SOUTH SAN FRANCISCO, Calif.,
Nov. 15, 2021 /PRNewswire/
-- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a synthetic
lethality focused precision medicine oncology company committed to
the discovery and development of targeted therapeutics, provided a
business update and announced financial results for the third
quarter ended September 30, 2021.
![IDEAYA_Logo IDEAYA_Logo](https://mma.prnewswire.com/media/820568/IDEAYA_Logo.jpg)
"Early clinical data on our potential best-in-class Phase 1
MAT2A inhibitor, IDE397, in MTAP-deletion patients shows
preliminary signals of clinical activity, including pharmacodynamic
modulation and tumor shrinkage in multiple patients. In
addition, we selected a lead compound as a potential first-in-class
development candidate for IND-enabling studies for our PARG
synthetic lethality program and made progress towards our goal to
select a potential first-in-class development candidate with
GlaxoSmithKline for the Pol Theta Helicase program this year.
We are targeting to provide an update in the fourth quarter of 2021
for the Phase 2 clinical trial evaluating darovasertib and
crizotinib combination in metastatic uveal melanoma, including
clinical efficacy and guidance on timing for a potential
registration enabling trial," said Yujiro
S. Hata, Chief Executive Officer and President of IDEAYA
Biosciences.
Program Updates
Key highlights for IDEAYA's pipeline
programs include:
IDE397 (MAT2A)
IDEAYA is evaluating IDE397, a potent and selective small molecule
inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in
patients having solid tumors with methylthioadenosine
phosphorylase (MTAP) deletion, a patient population estimated
to represent approximately 15% of solid tumors. IDEAYA
is leading early clinical development of IDE397. Subject to
exercise of its option, GlaxoSmithKline (GSK) will lead later stage
global clinical development. Highlights:
- Actively enrolling patients into Cohort 5 of the Phase 1
clinical trial IDE397-001 (NCT04794699)
- Patients are being identified by next generation sequencing
(NGS) or by MTAP immunohistochemistry (IHC) assay with confirmatory
NGS
- Evaluating IDE397 in patients with MTAP deletion across
multiple solid tumor types, including non-small cell lung cancer,
pancreatic cancer, thymic cancer, adenoid cystic carcinoma and
gastroesophageal cancer
- IDE397 has been generally well tolerated, with observed
drug-related adverse events as of November
5, 2021 of only grade 1/2 drug-related adverse events; there
were no reported drug-related serious adverse events and no
reported myelosuppression or liver toxicity; IDE397 has yet to
reach its Maximum Tolerated Dose
- Observed preliminary signals of clinical activity in
MTAP-deletion patients in early dose escalation cohorts, including
plasma s-adenosyl methionine (SAM) pharmacodynamic (PD) modulation
in IDE397 dose escalation Cohorts 1 through 3, and tumor shrinkage
in multiple patients in early dose escalation Cohorts 2 and 3
- Subject to initiation of an expansion cohort or establishing a
maximum tolerated dose, or MTD, targeting submission of IDE397
option data package to GSK in the first half of 2022, which would
trigger an evaluation period for GSK to make an opt-in decision;
subject to GSK election to opt-in and HSR clearance, the company is
entitled to receive a $50 million
opt-in payment from GSK
- Targeting a clinical data update on IDE397, including plasma
SAM and tumor SAM and SDMA pharmacodynamic data and tolerability,
upon delivery of the option data package to GSK in the first half
of 2022
- Targeting clinical protocol amendment submission to the FDA by
year end 2021 to support monotherapy cohort expansions in the first
half of 2022 in NSCLC, esophagastric cancer, as well as squamous
and non-squamous basket cohorts, and to support potential taxane
combinations in NSCLC, esophagastric and/or pancreatic cancer
- Subject to satisfactory progression of the dose escalation
portion of the Phase 1 clinical trial, planning to enroll MTAP
deletion patients into monotherapy expansion cohorts in the first
half of 2022 with an aggregate of 150 or more patients across
expansion cohorts
- Observed preclinical in vivo efficacy of IDE397 in combination
with a taxane, showing enhanced TGI in pancreatic cancer PDX
models; evaluating additional potential IDE397 combination
strategies with therapeutics targeting DDR, selected co-alteration
targets, and selected MTAP-SL targets
PARG
IDEAYA is advancing preclinical research for an inhibitor of poly
(ADP-ribose) glycohydrolase (PARG) in patients having tumors with a
defined biomarker based on genetic mutations and/or molecular
signature. PARG is a novel target in the same
clinically validated biological pathway as poly (ADP-ribose)
polymerase (PARP). IDEAYA owns or controls all commercial
rights in its PARG program. Highlights:
- Identified a novel and proprietary HRD biomarker to guide
patient selection, with validation in vitro and in vivo in CDX
models across multiple solid tumor indications
