- Strong balance sheet of $511.1
million of cash, cash equivalents and marketable securities
as of September 30, 2023,
supplemented by $134.7 million
estimated net proceeds from subsequent follow-on financing and
$10.0 million receivable from GSK
milestones
- Multiple patients dosed and international site activation and
enrollment ongoing in Phase 2/3 potential registrational trial
evaluating darovasertib and crizotinib combination in 1L
HLA-A2-negative MUM, and proffered paper oral presentation at ESMO
2023
- Enrollment is ongoing in the Phase 1/2 study with IDE397
(MAT2A) and AMG 193 (PRMT5MTA) in MTAP-deletion solid
tumors
- Demonstrated eye preservation in 3 of 6 (50%) evaluable
patients treated with darovasertib as neoadjuvant therapy for
primary UM; observed PRs by RECIST 1.1 in 2 of 4 (50%) GNAQ/11
cutaneous melanoma patients on darovasertib and crizotinib
- Reported PRs by RECIST 1.1 and initiated IDE161 Ph1 expansion
in HRD+ solid tumor types, and received Fast Track Designation for
IDE161 in BRCA 1/2 ovarian and breast cancer
- IND clearance for GSK101 (IDE705) Pol Theta Helicase inhibitor
($7.0 million milestone), and
selected Werner Helicase Inhibitor Development Candidate
($3.0 million milestone)
- Targeting multiple wholly-owned next generation development
candidate nominations in 2024, including in MTAP-deletion, further
advancing IDEAYA's multi-pronged strategy
- Hosting Investor R&D Day on December
4, 2023, with participation from GSK and KOL
SOUTH
SAN FRANCISCO, Calif., Nov. 7, 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 third quarter ended
September 30, 2023.
"We have advanced a diverse clinical pipeline of precision
medicine oncology therapies targeting biomarker-defined solid tumor
populations. Our innovative clinical pipeline has four potential
first-in-class clinical programs, including darovasertib (PKC)
in a Phase 2/3 potential registrational trial, IDE397 (MAT2A) in
Phase 2, IDE161 (PARG) in Phase 1, and GSK101/IDE705 (Pol Theta
Helicase) in Phase 1. We also selected a Werner Helicase
Development Candidate in collaboration with GSK, for which an IND
submission is planned for 2024. These programs represent five
potential first-in-class programs, further validating our robust
drug discovery platform and enhancing our industry leadership in
precision medicine oncology," said Yujiro S. Hata, Chief
Executive Officer, IDEAYA Biosciences.
"Darovasertib is being evaluated across the patient journey in
uveal melanoma – including as a monotherapy in the neoadjuvant and
adjuvant settings, and in combination with crizotinib in the
metastatic setting. We also initiated a Phase 2 expansion
in GNAQ/11 cutaneous melanoma based on multiple durable
partial responses observed in our Phase 2 trial. With respect to
IDE397, Phase 2 monotherapy expansion is ongoing in bladder and
squamous NSCLC, and in collaboration with Amgen we are also testing
IDE397 in combination with AMG193, the Amgen PRMT5MTA
inhibitor, with a planned focus on NSCLC in the expansion phase.
Lastly, in the IDE161 first-in-human study we have observed partial
responses in the Phase 1 dose escalation, enabling the Phase 1 dose
expansion in high priority HRD+ solid tumor types, including
breast, ovarian, endometrial, and colorectal cancer," said Dr.
Darrin 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, or UM, in both primary and metastatic disease settings.
The company has initiated a potential registration-enabling Phase
2/3 clinical trial to evaluate the darovasertib and crizotinib
combination in first-line Human Leukocyte Antigen- (HLA-) A2*02:01
negative serotype (HLA-A2(-)) metastatic UM (MUM). IDEAYA also
initiated a company-sponsored Phase 2 clinical trial for evaluating
single-agent darovasertib as neoadjuvant and adjuvant therapy in
primary UM.
IDEAYA is evaluating IDE397, its methionine adenosyltransferase
2a, or MAT2A, inhibitor, as monotherapy in a Phase 2 expansion
cohort in patients having tumors with methylthioadenosine
phosphorylase, or MTAP, deletion, including high-priority tumors
such as squamous NSCLC and bladder cancer. Enrollment is ongoing in
the Amgen-sponsored Phase 1/2 clinical trial evaluating IDE397 in
combination with AMG 193, the Amgen investigational MTA-cooperative
PRMT5 inhibitor, in patients having tumors with MTAP gene
deletion.
