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Cellectis to Report Fourth Quarter and Year-End 2022 Financial Results on March 8, 2023

On March 1, 2023 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that it will report financial results for the fourth quarter and year-end 2022 ending December 31st, 2022, on Wednesday, March 8, 2023, after the close of the US market (Press release, Cellectis, MAR 1, 2023, View Source [SID1234627997]).

The announcement will be followed by a conference call and live audio webcast on Thursday, March 9, 2023, at 8:00 AM ET / 2:00 PM CET. The call will include the Company’s fourth quarter results, year-end results, and an update on business activities. Details for the call are as follows:

Dial-in information:

Domestic: 1-877-451-6152
International: 1-201-389-0879
Webcast: View Source;passcode=13727032&h=true&info=company-email&r=true&B=6

Alector to Participate in Upcoming Healthcare Conferences

On March 1, 2023 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that management will participate in the following upcoming investor conferences (Press release, Alector, MAR 1, 2023, View Source [SID1234627996]).

Cowen 43rd Annual Health Care Conference (Boston, Massachusetts)
Tuesday, March 7, 2023, at 10:30 a.m. ET, panel
Stifel 2023 CNS Days (Virtual)
Tuesday, March 28, 2023, at 12:00 p.m. ET, fireside chat
A webcast of each conference presentation will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source Replays of the Cowen and Stifel webcasts will be available on the Alector website for 30 and 90 days, respectively, following the presentation dates.

Zentalis Pharmaceuticals Reports Full Year 2022 Financial Results and Operational Updates

On March 1, 2023 ZentalisTM Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the year ended December 31, 2022 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, MAR 1, 2023, View Source [SID1234627995]).

"2022 was a year of considerable progress for Zentalis. We prioritized our portfolio, accelerated our clinical development strategy for our potentially first-in-class Wee1 inhibitor, azenosertib, and further strengthened our management team to drive execution," said Kimberly Blackwell, MD, Chief Executive Officer. "We are building on the momentum generated in 2022 with many clinical milestones and new programs planned for 2023. Our dose optimization activities for azenosertib remain a top priority, and we are on track to declare a monotherapy recommended Phase 2 dose in the first half of the year. We are also advancing our Cyclin E1 enrichment strategy in ovarian cancer, and we look forward to sharing Cyclin E1 preclinical data in the first half of the year and Cyclin E1 clinical data as part of the chemotherapy combination readout in the second half of the year. In addition, we plan to share progress on ZN-d5, our BCL-2 inhibitor, later this year. I am incredibly proud of the entire organization and our patient-driven mission, which guides our strategy and motivates us to continually accelerate our efforts."

Azenosertib (ZN-c3) Wee1 Inhibitor Program Highlights

•Dose optimization. The Company continues to optimize monotherapy dosing across the azenosertib program with the aim of maximizing exposure and tolerability, as well as enabling the potential clinical benefits of the agent to reach the broadest range of patients in need. The Company remains on track to provide an update on azenosertib monotherapy dose optimization activities in the first half of 2023, including declaring a monotherapy recommended Phase 2 dose (RP2D), as well as providing updates on program timelines and potential paths to registration.

•Cyclin E1 enrichment strategy. Zentalis identified high Cyclin E1 protein expression and/or CCNE1 gene amplification in high-grade serous ovarian cancer as a patient enrichment strategy

for azenosertib, which has become the focus of its ongoing Phase 1/2 clinical study examining enrichment strategies for azenosertib. The Company plans to present preclinical data supporting the rationale for the Cyclin E1 enrichment strategy at a scientific conference in the first half of 2023. In addition, Zentalis plans to report results from the Phase 1b chemotherapy combination clinical trial in ovarian cancer, which will include Cyclin E1 translational data, in the second half of 2023.

•BRAF V600E study. In October 2022, Zentalis and Pfizer announced a clinical development collaboration on a Phase 1/2 dose escalation study of azenosertib in combination with encorafenib and cetuximab (BEACON regimen) in BRAF V600E-mutated metastatic colorectal cancer (mCRC) patients. We initiated enrollment in this clinical trial in the first quarter of 2023.

