On May 9, 2022 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported financial results for the first quarter ended March 31, 2022 and provided a pipeline update on its six clinical-stage molecules targeting TIGIT, the adenosine axis (CD73 and dual A2a/A2b receptor), HIF-2a and PD-1 across multiple common cancers (Press release, Arcus Biosciences, MAY 9, 2022, View Source [SID1234613968]). In addition, today Arcus announced encouraging results from the third interim analysis of the ongoing Phase 2 ARC-7 study. In this interim analysis, both domvanalimab-containing arms continued to show meaningful differentiation compared to zimberelimab alone across multiple efficacy measures, including overall response rate (ORR) and duration of response (DoR). The clinical activity of zimberelimab alone was in line with established anti-PD-1 therapies in this patient population. At the time of data cut off, no unexpected safety signals were observed.

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"We are optimistic about the potential for and committed to the goal of domvanalimab becoming a best-in-class anti-TIGIT antibody," said Terry Rosen, Ph.D., chief executive officer of Arcus. "The results from our most recent interim analysis further support the significant investment we and Gilead are making in the domvanalimab program, which is on track to increase from two ongoing to four Phase 3 studies by year-end and include expansion into new areas of unmet need with broader populations in lung and upper gastrointestinal cancers. Moreover, with a strong cash balance and six clinical-stage molecules across multiple cancer types, we are well-positioned to develop potentially practice-changing therapies for cancer patients in need of better treatment options."

Anti-TIGIT program (domvanalimab and AB308)

Update on ARC-7:

Arcus conducted a third interim analysis (IA3) for ARC-7, a randomized Phase 2 study evaluating the safety and efficacy of zimberelimab alone vs. domvanalimab plus zimberelimab (doublet) vs. domvanalimab plus zimberelimab and etrumadenant (triplet) as a first-line treatment for metastatic NSCLC PD-L1 TPS≥50% with no actionable mutations. The study has a target total enrollment of 150 patients who are being randomized 1:1:1 across three study arms and treated until disease progression or loss of clinical benefit.
ARC-7 is an ongoing study and the data continues to mature as more patients are enrolled and patients are followed for longer durations.
Gilead and Arcus are co-developing and equally share co-development costs for the three investigational molecules: domvanalimab, an Fc-silent anti-TIGIT antibody, etrumadenant, a dual adenosine A2a/A2b receptor antagonist, and zimberelimab, an anti-PD1 antibody.
Summary of Efficacy and Safety Observations from IA3:

With more patients and longer follow up, both domvanalimab-containing arms continued to show meaningful differentiation compared to zimberelimab alone across multiple efficacy measures, including ORR and DoR.
Since the last interim analysis, ORR for the doublet continued to increase and further separate from zimberelimab alone.
Although early, the depth of response for the triplet remains encouraging; Arcus and Gilead will continue to monitor the triplet for potential differentiation in duration and depth of response vs. the doublet.
At this interim analysis, Arcus performed its first assessment of DoR. While the data are still immature, at the time of IA3, Arcus observed a substantial improvement for the domvanalimab-containing arms compared to zimberelimab alone.
Zimberelimab alone continued to demonstrate activity consistent with that of marketed anti-PD-1 antibodies in the setting.
No unexpected safety signals were observed; early safety data from this interim analysis showed a lower incidence of infusion reactions relative to published numbers from other anti-TIGIT plus anti-PD-(L)1 clinical studies.
Other Anti-TIGIT Updates:

In May 2022, Arcus presented Phase 1 and preclinical data at the Annual Meeting of the American Association of Immunologists; the data demonstrated the potential of domvanalimab, as an Fc-silent antibody, to achieve anti-tumor effects and the incidence of pruritis, rash, maculopapular rash and infusion-related adverse events appear to be lower than Fc-enabled anti-TIGIT monoclonal antibodies. The poster can be found in the publications section of the Arcus website.
2022 Anti-TIGIT Milestones:

Enrollment for ARC-7 remains on track to complete mid-2022; we expect to provide a data update in the second half of 2022.
Arcus and Gilead plan to initiate STAR-121, in 4Q 2022, a Phase 3 registrational trial to evaluate the combination of domvanalimab plus zimberelimab and chemotherapy versus standard of care pembrolizumab with chemotherapy in first-line NSCLC PD-L1 all-comers.
STAR-221, a pivotal Phase 3 study of a domvanalimab-based combination in upper gastrointestinal cancers, is currently in advanced stages of planning.
Arcus and Gilead expect to initiate two signal-finding Phase 2 studies to further evaluate multiple domvanalimab-combinations, including triplet combinations with etrumadenant and quemliclustat, by year-end.
Etrumadenant (A2a/A2b adenosine receptor antagonist)

Recent Etrumadenant Updates:

Gilead announced the addition of etrumadenant plus Trodelvy (sacituzumab govitecan-hziy) cohorts in the ongoing Phase 2 ARC-6 trial in castration-resistant prostate cancer.
2022 Etrumadenant Milestones:

As discussed above, Arcus and Gilead expect to initiate a Phase 2 platform study to evaluate domvanalimab-based combinations, including with etrumadenant, this year.
Data analysis from the randomized cohort of ARC-6 evaluating etrumadenant plus zimberelimab and docetaxel versus docetaxel in second-line metastatic castrate-resistant prostate cancer (CRPC) is anticipated in the second half of 2022 with a presentation of results expected in 2023.
Quemliclustat (small molecule CD73 inhibitor)

2022 Quemliclustat Milestones:

Results from ARC-8, including an assessment of progression-free survival, are expected in the second half of 2022 with detailed results to be presented at a future medical congress.
Additional clinical studies for quemliclustat are being planned with Gilead.
AB521 (HIF-2a inhibitor)

Recent AB521 Updates:

Initial PK/PD data from the evaluation of AB521 in healthy human volunteers as well as preclinical data for AB521, alone and in combination with cabozantinib, were presented at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress in March 2022. The early clinical data suggest that AB521 potentially has an improved clinical profile compared to that of the approved HIF-2a inhibitor.
2022 AB521 Milestones:

A Phase 1/1b study to explore AB521 in clear-cell renal cell carcinoma, alone and in combination with other molecules, including those targeting the CD73-adenosine axis, is anticipated to be initiated in mid-2022. Data from the healthy volunteer study should enable Arcus to start dose escalation in patients at a biologically relevant dose level.
Discovery Programs:

AB598 (Arcus’ anti-CD39 antibody) continues to progress through preclinical development, and we expect to file an IND in the first half of 2023. Recent clinical data at AACR (Free AACR Whitepaper) from a competitor antibody is supportive of Arcus’ development plans for this molecule, in combination with other agents in our portfolio.
Arcus anticipates selection of a development candidate for at least one other discovery program to occur this year, with potential for IND filing in 2023.
Financial Results for the First Quarter 2022

Cash, cash equivalents and investments were $1,342.4 million as of March 31, 2022, compared to $681.3 million as of December 31, 2021. The increase was primarily due to the receipt of $725 million from Gilead in January 2022. Arcus expects cash, cash equivalents and marketable securities on-hand to be sufficient to fund operations into 2026.
Revenues: Collaboration and license revenues were $18.0 million for the three months ended March 31, 2022, compared to $9.5 million for the same period in 2021. In the three months ended March 31, 2022, Arcus recognized $8.3 million in collaboration revenue related to Gilead’s ongoing rights to access Arcus’ research and development pipeline in accordance with the Gilead collaboration agreement, $7.9 million in license and development service revenues for all programs optioned by Gilead, based on estimates of progress made toward satisfying the related performance obligations, as well as $1.8 million related to the collaboration agreement with Taiho. In the three months ended March 31, 2021, Arcus recognized $7.7 million in other collaboration revenue related to Gilead’s access to Arcus’ research and development pipeline, as well as $1.8 million related to the Taiho collaboration agreement.
R&D Expenses: Research and development expenses were $61.2 million for the three months ended March 31, 2022, compared to $66.4 million for the same period in 2021. The decrease was due to increased cost-sharing reimbursements from Gilead for its optioned programs and decreases in milestone expenses due to the timing of development milestones and the related payments, largely offset by an increase in costs incurred to support Arcus’ expanded clinical and development activities. There was a $2.3 million increase in compensation costs related to non-cash stock-based compensation to approximately $8.5 million for the three months ended March 31, 2022 compared to the prior year period.
G&A Expenses: General and administrative expenses were $24.0 million for the three months ended March 31, 2022, compared to $15.8 million for the same period in 2021. The increase was driven by the increased size and complexity of Arcus’s clinical development organization associated with Arcus’s expanding clinical pipeline and collaboration obligations. Arcus’s growing employee base and 2022 stock awards drove increases in office facilities expense and employee compensation costs, including a $1.4 million increase in non-cash stock-based compensation to approximately $8.0 million for the three months ended March 31, 2022 compared to the prior year period.
Net Loss: Net loss was $68.0 million for the three months ended March 31, 2022, compared to a net loss of $72.6 million for the same period in the prior year.
Arcus Ongoing and Announced Clinical Studies

Trial Name

Arms

Setting

Status

NCT No.

