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,
2022 and reviewed business highlights.
“With steady execution of multiple clinical programs around the
world, we are building momentum for the many datasets expected from
SLATE, CORAL and GRANITE over the coming months and through 2023,”
said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief
Executive Officer of Gritstone. “We have observed a correlation
between molecular response and extended overall survival in
multiple subjects with end-stage colorectal cancer treated with
GRANITE, our individualized neoantigen immunotherapy. Today, we
shared data demonstrating that the high neutralizing antibody
titers to SARS-CoV-2 induced by our self-amplifying mRNA (samRNA)
vaccine candidate persisted with no decay for at least 6 months.
These data, from a subset of subjects in our CORAL-BOOST study, are
encouraging since lack of neutralizing antibody persistence is a
major limitation of first-generation vaccines, necessitating
frequent boost vaccinations. Our novel samRNA vaccine platform may
be driving this durable effect due to its self-replicating nature,
an inherent potential benefit of samRNA compared to
first-generation mRNA vaccines. We look forward to sharing more
data from the CORAL (SARS-CoV-2) program, as well as the SLATE
programs later this year.”
Clinical Program UpdatesTumor-Specific
Neoantigen (TSNA) Oncology ProgramsGRANITE –
Individualized, TSNA-directed vaccine-based immunotherapy
- In May, Gritstone provided updated overall survival (OS) data
from GRANITE Phase 1/2 study in end-stage colorectal cancer (n=9).
- Of the four patients who demonstrated molecular response,
median overall survival (mOS) is not yet reached and will exceed 18
months. This compares to 7.8 months mOS in those who did not have a
molecular response.
- All patients alive at the time of the ESMO 2021 data
presentation (the initial presentation of data from the Phase 1/2
study) remain alive after an additional 35 weeks of follow-up.
- 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),
is ongoing. Preliminary data (molecular response and
progression-free survival) from the Phase 2 portion of the trial
are expected in 2H 2023.
- GRANITE-ADJUVANT, a randomized, controlled Phase 2 trial in
patients with high-risk stage II/III colon cancer who are
circulating tumor DNA (ctDNA)+ after definitive surgery, is open
for enrollment.
SLATE – “Off-the-shelf” shared neoantigen-directed vaccine-based
immunotherapy intended for patients who have relevant KRAS
mutations and suitable tissue type (HLA)
- Initial data from the ongoing Phase 2 study of SLATE-KRAS, an
optimized, KRAS-specific version of SLATE, will be presented during
a mini-oral presentation at the European Society for Medical
Oncology (ESMO) in September 2022. SLATE-KRAS is being evaluated 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 Gritstone’s original candidate, SLATE v1.
- 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 highly prevalent
tumor-specific antigens across a number of patient populations and
cancer types.
Infectious Disease ProgramsGritstone’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.
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 mRNA products by inducing
potent and persistent neutralizing antibody responses with broad
variant protection, plus T cell responses to conserved regions from
across the SARS-CoV-2 genome (not just Spike).
- In June, results from a preclinical study of its samRNA vaccine
against SARS-CoV-2 were published in Nature Communications (article
here). The results of the study, which were previously pre-printed
in bioRxiv (in November 2021), demonstrate the samRNA vaccine
candidate induced broad and potent neutralizing antibodies and T
cell immune responses following administration to non-human
primates (NHP) at low doses, and that these immune responses were
protective against SARS-CoV-2 challenge.
- Today, Gritstone reported antibody durability results from the
first two cohorts of its CORAL-BOOST trial showing the strong
neutralizing antibody response observed following single boost
administration of samRNA (10µg or 30µg) persisted without decay
after 6 months. In a small subset of subjects who elected to
receive only a single samRNA boost vaccination (n=7), at six
months:
- Durable neutralizing antibodies against wild type Spike as well
as key Spike variants of concern (Beta, Delta and Omicron) were
observed.
- Neutralizing antibody titers formed a plateau and remained
stable for at least 6 months.
- These results can be found in Gritstone’s corporate
presentation.
- Additionally, T cell responses to Spike and non-Spike T cell
epitopes (TCEs) remained generally stable over the 6-month
observation period (Omicron mutations impacted TCEs
minimally).
- Three Phase 1 studies – CORAL-BOOST, CORAL-CEPI and CORAL-NIH –
are ongoing and data from each are expected in the second half of
2022.
- The CORAL-BOOST study is a Phase 1 study in the UK evaluating a
T cell enhanced samRNA vaccine as a booster against SARS-CoV-2 in
healthy volunteers over 60 years old who had received two prior
doses of Vaxzevria (AstraZeneca COVID-19 vaccine). In January,
Gritstone announced positive clinical data from the first cohort
and subsequently expanded the study to permit boosting after both
mRNA as well as adenoviral primary vaccine series.
- 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 (plus TCE)
constructs in virus-naïve, convalescent, and HIV+ patients.
- 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 adenoviral 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.
- If Gilead decides to progress development beyond the initial
Phase 1 study by exercising their exclusive option, the Company
will receive a $40.0 million non-refundable option exercise
fee.
Corporate Highlights
- Established a credit facility of up to $80 million with
Hercules Capital (NYSE: HTGC) and Silicon Valley Bank and drew $20
million at closing (July 2022). An additional $10 million is
available for drawdown by March 15, 2023, and the remaining $50
million becomes available in tranches through June 15, 2024, upon
achievement of certain milestones by Gritstone. Gritstone is under
no obligation to draw funds in the future, and there are no
warrants associated with this transaction.
- Earned Great Place to Work® Certification (May 2022).