BCL-2 Inhibitor (ZN-d5) Update

•Amyloidosis study. Zentalis plans to announce interim clinical data and declare the RP2D for the Phase 1/2 monotherapy clinical trial of ZN-d5 in relapsed or refractory light chain (AL) amyloidosis in the second half of 2023.

•AML study. The Company has initiated a Phase 1/2 combination study of ZN-d5 and azenosertib in relapsed or refractory acute myeloid leukemia (AML) and expects to provide preliminary data from the trial in the second half of 2023.

BCL-xL Degrader Update

•In November 2022, the Company announced that it declared its BCL-xL degrader candidate and had initiated IND-enabling studies. The BCL-xL degrader candidate demonstrates potent anti-cancer activity in several preclinical models.

Corporate Highlights

•In February 2023, the Company appointed Iris Roth, PhD, as Chief Operating Officer. Dr. Roth joins Zentalis with over two decades of biopharmaceutical experience building and executing clinical and operational strategies, successfully advancing the development of multiple investigational therapies in oncology.

Full Year 2022 Financial Results

•Cash and Marketable Securities Position: As of December 31, 2022, Zentalis had cash, cash equivalents and marketable securities of $437.4 million. The Company believes that its existing cash, cash equivalents and marketable securities as of December 31, 2022 will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2025.

•Research and Development Expenses: Research and development (R&D) expenses for the year ended December 31, 2022 were $172.7 million, compared to $175.6 million for the year ended December 31, 2021. Total R&D expenses for the year ended December 31, 2022 were in line with the comparable period; however, the year-over-year composition shifted from spend across multiple programs to spend primarily focused on azenosertib and ZN-d5. The decrease of $2.9 million was primarily due to non-recurring charges incurred in 2021 of $10.0 million for

milestone payments and an impairment charge of $8.8 million for in-process research and development. Other reductions in R&D expenses in 2022 as compared to 2021 included $14.0 million of decreased manufacturing costs, $2.7 million of decreased collaborative and consulting costs and a $5.7 million increase in R&D expense reimbursements from Zentera. These reductions were partially offset by increases in clinical trial related expenditures of $19.8 million, increases in personnel costs of $14.4 million and increases in facility, overhead allocations, and other costs of $4.1 million.

•General and Administrative Expenses: General and administrative (G&A) expenses for the year ended December 31, 2022 were $54.5 million, compared to $40.9 million during the year ended December 31, 2021. The increase of $13.6 million was primarily attributable to an increase of $8.5 million in employee-related costs, $5.5 million of which represents non-cash stock-based compensation. Other increases in 2022 as compared to 2021 include $7.2 million of higher facilities, software and supplies costs, $6.0 million of which related to rent and common area maintenance expenses, $1.5 million of higher consulting services and $1.3 million of increased legal expenses. These amounts were partially offset by a reduction of $1.4 million for permits, fees and other expenses and increased allocations to R&D from G&A of $3.5 million.

Melissa Epperly, Chief Financial Officer, stated, "We are pleased to have extended our cash runway into the second quarter of 2025 through portfolio prioritization and disciplined spending, coupled with sales of common stock via our at-the-market facility."

Zai Lab Announces Full-Year 2022 Financial Results and Recent Corporate Updates

On March 1, 2023 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported full-year 2022 financial results, along with recent product highlights and corporate updates (Press release, Zai Laboratory, MAR 1, 2023, View Source [SID1234627994]).

"In 2022, our four marketed products each had substantial sales growth, and we made exciting progress across our pipeline globally," said Dr. Samantha Du, Founder, Chief Executive Officer, and Chairperson of the Board of Directors of Zai Lab. "Our pipeline assets continued to demonstrate potential global best-in-class and/or first-in-class profile with numerous positive late-stage data readouts announced during the year, including adagrasib in non-small cell lung cancer, KarXT in schizophrenia, and efgartigimod in primary immune thrombocytopenia and generalized myasthenia gravis. We are also pleased to have contributed to several successful registrational studies, including the Tumor Treating Fields LUNAR study and the repotrectinib TRIDENT-1 study. We are also pleased to have added QINLOCK and NUZYRA to China’s National Reimbursement Drug List (NRDL) in 2023. We further deepened our women’s cancer franchise through our strategic collaboration with Seagen for TIVDAK. And, we continued to significantly enhance our talented global team."

