IDEAYA Biosciences, Inc. Stories Third Quarter 2021 Monetary Outcomes and Offers Enterprise Replace

– Robust steadiness sheet of ~$386 million money, money equivalents and marketable securities is anticipated to fund deliberate operations into 2025

– Noticed IDE397 preliminary scientific exercise in early Part 1 dose escalation cohorts, together with pharmacodynamic modulation and tumor shrinkage

– Enrolling IDE397 Cohort 5 with no noticed drug-related critical hostile occasions and the utmost tolerated dose has not but been reached

– Concentrating on IDE397 cohort expansions and supply of GSK possibility information package deal in first half of 2022 to set off a evaluation interval for potential $50 million opt-in choice

– Concentrating on webcast in This fall 2021 to current darovasertib and crizotinib scientific mixture information, together with scientific efficacy and tolerability

– Chosen a possible improvement candidate PARG inhibitor; planning to provoke additional preclinical improvement research, together with IND-enabling research

– Concentrating on improvement candidate for Pol Theta Helicase program in December 2021; $20 million in mixture potential GSK milestone funds from preclinical to early Part 1

SOUTH SAN FRANCISCO, Calif., Nov. 15, 2021 /PRNewswire/ — IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an artificial lethality targeted precision medication oncology firm dedicated to the invention and improvement of focused therapeutics, offered a enterprise replace and introduced monetary outcomes for the third quarter ended September 30, 2021.

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“Early scientific information on our potential best-in-class Part 1 MAT2A inhibitor, IDE397, in MTAP-deletion sufferers exhibits preliminary indicators of scientific exercise, together with pharmacodynamic modulation and tumor shrinkage in a number of sufferers. As well as, we chosen a lead compound as a possible first-in-class improvement candidate for IND-enabling research for our PARG artificial lethality program and made progress in direction of our objective to pick out a possible first-in-class improvement candidate with GlaxoSmithKline for the Pol Theta Helicase program this 12 months. We’re focusing on to supply an replace within the fourth quarter of 2021 for the Part 2 scientific trial evaluating darovasertib and crizotinib mixture in metastatic uveal melanoma, together with scientific efficacy and steerage on timing for a possible registration enabling trial,” mentioned Yujiro S. Hata, Chief Govt Officer and President of IDEAYA Biosciences.

Program Updates
Key highlights for IDEAYA’s pipeline applications embody:

IDE397 (MAT2A)
IDEAYA is evaluating IDE397, a potent and selective small molecule inhibitor focusing on methionine adenosyltransferase 2a (MAT2A), in sufferers having stable tumors with methylthioadenosine phosphorylase (MTAP) deletion, a affected person inhabitants estimated to characterize roughly 15% of stable tumors. IDEAYA is main early scientific improvement of IDE397. Topic to train of its possibility, GlaxoSmithKline (GSK) will lead later stage world scientific improvement. Highlights:

  • Actively enrolling sufferers into Cohort 5 of the Part 1 scientific trial IDE397-001 (NCT04794699)

  • Sufferers are being recognized by subsequent technology sequencing (NGS) or by MTAP immunohistochemistry (IHC) assay with confirmatory NGS

  • Evaluating IDE397 in sufferers with MTAP deletion throughout a number of stable tumor varieties, together with non-small cell lung most cancers, pancreatic most cancers, thymic most cancers, adenoid cystic carcinoma and gastroesophageal most cancers

  • IDE397 has been typically properly tolerated, with noticed drug-related hostile occasions as of November 5, 2021 of solely grade 1/2 drug-related hostile occasions; there have been no reported drug-related critical hostile occasions and no reported myelosuppression or liver toxicity; IDE397 has but to succeed in its Most Tolerated Dose

  • Noticed preliminary indicators of scientific exercise in MTAP-deletion sufferers in early dose escalation cohorts, together with plasma s-adenosyl methionine (SAM) pharmacodynamic (PD) modulation in IDE397 dose escalation Cohorts 1 by way of 3, and tumor shrinkage in a number of sufferers in early dose escalation Cohorts 2 and three

