IDEAYA Biosciences Inc
For the period ended Jun 30, 2024. Filed Aug 6, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 6, 2024
IDYA$31.24+1.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-07.
0000950170-24-054466
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-06.
0000950170-24-091823
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 177 previous paragraphs and 188 current paragraphs.
128 unchanged; 39 reworded; 21 added; 4 removed; 6 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (21)
Current report
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Current report
In June 2024, we announced interim clinical data from the ongoing investigator-sponsored Phase 2 trial of darovasertib as neoadjuvant/adjuvant treatment in UM, which was included in an oral presentation at the American Society of Clinical Oncology, or ASCO, 2024 Annual Meeting, and preliminary clinical data from our Phase 2 trial of darovasertib for neoadjuvant UM.
Current report
ASCO Clinical Data from Investigator-Sponsored Phase 2 Trial
Current report
In our ongoing investigator-sponsored Phase 2 trial of darovasertib as neoadjuvant/adjuvant treatment in UM, 15 patients planned for enucleation with localized UM were treated twice daily with a 300 mg dose of darovasertib in the Phase 2 investigator-sponsored clinical trial as of May 14, 2024. An initial safety cohort of three patients was treated for one month, and the remaining 12 patients were treated in an expansion cohort for up to six months with darovasertib as neoadjuvant treatment prior to their primary intervention (enucleation, plaque brachytherapy or external beam radiotherapy, or EBRT) across three Australian centers. As of May 14, 2024, 13 patients had completed neoadjuvant darovasertib treatment, 11 patients received adjuvant darovasertib treatment after primary treatment of UM, with five patients completing the planned six months of therapy. As of May 14, 2024, 75% (nine out of 12 enucleation patients) had confirmed preservation of the eye, by conversion from planned enucleation to plaque brachytherapy or EBRT, and approximately 67% (eight out of 12 enucleation patients) observed greater than 30% tumor shrinkage (maximum tumor volume change) after six months. Median tumor shrinkage (maximum tumor volume change) in the 12 enucleation patients was approximately 47% after six months. The darovasertib monotherapy neoadjuvant treatment had a manageable adverse event, or AE, profile with no drug-related serious adverse events, or SAEs, observed in the investigator-sponsored Phase 2 trial. Drug-related AEs in the trial were predominantly Grade 1 or Grade 2 and 20% of patients reported at least one drug-related Grade 3 AE.
Current report
Company-Sponsored Phase 2 Trial
Current report
As of July 31, 2024, our Phase 2 company-sponsored darovasertib neoadjuvant UM trial has activated 20 sites globally and enrolled over 50 patients. As of May 24, 2024, eight patients (six enucleation and two plaque eligible) had received darovasertib neoadjuvant treatment for four months or more and observed median tumor shrinkage (maximum change in tumor height, base and volume) of approximately 40% in tumor height, 25% in tumor base and 72% in tumor volume and the majority of the six enucleation patients had reported preservation of the eye, by conversion from planned enucleation to plaque brachytherapy or EBRT. In the eight patients that had been treated with neoadjuvant darovasertib for four months or more as of May 24, 2024, darovasertib had a manageable AE profile with no drug-related SAEs observed in the company-sponsored Phase 2 trial. Drug-related AEs were predominantly Grade 1 or Grade 2 and approximately 13% of patients reported at least one drug-related Grade 3 AE.
Current report
We have scheduled a Type C meeting with the FDA to discuss a potential registrational trial in the neoadjuvant UM setting in the third quarter of 2024 and are targeting a clinical efficacy update in over 30 patients in the second half of 2024.
Current report
An amendment to the study protocol was submitted to the FDA in July 2024 to enable dosing of darovasertib as neoadjuvant and adjuvant therapy up to 12 months each. As part of this amendment the number of patients in the study was increased from 82 to 122 patients and the part 2 of the study will, once the amendment is effective, consist of adjuvant treatment with darovasertib in combination with crizotinib for patients with disease characteristics suggesting high or intermediate risk of metastasis.
Current report
Company-Sponsored Phase 1/2 Monotherapy Expansion in MTAP-Deletion Urothelial and Lung Cancer
Current report
In July 2024, we announced clinical data for the IDE397 Phase 1/2 monotherapy expansion dose demonstrating preliminary clinical efficacy in heavily pre-treated MTAP-deletion urothelial cancer and squamous NSCLC patients. The patients evaluated had a median of two prior lines of therapy, ranging from one to nine prior lines of treatment. The reported Phase 1/2 clinical data were based on 18 evaluable MTAP-deletion patients, including seven urothelial cancer patients, four adenocarcinoma squamous NSCLC patients, and seven squamous NSCLC patients at the expansion dose of 30 mg once-a-day, or QD, of IDE397. In the interim update for 18 evaluable patients, with a data analysis cutoff date of June 21, 2024, we reported an overall response rate of approximately 39% (one complete response and six partial responses by RECIST 1.1 evaluation), which includes two unconfirmed partial responses (one urothelial cancer patient that had a 100% tumor reduction in the target lesion at the last CT-scan assessment that has now been confirmed and one adenocarcinoma squamous NSCLC patient that is awaiting confirmation as of July 31, 2024). We also observed a disease control rate of 94%, including one complete response, six partial responses and ten stable disease by RECIST 1.1 evaluation. In addition, we observed tumor shrinkage in 14 of the 18 evaluable patients. 11 of the evaluable patients are still on treatment and five of the seven responses by RECIST 1.1 evaluation remain in response. We also reported a ctDNA molecular response, or MR, rate of 81%, representing 13 of 16 reportable patients with 50% or greater ctDNA reduction (several quality control failures of patient samples precluded the other patients from MR analysis).
