- Strong balance sheet of $510.1
million of cash, cash equivalents and marketable securities
as of June 30, 2023 anticipated to
fund operations into 2027
- Initiated Phase 2/3 registrational trial for darovasertib and
crizotinib combination in first-line HLA-A2 negative metastatic UM,
and also initiated a separate Phase 2 clinical trial to evaluate
single-agent darovasertib as neoadjuvant and adjuvant therapy for
primary UM
- Targeting darovasertib clinical program updates in Q4 2023,
including ctDNA data from Phase 2 MUM trial at ESMO 2023, as well
as prevalence of HLA-A2 (+)/(-) serotypes and clinical data update
for darovasertib as neoadjuvant therapy in primary UM
- First patient dosed in Amgen-sponsored Phase 1/2 clinical trial
evaluating IDE397 (MAT2A) and AMG 193 (PRMT5MTA)
combination in patients with MTAP-deletion solid tumors
- IDE397 Phase 2 monotherapy expansion proceeding for
MTAP-deletion high-priority tumors – NSCLC, bladder, gastric and
esophageal cancers
- Observed responses to IDE397 monotherapy in multiple
MTAP-deletion high-priority tumor types based on experience across
several patients in early phase of dose expansion
- Ongoing dose escalation for Phase 1 clinical trial evaluating
IDE161 in patients with HRD solid tumors, with strategic focus in
ER+, Her2- breast cancer
- Submitted IND and anticipating FDA clearance in Q3 2023 for
GSK101 (IDE705) Pol Theta Helicase inhibitor in a GSK-sponsored
clinical trial, with potential $7
million milestone
- Targeting Werner Helicase development candidate with GSK in H2
2023, with potential $3 million
milestone from GSK in connection with IND-enabling studies
SOUTH
SAN FRANCISCO, Calif., Aug. 10,
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 second
quarter ended June 30, 2023.
"We are executing on our clinical strategy to deliver precision
medicine therapies to patients and build value for our
shareholders. Our broad clinical pipeline includes three potential
first-in-class clinical candidates for which we own or control all
worldwide commercial rights – darovasertib (PKC), IDE397 (MAT2A)
and IDE161 (PARG). We have a fourth potential first-in-class
clinical candidate, GSK101 (Pol Theta Helicase), pending clearance
of the IND, which will be evaluated in combination with niraparib
in a GSK-sponsored clinical trial," said Yujiro S. Hata, Chief Executive Officer, IDEAYA
Biosciences.
"We are initiating clinical studies which have the potential to
be broadly impactful to uveal melanoma patients throughout their
journey – including a Phase 2 clinical trial for single-agent
darovasertib as neoadjuvant and adjuvant therapy in primary UM and
a registrational trial for the darovasertib and crizotinib
combination in first-line, HLA-A2(-) metastatic UM," said Dr.
Darrin Beaupre, M.D., Ph.D., Chief
Medical Officer, IDEAYA Biosciences.
"Additionally, a first patient has been dosed in the
Amgen-sponsored Phase 1/2 clinical trial evaluating IDE397 in
combination with AMG 193 in MTAP-deletion tumors, with an estimated
enrollment of approximately 180 patients and an expansion focus on
NSCLC. We are also advancing IDE397 in a Phase 2 monotherapy
expansion in high-priority MTAP deletion tumors – NSCLC, bladder,
gastric and esophageal cancers. We are encouraged by the responses
observed in multiple high-priority MTAP deletion tumors. Enrollment
into the dose escalation of our Phase 1/2 clinical trial for IDE161
is ongoing. Lastly, we are anticipating IND clearance for
evaluation of GSK101, our Pol Theta Helicase inhibitor, in the
GSK-sponsored Phase 1/2 clinical trial in combination with
niraparib," continued Dr. Beaupre.
