On May 11, 2023 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the first quarter ended March 31, 2023 (Press release, LianBio, MAY 11, 2023, View Source [SID1234631518]).

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"We continue to achieve multiple significant milestones, propelling the company towards the anticipated commercial launch of mavacamten in China," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "Our team’s demonstrated proficiency in navigating the Chinese regulatory landscape instills confidence in our cross-border model. With the recent progress we’ve made, we believe we are on track to bring our first drug to market in China next year, while we continue to advance our other key programs through the clinic."
Recent Business Highlights and Clinical Development Updates

Mavacamten late-stage clinical development and launch readiness activities on track in China with NDA on file; mavacamten approved in Macau; NDAs under review in Singapore and Hong Kong
•In January 2023, mavacamten was added to The Joint Committee of Cardiomyopathy Specialty Alliance, National Center for Cardiovascular Diseases/Cardiovascular Precision Medicine Branch of China International Exchange and Promotive Association for Medical and Health Care’s 2023 Guidelines for the Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy.
•In April 2023, the China NMPA accepted with priority review the NDA for mavacamten for the treatment of adults with symptomatic oHCM.
•In April 2023, LianBio announced topline results from the Phase 3 EXPLORER-CN trial evaluating mavacamten in Chinese patients with oHCM. EXPLORER-CN met the primary endpoint, demonstrating statistically significant and clinically meaningful improvement in Valsalva left ventricular outflow tract gradient from baseline to week 30 compared to placebo, and a safety profile consistent with previous studies.
•In May 2023, mavacamten was approved for the treatment of adults with symptomatic New York Heart Association Class II-III oHCM in the Macau Special Administrative Region.

Commercial infrastructure build continues in preparation for anticipated 2024 mavacamten launch
•In April 2023, Pascal Qian was promoted to Chief Commercial Officer to oversee the continued growth of the company’s commercial capabilities in preparation for the anticipated mavacamten commercial launch in China. He will continue to also serve as the company’s China General Manager.
Business is well-positioned to achieve anticipated milestones
•Current cash runway is projected to extend through the end of 2024.
Key Anticipated Milestones
Mavacamten
•LianBio plans to present detailed results from EXPLORER-CN at an upcoming medical meeting.
TP-03
•LianBio expects to report topline data from the Phase 3 LIBRA trial of TP-03 in Chinese patients with Demodex blepharitis in the fourth quarter of 2023.
Infigratinib
•LianBio expects to report topline data from the ongoing Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR genomic alterations in the second half of 2023.
•LianBio expects to initiate a pivotal Phase 2 trial of infigratinib in locally advanced or metastatic gastric cancer patients with FGFR2 gene amplification in the first half of 2024 to support regulatory approval in China.
BBP-398
•LianBio expects to initiate a Phase 1 clinical trial of BBP-398 in combination with an EGFR-inhibitor in non-small cell lung cancer in the second half of 2023.

First Quarter 2023 Financial Results

Research & Development Expenses

Research and development expenses were $10.8 million for the first quarter of 2023 compared to $12.3 million for the first quarter of 2022. The decrease was primarily attributable to increased milestone payments in 2022, and was offset by higher development activities to support clinical trials in 2023.
General & Administrative Expenses
General and administrative expenses were $15.1 million for the first quarter of 2023 compared to $16.1 million for the first quarter of 2022. The decrease was primarily attributable to decreases in expenses for legal, consulting and accounting services.

Net Loss

Net loss was $24.0 million for the first quarter of 2023 compared to net loss of $27.7 million for the first quarter of 2022.

Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at March 31, 2023 totaled $286.6 million compared to $302.4 million as of December 31, 2022. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan through the end of 2024.

On May 11, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported financial results for the first quarter of 2023 and provided a corporate update (Press release, Kineta, MAY 11, 2023, View Source;utm_medium=rss&utm_campaign=kineta-reports-first-quarter-2023-financial-results-and-provides-corporate-update [SID1234631517]).

