- Strong balance sheet of ~$373.1
million cash, cash equivalents and marketable securities as
of December 31, 2022 is anticipated
to fund planned operations into 2026
- Planning regulatory update on potential registration-enabling
clinical trial for darovasertib / crizotinib combination in MUM
following scheduled FDA meeting in Q1 2023
- Targeting mid-year 2023 darovasertib / crizotinib clinical
efficacy update with approximately 20 first-line MUM patients,
including confirmed ORR and median PFS; program goals are >20%
confirmed ORR and >5 months median PFS
- Targeting interim clinical efficacy update from ongoing
investigator sponsored trial for darovasertib as neoadjuvant
therapy in UM in 2023
- On track for first-patient dosing of IDE161 in Q1 2023 in Phase
1/2 clinical trial for patients having solid tumors with HRD
- Anticipating IND submission for Pol Theta Helicase DC in Q2
2023, in GSK-sponsored Phase 1/2 trial, and potential $7 million milestone upon IND-effectiveness
- Targeting selection of Werner Helicase DC in 2023 in
collaboration with GSK, with potential for $3 million milestone in connection with
IND-enabling studies
SOUTH
SAN FRANCISCO, Calif., March 7,
2023 /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 year ended December 31, 2022.
![(PRNewsfoto/IDEAYA Biosciences, Inc.) (PRNewsfoto/IDEAYA Biosciences, Inc.)](https://mma.prnewswire.com/media/820568/IDEAYA_Logo.jpg)
"We are excited about our maturing portfolio as we start 2023.
We now have three potential first-in-class clinical-stage programs
which are wholly owned or controlled – darovasertib (PKC) in late
Phase 2, IDE397 (MAT2A) in Phase 2 monotherapy expansion, and
IDE161 (PARG) in Phase 1 dose escalation. A fourth potential
first-in-class program, our Pol Theta Helicase development
candidate, is advancing into the clinic with IND submission planned
in the second quarter of 2023, and the Werner Helicase development
candidate nomination is targeted for this year, both in
collaboration with GSK. This diverse pipeline of precision medicine
therapeutics is unique among our peers and positions us as a leader
in precision medicine oncology," said Yujiro S. Hata, President and Chief Executive
Officer, IDEAYA Biosciences.
"We are developing darovasertib, our most-advanced clinical
program, with a strategy that could broadly impact ocular melanoma
– including as neoadjuvant monotherapy for primary uveal melanoma
with the goals of avoiding enucleation and/or preserving vision, as
adjuvant monotherapy after primary interventional treatment, and as
a first-line metastatic therapy in combination with crizotinib,"
said Dr. Darrin M. Beaupre, M.D.,
Ph.D., Senior Vice President and Chief Medical Officer of IDEAYA
Biosciences.
"We are also continuing to invest in our preclinical synthetic
lethality pipeline and platform capabilities, reflecting our
commitment to discover and develop transformative and potential
first-in-class precision medicine oncology therapies," added Dr.
Michael White, Ph.D., Senior Vice
President and Chief Scientific Officer of IDEAYA Biosciences.
IDEAYA is advancing darovasertib, its most advanced clinical
program, toward a potentially registrational Phase 2/3 clinical
trial. Darovasertib is a potential first-in-class small molecule
oral protein kinase C (PKC) inhibitor being developed for patients
having ocular melanoma, including metastatic uveal melanoma (MUM)
and primary uveal melanoma (UM).
The company is targeting a regulatory update on the potentially
registrational clinical trial design for darovasertib in
combination with crizotinib in MUM, following receipt of FDA
minutes from its meeting with the FDA, which is scheduled in the
first quarter of 2023. IDEAYA is enrolling additional first-line
(1L) MUM patients into its ongoing Phase 2 clinical trial
evaluating the darovasertib / crizotinib combination, and is
planning for a mid-year (second or third quarter) 2023 clinical
data update, including clinical efficacy (e.g., confirmed overall
response rate (ORR) and median progression free survival (PFS)).
