- Strong balance sheet of ~$324
million cash, cash equivalents and marketable securities as
of June 30, 2022 is anticipated to
fund planned operations into 2025
- Initiated IDE397 Phase 2 monotherapy expansion cohorts and
Phase 1 combination dose escalation cohorts in solid tumors with
MTAP deletion
- Entered into Clinical Trial Collaboration and Supply Agreement
with Amgen to clinically evaluate IDE397 MAT2A inhibitor in
combination with AMG 193, Amgen's investigational small molecule
MTA-cooperative inhibitor of PRMT5, in MTAP-null solid tumors
- Retained worldwide rights to IDE397, following GSK waiver of
its option to an exclusive license to further develop and
commercialize IDE397
- Targeting interim Phase 2 clinical data update for darovasertib
and crizotinib synthetic lethal combination in MUM in September 2022, including ORR, mPFS, mDOR, and
AEs
- Tracking to submit an IND in Q4 2022 for PARG development
candidate IDE161
- Selected potential first-in-class Pol Theta Helicase
development candidate with GSK, and targeting Phase 1 initiation in
H1 2023 for solid tumors with HRD
SOUTH
SAN FRANCISCO, Calif., Aug. 15,
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 second quarter ended June 30, 2022.
"The IDE397 program is at a key inflection point, and as a
wholly-owned program, is uniquely positioned for value accretion as
we initiate monotherapy expansion and combination cohorts. Our
clinical trial collaboration with Amgen enables clinical evaluation
of IDE397 in combination with AMG 193, Amgen's investigational
MTA-cooperative PRMT5 inhibitor, a potential first-in-class
combination inhibiting two complementary synthetic lethal nodes
within the MTAP pathway. The clinical ctDNA molecular response data
from the IDE397 monotherapy dose escalation demonstrates target
engagement and tumor pharmacodynamic modulation, and provides
additional data on clinical activity," said Yujiro S. Hata, President and Chief Executive
Officer, IDEAYA Biosciences.
"We look forward to providing the interim Phase 2 clinical data
update for darovasertib and crizotinib synthetic lethal combination
in first-line and any-line MUM patients in September 2022. This clinical data update will
include, confirmed ORR by RECIST, median PFS, median
duration-of-response, and an adverse event summary. We will also
provide an update on a potential registrational path in MUM, and
share observations supporting clinical proof of concept for
potential use of darovasertib in the (neo)adjuvant UM setting,"
continued Mr. Hata.
"We have a pipeline of potential first-in-class synthetic
lethality therapeutics advancing toward the clinic. We are
targeting an IND in Q4 2022 for IDE161, our PARG inhibitor, for
patients having tumors with HRD. In collaboration with GSK, we are
targeting first-in-human clinical evaluation in H1 2023 for our Pol
Theta Helicase development candidate in combination with niraparib
for patients having tumors with HRD, and our Werner Helicase
program with GSK continues to be on track for development candidate
nomination 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 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). Highlights:
- Patients are being identified by next generation sequencing
(NGS) or by MTAP immunohistochemistry (IHC) assay with confirmatory
NGS
- Initiated monotherapy expansion cohorts with enrollment open
for NSCLC and esophagogastric tumors with MTAP deletion
- Initiated combination dose escalation cohorts with enrollment
open for combinations with docetaxel in NSCLC, paclitaxel in
esophagogastric cancer, and with pemetrexed in NSCLC and
potentially other solid tumors
- Entered into Clinical Trial Collaboration and Supply Agreement
with Amgen to clinically evaluate IDE397 MAT2A inhibitor in
combination with AMG 193, Amgen's investigational small molecule
MTA-cooperative inhibitor of PRMT5, in MTAP-null solid tumors
- Delivered IDE397 option data package to GSK comprising
preclinical data and clinical data from the monotherapy dose
escalation study of the Phase 1 clinical trial, including safety
and tolerability data, pharmacokinetic and pharmacodynamic data
- Retained and fully own all right, title and interest in and to
IDE397 and the MAT2A Program, following receipt of notice from GSK
waiving its rights to exercise its option to obtain an exclusive
license to further develop and commercialize IDE397, as well as
other IDEAYA compounds, if any, directly targeting MAT2A
-
- Wholly-owned Phase 2 clinical asset, IDE397 provides company
with additional strategic optionality as monotherapy and
combination therapies advance
- Strategic rationale of the IDE397 collaboration with GSK became
less compelling for IDEAYA following GSK termination of its
internal PRMT5 and Type 1 PRMT clinical programs, each of which was
contemplated as a potential combination partner with IDE397 when
the partnership was formed in June
2020
- IDEAYA is sufficiently capitalized to execute the IDE397 Phase
2 clinical program
- Demonstrated IDE397 clinical tumor pharmacodynamic modulation
based on ctDNA Molecular Responses observed in thirteen evaluable
patients with liquid biopsy samples available at baseline and after
first treatment cycle, including:
-
- 31% (n=4 of 13) of evaluable patients treated with IDE397
across all dose escalation Cohorts 1 thru 6 observed ctDNA
molecular responses
- 75% (n=3 of 5) of evaluable patients treated with IDE397 at
higher doses in Cohorts 5 and 6 observed ctDNA molecular
responses
- 100% (n=2 of 2) of evaluable NSCLC patients observed ctDNA
molecular responses
Darovasertib (PKC)
IDEAYA continues to advance its Phase 1/2 clinical trial evaluating
darovasertib (IDE196), a potent and selective PKC inhibitor, 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 (neo)adjuvant uveal melanoma (UM) as monotherapy through an
investigator sponsor clinical trial (IST).