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"The year began with an exciting start as we opened our first-in-human clinical trial of KVA12123 and dosed our first patient in the Phase 1/2 study in advanced solid tumors. Our team is laser focused on working with clinical partners to enroll patients in this study and report initial clinical data by the end of the year," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "Additionally, in April 2023, we strengthened our balance sheet with a $6 million financing to provide the company with runway through early 2025."

RECENT CORPORATE HIGHLIGHTS

Dosed first patient in Phase 1/2 clinical study evaluating KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors
Closed $6 million registered direct offering priced at-the-market under Nasdaq rules
Presented VISTA biomarker data and KVA12123 Phase 1/2 clinical trial update at the AACR (Free AACR Whitepaper) Annual Meeting 2023
Expanded the company’s Scientific Advisory Board (SAB) with the addition of two internationally-renowned clinical immuno-oncology experts:
Myriam Chalabi, M.D.: Medical oncologist and researcher at the Netherlands Cancer Institute
Evan Y. Yu, M.D.: Section Head for Cancer Medicine, Clinical Research Division at the Fred Hutchinson Cancer Center and Medical Director for Clinical Research at the Fred Hutchinson Cancer Consortium
Hosted Key Opinion Leader Event on KVA12123: VISTA as an Immuno-oncology target with Dr. Michael A. Curran, Ph.D. (MD Anderson Cancer Center Department of Immunology) and Dr. Patricia LoRusso, D.O. (Yale School of Medicine Cancer Center)
ANTICIPATED FUTURE MILESTONES

Dose first patient in the combination arm (Part B) of the ongoing KVA12123 Phase 1/2 clinical study

Report initial clinical data of KVA12123 by end of 2023

FIRST QUARTER 2023 FINANCIAL HIGHLIGHTS

Cash position: As of March 31, 2023, cash was $9.2 million, compared to $13.1 million as of December 31, 2022. The decrease was primarily due to cash used for clinical trial development of KVA12123 as well as general corporate purposes, partially offset by $0.8 million net proceeds received from the sale of 126,503 shares of our common stock in connection with an at-the-market equity offering program. We believe our cash position as of March 31, 2023, together with the $5.5 million net proceeds received in April 2023 plus the committed proceeds of $22.5 million pursuant to the second closing of the private placement expected in July 2023, will be sufficient to fund operating expenses and capital expenditure requirements into early 2025.

Research and development (R&D) expense: R&D expenses were $2.8 million for the three months ended March 31, 2023 compared to $4.0 million for the three months ended March 31, 2022. The decrease in R&D expenses was primarily due to lower activities for KVA12123 as we began securing clinical trial sites and enrolling patients in advance of enrolling the first patient, which occurred in April 2023. We expect our R&D expenses to increase over time this year as we enroll and dose additional patients.

General and administrative expense: General and administrative expenses were $3.9 million for the three months ended March 31, 2023 compared to $1.6 million for the three months ended March 31, 2022. The increase was primarily due to higher personnel-related costs from non-cash stock-based compensation with performance conditions contingent upon the closing of the reverse merger and increased public company expenses such as professional services fees and insurance.

Net loss: The Company reported a net loss of $6.5 million, or $0.77 per basic and diluted share, compared to a net loss of $5.0 million, or $1.07 per basic and diluted share, for the prior year.

On May 11, 2023 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune mediated and oncologic disorders, reported financial results for the first quarter ended March 31, 2023 and provided a business update (Press release, Kezar Life Sciences, MAY 11, 2023, View Source [SID1234631516]).

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"This quarter, Kezar continued to make meaningful progress on its clinical strategy. We remain focused on actively exploring zetomipzomib’s promise in lupus nephritis and autoimmune hepatitis, in addition to advancing our protein secretion inhibitor pipeline, showcasing our ability to discover and develop first in class small molecule therapeutics against novel targets," said John Fowler, Kezar’s Co-Founder and Chief Executive Officer. "To that end, we recently presented the trial design for PALIZADE, our Phase 2b clinical trial of zetomipzomib in lupus nephritis, and provided an encouraging early update from our Phase 1 oncology study of KZR-261, our Sec61 translocon inhibitor. We look forward to continued strong execution in our programs and are excited to share results from our KZR-261 dose escalation trial in the second half of this year."

