Gritstone bio Reports Third Quarter 2023 Financial Results and Provides Corporate Updates
08 Novembre 2023 - 10:05PM
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 third quarter ended September
30, 2023 and provided recent corporate and clinical updates.
“As cancer and infectious diseases continue to challenge human
health across the globe, we at Gritstone continue advancing our
vision to deliver more potent and durable vaccines,” said Andrew
Allen, M.D., Ph.D., Co-founder, President, and Chief Executive
Officer of Gritstone bio. “The ongoing advancement of our CORAL
program positions our infectious disease approach, which combines
self-amplifying mRNA (samRNA) with novel B and T cell targets, as a
leading potential next-generation vaccine platform for COVID-19 and
beyond. We believe the data recently shared at IDWeek underscore
the promise of this novel approach to drive broad and long-lasting
clinical protection against COVID-19 with vaccine-elicited
neutralizing antibodies against the virus persisting at high
concentrations for at least 12 months, unlike current approved
vaccines. In oncology, preliminary findings from the randomized
Phase 2/3 study of our personalized cancer vaccine, GRANITE, in
MSS-CRC are rapidly approaching. This is important data not only
for Gritstone but for the field, as GRANITE represents an
opportunity to bring a new class of therapy to patients with ‘cold’
solid tumors, for whom the benefits of today’s immunotherapies are
minimal. The scientific bedrock of GRANITE extends to SLATE, where
our collaboration with Steven A. Rosenberg and the NCI is now
advancing. With GRANITE and CORAL now in or entering randomized
Phase 2 studies, Gritstone stands at the precipice of unlocking the
full potential of our novel vaccine platforms in both oncology and
infectious diseases.”
Corporate Update
- In August 2023, Gritstone and Genevant Sciences entered
into a multi-year option and license agreement that provides
Gritstone with nonexclusive access to Genevant’s leading LNP
technology, on a pathogen-by-pathogen basis, for development and
commercialization of Gritstone’s samRNA infectious disease
vaccines.
Clinical Program Updates Tumor-Specific
Neoantigen Oncology Programs (GRANITE and SLATE)GRANITE –
Personalized neoantigen vaccine programSLATE – “Off-the-shelf”
neoantigen vaccine program
- The Phase 2 portion of the Phase 2/3 study evaluating
GRANITE as a maintenance therapy in first-line MSS-CRC remains
ongoing, and preliminary efficacy data from the Phase 2 portion
remain expected in the first quarter of 2024. Gritstone
met its enrollment target of 100 patients randomized in August
2023.
- The clinical trial collaboration with the National
Cancer Institute (NCI) to evaluate an autologous T cell therapy in
combination with Gritstone’s KRAS-directed “off the shelf” vaccine
candidate, SLATE-KRAS, is ongoing. An IND to run a Phase 1 study
was cleared by the U.S. Food and Drug Administration (FDA) in
October 2023. The study is led by Steven A. Rosenberg,
M.D., Ph.D., Chief of the Surgery Branch at the NCI's Center for
Cancer Research. 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 at the NIH Clinical
Center.
- Gritstone intends to initiate a randomized Phase 2
clinical trial within SLATE (“off-the-shelf” neoantigen vaccine
program) in 2024.
Infectious Disease ProgramsCORAL –
Next-generation SARS-CoV-2 vaccine program that serves as
proof-of-concept for Gritstone’s samRNA platform and novel approach
in infectious diseases
- In September 2023, Gritstone was awarded a contract by
BARDA (the Biomedical Advanced Research and Development Authority),
part of the Administration for Strategic Preparedness and Response
in the U.S. Department of Health and Human Services, to conduct a
Phase 2b comparative study evaluating its next-generation vaccine
candidate against
COVID-19(a). Per the
contract, which is valued at up to $433.0 million, Gritstone is
currently preparing to conduct a 10,000 participant, randomized
Phase 2b double-blinded study to compare the efficacy, safety, and
immunogenicity of Gritstone’s samRNA vaccine candidate against an
approved COVID-19 vaccine. Preparations for the study are covered
under the initial base period of the contract. Gritstone expects
the study to be initiated in the first quarter of 2024.
- In October 2023, new data was presented from
Gritstone’s three Phase 1 CORAL studies. Results across these
studies highlighted the potential of Gritstone’s next-generation
samRNA-based approach, which incorporates Spike plus other viral
targets (“Spike plus”), to drive broad and long-lasting clinical
protection against COVID-19. Highlights from the data,
which were presented at IDWeek 2023, include:
- High neutralizing antibody (nAb) responses were sustained
through the latest evaluable timepoints across all three studies,
highlighting potential for durable clinical protection.
- High nAb levels were demonstrated through at least 12 months in
the CORAL-CEPI and CORAL-BOOST studies and at least 6 months in the
CORAL-NIH study.
- T cell responses to Spike plus other viral targets observed in
all Phase 1 studies, demonstrating broad and potentially
variant-proof immune response.
- Vaccine candidates were generally well tolerated in all Phase 1
studies; over 300 subjects dosed to date. See all poster
presentations here: CORAL-CEPI, CORAL-BOOST, CORAL-NIH
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.
Third Quarter 2023 Financial Results
- Cash, cash equivalents, marketable securities and
restricted cash were $90.5 million as of September 30,
2023, compared to $185.2 million as of December 31, 2022.
- Research and development expenses were $32.8
million for the three months ended September 30, 2023, compared to
$26.4 million for the three months ended September 30, 2022. The
increase of $6.3 million was primarily due increases of $2.5
million in milestone and license payments, $1.0 million in
personnel-related expenses, $2.0 million in facilities-related
costs, and $0.9 million in outside services, consisting primarily
of clinical trial and other chemistry, manufacturing and
controls-related expenses, offset by decreases of $0.1 million in
laboratory supplies.