IDEAYA is evaluating IDE161, its poly (ADP-ribose)
glycohydrolase, or PARG, inhibitor in a Phase 1/2 clinical trial in
patients having tumors with homologous recombination deficiency, or
HRD. IDEAYA is enrolling patients into the Phase 1 monotherapy
expansion in priority tumor types, including ER+, Her2- HRD+ breast
cancer patients, HRD+ ovarian cancer patients and in patients
having other solid tumors with HRD, such as HRD+ endometrial and
colorectal cancer.
Investigational new drug, or IND, clearance by the U.S. FDA was
achieved for GSK101 (IDE705), a Pol Theta Helicase inhibitor,
triggering a $7.0 million milestone
payment from GSK. Initiation of the first-in-human study is planned
for the fourth quarter of 2023 to evaluate GSK101 in a
GSK-sponsored Phase 1/2 clinical trial in combination with
niraparib, GSK's commercial poly (ADP-ribose) polymerase, or PARP,
inhibitor, for patients having tumors with HR mutations such as
BRCA mutations, or with HRD.
IDEAYA, in collaboration with GSK, selected a Werner Helicase
Inhibitor Development Candidate, or DC, and earned a $3.0 million milestone payment in October 2023 from GSK in connection with
IND-enabling studies. Subject to IND-enabling studies,
IND-submission is targeted in 2024 to enable clinical evaluation of
the Werner Helicase Inhibitor DC in patients having tumors that are
microsatellite instability, or MSI, high.
The company's preclinical pipeline includes several additional
potential first-in-class precision medicine
therapeutics.
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 controls all commercial rights in its
darovasertib program, including in metastatic UM, or MUM, and in
primary UM, subject to certain economic obligations pursuant to its
exclusive, worldwide license to darovasertib with
Novartis.
Registration-Enabling Clinical Trial in First-Line
HLA-A2*02:01(-) Metastatic Uveal Melanoma
Multiple patients have been dosed and international site
activation and enrollment is ongoing into a potential
registration-enabling Phase 2/3 clinical trial, designated as
IDE196-002, to evaluate the darovasertib and crizotinib combination
in first-line HLA-A2(-) MUM patients. The company has several
clinical sites open and is targeting to open an aggregate of over
50 clinical sites across U.S., Europe and Australia to support this registrational
study.
Phase 2 Clinical Trial Evaluating Darovasertib + Crizotinib
Combination in MUM
In parallel, IDEAYA is continuing to evaluate darovasertib in
its ongoing Phase 2 clinical trial, designated as IDE196-001, as a
combination therapy with crizotinib in MUM. IDEAYA is the sponsor
of this Phase 2 clinical trial and is collaborating with Pfizer on
this Phase 2 clinical trial pursuant to the Clinical Trial
Collaboration and Supply Agreement, or Pfizer Agreement.
Highlights:
- A clinical update was presented by Dr. Merideth McKean, a
clinical investigator, at the 2023 European Society for Medical
Oncology's Congress (ESMO 2023), including clinical efficacy in
HLA-A2(-)/(+) data subsets, clinical ctDNA data and updated
duration of treatment from IDEAYA's Phase 2 clinical trial in MUM.
- Phase 2 clinical data update was based on twenty
(20) evaluable first-line and sixty-three (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; these data were preliminary and
based on investigator review from an unlocked database as of the
data analyses cutoff date of August 22,
2023.
- Clinical efficacy was observed irrespective of HLA-A2 status,
including in HLA-A2(-) and HLA-A2(+) serotypes. Observed an overall
response rate, or ORR, of 42% in HLA-A2(-) and 60% in HLA-A2(+)
first-line MUM patients by RECIST 1.1. A total of n=50
all-line MUM patients with known HLA-A2 status were among the n=63
patients evaluable for efficacy, including 31 HLA-A2(-) and 19
HLA-A2(+) patients. For HLA-A2(-) MUM patients, confirmed partial
responses, or PRs, were observed in 9 of 31 (29% ORR) any-line
and in 5 of 12 (42% ORR) first-line patients. For HLA-A2(+) MUM
patents, confirmed PRs observed in 6 of 19 (32% ORR) any-line
and in 3 of 5 (60% ORR) first-line patients.