Zetomipzomib: Selective Immunoproteasome Inhibitor

PALIZADE – Phase 2b clinical trial of zetomipzomib in patients with active lupus nephritis (LN) (ClinicalTrials.gov: NCT05781750)

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PALIZADE is a global, placebo-controlled, randomized, double-blind Phase 2b clinical trial evaluating the efficacy and safety of two dose-levels of zetomipzomib in patients with active LN. Target enrollment will be 279 patients, randomly assigned (1:1:1) to receive 30 mg of zetomipzomib, 60 mg of zetomipzomib or placebo subcutaneously once weekly for 52 weeks, in addition to standard background therapy. Background therapy can, but will not be mandated to, include standard induction therapy. Over the initial 16 weeks, there will be a mandatory corticosteroid taper to 5 mg per day or less. End-of-treatment assessments will occur at Week 53, and the end-of-study assessments will occur at Week 57. The primary efficacy endpoint is the proportion of patients who achieve a complete renal response (CRR) at Week 37, including a urine protein-to-creatine ratio (UPCR) of 0.5 or less without receiving rescue or prohibited medications. PALIZADE is on track to initiate in the first half of 2023.
PORTOLA – Phase 2a clinical trial of zetomipzomib in patients with autoimmune hepatitis (AIH) who have not benefited from standard-of-care treatment (ClinicalTrials.gov: NCT05569759)

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PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH that are insufficiently responding to

standard of care or have relapsed. Target enrollment will be 24 patients, randomized (2:1) to receive 60mg of zetomipzomib or placebo in addition to background corticosteroid therapy for 24 weeks, with a protocol-mandated steroid taper by Week 14. The primary efficacy endpoint will measure the proportion of patients who achieve a complete response measured as normalization of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels with a successful corticosteroid taper by Week 24.
MISSION – Completed open-label Phase 2 clinical trial of zetomipzomib in patients with active LN (ClinicalTrials.gov: NCT03393013)

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An abstract featuring post-hoc analysis across LN biopsy classes from the open-label Phase 2 MISSION clinical trial was presented at the National Kidney Foundation (NKF) Spring Clinical Meeting 2023, which took place April 11-15, 2023 in Austin, Texas.
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An abstract featuring complete MISSION Phase 1b/2 results, along with a post hoc subgroup analysis in the Phase 2 Hispanic/Latino population, was presented at the Pan American League of Associations for Rheumatology (PANLAR) 2023 Congress, which took place April 26-29, 2023 in Rio de Janeiro, Brazil.
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An abstract featuring complete MISSION Phase 1b/2 results has been selected for oral presentation at the upcoming LUPUS & KCR 2023 meeting, taking place May 17-20, 2023 in Seoul, Korea.
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Three abstracts featuring complete MISSION Phase 2 results, MISSION Phase 2 uCD163 data, and the unmet need of European patients with LN have been selected for poster presentations at the upcoming European Alliance of Associations for Rheumatology (EULAR) 2023 Congress, taking place May 31 – June 3, 2023 in Milan, Italy.
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Two abstracts featuring post-hoc analysis of MISSION Phase 2 patients with nephrotic range proteinuria and the unmet need of European patients with LN will be presented as focused oral presentations at the 60th European Renal Association (ERA) Congress, taking place June 15-18, 2023 in Milan, Italy.
Protein Secretion Inhibition Platform

KZR 261: Broad-Spectrum Sec61 Translocon Inhibitor

KZR-261-101 – Phase 1 clinical trial of KZR-261 in patients with locally advanced or metastatic solid malignancies (ClinicalTrials.gov: NCT05047536)

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The Phase 1 clinical trial of KZR-261 is being conducted in two parts: dose escalation and dose expansion in four tumor-specific solid tumors and one all-tumor cohort. The study is designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, identify a recommended Phase 2 dose and to explore the preliminary anti-tumor activity of KZR-261 in patients with locally advanced or metastatic disease. Kezar plans to initiate the dose expansion study in the second half of 2023, with topline data expected starting mid-2024.

