On March 29, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline and business progress and fourth quarter and full year 2021 financial results (Press release, Nuvalent, MAR 29, 2022, View Source [SID1234611091]).

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As part of today’s update, Nuvalent is announcing that its Investigational New Drug (IND) application for NVL-655 for the treatment of ALK-positive NSCLC and other solid tumors was cleared by the U.S. Food and Drug Administration (FDA). NVL-655 is a novel ALK-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of currently available ALK inhibitors. Nuvalent plans to initiate the ALKOVE-1 Phase 1/2 study of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors in the second quarter of 2022.

"The Nuvalent team has continued to demonstrate the ability to discover novel molecules with preclinical profiles suggesting best-in-class potential and to progress them efficiently into clinical development. With the clearance of our IND for NVL-655, Nuvalent is on track to have two parallel lead compounds in clinical trials by mid-year," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We believe we are well positioned with two clinical-stage, novel product candidates in areas of significant medical need, and sustainable internal discovery efforts with the goal of delivering multiple additional product candidates. I am incredibly proud of all that this team has accomplished and their continued dedication to advancing new potential therapeutic options for patients in need."

Recent Pipeline Highlights

Enrollment Ongoing in ARROS-1 Trial of NVL-520 for Patients with Advanced ROS1-positive NSCLC: Nuvalent is actively enrolling patients in the Phase 1 portion of its ARROS-1 clinical trial, a Phase 1/2 study evaluating NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors. NVL-520, Nuvalent’s lead product candidate, is a novel ROS1-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, CNS adverse events, and brain metastases that may limit the use of currently available ROS1 kinase inhibitors.
Discovery Pipeline Advancing toward Selection of Next Development Candidates: Nuvalent continues to advance its early pipeline efforts with multiple discovery-stage research programs. The company expects to nominate product candidates in 2022 for its discovery programs directed toward ALK IXDN compound resistance mutations and HER2 exon 20 insertions.
Recent Business Highlights

Strengthened Board of Directors with Appointment of Emily Drabant Conley, Ph.D.: In February 2022, Nuvalent appointed Emily Drabant Conley, Ph.D., Chief Executive Officer of Federation Bio, to its Board of Directors. Dr. Conley’s work has contributed to industry-shaping advances in genomics that empower patients and clinicians with actionable health data. Prior to Federation Bio, she spent over a decade at 23andMe where, as Vice President of Business Development, she was instrumental in powering the company’s growth from 30 employees into a household name.
Fourth Quarter and Full Year 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $288.1 million as of December 31, 2021. Nuvalent expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into 2024.
R&D Expenses: Research and development (R&D) expenses were $13.2 million for the quarter ended December 31, 2021, and $35.6 million for the year ended December 31, 2021.
G&A Expenses: General and administrative (G&A) expenses were $4.2 million for the quarter ended December 31, 2021, and $10.3 million for the year ended December 31, 2021.
Net Loss: Net loss was $17.3 million for the quarter ended December 31, 2021, and $46.3 million for the year ended December 31, 2021.

O March 29, 2022 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling technology, reported its financial results for the year ended December 31, 2021 (Press release, HTG Molecular Diagnostics, MAR 29, 2022, View Source [SID1234611116]).

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Recent Business Highlights

HTG Transcriptome Panel ("HTP") revenue continued to increase in the fourth quarter of 2021, ending the year as the top selling assay at approximately 16% of total revenue, just 5 months after commercial sales availability.

Announced the expansion of its therapeutics team with the addition of several highly experienced professionals, led by Stephen Barat, Ph.D., a drug development veteran who most recently served with the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen).

Expanded its HTG Therapeutics business unit’s Scientific Advisory Board with the addition of Jerald Radich, M.D., a pioneer in the fields of leukemia research and molecular genetics, and Robert Spitale, Ph.D., Associate Director and Associate Dean of Research in the School of Pharmacy and Pharmaceutical Services at the University of California, Irvine.

Added extensive biopharmaceutical industry experience and therapeutic depth to its Board of Directors with the addition of Christopher Kiritsy, formerly of KOS Pharmaceuticals.

Completed a private placement of its securities for gross proceeds of approximately $7.5 million.

Full Year 2021 Financial Highlights:

Total revenue for the year ended December 31, 2021 was $8.9 million, compared with $8.5 million for the year ended December 31, 2020.