Current report
Regarding safety data, we also reported a favorable AE profile at the 30 mg QD expansion dose. Approximately 5.6% of patients experienced a Grade 3 or higher drug-related AE at the 30 mg QD dose, represented by one instance of Grade 3 asthenia, and no drug-related SAEs were observed. We observed no drug-related AEs leading to discontinuations, and one non-evaluable patient discontinued due to rapid clinical progression of cancer fatigue and drug-unrelated adverse events in the first cycle of treatment. We anticipate that the favorable AE profile and dosing convenience of a 30 mg QD tablet has the potential to enable long-term dosing and combination development.
Current report
B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC) program with Biocytogen
Current report
In July 2024, we entered into an option and license agreement with Biocytogen, pursuant to which Biocytogen granted us an option for an exclusive worldwide license from Biocytogen for a potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload BsADC program, or the Option. 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 topoisomerase-I-inhibitor-payload BsADC program has the potential to be developed as a monotherapy agent and used in combination with multiple programs in our pipeline targeting DDR-based therapies, including our PARG inhibitor IDE161. A development candidate nomination for the B7H3/PTK7 topoisomerase-I-inhibitor payload BsADC program is targeted for the second half of 2024.
Current report
Under the terms of the agreement, we will pay Biocytogen an upfront fee and, upon our potential exercise of the Option, an exercise fee totaling up to $6.5 million. We may exercise the Option within a specified time period after we obtain all data and results from certain non-GLP toxicology studies specified in the Agreement, which we will conduct at our own cost.
Current report
Subject to our exercise of the Option, Biocytogen will be eligible to receive an option exercise fee, development and regulatory milestone payments and commercial milestone payments, as well as low to mid single-digit royalties on net sales. Total potential milestone payments equal an aggregate of $400.0 million, including development and regulatory milestone payments of up to $100.0 million. Our royalty obligations continue with respect to each country and each product until the later of (i) the date on which such product is no longer covered by certain intellectual property rights in such country and (ii) the 10 thanniversary of the first commercial sale of such product in such country.
Current report
Small and Medium Enterprise Status from the European Medicines Agency
Current report
In June 2024, we were granted Small and Medium Enterprise (SME) status by the European Medicines Agency (EMA). This enables us to have access to administrative, regulatory and financial support, including fee reductions for scientific advice and regulatory procedures across all our programs.
Current report
Comparison of Six Months Ended June 30, 2024 and June 30, 2023
Current report
Research and development expenses increased by $40.3 million, or 71%, during the six months ended June 30, 2024 compared to the six months ended June 30, 2023. The increase in research and development expenses was primarily due to increases of $29.6 million in fees paid to CROs, CMOs and consultants related to the advancement of our lead product candidates through preclinical and clinical studies, increases of $8.3 million in personnel-related expenses, including stock-based compensation and salaries and benefits to support our growth, and increases in $2.4 million in costs for laboratory supplies, facilities, and software to support our research and development programs.
Current report
In July 2024, we entered into an option and license agreement with Biocytogen, pursuant to which Biocytogen granted us an option for an exclusive worldwide license for a potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload BsADC program. Under the terms of the agreement, we will pay Biocytogen an upfront fee and, upon IDEAYA’s potential exercise of the Option, an exercise fee totaling up to $6.5 million. We may exercise the Option within a specified time period after we obtain all data and results from certain non-GLP toxicology studies specified in the Agreement, which we will conduct at our own cost. Subject to our exercise of the Option, Biocytogen will be eligible to receive an option exercise fee, development and regulatory milestone payments and commercial milestone payments, as well as low to mid single-digit royalties on net sales. Total potential milestone payments equal an aggregate of $400.0 million, including development and regulatory milestone payments of up to $100.0 million.
Current report
Net cash provided by financing activities was $194.0 million for the six months ended June 30, 2023, which consisted primarily of $153.8 million of proceeds from issuance of common stock upon public offering, $35.1 million of proceeds from issuance of pre-funded warrants, $2.5 million of net proceeds from at-the-market offerings and $1.9 million of net proceeds from exercise of common stock options and $0.6 million of proceeds from ESPP purchase.
Removed paragraphs (4)
Previous report
The IDE196-009 clinical protocol includes neoadjuvant treatment with darovasertib to maximum benefit up to 6 months, primary treatment, then up to 6 months of follow-up adjuvant therapy.
Previous report
In the neoadjuvant setting, one cohort of UM patients with large tumors will be treated with darovasertib until maximum benefit or six months, at which time they will undergo a primary interventional treatment. The neoadjuvant endpoint for this large-sized tumor cohort is eye preservation. For example, a patient who would otherwise have undergone enucleation would instead be eligible for radiation treatment. Another neoadjuvant cohort of UM patients with small or medium sized tumors will be treated with darovasertib until maximum benefit or six months, at which time they will undergo radiation therapy. Neoadjuvant endpoints for this small- or medium-sized tumor cohort include (i) reducing the radiation dose that the patient receives, relative to the radiation dose they would have otherwise received without the neoadjuvant treatment, and (ii) functional vision preservation.
Previous report
In the adjuvant setting, each of the two neoadjuvant cohorts will be treated with darovasertib for up to six months as follow-up adjuvant therapy after the primary interventional treatment. The adjuvant endpoints for this portion of the clinical trial include relapse free survival and useful vision.
Previous report
Research and development expenses increased by $4.0 million, or 10%, during the three months ended March 31, 2024 compared to the three months ended December 31, 2023 due to an increase of $3.9 million primarily driven by our potentially registration-enabling darovasertib clinical trial and Werner Helicase program expenses, $0.8 million in stock-based compensation related to our annual option grants and $1.2 million in personnel-related expenses, including salaries and benefits to support our growth, and $0.3 million in costs for facilities and software to support our research and development programs, which was partially offset by a decrease of $2.2 million driven by timing of clinical pharmacology studies and CMC manufacturing costs for darovasertib.