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 HLA-A2(-) metastatic UM. 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 as monotherapy in a Phase 2
expansion cohort in patients having tumors with methylthioadenosine
phosphorylase, or MTAP, deletion, including high-priority NSCLC,
bladder, gastric and esophogeal cancers. Amgen has initiated and
dosed a first patient in the Amgen-sponsored Phase 1/2 clinical
trial evaluating IDE397, IDEAYA's methionine adenosyltransferase
2a, or MAT2A, inhibitor, 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 dose
escalation portion of the clinical trial. 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 is anticipating IND clearance in the third quarter
of 2023 to enable the GSK-sponsored Phase 1/2 clinical trial to
evaluate its Pol Theta Helicase inhibitor, GSK101 (IDE705), in
combination with niraparib for patients having tumors with HR
mutations such as BRCA mutations, or with homologous recombination
deficiency, or HRD. Subject to IND clearance for GSK101,
IDEAYA will be entitled to receive a $7
million milestone payment from GSK.
The company's preclinical pipeline includes several potential
first-in-class precision medicine therapeutics. The
Werner Helicase program continues in collaboration with GSK
toward a development candidate nomination in the second half of
2023. IDEAYA will be entitled to receive a $3 million milestone payment from GSK in
connection with IND-enabling studies for the selected development
candidate.
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 initiated a potential registration-enabling Phase 2/3
clinical trial, designated as IDE196-002, with clinical sites open
and recruiting patients for enrollment, to evaluate the
darovasertib and crizotinib combination in first-line HLA-A2(-)
MUM. Highlights:
- In April, 2023, the company 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
reported data included a safety and clinical efficacy profile for
evaluable first-line (n=20) and any-line (n=63) patients, who were
treated at the expansion dose of 300 mg twice-a-day darovasertib
and 200 mg twice-a-day crizotinib. The evaluable patients generally
had a significant disease burden and were heavily pre-treated. The
reported data were preliminary and based on investigator review
from an unlocked database as of the data analyses cutoff date of
March 8, 2023.
-
- In 20 evaluable first-line MUM patients, the
investigator-reviewed data by RECIST 1.1 included: 45% overall
response rate, or ORR, 90% disease control rate, or DCR, and
approximately seven months median progression free survival, or
PFS.
- In 63 evaluable any-line MUM patients, the
investigator-reviewed data by RECIST 1.1 included: 30% ORR, 87%
DCR, and approximately seven months median PFS.
- In a subset of 20 evaluable hepatic-only MUM patients –
first-line and pre-treated patients with only hepatic metastases,
the investigator-reviewed data by RECIST 1.1 included: 35% ORR,
100% DCR and approximately 11 months median PFS.
- Clinical efficacy was observed irrespective of HLA-A2 status,
including in HLA-A2(-) and HLA-A2(+) serotypes.
- The darovasertib and crizotinib combination therapy
demonstrated 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.
- In May 2023, IDEAYA expanded its
relationship with Pfizer under the Second Pfizer Agreement to
support the Phase 2/3 registrational trial to evaluate darovasertib
and crizotinib as a combination therapy in MUM, pursuant to which
Pfizer will provide the company with a first defined quantity of
crizotinib at no cost, as well as an additional second defined
quantity of crizotinib at a lump-sum cost. IDEAYA anticipates that
the supply of crizotinib under the Second Pfizer Agreement, as
amended, will be sufficient to support the planned Phase 2 and
Phase 3 portions of the Phase 2/3 registrational trial.
- The company is planning for darovasertib clinical program
updates in the fourth quarter of 2023, including ctDNA data from
Phase 2 MUM trial at the European Society for Medical Oncology's
Congress in October 2023, or ESMO
2023. Other potential updates may also include a summary of the
prevalence of HLA-A2(-) and HLA-A2(+) serotypes from IDEAYA's data
set of approximately 145 MUM patients enrolled in clinical trials
evaluating darovasertib.