"Zai Lab is already a leading global biotech with relevant scale, a world-class pipeline, and a growing commercial portfolio in China. We expect to achieve commercial profitability this year, and we are preparing to launch at least 8 additional products and achieve overall corporate profitability by the end of 2025," Dr. Du continued. "We will continue to invest in research and development as we seek to advance our product pipeline, including our internal discovery activities, and accelerate medicines to patients in need. We also aim to strengthen our portfolio and strategic positioning with potentially transformative assets and partnerships."

"We believe that the global regulatory environment will continue to be supportive of innovative biopharmaceutical companies like Zai Lab," Dr. Du concluded. "We will continue to build on our success in pursuit of our overall goal of improving human health, in China and globally."

2023 Strategic Priorities

Zai Lab will focus on the following strategic priorities in 2023 to drive innovation in China and beyond:

Regulatory and Commercial

•BLA approval by China’s National Medical Products Administration (NMPA) and commercial launch for efgartigimod alfa injection for the treatment of adult patients with generalized myasthenia gravis (gMG)

•NDA submission to the NMPA for repotrectinib for ROS1+ advanced non-small cell lung cancer (NSCLC)

•BLA submission to the NMPA for subcutaneous (SC) efgartigimod for gMG in mid-2023

•ZEJULA becoming the leader in PARP inhibitors sales for ovarian cancer in China

•A significant increase in sales of QINLOCK and NUZYRA following their inclusion on the NRDL

Research and Clinical Development

•Topline data readouts of the SC efgartigimod study for chronic inflammatory demyelinating polyneuropathy (CIDP) in the second quarter of 2023, and for pemphigus and immune thrombocytopenia (ITP) in the second half of 2023

•Full data readout of the Tumor Treating Fields LUNAR study in NSCLC in the first half of 2023

•Clinical data update for adagrasib in combination with pembrolizumab in first-line KRASG12C-mutated NSCLC in the second half of 2023

•Complete enrollment in the global Phase 3 innovaTV 301 study of TIVDAK in second- and third-line cervical cancer in the first half of 2023

•Join the global Phase 3 FORTITUDE-101 study of bemarituzumab in first-line gastric cancer in China in mid-2023

•Initiate a bridging study of KarXT for schizophrenia in China in mid-2023

•Initiate a global Phase 2 study for ZL-1102 (IL-17 Humabody) in chronic plaque psoriasis (CPP)

•Initiate a global Phase 1 study for ZL-1218 (CCR8) in the first half of 2023

Recent Product Highlights and Anticipated Milestones

Oncology

ZEJULA (niraparib)

ZEJULA is an oral, once-daily small-molecule poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor. It is the only PARP inhibitor approved in the United States (FDA), the European Union (EMA), and mainland China (NMPA) as a first-line maintenance monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.

Recent Product Highlights

•In February 2023, Zai Lab received the complete approval of ZEJULA in first-line ovarian cancer maintenance treatment by the NMPA. The complete approval was based on the data of Phase 3 PRIME study in Chinese patients.

•In December 2022, Zai Lab presented new interim overall survival (OS) data in Chinese patients with platinum-sensitive recurrent ovarian cancer (PSROC) from the Phase 3 NORA study for ZEJULA at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary.

–Median OS (mOS) was numerically longer for patients receiving ZEJULA regardless of biomarker status, at 46.3 months compared to 43.4 months in the placebo group [HR=0.82; 95% CI, 0.56-1.21].

–Based on the OS analysis adjusted for subsequent PARP inhibitor therapy, mOS for patients receiving ZEJULA was 46.3 months compared to 34.3 months in the placebo group [HR=0.69; 95% CI, 0.45-1.07].

