Gritstone Oncology Reports Second Quarter Financial Results and Recent Highlights
August 05 2020 - 9:01AM
Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage
biotechnology company developing the next generation of cancer
immunotherapies to fight multiple cancer types, today reported
financial results for the second quarter ended June 30, 2020 and
reviewed business highlights.
“We have made important advances in our two
cancer immunotherapy programs, GRANITE and SLATE, demonstrating
early signals of clinical benefit together with a well-tolerated
safety profile,” said Andrew Allen, M.D., Ph.D., co-founder,
president and chief executive officer of Gritstone Oncology.
“Building upon our data presented 6 months ago, we have shown that
GRANITE, our personalized ‘N of 1’ therapy, consistently elicited
large numbers of Class I HLA-presented neoantigen-specific CD8+ T
cells in all patients treated. Furthermore, we have shown that
these very same T cells can expand within the tumor mass.
Excitingly, we have seen signs of clinical benefit, with no GRANITE
patient at dose level 3 or above having experienced disease
progression to date. Most notably, in a microsatellite-stable colon
cancer patient treated at dose level three, we are observing
ongoing clinical response, corresponding with a decline in the
tumor marker CEA and the normalization of liver function tests. We
await further CT scans to assess for RECIST response. Further
colorectal cancer patients with microsatellite-stable disease are
on treatment at dose level 4, and we expect to present additional
data from this dose level later this year. For SLATE, our shared
neoantigen program, we are initiating Phase 2 expansion
cohorts.”
Recent Accomplishments
- Presented preliminary efficacy,
immunogenicity, and safety data from the ongoing Phase 1 study
evaluating GRANITE in combination with immune checkpoint blockade
for the treatment of patients with advanced solid tumors, including
microsatellite stable colorectal cancer (MSS-CRC), gastroesophageal
cancer, metastatic non-small cell lung cancer (NSCLC), and bladder
cancer• Demonstrated consistent, strong neoantigen-specific CD8+ T
cells generated in all patients tested and signals of clinical
benefit, as well as a favorable safety profile
- Presented the same data types from
the Phase 1 study evaluating SLATE in combination with immune
checkpoint blockade for the treatment of patients with metastatic
NSCLC, pancreatic ductal adenocarcinoma and MSS-CRC, as well as in
patients with other solid tumor types who have relevant
mutation/human leukocyte antigen (HLA) combinations• Induced CD8+ T
cells against multiple KRAS driver mutations, with the most
pronounced response against immunodominant neoantigens such as
TP53mut, and demonstrated a favorable safety profile
- Expanded the training dataset of
HLA class II peptides and alleles for the EDGE platform
- Augmented its Scientific Advisory
Board with the addition of Jean-Charles Soria, M.D., Ph.D., chief
executive officer of Gustave Roussy Cancer Campus, the premier
European comprehensive cancer center based in Villejuif,
France
- Appointed Rahsaan W. Thompson,
J.D., seasoned legal executive with over 20 years of corporate
counsel experience, as executive vice president and general
counsel
- Appointed Elaine V. Jones, Ph.D.,
an existing board member, to the position of chair of the board of
directors
Anticipated Upcoming
Milestones
- Present additional efficacy and
safety data from the Phase 1 GRANITE study, including at the higher
GRANITE dose level, in 2020
- Initiate single-arm Phase 2
expansion cohorts with GRANITE for patients with MSS CRC and
gastroesophageal cancer in 2020
- Initiate single-arm Phase 2
expansion cohorts with SLATE for patients with NSCLC following
previous therapy with checkpoint inhibitors and patients with TP53
mutations in 2020
- Nominate a lead bispecific antibody
development candidate directed towards a novel solid tumor-specific
HLA-peptide complex in 2020
- Present data from Phase 2 SLATE
cohorts in the first half of 2021
- Present data from Phase 2 GRANITE
cohorts in the second half of 2021
- Report data from SLATE cassette
optimized for KRAS mutations in patients with NSCLC in the second
half of 2021
Second Quarter 2020 Financial
ResultsFor the three months ended June 30, 2020, Gritstone
reported a net loss of $25.9 million, compared to a net loss of
$21.2 million for the three months ended June 30, 2019.
Collaboration revenue was $0.5 million for the
three months ended June 30, 2020, compared to $1.2 million for the
three months ended June 30, 2019. Collaboration revenue was due to
the Research Collaboration and License Agreement with bluebird bio
Inc and another small collaboration agreement.
Total research and development expenses were
$21.3 million for the three months ended June 30, 2020, compared to
$18.5 million for the three months ended June 30, 2019. The
increase was primarily attributable to an increase in
personnel-related expenses driven by increased headcount, as well
as an increase in facilities-related expenses to accommodate our
manufacturing expansion and increased personnel.
General and administrative expenses were $5.3
million for the three months ended June 30, 2020, compared to $4.8
million for the three months ended June 30, 2019. The increase was
primarily attributable to an increase in personnel-related
expenses.
Cash, cash equivalents, marketable securities
and restricted cash were $92.9 million as of June 30, 2020,
compared to $128.8 million as of December 31, 2019.
