IDEAYA Biosciences, Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update
- Strong cash balance of $632.6 million as of December 31, 2023.
- Targeting multiple Phase 2 clinical updates for darovasertib in neoadjuvant uveal melanoma in mid-2024.
- Established clinical study collaboration with Gilead Sciences for IDE397 and Trodelvy® combo in MTAP bladder cancer.
- Progressing Werner IND-filing in collaboration with GSK with a $7.0 million milestone upon IND clearance.
- Multiple wholly-owned next-generation development candidate nominations in 2024.
- Reported compelling results for darovasertib and crizotinib combination in MUM patients.
- Expanded balance sheet with gross proceeds of $352.0 million in January 2024.
- Recent key developments include IND-enabling studies for Werner helicase inhibitor and new clinical trial collaborations.
- Hosted R&D Investor Day showcasing synthetic lethality pipeline and next-generation initiatives.
- Darovasertib program targets tumors with GNAQ or GNA11 mutations, with FDA Fast Track designation for darovasertib + crizotinib combination in MUM.
- None.
Insights
The financial prospects of IDEAYA Biosciences are bolstered by the recent announcement of their cash balance and additional funding through ATM offerings. With a cash balance of $632.6 million and supplementary net proceeds of $342.3 million, the company is well-capitalized, projecting to fund operations into 2028. This financial stability is critical for investors as it reduces the immediate risk of dilution and provides a runway for the company to advance its pipeline without the need for near-term additional capital raising.
Furthermore, the potential milestone payments from GSK, which could total up to $465.0 million in development milestones and $475.0 million in commercial milestones, represent significant future income streams. This financial incentive structure is indicative of the high stakes and potential rewards associated with drug development, particularly in the oncology space where successful treatments can command premium pricing.
The clinical progress of darovasertib, particularly in neoadjuvant Uveal Melanoma (UM), is noteworthy due to the orphan drug status often associated with rare cancers like UM, which can lead to expedited review and approval processes. The FDA Fast Track designation for the darovasertib and crizotinib combination in metastatic UM (MUM) underscores the unmet medical need in this area and may facilitate a quicker path to market, pending positive clinical outcomes.
The collaboration with Gilead Sciences to evaluate IDE397 in combination with Trodelvy® in MTAP-deletion bladder cancer is another strategic move, potentially expanding the therapeutic reach of IDEAYA's pipeline. The MTAP pathway is a relatively novel target in oncology and advancements here could lead to first-in-class therapies that disrupt the current treatment landscape.
The strategic focus on precision medicine oncology, particularly with the development of darovasertib, IDE397 and the Werner helicase inhibitor, represents a paradigm shift in cancer treatment towards more targeted therapies. The mention of superior clinical efficacy of the darovasertib and crizotinib combination compared to standard of care is significant, as it suggests a potential improvement in treatment outcomes for patients with MUM, a disease with historically poor prognoses.
Moreover, the expansion of the darovasertib and crizotinib combination trial into cutaneous melanoma indicates the potential versatility of the drug, which could lead to broader applications and market opportunities. The company's focus on multiple first-in-class programs is ambitious and, if successful, could lead to breakthroughs in the treatment of various cancers with high unmet needs.
- Targeting two independent Phase 2 clinical efficacy updates for darovasertib in neoadjuvant uveal melanoma (UM) in mid-2024, including from the Phase 2 IST and Phase 2 company-sponsored study
- Targeting FDA regulatory guidance on darovasertib in neoadjuvant UM indication in 2024
- Ongoing enrollment of IDE397 and AMG 193 Phase 1 combo in MTAP solid tumors and targeting development of joint Amgen / IDEAYA publication strategy in 2024
- Established clinical study collaboration with Gilead Sciences to evaluate IDE397 and Trodelvy® combo in MTAP bladder cancer with FPI targeted for mid-year 2024
- Targeting IDE161 clinical program update(s) and enabling of clinical combination(s) in 2024
- Targeting Werner IND-filing in 2024 (
$7.0 million - Targeting multiple wholly-owned next generation development candidate nominations in 2024, including in MTAP, representing 7 or more potential first-in-class programs
$632.6 million $342
"We believe the ongoing clinical advancement of darovasertib in neoadjuvant Uveal Melanoma, IDE397 and AMG 193 clinical combination in MTAP solid tumors, and IDE161 and GSK101 both in HRD solid tumors, represent important clinical initiatives for IDEAYA in 2024 as potential first-in-class opportunities that address high unmet medical needs. Next, we are targeting this year the Werner IND-filing and multiple development candidate nominations, including in MTAP, representing 7 or more potential first-in-class programs and further advancing our vision to build a leading precision medicine oncology company," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.