Product and product-related services revenue increased by 13% for the year ended December 31, 2021 to $8.9 million, compared with $7.9 million for the year ended December 31, 2020. Revenue for the year ended December 31, 2021 included $1.4 million of revenue recognized from the sale of HTP assays and sample processing services. Revenue for the year ended December 31, 2020 included $0.7 million of collaborative development services revenue.

Net loss from operations for the year ended December 31, 2021 was $17.1 million, compared with $20.9 million for the year ended December 31, 2020. Net loss per share was $(2.47) for the year ended December 31, 2021 compared with $(4.51) for the year ended December 31, 2020.

Cash, cash equivalents and short-term available-for-sale securities totaled $21.9 million as of December 31, 2021, with current liabilities of approximately $9.9 million and non-current liabilities of $10.1 million.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

On March 29, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared UroGen’s Investigational New Drug (IND) application to begin a novel Phase 1 clinical study of the anti-CTLA-4 immunotherapy UGN-301 (zalifrelimab) in patients with recurrent NMIBC (Press release, UroGen Pharma, MAR 29, 2022, View Source [SID1234611132]). The multi-arm Phase 1 study is expected to start in April and support the development of UGN-301 in high-grade (HG) NMIBC.

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UroGen’s pursuit to harness the power of the immune system to fight cancer begins with UGN-301, which UroGen views as a potential cornerstone of a variety of combination therapies targeting recurrent NMIBC and high-grade cancers. UroGen initially plans to combine UGN-301 with UGN-201, the Company’s proprietary formulation of imiquimod a toll-like receptor 7 (TLR7) agonist, which has demonstrated single-agent activity in high-risk bladder cancer patients.

The novel study design will utilize a Master Protocol that UroGen believes is a more efficient and streamlined approach to development. It will provide more flexibility to add study arms as the trial progresses and increase efficiency and reduces costs. UroGen expects the Master Protocol will allow the Company to more quickly evaluate safety, tolerability and dosing of UGN-301 in combination with additional immunomodulators and chemotherapies, with the goal of developing optimized medicines for patients.

"We are pleased that our IND application was cleared to proceed, and we can begin to explore our innovative approach to meeting the high unmet needs in bladder cancer, especially for patients with high-grade disease," says Mark Schoenberg, Chief Medical Officer, UroGen Pharma. "Intravesical delivery of combination therapies is unique with the goal of improving efficacy while avoiding the toxicities associated with systemic treatment of immunotherapies. Our proprietary technology enables local delivery of treatments, which provide opportunities to pursue several promising drug combinations."

Unmet Needs in Bladder Cancer
Bladder cancers are described as muscle invasive or non-muscle invasive based on whether they have invaded the wall of the bladder. HG NMIBC is associated with an increased risk of recurrence and progression. Approximately 25,000 people are diagnosed with HG NMIBC annually. Transurethral resection of bladder tumor (TURBT) followed by intravesical bacillus Calmette-Guérin (BCG) is currently the standard of care for treatment of HG NMIBC.

HG NMIBC patient response to BCG therapy has long been interpreted as evidence that bladder cancer is sensitive to immunotherapy. Unfortunately, many patients with HG disease do not respond to BCG or relapse following therapy. In these cases, patients have limited therapeutic options and often proceed to bladder removal as a means of forestalling disease progression which has a significant association with cancer specific mortality. UroGen’s proprietary RTGel technology provides a novel method for delivering alternatives to BCG including immunomodulatory molecules such as UGN-301 as well as chemotherapeutic agents and other drugs with diverse molecular characteristics and sizes.

On March 29, 2022 Mursla, a novel multi-omics exosome characterisation company, reported that it has secured mentorship support from Roche Diagnostics Ltd for a new liquid biopsy prospective pilot study for liver cancer surveillance through MedCity’s Collaborate to Innovate: London Diagnostics programme (Press release, Mursla, MAR 29, 2022, View Source [SID1234611153]). Liver cancer is the third most common cause of premature cancer death worldwide and its incidence has increased significantly over other forms of cancer in the last three decades.

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Mursla’s aim is to develop a blood test that can detect early-stage hepatocellular carcinoma (HCC) more effectively than the current standard of care. To this end, the primary objective of the prospective pilot study is to select and confirm the relevance of novel HCC biomarkers for a larger longitudinal study demonstrating high clinical performance in a more tailored cohort. A secondary objective is the assessment of Mursla’s tissue-specific and multi-omics exosome approach as proof of concept for the development of other related cancer liquid biopsy tests.

