- Strong balance sheet of $351.2
million of cash, cash equivalents and marketable securities
as of March 31, 2023 supplemented by
$188.7 million estimated net proceeds
from closing of underwritten public offering on April 27, 2023, anticipated to fund operations
into 2027
- Initiating Phase 2/3 registrational trial in Q2 2023 of
darovasertib and crizotinib combination in First-Line HLA-A2
negative MUM, with median PFS as primary endpoint for potential
accelerated approval
- Reported compelling darovasertib program Phase 2 clinical
efficacy, including in First-Line and Any-Line MUM, and additional
clinical efficacy as neoadjuvant therapy in primary UM
- Targeting darovasertib clinical program updates in H2 2023
- IDE397 Phase 2 monotherapy expansion international site
activation ongoing, including in Europe and Asia, to enhance patient enrollment in high
priority MTAP-deletion tumors
- Compelling preclinical efficacy data (AACR 2023) supports
anticipated clinical evaluation of IDE397 (MAT2A) and AMG 193
(PRMT5) combination targeting MTAP-deletion tumors
- Enrolled first cohort and accruing waitlist in Phase 1 trial
evaluating IDE161 in patients having solid tumors with HRD, with
planned strategic focus in ER+, Her2- breast cancer
- Anticipating IND submission for Pol Theta Helicase DC in Q2
2023 (potential $7 million milestone
from GSK upon IND-effectiveness) and selection of Werner Helicase
DC in 2023 (potential $3 million
milestone from GSK in connection with IND-enabling studies)
SOUTH
SAN FRANCISCO, Calif., May 9, 2023
/PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a
precision medicine oncology company committed to the discovery and
development of targeted therapeutics, provided a business update
and announced financial results for the first quarter ended
March 31, 2023.
"This has been a transformational quarter for IDEAYA, with our
lead clinical candidate, darovasertib, on-track to initiate a
potential accelerated approval trial in first-line MUM this
quarter, IDE397 in Phase 2 with ongoing international site
activation to accelerate monotherapy expansion and compelling
preclinical combination efficacy presented at AACR with Amgen's AMG
193 for treating MTAP-deletion solid tumors, and IDE161 first
cohort enrolled in HRD solid tumors. Our preclinical pipeline
and platform also continue to deliver potential first-in-class
breakthrough therapies, including a Pol Theta Helicase IND targeted
for this quarter and our Werner Helicase inhibitor development
candidate nomination on track for this year," said Yujiro S. Hata, Chief Executive Officer, IDEAYA
Biosciences."
"We observed compelling Phase 2 clinical efficacy of the
darovasertib and crizotinib combination in First-Line, Any-Line and
Hepatic-Only MUM, and encouraging clinical efficacy for
darovasertib as a neoadjuvant therapy in primary uveal melanoma
(UM), including one neoadjuvant UM patient who experienced an ~80%
ocular tumor shrinkage after 4 months of treatment and was able to
avoid enucleation, and an additional neoadjuvant UM patient on
darovasertib that experienced a partial response after only one
month of treatment. We are excited to launch the
registrational trial in First-Line HLA-A2(-) MUM this quarter, with
the opportunity to address a high unmet medical need. We look
forward to sharing an additional clinical program update for
darovasertib in 2023," said Dr. Darrin M.
Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA
Biosciences.
IDEAYA is advancing darovasertib, its protein kinase C, or PKC,
inhibitor, with a clinical strategy to broadly address uveal
melanoma –in both primary and metastatic disease settings.
The company reported updated clinical data from the ongoing Phase 2
expansion cohort evaluating darovasertib and crizotinib in
MUM. These data demonstrated robust clinical efficacy in
first-line MUM patients (e.g., 45% ORR, 90% DCR, 7 months median
PFS) with a manageable safety profile and support the Company's
plan to initiate a potential registration-enabling Phase 2/3
clinical trial to evaluate the darovasertib and crizotinib
combination in first-line HLA-A2(-) MUM in Q2 2023. As an
independent clinical strategy, IDEAYA is also planning to enroll
additional HLA-A2(+) patients in its ongoing Phase 2 clinical trial
to address the HLA-A2(+) patient population in MUM.