The program objective is to observe a confirmed ORR of 20% or
greater and a mPFS of 5 months or greater, where historical
clinical efficacy reported in MUM have been an ORR of 0 to 5% and a
mPFS of 2 to 3 months.
In primary UM, IDEAYA is starting a company-sponsored Phase 2
clinical trial to evaluate darovasertib as a single-agent
neoadjuvant therapy prior to enucleation or radiation therapy and
as adjuvant therapy following such interventional treatment. IDEAYA
is targeting an interim clinical data update from the ongoing
investigator sponsored trial (IST) for darovasertib as neoadjuvant
therapy in UM in 2023.
The IDE397 clinical development strategy includes Phase 2
monotherapy expansion in select indications and a planned Phase 1/2
evaluation of IDE397 in combination with AMG193, the Amgen
investigational MTA-cooperative PRMT5. The IDEAYA-sponsored Phase 2
clinical trial is evaluating IDE397 as monotherapy in a basket of
MTAP-null Non-Small-Cell Lung Cancer (NSCLC), Esophagogastric
Cancer and Bladder Cancer.
IDEAYA is collaborating with Amgen on a planned Amgen-sponsored
Phase 1/2 clinical trial to evaluate the IDE397 / AMG 193
combination in patients having solid tumors with MTAP deletion. The
company is prioritizing the AMG 193 clinical combination and at
this time is discontinuing enrollment into the IDE397-001 clinical
trial cohorts evaluating IDE397 and chemotherapy combinations. This
approach is based on favorable preclinical combination efficacy and
tolerability data observed with the IDE397 / AMG 193 combination,
and on the proposed target enrollment and budget for the planned
global clinical trial pursuant to the Amgen Clinical Trial
Collaboration and Supply Agreement (Amgen CTCSA). Pursuant to the
Amgen CTCSA, Amgen is the sponsor of the IDE397 / AMG 193
combination study and will execute the clinical trial. Amgen will
supply AMG 193, IDEAYA will supply IDE397 and each party will pay
for fifty percent (50%) of the external third-party costs of the
IDE397 / AMG 193 combination study.
IDEAYA's clinical pipeline also includes IDE161, a potential
first-in-class Phase 1/2 PARG inhibitor, for patients having tumors
with HRD, including BRCA1/2-mutant breast and ovarian cancers. The
IDE161 monotherapy clinical focus will include ER+ / Her2- breast
cancer with HRD, representing approximately 10% to 14% of breast
cancer. The company is targeting first-patient-dosing of IDE161 in
the first quarter of 2023.
The company's preclinical pipeline includes several potential
first-in-class synthetic lethal therapeutics advancing toward the
clinic. IDEAYA is, in collaboration with GSK, targeting an IND
submission in the second quarter of 2023 for a GSK-sponsored Phase
1/2 clinical trial to evaluate its Pol Theta Helicase inhibitor
development candidate (DC) in combination with niraparib for
patients having tumors with HRD. The Werner Helicase program
continues in collaboration with GSK toward a development candidate
nomination in 2023.
Program Updates
Key highlights for IDEAYA's pipeline
programs include:
Darovasertib (PKC)
IDEAYA continues to advance its Phase 2 clinical trials evaluating
darovasertib (IDE196), a potent and selective PKC inhibitor. The
company is pursuing a clinical strategy for darovasertib to broadly
address ocular melanoma, including in combination with crizotinib,
a cMET inhibitor, in metastatic uveal melanoma (MUM) in a Phase 2
clinical trial, IDE196-001 (NCT03947385) and as neoadjuvant /
adjuvant monotherapy in primary UM in a company-sponsored Phase 2
clinical trial, IDE196-009, and, separately, through an
investigator sponsor clinical trial (IST).
IDEAYA owns or control all commercial rights in its darovasertib
program, including in MUM and in primary UM, subject to certain
economic obligations pursuant to its exclusive, worldwide license
to darovasertib with Novartis.