•
The KZR-261 trial is currently enrolling Cohort 6 (27 mg/m2). To date, KZR-261 has shown dose-proportional exposure and no signs of accumulation or altered pharmacokinetics with repeated dosing. There have been no consistent patterns of safety signals. Kezar plans to report safety and dose escalation data from this trial in the second half of 2023.
Financial Results

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Cash, cash equivalents and marketable securities totaled $257.7 million as of March 31, 2023, compared to $276.6 million as of December 31, 2022. The decrease was primarily attributable to cash used to advance clinical-stage programs and preclinical research and development.
•
Research and development expenses for the first quarter of 2023 increased by $7.4 million to $18.3 million compared to $10.9 million in the first quarter of 2022. This increase was primarily due to advancing the zetomipzomib clinical program in multiple indications and the KZR-261 clinical program, and an increase in compensation and related personnel costs, including non-cash stock-based compensation expense, attributable to higher headcount to support the progression of the company’s programs and drug discovery.
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General and administrative (G&A) expenses for the first quarter of 2023 increased by $1.3 million to $6.2 million compared to $4.9 million in the first quarter of 2022. The increase was primarily due to an increase in legal and professional services and an increase in compensation and related personnel costs, including non-cash stock-based compensation expense as a result of an increase in headcount and salaries.
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Net loss for the first quarter of 2023 was $22.2 million, or $0.31 per basic and diluted common share, compared to a net loss of $16.0 million, or $0.26 per basic and diluted common share, for the first quarter of 2022.
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Total shares of common stock outstanding were 70.8 million shares as of March 31, 2023. Additionally, there were outstanding pre-funded warrants to purchase 1.6 million shares of common stock at an exercise price of $0.001 per share, 0.5 million outstanding restricted stock units and options to purchase 12.5 million shares of common stock at a weighted-average exercise price of $7.83 per share as of March 31, 2023.

On May 11, 2023 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win technology platform, reported its financial results for the first quarter ended March 31, 2023 (Press release, IO Biotech, MAY 11, 2023, View Source [SID1234631515]). The company continues to advance its lead cancer vaccine candidate, IO102-IO103, with two company-sponsored clinical trials currently recruiting, as well as five investigator-initiated trials contracted with leading cancer institutions in the United States and Europe.

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"Our team remains keenly focused on advancing the development of IO102-IO103, our novel, investigational immune-modulating cancer vaccine, across multiple programs," said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. "As anticipated, enrollment in our global Phase 3 pivotal trial for patients with advanced melanoma has accelerated, and we expect to reach 225 patients randomized by mid-2023 and expect full enrollment in the trial by the end of 2023. Importantly, the protocol calls for an interim analysis to be conducted one year after 225 patients have been randomized. If these data are supportive, we could then prepare and submit a Biologics License Application for accelerated approval in the US.

Dr. Zocca continued, "Additionally, we are pleased that the FDA has cleared our IND to study the use of IO102-IO103 for the neo-adjuvant/adjuvant treatment of solid tumors in patients with melanoma and head and neck cancers. We plan to initiate this Phase 2 trial in the second half of 2023."

Highlights for First Quarter 2023 and Recent Weeks

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The company’s Phase 3 trial (IOB-013/KN-D18) is evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients. The company continues to expect to enroll 225 patients by mid-2023 and fully enroll the trial by the end of 2023. The Phase 3 trial protocol calls for an interim analysis of overall response rate one year after 225 patients have been randomized; if these data are supportive this interim analysis could allow for submission of a Biologics License Application for an accelerated approval in the US.

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The company’s Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, or metastatic bladder cancer showed encouraging initial data from 10 lung cancer patients; of the 10 patients, 9 were efficacy evaluable per protocol having received at least one full cycle of treatment. Among the 9 evaluable patients, 4 patients had a partial response while 4 had stable disease; one patient had progressive disease. The safety profile observed at the time of the interim readout is consistent with prior clinical experience with IO102-IO103. The trial continues to recruit patients and the company expects to report additional data from this trial this year.
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The FDA has cleared the company’s IND for the evaluation of IO102-IO103 in the neo-adjuvant / adjuvant treatment of solid tumors. The company plans to initiate a Phase 2 basket trial evaluating the use of IO102-IO103 in combination with pembrolizumab in the neo-adjuvant/adjuvant setting in patients with melanoma and head and neck cancer.

