On August 15, 2022 Roivant Sciences Ltd. (Nasdaq: ROIV), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, reported its financial results for the first quarter ended June 30, 2022 and provided an update on the Company’s operations (Press release, Roivant Sciences, AUG 15, 2022, View Source [SID1234618316]).

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Roivant’s Chief Executive Officer, Matt Gline, noted: "I’m excited by the strong early signals we’re seeing from the ongoing VTAMA launch in psoriasis, including approximately 14,000 prescriptions in the first eleven weeks. The recent positive topline results from Torii Pharmaceutical and Japan Tobacco’s study of tapinarof in atopic dermatitis underscore our conviction in VTAMA’s potential in AD as our own Phase 3 trials progress. We are also pleased with recent execution across the rest of our pipeline, including the continued progress in our pivotal trials at Immunovant and Priovant. We are proud to advance the development of these important medicines for patients."

Roivant also announced today that Amy Mahery will be joining the company as Chief Commercial Officer and will serve as a member of the leadership team. Amy has more than twenty years of industry experience and has been involved in the commercialization and launch of therapies across oncology, neurology and immunology. Most recently, she was the Senior Vice President and Head of the Global Business Franchise, Neurology and Immunology (N&I) at EMD Serono, where she led commercial strategy for the N&I portfolio from clinical development to launch and late lifecycle.

On September 28, Roivant will host an investor day, at which the Company will provide updates on the ongoing VTAMA launch in psoriasis, clinical development at the Vants and continued progress in drug discovery. The webcast for this virtual event will begin at 11 a.m. EDT, and participants can register to attend at View Source

Recent Developments

Dermavant: Since its launch in late May, VTAMA has had approximately 14,000 prescriptions written by more than 3,000 unique prescribers based on the latest available IQVIA data through August 5 for prescriptions and July 29 for prescribers. VTAMA became the most prescribed branded topical for the treatment of psoriasis in the U.S. within eight weeks of launch. In July, Torii Pharmaceutical and Japan Tobacco announced positive topline results from their Phase 3 study of tapinarof in atopic dermatitis. In this trial, tapinarof showed statistical superiority to vehicle on the primary endpoint of efficacy, IGA response at week 8. In addition, tapinarof showed statistical superiority to vehicle for EASI achievement rate at week 8, a key secondary endpoint of efficacy. There were no new observed safety or tolerability findings reported.
Priovant: Priovant expects to complete enrollment for its ongoing potentially registrational global trial evaluating oral brepocitinib for the treatment of SLE in August 2022. Oral brepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1 licensed from Pfizer that has been evaluated in 14 completed Phase 1 and Phase 2 trials, including 5 placebo-controlled Phase 2 trials in psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata and hidradenitis suppurativa that generated statistically significant and clinically meaningful efficacy results. Priovant is also developing oral brepocitinib for the treatment of dermatomyositis, for which it recently initiated a single registrational Phase 3 trial.
Major Upcoming Milestones

Dermavant: Dermavant expects to provide updates on the commercial launch of VTAMA for psoriasis on a periodic basis and to report topline data from the Phase 3 trials of VTAMA for the treatment of atopic dermatitis in the first half of calendar year 2023.
Priovant: Priovant plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with SLE in the second half of calendar year 2023.
Immunovant: Immunovant plans to initiate two pivotal trials to evaluate batoclimab for the treatment of thyroid eye disease in the second half of calendar year 2022, with topline results expected in the first half of calendar year 2025. Immunovant plans to announce two new indications for batoclimab and the third indication (in addition to MG and TED) it will initiate as a pivotal trial in calendar year 2022 on an investor call scheduled for September 7, 2022.
Hemavant: Hemavant plans to announce data from the ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk MDS patients in the second half of calendar year 2023.
Kinevant: Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the first half of calendar year 2024.
First Quarter Ended June 30, 2022 Financial Summary

Cash Position

As of June 30, 2022, we had cash, cash equivalents and restricted cash of approximately $2.0 billion.