Darovasertib / Crizotinib Combination Therapy in Metastatic
Uveal Melanoma (MUM)
IDEAYA is continuing patient enrollment
into the darovasertib / crizotinib combination arm of the Phase 2
clinical trial in MUM under clinical trial collaboration and supply
agreements with Pfizer, with continued emphasis on enrollment of
first-line MUM patients. Highlights:
- Planning regulatory update on potential registration-enabling
clinical trial for darovasertib + crizotinib in MUM following
scheduled FDA meeting in Q1 2023;
- Potential registration-enabling trial for the darovasertib and
crizotinib combination in MUM will be sponsored by IDEAYA, subject
to FDA feedback and guidance, in collaboration with Pfizer under a
clinical collaboration and supply agreement;
- Targeting mid-year (second or third quarter) 2023 clinical data
update with approximately 20 first-line MUM patients, including
clinical efficacy (e.g., ORR, PFS), for the ongoing Phase 2
clinical trial evaluating the darovasertib and crizotinib
combination in MUM;
- IDEAYA presented interim Phase 2 darovasertib and crizotinib
clinical combination data in September
2022. The reported data, based on an unlocked database with
a data analyses cutoff date of June 26,
2022, showed robust clinical activity. These
investigator-reviewed data by RECIST 1.1 include, as of the data
analysis cutoff date:
-
- 89% of patients show tumor shrinkage in Any-Line MUM: 31 of 35
evaluable patients showed tumor shrinkage as determined by target
lesion size reduction;
- 83% Disease Control Rate (DCR) in Any-Line MUM: 29 of 35
evaluable patients showed stable disease or better as determined by
target lesion size reduction;
- 50% Overall Response Rate (ORR) in First-Line MUM: 4 of 8
evaluable patients had a confirmed partial response;
- 31% Overall Response Rate (ORR) in Any-Line MUM: 11 of 35
evaluable patients had a confirmed partial response;
- 43% of patients with >30% Tumor Reduction in Any-Line MUM:
15 of 35 evaluable patients observed partial responses with >30%
tumor reduction, including 11 confirmed and 4 unconfirmed partial
responses;
- Median Study Follow-Up of 6.5 months for First-Line MUM
patients and 7.8 months for Any-Line MUM patients;
- Median Duration of Response (DOR) in evaluable First-Line MUM
patients has not yet been reached and 4 of 4 patients with
confirmed PR's in First-Line MUM remain in response; median DOR in
evaluable Any-Line MUM patients has not yet been reached and 7 of
11 patients with confirmed PR's in Any-Line MUM remain in
response;
- Median Progression Free Survival (PFS) in First-Line MUM
patients has not yet been reached and is >5 months in evaluable
First-Line MUM patients; median PFS for evaluable Any-Line MUM
patients is ~5 months; and
- The darovasertib and crizotinib combination therapy has
indicated a manageable adverse event profile in MUM patients (n=37)
at the combination expansion doses, with a low rate of drug-related
serious adverse events (SAEs) and with no Grade 4 or Grade 5
drug-related adverse events observed as of the data analysis cutoff
date of June 26, 2022;
- In November, 2022, the U.S. FDA granted Fast Track designation
for evaluation of darovasertib in combination with crizotinib in
adult patients being treated for MUM. Under the Fast Track
designation, the darovasertib / crizotinib development program in
MUM is eligible for various expedited regulatory review processes,
including generally more frequent FDA interactions (e.g., meetings,
written communications), potential eligibility for rolling review
of a New Drug Application (NDA) and potential accelerated approval
and priority review of an NDA; and
- In April 2022, the U.S. FDA
designated darovasertib as an Orphan Drug in Uveal Melanoma,
including MUM. Under an Orphan Drug designation, IDEAYA may be
entitled to certain tax credits, exemption from user fees, and
subject to FDA approval of a marketing application for darovasertib
as a designated orphan-drug product, seven years of statutory
marketing exclusivity.