Darovasertib—Design of Registration-Enabling Clinical Trial
in First-Line HLA-A2*02:01(-) 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—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 to separately address MUM
patients with an HLA-A*02:01 positive serotype. The company is
planning to enroll HLA-A2(+) patients into a separate clinical
trial, such as its ongoing Phase 2 clinical trial evaluating the
darovasertib and crizotinib combination treatment. Clinical
efficacy data from the HLA-A2(+) patients in this clinical trial
could support publication and potential inclusion in NCCN Clinical
Practice Guidelines in Oncology.
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 initiated, with clinical sites open and recruiting
patients for enrollment into, 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.
- In April 2023 and June 2023, the company reported 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 with best tumor response measurement based on maximal
percent reduction in measured apical height or longest basal
diameter. The reported investigator-reviewed data included:
-
- Tumor shrinkage of primary ocular lesions in nine of nine
(100%) primary or metastatic UM patients treated as monotherapy or
in combination with crizotinib
- Ocular tumor shrinkage in six of six (100%) primary UM patients
treated with darovasertib (n=5) or in combination with crizotinib
(n=1) as neoadjuvant therapy, including one patient with a partial
response (~31% ocular tumor shrinkage) at one month of treatment,
three patients with ~22-24% ocular tumor shrinkage after 1, 2 or 4
months of treatment and one patient with ~80% ocular tumor
shrinkage after 4 months of treatment.
- Two reported cases – first and second initial cases – of
primary UM patients who were spared enucleation and were able to
retain vision. One patient, who was already blind in one eye from
vascular disease and was treated under a compassionate use
protocol, observed an 80% reduction in ocular tumor size following
fourth months of neoadjuvant treatment with darovasertib in
combination with crizotinib. A second patient, who was treated in
the NADOM IST, observed a 24% reduction in ocular tumor size
following four months of neoadjuvant treatment with darovasertib as
monotherapy. In each of these cases, the neoadjuvant treatment
enabled plaque brachytherapy as a primary interventional treatment
rather than an originally planned enucleation.
- IDEAYA is additionally supporting evaluation of single-agent
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.
- IDEAYA is targeting a clinical data update in the fourth
quarter of 2023 from the NADOM IST evaluating single-agent
darovasertib as neoadjuvant therapy in primary UM patients.
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, designated as 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:
- First patient dosed in 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) has an
estimated 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.
- IDE397 monotherapy Phase 2 expansion enrolling patients with
MTAP-deletion NSCLC, bladder, esophageal and gastric cancers.
- Preliminary clinical data for IDE397 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 (~47%
tumor reduction) in one of the high-priority tumor types and an
additional observed~33% tumor reduction in NSCLC as measured by
CT-PET.
- International site activation ongoing in support of monotherapy
expansion, including in Europe and
Asia, to enhance patient
enrollment in high priority MTAP-deletion tumors.
- 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, designated as IDE161-001, in 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:
- Ongoing enrollment of patients having tumors with HRD into the
dose escalation portion of the Phase 1/2 clinical trial
- 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
GSK101 (IDE705) – Pol Theta Helicase Inhibitor in Tumors with HR
Mutations
GSK101 (IDE705) is targeting Pol Theta Helicase for solid
tumors with homologous recombination (HR) mutations, such as BRCA,
or homologous recombination deficiency (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:
- Submitted IND and anticipating clearance by U.S. FDA in Q3 2023
to enable a GSK-sponsored Phase 1/2 clinical trial to evaluate
GSK101 in combination with niraparib for patients having solid
tumors with HR mutations, such as BRCA, or HRD.