IDEAYA reported clinical proof-of-concept (PoC) data for use of
darovasertib as neoadjuvant therapy in primary, non-metastatic UM
patients. These data (e.g., ocular tumor shrinkage in 6 of 6
patients) showed evidence of anti-tumor activity and support
further clinical evaluation of darovasertib to determine its
potential as a neoadjuvant and/or adjuvant therapy.
The company is planning to provide updates in the second half of
2023 on the darovasertib clinical program.
IDEAYA is collaborating with Amgen to evaluate IDE397, its
methionine adenosyltransferase 2a, or MAT2A, inhibitor, in
combination with AMG 193, the Amgen investigational MTA-cooperative
PRMT5 inhibitor, in patients having tumors with methylthioadenosine
phosphorylase, or MTAP, gene deletion. IDEAYA is separately
evaluating IDE397 in Phase 2 monotherapy expansion cohorts with
ongoing international clinical site activation, including in
Europe and Asia to enhance patient enrollment in high
priority MTAP-deletion tumors, and in Phase 1 monotherapy dose
escalation cohorts in patients having tumors with MTAP
deletion.
IDE161, the Company's poly (ADP-ribose) glycohydrolase, or PARG,
inhibitor, is being evaluated in a Phase 1/2 clinical trial in
patients having tumors with homologous recombination deficiency, or
HRD. IDEAYA has enrolled its first cohort of patients into
the dose escalation portion of the clinical trial and is accruing
patients on a waitlist for subsequent cohorts. The company is
planning for expansion cohorts in ER+, Her2- HRD breast cancer
patients, HRD ovarian cancer patients and other HRD solid
tumors.
The company's preclinical pipeline includes several potential
first-in-class synthetic lethal therapeutics advancing toward the
clinic. GSK is targeting an IND submission in the second quarter of
2023 for a GSK-sponsored Phase 1/2 clinical trial to evaluate the
IDEAYA/GSK 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 Inhibitor in Tumors with GNAQ or GNA11
Mutations
Darovasertib is a potent, selective inhibitor of PKC which the
company is developing for genetically defined cancers having GNAQ
or GNA11 gene mutations. PKC is a protein kinase that functions
downstream of the GTPases GNAQ and GNA11. IDEAYA is pursuing a
clinical strategy for darovasertib to broadly address uveal
melanoma, alternatively referred to as ocular melanoma, in both
primary and metastatic disease.
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
IDEAYA reported data from its ongoing Phase 2 clinical trial,
designated as IDE196-001, demonstrating compelling clinical
efficacy of the darovasertib and crizotinib combination therapy in
first-line and any-line MUM patients. The company is planning
to initiate a potential registration-enabling Phase 2/3 clinical
trial to evaluate the darovasertib and crizotinib combination in
first-line HLA-A2(-) MUM. Highlights:
- Reported updated clinical data, including a safety and clinical
efficacy profile, from the Phase 2 expansion cohort evaluating
darovasertib and crizotinib in MUM. Reported data are based
on 20 evaluable first-line and 63 evaluable any-line patients
enrolled as of September 22, 2022 in
the darovasertib and crizotinib combination study at the expansion
dose of 300 mg twice-a-day darovasertib and 200 mg twice-a-day
crizotinib. Reported data are preliminary and based on investigator
review from an unlocked database as of the data analyses cutoff
date of March 8, 2023:
-
- Evaluable patients had a significant disease burden and were
heavily pre-treated: baseline LDH was greater than the upper limit
of normal in 60% of any-line and 50% of first-line patients; the
largest metastatic lesion greater than 3.0 cm in 65% of any-line
and 60% of first-line patients, and greater than 8.0 cm in 10% of
any-line and 15% of first-line patients; patient metastases
included both hepatic and extrahepatic loci in 64% of any-line and
50% of first-line patients; among any-line patients, 68% had
received one or more prior lines of therapy and 43% had received
two or more prior lines of therapy.