  • Topic to initiation of an growth cohort or establishing a most tolerated dose, or MTD, focusing on submission of IDE397 possibility information package deal to GSK within the first half of 2022, which might set off an analysis interval for GSK to make an opt-in choice; topic to GSK election to opt-in and HSR clearance, the corporate is entitled to obtain a $50 million opt-in cost from GSK

  • Concentrating on a scientific information replace on IDE397, together with plasma SAM and tumor SAM and SDMA pharmacodynamic information and tolerability, upon supply of the choice information package deal to GSK within the first half of 2022

  • Concentrating on scientific protocol modification submission to the FDA by 12 months finish 2021 to help monotherapy cohort expansions within the first half of 2022 in NSCLC, esophagastric most cancers, in addition to squamous and non-squamous basket cohorts, and to help potential taxane mixtures in NSCLC, esophagastric and/or pancreatic most cancers

  • Topic to passable development of the dose escalation portion of the Part 1 scientific trial, planning to enroll MTAP deletion sufferers into monotherapy growth cohorts within the first half of 2022 with an mixture of 150 or extra sufferers throughout growth cohorts

  • Noticed preclinical in vivo efficacy of IDE397 together with a taxane, exhibiting enhanced TGI in pancreatic most cancers PDX fashions; evaluating further potential IDE397 mixture methods with therapeutics focusing on DDR, chosen co-alteration targets, and chosen MTAP-SL targets

PARG
IDEAYA is advancing preclinical analysis for an inhibitor of poly (ADP-ribose) glycohydrolase (PARG) in sufferers having tumors with an outlined biomarker based mostly on genetic mutations and/or molecular signature. PARG is a novel goal in the identical clinically validated organic pathway as poly (ADP-ribose) polymerase (PARP). IDEAYA owns or controls all industrial rights in its PARG program. Highlights:

  • Recognized a novel and proprietary HRD biomarker to information affected person choice, with validation in vitro and in vivo in CDX fashions throughout a number of stable tumor indications

  • Demonstrated PARGi dose-dependent in vivo efficacy as monotherapy with tumor regression or stasis in ovarian, gastric and breast most cancers CDX fashions

  • Noticed in vivo efficacy with enhanced TGI or tumor regressions relative to niraparib, a PARPi, in a number of CDX fashions, together with in a niraparib-resistant CDX mannequin

  • Confirmed tumor regressions in a number of breast most cancers PDX fashions with outlined genetic and subtyping profiles, together with in niraparib resistant PDX fashions

  • Confirmed pharmacological inhibition of PARG in a panel of homologous recombination poor cell strains and in CDX and PDX fashions; research information reported at AACR 2021

  • Chosen a possible improvement candidate PARG inhibitor and initiating additional toxicology research; planning to provoke additional preclinical improvement research, together with IND-enabling research of the chosen lead compound

Pol Theta
IDEAYA’s DNA Polymerase Theta, (Pol Theta) program targets tumors with BRCA or different homologous recombination deficiency, or HRD, mutations. IDEAYA and GSK are collaborating on ongoing preclinical analysis, together with small molecules and protein degraders, and GSK will lead scientific improvement for the Pol Theta program. Highlights:

  • Demonstrated in vivo efficacy with tumor regression in BRCA2 -/- xenograft mannequin with IDEAYA Pol Theta Helicase inhibitor together with niraparib, a GSK PARP inhibitor; and

  • Topic to additional preclinical research, IDEAYA is focusing on choice of a Pol Theta Helicase inhibitor improvement candidate in December 2021

  • Potential for as much as $20 million in mixture milestone funds from GlaxoSmithKline for advancing a Pol Theta Helicase inhibitor from preclinical to early Part 1 scientific