- Eligible to receive $7 million
milestone payment from GSK upon IND clearance, and potential
additional $10 million upon
initiation of Phase 1 clinical dose expansion
- Observed tumor regressions in preclinical combination studies
of Pol Theta Helicase DC with niraparib in multiple in vivo PDX and
CDX HRD models
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 microsatellite instability (MSI), and GSK will lead clinical
development for the Werner Helicase program. Highlights:
- Targeting selection of a Werner Helicase development candidate
in H2 2023, in collaboration with GSK
- Potential to receive $3 million
milestone payment from GSK in connection with IND-enabling studies
and up to an additional $17 million
aggregate through early Phase 1
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. IDEAYA owns or
controls all commercial rights in its next generation NT
programs.
Corporate Updates
IDEAYA's net losses were $27.9
million and $23.6 million for
the three months ended June 30, 2023
and March 31, 2023, respectively. As
of June 30, 2023, the company had an
accumulated deficit of $287.0
million.
As of June 30, 2023, IDEAYA had
cash, cash equivalents and marketable securities of $510.1 million. These funds are anticipated to
fund IDEAYA's planned operations into 2027 and support the
company's activities through potential achievement of multiple
preclinical and clinical milestones across multiple programs.
On April 27, 2023, IDEAYA
announced the closing of an underwritten public offering of shares
of IDEAYA common stock and of pre-funded warrants to purchase
IDEAYA common stock, resulting in aggregate net proceeds of
approximately $188.7 million, after
deducting underwriting discounts and commissions and other offering
expenses.
On June 26, 2023, the company
filed a new Form S-3 Registration Statement as an automatic shelf
registration statement and as a "well-known seasoned issuer" as
defined in Rule 405 under the Securities Act of 1933, following the
lapse of the prior Form S-3 Registration Statement filed under the
Securities Act of 1933 and effective as of June 10, 2020.
On June 26, 2023, IDEAYA entered
into a new Open Market Sales Agreement, or June 2023 Sales Agreement, with Jefferies
relating to an at-the-market offering program under which the
company may offer and sell, from time to time at its sole
discretion, shares of its common stock, par value $0.0001 per share, having aggregate gross
proceeds of up to $250.0 million
through Jefferies as sales agent. During the reporting period for
the quarter ended June 30,
2023, IDEAYA sold an aggregate of 10,124 shares of our common
stock for aggregate net proceeds of $0.2
million at a weighted average sales price of approximately
$23.52 per share under the
at-the-market offering pursuant to the June
2023 Sales Agreement with Jefferies as sales agent. As of
June 30, 2023, $249.8 million of common stock remained available
to be sold under the at-the-market facility associated with the
June 2023 Sales Agreement.
Subsequent to the reporting period for the quarter ended
June 30, 2023, the company sold an
aggregate of 76,421 shares of our common stock for aggregate net
proceeds of $1.7 million at a
weighted average sales price of approximately $23.53 per share under the at-the-market offering
pursuant to the June 2023 Sales
Agreement with Jefferies as sales agent.
IDEAYA's updated corporate presentation is available on its
website, at its Investor Relations
page: https://ir.ideayabio.com/.
Financial Results
As of June 30, 2023, IDEAYA had
cash, cash equivalents and short-term marketable securities
totaling $510.1 million. This
compared to cash, cash equivalents and short-term and long-term
marketable securities of $351.2
million as of March 31, 2023.
The increase was attributable to net proceeds of $188.7 million from the sale of shares of IDEAYA
common stock and pre-funded warrants to purchase IDEAYA common
stock in connection with the underwritten public offering, offset
by cash used in operations.
Collaboration revenue for the three months ended June 30, 2023 totaled $3.5
million compared to $7.9
million for the three months ended March 31, 2023. Collaboration revenue was
recognized for the performance obligations satisfied through
June 30, 2023 under the GSK
Collaboration Agreement.
Research and development (R&D) expenses for the three months
ended June 30, 2023 totaled
$29.2 million compared to
$27.9 million for the three months
ended March 31, 2023. The increase
was primarily due to higher clinical trial expenses.
General and administrative (G&A) expenses for the three
months ended June 30, 2023 totaled
$7.1 million compared to $6.3 million for the three months ended
March 31, 2023. The increase was
primarily due to higher audit and tax fees.