First Quarter 2023 Financial Results

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Net loss for the three months ended March 31, 2023 was $17.0 million, compared to $17.2 million for the three months ended March 31, 2022.

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Research and development expenses were $11.9 million for the three months ended March 31, 2023, compared to $10.3 million for the three months ended March 31, 2022. The increase was primarily related to clinical trial-related activities for our IO102-IO103 product candidate, including the continued execution of our Phase 3 clinical trial. The Company recognized $0.7 million in research and development equity-based compensation for both the three months ended March 31, 2023 and 2022.
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General and administrative expenses were $6.0 million for the three months ended March 31, 2023, compared to $6.7 million for the three months ended March 31, 2022. The decrease was related to lower professional services and consulting costs, offset by an increase in headcount. The Company recognized $1.2 million in general and administrative equity-based compensation for the three months ended March 31, 2023, compared to $0.9 million for the three months ended March 31, 2022.
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Cash and cash equivalents as of March 31, 2023 were $128.5 million, compared to $142.6 million at December 31, 2022. During the three months ended March 31, 2023, the Company used cash, cash equivalents and restricted cash of $14.8 million from operating and investing activities that was offset by an increase of $0.7 million in cash due to the effects of foreign currency exchange rates.
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Cash on hand is expected to support operations through the third quarter of 2024.

About IO102-IO103

IO102-IO103 is an investigational immune-modulating cancer vaccine designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1.

About the IOB-013/KN-D18 Phase 3 Clinical Trial

IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment is 300 patients from centers spread across the United States, Europe, Australia, Israel and South Africa. Biomarker analyses will also be conducted. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial

IOB-022/KN-D38 is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line advanced cancers: non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial bladder cancer (UBC). The clinical trial is sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.

On May 11, 2023 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its first quarter 2023 financial results and provided a corporate update (Press release, Instil Bio, MAY 11, 2023, View Source [SID1234631514]).

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First Quarter 2023 Highlights and Anticipated Milestones:

ITIL-306 phase 1 study in UK anticipated to initiate in 2H’2023: Instil has recently received positive initial feedback from the Medicines and Healthcare products Regulatory Agency, or MHRA, on the proposed study design for the phase 1 dose escalation study of ITIL-306 in the United Kingdom, and anticipates initiating such study in the second half of 2023 following anticipated Clinical Trial Application, or CTA, clearance from the MHRA. Instil expects to report initial clinical data from the ITIL-306 program in 2024.
Instil confirms cash runway beyond 2026 with consolidation of R&D operations to the UK: In January 2023, the Company announced the consolidation of the Phase 1 clinical trial and related manufacturing of CoStAR-TIL to its active operations in Manchester, UK leading to an extension of the expected cash runway to beyond 2026. Instil’s Manchester, UK operations have extensive experience in the manufacture and development of TIL and other cell therapies since 2011. Instil continues to pursue a potential lease or sale of its manufacturing facility in Tarzana, California. Under the current operating plan, starting in the second half of 2023, Instil expects quarterly cash burn of less than $10 million through the end of 2024.
First Quarter 2023 Financial and Operating Results:

As of March 31, 2023, Instil had cash, cash equivalents, restricted cash and marketable securities of $223.9 million, which consists of $27.4 million in cash and cash equivalents, $0.7 million in restricted cash and $195.8 million in marketable securities, compared to $260.9 million in total cash and cash equivalents and marketable securities, consisting of $43.7 million in cash and cash equivalents and $217.2 million in marketable securities as of December 31, 2022. Instil expects that its cash, cash equivalents and marketable securities as of March 31, 2023 will enable it to fund its operating plan beyond 2026.

Research and development expenses were $20.7 million for the three months ended March 31, 2023, compared to $39.2 million for the three months ended March 31, 2022.

General and administrative expenses were $13.2 million for the three months ended March 31, 2023, compared to $15.1 million for the three months ended March 31, 2022.

Restructuring and impairment charges were $24.6 million for the three months ended March 31, 2023.