Reworded paragraphs (39)
Previous wording
Our clinical pipeline includes four potential first-in-class clinical-stage product candidates – darovasertib (PKC), IDE397 (MAT2A), IDE161 (PARG) and GSK101 (Pol Theta Helicase). We own or control all commercial rights of the three most-advanced of these product candidates: darovasertib, IDE397, and IDE161. We are also advancing our Werner Helicase program for which a development candidate has been selected in collaboration with GlaxoSmithKline, or GSK and, subject to investigational new drug-, or IND-, enabling studies, are targeting an IND in 2024. We also have multiple earlier-stage preclinical programs. We have established selective, value-accretive collaborations with leading pharmaceutical companies to support our clinical development activities.
Current wording
Our clinical pipeline includes four potential first-in-class clinical-stage product candidates – darovasertib (PKC), IDE397 (MAT2A), IDE161 (PARG) and GSK101 (Pol Theta Helicase). We own or control all commercial rights of the three most-advanced of these product candidates: darovasertib, IDE397, and IDE161. We are also advancing our Werner Helicase program for which a development candidate has been selected in collaboration with GlaxoSmithKline, or GSK and, subject to investigational new drug-, or IND-, enabling studies, are targeting an IND in 2024. In July 2024, we entered into an Option and License Agreement with Biocytogen Pharmaceuticals (Beijing) Co., Ltd., or Biocytogen, pursuant to which Biocytogen granted to us an option for an exclusive worldwide license to develop and commercialize products in connection with a potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate program. We also have multiple earlier-stage preclinical programs. We have established selective, value-accretive collaborations with leading pharmaceutical companies to support our clinical development activities.
Previous wording
We have achieved double-digit patient enrollment and have opened multiple clinical sites, including international sites, in our potential registration-enabling Phase 2/3 clinical trial, designated as IDE196-002. The purpose of the clinical trial is to evaluate darovasertib in combination with crizotinib, Pfizer’s investigational cMET inhibitor, in patients having metastatic uveal melanoma, or MUM, with human leukocyte antigen-, or HLA-A*02:01 negative, or HLA-A2(-), serotype, as part of a second Clinical Trial Collaboration and Supply Agreement, or Second Pfizer agreement, with Pfizer. We are targeting clinical program update(s) in 2024.
Current wording
We have achieved triple-digit patient enrollment and have opened multiple clinical sites, including international sites, in our potential registration-enabling Phase 2/3 clinical trial, designated as IDE196-002. The purpose of the clinical trial is to evaluate darovasertib in combination with crizotinib, Pfizer’s investigational cMET inhibitor, in patients having metastatic uveal melanoma, or MUM, with human leukocyte antigen-, or HLA-A*02:01 negative, or HLA-A2(-), serotype, as part of a second Clinical Trial Collaboration and Supply Agreement, or Second Pfizer agreement, with Pfizer.
Previous wording
We separately initiated and have achieved double-digit patient enrollment in our Phase 2 clinical trial, designated as IDE196-009, evaluating darovasertib as single-agent neoadjuvant and adjuvant therapy in patients having primary uveal melanoma, or UM, with ongoing enrollment and multiple clinical sites open. A clinical efficacy update on over 30 patients and an U.S. Food and Drug Administration, or FDA, regulatory guidance update are both targeted in the second half of 2024.
Current wording
We separately initiated and have achieved double-digit patient enrollment in our Phase 2 clinical trial, designated as IDE196-009, evaluating darovasertib as single-agent neoadjuvant and adjuvant therapy in patients having primary uveal melanoma, or UM, with ongoing enrollment and multiple clinical sites open. We have scheduled a Type C meeting with the U.S. Food and Drug Administration, or FDA, to discuss a potential registrational trial in the neoadjuvant UM setting in the third quarter of 2024 and are targeting a clinical efficacy update in over 30 patients in the second half of 2024.
Previous wording
We are also supporting evaluation of darovasertib as single-agent neoadjuvant and adjuvant therapy in primary UM in an ongoing investigator-sponsored clinical trial, or IST, captioned as “Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma”, or NADOM, led by St. Vincent’s Hospital in Sydney with the participation of Alfred Health and the Royal Victorian Eye and Ear Hospital in Melbourne. The interim results from the trial have been accepted for an oral presentation at the upcoming 2024 American Society of Clinical Oncology, or ASCO, annual meeting in June 2024.
Current wording
We are also supporting evaluation of darovasertib as single-agent neoadjuvant and adjuvant therapy in primary UM in an ongoing investigator-sponsored clinical trial, or IST, captioned as “Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma”, or NADOM, led by St. Vincent’s Hospital in Sydney with the participation of Alfred Health and the Royal Victorian Eye and Ear Hospital in Melbourne.
Previous wording
We have initiated and achieved double-digit patient enrollment in our company-sponsored Phase 2 clinical trial designated as IDE196-009, with ongoing enrollment and multiple clinical sites open. The purpose of the clinical trial is to evaluate single-agent darovasertib as neoadjuvant treatment of primary UM prior to primary interventional treatment of enucleation or radiation therapy and also as adjuvant therapy following the primary treatment. A clinical efficacy update on over 30 patients and an FDA regulatory guidance update are both targeted in the second half of 2024.
Current wording
We have initiated and achieved double-digit patient enrollment in our company-sponsored Phase 2 clinical trial designated as IDE196-009, with ongoing enrollment and multiple clinical sites open. The purpose of the clinical trial is to evaluate single-agent darovasertib as neoadjuvant treatment of primary UM prior to primary interventional treatment of enucleation or radiation therapy and also as adjuvant therapy following the primary treatment.
