- Strong balance sheet of ~$346
million cash, cash equivalents and marketable securities as
of March 31, 2022 is anticipated to
fund planned operations into 2025
- Targeting initiation of IDE397 Phase 1/2 monotherapy expansion
and Phase 1 combination cohorts, and delivery of GSK option data
package mid-year 2022
- Darovasertib and crizotinib Phase 1/2 clinical combination data
update and regulatory guidance on potential registration-enabling
trial anticipated mid-year 2022
- On-track to submit an IND in Q4 2022 for IDE161, a PARG
development candidate, and to nominate a Pol Theta development
candidate in Q2 2022
SOUTH
SAN FRANCISCO, Calif., May 10, 2022
/PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic
lethality focused precision medicine oncology company committed to
the discovery and development of targeted therapeutics, provided a
business update and announced financial results for the first
quarter ended March 31, 2022.
"The IDE397 Phase 1 dose escalation clinical data supports
advancing the program to monotherapy expansions and clinical
combinations in patients with MTAP deletion tumors. In
addition, the darovasertib Phase 2 data is maturing to enable FDA
discussions on potential registrational trial design in MUM, and we
are preclinically exploring potential darovasertib expansion
opportunities in additional cMET driven tumors," said Yujiro S. Hata, Chief Executive Officer and
President of IDEAYA Biosciences.
"We are building a broad and deep pipeline of potential
first-in-class synthetic lethality therapeutics. Several of
our synthetic lethality programs are advancing toward the clinic,
including our PARG inhibitor, IDE161, for which we are targeting an
IND in Q4 2022, and our potential first-in-class Pol Theta helicase
inhibitor, for which we are collaborating with GSK to select a
development candidate in Q2 2022. Our potential first in
class Werner helicase inhibitor is also progressing in
collaboration with GSK; we are targeting development candidate
selection in 2023," said Michael
White, Senior Vice President and Chief Scientific Officer of
IDEAYA Biosciences.
Program Updates
Key highlights for IDEAYA's pipeline
programs include:
IDE397 (MAT2A)
IDEAYA is evaluating IDE397, a potent and selective small molecule
inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in
patients having solid tumors with methylthioadenosine phosphorylase
(MTAP) deletion, a patient population estimated to represent
approximately 15% of solid tumors. IDEAYA is leading
early clinical development of IDE397. Subject to exercise of
its option for an exclusive license, GlaxoSmithKline (GSK) will
lead global clinical development. Highlights:
- Actively enrolling patients into dose-escalation cohorts of the
Phase 1 clinical trial IDE397-001 (NCT04794699); as of May 1, 2022, the company has enrolled 21
MTAP-deletion patients into the dose escalation
- Patients are being identified by next generation sequencing
(NGS) or by MTAP immunohistochemistry (IHC) assay with confirmatory
NGS
- Evaluating IDE397 in patients with MTAP deletion across
multiple solid tumor types, including non-small cell lung cancer,
pancreatic cancer, thymic cancer, adenoid cystic carcinoma,
esophagogastric cancer and bladder cancer
- Observed in vivo efficacy of IDE397 in combination with
a MTAP-SL inhibitor in preclinical studies, including a complete
response (CR) in NSCLC MTAP-null CDX model
- Targeting IDE397 Phase 1/2 monotherapy cohort expansion and
initiation of Phase 1 combination cohorts in the second or third
quarter, or mid-year, 2022
- Targeting delivery of IDE397 option data package to GSK
mid-year 2022, subject to initiation of expansion cohorts or
establishing the MTD; the option data package will trigger an
evaluation period for GSK to make an opt-in decision
- Subject to GSK election to opt-in, the company is entitled to
receive a $50 million opt-in payment
from GSK, ongoing development costs will be shared as 80% GSK / 20%
IDEAYA, and IDEAYA is entitled to potential development and
regulatory milestones aggregate up to $465
million; upon commercialization, IDEAYA is entitled to 50%
of U.S. net profits and tiered royalties on global non-U.S. net
sales ranging from high single digit to sub-teen double digit
percentages, as well as certain commercial milestones of up to
$475 million
PARG
IDEAYA is advancing preclinical research for an inhibitor of poly
(ADP-ribose) glycohydrolase (PARG) in patients having tumors with a