Darovasertib – Neoadjuvant / Adjuvant Uveal Melanoma
(UM)
IDEAYA is evaluating the potential for darovasertib in
neoadjuvant and/or adjuvant uveal melanoma. Highlights:
- Reported preliminary clinical proof-of-concept data in
September 2022 with observed clinical
activity supporting potential darovasertib use in the neoadjuvant
uveal melanoma setting. As of a data cut-off date of August 19, 2022, these data include observed
reductions in tumor size based on ultrasound, PET or MRI by
investigator review of primary ocular lesions in 5 of 5 (100%) UM
or MUM patients treated as monotherapy or in combination with
crizotinib and observed improvement in visual symptoms in the
affected eye in two MUM patients having intact primary tumors;
- Initiating a company-sponsored Phase 2 clinical trial to
evaluate darovasertib as a single-agent neoadjuvant therapy prior
to enucleation or radiation therapy and as adjuvant therapy
following such interventional treatment;
- In the neoadjuvant setting, the Phase 2 clinical trial includes
a first cohort of UM patients with large tumors who would, without
neoadjuvant treatment, otherwise undergo enucleation as a primary
interventional treatment, and a second cohort of UM patients with
small or medium tumors who would otherwise undergo radiation
therapy, such as plaque brachytherapy;
- Each of the neoadjuvant cohorts will be treated with
darovasertib prior to a primary interventional treatment until
maximum benefit or six months, at which time they will undergo a
primary interventional treatment. Neoadjuvant endpoints for the
small- or medium-sized tumor cohort include (i) reducing the
radiation dose that the patient received, relative to the radiation
dose they would have otherwise received without the neoadjuvant
treatment, and (ii) functional vison preservation;
- In the adjuvant setting of the Phase 2 clinical trial, each of
the two neoadjuvant cohorts will be treated with darovasterib after
the primary interventional treatment for up to six months as
follow-up adjuvant therapy. Adjuvant endpoints for this portion of
the clinical trial include relapse free survival and useful
vision;
- Supporting evaluation of darovasertib as neoadjuvant / adjuvant
therapy in primary UM in an ongoing investigator-sponsored clinical
trial, or IST, captioned as "Neoadjuvant / Adjuvant trial of
Darovasertib in Ocular Melanoma" (NADOM) led by St. Vincent's
Hospital in Sydney with
participation of Alfred Health and the Royal Victorian Eye and Ear
Hospital in Melbourne; and
- Targeting an interim clinical data update from the ongoing IST
for darovasertib as neoadjuvant therapy in UM in 2023.
Darovasertib – Other Potential Indications
IDEAYA is
currently prioritizing neoadjuvant and adjuvant primary UM as an
expansion opportunity for darovasterib. The company has, however,
also considered and/or evaluated the potential for darovasertib in
other oncology indications, including (i) darovasertib in
combination with crizotinib in cMET-driven solid tumors such as HCC
or NSCLC, and (ii) darovasertib in combination with a KRAS
inhibitor in KRAS-driven solid tumors.
IDE397 (MAT2A)
IDEAYA is clinically 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 continuing clinical development of IDE397 in its
Phase 1/2 clinical trial, IDE397-001 (NCT04794699).