–No new safety issues were identified based on long-term follow-up.

Anticipated 2023 Zai Milestone

•Present final OS analysis of the Phase 3 NORA study.

Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that disrupt cancer cell division. Optune and Optune Lua, commercial TTFields devices, are approved or marketed in certain countries or regions, including the United States, Greater China (mainland China, Hong Kong, Macau, and Taiwan), Europe, and Japan, for the treatment of newly diagnosed and recurrent glioblastoma and malignant pleural mesothelioma.

Recent Product Highlights

•In March 2023, NovoCure Ltd. announced that the last patient has been enrolled in the pivotal METIS study evaluating the efficacy of TTFields therapy following stereotactic radiosurgery (SRS) for treatment of patients with brain metastases resulting from NSCLC. Zai Lab participated in the study in Greater China.

•In February 2023, NovoCure announced that the last patient has been enrolled in the pivotal PANOVA-3 study evaluating the efficacy of TTFields together with nab-paclitaxel and gemcitabine for treatment of patients with locally advanced pancreatic cancer. Zai Lab participated in the study in Greater China.

•In January 2023, Zai Lab and NovoCure announced that the pivotal LUNAR study for patients with stage 4 NSCLC who progressed during or after platinum-based therapy met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in OS for patients treated with TTFields and standard therapies (either immune checkpoint inhibitor or docetaxel) versus standard therapies alone.

•As of December 31, 2022, Optune had been listed in 87 regional customized commercial health insurance plans guided by provincial or municipal governments (or supplemental insurance plans) since its commercial launch in mainland China for the treatment of glioblastoma in the third quarter of 2020, up from 33 such plans as of December 31, 2021.

•In November 2022, the Marketing Authorization Application (MAA) for malignant pleural mesothelioma was accepted by the NMPA.

Anticipated 2023 Partner and Zai Milestones

•Present data from the LUNAR study in NSCLC at a future medical conference.

•Provide topline data readout from the pivotal INNOVATE-3 clinical study testing the efficacy of TTFields together with paclitaxel in platinum-resistant ovarian cancer in the second half of 2023.

QINLOCK (ripretinib)

QINLOCK is an orally administered switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and PDGFRα-mutated kinases. It is the only therapeutic approved in the United States and mainland China for the treatment of advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.

Recent Product Highlights

•In January 2023, the NRDL released by China’s National Healthcare Security Administration (NHSA) was updated to include QINLOCK for advanced GIST patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.

•In January 2023, Zai Lab partner Deciphera Pharmaceuticals, Inc. (Deciphera) presented additional data from the planned exploratory analysis from the INTRIGUE Phase 3 clinical study of QINLOCK using circulating tumor DNA (ctDNA) for second-line GIST patients. Patients with mutations in KIT exon 11 and 17 and/or 18 and the absence of mutations in KIT exon 9, 13, and/or 14 (also referred to as patients with mutations in KIT exon 11 and 17/18) derived substantially improved clinical benefit with QINLOCK versus sunitinib. Deciphera plans to initiate the INSIGHT pivotal Phase 3 clinical study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18 in the second half of 2023.

TIVDAK (tisotumab vedotin)

TIVDAK is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed against cell surface tissue factor (TF) and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody.

Recent Product Highlight

•In February 2023, Zai Lab dosed the first patient in China for the global Phase 3 confirmatory innovaTV 301 study in second- or third-line recurrent or metastatic (r/m) cervical cancer.

Anticipated 2023 Partner and Zai Milestone

•Complete global patient enrollment for the innovaTV 301 study in the first half of 2023, with potential for topline data readout by year-end 2023.

Anticipated 2023 Partner Milestones

•Clinical data update for the innovaTV 207 study in head and neck cancer in the first half of 2023.

•Clinical data update for the innovaTV 205 study in first-line+ r/m cervical cancer in the second half of 2023.