IDEAYA is planning to initiate a company-sponsored clinical
trial to evaluate darovasertib in (neo)adjuvant uveal melanoma. The
company is also evaluating other potential darovasertib expansion
opportunities, including in cMET driven tumors and in KRAS-mutation
tumors.
Darovasertib / Crizotinib Combination Therapy in Metastatic
Uveal Melanoma (MUM)
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:
- IDEAYA presented preliminary darovasertib and crizotinib
clinical combination data in December
2021. The reported preliminary data, based on an unlocked
database, showed robust clinical activity, including 31% ORR (n=4
of 13 evaluable) in heavily pre-treated MUM patents, with
manageable side effect profile
- Historical % ORR and median PFS by other therapies in MUM have
been low, including ranging from 0% to 5% ORR and 2 to 3 months
median PFS
- Prioritizing enrollment of additional first-line MUM patients
based on observed early clinical partial responses
- Targeting interim Phase 2 clinical results for darovasertib and
crizotinib synthetic lethal combination in first-line and any-line
MUM patients in September 2022,
including:
-
- clinical efficacy in MUM based on confirmed overall response
rate by RECIST, median progression-free survival, median duration
of response and adverse event summary
- potential registrational path for darovasertib and crizotinib
combination in MUM
- clinical proof of concept for potential use of darovasertib in
(neo) adjuvant UM
- In April 2022, the FDA designated
darovasertib as an Orphan Drug in Uveal Melanoma, including 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 – (Neo)Adjuvant Uveal Melanoma
(UM)
IDEAYA is evaluating the potential for darovasertib in
neoadjuvant and/or adjuvant uveal melanoma. Highlights:
- (Neo)adjuvant UM represents a significant expansion opportunity
– with a potential annual incidence of approximately 6,400 patients
aggregate in US and Europe
- IDEAYA has initiated an Investigator Sponsored Trial with St.
Vincent's Hospital Sydney Limited to evaluate darovasertib as
monotherapy in a neo-adjuvant and/or adjuvant setting in uveal
melanoma patients
Darovasertib – Other Potential Indications
IDEAYA is
evaluating the potential for darovasertib in other oncology
indications, including in cMET-driven tumors and RAS-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; targeting initiation of a Phase 1/2 clinical trial in the
first quarter of 2023
- Evaluating darovasertib in combination with a KRAS inhibitor in
preclinical studies in KRAS-driven solid tumors
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
- Considering potential development approaches based on observed
activity of IDE161 in PARPi resistant and/or platinum-resistant
tumors, differentiated sensitivity relative to PARP inhibitors, and
improved preliminary safety profile relative to PARP
inhibitors
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:
- Selected a potential first-in-class Pol Theta Helicase
development candidate in collaboration with GSK
- Observed complete responses in preclinical combination studies
of Pol Theta Helicase DC with niraparib in multiple in vivo PDX and
CDX HRD models
- Targeting first-in-human clinical evaluation of Pol Theta
Helicase DC combination with niraparib in H1 2023 for patients
having tumors with HRD
- IDEAYA is eligible to receive future development and regulatory
milestones of up to $485 million
aggregate from GSK:
-
- Preclinical and clinical milestones of up to $20 million in aggregate for advancing a Pol
Theta Helicase inhibitor from preclinical to early Phase 1
clinical, including up to $10 million
aggregate through IND effectiveness
Werner Helicase
IDEAYA is advancing preclinical research for an inhibitor targeting
Werner Helicase for tumors with high microsatellite instability
(MSI). IDEAYA and GSK are collaborating on ongoing preclinical
research, and GSK will lead clinical development for the Werner
Helicase program. Highlights:
- Targeting selection of a Werner Helicase development candidate
in 2023
- 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.
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
$22.1 million and $14.0 million for the three months ended
June 30, 2022 and March 31, 2022, respectively. As of June 30, 2022, the company had an accumulated
deficit of $212.8 million.