- With ~5.5 months of further follow-up from the previous
March 8, 2023 cut-off date, we
observed a median PFS of 7.1 months in first-line MUM, 6.8 months
in any-line MUM, and 11.0 months in hepatic-only MUM. In addition,
based on the two-year PFS analysis, over 20% (13 of 63 evaluable
patients) of any-line patients on the darovasertib and crizotinib
clinical combination are progression free at two-years,
demonstrating a long tail effect.
- Circulating tumor DNA, or ctDNA, molecular responses reported
at ESMO 2023 were determined based on measured changes in mean
allele frequency (MAF) on-treatment as compared to MAF levels at
baseline for a subset of any-line MUM patients (n=32).
- A reduction in MAF was observed in all but one patient – in 31
or 32 evaluable any-line MUM patients.
- Patients whose ctDNA showed a reduction of greater than 50% MAF
following treatment were characterized as having a ctDNA molecular
response, or MR.
- ctDNA MR was observed in 30 of 32 evaluable any-line MUM
patients, reflecting a 94% ctDNA MR rate. The ctDNA molecular
responses were deep and sustained, with approximately 80% of
measured patients having >80% reduction in MAF. The ctDNA
molecular responses correlated with observed efficacy, including
confirmed PRs as determined by RECIST 1.1.
- Treatment durations were observed for any-line (n=63) patients:
approximately 50% of patients were treated for greater than six
months, and approximately 30% of patients were treated for greater
than one year.
- The darovasertib and crizotinib combination therapy continued
to demonstrate an overall manageable adverse event profile in MUM
patients (n=68) at the combination expansion doses, with a low rate
(10%) of drug-related serious adverse events, or SAEs, and limited
Grade 4 and Grade 5 SAEs and discontinuations. Drug-related adverse
events, or AEs, were predominantly Grade 1 or Grade 2. 31% of
patients reported at least one Grade 3 AE; no patients observed a
Grade 4 AE; and one patient observed a Grade 5 AE. Five patients
(7%) discontinued treatment with darovasertib and crizotinib
combination due to a drug-related AE.
Prevalence of HLA-A2*02:01 Negative Serotype in MUM
Data from darovasertib clinical trials in MUM demonstrate that
approximately 70% of MUM patients with known human leukocyte
antigen (HLA)-A*02:01 (HLA-A2) status were HLA-A2(-).
As also reported at ESMO 2023 by Dr. McKean, the HLA-A2 status
was known in subsets of patients enrolled in clinical trials
evaluating darovasertib. Prevalence of HLA-A2(+) and HLA-A2(-) was
shown:
- In a first data set of 149 MUM patients treated with
darovasertib as monotherapy or in a combination arm of a clinical
trial, 68% (102 of 149) of patients were HLA-A2(-) serotype and 32%
of patients were HLA-A2(+) serotype.
- In a second data set of 118 MUM patients treated with the
darovasertib and crizotinib combination, 69% (81 of 118) of
patients were HLA-A2(-) serotype and 31% of patients were HLA-A2(+)
serotype.
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 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:
- IDEAYA has dosed 7 patients as of November 1 2023, has clinical sites open and is
actively recruiting additional patients into the 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
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.
- In October 2023, IDEAYA reported
updated data from the ongoing Phase 1 investigator-sponsored trial,
or IST, captioned as "Neoadjuvant / Adjuvant trial of Darovasertib
in Ocular Melanoma" (NADOM) being led by principal investigator
Professor Anthony Joshua, MBBS, PhD,
FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre,
St. Vincent's Hospital in Sydney
with participating sites of Alfred Health and the Royal Victorian
Eye and Ear Hospital in Melbourne.
The study reported a preliminary interim update with a data cut-off
as of July 17, 2023.
- In total, 11 patients eligible to receive 6 months
of neoadjuvant therapy had been enrolled as of October 2023 in the IST. Per current protocol,
patients with planned enucleation who are enrolled in the study are
treated to maximal benefit or up to 6 months with darovasertib
monotherapy.
- Seven patients were treated to maximal response or have ongoing
treatment with darovasertib in the neo-adjuvant setting as of the
data cut-off date. Six of these seven patients treated were
considered evaluable based on evaluation with at least one
ultrasound scan.
- Two evaluable patients had a confirmed eye preservation (Eye
Saved), based on conversion of their primary treatment from the
planned enucleation to plaque brachytherapy. A third evaluable
patient was confirmed as plaque-eligible and treatment of this
patient is ongoing with darovasertib neo-adjuvant treatment until
maximal benefit. These data reflect a 50% overall eye preservation
rate for the six evaluable patients.