"We have seen compelling results from our Phase 2 darovasertib and crizotinib program in patients with MUM and are targeting two clinical efficacy updates from our Phase 2 company sponsored neoadjuvant UM study and Phase 2 IST in mid-year 2024. Our IDE397 program trials remain on track, and we established a new clinical trial collaboration with Gilead Sciences to evaluate IDE397 in combination with Trodelvy® in patients with bladder cancer, with trial initiation activities now underway. Additionally, IND-enabling studies of the Werner helicase inhibitor for microsatellite instability (MSI)-high cancers are progressing well, further expanding our pipeline of first-in-class precision medicine candidates." added Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
Recent Key Developments
- Reported top-line results of darovasertib and crizotinib combination demonstrating evidence of superior clinical efficacy in any-line and first-line MUM patients compared to standard of care as a Proffered Paper oral presentation at the 2023 European Society for Medical Oncology's Congress (ESMO).
- Expanded Phase 2 trial evaluating the darovasertib and crizotinib combination in GNAQ/11 metastatic cutaneous melanoma based on preliminary clinical efficacy observed.
- Selected Werner helicase inhibitor development candidate and progressing IND-enabling GLP studies in collaboration with GSK; received
$3.0 million $17.0 million $7.0 million $465.0 million $475.0 million 50% ofU.S. net profits. - Established clinical study collaboration with Gilead Sciences to evaluate IDE397 and Trodelvy® combination in MTAP-deletion bladder cancer.
- Significantly expanded balance sheet
- Raised gross proceeds of approximately
$352.0 million - Raised gross proceeds of approximately
$143.7 million
- Raised gross proceeds of approximately
- Hosted an R&D Investor Day in December 2023 showcasing the synthetic lethality pipeline, including IDE397 in Phase 2, IDE161 in Phase 1, GSK101/IDE705 in Phase 1, and the Werner Helicase program, as well as its next generation initiatives for MTAP-deletion.
Clinical Programs Update and Upcoming Milestones
Darovasertib Program in Tumors with GNAQ or GNA11 Mutations
Darovasertib is a potent and selective protein kinase C (PKC) inhibitor for which the Company owns the worldwide commercial rights, subject to certain economic obligations pursuant to its exclusive, worldwide license with Novartis. IDEAYA is developing darovasertib to broadly address primary and metastatic UM.
Darovasertib is currently being evaluated in four ongoing clinical trials, three of which are in collaboration with Pfizer. The darovasertib + crizotinib combination in MUM has
IDE196-002: Phase 2/3 Potential Registration-Enabling Clinical Trial of Darovasertib + Crizotinib combination in First-Line HLA-A2*02:01(-) MUM
This study (NCT05987332) has an accelerated approval trial design and international site activation, and double-digit patient enrollment has been achieved to date. The company has several clinical sites open and is targeting to open an aggregate of over 50 clinical sites across
IDE196-001: Phase 1/2 Clinical Trial Evaluating Darovasertib + Crizotinib Combination in MUM
A clinical update of preliminary data from 20 evaluable first-line and 63 evaluable any-line patients from the study (NCT03947385) at the expansion dose of 300 mg twice-a-day darovasertib and 200 mg twice-a-day crizotinib was presented at ESMO 2023. Darovasertib and crizotinib combination treatment demonstrated evidence of superior clinical efficacy in any-line and first-line compared to standard of care. The detailed results can be found here.
Phase 2 Clinical Trial Evaluating Darovasertib Combination in Cutaneous Melanoma
Based on the Cancer Genome Atlas, about
Along with other available data and IDEAYA's strategic priority to broaden its darovasertib program to the multiple solid tumor setting, in October 2023, the Company expanded its Phase 2 expansion of the darovasertib and crizotinib combination in metastatic cutaneous melanoma.
The expansion was based on preliminary clinical activity observed in three cohorts of patients treated with darovasertib, either as monotherapy or in combination with either binimetinib or crizotinib. The detailed results were reported in October 2023 and can be found here.
Phase 1 and 2 Trials Darovasertib as Neoadjuvant / Adjuvant Therapy in Primary UM
Darovasertib is being evaluated as monotherapy in two clinical trials as neoadjuvant / adjuvant therapy:
- IDE196-009: a company-sponsored Phase 2 trial (NCT05907954) evaluating darovasertib as neoadjuvant treatment of UM prior to primary interventional treatment of enucleation or radiation therapy, and as adjuvant therapy following the primary treatment.