- Demonstrated PARGi dose-dependent in vivo efficacy as
monotherapy with tumor regression or stasis in ovarian, gastric and
breast cancer CDX models
- Observed in vivo efficacy with enhanced TGI or tumor
regressions relative to niraparib, a PARPi, in multiple CDX models,
including in a niraparib-resistant CDX model
- Showed tumor regressions in multiple breast cancer PDX models
with defined genetic and subtyping profiles, including in niraparib
resistant PDX models
- Showed pharmacological inhibition of PARG in a panel of
homologous recombination deficient cell lines and in CDX and PDX
models; study data reported at AACR 2021
- Selected a potential development candidate PARG inhibitor and
initiating further toxicology studies; planning to initiate further
preclinical development studies, including IND-enabling studies of
the selected lead compound
Pol Theta
IDEAYA's DNA Polymerase Theta, (Pol Theta) program targets tumors
with BRCA or other homologous recombination deficiency, or HRD,
mutations. IDEAYA and GSK are collaborating on ongoing
preclinical research, including small molecules and protein
degraders, and GSK will lead clinical development for the Pol Theta
program. Highlights:
- Demonstrated in vivo efficacy with tumor regression in
BRCA2 -/- xenograft model with IDEAYA Pol Theta Helicase inhibitor
in combination with niraparib, a GSK PARP inhibitor; and
- Subject to further preclinical studies, IDEAYA is targeting
selection of a Pol Theta Helicase inhibitor development candidate
in December 2021
- Potential for up to $20 million
in aggregate milestone payments from GlaxoSmithKline for advancing
a Pol Theta Helicase inhibitor from preclinical to early Phase 1
clinical
Werner Helicase
IDEAYA is advancing preclinical research for an inhibitor targeting
Werner Helicase for tumors with high microsatellite instability
(MSI). IDEAYA and GSK are collaborating on ongoing preclinical
research, and GSK will lead clinical development for the Werner
Helicase program. Highlights:
- observed dose-dependent cellular viability effect and
dose-dependent cellular PD response in multiple endogenous MSI high
cell lines
- Demonstrated efficacy and PD response in relevant MSI high
in vivo models
- Potential for up to $20 million
in aggregate milestone payments from GlaxoSmithKline for advancing
a Werner Helicase inhibitor from preclinical to early Phase 1
clinical
Other Synthetic Lethality Pipeline Programs
IDEAYA is advancing additional preclinical research programs to
identify small molecule inhibitors for an MTAP-synthetic lethality
target, as well as for multiple potential first-in-class synthetic
lethality programs for patients with solid tumors characterized by
proprietary biomarkers or gene signatures.
Darovasertib (IDE196)
IDEAYA continues to execute on its clinical trial strategy to
evaluate darovasertib (IDE196), a potent and selective PKC
inhibitor.
IDEAYA is evaluating darovasertib in metastatic uveal melanoma
(MUM) as monotherapy and in combination therapies, including
combinations of darovasertib / binimetinib and independently,
darovasertib / crizotinib. The company is continuing to
enroll MUM patients into each of the combination arms of the Phase
1/2 clinical trial.
IDEAYA is targeting a clinical data update for darovasertib and
crizotinib combination in the fourth quarter of 2021, including
adverse event profile and clinical efficacy. IDEAYA is
planning to seek FDA regulatory guidance for potential
registration-enabling trial design to evaluate darovasertib and
crizotinib combination in MUM in the first half of 2022.
The company is continuing to evaluate darovasertib in patients
having non-MUM tumors harboring GNAQ or GNA11 activating mutations,
with a focus in skin and mucosal melanoma.
Darovasertib Monotherapy
IDEAYA has completed
enrollment into its ongoing Phase 1/2 clinical trial evaluating
darovasertib as monotherapy in MUM patients.
IDEAYA is coordinating with St. Vincent's Hospital Sydney
Limited to initiate an Investigator Sponsored Trial, or IST, to
evaluate IDE196 as monotherapy in a neo-adjuvant / adjuvant setting
in (non-metastatic) uveal melanoma (UM) patients. Data from this
clinical trial may offer proof of concept on our hypothesis that
earlier treatment of UM patients with IDE196, prior to tumor
metastasis, may lead to improved patient outcomes.
Darovasertib / Binimetinib Combination Therapy
IDEAYA
is continuing patient enrollment into the darovasertib /
binimetinib combination arm of the Phase 1/2 clinical trial under
the clinical trial collaboration and supply agreement with
Pfizer. Highlights:
- As of November 5, 2021, the
company has enrolled 32 MUM patients into the
darovasertib/binimetinib combination arm, and is continuing patient
enrollment in the dose expansion cohort of this combination
arm
Darovasertib / Crizotinib Combination Therapy
IDEAYA
is continuing patient enrollment into the darovasertib / crizotinib
combination arm of the Phase 1/2 clinical trial under the clinical
trial collaboration and supply agreement with Pfizer.