To enable the pilot study, Mursla will leverage its proprietary multi-omics exosome characterisation platform technology for the discovery and profiling of exosome phenotypes, ExoPheno. It consists of proprietary and patented technologies, which integrate wet lab (validated exosome tissue-of-origin markers, pre-analytical multi-omics sequencing workflow and ultrasensitive exosome marker detection systems) and dry lab analysis via machine learning.

Hundreds of blood samples will be prospectively collected by Tissue Access for Patient Benefit (TAPB), a University of College London (UCL) and NHS initiative based at the Royal Free Hospital in London, UK, and by Biobanco-IMM Lisbon Academic Medical Center Portugal in collaboration with Gastroenterology Service at Hospital de Santa Maria in Lisbon, Portugal. The samples will then be characterised by ExoPheno to establish differences in the multi-omics cargo of specific exosome sub-populations between patients with various chronic liver diseases and cancer at various stages. In addition, Roche Diagnostics Ltd will support Mursla in bringing its solution to the clinic by sharing its expertise and best practice in evidence generation, scaling up and market access.

First generation liquid biopsy tests measure circulating tumor DNA (ctDNA) mutations and/or epigenetic markers (such as ctDNA methylation or fragmentation patterns) with low positive predictive value (PPV) for early-stage cancer detection, potentially leading to millions of distressing false positives. Mursla intends to improve PPV with its novel ExoPheno platform which:

Uses tissue-of-origin markers to capture tissue-specific exosomes in blood.
Detects specific multi-omics disease markers (including DNA, RNA, proteins, lipids and metabolites) contained in exosomes, mirroring the parental cell with disease.
Focuses on dynamic information released by living cells in exosomes, not by dying cells in the case of ctDNA.
Gerard Harkin, Head of Innovation UK & Ireland, Roche Diagnostics Ltd commented: "We are delighted to support the MedCity programme that encourages innovations in diagnostics and to provide in-kind mentorship to Mursla. In the field of cancer, we see the potential for new technologies to significantly improve the existing standard of care."

Pierre Arsène, Founder and CEO, Mursla added: "We are very pleased to receive the support of Roche’s UK team for the application of our novel exosome characterisation platform in early-stage liver cancer detection and beyond. We believe that the specific multi-omics information carried by blood exosomes from the tumor and its microenvironment will enable the next generation of liquid biopsy tests."

The collaboration has been enabled via Collaborate to Innovate: London Diagnostics, a MedCity programme, which is part grant-funded by the London Economic Action Partnership (LEAP). Collaborate to Innovate is an initiative that streamlines the process for building effective collaborations between SMEs and academia, commercial and non-profit partners, by helping SMEs to refine and validate their promising early-stage innovative scientific developments in their journey to provide established commercial solutions.

Mursla is one of nine successful SMEs to be selected to proceed with its study having been chosen by a panel comprising leading experts from Cancer Research UK, NHS England, BIVDA, LifeArc and world leading London academic institutions. Mursla will retain full intellectual and economic rights.

On March 29, 2022 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases reported 2021 annual results including its major achievements and progress (Press release, Innovent Biologics, MAR 29, 2022, View Source [SID1234611483]).

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "2021 is the 10th year since our company’s inception. Over the past decade, bearing the mission to develop and commercialize high-quality biopharmaceutical products that are affordable to ordinary people, Innovent has developed into a leading Chinese biopharmaceutical company with fully-integrated platform capability, strong execution with track record and a healthy financial position. For the past year, we are determined with the global innovation strategy and have made tremendous progress in all aspects including R&D, clinical development, CMC, commercialization and business collaboration. The company has rolled out development for a pipeline of 32 valuable assets in various clinic stages. We plan to expand commercial portfolio to over ten products in two years with continuous strong revenue growth, supported by our validated commercial platform capability and competitive cost advantage under large scale and high quality manufacturing facilities. Besides, we further fortified R&D structure and platform to expedite the development for over a dozens of clinical stage candidates with global potential and more preclinical projects with global innovation. For the year of 2022, as the inflection point for next decade of development, we will adhere to the company strategy of global innovation, strive to be a global premier biopharmaceutical company with steady growth prospects, and create sustainable value for patients, employees, shareholders and the society."