The net loss for the three months ended June 30, 2023 was $27.9
million compared to the net loss of $23.6 million for the three months ended
March 31, 2023. Total stock
compensation expense for the three months ended June 30, 2023 was $4.7
million compared to $3.7
million for the three months ended March 31, 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 extent to which IDEAYA's existing
cash, cash equivalents, and marketable securities will fund its
planned operations, (ii) the timing and content of a darovasertib
clinical program update, (iii) the timing of IND clearance for
GSK101 (IDE705), (iv) the receipt of development and regulatory
milestones, (v) the timing of selection of a development candidate
for a Werner Helicase inhibitor, (vi) the potential therapeutic
benefits of IDEAYA therapeutics, (vii) the number of patients to be
enrolled in the IDE397 and AMG 193 combination clinical trial,
(viii) the clinical focus for the IDE161 Phase 1 trial, (ix) the
clinical trial strategy for the darovasertib and crizotinib
combination, and (x) the potential exclusion of certain IDEAYA
products from mandatory price negotiation provisions of the 2022
Inflation Reduction Act. 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 August
10, 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
|
|
|
Six Months
Ended
|
|
|
|
June 30,
2023
|
|
|
March 31,
2023
|
|
|
June 30,
2023
|
|
|
June 30,
2022
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
Collaboration
revenue
|
|
$
|
3,544
|
|
|
$
|
7,880
|
|
|
$
|
11,424
|
|
|
$
|
17,210
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
29,178
|
|
|
|
27,859
|
|
|
|
57,037
|
|
|
|
42,451
|
|
General and
administrative
|
|
|
7,075
|
|
|
|
6,300
|
|
|
|
13,375
|
|
|
|
11,478
|
|
Total operating
expenses
|
|
|
36,253
|
|
|
|
34,159
|
|
|
|
70,412
|
|
|
|
53,929
|
|
Loss from
operations
|
|
|
(32,709)
|
|
|
|
(26,279)
|
|
|
|
(58,988)
|
|
|
|
(36,719)
|
|
Interest income and
other income, net
|
|
|
4,783
|
|
|
|
2,639
|
|
|
|
7,422
|
|
|
|
650
|
|
Net loss
|
|
|
(27,926)
|
|
|
|
(23,640)
|
|
|
|
(51,566)
|
|
|
|
(36,069)
|
|
Unrealized loss on
marketable securities
|
|
|
226
|
|
|
|
1,466
|
|
|
|
1,692
|
|
|
|
(2,917)
|
|
Comprehensive
loss
|
|
$
|
(27,700)
|
|
|
$
|
(22,174)
|
|
|
$
|
(49,874)
|
|
|
$
|
(38,986)
|
|
Net loss per share
attributable to common
stockholders, basic and diluted
|
|
$
|
(0.50)
|
|
|
$
|
(0.49)
|
|
|
$
|
(0.99)
|
|
|
$
|
(0.93)
|
|
Weighted-average number
of shares outstanding,
basic and diluted
|
|
|
56,251,130
|
|
|
|
48,370,074
|
|
|
|
52,332,373
|
|
|
|
38,626,659
|
|
IDEAYA Biosciences,
Inc. Condensed Balance Sheet Data (in
thousands)
|
|
|
|
June 30,
2023
|
|
|
December 31,
2022
|
|
|
|
(Unaudited)
|
|
Cash and cash
equivalents and short-term and long-term
marketable securities
|
|
$
|
510,093
|
|
|
$
|
373,146
|
|
Total assets
|
|
|
527,557
|
|
|
|
387,969
|
|
Total
liabilities
|
|
|
25,948
|
|
|
|
38,514
|
|
Total liabilities and
stockholders' equity
|
|
|
527,557
|
|
|
|
387,969
|
|
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SOURCE IDEAYA Biosciences, Inc.