- Of the evaluable patients (6 of 7), approximately 83% of
patients had tumor shrinkage.
- Two patients enrolled into the IST did not complete their
treatment to maximal response. One of these patients had
sub-retinal blood present at baseline and with lack of shrinkage
and visual deterioration and the patient discontinued treatment
after 6 weeks. A second of these patients had a Grade 3
drug-related AE of dermatitis and discontinued treatment before a
first scan.
- Enrollment into the IST is ongoing. Two out of four additional
patients enrolled after the data cutoff date of July 17, 2023 are likely plaque eligible (22%
ocular tumor shrinkage at 1-month and 20% ocular tumor shrinkage at
2-months) and are continuing darovasertib neoadjuvant therapy until
maximal benefit. One patient is being enucleated. The status of the
fourth patient was not reported.
Darovasertib – Expansion Opportunity in Cutaneous
Melanoma
IDEAYA initiated a Phase 2 expansion arm in the clinical trial
evaluating the darovasertib and crizotinib combination in GNAQ/11
metastatic cutaneous melanoma as a further expansion opportunity.
In October 2023, the company reported
that in a genetically defined GNAQ/GNA11 patient population with
cutaneous melanoma, 3 cohorts of patients treated with
darovasertib, either as monotherapy or in combination with either
binimetinib or crizotinib, have shown preliminary clinical
activity:
- Darovasertib Monotherapy Cutaneous Melanoma Cohort (n=8): 5 of
7 evaluable patients had tumor shrinkage (approximately 71%) with
one patient having a PR and remaining on treatment over 10 months
after previously receiving multiple prior lines of
immunotherapy.
- Darovasertib plus Binimetinib Cutaneous Melanoma Cohort (n=2):
1 of 2 cutaneous melanoma patients with a PR demonstrated 50% tumor
shrinkage and remained on treatment approximately 600 days after
previously receiving multiple prior lines of immunotherapy.
- Darovasertib plus Crizotinib Cutaneous Melanoma Cohort (n=2): 1
of 2 cutaneous melanoma patients had tumor shrinkage of 60% with
one patient having a PR and remaining on treatment (approximately
600 days) after previously receiving multiple prior lines of
immunotherapy.
Darovasertib, as monotherapy or in combination with either
binimetinib or crizotinib, has indicated a manageable adverse event
profile in cutaneous melanoma patients with certain drug-related
AEs being reported in certain cohorts. These preliminary clinical
data support the Company's reported initiation of a Phase 2
expansion of the darovasertib and crizotinib combination in GNAQ/11
metastatic cutaneous melanoma. There are currently no FDA approved
therapies in this genetically-defined GNAQ/11 cutaneous melanoma
patient population.
The GNAQ/11 prevalence in cutaneous melanoma has been
reported at approximately 5% in The Cancer Genome Atlas.
The GNAQ/11 cutaneous melanoma estimated annual incidence is
approximately 5,000 patients in the U.S. and 8,000 patients in the
EU28, and the estimated total prevalence of GNAQ/11 cutaneous
melanoma is approximately 70,000 patients in the U.S. and 110,000
patients in the EU28.
Based on several metastatic cancer patient databases, including
Memorial Sloan Kettering Cancer Center Impact, we believe GNAQ/11
metastatic cutaneous melanoma has the potential to be another
significant expansion opportunity for darovasertib, reflecting
approximately double or more of the annual addressable metastatic
patient population of metastatic uveal melanoma alone.
IDE397—MAT2A Inhibitor in Tumors with MTAP Deletion
IDEAYA is clinically evaluating IDE397, a potent and selective
small molecule inhibitor targeting MAT2A in patients having solid
tumors with 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,
designated as IDE397-001 (NCT04794699).
The IDE397 clinical development strategy is focused as
monotherapy in select indications and on the IDE397 combination
with AMG 193, 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:
- Enrollment is ongoing in the dose escalation portion of the
Amgen-sponsored Phase 1/2 clinical trial evaluating IDE397 (MAT2A)
and AMG 193 (PRMT5MTA) combination in patients with
MTAP-deletion solid tumors.
- Amgen-sponsored Phase 1/2 clinical trial (NCT 05975073) to
evaluate the IDE397 and AMG 193 combination has an estimated
planned enrollment of approximately 180 patients with solid tumors
having MTAP deletion, with a planned expansion focus in NSCLC, to
evaluate the safety, tolerability, pharmacokinetics,
pharmacodynamics and efficacy of the combination.