- Phase 1 Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma, or NADOM: an investigator-sponsored trial (IST) Phase 1 study (NCT05187884). The study is being led by Anthony Joshua, MBBS, PhD, FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent's Hospital in Sydney with additional participating sites in Melbourne,
Australia .
The clinical objectives of 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. Preliminary clinical data of darovasertib as neoadjuvant treatment showed evidence of anti-tumor activity and supported further clinical evaluation of darovasertib to determine its potential as a neoadjuvant therapy or an adjuvant therapy.
As of February 1, 2024, double digit patients have been dosed with several sites open and actively recruiting additional patients into the company-sponsored Phase 2 clinical trial. Two independent clinical efficacy updates for darovasertib in neoadjuvant UM are anticipated in mid-2024, including from the Phase 2 IST study and IDEAYA's Phase 2 company-sponsored study. A regulatory guidance update is planned in 2024.
In preliminary results from the Phase 1 NADOM trial darovasertib demonstrated eye preservation in 3 of 6 (
IDE397 Program in Solid Tumors and Bladder Cancer with MTAP Deletion
IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. MTAP deletion is found in
The Company is focused on evaluating IDE397 in select monotherapy indications and in high conviction clinical combinations with AMG 193, Amgen's investigational MTA-cooperative PRMT5 inhibitor, and in combination with Gilead's Trop-2 directed antibody-drug conjugate (ADC) Trodelvy (Sacituzumab-govitecan-hziy). IDEAYA owns all rights, title, and interest in and to the IDE397 and MAT2A program, including all worldwide commercial rights thereto.
IDE397-001: Phase 2 IDE397 Monotherapy Expansion in MTAP-Deletion NSCLC and Bladder Cancer
The Company-sponsored IDE397 monotherapy Phase 2 expansion trial (NCT04794699) is continuing to enroll patients with MTAP-deletion squamous NSCLC and bladder cancers.
Preliminary clinical data demonstrated responses in multiple MTAP-deletion high-priority tumor types based on experience across several patients in the early phase of the monotherapy dose expansion:
- RECIST 1.1 compete response in a bladder cancer patient and a
33% tumor reduction in squamous NSCLC patient as measured by CT-PET. - Multiple ctDNA molecular responses were observed in NSCLC and bladder cancer patients.
- Low rates of discontinuations and serious adverse events (SAEs) were observed.
- As of October 13, 2023: 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.
Phase 1/2 trial of IDE397 + AMG 193 in MTAP-Deletion NSCLC
Enrollment is ongoing in the dose escalation portion of the Amgen-sponsored Phase 1/2 trial (NCT05975073) evaluating IDE397 and AMG 193 (PRMT5MTA)) combination in patients with MTAP-deletion solid tumors. Additionally, in 2024, the Company will develop a joint publication strategy with Amgen.
Phase 1 trial of IDE397 + Trodelvy in MTAP-Deletion Bladder Cancer
The Company-sponsored Phase 1 (NCT04794699) in patients with MTAP-deletion bladder cancer will evaluate IDE397 in combination with Trodelvy, a Trop-2 directed ADC which is currently approved in the
Trial initiation activities are under way and the first-patient-in is anticipated in mid-2024.
IDE161 Program in Tumors with Homologous Recombination Deficiency
IDE161 is a potential first-in-class inhibitor of poly(ADP-ribose) glycohydrolase (PARG), 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
IDE161 received two FDA Fast Track designations in platinum-resistant advanced or metastatic ovarian cancer patients having tumors with BRCA1/2 mutations, and pretreated advanced or metastatic HR+, Her2-, BRACA1/2 mutant breast cancer.
IDE161-001: Phase 1/2 of IDE161 Monotherapy Dose Escalation and Expansion in HRD Solid Tumors
The Phase 1 trial (NCT05787587) is evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 in patients having tumors with homologous recombination deficiency (HRD). Early clinical data from the dose escalation cohorts showed:
- Multiple partial responses (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 PR, which was subsequently confirmed by RECIST 1.1 at the second scan and an
87% reduction of the CA-125 marker. - A colorectal cancer subject with a second imaging assessment of a PR, which was subsequently confirmed by RECIST 1.1
- Over
50% reduction in prostate-specific antigen (PSA) in prostate cancer patient with non-measurable disease
- An endometrial cancer subject with a first imaging assessment of a PR, which was subsequently confirmed by RECIST 1.1 at the second scan and an
- No drug related discontinuations or SAEs at the IDE161 expansion dose observed.
