11/04/2024 | Press release | Distributed by Public on 11/04/2024 07:36
In the news release, IDEAYA Biosciences, Inc. Reports Third Quarter 2024 Financial Results and Provides Business Update, issued Nov. 4, 2024by IDEAYA Biosciences, Inc. over PR Newswire, we are advised by the company that the first subhead should read "Enrollment in darovasertib + crizotinib 1L HLA-A2(-) MUM potential..." rather than "Enrollment in darovasertib + crizotinib 1L HLA-A2+ MUM potential..." as originally issued inadvertently. The complete, corrected release follows:
IDEAYA Biosciences, Inc. Reports Third Quarter 2024 Financial Results and Provides Business Update
SOUTH SAN FRANCISCO, Calif., Nov. 4, 2024/PRNewswire / -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, provided a business update, and announced financial results for the third quarter ended September 30, 2024.
"This was a transformational quarter for IDEAYA, including completion of an oversubscribed ~$302.4 millionfollow-on financing, a late breaker oral presentation at ENA 2024 for IDE397 in heavily pre-treated MTAP-deletion urothelial and lung cancer patients, and a successful Type C meeting with the FDA to enable a potential registration-enabling trial for darovasertib in neoadjuvant uveal melanoma. Next, we received IND clearance for Werner Helicase inhibitor IDE275 with our partner GSK, representing our fifth potential first-in-class clinical program," said Yujiro S. Hata, Chief Executive Officer and Founder, IDEAYA Biosciences. "We continue to execute on our strategic vision to build a leading precision medicine oncology pipeline, and are on track to nominate our 6th, 7th, and 8th development candidate by year-end, including from our B7H3/PTK7 bi-specific topo-ADC, MTAP-deletion, and KAT6 pathway programs. We look forward to highlighting IDEAYA's potential first-in-class preclinical and clinical programs, and to continue to establish our scientific leadership in precision medicine oncology at our upcoming investor R&D day," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.
"This past quarter, we made significant progress on the darovasertib program, including being ahead of our enrollment targets for the first-line MUM potential registration-enabling trial, and a successful Type C meeting with the FDA to inform a potentially registration-enabling trial in the neoadjuvant uveal melanoma setting. Next, the clinical data update from ENA 2024, provides further clinical proof-of-concept for IDE397 at the RP2D in MTAP-deletion urothelial and lung cancer. We are excited to advance our broader IDE397 rational combination strategy, including target expansion with AMG 193 in MTAP-deletion NSCLC in late 2024 to early 2025, and target expansion with Trodelvy® (sacituzumab govitecan-hziy), Gilead's Trop-2 directed antibody-drug conjugate, in MTAP-deletion urothelial cancer in the fourth quarter. Lastly, we are targeting to select a monotherapy expansion dose for IDE161, and achieve FPI in combination with Keytruda in MSI-High and MSS endometrial cancer by year-end," added Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
Summary of Q3 and Recent Key Developments
Research and Clinical Development
Corporate Development
Clinical Programs and Upcoming Milestones
Darovasertib (IDE196) Program in Tumors with GNAQ or GNA11 Mutations
Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed to broadly address primary and metastatic UM. Darovasertib is currently being evaluated in four ongoing clinical trials. The darovasertib and crizotinib combination in MUM has FDA Fast Track designation:
IDE397 Program in Tumors 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. IDEAYA continues to evaluate IDE397 in two trials in select monotherapy indications and in high conviction clinical combinations:
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). IDE161 received two FDA Fast Track designations in platinum-resistant advanced or metastatic ovarian cancer patients having tumors with BRCA1/2 mutations, and in pretreated advanced or metastatic HR+, Her2-, BRACA1/2 mutant breast cancer.
IDE161 is currently being evaluated in IDE161-001 (NCT05787587), a Phase 1 trial of IDE161 monotherapy in solid tumors with homologous recombination deficiency (HRD) and in the planned combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in microsatellite instability high (MSI-High) and microsatellite stable (MSS) endometrial cancer. Selection of an initial Phase 1/2 IDE161 monotherapy expansion dose in priority solid tumors type(s) is targeted in the fourth quarter of 2024. Separately, a first-patient-in for IDE161 in combination with KEYTRUDA is targeted in the fourth quarter of 2024. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
In addition, preclinical results on IDE161 and ADC combination rationale were presented as a poster at ENA 2024.
GSK-Partnered Programs
IDE705 (GSK101) Program in Tumors with HRD
IDE705 (GSK101) 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. The dose escalation portion of the GSK-sponsored Phase 1/2 clinical trial to evaluate GSK101 in combination with niraparib, the GSK small molecule inhibitor of PARP, for patients having solid tumors with BRCA or other HR mutations, or with HRD is currently ongoing.
Upon initiation of the Phase 1 dose expansion, IDEAYA will be eligible to receive a $10.0 million milestone payment, with the collaboration having potential further aggregate later-stage development and regulatory milestones of up to $465.0 million. GSK is responsible for all research and development costs for the program. Upon commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones, and tiered royalties on global net sales of GSK101 - ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions.
IDE275 (GSK959) Program in Tumors with MSI-High
IDE275 (GSK959) is a potential first-in-class Werner helicase inhibitor that received FDA IND clearance for a Phase 1 trial in October 2024. The GSK-sponsored Phase 1 trial will evaluate IDE275 (GSK959) in patients having MSI-High tumors, as a monotherapy and in combination with a PD-1 inhibitor.