Werner Helicase
IDEAYA is advancing preclinical analysis for an inhibitor focusing on Werner Helicase for tumors with excessive microsatellite instability (MSI). IDEAYA and GSK are collaborating on ongoing preclinical analysis, and GSK will lead scientific improvement for the Werner Helicase program. Highlights:

  • noticed dose-dependent mobile viability impact and dose-dependent mobile PD response in a number of endogenous MSI excessive cell strains

  • Demonstrated efficacy and PD response in related MSI excessive in vivo fashions

  • Potential for as much as $20 million in mixture milestone funds from GlaxoSmithKline for advancing a Werner Helicase inhibitor from preclinical to early Part 1 scientific

Different Artificial Lethality Pipeline Applications
IDEAYA is advancing further preclinical analysis applications to establish small molecule inhibitors for an MTAP-synthetic lethality goal, in addition to for a number of potential first-in-class artificial lethality applications for sufferers with stable tumors characterised by proprietary biomarkers or gene signatures.

Darovasertib (IDE196)
IDEAYA continues to execute on its scientific trial technique to judge darovasertib (IDE196), a potent and selective PKC inhibitor.

IDEAYA is evaluating darovasertib in metastatic uveal melanoma (MUM) as monotherapy and together therapies, together with mixtures of darovasertib / binimetinib and independently, darovasertib / crizotinib. The corporate is constant to enroll MUM sufferers into every of the mixture arms of the Part 1/2 scientific trial.

IDEAYA is focusing on a scientific information replace for darovasertib and crizotinib mixture within the fourth quarter of 2021, together with hostile occasion profile and scientific efficacy. IDEAYA is planning to hunt FDA regulatory steerage for potential registration-enabling trial design to judge darovasertib and crizotinib mixture in MUM within the first half of 2022.

The corporate is constant to judge darovasertib in sufferers having non-MUM tumors harboring GNAQ or GNA11 activating mutations, with a spotlight in pores and skin and mucosal melanoma.

Darovasertib Monotherapy
IDEAYA has accomplished enrollment into its ongoing Part 1/2 scientific trial evaluating darovasertib as monotherapy in MUM sufferers.

IDEAYA is coordinating with St. Vincent’s Hospital Sydney Restricted to provoke an Investigator Sponsored Trial, or IST, to judge IDE196 as monotherapy in a neo-adjuvant / adjuvant setting in (non-metastatic) uveal melanoma (UM) sufferers. Knowledge from this scientific trial could supply proof of idea on our speculation that earlier therapy of UM sufferers with IDE196, previous to tumor metastasis, could result in improved affected person outcomes.

Darovasertib / Binimetinib Mixture Remedy
IDEAYA is constant affected person enrollment into the darovasertib / binimetinib mixture arm of the Part 1/2 scientific trial beneath the scientific trial collaboration and provide settlement with Pfizer. Highlights:

  • As of November 5, 2021, the corporate has enrolled 32 MUM sufferers into the darovasertib/binimetinib mixture arm, and is constant affected person enrollment within the dose growth cohort of this mix arm

Darovasertib / Crizotinib Mixture Remedy
IDEAYA is constant affected person enrollment into the darovasertib / crizotinib mixture arm of the Part 1/2 scientific trial beneath the scientific trial collaboration and provide settlement with Pfizer. Highlights:

  • As of November 5, 2021, the corporate has enrolled 28 MUM sufferers into the darovasertib/crizotinib mixture arm, and is constant affected person enrollment within the dose growth cohort of this mix arm

  • Amended Pfizer scientific trial collaboration and provide settlement to allow growth for 40 further sufferers on darovasertib / crizotinib mixture

  • Noticed preclinical synergies between darovasertib and crizotinib in related mobile fashions beneath situations simulating a tumor microenvironment within the liver, the positioning of roughly 90% of uveal melanoma metastases; research information reported at AACR 2021

  • Correlated cMET expression and activation to noticed scientific response based mostly on a retrospective evaluation of human scientific biopsies from the Novartis darovasertib Part 1 scientific trial, supporting cMET expression / activation as potential mixture agent