IDEAYA owns all right, title and interest in and to IDE397 and
the MAT2A program, including all worldwide commercial rights
thereto. Highlights:
- Patients are being identified by next generation sequencing
(NGS) or by MTAP immunohistochemistry (IHC) assay, with potential
confirmatory NGS;
- Focusing IDE397 clinical development strategy as monotherapy in
select indications and on IDE397 combination with AMG193, the
Amgen investigational MTA-cooperative PRMT5 inhibitor;
- Initiated and enrolling patients into monotherapy expansion
cohorts, with a focus on squamous cell NSCLC, esophagogastric
cancer, and bladder cancer, consistent with preclinical efficacy
and translational data; continuing to enroll patients in parallel
into the monotherapy dose escalation portion of the clinical trial
with a goal to determine the dose limiting toxicity, or DLT;
advanced combination dose escalation cohorts for combinations of
IDE397 with chemotherapy agents, including pemetrexed and
taxanes;
- Collaborating on planned Amgen-sponsored Phase 1/2 clinical
trial to evaluate IDE397 in combination with AMG 193, the Amgen
investigational MTA-cooperative PRMT5 inhibitor, in patients having
solid tumors with MTAP deletion, pursuant to a Clinical Trial
Collaboration and Supply Agreement with Amgen (Amgen CTCSA). The
combination of IDE397 with AMG 193 is a novel and potential
first-in-class synthetic lethality combination which targets two
distinct and mechanistically complementary nodes of the MTAP
methylation pathway – MAT2A and PRMT5, providing a complementary
approach for targeting MTAP-deletion tumors. The company is
prioritizing the AMG 193 clinical combination, and at this time is
discontinuing enrollment into the IDE397-001 clinical trial cohorts
evaluating IDE397 and chemotherapy combinations. This approach is
based on favorable preclinical combination efficacy and
tolerability data observed with the IDE397 / AMG 193 combination,
and on the proposed target enrollment and budget for the planned
global clinical trial pursuant to the Amgen CTCSA;
- Pursuant to the Amgen CTCSA entered into in July 2022, Amgen is the sponsor of the IDE397 /
AMG 193 combination study and will execute the clinical trial.
Amgen will provide AMG 193, IDEAYA will provide IDE397 and each
party will pay for fifty percent (50%) of the external third-party
costs of the IDE397 / AMG 193 combination study;
- In August 2022 GSK waived its
right to exercise its option to obtain an exclusive license to
further develop and commercialize IDE397, as well as other IDEAYA
compounds, if any, directly targeting MAT2A; and
- Demonstrated IDE397 clinical tumor pharmacodynamic modulation
based on ctDNA Molecular Responses observed in thirteen evaluable
patients with liquid biopsy samples available at baseline and after
first treatment cycle, including:
-
- 31% (n=4 of 13) of evaluable patients treated with IDE397
across all dose escalation Cohorts 1 thru 6 observed ctDNA
molecular responses;
- 75% (n=3 of 5) of evaluable patients treated with IDE397 at
higher doses in Cohorts 5 and 6 observed ctDNA molecular responses;
and
- 100% (n=2 of 2) of evaluable NSCLC patients observed ctDNA
molecular responses.
PARG
IDEAYA is clinically evaluating its poly (ADP-ribose)
glycohydrolase (PARG) inhibitor development candidate, IDE161, in a
Phase 1/2 clinical trial, IDE161-001, in patients having tumors
with a defined biomarker based on genetic mutations and/or
molecular signature. IDE161 is a potential first-in-class PARG
inhibitor development candidate for patients having tumors with
homologous recombination deficiencies (HRD), including BRCA1 and
BRCA2, and potentially other alterations, in solid tumors such as
breast cancer or ovarian cancer. 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 to IDE161 and its
PARG program, subject to certain economic obligations pursuant
to its exclusive, worldwide license with Cancer Research UK and
University of Manchester.
Highlights:
- An IND application for clinical evaluation of IDE161 in solid
tumors was submitted to and, in the fourth quarter of 2022, was
cleared by the U.S. FDA following completion of its safety
review;
- Initiating the Phase 1/2 clinical trial to evaluate IDE161, a
PARG inhibitor, for the treatment of patients having solid tumors
with homologous recombination deficiency (HRD), such as
BRCA1/2-mutant breast and ovarian cancer patients;
- IDEAYA plans to initiate dosing of a first patient in the Phase
1 dose escalation portion of this clinical trial in the first
quarter of 2023, with a planned initial starting dose of IDE161 in
the dose escalation of approximately one-half of the projected
human efficacious dose, based on preclinical studies; and
- Phase 1/2 clinical trial will evaluate IDE161 as monotherapy
with a clinical focus on a cohort of breast cancer patients having
tumors with HRD which are estrogen receptor positive (ER+) and
human epidermal growth factor receptor 2 negative (Her2-). This
patient population of ER+ / Her2- breast cancer with HRD represents
approximately 10% to 14% of breast cancer. The Phase 1/2 clinical
trial will also include a cohort of ovarian cancer patients having
tumors with HRD, and a basket cohort of other solid tumors with
HRD.