- In 20 evaluable first-line MUM patients at the expansion dose,
the investigator-reviewed data by RECIST 1.1 included: (i) 45%
overall response rate, or ORR, in first-line MUM: nine of 20
evaluable patients had a confirmed partial response, or PR; (ii)
90% disease control rate, or DCR, in first-line MUM: 18 of 20
evaluable patients showed disease control, including nine confirmed
PRs, one unconfirmed PR and eight stable disease; and (iii)
approximately seven months median progression free survival, or PFS
in first-line MUM.
- In 63 evaluable any-line MUM patients at the expansion dose,
the investigator-reviewed data by RECIST 1.1 included: (i) 30% ORR
in any-line MUM: 19 of 63 evaluable patients had a confirmed PR;
(ii) 87% DCR in any-line MUM: 55 of 63 evaluable patients showed
disease control, including 19 confirmed PRs, four unconfirmed PRs
and 2 stable disease; and (iii) approximately seven months
median PFS in any-line MUM. Notably, the observed median PFS was
enhanced from the median PFS of approximately five months as
previously reported in September 2022
based on 35 evaluable any-line MUM patients.
- In a subset of 20 evaluable hepatic-only MUM patients,
including first-line and pre-treated patients with only hepatic
metastases, for whom the investigator-reviewed data by RECIST 1.1
included: (i) 35% ORR in hepatic-only MUM: seven of 20 evaluable
patients had a confirmed PR; (ii) 100% DCR in hepatic-only MUM: 20
of 20 evaluable patients showed disease control, including seven
confirmed PRs, one unconfirmed PR and 12 stable disease; and (iii)
~11 months median PFS in hepatic-only MUM. The reported Phase 2
data demonstrate clinical efficacy in both hepatic and well as
extra-hepatic metastases.
- Observed clinical efficacy irrespective of HLA-A2 status,
including in HLA-A2(-) and HLA-A2(+) serotypes.
- The darovasertib and crizotinib combination therapy continues
to demonstrate a manageable adverse event profile in MUM patients
(n=68) at the combination expansion doses, with a low rate of
drug-related serious adverse events (SAEs), and a low rate of
patients who discontinued treatment with either darovasertib or
crizotinib due to a drug-related adverse event.
Darovasertib—Potential Registration-Enabling Clinical Trial
in First-Line HLA-A2*02:01 MUM
IDEAYA is planning to initiate a potential registration-enabling
Phase 2/3 clinical trial to evaluate darovasertib and crizotinib as
a combination therapy in MUM. The protocol of the Phase 2/3
clinical trial design incorporates guidance and feedback following
a Type C meeting with the FDA in March
2023. Highlights:
- Design: Integrated Phase 2/3 open-label study-in-study in
first-line, or 1L, MUM patients with an HLA-A(-)serotype; median
PFS as Phase 2 primary endpoint for potential accelerated approval;
patients enrolled in Phase 2 will continue on treatment within the
same study and will be considered, together with additional
enrolled patients, to support overall survival, or OS as Phase 3
primary endpoint for potential approval.
- Phase 2: ~230 patients total, of which ~200 patients will be
randomized on a 2:1 basis for treatment with the darovasertib and
crizotinib combination in the treatment arm or investigators choice
in the control arm, selected from a combination of ipilimumab (ipi)
and nivolumab (nivo), PD1-targeted monotherapy or dacarbazine, and
of which ~30 will support a nested study to confirm the move
forward combination dose for the integrated Phase 2/3 clinical
trial; potential accelerated approval based on Phase 2 median PFS
by blinded independent central review, or BICR, as a primary
endpoint.
- Phase 3: ~120 additional patients with 2:1 randomization on the
same basis as Phase 2, supplementing the ~200 patients enrolled in
the Phase 2 and continuing on treatment at the selected
treatment dose, to support data analysis for Phase 3 efficacy;
potential approval based on Phase 3 median OS by BICR as a primary
endpoint.
Darovasertib as Neoadjuvant / Adjuvant Therapy in Primary
Uveal Melanoma
IDEAYA is clinically evaluating the potential for darovasertib
as neoadjuvant and/or adjuvant therapy, or (neo)adjuvant therapy,
in primary, non-metastatic UM patients.