Business Highlight Overview

For the year of 2021, achieved RMB4,261million total revenue and RMB4,001million product revenue with an increase of 69.0% compared to the prior year.
For the year of 2021, commercial portfolio increased to six products with two innovative anti-cancer drugs approved.
Expanded strategic partnership with Eli Lilly in March 2022 added the seventh newly approved product and a ready-to-launch product at New Drug Application (NDA) stage.
TYVYT received three additional first-line indication approvals for major types of cancer and successfully included in the updated National Reimbursement Drug List (NRDL), also as the only PD-1 inhibitor globally with positive Phase 3 data in the first-line treatment for 5 major types of cancer.
6 molecules at NDA or late clinical stage.
7 molecules achieved positive Proof of Concept (PoC) data readout.
Acceleration of Global R&D and clinical development, to explore first-in-class (FIC) targets with full-functional global development platform and global talents.
About 10 strategic collaborations with global and regional partners in research, development and commercialization, unleashing the platform potential and explore synergic value of pipeline portfolio.
Commercial – Strong Track Record

Product revenue RMB4,001 million in 2021: an increase of 69.0% compared with the prior year.
Expansion of commercial portfolio into six approved products, including: TYVYT, BYVASDA, SULINNO, HALPRYZA, PEMAZYRE and NAILIKE by the end of 2021.
In March 2022, expansion of strategic collaboration with Eli Lilly, which showed further recognition by the global MNC: for Innovent to obtain sole commercialization right of the 7th approved product Cyramza (ramucirumab) and NDA-stage asset Retsevmo (selpercatinib), and the right of first negotiation for future potential commercialization of late-stage asset Pirtobrutinib (BTK inhibitor) in mainland China.
Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team expanded to cover over 5,100 hospitals and 1,100 pharmacies across more than 320 cities, and a well-structured commercial team with nearly 3,000 people.
Pipeline – Expedited Speed to Launch

– TYVYT as leading brand in PD-(L)1 market:

Newly approved 3 additional indications got successfully included in the NRDL (non-squamous Non-Small Cell Lung Cancer [nsqNSCLC], sqNSCLC, hepatocellular carcinoma [HCC]).
The only PD-1 inhibitor with positive Phase 3 data in first-line treatments of five major types of cancer (1L nsqNSCLC, 1L sqNSCLC, 1L HCC, 1L esophageal squamous cell carcinoma [ESCC], 1L gastric cancer [GC]).
Multiple clinical datasets of TYVYT were published in world-renowned medical journals such as EClinicalMedicine, ESMO (Free ESMO Whitepaper) Open, BMJ etc.
– Six assets at late stage incl. NDA/pivotal trials:

Retsevmo (selpercatinib), NDA submitted
IBI-326 (BCMA CAR-T), planned NDA submission in 2022
IBI-306 (PCSK9), planned NDA submission in 2022
IBI-310 (CTLA-4), planned NDA submission in 2022
IBI-344 (ROS1/NTRK), ongoing pivotal Phase 2
IBI-376 (PI3Kδ), ongoing pivotal Phase 2[1]
– Seven innovative molecules achieved positive PoC data readout, plan to advance into the late stage in clinic:

IBI-188 (CD47): achieved preliminary PoC data readout in Phase 1b study for 1L MDS, promising efficacy data (ORR 83.3%) and a good safety profile. Plan to initiate Phase 3 study for 1L MDS in 2022.
IBI-362 (GLP-1/GCGR): showed robust efficacy in weight loss for Phase 1b in obesity, data published in EClinicalMedicine. Robust efficacy in blood glucose lowering effects in diabetics patients. Potentially the best GLP1-/GCGR dual agonist. Plan to initiate Phase 3 studies for obesity and type 2 diabetes in 2022.
IBI-326 (BCMA CAR-T): demonstrated impressive efficacy and safety in Phase 1/2 study, with improved in-vivo persistency and encouraging efficacy in patients with prior murine BCMA CAR-T treatment failure. Plan to submit NDA in 2022.
IBI-344 (ROS1/NTRK): ORR 90.5% in the crizotinib-naïve patient and ORR 43.8% in the crizotinib-treated patient group. Received NMPA BTD for ROS1+ NSCLC. Pivotal Phase 2 study ongoing.
IBI-310 (CTLA-4): achieved positive PoC in combination with sintilimab for CC and HCC. Plan to submit NDA for CC in 2022.
IBI-302 (VEGF/C): showed visual acuity improvement with edema reduction in Phase 1b study, ongoing Phase 2 study for nAMD.
IBI-112 (IL-23p19): observed significant efficacy signal in the Phase 2 study for psoriasis with long-acting potential. Plan to initiate Phase 3 study in 2022.
– Expedite the clinical development of multiple molecule clusters with global potentials, expected PoC data readout roll out in a well-schemed plan:

CD47 cluster: IBI-188 (CD47), IBI-322 (PD-L1/CD47), IBI-397 (SIRPα)
LAG-3 cluster: IBI-110 (LAG-3), IBI-323 (PD-L1/LAG-3)
TIGIT cluster: IBI-939 (TIGIT), IBI-321 (PD-1/TIGIT)
VEGF cluster: IBI-302 (VEGF/C), IBI-324 (VEGF/ANG-2), IBI-333 (VEGF-A/VEGF-C)
R&D: Infrastructure Set for Global Innovation

– Innovent US Lab established: primarily focused on disease mechanism study and technology-platform development, accelerating the translation of scientific discovery into the next-generation drug candidates.

– The Scientific Advisory Board (SAB) established: comprising three World-renowned scientists to provide insights of frontline global innovation in cancer biology and immunology and contribute scientific advice to our research and clinical pipelines.

– The CMC Advisory Board (CAB) established: comprising industry-leading experts to provide professional advice on production structure and process streamline, resources investment and strategic development.

– The global product development team expansion and infrastructure improvement: have built a full-functional global development team and expect to have 100+ employees in near term. Have established an effective global development platform and process which enables to cooperate seamlessly with China clinical development team of 1,000 people to carry out global development for our novel assets.

– Technology platform collaborations for global innovation:

The development of the proprietary ADC technologies with Synaffix.
The development of three new therapeutic immune-stimulating antibody conjugate (ISAC) candidates with Bolt Biotherapeutics.
The development of up to three enzyme specific inhibitors with Amagma Therapeutics.
The license-out of non-exclusive commercial right of fully-human BCMA CAR construct to SANA Biotechnology for certain in vivo gene therapy and ex vivo hypo-immune cell therapy application.
BD: Meaningful Collaboration to Succeed

– Established multiple co-development and co-commercialization collaboration to unlock assets potential:

Expanded strategic collaboration with Eli Lilly for the sole commercialization right of Cyramza (ramucirumab) and Retsevmo (selpercatinib), and right of first negotiation for future commercialization of pirtobrutinib (BTK inhibitor) in mainland China.
Taletrectinib (ROS1/NTRK) – a next-generation TKI designed to effectively target ROS1 and NTRK, co-development and co-commercialization with AnHeart in China.
NAILIKE (olverembatinib) – a novel third-generation BCR-ABL TKI, co-development and co-commercialization with Ascentage Pharma in China.
GFH925 (KRAS G12C inhibitor) – a novel, orally active, potent KRAS G12C inhibitor, co-development and co-commercialization with GenFleet Therapeutics in China and opt-in right for global development and commercialization.
Orismilast (PDE4 inhibitor) – a novel, orally active PDE4 inhibitor for broad target indications, granted sole development and sole commercialization right in China from UNION therapeutics A/S.
Manufacturing Facilities Upgradation

New Commercial Facility: successfully expanded the production capacity from 24,000L to 60,000L, which is one of the largest stainless steel production capacity in China.
Quality compliance to GMP and cost advantage further strengthen market competitiveness.
Financial Highlights (Non-IFRS measure)

Total revenue was RMB 4,261 million, including product revenue 4,001 million with an increase of 69.0% compared to the prior year.
Gross profit margin was 88.6%，an increase of 3.7% compared to the prior year.
R&D expenses were RMB2,116 million an increase of 23.2% compared to the prior year.
Loss for the year was RMB2,243 million.
Cash on hand and short-term financial assets at the end of 2021 was approximately USD1,415million, which enables strategical focus on the long-term development strategies.[2]
Note: [1] In January 2022, Incyte has withdrawn the application of parsaclisib in FL, MZL and MCL in the U.S. as a business decision and is not related to any changes in either the efficacy or safety of parsaclisib. We plan to have communication with China NMPA regarding the potential submission of PI3Kδ.

[2] The financial numbers mentioned above was based on non-IFRS measure which excluded certain non-cash items and non-recurring events. Detailed disclosure can be found at the Company’s annual result announcement.