- General and administrative expenses were $7.4
million for the three months ended September 30, 2023, compared to
$6.5 million for the three months ended September 30, 2022. The
increase of $0.9 million was primarily due to increases of $0.5
million in outside services, $0.2 million in personnel-related
expenses, and $0.2 million in facilities-related costs.
- Collaboration, license, and grant revenues
were $1.6 million for the three months ended September 30, 2023,
compared to $3.0 million for the three months ended September 30,
2022. During the three months ended September 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, $0.8 million in grant revenue
from the CEPI funding agreement, and $0.4 million in grant revenue
pursuant to the Gates grant agreement.
(a)This project has been supported in whole or in part with federal
funds from the Department of Health and Human Services;
Administration for Strategic Preparedness and Response; Biomedical
Advanced Research and Development Authority (BARDA), under contract
number 75A50123C00062. |
|
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. 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 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) |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
2022 |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
29,539 |
|
|
$ |
55,498 |
|
Marketable securities |
|
|
54,409 |
|
|
|
116,389 |
|
Restricted cash |
|
|
1,242 |
|
|
|
3,977 |
|
Prepaid expenses and other current assets |
|
|
5,630 |
|
|
|
7,014 |
|
Total current assets |
|
|
90,820 |
|
|
|
182,878 |
|
Long-term restricted cash |
|
|
5,290 |
|
|
|
5,290 |
|
Property and equipment, net |
|
|
18,952 |
|
|
|
21,335 |
|
Lease right-of-use assets |
|
|
70,909 |
|
|
|
17,481 |
|
Deposits and other long-term
assets |
|
|
1,246 |
|
|
|
9,739 |
|
Long-term marketable
securities |
|
|
— |
|
|
|
4,031 |
|
Total assets |
|
$ |
187,217 |
|
|
$ |
240,754 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
4,265 |
|
|
$ |
8,694 |
|
Accrued compensation |
|
|
7,772 |
|
|
|
8,215 |
|
Accrued liabilities |
|
|
1,660 |
|
|
|
4,124 |
|
Accrued research and development expenses |
|
|
2,382 |
|
|
|
3,343 |
|
Lease liabilities, current portion |
|
|
6,003 |
|
|
|
5,294 |
|
Deferred revenue, current portion |
|
|
1,301 |
|
|
|
5,131 |
|
Total current liabilities |
|
|
23,383 |
|
|
|
34,801 |
|
Other liabilities,
noncurrent |
|
|
554 |
|
|
|
150 |
|
Lease liabilities, net of current
portion |
|
|
59,430 |
|
|
|
15,673 |
|
Debt, noncurrent |
|
|
29,868 |
|
|
|
19,349 |
|
Total liabilities |
|
|
113,235 |
|
|
|
69,973 |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
22 |
|
|
|
22 |
|
Additional paid-in capital |
|
|
702,755 |
|
|
|
691,910 |
|
Accumulated other comprehensive loss |
|
|
(52 |
) |
|
|
(80 |
) |
Accumulated deficit |
|
|
(628,743 |
) |
|
|
(521,071 |
) |
Total stockholders’ equity |
|
|
73,982 |
|
|
|
170,781 |
|
Total liabilities and
stockholders’ equity |
|
$ |
187,217 |
|
|
$ |
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 September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenues |
|
$ |
361 |
|
|
$ |
436 |
|
|
$ |
1,302 |
|
|
$ |
7,942 |
|
Grant revenues |
|
|
1,204 |
|
|
|
2,585 |
|
|
|
4,659 |
|
|
|
7,741 |
|
Total revenues |
|
|
1,565 |
|
|
|
3,021 |
|
|
|
5,961 |
|
|
|
15,683 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
32,763 |
|
|
|
26,436 |
|
|
|
94,244 |
|
|
|
81,983 |
|
General and administrative |
|
|
7,406 |
|
|
|
6,462 |
|
|
|
20,867 |
|
|
|
22,209 |
|
Total operating expenses |
|
|
40,169 |
|
|
|
32,898 |
|
|
|
115,111 |
|
|
|
104,192 |
|
Loss from operations |
|
|
(38,604 |
) |
|
|
(29,877 |
) |
|
|
(109,150 |
) |
|
|
(88,509 |
) |
Interest income |
|
|
1,167 |
|
|
|
462 |
|
|
|
4,324 |
|
|
|
663 |
|
Interest expense |
|
|
(991 |
) |
|
|
(551 |
) |
|
|
(2,818 |
) |
|
|
(551 |
) |
Other expense |
|
|
(6 |
) |
|
|
— |
|
|
|
(28 |
) |
|
|
— |
|
Net loss |
|
|
(38,434 |
) |
|
|
(29,966 |
) |
|
|
(107,672 |
) |
|
|
(88,397 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
|
73 |
|
|
|
129 |
|
|
|
28 |
|
|
|
(208 |
) |
Comprehensive loss |
|
$ |
(38,361 |
) |
|
$ |
(29,837 |
) |
|
$ |
(107,644 |
) |
|
$ |
(88,605 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.94 |
) |
|
$ |
(1.02 |
) |
Weighted-average number of shares
used in computing net loss per share, basic and diluted |
|
|
115,342,613 |
|
|
|
86,597,405 |
|
|
|
114,898,379 |
|
|
|
86,441,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grafico Azioni Gritstone bio (NASDAQ:GRTS)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Gritstone bio (NASDAQ:GRTS)
Storico
Da Set 2023 a Set 2024