KRAZATITM (adagrasib)

KRAZATITM is a highly selective and potent oral small-molecule inhibitor of KRASG12C for treating KRASG12C-mutated NSCLC, colorectal cancer (CRC), pancreatic cancer and other solid tumors.

Recent Product Highlights

•In December 2022, Zai Lab partner Mirati Therapeutics, Inc. (Mirati) announced that the FDA has granted Breakthrough Therapy Designation (BTD) to adagrasib in combination with cetuximab in patients with KRASG12C-mutated, advanced CRC whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy. This designation is supported by results from the Phase 1b cohort of the KRYSTAL-1 trial. Zai Lab is participating in the KRYSTAL-10 Phase 3 trial in patients with second-line KRASG12C-mutated CRC.

•In December 2022, Mirati announced that the FDA has granted accelerated approval for KRAZATI, a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

•In December 2022, Mirati reported results from the KRYSTAL-7 Phase 2 trial and KRYSTAL-1 Phase 1b cohort evaluating adagrasib concurrently combined with pembrolizumab in patients for the treatment of first-line NSCLC harboring a KRASG12C mutation across all PD-L1 subgroups. These results are the first to demonstrate the tolerability and feasibility of a concurrent combination regimen of a KRASG12C inhibitor and a PD-1/L1 checkpoint inhibitor.

Anticipated 2023 Partner and Zai Milestones

•Provide a clinical data update for adagrasib in combination with pembrolizumab in first-line KRASG12C-mutated NSCLC in the second half of 2023.

•Initiate Phase 3 studies in first-line KRASG12C-mutated NSCLC in 2023.

Anticipated 2023 Partner Milestones

•Submit the supplemental New Drug Application (sNDA) in third-line+ KRASG12C-mutated advanced CRC by year end 2023, and move forward with Accelerated Approval pathway.

•Provide a clinical data update for pancreatic cancer and other solid tumors in the second quarter of 2023.

Bemarituzumab

Bemarituzumab is a potential first-in-class humanized monoclonal antibody that is in clinical development as a targeted therapy for gastric and gastroesophageal junction cancer patients whose tumors overexpress FGFR2b.

Recent Product Highlight

•Zai Lab partner Amgen Inc. continues to enroll patients in several studies of bemarituzumab, including:

–FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy, versus placebo plus chemotherapy in first-line gastric cancer with FGFR2b overexpression.

–FORTITUDE-102, Phase 3 portion of a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab versus chemotherapy and nivolumab in first-line gastric cancer with FGFR2b overexpression.

Anticipated 2023 Zai Milestones

•Join the global Phase 3 FORTITUDE-101 study in first-line gastric cancer in China in mid-2023.

•Join the global Phase 3 FORTITUDE-102 study in first-line gastric cancer in China.

Odronextamab

Odronextamab is an investigational bispecific monoclonal antibody designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).

Recent Product Highlight

•In December 2022, Zai Lab partner Regeneron announced positive first interim data from the ELM-2 Phase 2 trial in patients with heavily pre-treated, relapsed/refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL). The data were presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

Anticipated 2023 Zai Milestone

•Complete enrollment in China in the registrational global ELM-2 Phase 2 trial in B-Cell Non-Hodgkin Lymphoma (B-NHL) in the first quarter of 2023.

Anticipated 2023 Partner Milestones

•Initiate confirmatory studies in FL and DLBCL, including in earlier lines in the first half of 2023.

•Submit a Biologics License Application (BLA) for R/R DLBCL and R/R FL in the second half of 2023.

Repotrectinib

Repotrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A/B/C in TKI-naïve or TKI-pretreated cancer patients.

Anticipated 2023 Zai Milestones

•Discuss regulatory pathway with the NMPA at a pre-NDA meeting in the first quarter of 2023.

•Submit an NDA to the NMPA for ROS1+ advanced NSCLC in 2023.

Zipalertinib (previously CLN-081)

Zipalertinib is an orally available small molecule designed as a next-generation, irreversible epidermal growth factor receptor (EGFR) inhibitor in development for the treatment of patients with EGFR exon 20 insertion NSCLC.