Darovasertib – Different Potential Indications
IDEAYA is evaluating the potential for darovasertib in GNAQ mutation-mediated uncommon ailments, together with Sturge-Weber Syndrome (SWS) and Port Wine Stains (PWS), neurocutaneous problems characterised by capillary malformations and related to mutations in GNAQ. Highlights:

  • Topic to FDA suggestions and steerage, planning to provoke a Part 1 scientific trial to judge darovasertib in SWS and, topic to additional preclinical and scientific information, additionally in PWS sufferers with in depth involvement

Normal
IDEAYA continues to observe Covid-19 and its potential affect on scientific trials and timing of scientific information outcomes. Initiation of scientific trial websites, affected person enrollment and ongoing monitoring of enrolled sufferers, together with acquiring affected person computed tomography (CT) scans, could also be impacted for IDEAYA scientific trials evaluating IDE397 and darovasertib; the particular impacts are at present unsure.

Company Updates
IDEAYA’s web losses have been $11.6 million and $10.9 million for the three months ended September 30, 2021 and June 30, 2021, respectively. As of September 30, 2021, the corporate had an gathered deficit of $158.5 million.

As of September 30, 2021, IDEAYA had money, money equivalents and marketable securities of $385.8 million. IDEAYA believes that its money, money equivalents and marketable securities can be ample to fund its deliberate operations into 2025. These funds will help the corporate’s efforts by way of potential achievement of a number of preclinical and scientific milestones throughout a number of applications.

Our up to date company presentation is offered on our web site, at our Investor Relations web page: https://ir.ideayabio.com/.

Monetary Outcomes
As of September 30, 2021, IDEAYA had money, money equivalents and short-term marketable securities totaling $385.8 million. This in comparison with money, money equivalents and short-term and long-term marketable securities of $312.4 million at June 30, 2021. The rise was primarily attributable to $86.0 million in web proceeds acquired throughout the three months ended September 30, 2021 from issuance of frequent inventory in an underwritten public providing on July 12, 2021, offset by money utilized in operations and purchases of property and tools.

Collaboration income for the three months ended September 30, 2021 totaled $9.0 million in comparison with $8.8 million for the three months ended June 30, 2021. Collaboration income was acknowledged for the efficiency obligations glad by way of September 30, 2021 beneath the GSK Collaboration Settlement.

Analysis and improvement (R&D) bills for the three months ended September 30, 2021 totaled $15.5 million in comparison with $15.0 million for the three months ended June 30, 2021. The rise was primarily attributable to will increase in charges to CROs and exterior consultants, and better compensation bills.

Normal and administrative (G&A) bills for the three months ended September 30, 2021 totaled $5.2 million in comparison with $4.8 million for the three months ended June 30, 2021. The rise was primarily attributable to will increase in IT bills, and authorized bills.

The web loss for the three months ended September 30, 2021 was $11.6 million in comparison with $10.9 million for the three months ended June 30, 2021. Whole inventory compensation expense for the three months ended September 30, 2021 was $2.2 million in comparison with $2.1 million for the three months ended June 30, 2021.

About IDEAYA Biosciences
IDEAYA is an artificial lethality targeted precision medication oncology firm dedicated to the invention and improvement of focused therapeutics for affected person populations chosen utilizing molecular diagnostics. IDEAYAs method integrates capabilities in figuring out and validating translational biomarkers with drug discovery to pick out affected person populations most probably to learn from its focused therapies. IDEAYA is making use of its analysis and drug discovery capabilities to artificial lethality – which represents an rising class of precision medication targets.