Previous wording
We are additionally supporting evaluation of darovasertib as (neo)adjuvant therapy in primary UM in the ongoing NADOM IST. Pursuant to an as-amended protocol for the NADOM study, uveal melanoma patients who would otherwise undergo enucleation are instead treated with single agent darovasertib as neoadjuvant treatment for up to six months or maximum benefit. This reflects an increase in potential treatment duration versus the initial approach of one month neoadjuvant therapy, following which these patients will undergo a primary interventional treatment. Patients will subsequently be treated with darovasertib for up to six months as follow-up adjuvant therapy after the primary interventional treatment. The topline results from the trial have been accepted for an oral presentation at the upcoming 2024 ASCO annual meeting.
Current wording
We are additionally supporting evaluation of darovasertib as (neo)adjuvant therapy in primary UM in the ongoing NADOM IST. Pursuant to an as-amended protocol for the NADOM study, uveal melanoma patients who would otherwise undergo enucleation are instead treated with single agent darovasertib as neoadjuvant treatment for up to six months or maximum benefit. This reflects an increase in potential treatment duration versus the initial approach of one month neoadjuvant therapy, following which these patients will undergo a primary interventional treatment. Patients will subsequently be treated with darovasertib for up to six months as follow-up adjuvant therapy after the primary interventional treatment.
Previous wording
We are enrolling patients into a Phase 2 clinical trial designated as IDE397-001 to evaluate IDE397 for patients having certain tumors with MTAP gene deletion. We are proceeding with enrollment of MTAP-deletion patients into a monotherapy Phase 2 expansion cohort with an initial focus on high priority solid tumor types, including non-small cell lung cancer, or NSCLC, and bladder cancers. We have selected a move-forward Phase 2 expansion dose for IDE397 monotherapy in MTAP-deletion squamous NSCLC, based on adverse event profile and preliminary clinical efficacy observed, including multiple partial responses by RECIST 1.1. MTAP-deletion squamous NSCLC is estimated to have a global annual incidence greater than 100,000 patients. In addition, multiple partial responses by RECIST 1.1 have also been observed in MTAP-deletion bladder cancer with IDE397 monotherapy and evaluation is ongoing for further potential Phase 2 expansion in this tumor type.
Current wording
We are enrolling patients into a Phase 1/2 clinical trial designated as IDE397-001 to evaluate IDE397 for patients having certain tumors with MTAP gene deletion. We are proceeding with enrollment of MTAP-deletion patients into a monotherapy Phase 1/2 expansion cohort with an initial focus on high priority solid tumor types, including squamous non-small cell lung cancer, or NSCLC, and urothelial cancers. We have selected a move-forward Phase 1/2 expansion dose for IDE397 monotherapy in MTAP-deletion squamous NSCLC and urothelial cancer, based on adverse event profile and preliminary clinical efficacy observed, including multiple partial responses by RECIST 1.1. The estimated U.S. MTAP-deletion annual incidence in squamous NSCLC and urothelial cancer is approximately 48,000 patients.
Previous wording
In August 2023, Amgen initiated and dosed a first patient in the IDE397 /AMG 193 combination study, following FDA authorization to proceed with the clinical trial. This Phase 1/2 clinical trial (NCT: 05975073) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with AMG 193, with an initial focus for expansion in NSCLC patients and an estimated enrollment of approximately 180 patients. Enrollment is ongoing in the dose escalation portion of this Phase 1/2 clinical trial. We are targeting the development of a joint publication strategy in 2024.
Current wording
In August 2023, Amgen initiated and dosed a first patient in the IDE397 /AMG 193 combination study, following FDA authorization to proceed with the clinical trial. This Phase 1/2 clinical trial (NCT: 05975073) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with AMG 193, with an initial focus for expansion in NSCLC patients and an estimated enrollment of approximately 180 patients. Enrollment is ongoing in the dose escalation portion of this Phase 1/2 clinical trial. We are targeting the development of a joint publication strategy in 2024. Separately, in consultation with Amgen, we have now financially budgeted to support our obligations for target IDE397 / AMG 193 clinical combination expansion in NSCLC.
Previous wording
We are separately collaborating with Gilead to clinically evaluate IDE397 in combination with sacituzumab-govitecan-hziy, or Trodelvy, Gilead’s Trop-2 directed anti-body conjugate, or ADC, in patients having MTAP deletion bladder cancer, in the Phase 1 IDEAYA-sponsored clinical trial pursuant to a Clinical Study Collaboration and Supply Agreement, or Gilead CSCSA, with Gilead Sciences, Inc., or Gilead. Trial initiation activities for the IDE397 and Trodelvy clinical combination are ongoing and the dosing of a first patient is anticipated in mid-year, or the second or third quarters of, 2024.
Current wording
We are separately collaborating with Gilead to clinically evaluate IDE397 in combination with sacituzumab-govitecan-hziy, or Trodelvy, Gilead’s Trop-2 directed anti-body conjugate, or ADC, in patients having MTAP- deletion urothelial cancer, in our Phase 1 clinical trial pursuant to a Clinical Study Collaboration and Supply Agreement, or Gilead CSCSA, with Gilead Sciences, Inc., or Gilead. A first patient was dosed for the Phase 1 trial in June 2024 and enrollment is ongoing.
Previous wording
We own all rights, title, and interest in and to IDE397 and the MAT2A program, including all worldwide commercial rights thereto.
Current wording
We are also advancing multiple preclinical stage MTAP-deletion programs to enable wholly-owned combinations with IDE397, including a program targeting a development candidate nomination in the second half of 2024. We own all rights, title, and interest in and to IDE397 and the MAT2A program, including all worldwide commercial rights thereto.
Previous wording
In March 2024, we entered into the Clinical Trial Collaboration and Supply Agreement, or Merck CTCSA, with MSD International Business GmbH, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. We are planning to evaluate IDE161 in a combination study with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with high microsatellite instability, or MSI, and microsatellite stable, or MSS, endometrial cancer. We are targeting a first-patient dosing for this study in the second half of 2024.