defined biomarker based on genetic mutations and/or molecular
signature. PARG is a novel target in the same
clinically validated biological pathway as poly (ADP-ribose)
polymerase (PARP). IDEAYA owns or controls all commercial
rights in its PARG program. Highlights:
- Ongoing IND-enabling studies for IDE161, a potential
first-in-class PARG inhibitor development candidate for patients
having tumors with homologous recombination deficiencies (HRD),
including BRCA1 and BRCA2, and potentially other alterations
- Targeting IND for IDE161 in the fourth quarter of 2022
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 are
collaborating on ongoing preclinical research, including small
molecules and protein degraders, and GSK will lead clinical
development for the Pol Theta program. Highlights:
- Targeting development candidate nomination and initiation of
IND-enabling studies for a Pol Theta helicase inhibitor in the
second quarter of 2022 in collaboration with GSK
- Potential for up to $20 million
in aggregate milestone payments from GSK for advancing a Pol Theta
Helicase inhibitor from preclinical to early Phase 1 clinical
Werner Helicase
IDEAYA is advancing preclinical research for an inhibitor targeting
Werner Helicase for tumors with high microsatellite instability
(MSI). IDEAYA and GSK are collaborating on ongoing preclinical
research, and GSK will lead clinical development for the Werner
Helicase program. Highlights:
- Targeting selection of a Werner Helicase development candidate
in 2023
- Potential for up to $20 million
in aggregate milestone payments from GlaxoSmithKline for advancing
a Werner Helicase inhibitor from preclinical to early Phase 1
clinical
Other Synthetic Lethality Pipeline Programs
IDEAYA is advancing additional preclinical research programs to
identify small molecule inhibitors for an MTAP-synthetic lethality
target, as well as for multiple potential first-in-class synthetic
lethality programs for patients with solid tumors characterized by
proprietary biomarkers or gene signatures.
Darovasertib (IDE196)
IDEAYA continues to execute on its clinical trial strategy to
evaluate darovasertib (IDE196), a potent and selective PKC
inhibitor.
IDEAYA is evaluating darovasertib in combination with
crizotinib, a cMET inhibitor, in metastatic uveal melanoma
(MUM). The company is also clinically evaluating darovasertib
as a combination with crizotinib in GNAQ/11 mutant skin melanoma in
an ongoing arm of the current clinical trial, and in adjuvant
primary uveal melanoma (UM) as monotherapy through an investigator
sponsor clinical trial (IST). IDEAYA is also evaluating other
potential darovasertib expansion opportunities, including in cMET
driven tumors and in KRAS-mutation tumors.
Darovasertib / Crizotinib Combination Therapy
IDEAYA
is continuing patient enrollment into the darovasertib / crizotinib
combination arm of the Phase 1/2 clinical trial under clinical
trial collaboration and supply agreements with Pfizer.
Highlights:
- As of May 1, 2022, the company
has enrolled 72 MUM patients into the darovasertib/crizotinib
combination arm; the company is prioritizing enrollment into
first-line MUM based on observed early clinical partial
responses
- IDEAYA presented darovasertib and crizotinib clinical
combination data in December 2021. The reported preliminary
data, based on an unlocked database, showed robust clinical
activity with manageable side effect profile
- In April 2022, the FDA designated
darovasertib as an Orphan Drug in MUM under 21 C.F.R Part
316. Under an Orphan Drug designation, IDEAYA may be entitled
to certain tax credits, exemption from user fees, and subject to
FDA approval of a marketing application for darovasertib as a
designated orphan-drug product, seven years of statutory marketing
exclusivity
- The company is targeting a clinical data update for
darovasertib and crizotinib combination in mid-year 2022, including
tolerability and clinical efficacy. IDEAYA is also planning to seek
FDA regulatory guidance in mid-year 2022 for potential
registration-enabling trial design to evaluate darovasertib and
crizotinib combination in MUM
- Collaborating with Pfizer under a clinical collaboration and
supply agreement to support clinical evaluation of darovasertib and
crizotinib combination in a potential registration-enabling
clinical trial in MUM, subject to FDA feedback and guidance
Darovasertib Monotherapy
IDEAYA has completed
enrollment into its ongoing Phase 1/2 clinical trial evaluating
darovasertib as monotherapy in MUM patients.