Recent Product Highlight

•Zai Lab partner Taiho Pharmaceuticals (which acquired Cullinan Pearl in 2022) initiated a pivotal study of zipalertinib in patients with EGFR exon 20 insertion NSCLC progressing after prior systemic therapy in the fourth quarter of 2022.

MARGENZA (margetuximab)

MARGENZA is an investigational, immune-enhancing monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2)-positive tumors, including certain types of breast and gastroesophageal cancers.

Anticipated 2023 Zai Milestone

•Potential China NDA approval by the NMPA in third-line+ metastatic HER2-positive breast cancer in 2023.

BLU-945

BLU-945 is a potential next-generation investigational oral EGFR inhibitor designed to selectively target the EGFR L858R activating mutation as well as C797X and T790M on-target resistance mutations, while being highly selective against wild-type EGFR. BLU-945 is in development for the potential treatment of EGFR-mutant NSCLC.
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Anticipated 2023 Partner Milestone

•Provide an initial clinical data update on SYMPHONY trial expansion of BLU-945 in combination with osimertinib in first-line EGFR L858R-positive NSCLC in the second half of 2023.

Retifanlimab

Retifanlimab is an investigational monoclonal antibody that inhibits PD-1.

Recent Product Highlights

•In February 2023, Zai Lab initiated enrollment of two proof-of-concept trials in autoimmune renal diseases.

•As of December 31, 2022, efgartigimod had been listed in 15 supplemental insurance plans in China.

•In November 2022, Zai Lab partner argenx announced the FDA has accepted for priority review a BLA for SC efgartigimod for the treatment of adult patients with gMG.

Anticipated 2023 Zai Milestones

•Potential BLA approval by the NMPA for efgartigimod alfa injection for the treatment of adult patients with gMG in China.

•Potential BLA submission to the NMPA for SC efgartigimod for the treatment of adult patients with gMG in mid-2023.

•Join the global Phase 2/3 BALLAD study in adult patients with bullous pemphigoid in China.

•Continue to explore and advance additional indications in coordination with argenx.

Anticipated 2023 Partner Milestones

•Potential BLA approval by the FDA for SC efgartigimod for gMG in the first half of 2023, with the Prescription Drug User Fee Act (PDUFA) date of June 20, 2023.

•Report topline data from the registrational ADHERE trial of SC efgartigimod for CIDP in the second quarter of 2023.

•Report topline data from the registrational Phase 3 ADDRESS trial of SC efgartigimod in pemphigus and the registrational Phase 3 ADVANCE-SC trial of SC efgartigimod in ITP in the second half of 2023.

ZL-1102 (IL-17 Human VH Antibody Fragment, Global Rights)

ZL-1102 is a human VH antibody fragment (Humabody) targeting the IL-17A cytokine with high affinity and avidity. Unlike other anti-IL-17 products, ZL-1102 is being developed as a topical treatment for mild-to-moderate chronic plaque psoriasis (CPP).

Anticipated 2023 Zai Milestone

•Initiate a global Phase 2 study for CPP.

Infectious Disease

Sulbactam-Durlobactam (SUL-DUR, Asia Pacific rights)

Sulbactam-Durlobactam is a combination of a beta-lactam antibiotic (sulbactam) and a beta-lactamase inhibitor (durlobactam) for the treatment of serious infections caused by Acinetobacter, including multi-drug and carbapenem-resistant strains.

Recent Product Highlights

•In February 2023, China’s NMPA accepted the NDA for SUL-DUR for the treatment of infections caused by Acinetobacter baumannii, including multidrug-resistant and carbapenem-resistant (CRAB) strains. Previously, in January 2023, the NMPA granted priority review status to the NDA for SUL-DUR.

•In November 2022, Zai Lab partner Entasis Therapeutics announced that the FDA accepted the NDA for SUL-DUR for priority review with an action date of May 29, 2023.

Anticipated 2023 Partner Milestone

•Potential NDA approval by the FDA.

NUZYRA (omadacycline)

NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in both hospital and community settings.