Pol Theta
IDEAYA's DNA Polymerase Theta, (Pol Theta) program targets tumors
with BRCA or other homologous recombination (HR) mutations or
homologous recombination deficiency (HRD). IDEAYA and GSK
collaborated on preclinical research and, following selection of
the development candidate, GSK will lead clinical development for
the Pol Theta program. Highlights:
- Selected a potential first-in-class Pol Theta Helicase
inhibitor development candidate (DC) in collaboration with
GSK;
- Observed tumor regressions in preclinical combination studies
of Pol Theta Helicase DC with niraparib in multiple in vivo PDX and
CDX HRD models;
- Targeting an IND submission, in collaboration with GSK, in the
second quarter of 2023 to evaluate Pol Theta Helicase inhibitor DC
combination with niraparib for patients having tumors with HRD;
and
- IDEAYA is eligible to receive total development and regulatory
milestones of up to $485 million
aggregate from GSK, with up to $20
million in aggregate for advancing a Pol Theta Helicase
inhibitor from preclinical to early Phase 1 clinical. These include
up to $10 million aggregate through
IND effectiveness, of which IDEAYA received a $3.0 million milestone payment for achievement of
the first preclinical development milestone in connection with
IND-enabling studies to support evaluation of Pol Theta Helicase
Inhibitor DC, and has the potential to receive up to an
additional $7.0 million for advancing
the Pol Theta Helicase Inhibitor DC through IND effectiveness.
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:
- Targeting selection of a Werner Helicase development candidate
in 2023, in collaboration with GSK, with potential for $3 million milestone in connection with
IND-enabling studies; and
- IDEAYA is eligible to receive future development and regulatory
milestones of up to $485 million
aggregate from GSK, with potential for up to $20 million in aggregate for advancing a Werner
Helicase inhibitor from preclinical to early Phase 1 clinical.
These include up to $10 million
aggregate through IND effectiveness – $3
million in connection with IND-enabling studies and up to an
additional $7 million through IND
effectiveness.
Other Synthetic Lethality Pipeline Programs
IDEAYA is advancing additional preclinical research programs to
identify small molecule inhibitors for next-generation, potential
first-in-class synthetic lethality programs for patients with solid
tumors characterized by proprietary biomarkers or gene
signatures.
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
$58.7 million and $49.8 million for the years ended December 31, 2022 and December 31, 2021, respectively. As of
December 31, 2022, the company had an
accumulated deficit of $235.4
million.
As of December 31, 2022, IDEAYA
had cash, cash equivalents and marketable securities of
$373.1 million. IDEAYA believes that
its cash, cash equivalents and marketable securities will be
sufficient to fund its planned operations into 2026. 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 December 31, 2022, IDEAYA
had cash, cash equivalents and short-term marketable securities
totaling $373.1 million. This
compared to cash, cash equivalents and short-term and long-term
marketable securities of $368.1
million as of December 31,
2021. The increase was attributable to receipt of aggregate
net proceeds of $86.1 million from
the sale of shares of IDEAYA common stock in an underwritten public
financing in September 2022 and net
proceeds of $8.8 million from the
sale of shares of IDEAYA common stock under an at-the-market
offering program during the year ended December 31, 2022, partially offset by cash used
in operations.
Collaboration revenue for the three months ended December 31, 2022 totaled $4.0 million compared to $3.0 million for the three months ended
December 31, 2021. Collaboration
revenue was recognized for the performance obligations satisfied
through December 31, 2022 under the
GSK Collaboration Agreement.
Research and development (R&D) expenses for the three months
ended December 31, 2022 totaled
$24.7 million compared to
$16.1 million for the three months
ended December 31, 2021. The increase
was primarily due to higher clinical trial, external research and
personnel-related expenses.
General and administrative (G&A) expenses for the three
months ended December 31, 2022
totaled $5.8 million compared to
$5.2 million for the three months
ended December 31, 2021. The increase
was primarily due to higher operational, consulting and
personnel-related expenses.