Second Quarter 2022 Financial Results
Cash, cash equivalents, marketable securities and
restricted cash were $159.2 million as of June 30, 2022,
compared to $223.5 million as of December 31, 2021.
Research and development expenses were $27.3
million for the three months ended June 30, 2022, compared to $22.1
million for the three months ended June 30, 2021. The increase of
$5.2 million was primarily due to increases of $1.9 million in
personnel-related expenses, $3.1 million in outside services,
consisting primarily of clinical trial and other chemistry,
manufacturing and controls (“CMC”) related expenses, and $0.8
million in facilities related costs, offset by a decrease of $0.5
million in laboratory supplies.
General and administrative expenses were $7.8
million for the three months ended June 30, 2022, compared to $5.9
million for the three months ended June 30, 2021. The increase of
$1.9 million was primarily attributable to increases of $1.5
million in personnel-related expenses and $0.6 million in outside
services, offset by a decrease of $0.2 million in
facilities-related costs.
Collaboration, license, and grant revenues were
$5.5 million for the three months ended June 30, 2022, compared to
$2.8 million for the three months ended June 30, 2021. The $2.7
million increase was primarily attributable to revenue recognized
under the CEPI Funding Agreement, which was entered into in August
2021, for the three months ended June 30, 2022.
Conference call and webcast detailsA conference
call to discuss second quarter results will be held at 4:30 p.m. ET
August 4:
Conference call: 800-263-0877Conference passcode:
8108859Webcast:
https://event.webcasts.com/starthere.jsp?ei=1561514&tp_key=4f6eab0ea9
About Gritstone Gritstone 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 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’
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
Quarterly Report on Form 10-Q filed on August 4, 2022 and any
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 Statements of
Operations (Unaudited) (In thousands,
except share and per share amounts)
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license
revenues |
$ |
2,761 |
|
|
$ |
2,843 |
|
|
$ |
7,506 |
|
|
$ |
42,536 |
|
Grant revenues |
|
2,710 |
|
|
|
- |
|
|
|
5,156 |
|
|
|
- |
|
Total revenue |
|
5,471 |
|
|
|
2,843 |
|
|
|
12,662 |
|
|
|
42,536 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
27,347 |
|
|
|
22,072 |
|
|
|
55,546 |
|
|
|
46,928 |
|
General and administrative |
|
7,792 |
|
|
|
5,937 |
|
|
|
15,747 |
|
|
|
12,878 |
|
Total operating expenses |
|
35,139 |
|
|
|
28,009 |
|
|
|
71,293 |
|
|
|
59,806 |
|
Loss from operations |
|
(29,668 |
) |
|
|
(25,166 |
) |
|
|
(58,631 |
) |
|
|
(17,270 |
) |
Interest income, net |
|
153 |
|
|
|
48 |
|
|
|
200 |
|
|
|
75 |
|
Net loss |
$ |
(29,515 |
) |
|
$ |
(25,118 |
) |
|
$ |
(58,431 |
) |
|
$ |
(17,195 |
) |
Net loss per share, basic and
diluted |
$ |
(0.34 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.68 |
) |
|
$ |
(0.23 |
) |
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
|
86,448,632 |
|
|
|
76,749,641 |
|
|
|
86,363,116 |
|
|
|
76,368,506 |
|
Gritstone bio, Inc.
Condensed Consolidated Balance
Sheets(Unaudited) (In thousands)
|
June 30,2022 |
|
December 31,2021 |
|
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
65,694 |
|
|
$ |
93,287 |
|
Marketable securities |
|
78,939 |
|
|
|
108,346 |
|
Restricted cash |
|
9,311 |
|
|
|
11,285 |
|
Prepaid expenses and other current assets |
|
7,791 |
|
|
|
7,672 |
|
Total current assets |
|
161,735 |
|
|
|
220,590 |
|
Restricted cash |
|
5,290 |
|
|
|
6,005 |
|
Property and equipment,
net |
|
22,712 |
|
|
|
21,622 |
|
Lease right-of-use assets |
|
21,126 |
|
|
|
22,920 |
|
Deposits and other long-term
assets |
|
3,090 |
|
|
|
2,352 |
|
Long-term marketable
securities |
|
- |
|
|
|
4,617 |
|
Total assets |
$ |
213,953 |
|
|
$ |
278,106 |
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,381 |
|
|
$ |
4,230 |
|
Accrued compensation |
|
5,331 |
|
|
|
6,925 |
|
Accrued liabilities |
|
2,035 |
|
|
|
411 |
|
Accrued research and development |
|
4,386 |
|
|
|
3,706 |
|
Lease liabilities, current portion |
|
7,174 |
|
|
|
7,483 |
|
Deferred revenue, current portion |
|
11,079 |
|
|
|
17,201 |
|
Total current liabilities |
|
32,386 |
|
|
|
39,956 |
|
Lease liabilities, net of
current portion |
|
17,800 |
|
|
|
18,936 |
|
Deferred revenue, net of
current portion |
|
389 |
|
|
|
3,128 |
|
Total liabilities |
|
50,575 |
|
|
|
62,020 |
|
Commitments and
contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Common stock |
|
20 |
|
|
|
20 |
|
Additional paid-in capital |
|
623,583 |
|
|
|
617,523 |
|
Accumulated other comprehensive loss |
|
(410 |
) |
|
|
(73 |
) |
Accumulated deficit |
|
(459,815 |
) |
|
|
(401,384 |
) |
Total stockholders'
equity |
|
163,378 |
|
|
|
216,086 |
|
Total liabilities and
stockholders' equity |
$ |
213,953 |
|
|
$ |
278,106 |
|
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