Preliminary clinical data in the neoadjuvant setting show
evidence of anti-tumor activity and support further clinical
evaluation of darovasertib to determine its potential as a
neoadjuvant therapy or an adjuvant therapy. Clinical
objectives as neoadjuvant therapy are to save the eye by avoiding
enucleation and/or to reduce the tumor thickness in the eye,
enabling treatment with less radiation to preserve vision. As
an adjuvant therapy, a clinical goal is to potentially extend
relapse free survival. Highlights:
- Reported additional clinical data demonstrating clinical
activity for darovasertib as neoadjuvant therapy in primary UM,
including tumor shrinkage in ocular tumor lesions. Data was
reported from an ongoing IST evaluating darovasertib in
(neo)adjuvant primary UM, from a compassionate use protocol in
neoadjuvant UM and from patients having an ocular tumor lesion
during their course of treatment in the Phase 1 and Phase 1/2
clinical trial evaluating darovasertib as monotherapy or in
combination with crizotinib in MUM.
- Ocular tumor shrinkage was measured by various methods,
including MRI, ultrasound, CT-scan or PET scan, with best tumor
response measurement based on maximal percent reduction in measured
apical height or Longest Basal Diameter. The reported
investigator-reviewed data included:
-
- Observed tumor shrinkage of primary ocular lesions in nine of
nine (100%) UM or MUM patients treated as monotherapy or in
combination with crizotinib, including in six of six primary UM
patients treated with darovasertib (n=5) or in combination with
crizotinib (n=1) as neoadjuvant therapy.
- One neoadjuvant UM patient observed 31% ocular tumor shrinkage,
reflecting a partial response at one month of treatment with
darovasertib.
- Another neoadjuvant UM patient observed ~80% ocular tumor
shrinkage after four months of treatment with the darovasertib and
crizotinib combination under a compassionate use protocol.
- In the compassionate use case, a primary UM patient who was
already blind in one eye from vascular disease developed a large
uveal melanoma lesion in his other eye with an associated cataract.
The patient sought neoadjuvant treatment under a compassionate use
protocol with a goal to avoid enucleation and potentially preserve
vision in the affected eye. The patient, who remains on therapy as
of April 20, 2023, was treated with
the darovasertib and crizotinib combination. The reported
investigator-reviewed data included:
-
- The preliminary clinical data showed prompt responsiveness to
treatment, including an observed progressive tumor shrinkage over
each month of treatment—namely, ~30% after one month, ~50% after
two months and ~70% after three months, and ~80% ocular tumor
shrinkage after four months of treatment, in each case determined
by measurement of apical height.
- Ocular lesion size after one month of treatment was
sufficiently reduced to approach the threshold for radiation
therapy (e.g. plaque brachytherapy).
- Avoided enucleation of the patient's affected eye having the
uveal melanoma, which reflects an initial case, and the company
believes is a first-reported case of systemic neoadjuvant therapy
resulting in eye preservation by avoiding enucleation.
- Restored normal vision of the patients affected eye following
the course of neoadjuvant treatment and treatment of the associated
cataract, with a reported post-treatment vision score of 6/5
(measurement in meters: 6/6 m = 20/20 ft), reflecting a >20 fold
improvement in vision, resulting in eye preservation by avoiding
enucleation.
- IDEAYA initiated a company-sponsored Phase 2 clinical trial
designated as IDE196-009 to evaluate darovasertib as neoadjuvant
treatment of UM prior to primary interventional treatment of
enucleation or radiation therapy, and also as adjuvant therapy
following the primary treatment. The clinical protocol includes
neoadjuvant treatment with darovasertib to maximum benefit up to
six months, primary treatment, then up to six months of follow-up
adjuvant therapy.
-
- Neoadjuvant – Enucleation Cohort: UM patients with large tumors
will be treated with darovasertib until maximum benefit or six
months, at which time they will undergo a primary interventional
treatment. The neoadjuvant endpoint for this large-sized tumor
cohort is eye preservation. For example, a patient who would
otherwise have undergone enucleation would instead be eligible for
radiation treatment.