Highlights:
- As of November 5, 2021, the
company has enrolled 28 MUM patients into the
darovasertib/crizotinib combination arm, and is continuing patient
enrollment in the dose expansion cohort of this combination
arm
- Amended Pfizer clinical trial collaboration and supply
agreement to enable expansion for 40 additional patients on
darovasertib / crizotinib combination
- Observed preclinical synergies between darovasertib and
crizotinib in relevant cellular models under conditions simulating
a tumor microenvironment in the liver, the site of approximately
90% of uveal melanoma metastases; study data reported at AACR
2021
- Correlated cMET expression and activation to observed clinical
response based on a retrospective analysis of human clinical
biopsies from the Novartis darovasertib Phase 1 clinical trial,
supporting cMET expression / activation as potential combination
agent
Darovasertib – Other Potential Indications
IDEAYA is
evaluating the potential for darovasertib in GNAQ mutation-mediated
rare diseases, including Sturge-Weber Syndrome (SWS) and Port Wine
Stains (PWS), neurocutaneous disorders characterized by capillary
malformations and associated with mutations in GNAQ.
Highlights:
- Subject to FDA feedback and guidance, planning to initiate a
Phase 1 clinical trial to evaluate darovasertib in SWS and, subject
to further preclinical and clinical data, also in PWS patients with
extensive involvement
General
IDEAYA continues to monitor Covid-19 and its
potential impact on clinical trials and timing of clinical data
results. Initiation of clinical trial sites, patient
enrollment and ongoing monitoring of enrolled patients, including
obtaining patient computed tomography (CT) scans, may be impacted
for IDEAYA clinical trials evaluating IDE397 and darovasertib; the
specific impacts are currently uncertain.
Corporate Updates
IDEAYA's net losses were
$11.6 million and $10.9 million for the three months ended
September 30, 2021 and June 30, 2021, respectively. As of September 30, 2021, the company had an
accumulated deficit of $158.5
million.
As of September 30, 2021, IDEAYA
had cash, cash equivalents and marketable securities of
$385.8 million. IDEAYA believes
that its cash, cash equivalents and marketable securities will be
sufficient to fund its planned operations into 2025. These funds
will support the company's efforts through potential achievement of
multiple preclinical and clinical milestones across multiple
programs.
Our updated corporate presentation is available on our website,
at our Investor Relations page:
https://ir.ideayabio.com/.
Financial Results
As of September 30, 2021, IDEAYA had cash, cash
equivalents and short-term marketable securities totaling
$385.8 million. This compared to
cash, cash equivalents and short-term and long-term marketable
securities of $312.4 million at
June 30, 2021. The increase was
primarily due to $86.0 million in net
proceeds received during the three months ended September 30, 2021 from issuance of common stock
in an underwritten public offering on July
12, 2021, offset by cash used in operations and purchases of
property and equipment.
Collaboration revenue for the three months ended September 30, 2021 totaled $9.0 million compared to $8.8 million for the three months ended
June 30, 2021. Collaboration revenue
was recognized for the performance obligations satisfied through
September 30, 2021 under the GSK
Collaboration Agreement.
Research and development (R&D) expenses for the three months
ended September 30, 2021 totaled
$15.5 million compared to
$15.0 million for the three
months ended June 30, 2021. The
increase was primarily due to increases in fees to CROs and
external consultants, and higher compensation expenses.
General and administrative (G&A) expenses for the three
months ended September 30, 2021
totaled $5.2 million compared to
$4.8 million for the three
months ended June 30, 2021. The
increase was primarily due to increases in IT expenses, and legal
expenses.
The net loss for the three months ended September 30, 2021
was $11.6 million compared to $10.9 million for
the three months ended June 30, 2021.
Total stock compensation expense for the three months
ended September 30, 2021
was $2.2 million compared
to $2.1 million for the three months ended
June 30, 2021.
About IDEAYA Biosciences
IDEAYA is a synthetic
lethality focused precision medicine oncology company committed to
the discovery and development of targeted therapeutics for patient
populations selected using molecular diagnostics. IDEAYAs
approach integrates capabilities in identifying and validating
translational biomarkers with drug discovery to select patient
populations most likely to benefit from its targeted
therapies. IDEAYA is applying its research and drug discovery
capabilities to synthetic lethality – which represents an emerging
class of precision medicine targets.