Current wording
In March 2024, we entered into the Merck CTCSA with MSD International Business GmbH, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. We are planning to evaluate IDE161 in a combination study with KEYTRUDA in patients with high microsatellite instability, or MSI, and microsatellite stable, or MSS, endometrial cancer. We are targeting a first-patient dosing for this study in the second half of 2024.
Previous wording
A Werner Helicase Inhibitor development candidate, or DC, has been selected in collaboration with GSK. We, in collaboration with GSK, have completed the IND-enabling GLP toxicology studies and we are targeting an IND submission in the second half of 2024 to enable first-in-human clinical evaluation of Werner Helicase Inhibitor DC for patients having tumors with high MSI. Subject to IND submission and clearance, GSK will lead clinical development for the Werner Helicase program. GSK is responsible for 80% of global research and development costs and IDEAYA is responsible for 20% of such costs. GSK holds a global, exclusive license to develop and commercialize the Werner Helicase Inhibitor DC.
Current wording
A Werner Helicase Inhibitor development candidate, or DC, has been selected in collaboration with GSK. We, in collaboration with GSK, have completed the IND-enabling GLP toxicology studies and we are targeting an IND submission in the second half of 2024 to enable first-in-human clinical evaluation of Werner Helicase Inhibitor DC for patients having tumors with high MSI. Subject to IND submission and clearance, GSK will lead clinical development for the Werner Helicase program. GSK is responsible for 80% of global research and development costs and we are responsible for 20% of such costs. GSK holds a global, exclusive license to develop and commercialize the Werner Helicase Inhibitor DC.
Previous wording
In October 2023, we achieved and earned a $3 million milestone in connection with IND-enabling studies. We have the potential to earn up to an additional $17 million aggregate milestone payments through early Phase 1 clinical studies, including $7.0 million upon IND clearance. We are also eligible to receive additional future aggregate total development milestones of up to $465 million. Upon commercialization, we 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 DC – ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions.
Current wording
In October 2023, we achieved and earned a $3.0 million milestone in connection with IND-enabling studies. We have the potential to earn up to an additional $17 million aggregate milestone payments through early Phase 1 clinical studies, including $7.0 million upon IND clearance. We are also eligible to receive additional future aggregate total development milestones of up to $465.0 million. Upon commercialization, we will be eligible to receive up to $475.0 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 DC – ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions.
Previous wording
We have initiated early preclinical research programs focused on pharmacological inhibition of several new targets, or NTs, for patients with solid tumors characterized by defined biomarkers based on genetic mutations and/or molecular signatures. We believe these research programs have the potential for discovery and development of first-in-class or unique-in-class or best-in-class therapeutics. We are targeting development candidate nominations in the second half of 2024 for multiple NTs, including a development candidate to treat MTAP-deletion solid tumors to enable a potential wholly-owned clinical combination with IDE397. Collectively, we believe these efforts will further advance our multi-pronged clinical and business strategy. We own or control all commercial rights in our next-generation NT programs.
Current wording
We have initiated early preclinical research programs focused on pharmacological inhibition of several new targets, or NTs, for patients with solid tumors characterized by defined biomarkers based on genetic mutations and/or molecular signatures. We believe these research programs have the potential for discovery and development of first-in-class or unique-in-class or best-in-class therapeutics. We are targeting development candidate nominations in the second half of 2024 for multiple NTs, including a development candidate to treat MTAP-deletion solid tumors to enable a potential wholly-owned clinical combination with IDE397, and separately a potential first-in-class program in the KAT6 pathway. Collectively, we believe these efforts will further advance our multi-pronged clinical and business strategy. We own or control all commercial rights in our next-generation NT programs.
Previous wording
On January 19, 2024, we entered into a new Open Market Sales Agreement, or January 2024 Sales Agreement, with Jefferies relating toan at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of common stock having aggregate gross proceeds of up to $350.0 million through Jefferies as sales agent.
Current wording
On January 19, 2024, we entered into a new Open Market Sales Agreement, or January 2024 Sales Agreement, with Jefferies, or Jefferies, relating toan at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of common stock, par value $0.0001 per share, or common stock, having aggregate gross proceeds of up to $350.0 million through Jefferies as sales agent.
Previous wording
Subsequent to March 31, 2024, from April 1, 2024 through April 24, 2024, we sold an aggregate of 922,000 shares of common stock for aggregate gross proceeds of approximately $37.2 million at a weighted average sales price of approximately $40.40 per share through at-the-market offerings, generating net proceeds of approximately $36.5 million, after deducting underwriting discounts and commissions and other estimated offering expense, pursuant to the January 2024 Sales Agreement with Jefferies as sales agent. As of April 24, 2024, approximately $182.1 million of common stock remained available to be sold under the ATM facility.
Current wording
During the three months ended June 30, 2024, pursuant to the January 2024 Sales Agreement, we sold an aggregate of 922,000 shares of common stock through at-the-market offerings for aggregate net proceeds of $36.5 million, after deducting underwriting discounts and commissions and other offering expenses, at a weighted average sales price of approximately $40.40 per share. As of June 30, 2024, approximately $182.1 million of common stock remained available to be sold pursuant to the January 2024 Sales Agreement.
Previous wording
We do not have any products approved for sale and have not generated any product revenue since inception. We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK. As of March 31, 2024, we had cash, cash equivalents and marketable securities of $941.4 million, consisting primarily of money market funds, U.S. government securities, commercial paper, and corporate bonds.
Current wording
We do not have any products approved for sale and have not generated any product revenue since inception. We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $952.7 million, consisting primarily of money market funds, U.S. government securities, commercial paper, and corporate bonds.
Previous wording
Our net losses were $39.6 million and $23.6 million for the three months ended March 31, 2024 and March 31, 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $387.9 million.
Current wording
Our net losses were $92.3 million and $51.6 million for the six months ended June 30, 2024 and June 30, 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $440.7 million.