Research and Development Expenses

Research and development (R&D) expenses were $135.8 million for the three months ended June 30, 2022 compared to $78.5 million for the three months ended June 30, 2021. The quarter-over-quarter increase was primarily due to increases in program-specific costs and personnel-related expenses, reflecting the progression of our programs and drug discovery. Additionally, share-based compensation expense increased largely as a result of the ongoing vesting of certain equity instruments for which the liquidity event vesting condition was met upon the closing of the business combination with MAAC in September 2021. We did not recognize share-based compensation expense related to these equity instruments during the three months ended June 30, 2021 as the liquidity event requirement had not been met and was not deemed probable of being met. Non-GAAP R&D expenses were $122.5 million for the three months ended June 30, 2022 compared to $76.2 million for the three months ended June 30, 2021.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $149.1 million for the three months ended June 30, 2022 compared to $82.8 million for the three months ended June 30, 2021. The quarter-over-quarter increase was primarily due to increases in share-based compensation expense largely as a result of the ongoing vesting of certain equity instruments for which the liquidity event vesting condition was met upon the closing of the business combination with MAAC in September 2021. We did not recognize share-based compensation expense related to these equity instruments during the three months ended June 30, 2021 as the liquidity event requirement had not been met and was not deemed probable of being met. Additionally, SG&A expenses for Dermavant have increased as a result of the commercial launch of VTAMA in May 2022. Non-GAAP SG&A expenses were $87.7 million for the three months ended June 30, 2022 compared to $64.4 million for the three months ended June 30, 2021.

Net Loss

Net loss was $353.8 million for the three months ended June 30, 2022 compared to $101.1 million for the three months ended June 30, 2021. On a per common share basis, net loss was $0.48 for the three months ended June 30, 2022 and $0.13 for the three months ended June 30, 2021. Non-GAAP net loss was $210.7 million for the three months ended June 30, 2022 compared to $133.4 million for the three months ended June 30, 2021.

(1) Represents non-cash amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.

(2) Represents non-cash share-based compensation expense.

(3) Represents non-cash depreciation and amortization expense, other than amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.

(4) Represents the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings.

(5) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized loss (gain) relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.

(6) Represents the one-time gain on termination of the options held by Sumitomo Pharma Co., Ltd. to purchase Roivant’s ownership interest in certain Vants (the "Sumitomo Options").

(7) Represents the estimated tax effect of the adjustments.

Beginning in the fourth quarter of the fiscal year ended March 31, 2022, the Company no longer excludes from its non-GAAP financial measures acquired IPR&D expenses, which include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones. Previously, these items were excluded from the Company’s non-GAAP financial measures. In conjunction with this change, acquired IPR&D expenses are now reported as a separate line item in its consolidated statements of operations. Prior period amounts have been revised to conform to the current presentation.

There was no acquired IPR&D expense for the three months ended June 30, 2022. For the three months ended June 30, 2021, acquired IPR&D expense was $0.1 million.

Investor Conference Call Information

Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, August 15, 2022 to report its financial results for the fiscal quarter ended June 30, 2022 and provide a corporate update.

To access the conference call by phone, please register online using this registration link. A webcast of the call will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.

On August 15, 2022 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the second quarter ended June 30, 2022 and provided a business update on recent corporate and regulatory developments (Press release, Protalix, AUG 15, 2022, View Source [SID1234618315]).

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"Positive topline results from our phase III BALANCE clinical trial of PRX-102 for the treatment of adult patients with Fabry disease were announced last April. The clinical study report (CSR) for the trial is now complete," said Dror Bashan, Protalix’s President and Chief Executive Officer. "The final analysis of the BALANCE study, which was designed to evaluate the efficacy and safety of 1 mg/kg of PRX–102 administered every other week compared to agalsidase beta in patients previously treated with agalsidase beta, confirms the positive topline results and favorable tolerability profile. The results from the BALANCE study highlight our confidence that PRX–102 has the potential to become an important treatment option for patients with Fabry disease. We are excited to move closer to potential approval of PRX–102 and commercial launch, and thank our team members and external partners for their continued support."

2022 Second Quarter and Recent Business Highlights

Corporate Developments

On June 30, 2022, the Company announced the appointment of Shmuel "Muli" Ben Zvi, Ph.D. to the Board of Directors. Dr. Ben Zvi is serving as the new Chairman of the Audit Committee and as a member of the Compensation Committee.
Second Quarter 2022 Financial Highlights