IDEAYA is planning to initiate an Investigator Sponsored Trial,
with St. Vincent's Hospital Sydney Limited to evaluate darovasertib
as monotherapy in a neo-adjuvant / adjuvant setting in
(non-metastatic) uveal melanoma (UM) patients.
Darovasertib – Other Potential Indications
IDEAYA is
evaluating the potential for darovasertib in other oncology
indications, including in cMET-driven tumors and in KRAS-mutation
tumors. Highlights:
- Collaborating with Pfizer under a clinical collaboration and
supply agreement for clinical evaluation of darovasertib and
crizotinib combination therapy in cMET-driven tumors, such as NSCLC
or HCC, subject to preclinical validation studies
- Evaluating darovasertib in combination with a KRAS inhibitor in
preclinical studies in KRAS-driven solid tumors
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
$14.0 million and $18.2 million for the three months ended
March 31, 2022 and December 31, 2021, respectively. As of
March 31, 2022, the company had an
accumulated deficit of $190.8
million.
As of March 31, 2022, IDEAYA had
cash, cash equivalents and marketable securities of $346.2million. IDEAYA believes that its
cash, cash equivalents and marketable securities will be sufficient
to fund its planned operations into 2025. These funds will support
the company's efforts through potential achievement of multiple
preclinical and clinical milestones across multiple programs.
Our updated corporate presentation is available on our website,
at our Investor Relations page:
https://ir.ideayabio.com/.
Financial Results
As of March
31, 2022, IDEAYA had cash, cash equivalents and short-term
marketable securities totaling $346.2
million. This compared to cash, cash equivalents and
short-term and long-term marketable securities of $368.1 million at December
31, 2021. The decrease was primarily due to cash used
in operations.
Collaboration revenue for the three months ended March 31, 2022 totaled $11.4 million compared to $3.0 million for the three months ended
December 31, 2021. Collaboration
revenue was recognized for the performance obligations satisfied
through March 31, 2022 under the GSK
Collaboration Agreement.
Research and development (R&D) expenses for the three months
ended March 31, 2022 totaled
$19.7 million compared to
$16.1 million for the three months
ended December 31, 2021. The increase
was primarily due to higher personnel-related expenses, clinical
trial expenses and consulting fees.
General and administrative (G&A) expenses for the three
months ended March 31, 2022 totaled
$5.9 million compared to $5.2 million for the three months ended
December 31, 2021. The increase was
primarily due to higher personnel-related expenses and consulting
fees.
The net loss for the three months ended March 31, 2022 was $14.0
million compared to $18.2
million for the three months ended December 31, 2021. Total stock compensation
expense for the three months ended March 31,
2022 was $2.6 million compared
to $2.1 million for the three months
ended December 31, 2021.
About IDEAYA Biosciences
IDEAYA is a synthetic
lethality focused precision medicine oncology company committed to
the discovery and development of targeted therapeutics for patient
populations selected using molecular diagnostics. IDEAYA's
approach integrates capabilities in identifying and validating
translational biomarkers with drug discovery to select patient
populations most likely to benefit from its targeted
therapies. IDEAYA is applying its research and drug discovery
capabilities to synthetic lethality – which represents an emerging
class of precision medicine targets.