IDEAYA earned a $7 millionmilestone payment for the IND clearance and has the potential to earn up to an additional $10.0 million upon initiation of Phase 1 clinical dose expansion. In addition, IDEAYA is entitled to receive up to $465.0 million in further later-stage development and regulatory milestones. GSK is responsible for 80% of global research and development costs and IDEAYA is responsible for 20% of such costs. Upon commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones, 50% of U.S. net profits and tiered royalties on global non-U.S. net sales of the Werner Helicase inhibitor development candidate (DC) - ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions.
B7H3/PTK7 Topo-Payload BsADC Program
IDEAYA entered into an option and license agreement for a potential first-in-class B7H3/PTK7 Topo-Payload BsADC program with Biocytogen in July 2024. The agreement grants IDEAYA an option for an exclusive worldwide license from Biocytogen for a potential first-in-class B7H3/PTK7 Topo-Payload BsADC program. B7H3/PTK7 has been found to be co-expressed in multiple solid tumor types, including double-digit percent prevalence in lung, colorectal, and head and neck cancers, among others. Based on preclinical data, the potential first-in-class B7H3/PTK7 Topo-Payload BsADC program has the potential to be developed as a monotherapy agent and used in combination with multiple programs in IDEAYA's pipeline targeting DDR-based therapies, including the PARG inhibitor IDE161. A development candidate nomination for the B7H3/PTK7 Topo-Payload BsADC program is targeted in the fourth quarter of 2024.
Next-Generation Precision Medicine Pipeline Programs
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 are ongoing. These programs have the potential for discovery and development of first-in-class or best-in-class therapeutics with multiple wholly owned DC nominations targeted in the fourth quarter of 2024, including in MTAP-deletion solid tumors indications to enable a potential wholly-owned clinical combination with IDE397, and separately a DC nomination in the lysine acetyltransferase 6 (KAT6) pathway.
Financial Results
As of September 30, 2024, IDEAYA had cash, cash equivalents and marketable securities totaling $1.2 billion. This compared to cash, cash equivalents and marketable securities of $952.7 millionas of June 30, 2024. The increase was primarily attributable to $283.8 millionin net proceeds from the underwritten public offering of common stock and pre-funded warrants to purchase common stock in July 2024, partially offset by net cash used in operations.
Research and development (R&D) expenses for the three months ended September 30, 2024totaled $57.2 millioncompared to $54.5 millionfor the three months ended June 30, 2024. The increase was primarily due to clinical trial and outside services expenses.
General and administrative (G&A) expenses for the three months ended September 30, 2024totaled $9.7 millioncompared to $10.4 millionfor the three months ended June 30, 2024. The decrease was primarily due to stock-based compensation expense.
The net loss for the three months ended September 30, 2024was $51.8 millioncompared to the net loss of $52.8 millionfor the three months ended June 30, 2024. Total stock compensation expense for the three months ended September 30, 2024was $9.2 millioncompared to $9.7 millionfor the three months ended June 30, 2024.
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 expansion of Phase 1/2 trial of IDE397 in combination with Trodelvy® in MTAP-deletion UC, (iii) the timing of expansion of Phase 1 trial of IDE397 in combination with AMG 193 in NSCLC, (iv) the timing of finalization of Phase 3 registration trial protocol and initiation of trial for darovasertib, (v) the timing of a first-patient-in in the IDE161 and KEYTRUDA combination study, (vi) the timing of DC nominations for MTAP-deletion, KAT6 pathway and B7H3/PTK7 Topo-Payload Bispecific-ADC programs, (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 estimate of patient populations, (x) additional clinical combinations, and (xi) 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, 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 Annual Report on Form 10-K dated February 20, 2024 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
[email protected]
IDEAYA Biosciences, Inc. |
||||||||||||||||
Condensed Statements of Operations and Comprehensive Loss |
||||||||||||||||
(in thousands, except share and per share amounts) |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
September |
June 30, |
September |
September |
|||||||||||||
(Unaudited) |
(Unaudited) |
|||||||||||||||
Collaboration revenue |
$ |
- |
$ |
- |
$ |
- |
$ |
19,463 |
||||||||
Operating expenses: |
||||||||||||||||
Research and development |
57,152 |
54,533 |
154,490 |
90,738 |
||||||||||||
General and administrative |
9,741 |
10,394 |
28,347 |
21,237 |
||||||||||||
Total operating expenses |
66,893 |
64,927 |
182,837 |
111,975 |
||||||||||||
Loss from operations |
(66,893) |
(64,927) |
(182,837) |
(92,512) |
||||||||||||
Interest income and other income, net |
15,072 |
12,155 |
38,672 |
13,506 |
||||||||||||
Net loss |
(51,821) |
(52,772) |
(144,165) |
(79,006) |
||||||||||||
Unrealized (losses) gains on marketable |
5,252 |
(493) |
3,274 |
2,121 |
||||||||||||
Comprehensive loss |
$ |
(46,569) |
$ |
(53,265) |
$ |
(140,891) |
$ |
(76,885) |
||||||||
Net loss per share |
$ |
(0.60) |
$ |
(0.68) |
$ |
(1.81) |
$ |
(1.44) |
||||||||
Weighted-average number of shares |
86,188,510 |
77,962,730 |
79,776,728 |
54,916,150 |
IDEAYA Biosciences, Inc. |
||||||||
Condensed Balance Sheet Data |
||||||||
(in thousands) |
||||||||
September 30, |
December 31, |
|||||||
2024 |
2023 |
|||||||
(Unaudited) |
||||||||
Cash and cash equivalents and short-term and |
$ |
1,200,157 |
$ |
632,606 |
||||
Total assets |
1,239,873 |
649,316 |
||||||
Total liabilities |
59,455 |
28,226 |
||||||
Total liabilities and stockholders' equity |
1,239,873 |
649,316 |
SOURCE IDEAYA Biosciences, Inc.