Previous wording
As of March 31, 2024, we had cash, cash equivalents, and short-term and long-term marketable securities of $941.4 million.
Current wording
As of June 30, 2024, we had cash, cash equivalents, and short-term and long-term marketable securities of $952.7 million.
Previous wording
A discussion regarding our financial condition and results of operations for the three months ended March 31, 2024 compared to the three months ended December 31, 2023 and three months ended March 31, 2023 is presented below.
Current wording
A discussion regarding our financial condition and results of operations for the three months ended June 30, 2024 compared to the three months ended March 31, 2024 and six months ended June 30, 2024 compared to the six months ended June 30, 2023 is presented below.
Previous wording
There was no collaboration revenue recognized for the three months ended March 31, 2024 compared to $3.9 million for the three months ended December 31, 2023. We completed all performance obligations related to the upfront payment under the GSK Collaboration Agreement as of December 31, 2023. Future collaboration revenue recognized under the GSK Collaboration Agreement will be related to future milestone payments as they are earned.
Current wording
There was no collaboration revenue recognized for the three months ended June 30, 2024 and for the three months ended March 31, 2024. We completed all performance obligations related to the upfront payment under the GSK Collaboration Agreement as of December 31, 2023. Future collaboration revenue recognized under the GSK Collaboration Agreement will be related to future milestone payments as they are earned.
Previous wording
Research and development expenses increased by $14.9 million, or 54%, during the three months ended March 31, 2024 compared to the three months ended March 31, 2023. The increase in research and development expenses was primarily due to increases of $11.0 million in fees paid to CROs, CMOs and consultants related to the advancement of our lead product candidates through preclinical and clinical studies, $1.7 million in stock-based compensation and
Current wording
Research and development expenses increased by $11.7 million, or 27%, during the three months ended June 30, 2024 compared to the three months ended March 31, 2024 due to an increase of $8.2 million primarily driven by fees paid to CROs, CMOs and consultants related to the advancement of our lead product candidates through preclinical and clinical studies, increase in $2.3 million in personnel-related expenses, including stock-based compensation and salaries and benefits to support our growth, and an increase in $1.2 million in costs for laboratory supplies, facilities and software to support our research and development programs.
Previous wording
General and administrative expenses increased by $1.1 million, or 16%, during the three months ended March 31, 2024 compared to the three months ended December 31, 2023. The increase in general and administrative expenses was primarily due to increases of $0.7 million in stock-based compensation related to our annual option grants and $0.4 million personnel-related expenses, including salaries and benefits to support our growth.
Current wording
General and administrative expenses increased by $2.2 million, or 27%, during the three months ended June 30, 2024 compared to the three months ended March 31, 2024. The increase in general and administrative expenses was primarily due to increases of $1.2 million in stock-based compensation to support our growth, and $1.0 million in fees paid to consultants.
Previous wording
Interest income increased by $3.5 million, or 44%, during the three months ended March 31, 2024 compared to the three months ended December 31, 2023, primarily due to higher investment balances and interest rates.
Current wording
Interest income increased by $0.7 million, or 6%, during the three months ended June 30, 2024 compared to the three months ended March 31, 2024, primarily due to higher investment balances and interest rates.
Previous wording
There was no collaboration revenue recognized for the three months ended March 31, 2024 compared to $7.9 million for the three months ended March 31, 2023. We completed all performance obligations related to the upfront payment under the GSK Collaboration Agreement as of December 31, 2023. Future collaboration revenue recognized under the GSK Collaboration Agreement will be related to future milestone payments as they are earned.
Current wording
There was no collaboration revenue recognized for the six months ended June 30, 2024 compared to $11.4 million for the six months ended June 30, 2023. We completed all performance obligations related to the upfront payment under the GSK Collaboration Agreement as of December 31, 2023. Future collaboration revenue recognized under the GSK Collaboration Agreement will be related to future milestone payments as they are earned.
Previous wording
General and administrative expenses increased by $1.9 million, or 30%, during the three months ended March 31, 2024 compared to three months ended March 31, 2023. The increase in general and administrative expenses was primarily due to increases of $0.8 million for consulting and legal services, and $1.0 million in stock-based compensation and $0.3 million in personnel-related expenses, including salaries and benefits, related to an increase in headcount to support our growth, partially offset by a decrease of $0.2 million in facility costs due to larger allocation to research & development expenses.
Current wording
General and administrative expenses increased by $5.2 million, or 39%, during the six months ended June 30, 2024 compared to six months ended June 30, 2023. The increase in general and administrative expenses was primarily due to increases of $1.8 million of consulting and legal services and increases in $3.4 million of personnel-related expenses, including stock-based compensation and salaries and benefits to support our growth.
Previous wording
Interest income increased by $8.8 million, or 334%, during the three months ended March 31, 2024 compared to the three months ended March 31, 2023, primarily due to higher investment balances and interest rates.
Current wording
Interest income increased by $16.2 million, or 218%, during the six months ended June 30, 2024 compared to the six months ended June 30, 2023, primarily due to higher investment balances and interest rates.
Previous wording
We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK. As of March 31, 2024, we had cash, cash equivalents and marketable securities of $941.4 million, consisting primarily of money market funds, U.S. government securities, commercial paper, and corporate bonds.
Current wording
We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $952.7 million, consisting primarily of money market funds, U.S. government securities, commercial paper, and corporate bonds.
Previous wording
We have incurred net losses since our inception. For the three months ended March 31, 2024 and three months ended March 31, 2023, we had net losses of $39.6 million and $23.6 million, respectively, and we expect to incur substantial additional losses in future periods. As of March 31, 2024, we had an accumulated deficit of $387.9 million. Based on our current business plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations for at least the next 12 months from the issuance date of this Quarterly Report on Form 10-Q.