Forward-Looking Statements
This press release contains
forward-looking statements, including, but not limited to,
statements related to (i) the extent to which IDEAYA's existing
cash, cash equivalents, and marketable securities will fund its
planned operations, (ii) the timing of monotherapy cohort expansion
and combination cohort initiation in the IDE397 Phase 1 clinical
trial, (iii) the timing of the delivery of the GSK option data
package, (iii) the timing and content of an additional clinical
data update for the darovasertib and crizotinib combination, (iv)
the timing of submitting an IND for PARG inhibitor, IDE161, (v) the
timing of identification of a development candidate and initiating
IND-enabling studies for a Pol Theta inhibitor, (vi) the timing of
identification of a development candidate for a Werner Helicase
inhibitor, (vii) the potential receipt of GSK milestone payments,
(viii) the timing of obtaining FDA guidance for potential
registration-enabling trial design to evaluate the darovasertib and
crizotinib combination, (ix) the initiation of an IST to evaluate
ID196 in a neo-adjuvant / adjuvant setting, (xi) and (x) the
impact of COVID-19. Such forward-looking statements involve
substantial risks and uncertainties that could cause IDEAYA's
preclinical and clinical development programs, future results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the uncertainties inherent
in the drug development process, including IDEAYA's programs' early
stage of development, the process of designing and conducting
preclinical and clinical trials, the regulatory approval processes,
the timing of regulatory filings, the challenges associated with
manufacturing drug products, IDEAYA's ability to successfully
establish, protect and defend its intellectual property, the
effects on IDEAYA's business of the worldwide COVID-19 pandemic,
the ongoing military conflict between Russia and Ukraine, and other matters that could affect
the sufficiency of existing cash to fund operations. IDEAYA
undertakes no obligation to update or revise any forward-looking
statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of IDEAYA in general, see IDEAYA's recent
Quarterly Report on Form 10-Q filed on May
10, 2022 and any current and periodic reports filed with the
U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Paul Stone
Senior Vice President and Chief Financial Officer
investor@ideayabio.com
IDEAYA Biosciences,
Inc.
|
Condensed Statements
of Operations and Comprehensive Loss
|
(in thousands,
except share and per share amounts)
|
(Unaudited)
|
|
|
Three Months Ended
|
|
March 31,
2022
|
|
December 31,
2021
|
Collaboration
revenue
|
$
|
11,359
|
|
$
|
2,963
|
Operating
expenses:
|
|
|
|
Research and development
|
|
19,656
|
|
|
16,109
|
General and administrative
|
|
5,923
|
|
|
5,223
|
Total operating
expenses
|
|
25,579
|
|
|
21,332
|
Loss from
operations
|
|
(14,220)
|
|
|
(18,369)
|
Interest income and
other income, net
|
|
207
|
|
|
157
|
Net loss
|
|
(14,013)
|
|
|
(18,212)
|
Unrealized loss on marketable securities
|
|
(2,092)
|
|
|
(662)
|
Comprehensive
loss
|
$
|
(16,105)
|
|
$
|
(18,874)
|
Net loss per share
attributable to common
stockholders, basic and diluted
|
$
|
(0.36)
|
|
$
|
(0.47)
|
Weighted-average number
of shares outstanding,
basic and diluted
|
|
38,591,966
|
|
|
38,501,335
|
IDEAYA Biosciences,
Inc.
|
Condensed Balance
Sheet Data
|
(in
thousands)
|
|
|
March 31,
2022
|
|
December 31,
2021
|
|
(Unaudited)
|
|
|
Cash and cash
equivalents and short-term and long-term
marketable securities
|
$
|
346,227
|
|
$
|
368,063
|
Total assets
|
|
358,867
|
|
|
381,347
|
Total
liabilities
|
|
70,200
|
|
|
79,833
|
Total liabilities and
stockholders' equity
|
|
358,867
|
|
|
381,347
|
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SOURCE IDEAYA Biosciences, Inc.