The net loss for the three months ended December 31, 2022 was $24.2 million compared to the net loss of
$18.2 million for the three months
ended December 31, 2021. Total stock
compensation expense for the three months ended December 31, 2022 was $3.0
million compared to $2.1
million for the same period in 2021.
The net loss for the year ended December
31, 2022 was $58.7 million
compared to $49.8 million for the
same period in 2021. Total stock compensation expense for the year
ended December 31, 2022 was
$11.6 million compared to
$8.2 million for the same period in
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. IDEAYA's 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 a
regulatory update for the darovasertib and crizotinib combination,
(iii) the timing and content of an efficacy update for the
darovasertib and crizotinib combination, (iv) timing of an interim
clinical efficacy update for the darovasertib IST as neoadjuvant
therapy in MUM, (v) the timing of first-patient dosing with PARG
inhibitor, IDE161, (vi) the timing of IND submission for Pol Theta
Helicase DC, (vii) the timing of selection of a development
candidate for a Werner Helicase inhibitor, (viii) the receipt of
development and regulatory milestones, (ix) the potential medical
impact of IDEAYA therapeutic products, (x) the clinical evaluation
of IDE397 in combination with AMG 193, and (xi) 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,
the ongoing military conflict between Russia and Ukraine, 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 Annual
Report on Form 10-K dated March 7,
2023 and any current and periodic reports filed with the
U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Paul Stone
Senior Vice President and Chief Financial Officer
investor@ideayabio.com
IDEAYA Biosciences, Inc.
|
Condensed Statements
of Operations and Comprehensive Loss
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
Year
Ended
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
Collaboration
revenue
|
|
$
|
4,022
|
|
|
$
|
2,963
|
|
|
$
|
50,931
|
|
|
$
|
27,941
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
24,714
|
|
|
|
16,109
|
|
|
|
89,536
|
|
|
|
58,158
|
|
General and
administrative
|
|
|
5,752
|
|
|
|
5,223
|
|
|
|
23,897
|
|
|
|
20,051
|
|
Total operating
expenses
|
|
|
30,466
|
|
|
|
21,332
|
|
|
|
113,433
|
|
|
|
78,209
|
|
Loss from
operations
|
|
|
(26,444)
|
|
|
|
(18,369)
|
|
|
|
(62,502)
|
|
|
|
(50,268)
|
|
Interest income and
other income, net
|
|
|
2,243
|
|
|
|
157
|
|
|
|
3,847
|
|
|
|
506
|
|
Net loss
|
|
|
(24,201)
|
|
|
|
(18,212)
|
|
|
|
(58,655)
|
|
|
|
(49,762)
|
|
Unrealized gains
(losses) on marketable securities
|
|
|
1,131
|
|
|
|
(662)
|
|
|
|
(2,159)
|
|
|
|
(719)
|
|
Comprehensive
loss
|
|
$
|
(23,070)
|
|
|
$
|
(18,874)
|
|
|
$
|
(60,814)
|
|
|
$
|
(50,481)
|
|
Net loss per share
attributable to common
stockholders, basic and diluted
|
|
$
|
(0.50)
|
|
|
$
|
(0.47)
|
|
|
$
|
(1.42)
|
|
|
$
|
(1.41)
|
|
Weighted-average number
of shares
outstanding, basic and diluted
|
|
|
48,132,003
|
|
|
|
38,501,335
|
|
|
|
41,444,696
|
|
|
|
35,252,443
|
|
IDEAYA Biosciences, Inc.
|
Condensed Balance
Sheet Data
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
|
|
(Unaudited)
|
|
Cash and cash
equivalents and short-term and
long-term marketable securities
|
|
$
|
373,146
|
|
|
$
|
368,063
|
|
Total assets
|
|
|
387,969
|
|
|
|
381,347
|
|
Total
liabilities
|
|
|
38,514
|
|
|
|
79,833
|
|
Total liabilities and
stockholders' equity
|
|
|
387,969
|
|
|
|
381,347
|
|
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SOURCE IDEAYA Biosciences, Inc.