- IDEAYA-sponsored IDE397 monotherapy Phase 2 expansion is
enrolling patients with MTAP-deletion squamous NSCLC and bladder
cancers.
- Preliminary clinical data for IDE397 in the Company's Phase 2
clinical trial shows responses in multiple MTAP-deletion
high-priority tumor types based on experience across several
patients in the early phase of the monotherapy dose expansion.
These include an earlier-reported unconfirmed partial response
which was subsequently confirmed (approximately 47% tumor
reduction), and at the week-18 CT scan converted to a complete
response (bladder cancer patient), and an additional observed
approximately 33% tumor reduction in squamous NSCLC patient as
measured by CT-PET. 8 patients have been dosed in the IDE397
monotherapy expansion in the priority tumor types, and 2 patients
have not yet had a first tumor scan assessment, as of the
October 13, 2023 cut-off date.
- We have observed relatively low rates of discontinuations and
SAEs in the IDE397 monotherapy clinical evaluation as of the
October 13, 2023 cut-off date.
- International site activation is ongoing in support of Phase 2
monotherapy expansion, including in Europe and Asia, to enhance patient enrollment in high
priority MTAP-deletion tumor types of squamous NSCLC and bladder
cancer.
IDE161—PARG Inhibitor in Tumors with Homologous Recombination
Deficiency
IDEAYA is clinically evaluating its PARG inhibitor development
candidate, IDE161, in a Phase 1/2 clinical trial, designated as
IDE161-001, in patients having tumors with 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 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 IDE161 Phase 1 expansion based on multiple PRs by
RECIST 1.1 and tumor shrinkage observed in multiple HRD solid tumor
patients, including an endometrial cancer subject with a first
imaging assessment of a partial response and an 87% reduction of
the CA-125 marker, which was subsequently confirmed by RECIST 1.1
at the second scan.
- 7 patients treated at the expansion dose in the priority solid
tumor types and 2 patients have not yet had a first tumor scan
assessment as of the October 13, 2023
cut-off date.
- We have observed no drug related discontinuations or SAEs at
the IDE161 expansion dose as of the October
13, 2023 cut-off date.
- Phase 1 expansion focus in ER+, Her2(-), HRD+ breast cancer
representing approximately 10% to 14% of breast cancer, HRD+
ovarian cancer representing approximately 50% of ovarian cancer,
and other solid tumors with HRD, including HRD+ endometrial
cancer.
- Demonstrated IDE161 target engagement based on pharmacodynamic
modulation of PAR, and achieved human exposures correlating to
tumor regressions in preclinical models.
- Phase 1 dose optimization ongoing to confirm move forward Phase
2 expansion dose.
- Received Fast Track Designation from the U.S. FDA for IDE161
for adult, pretreated, advanced or metastatic BRCA 1/2m ovarian- and HR+, Her2-, BRCA 1/2m breast- cancer patients, including
specifically for:
- Treatment of adult patients having advanced or metastatic
hormone receptor positive, or HR+, Her2- breast cancer
with germline or somatic BRCA 1/2 mutations who have
progressed following treatment with at least one line of a hormonal
therapy, a CDK4/6 inhibitor therapy and a PARP inhibitor therapy;
and
- Treatment of adult patients having advanced or metastatic
ovarian cancer with germline or somatic BRCA 1/2 mutations who are
platinum resistant and have received prior antiangiogenic and PARP
inhibitor therapies.
- Targeting IDE161 clinical program updates in the fourth quarter
of 2023.
GSK101 (IDE705) – Pol Theta Helicase Inhibitor in Tumors with HR
Mutations
GSK101 (IDE705) is targeting Pol Theta Helicase for solid tumors
with homologous recombination, or HR mutations, such as BRCA, or
HRD. IDEAYA and GSK collaborated on preclinical research and,
following selection of GSK101 as the development candidate, GSK is
leading clinical development for the Pol Theta program.
Highlights:
- Obtained IND clearance from U.S. FDA to enable GSK-sponsored
Phase 1/2 clinical trial to evaluate GSK101 in combination with
niraparib, the GSK small molecule inhibitor of PARP, for patients
having solid tumors with HR mutations, such as BRCA or other HR
mutations, or with HRD.
- Targeting first-in-human studies for GSK101 in the fourth
quarter of 2023.