As of June 30, 2022, IDEAYA had
cash, cash equivalents and marketable securities of $323.8 million. 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 June
30, 2022, IDEAYA had cash, cash equivalents and short-term
marketable securities totaling $323.8
million. This compared to cash, cash equivalents and
short-term and long-term marketable securities of $346.2 million at March
31, 2022. The decrease was primarily due to cash used in
operations.
Collaboration revenue for the three months ended June 30, 2022 totaled $5.9
million compared to $11.4
million for the three months ended March 31, 2022. Collaboration revenue was
recognized for the performance obligations satisfied through
June 30, 2022 under the GSK
Collaboration Agreement.
Research and development (R&D) expenses for the three months
ended June 30, 2022 totaled
$22.8 million compared to
$19.7 million for the three months
ended March 31, 2022. The increase
was primarily due to higher personnel-related expenses, clinical
trial expenses and outside services.
General and administrative (G&A) expenses for the three
months ended June 30, 2022 totaled
$5.6 million compared to $5.9 million for the three months ended
March 31, 2022. The decrease was
primarily due to lower personnel-related expenses and outside
services.
The net loss for the three months ended June 30, 2022 was $22.1
million compared to $14.0
million for the three months ended March 31, 2022. Total stock compensation expense
for the three months ended June 30,
2022 was $3.0 million compared
to $2.6 million for the three months
ended March 31, 2022.
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 and content of an additional
clinical data update for the darovasertib and crizotinib
combination, (iii) the timing of submitting an IND for PARG
inhibitor, IDE161, (iv) the timing of identification of initiating
first-in-human clinical evaluation of Pol Theta inhibitor with
niraparib, (v) the initiation of an IST to evaluate ID196 in a
neo-adjuvant / adjuvant setting, (vi) the timing of initiation of a
Phase 1/2 darovasertib and crizotinib clinical trial in cMET-driven
tumors, (vii) the timing of identification of a development
candidate for a Werner Helicase inhibitor, and (viii) 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 August 15, 2022 and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
IDEAYA Biosciences,
Inc. Condensed Statements of Operations and Comprehensive
Loss (in thousands, except share and per share
amounts) (Unaudited)
|
|
|
|
|
|
Three Months
Ended
|
|
|
Six Months
Ended
|
|
|
|
June 30,
2022
|
|
|
March 31,
2022
|
|
|
June 30,
2022
|
|
|
June 30,
2021
|
|
Collaboration
revenue
|
|
$
|
5,851
|
|
|
$
|
11,359
|
|
|
$
|
17,210
|
|
|
$
|
16,003
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
22,796
|
|
|
|
19,656
|
|
|
|
42,451
|
|
|
|
26,546
|
|
General and
administrative
|
|
|
5,554
|
|
|
|
5,923
|
|
|
|
11,478
|
|
|
|
9,643
|
|
Total operating
expenses
|
|
|
28,350
|
|
|
|
25,579
|
|
|
|
53,929
|
|
|
|
36,189
|
|
Loss from
operations
|
|
|
(22,499)
|
|
|
|
(14,220)
|
|
|
|
(36,719)
|
|
|
|
(20,186)
|
|
Interest income and
other income, net
|
|
|
443
|
|
|
|
207
|
|
|
|
650
|
|
|
|
218
|
|
Net loss
|
|
|
(22,056)
|
|
|
|
(14,013)
|
|
|
|
(36,069)
|
|
|
|
(19,968)
|
|
Unrealized loss on
marketable securities
|
|
|
(825)
|
|
|
|
(2,092)
|
|
|
|
(2,917)
|
|
|
|
(11)
|
|
Comprehensive
loss
|
|
$
|
(22,881)
|
|
|
$
|
(16,105)
|
|
|
$
|
(38,986)
|
|
|
$
|
(19,979)
|
|
Net loss per share
attributable to common
stockholders, basic and diluted
|
|
$
|
(0.57)
|
|
|
$
|
(0.36)
|
|
|
$
|
(0.93)
|
|
|
$
|
(0.62)
|
|
Weighted-average number
of shares outstanding,
basic and diluted
|
|
|
38,660,971
|
|
|
|
38,591,966
|
|
|
|
38,626,659
|
|
|
|
32,321,481
|
|
IDEAYA Biosciences,
Inc. Condensed Balance Sheet Data (in
thousands)
|
|
|
|
|
|
June 30,
2022
|
|
|
December 31,
2021
|
|
|
|
(Unaudited)
|
|
|
|
|
Cash and cash
equivalents and short-term and long-term
marketable securities
|
|
$
|
323,791
|
|
|
$
|
368,063
|
|
Total assets
|
|
|
338,007
|
|
|
|
381,347
|
|
Total
liabilities
|
|
|
68,686
|
|
|
|
79,833
|
|
Total liabilities and
stockholders' equity
|
|
|
338,007
|
|
|
|
381,347
|
|
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SOURCE IDEAYA Biosciences, Inc.