- Neoadjuvant – Radiation (e.g., Brachytherapy) Cohort: UM
patients with small or medium tumors will be treated with
darovasertib until maximum benefit or six months, at which time
they will undergo radiation therapy. The neoadjuvant
endpoints for this small or medium-sized tumor cohort include (i)
reducing the radiation dose that the patient receives, relative to
the radiation dose they would have otherwise received without the
neoadjuvant treatment and (ii) functional vison preservation.
- Adjuvant – In the adjuvant setting, each of the two neoadjuvant
cohorts will be treated with darovasertib for up to six months as
follow-up adjuvant therapy after the primary interventional
treatment. The adjuvant endpoints for this portion of the clinical
trial include relapse free survival and useful vision.
- IDEAYA is additionally supporting evaluation of darovasertib as
(neo)adjuvant therapy in primary UM in an ongoing IST captioned as
"Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma"
(NADOM) and led by St. Vincent's Hospital in Sydney with the participation of Alfred Health
and the Royal Victorian Eye and Ear Hospital in Melbourne.
Darovasertib—Strategy for HLA-A2*02:01 Positive MUM
Based on preliminary analyses of darovasertib clinical data from
the monotherapy and combination arms of the clinical trial, and
based on the darovasertib mechanism of action, darovasertib
clinical activity is independent of Human Leukocyte Antigen, or
HLA, serotype in UM, MUM and other GNAQ/11-mutation cancers.
Accordingly, IDEAYA is planning its clinical strategy to
separately address MUM patients with an HLA-A*02:01 positive
serotype. The company is planning to enroll additional HLA-A2(+)
patients into its ongoing Phase 2 clinical trial evaluating the
darovasertib and crizotinib combination treatment. Clinical
efficacy data from the subset of HLA-A2(+) patients in this Phase 2
clinical trial could support publication and potential inclusion in
NCCN Clinical Practice Guidelines in Oncology.
Darovasertib Orphan Drug Designation in UM and Fast Track
Designation in MUM
In April 2022, the FDA designated
darovasertib as an Orphan Drug in UM, including primary and
metastatic disease under 21 C.F.R Part 316. Under an Orphan Drug
designation, darovasertib may be entitled to certain tax credits
for qualifying clinical trial expenses, exemption from certain user
fees and, subject to FDA approval of a new drug application, or
NDA, for darovasertib in UM, seven years of statutory marketing
exclusivity. As an FDA-designated Orphan Drug, darovasertib may
also be excluded from certain mandatory price negotiation
provisions of the 2022 Inflation Reduction Act.
In November 2022, the FDA granted
Fast Track designation to IDEAYA's development program
investigating darovasertib in combination with crizotinib in adult
patients being treated for MUM. The Fast Track designation makes
IDEAYA's darovasertib and crizotinib development program eligible
for various expedited regulatory review processes, including
generally more frequent FDA interactions, such as meetings and
written communications, potential eligibility for rolling review of
a future NDA and potential accelerated approval and priority review
of an NDA.
IDE397—MAT2A Inhibitor in Tumors with MTAP Deletion
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).
The IDE397 clinical development strategy is focused as
monotherapy in select indications and on the IDE397 combination
with AMG193, the Amgen investigational MTA-cooperative PRMT5
inhibitor.
IDEAYA owns all right, title and interest in and to IDE397 and
the MAT2A program, including all worldwide commercial rights
thereto. Highlights:
- 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.
- International site activation ongoing in support of monotherapy
expansion, including in Europe and
Asia, to enhance patient
enrollment in high priority MTAP-deletion tumors
- Data from preclinical efficacy studies completed in
collaboration with Amgen support clinical evaluation of IDE397 in
combination with AMG 193, the Amgen investigational MTA-cooperative
PRMT5 inhibitor, in patients having solid tumors with MTAP
deletion. Clinical investigation of the IDE397 and AMG 193
combination is anticipated to be conducted under an Amgen-sponsored
clinical trial pursuant to a Clinical Trial Collaboration and
Supply Agreement with Amgen (Amgen CTCSA).