- Earned $7.0 million milestone
payment from GSK based on IND clearance, with potential to receive
additional $10.0 million upon
initiation of Phase 1 clinical dose expansion, as well as potential
further aggregate later-stage development and regulatory milestones
of up to $465.0 million.
- GSK is the sponsor of the Phase 1/2 clinical trial and will
lead clinical development for the Pol Theta program pursuant to its
global, exclusive license from IDEAYA. GSK is responsible for all
research and development costs for the program.
WRN Inhibitor 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
MSI, and GSK will lead clinical development for the Werner Helicase
program. Highlights:
- Selected a Werner Helicase Inhibitor DC in collaboration with
GSK.
- Targeting an IND in 2024 to enable first-in-human clinical
evaluation of Werner Helicase Inhibitor DC for patients having
tumors with MSI-High.
- Earned $3.0 million milestone
from GSK in connection with IND-enabling studies with potential for
up to an additional $17.0 million
aggregate milestones through early Phase 1, as well as potential
further aggregate later-stage development and regulatory milestones
of up to $465.0 million.
- Subject to IND submission and clearance, GSK will lead clinical
development for the Werner Helicase program pursuant to its global,
exclusive license to develop and commercialize the Werner Helicase
Inhibitor DC. GSK is responsible for 80% of global research and
development costs and IDEAYA is responsible for 20% of such
costs.
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. These
research programs have the potential for discovery and development
of first-in-class or best-in-class therapeutics with multiple
wholly-owned development candidate nominations targeted in 2024,
including to treat MTAP-deletion solid tumors.
IDEAYA Investor R&D Day
The IDEAYA Investor R&D Day will include participation from
GSK and a key opinion leader that will showcase scientific insights
and clinical development opportunities across IDEAYA's synthetic
lethality pipeline, including IDE397 (MAT2A) in Phase 2, IDE161
(PARG) in Phase 1, GSK101/IDE705 (Pol Theta Helicase) in Phase 1,
and the Werner Helicase program for which an IND submission is
planned for 2024. In addition, IDEAYA will highlight its next
generation initiatives in MTAP-deletion, including a wholly-owned
program where a development candidate nomination is targeted in
2024, further advancing IDEAYA's multi-pronged strategy.
Corporate Updates
IDEAYA's net losses were $27.4
million and $27.9 million for
the three months ended September 30,
2023 and June 30, 2023,
respectively. As of September 30,
2023, the company had an accumulated deficit of $314.4 million.
As of September 30, 2023, IDEAYA
had cash, cash equivalents and marketable securities of
$511.1 million. These funds were
supplemented by $134.7 million in
estimated net proceeds from a follow-on financing on October 27, 2023, and $10.0 million in milestones achieved from the GSK
collaboration. The $10.0 million in
GSK milestones includes $7.0 million
earned upon IND clearance from the Pol Theta Program in
August 2023, which was subsequently
received in October 2023, and
$3.0 million earned in connection
with the IND-enabling studies from the Werner Helicase program in
October 2023.
On October 27, 2023, subsequent to
the reporting period for the quarter ended September 30, 2023, the company completed an
underwritten public follow-on offering. The offering consisted of
5,797,872 shares of our common stock at an offering price to the
public of $23.50 per share, including
797,872 shares of common stock upon the exercise in full of the
overallotment option by the underwriters, and pre-funded warrants
to purchase 319,150 shares of common stock at a public offering
price of $23.4999 per pre-funded
warrant before underwriting discounts and commissions. Pursuant to
the offering, we received net proceeds of approximately
$134.7 million, after deducting
underwriting discounts and commissions and other offering
expenses.
IDEAYA's updated corporate presentation is available on its
website, at its Investor Relations page:
https://ir.ideayabio.com/.
Financial Results
As of September 30, 2023, IDEAYA
had cash, cash equivalents and short-term marketable securities
totaling $511.1 million. This
compared to cash, cash equivalents and short-term and long-term
marketable securities of $510.1
million as of June 30,
2023.
The increase was attributable to net proceeds of $26.3 million from the sale of shares of our
common stock under the at-the-market offerings pursuant to the
June 2023 Sales Agreement with
Jefferies as sales agent.
Collaboration revenue for the three months ended September 30, 2023, totaled $8.0 million compared to $3.5 million for the three months ended
June 30, 2023. Collaboration revenue
was recognized for the performance obligations satisfied through
September 30, 2023, under the GSK
Collaboration Agreement and the Pol Theta program's IND
effectiveness milestone achievement.
