|
(52 |
) |
|
|
(80 |
) |
Accumulated deficit |
|
(555,053 |
) |
|
|
(521,071 |
) |
Total stockholders’
equity |
|
140,878 |
|
|
|
170,781 |
|
Total liabilities and
stockholders’ equity |
$ |
209,952 |
|
|
$ |
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 March 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
Collaboration and license revenues |
|
$ |
542 |
|
|
$ |
4,745 |
|
Grant revenues |
|
|
1,901 |
|
|
|
2,446 |
|
Total revenues |
|
|
2,443 |
|
|
|
7,191 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
30,514 |
|
|
|
28,199 |
|
General and administrative |
|
|
6,745 |
|
|
|
7,955 |
|
Total operating expenses |
|
|
37,259 |
|
|
|
36,154 |
|
Loss from operations |
|
|
(34,816 |
) |
|
|
(28,963 |
) |
Interest income |
|
|
1,678 |
|
|
|
71 |
|
Interest expense |
|
|
(844 |
) |
|
|
(24 |
) |
Net loss |
|
|
(33,982 |
) |
|
|
(28,916 |
) |
Other comprehensive loss: |
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
|
28 |
|
|
|
(318 |
) |
Comprehensive loss |
|
$ |
(33,954 |
) |
|
$ |
(29,234 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.30 |
) |
|
$ |
(0.34 |
) |
Weighted-average number of
shares used in computing net loss per share, basic and
diluted |
|
|
114,423,000 |
|
|
|
86,277,599 |
|
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