- Presented preclinical efficacy data and supporting data at the
2023 Annual Meeting of the American Association for Cancer
Research, or AACR 2023:
-
- Preclinical data for the IDE397 and AMG 193 combination in a
NSCLC MTAP-null CDX model showed complete responses following
approximately 30 days of combination treatment, at doses below the
maximally efficacious preclinical dose for each of IDE397 and AMG
193. The complete responses were durable from approximately
study-day 40 to study-day 100. The IDE397 and AMG 193 combination
was well tolerated, with no observed body weight loss through the
approximate 30 days of combination treatment.
- Preclinical efficacy data at AACR 2023 showing deep and durable
anti-tumor efficacy and PD responses for IDE397 in combination with
representative MTA-cooperative PRMT5 inhibitors in NSCLC MTAP-null
CDX models, and for one representative compound, also in a
pancreatic MTAP-null CDX model.
- Results of gene expression analysis of hallmark pathways,
alternative splicing analysis and retained intron analysis
collectively demonstrate that combined pharmacological inhibition
of MAT2A and PRMT5 deepens the biological response through maximal
pathway suppression. The enhanced combination effect was observed
selectively in MTAP-null relative to MTAP wild-type models.
IDE161—PARG Inhibitor in Tumors with Homologous Recombination
Deficiency
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 clinical-stage small molecule inhibitor of PARG
being evaluated in a Phase 1/2 clinical trial designated as
IDE161-001 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, mechanistically distinct 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:
- Initiated and enrolled the first cohort and accruing patients
on a waitlist for subsequent cohorts of the dose escalation portion
of the Phase 1/2 clinical trial in patients having solid tumors
with HRD; the dose escalation protocol includes an initial starting
dose of IDE161 of approximately one-half of the projected human
efficacious dose, based on preclinical studies.
- Planned expansion cohorts will include ER+, Her2- HRD breast
cancer patients, which represent approximately 10% to 14% of breast
cancer patients, as well as HRD ovarian cancer patients, and a
basket expansion cohort of other solid tumors with HRD.
Pol Theta Helicase Inhibitor Development Candidate in 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 a GSK-sponsored IND submission in Q2 2023 to evaluate
Pol Theta Helicase inhibitor DC combination with niraparib for
patients having tumors with HRD.
- 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.
WRN Inhibitors in Tumors with High Microsatellite
Instability
IDEAYA and GSK are collaborating on ongoing preclinical research
for an inhibitor targeting Werner Helicase for tumors with high
microsatellite instability (MSI), 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.
Next-Generation Precision Medicine Pipeline Programs
IDEAYA has initiated early preclinical research programs focused
on pharmacological inhibition of several new targets, or NTs, for
patients with solid tumors characterized by defined biomarkers
based on genetic mutations and/or molecular signatures. The company
believes these research programs have the potential for discovery
and development of first-in-class or best-in-class therapeutics.
IDEAYA owns or controls all commercial rights in its next
generation NT programs.
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
$23.6 million and $24.2 million for the three months ended
March 31, 2023 and December 31, 2022, respectively. As of
March 31, 2023, the company had an
accumulated deficit of $259.0
million.
As of March 31, 2023, IDEAYA had
cash, cash equivalents and marketable securities of $351.2 million.
On April 27, 2023, and subsequent
to its reported financial statements for the quarter ending
March 31, 2023, IDEAYA announced the
closing of an underwritten public offering. The offering
included 8,858,121 shares of common stock (including 1,418,920
shares of common stock from the exercise in full of the
underwriters' option to purchase such additional shares) at a
public offering price of $18.50 per
share, as well as pre-funded warrants to purchase 2,020,270 shares
of common stock at a public offering price of $18.4999 per underlying share, in each case
before underwriting discounts and commissions. Gross proceeds from
the offering, before deducting underwriting discounts and
commissions and other offering expenses payable by IDEAYA, were
approximately $201.3
million.
Following the closing of the underwritten public offering,
IDEAYA's cash, cash equivalents and marketable securities of
$351.2 million as of March 31, 2023, supplemented by $188.7 million of estimated net proceeds from the
financing, is anticipated to fund its planned operations into 2027.