Recent Product Highlight

•In January 2023, the NRDL released by China’s NHSA was updated to include NUZYRA for the treatment of adults with CABP and ABSSSI for intravenous (IV) formulation.

Neuroscience

KarXT

KarXT (xanomeline-trospium) is an oral, investigational M1/M4-preferring muscarinic acetylcholine receptor agonist in development for the treatment of psychiatric and neurological conditions, including schizophrenia and dementia-related psychosis.

Anticipated 2023 Zai Milestone

•Initiate a bridging study for the treatment of patients with schizophrenia in China in mid-2023.

Anticipated 2023 Partner Milestones

•Report topline data from the Phase 3 EMERGENT-3 trial in schizophrenia in the first quarter of 2023.

•Submit an NDA to the FDA for KarXT in schizophrenia in mid-2023.

•Initiate the Phase 3 ADEPT-2 trial in Alzheimer’s disease psychosis in the second half of 2023.

Corporate Updates

•In January 2023, Michel Vounatsos was appointed to Zai Lab’s Board of Directors. Mr. Vounatsos brings to the Board extensive global leadership and management experience in the biopharmaceutical industry, including more than 25 years of service at leading companies. His expertise includes significant commercial experience in China and worldwide.

•In the fourth quarter of 2022, Zai Lab continued to enhance its global leadership team. In December 2022, Zai Lab appointed Rafael G. Amado, M.D. as President, Head of Global Oncology Research and Development. Dr. Amado joined the Company from Allogene Therapeutics and brings to Zai Lab deep expertise in the field of oncology and significant global biopharmaceutical R&D leadership.

•In 2022, we established our ESG Trust for Life strategy, which includes three commitments: improve human health, create better outcomes, and act right now with ethical business practices and strong corporate governance. As part of our corporate strategy, and the actions taken in support of our corporate goals, we seek to continue to develop and integrate our Trust for Life strategy into our business and operations.

Financial Results for Full-Year 2022

•Total revenues for 2022 were $215.0 million, an increase of 49.0% compared to 2021. This included total revenues of $62.6 million for the fourth quarter of 2022, an increase of 41.7% compared to the fourth quarter of 2021.

•Product revenues for 2022 were $145.2 million for ZEJULA, an increase of 55.2% y-o-y; $47.3 million for Optune, an increase of 21.6% y-o-y; $15.0 million for QINLOCK, an increase of 28.7% y-o-y; and $5.2 million for NUZYRA, compared to close to zero in 2021.

•Research and Development (R&D) expenses were $286.4 million in 2022, compared to $573.3 million for the same period in 2021. This decrease was primarily due to lower upfront payment for new licensing agreements, partially offset by higher payroll and payroll-related expenses from increased R&D headcount and an increase in expenses related to ongoing and newly initiated late-stage clinical trials. Excluding upfront payment for new licensing agreements, R&D expenses were $256.4 million in 2022, compared to $252.0 million in 2021.

•Selling, General and Administrative (SG&A) expenses were $259.0 million in 2022, compared to $218.8 million for the same period in 2021. This increase was primarily due to higher payroll and payroll-related expenses from increased headcount, as Zai Lab continued to expand and invest in its commercial operations in China and infrastructure in the United States in anticipation of substantial growth over the next few years.

•Zai Lab reported a net loss of $443.3 million, or a loss per share attributable to common stockholders of $0.46, for 2022, compared to a net loss of $704.5 million, or a loss per share attributable to common stockholders of $0.76, for 2021. The decrease in the net loss was primarily attributable to payments related to new business development activities.

•As of December 31, 2022, cash and cash equivalents, short-term investments and restricted cash totaled $1,009.3 million, compared to $1,409.9 million as of December 31, 2021.

Conference Call and Webcast Information

Zai Lab will host a live conference call and webcast tomorrow, March 2, 2023, at 8:00 a.m. ET. Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call.

Details are as follows:

Registration Link: https://register.vevent.com/register/BI7e1f2dd4243c461585564c4b7dd866a6

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

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