Current wording
We have incurred net losses since our inception. For the six months ended June 30, 2024 and six months ended June 30, 2023, we had net losses of $92.3 million and $51.6 million, respectively, and we expect to incur substantial additional losses in future periods. As of June 30, 2024, we had an accumulated deficit of $440.7 million. Based on our current business plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations for at least the next 12 months from the issuance date of this Quarterly Report on Form 10-Q.
Previous wording
We lease our laboratory and office facilities in 7000 Shoreline Court, South San Francisco, California under an operating lease with an expiration date in September 2024. In May 2018, we amended our 7000 Shoreline Court facility lease agreement to expand the size of the original premises by adding approximately 7,340 rentable square feet of additional space. In September 2019, we further amended our 7000 Shoreline Court facility lease agreement to expand the size of the premises by adding 5,588 rentable square feet of additional space. In April 2024, we again amended our 7000 Shoreline Court facility lease agreement to extend the expiration date from July 2024 to September 2024. As a result, we expect to make the total lease payments of $1.5 million through September 2024.
Current wording
We lease our laboratory and office facilities in 7000 Shoreline Court, South San Francisco, California under an operating lease with an expiration date in September 2024. In May 2018, we amended our 7000 Shoreline Court facility lease agreement to expand the size of the original premises by adding approximately 7,340 rentable square feet of additional space. In September 2019, we further amended our 7000 Shoreline Court facility lease agreement to expand the size of the premises by adding 5,588 rentable square feet of additional space. In April 2024, we again amended our 7000 Shoreline Court facility lease agreement to extend the expiration date from July 2024 to September 2024. As a result, we expect to make the total lease payments of $0.9 million through September 2024.
Previous wording
In June 2023, we entered into a lease agreement for 43,966 square feet of space at 5000 Shoreline Court, South San Francisco, California. The lease term is expected to commence in the third quarter of 2024 and the lease term is one hundred twenty months.
Current wording
In June 2023, we entered into a lease agreement for 43,966 square feet of space at 5000 Shoreline Court, South San Francisco, California. The lease term is expected to commence in the third quarter of 2024 and the lease term is one hundred twenty months. In May 2024, we amended our 5000 Shoreline Court facility lease agreement to expand the size of the original premises by adding approximately 11,321 rentable square feet of additional space.
Previous wording
In November 2023, we entered into the Gilead CSCSA with Gilead to clinically evaluate IDE397 in combination with Trodelvy (sacituzumab-govitecan-hziy), a Trop-2 directed ADC, in patients having MTAP-deletion bladder cancer, in a Phase 1 clinical trial. Under the mutually non-exclusive Gilead CSCSA, we will receive Trodelvy drug supply from Gilead and will sponsor the Phase 1 clinical combination trial evaluating ID397 and Trodelvy. Gilead will bear internal or external costs incurred in connection with its supply of Trodelvy. We will bear all internal and external costs and expenses associated with the conduct of the combination study. We and Gilead will jointly oversee clinical development of the combination therapy through a Joint Steering Committee responsible for coordinating all regulatory and other activities under the Gilead CSCSA. We and Gilead each retain commercial rights to our respective compounds, including with respect to use as a monotherapy agent or combination agent.
Current wording
In November 2023, we entered into the Gilead CSCSA with Gilead to clinically evaluate IDE397 in combination with Trodelvy (sacituzumab-govitecan-hziy), a Trop-2 directed ADC, in patients having MTAP-deletion urothelial cancer, in a Phase 1 clinical trial. Under the mutually non-exclusive Gilead CSCSA, we will receive Trodelvy drug supply from Gilead and will sponsor the Phase 1 clinical combination trial evaluating ID397 and Trodelvy. Gilead will bear internal or external costs incurred in connection with its supply of Trodelvy. We will bear all internal and external costs and expenses associated with the conduct of the combination study. We and Gilead will jointly oversee clinical development of the combination therapy through a Joint Steering Committee responsible for coordinating all regulatory and other activities under the Gilead CSCSA. We and Gilead each retain commercial rights to our respective compounds, including with respect to use as a monotherapy agent or combination agent.
Previous wording
In March 2024, we entered into the Merck CTCSA with Merck. We are planning to evaluate IDE161 in a combination study with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with MSI-high and MSS endometrial cancer. Pursuant to the Merck CTCSA, we are the sponsor of the combination study and we will provide the IDE161 compound and pay for the costs of the combination study. Merck will provide KEYTRUDA at no cost to us. We will jointly own clinical data from the combination and all inventions relating to the combined use of IDE161 and pembrolizumab. Each party retains commercial rights to its respective compounds, including with respect to use as a monotherapy or combination agent.
Current wording
In March 2024, we entered into the Merck CTCSA with Merck. We are planning to evaluate IDE161 in a combination study with KEYTRUDA, in patients with MSI-high and MSS endometrial cancer. Pursuant to the Merck CTCSA, we are the sponsor of the combination study and we will provide the IDE161 compound and pay for the costs of the combination study. Merck will provide KEYTRUDA at no cost to us. We will jointly own clinical data from the combination and all inventions relating to the combined use of IDE161 and KEYTRUDA. Each party retains commercial rights to its respective compounds, including with respect to use as a monotherapy or combination agent.
Previous wording
Net cash used in operating activities was $43.8 million for the three months ended March 31, 2024. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $39.6 million, adjusted for net non-cash charges of $1.1 million and changes in net operating assets and liabilities of $5.3 million. Our non-cash charges consisted of $6.3 million in stock-based compensation, $0.6 million in depreciation and $0.5 million of the amortization of right of use assets, partially offset by $6.3 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily of $3.1 million in prepaid and other assets, $1.3 million accrued and other liabilities due to CRO fees in support of research and manufacturing activities, $0.5 million in lease liabilities, and $0.5 million in accounts payable.