About Gritstone
OncologyGritstone Oncology (Nasdaq: GRTS), a
clinical-stage biotechnology company, is developing the next
generation of cancer immunotherapies to fight multiple cancer
types. Gritstone develops its products by leveraging two key
pillars—second, a proprietary machine learning-based platform,
Gritstone EDGETM, which is designed to predict, from a routine
tumor biopsy, the tumor-specific neoantigens (TSNA) that are
presented on a patient’s tumor cells; and second, the ability to
develop and manufacture potent immunotherapies utilizing patients’
TSNA to potentially drive the patient’s immune system to
specifically attack and destroy tumors. The company’s
individualized neoantigen-based immunotherapy, GRANITE, and its
“off the shelf” shared neoantigen-based immunotherapy, SLATE, are
being evaluated in clinical studies. Novel tumor-specific antigens
can also provide targets for bispecific antibody (BiSAb)
therapeutics for solid tumors, and Gritstone’s BiSAb program is
currently in lead optimization. For more information, please visit
gritstoneoncology.com.
Gritstone Forward-Looking
Statements This 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,
including the timing thereof. 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 August 5, 2020 and any
current and periodic reports filed with the Securities and Exchange
Commission.
ContactsMedia:Dan Budwick1AB(973)
271-6085dan@1abmedia.com
Investors:Alexandra SantosWheelhouse Life Science Advisors(510)
871-6161asantos@wheelhouselsa.com
Gritstone
Oncology, Inc. |
|
Condensed
Consolidated Statements of Operations |
|
(Unaudited) |
|
(In thousands,
except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Six Months
Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
488 |
|
|
$ |
1,150 |
|
|
$ |
1,750 |
|
|
$ |
2,497 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
21,290 |
|
|
|
18,529 |
|
|
|
43,758 |
|
|
|
34,428 |
|
|
General and administrative |
|
|
5,255 |
|
|
|
4,835 |
|
|
|
10,720 |
|
|
|
9,212 |
|
|
Total operating expenses |
|
|
26,545 |
|
|
|
23,364 |
|
|
|
54,478 |
|
|
|
43,640 |
|
|
Loss from
operations |
|
|
(26,057 |
) |
|
|
(22,214 |
) |
|
|
(52,728 |
) |
|
|
(41,143 |
) |
|
Interest and
other income, net |
|
|
189 |
|
|
|
1,042 |
|
|
|
654 |
|
|
|
1,962 |
|
|
Net
loss |
|
$ |
(25,868 |
) |
|
$ |
(21,172 |
) |
|
$ |
(52,074 |
) |
|
$ |
(39,181 |
) |
|
Net loss per
common share, basic and diluted |
|
$ |
(0.69 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.41 |
) |
|
$ |
(1.25 |
) |
|
Shares used
to compute for net loss per common share, basic and diluted |
|
|
37,256,247 |
|
|
|
33,582,844 |
|
|
|
37,027,405 |
|
|
|
31,273,696 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gritstone
Oncology, Inc. |
|
Condensed
Consolidated Balance Sheets |
|
(Unaudited) |
|
(In
thousands) |
|
|
|
|
|
|
|
June
30, |
|
December
31, |
|
|
|
|
|
|
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
$ |
62,631 |
|
|
$ |
57,408 |
|
|
Marketable securities |
|
|
|
|
|
|
29,282 |
|
|
|
70,368 |
|
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
2,584 |
|
|
|
3,497 |
|
|
Total
current assets |
|
|
|
|
|
|
94,497 |
|
|
|
131,273 |
|
|
Property and
equipment, net |
|
|
|
|
|
|
24,581 |
|
|
|
26,911 |
|
|
Operating
lease right-of-use assets |
|
|
|
|
|
|
23,909 |
|
|
|
23,427 |
|
|
Deposits and
other long-term assets |
|
|
|
|
|
|
2,679 |
|
|
|
2,778 |
|
|
Total
assets |
|
|
|
|
|
$ |
145,666 |
|
|
$ |
184,389 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
|
$ |
4,301 |
|
|
$ |
4,621 |
|
|
Accrued compensation |
|
|
|
|
|
|
3,765 |
|
|
|
4,598 |
|
|
Accrued liabilities |
|
|
|
|
|
|
138 |
|
|
|
1,041 |
|
|
Accrued research and development |
|
|
|
|
|
|
953 |
|
|
|
1,779 |
|
|
Lease liabilities, current portion |
|
|
|
|
|
|
4,240 |
|
|
|
2,505 |
|
|
Deferred revenue, current portion |
|
|
|
|
|
|
5,778 |
|
|
|
4,956 |
|
|
Total
current liabilities |
|
|
|
|
|
|
19,175 |
|
|
|
19,500 |
|
|
Other
non-current liabilities |
|
|
|
|
|
|
375 |
|
|
|
- |
|
|
Lease
liabilities, net of current portion |
|
|
|
|
|
|
22,258 |
|
|
|
20,985 |
|
|
Deferred
revenue, net of current portion |
|
|
|
|
|
|
7,630 |
|
|
|
9,560 |
|
|
Total
liabilities |
|
|
|
|
|
|
49,438 |
|
|
|
50,045 |
|
|
Commitments
and contingencies |
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
|
Convertible preferred stock |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
Common stock |
|
|
|
|
|
|
17 |
|
|
|
17 |
|
|
Additional paid-in capital |
|
|
|
|
|
|
369,223 |
|
|
|
355,291 |
|
|
Accumulated other comprehensive gain |
|
|
|
|
|
|
50 |
|
|
|
24 |
|
|
Accumulated deficit |
|
|
|
|
|
|
(273,062 |
) |
|
|
(220,988 |
) |
|
Total
stockholders' equity |
|
|
|
|
|
|
96,228 |
|
|
|
134,344 |
|
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
$ |
145,666 |
|
|
$ |
184,389 |
|
|
|
|
|
|
|
|
|
|
|
|
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