Research and development (R&D) expenses for the three months
ended September 30, 2023, totaled
$33.7 million compared to
$29.2 million for the three months
ended June 30, 2023. The increase was
primarily due to higher clinical trial expenses.
General and administrative (G&A) expenses for the three
months ended September 30, 2023,
totaled $7.9 million compared to
$7.1 million for the three months
ended June 30, 2023. The increase was
primarily due to higher consulting fees and personnel-related
expenses.
The net loss for the three months ended September 30, 2023, was $27.4 million compared to the net loss of
$27.9 million for the three months
ended June 30, 2023. Total stock
compensation expense for the three months ended September 30, 2023, was $5.3 million compared to $4.7 million for the three months ended
June 30, 2023.
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 timing of designation of next
generation development candidates, (ii) the timing, content and
participants in the Investor R&D Day and content of a
darovasertib clinical program update, (iii) the timing of IND
submission for the Werner Helicase inhibitor DC, (iv) the clinical
focus the IDE397 and AMG 193 combination clinical trial, (v) the
number of clinical trial sites in the darovasertib and crizotinib
combination potential registration-enabling Phase 2/3 clinical
trial, (vi) the potential therapeutic benefits of IDEAYA
therapeutics, (vii) the translation of preliminary clinical trial
results into future clinical trial results, (vii) the estimate of
patient populations, (viii) the timing and content of clinical
program updates, (ix) the timing of first-in-human studies for
GSK101, and (x) the receipt of development and regulatory
milestones. 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 November
7, 2023 and any current and periodic reports filed with the
U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
investor@ideayabio.com
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,
2023
|
|
|
June 30,
2023
|
|
|
September 30,
2023
|
|
|
September 30,
2022
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
Collaboration
revenue
|
|
$
|
8,038
|
|
|
$
|
3,544
|
|
|
$
|
19,463
|
|
|
$
|
46,909
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
33,701
|
|
|
|
29,178
|
|
|
|
90,738
|
|
|
|
64,823
|
|
General and
administrative
|
|
|
7,863
|
|
|
|
7,075
|
|
|
|
21,237
|
|
|
|
18,145
|
|
Total operating
expenses
|
|
|
41,564
|
|
|
|
36,253
|
|
|
|
111,975
|
|
|
|
82,968
|
|
Loss from
operations
|
|
|
(33,526)
|
|
|
|
(32,709)
|
|
|
|
(92,512)
|
|
|
|
(36,059)
|
|
Interest income and
other income, net
|
|
|
6,086
|
|
|
|
4,783
|
|
|
|
13,506
|
|
|
|
1,605
|
|
Net loss
|
|
|
(27,440)
|
|
|
|
(27,926)
|
|
|
|
(79,006)
|
|
|
|
(34,454)
|
|
Unrealized gains
(losses) on marketable securities
|
|
|
429
|
|
|
|
226
|
|
|
|
2,121
|
|
|
|
(3,290)
|
|
Comprehensive
loss
|
|
$
|
(27,011)
|
|
|
$
|
(27,700)
|
|
|
$
|
(76,885)
|
|
|
$
|
(37,744)
|
|
Net loss per share
attributable to common
stockholders, basic and diluted
|
|
$
|
(0.46)
|
|
|
$
|
(0.50)
|
|
|
$
|
(1.44)
|
|
|
$
|
(0.88)
|
|
Weighted-average number
of shares outstanding,
basic and diluted
|
|
|
59,999,449
|
|
|
|
56,251,130
|
|
|
|
54,916,150
|
|
|
|
39,191,098
|
|
IDEAYA Biosciences,
Inc. Condensed Balance Sheet Data (in
thousands)
|
|
|
|
|
|
|
|
|
|
September 30,
2023
|
|
|
December 31,
2022
|
|
|
|
(Unaudited)
|
|
Cash and cash
equivalents and short-term and long-term
marketable securities
|
|
$
|
511,145
|
|
|
$
|
373,146
|
|
Total assets
|
|
|
532,942
|
|
|
|
387,969
|
|
Total
liabilities
|
|
|
24,893
|
|
|
|
38,514
|
|
Total liabilities and
stockholders' equity
|
|
|
532,942
|
|
|
|
387,969
|
|
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SOURCE IDEAYA Biosciences, Inc.