Current wording
Net cash used in operating activities was $76.7 million for the six months ended June 30, 2024. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $92.3 million, adjusted for net non-cash charges of $5.3 million and changes in net operating assets and liabilities of $10.4 million. Our non-cash charges consisted of $16.0 million in stock-based compensation, $1.2 million in depreciation and $0.9 million of the amortization of right of use assets, partially offset by $13.0 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $9.2 million in accounts payable and $5.6 million accrued and other liabilities due to CRO fees in support of research and manufacturing activities, partially offset by outflows from $3.5 million in prepaid and other assets and $1.0 million in lease liabilities.
Previous wording
Net cash used in operating activities was $27.8 million for the three months ended March 31, 2023. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $23.6 million, adjusted for net non-cash charges of $3.1 million and changes in net operating assets and liabilities of $7.3 million. Our non-cash charges consisted of $3.7 million in stock-based compensation, $0.6 million in depreciation and $0.4 million amortization of right-of-use assets, partially offset by $1.6 million accretion of discount on marketable securities. The net change in our operating assets and liabilities consisted primarily of decreases of $7.5 million in contract liabilities due to revenue recognized under the GSK Collaboration Agreement, $0.5 million in lease liabilities, $0.4 million in accrued liabilities, and $0.3 million in accounts receivable from GSK for estimated program costs under the GSK Collaboration Agreement, partially offset by a decrease of $1.4 million in prepaid and other current assets.
Current wording
Net cash used in operating activities was $61.3 million for the six months ended June 30, 2023. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $51.6 million, adjusted for net non-cash charges of $6.2 million and changes in net operating assets and liabilities of $16.0 million. Our non-cash charges consisted of $8.4 million in stock-based compensation, $1.2 million in depreciation and $0.8 million amortization of right-of-use assets, partially offset by $4.1 million accretion of discount on marketable securities. The net change in our operating assets and liabilities consisted primarily of decreases of $10.9 million in contract liabilities due to revenue recognized under the GSK Collaboration Agreement, $3.3 million in accrued liabilities and $0.9 million in lease liabilities, and an increase of $2.5 million in prepaid and other assets, partially offset by an increase in accounts payable of $1.6 million.
Previous wording
Net cash used in investing activities was $354.0 million for the three months ended March 31, 2024, which consisted primarily of $475.8 million used to purchase marketable securities and $1.3 million used to purchase property and equipment, partially offset by $123.1 million provided by maturities of marketable securities.
Current wording
Net cash used in investing activities was $285.4 million for the six months ended June 30, 2024, which consisted primarily of $640.5 million used to purchase marketable securities and $2.3 million used to purchase property and equipment, partially offset by $357.4 million provided by maturities of marketable securities.
Previous wording
Net cash provided by investing activities was $23.5 million for the three months ended March 31, 2023, which consisted of $95.9 million provided by maturities of marketable securities, partially offset by $72.3 million used to purchase marketable securities.
Current wording
Net cash used in investing activities was $97.9 million for the six months ended June 30, 2023, which consisted of $292.5 million used to purchase marketable securities and $0.9 million used to purchase property and equipment, partially offset by $195.6 million provided by maturities of marketable securities.
Previous wording
Net cash provided by financing activities was $349.1 million for the three months ended March 31, 2024, which consisted primarily of $343.7 million of net proceeds from sales under our ATM facility and $5.5 million of proceeds from exercise of common stock options.
Current wording
Net cash provided by financing activities was $388.3 million for the six months ended June 30, 2024, which consisted primarily of $380.0 million of net proceeds from at-the-market offerings and $7.5 million of proceeds from exercise of common stock options and $0.8 million of proceeds from ESPP purchase.
Previous wording
For more detail on our critical accounting policies, refer to Note 2 in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, and the notes to the financial statements appearing elsewhere in our Annual Report on Form 10-K filed with the SEC on February 20, 2024. For the three months ended March 31, 2024, there were no material changes to our critical accounting policies from those disclosed in our Annual Report on Form 10-K filed with the SEC on February 20, 2024.
Current wording
For more detail on our critical accounting policies, refer to Note 2 in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, and the notes to the financial statements appearing elsewhere in our Annual Report on Form 10-K filed with the SEC on February 20, 2024. For the six months ended June 30, 2024, there were no material changes to our critical accounting policies from those disclosed in our Annual Report on Form 10-K filed with the SEC on February 20, 2024.
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
In June 2023, we entered into an Open Market Sales Agreement, or June 2023 Sales Agreement, with Jefferies LLC (Jefferies) relating toan at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, par value $0.0001 per share (“common stock”), having aggregate gross proceeds of up to $250.0 million through Jefferies as sales agent.
Previous report — wording carried elsewhere
During the quarter ended March 31, 2024, pursuant to the June 2023 Open Market Sales Agreement, with Jefferies as a sales agent, we sold an aggregate of 6,115,516 shares of common stock through at-the-market offerings for aggregate net proceeds of $215.9 million, after deducting underwriting discounts and commissions and other offering expenses, at a weighted average sales price of approximately $36.39 per share.
Previous report — wording carried elsewhere
During the quarter ended March 31, 2024, pursuant to the January 2024 Sales Agreement, we sold an aggregate of 3,144,866 shares of common stock through at-the-market offerings for aggregate net proceeds of $127.6 million at a weighted average sales price of approximately $41.53 per share. As of March 31, 2024, approximately $219.4 million of common stock remained available to be sold under the ATM facility.
Previous report — wording carried elsewhere
Comparison of Three Months Ended March 31, 2024 and 2023
Previous report — wording carried elsewhere
$1.7 million in personnel-related expenses, including salaries and benefits, to support our growth, and $0.5 million in costs for laboratory supplies, facilities, and software to support our research and development programs.
Previous report — wording carried elsewhere
Net cash provided by financing activities was $2.9 million for the three months ended March 31, 2023, which consisted primarily of $2.6 million of net proceeds from sales under our ATM facility and $0.4 million of net proceeds from exercise of common stock options.