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 March
31, 2023, IDEAYA had cash, cash equivalents and short-term
marketable securities totaling $351.2
million. This compared to cash, cash equivalents and
short-term and long-term marketable securities of $373.1 million as of December 31, 2022. The decrease was attributable
to net cash used in operations offset by net proceeds of
$2.5 million from the sale of shares
of IDEAYA common stock under an at-the-market offering program
during the period from January 1,
2023 to March 31, 2023.
Collaboration revenue for the three months ended March 31, 2023 totaled $7.9 million compared to $4.0 million for the three months ended
December 31, 2022. Collaboration
revenue was recognized for the performance obligations satisfied
through March 31, 2023 under the GSK
Collaboration Agreement.
Research and development (R&D) expenses for the three months
ended March 31, 2023 totaled
$27.9 million compared to
$24.7 million for the three months
ended December 31, 2022. The increase
was primarily due to higher clinical trials, external research and
personnel-related expenses.
General and administrative (G&A) expenses for the three
months ended March 31, 2023 totaled
$6.3 million compared to $5.8 million for the three months ended
December 31, 2022. The increase was
primarily due to higher personnel-related expenses to support our
growth.
The net loss for the three months ended March 31, 2023 was $23.6
million compared to the net loss of $24.2 million for the three months ended
December 31, 2022. Total stock
compensation expense for the three months ended March 31, 2023 was $3.7
million compared to $3.0
million for the three months ended December 31, 2022.
About IDEAYA Biosciences
IDEAYA is a 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 initiation of the Phase 2/3
registrational trial for the darovasertib and crizotinib
combination, (iii) the timing of a darovasertib clinical program
update, (iv) the clinical focus for the IDE161 Phase 1 trial, (v)
the timing of IND submission for Pol Theta Helicase DC, (vi) the
timing of selection of a development candidate for a Werner
Helicase inhibitor, (vii) the receipt of development and regulatory
milestones, (viii) the potential of preclinical research programs,
and (ix) 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, banking sector volatility, 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
Quarterly Report on Form 10-Q dated May 9,
2023 and any current and periodic reports filed with the
U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Paul Stone
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
|
|
|
|
|
March 31,
2023
|
|
|
December
31,2022
|
|
|
|
|
(Unaudited)
|
|
|
Collaboration
revenue
|
|
$
|
7,880
|
|
|
$
|
4,022
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
|
|
27,859
|
|
|
|
24,714
|
|
|
General and
administrative
|
|
|
6,300
|
|
|
|
5,752
|
|
|
Total operating
expenses
|
|
|
34,159
|
|
|
|
30,466
|
|
|
Loss from
operations
|
|
|
(26,279)
|
|
|
|
(26,444)
|
|
|
Interest income and
other income, net
|
|
|
2,639
|
|
|
|
2,243
|
|
|
Net loss
|
|
|
(23,640)
|
|
|
|
(24,201)
|
|
|
Unrealized gains on
marketable securities
|
|
|
1,466
|
|
|
|
1,131
|
|
|
Comprehensive
loss
|
|
$
|
(22,174)
|
|
|
$
|
(23,070)
|
|
|
Net loss per share
attributable to common
stockholders, basic and diluted
|
|
$
|
(0.49)
|
|
|
$
|
(0.50)
|
|
|
Weighted-average number
of shares
outstanding, basic and diluted
|
|
|
48,370,074
|
|
|
|
48,132,003
|
|
|
IDEAYA Biosciences,
Inc.
Condensed Balance Sheet Data (in
thousands)
|
|
|
|
March 31,
2023
|
|
|
December 31,
2022
|
|
|
|
(Unaudited)
|
|
Cash and cash
equivalents and short-term and
long-term marketable securities
|
|
$
|
351,210
|
|
|
$
|
373,146
|
|
Total assets
|
|
|
364,746
|
|
|
|
387,969
|
|
Total
liabilities
|
|
|
30,936
|
|
|
|
38,514
|
|
Total liabilities and
stockholders' equity
|
|
|
364,746
|
|
|
|
387,969
|
|
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SOURCE IDEAYA Biosciences, Inc.