- Phase 1 dose optimization is ongoing to confirm move forward Phase 2 expansion dose.
The Phase 1 expansion trial continues to enroll in HRD solid tumor types, including ER+ HER-breast, colorectal, endometrial, and prostate cancers. Clinical program update(s) are expected in 2024. IDEAYA is also validating IDE161 combination opportunities preclinically and is targeting identification of potential combination(s) in 2024.
GSK-Partnered Programs
GSK101 (IDE705) Program in Tumors with Homologous Recombination Mutations or HRD
GSK101 (IDE705) is a potential first-in-class small molecule inhibitor of Pol Theta Helicase being developed as a combination treatment with niraparib for advanced solid tumors with HRD. IND clearance was obtained from the
Werner Helicase Inhibitor in Tumors with High Microsatellite Instability
IDEAYA, in collaboration with GSK, selected a Werner Helicase inhibitor for further development and IDEAYA earned a
Next-Generation Precision Medicine Pipeline Programs
IDEAYA has initiated early preclinical research programs focused on pharmacological inhibition of several new targets 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.
Select Fourth Quarter and Full-Year 2023 Financial Results
As of December 31, 2023, IDEAYA had cash, cash equivalents and marketable securities of
Subsequent to the reporting period for the quarter ended December 31, 2023, the Company generated gross proceeds of approximately
IDEAYA believes that its cash, cash equivalents and marketable securities of
Collaboration revenue for the three months ended December 31, 2023, totaled
Research and development (R&D) expenses for the three months ended December 31, 2023, totaled
General and administrative (G&A) expenses for the three months ended December 31, 2023, totaled
The net loss for the three months ended December 31, 2023, was
The net loss for the year ended December 31, 2023, was
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.
IDEAYA's updated corporate presentation is available on its website, at its Investor Relations page: https://ir.ideayabio.com/.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing, content and venue of clinical program updates, (ii) the timing of FDA regulatory guidance, (iii) the timing for the development of a joint Amgen/IDEAYA publication strategy, (iv) the timing of a first-patient-in in the IDE397 and Trodelvy combination study, (v) additional clinical combinations, (vi) the timing of IND submission for the Werner Helicase inhibitor DC, (vii) the timing of designation of next generation development candidates, (viii) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations, (ix) the potential therapeutic benefits of IDEAYA therapeutics, (x) the translation of preliminary clinical trial results into future clinical trial results, (xi) the estimate of patient populations, and (xii) 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
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 | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||||
Collaboration revenue | $ | 3,923 | $ | 4,022 | $ | 23,385 | $ | 50,931 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 38,770 | 24,714 | 129,508 | 89,536 | ||||||||||||
General and administrative | 7,068 | 5,752 | 28,306 | 23,897 | ||||||||||||
Total operating expenses | 45,838 | 30,466 | 157,814 | 113,433 | ||||||||||||
Loss from operations | (41,915) | (26,444) | (134,429) | (62,502) | ||||||||||||
Interest income and other income, | 7,960 | 2,243 | 21,468 | 3,847 | ||||||||||||
Net loss | (33,955) | (24,201) | (112,961) | (58,655) | ||||||||||||
Unrealized gains (losses) on | 1,312 | 1,131 | 3,433 | (2,159) | ||||||||||||
Comprehensive loss | $ | (32,643) | $ | (23,070) | $ | (109,528) | $ | (60,814) | ||||||||
Net loss per share | $ | (0.52) | $ | (0.50) | $ | (1.96) | $ | (1.42) | ||||||||
Weighted-average number of shares | 65,246,361 | 48,132,003 | 57,519,929 | 41,444,696 | ||||||||||||
IDEAYA Biosciences, Inc. | ||||||||
Condensed Balance Sheet Data | ||||||||
(in thousands) | ||||||||
December 31, | December 31, | |||||||
2023 | 2022 | |||||||
(Unaudited) | ||||||||
Cash and cash equivalents and short-term and | $ | 632,606 | $ | 373,146 | ||||
Total assets | 649,316 | 387,969 | ||||||
Total liabilities | 28,226 | 38,514 | ||||||
Total liabilities and stockholders' equity | 649,316 | 387,969 | ||||||
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SOURCE IDEAYA Biosciences, Inc.
FAQ
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