The Company recorded revenues from selling goods of $3.4 million for the three months ended June 30, 2022, an increase of $0.2 million, or 6%, compared to revenues of $3.2 million for the same period of 2021.
Revenue from licenses and R&D services for the three months ended June 30, 2022 were $5.4 million, an increase of $2.2 million, or 69%, compared to $3.2 million for the same period in 2021. Revenues from license and R&D services are comprised primarily of revenues recognized in connection with the Chiesi Agreements.
Cost of goods sold for the three months ended June 30, 2022 was $4.1 million, a decrease of $0.6 million, or 13%, compared to cost of goods sold of $4.7 million for the same period in 2021. The decrease in cost of goods sold was primarily the result of decreased manufacturing costs due to higher yields and lower wastage.
Research and development expenses for the three months ended June 30, 2022 were $7.6 million, a decrease of $0.1 million, or 1%, compared to $7.7 million for the same period in 2021.
Selling, general and administrative expenses were $2.6 million for the three months ended June 30, 2022, a decrease of $0.6 million, or 19%, compared to $3.2 million for the same period in 2021. The decrease resulted primarily from a decrease in salary related and selling costs.
Financial income, net were $0.2 million for the three months ended June 30, 2022, compared to financial expenses, net of $2.1 million for the same period in 2021. The decrease resulted primarily from lower interest and debt amortization costs due to a decrease in the Company’s outstanding notes from an aggregate principal amount of $57.92 million of 2021 Notes to an aggregate principal amount of $28.75 million of 2024 Notes, and an increase in the exchange rate of New Israeli Shekels for U.S. Dollars over the period.
Cash, cash equivalents and short-term bank deposits were approximately $28.6 million at June 30, 2022.
Net loss for the three months ended June 30, 2022 was approximately $5.3 million, or $0.11 per share, basic and diluted, compared to a net loss of $11.2 million, or $0.25 per share, basic and diluted, for the same period in 2021.
Conference Call and Webcast Information

The Company will host a conference call today, August 15, 2022, at 8:30 a.m. Eastern Daylight Time, to review the corporate and clinical developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Conference Call Details:

The conference will be webcast live from the Company’s website and will be available via the following links:

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On August 15, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Quantum Leap Healthcare Collaborative ("Quantum Leap") reported that ALX Oncology’s next generation CD47 blocker, evorpacept, has been selected for a new investigational treatment arm in the I-SPY-P1 TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer (Press release, ALX Oncology, AUG 15, 2022, View Source [SID1234618314]). Sponsored by Quantum Leap, this Phase 1 (open-label), multi-center study arm will investigate evorpacept in combination with ENHERTU (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody-drug conjugate ("ADC"), to determine the safety, tolerability and efficacy of this drug combination.

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"Patients with advanced breast cancer who develop resistance to therapies are in need of novel and tolerable treatment options," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "We are thrilled to partner with Quantum Leap, recognized as a leader in the development of research initiatives supporting new therapies, to accelerate the advancement of evorpacept in breast cancer. Moreover, this collaboration expands our solid tumor investigations with evorpacept in combination with an ADC. We believe the addition of evorpacept can improve ENHERTU’s anti-cancer activity without increasing toxicity."

The I-SPY-P1 TRIAL will be led by Paula Pohlmann, Associate Professor of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center. ALX Oncology will provide funding and supply evorpacept. As the study sponsor, Quantum Leap will be responsible for managing the trial.

On August 15, 2022 ChromaDex Corp. (NASDAQ:CDXC) ("the Company") a global bioscience company dedicated to healthy aging, reported the U.S. Patent & Trademark Office’s Patent Trial and Appeal Board’s ("PTAB") decision to reject Thorne Research, Inc. attempt to invalidate U.S. Patent No. 8,197,807 ("the 807 patent") (Press release, ChromaDex, AUG 15, 2022, View Source [SID1234618313]). ChromaDex holds an exclusive license to the 807 patent for compositions including nicotinamide riboside (NR) from the Trustees of Dartmouth College. The decision, if upheld upon appeal, precludes Thorne Research, Inc. from raising these arguments, or any other arguments they could have reasonably raised before the PTAB in the New York District Court lawsuit ChromaDex brought against Thorne Research, Inc. wherein ChromaDex alleges Thorne Research, Inc. is infringing the 807 patent.

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ChromaDex is the exclusive supplier of nicotinamide riboside chloride, Niagen, a novel form of NR backed by 20 published and peer-reviewed clinical trials. Niagen has achieved regulatory acceptance by the world’s four leading regulatory bodies including the U.S. FDA, Health Canada, the European Commission, and the Therapeutic Goods Administration (TGA) of Australia.

ChromaDex maintains a strong and growing intellectual property portfolio for its proprietary ingredient, Niagen, including for use in supplements and foods, consisting of over 40 composition, process, and method of use patents for discoveries relating to NR and other precursors to NAD+ (nicotinamide adenine dinucleotide), a molecule at the forefront of healthy aging and cellular health.

On August 15, 2022 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported financial results for the second quarter ended June 30, 2022 (Press release, Ideaya Biosciences, AUG 15, 2022, View Source [SID1234618312]).

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"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: View Source

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.