Ahead-Wanting Statements
This press launch incorporates forward-looking statements, together with, however not restricted to, statements associated to (i) the extent to which IDEAYA’s current money, money equivalents, and marketable securities will fund its deliberate operations, (ii) the timing of and variety of sufferers within the cohort growth within the IDE397 Part 1 scientific trial, (iii) the timing of the supply of the GSK possibility information package deal, (iv) the timing of a scientific information replace for the darovasertib and crizotinib mixture, (v) the initiation of additional PARG inhibitor preclinical improvement research, (vi) the timing of identification of a improvement candidate for a Pol Theta inhibitor, (vii) the timing of a scientific information replace for the IDE397 Part 1 scientific trial, (viii) the timing of submission of a scientific protocol modification for the IDE397 Part 1 scientific trial, (ix) the timing of and associated tumor varieties for cohort growth within the IDE397 Part 1 scientific trial, (x) the potential receipt of GSK milestone funds, (xi) the timing of acquiring FDA steerage for potential registration-enabling trial design to judge the darovasertib and crizotinib mixture, (xii) the initiation of an IST to judge ID196 in a neo-adjuvant / adjuvant setting, al pathway, (xiii) the initiation of a Part 1 scientific trial to judge darovasertib in SWS and PWS, and (xiv) the affect of COVID-19. Such forward-looking statements contain substantial dangers and uncertainties that might trigger IDEAYA’s preclinical and scientific improvement applications, future outcomes, efficiency or achievements to vary considerably from these expressed or implied by the forward-looking statements. Such dangers and uncertainties embody, amongst others, the uncertainties inherent within the drug improvement course of, together with IDEAYA’s applications’ early stage of improvement, the method of designing and conducting preclinical and scientific trials, the regulatory approval processes, the timing of regulatory filings, the challenges related to manufacturing drug merchandise, IDEAYA’s skill to efficiently set up, shield and defend its mental property, the consequences on IDEAYA’s enterprise of the worldwide COVID-19 pandemic, and different issues that might have an effect on the sufficiency of current money to fund operations. IDEAYA undertakes no obligation to replace or revise any forward-looking statements. For an additional description of the dangers and uncertainties that might trigger precise outcomes to vary from these expressed in these forward-looking statements, in addition to dangers referring to the enterprise of IDEAYA normally, see IDEAYA’s current Quarterly Report on Kind 10-Q filed on November 15, 2021 and any present and periodic reviews filed with the U.S. Securities and Trade Fee.

IDEAYA Biosciences, Inc.

Condensed Statements of Operations and Complete Loss

(in hundreds, besides share and per share quantities)

Three Months Ended

9 Months Ended

September
30, 2021

June
30, 2021

September
30, 2021

September
30, 2020

Collaboration income

$

8,976

$

8,756

$

24,979

$

8,967

Working bills

Analysis and improvement

15,503

14,979

42,048

27,647

Normal and administrative

5,186

4,828

14,830

11,384

Whole working bills

20,689

19,807

56,878

39,031

Loss from operations

(11,713)

(11,051)

(31,899)

(30,064)

Curiosity revenue and different revenue (expense),

web

131

104

349

704

Internet loss

$

(11,582)

$

(10,947)

$

(31,550)

$

(29,360)

Change in unrealized positive aspects (losses) on

marketable securities

(46)

(3)

(57)

(30)

Complete loss

$

(11,628)

$

(10,950)

$

(31,607)

$

(29,390)

Internet loss per share attributable to frequent

stockholders, fundamental and diluted

$

(0.31)

$

(0.33)

$

(0.92)

$

(1.26)

Weighted common variety of shares

excellent, fundamental and diluted

37,681,205

32,854,926

34,157,578

23,235,218

IDEAYA Biosciences, Inc.

Condensed Steadiness Sheet Knowledge

(in hundreds)

September 30,

December 31,

2021

2020

Money and money equivalents and short-term and long-term

marketable securities

$

385,768

$

283,585

Whole belongings

399,444

298,269

Whole liabilities

81,815

99,995

Whole liabilities and stockholders’ fairness

399,444

298,269

Cision

Cision

View authentic content material:https://www.prnewswire.com/news-releases/ideaya-biosciences-inc-reports-third-quarter-2021-financial-results-and-provides-business-update-301423543.html

SOURCE IDEAYA Biosciences, Inc.

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