Forward-Looking Statements
This press release contains
forward-looking statements, including, but not limited to,
statements related to (i) the extent to which IDEAYA's existing
cash, cash equivalents, and marketable securities will fund its
planned operations, (ii) the timing of and number of patients in
the cohort expansion in the IDE397 Phase 1 clinical trial, (iii)
the timing of the delivery of the GSK option data package, (iv) the
timing of a clinical data update for the darovasertib and
crizotinib combination, (v) the initiation of further PARG
inhibitor preclinical development studies, (vi) the timing of
identification of a development candidate for a Pol Theta
inhibitor, (vii) the timing of a clinical data update for the
IDE397 Phase 1 clinical trial, (viii) the timing of submission of a
clinical protocol amendment for the IDE397 Phase 1 clinical trial,
(ix) the timing of and related tumor types for cohort expansion in
the IDE397 Phase 1 clinical trial, (x) the potential receipt of GSK
milestone payments, (xi) the timing of obtaining FDA guidance for
potential registration-enabling trial design to evaluate the
darovasertib and crizotinib combination, (xii) the initiation of an
IST to evaluate ID196 in a neo-adjuvant / adjuvant setting, al
pathway, (xiii) the initiation of a Phase 1 clinical trial to
evaluate darovasertib in SWS and PWS, and (xiv) the impact of
COVID-19. Such forward-looking statements involve substantial risks
and uncertainties that could cause IDEAYA's preclinical 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 IDEAYA'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, IDEAYA's ability to successfully
establish, protect and defend its intellectual property, the
effects on IDEAYA's business of the worldwide COVID-19 pandemic,
and other matters that could affect the sufficiency of existing
cash to fund operations. IDEAYA 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 IDEAYA in general, see
IDEAYA's recent Quarterly Report on Form 10-Q filed on November 15, 2021 and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
IDEAYA
Biosciences, Inc.
Condensed
Statements of Operations and Comprehensive
Loss
(in thousands,
except share and per share amounts)
|
|
|
Three Months
Ended
|
|
|
Nine Months
Ended
|
|
|
|
September
30, 2021
|
|
|
June
30, 2021
|
|
|
September
30, 2021
|
|
|
September
30, 2020
|
|
Collaboration
revenue
|
|
$
|
8,976
|
|
|
$
|
8,756
|
|
|
$
|
24,979
|
|
|
$
|
8,967
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
15,503
|
|
|
|
14,979
|
|
|
|
42,048
|
|
|
|
27,647
|
|
General and
administrative
|
|
|
5,186
|
|
|
|
4,828
|
|
|
|
14,830
|
|
|
|
11,384
|
|
Total operating
expenses
|
|
|
20,689
|
|
|
|
19,807
|
|
|
|
56,878
|
|
|
|
39,031
|
|
Loss from
operations
|
|
|
(11,713)
|
|
|
|
(11,051)
|
|
|
|
(31,899)
|
|
|
|
(30,064)
|
|
Interest income and
other income (expense),
net
|
|
|
131
|
|
|
|
104
|
|
|
|
349
|
|
|
|
704
|
|
Net loss
|
|
$
|
(11,582)
|
|
|
$
|
(10,947)
|
|
|
$
|
(31,550)
|
|
|
$
|
(29,360)
|
|
Change in unrealized
gains (losses) on
marketable securities
|
|
|
(46)
|
|
|
|
(3)
|
|
|
|
(57)
|
|
|
|
(30)
|
|
Comprehensive
loss
|
|
$
|
(11,628)
|
|
|
$
|
(10,950)
|
|
|
$
|
(31,607)
|
|
|
$
|
(29,390)
|
|
Net loss per share
attributable to common
stockholders, basic and diluted
|
|
$
|
(0.31)
|
|
|
$
|
(0.33)
|
|
|
$
|
(0.92)
|
|
|
$
|
(1.26)
|
|
Weighted average
number of shares
outstanding, basic and diluted
|
|
|
37,681,205
|
|
|
|
32,854,926
|
|
|
|
34,157,578
|
|
|
|
23,235,218
|
|
IDEAYA
Biosciences, Inc.
Condensed Balance
Sheet Data
(in thousands)
|
|
|
September
30,
|
|
|
December
31,
|
|
|
|
2021
|
|
|
2020
|
|
Cash and cash
equivalents and short-term and long-term
marketable
securities
|
|
$
|
385,768
|
|
|
$
|
283,585
|
|
Total
assets
|
|
|
399,444
|
|
|
|
298,269
|
|
Total
liabilities
|
|
|
81,815
|
|
|
|
99,995
|
|
Total liabilities and
stockholders' equity
|
|
|
399,444
|
|
|
|
298,269
|
|
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SOURCE IDEAYA Biosciences, Inc.