Lung Cancer

ARC-7

zim vs. dom + zim vs. dom + etruma + zim

1L NSCLC (PD-L1 ≥ 50%)

Ongoing Randomized Phase 2

NCT04262856

PACIFIC-8

dom + durva vs. durva

Curative-Intent Stage 3 NSCLC

Ongoing Registrational Phase 3

NCT05211895

ARC-10

dom + zim vs. zim vs. chemo

1L NSCLC (PD-L1 ≥ 50%)

Ongoing Registrational Phase 3

NCT04736173

STAR-121

dom + zim + chemo vs pembro + chemo

1L NSCLC (PD-L1 all-comers)

Planned Registrational Phase 3

TBD

EDGE-Lung

dom + zim + (quemli or etruma)

1L/2L NSCLC (lung cancer platform study)

In Planning Phase 2

TBD

Gastrointestinal Cancers

ARC-9

etruma + zim + mFOLFOX vs. SOC

2L/3L/3L+ CRC

Ongoing

Randomized Phase 2

NCT04660812

ARC-21

dom + zim ± chemo

1L/2L Upper GI Malignancies

Ongoing

Phase 2

NCT05329766

STAR-221

dom + zim + chemo vs. SOC

GI Malignancies

Planned Registrational Phase 3

TBD

Pancreatic Cancer

ARC-8

quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac

1L, 2L PDAC

Ongoing Randomized Phase 1/1b

NCT04104672

Prostate Cancer

ARC-6

etruma + zim + SOC vs. SOC (Adding sacituzumab govitecan (Trodelvy) combination cohorts)

2L/3L CRPC

Ongoing Randomized Phase 2

NCT04381832

Various

ARC-12

AB308 + zim

Advanced Malignancies

Ongoing

Phase 1/1b

NCT04772989

ARC-14

AB521

Healthy Volunteer

Ongoing

NCT05117554

Carbo/pem: carboplatin/pemetrexed; dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; quemli: quemliclustat; R/R: relapsed/refractory; SOC: standard of care; zim: zimberelimab CRC: colorectal cancer; CRPC: castrate-resistant prostate cancer; GI: gastrointestinal; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma

About the Gilead Collaboration

In May 2020, Gilead and Arcus entered into a 10-year collaboration that provided Gilead immediate rights to zimberelimab and the right to opt into all other Arcus programs arising during the collaboration term. In November 2021, Gilead and Arcus amended the collaboration in connection with Gilead’s option exercise for three of Arcus’s then-clinical stage programs. For all other programs that are in clinical development or new programs that enter clinical development thereafter, the opt-in payments are $150 million per program. Gilead’s option, on a program-by-program basis, expires after a specified period of time following the achievement of a development milestone for such program and Arcus’s delivery to Gilead of the requisite qualifying data package. Concurrent with the May 2020 collaboration agreement, Gilead and Arcus entered into a stock purchase agreement under which Gilead made a $200 million equity investment in Arcus. That stock purchase agreement was amended and restated in February 2021 in connection with Gilead’s increased equity stake in Arcus from 13% to 19.7%, with an additional $220 million investment.

Gilead and Arcus are co-developing and equally share global development costs for five clinical candidates, including domvanalimab, an Fc-silent anti-TIGIT antibody, etrumadenant, a dual adenosine A2a/A2b receptor antagonist, and zimberelimab, an anti-PD1 antibody.

On May 9, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the Company has extended and expanded its partnership with Bristol Myers Squibb (NYSE:BMY) in targeted protein degradation, originally signed in 2018 (Press release, Evotec, MAY 9, 2022, View Source [SID1234614065]). The initial collaboration has proven to be highly productive in generating a promising pipeline of molecular glue degraders. Based on this success, Bristol Myers Squibb and Evotec extend and expand this partnership for an additional 8 years with the goal to further broaden and deepen the strategic alliance.

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Molecular glue degraders are small, drug-like compounds that induce interactions between an E3 ubiquitin ligase and a molecular target. This induced interaction results in ubiquitination and subsequent degradation of the recruited protein leading to long-lasting therapeutic effects. Bristol Myers Squibb is a leader in this field based in particular on its unique library of cereblon E3 ligase modulators (CELMoD). Under the terms of the agreement, both parties will leverage all of Evotec’s proprietary EVOpanOmics and EVOpanHunter platforms as well as AI/ML-based drug discovery and development platforms.

Evotec receives an upfront payment of $ 200 m and expects to obtain further performance-based, near-term and programme-based milestone payments, resulting in a deal potential of $ 5 bn with additional tiered royalties on product sales.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, said: "Bristol Myers Squibb is the pioneer and industry-leader in the field of molecular glue degraders. Molecular glues are one of the most exciting new modalities as they can be developed into highly selective and potent degraders of high-value therapeutic targets, even reaching molecular targets which have been deemed undruggable by conventional means. We are extremely excited about the opportunity to significantly extend and expand our strategic partnership with Bristol Myers Squibb into 2030 and possibly beyond."

On May 9, 2022 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on its proprietary tRNA synthetase biology platform, reported first quarter 2022 results and provided a corporate update (Press release, aTyr Pharma, MAY 9, 2022, View Source [SID1234614113]).

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"We are pleased with the start of 2022 and the continued progress throughout the first quarter for our efzofitimod clinical program in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "With the receipt of U.S. Food and Drug Administration (FDA) orphan drug designation and a positive End-of-Phase 2 meeting with the FDA, we are on track to initiate a planned registrational study of efzofitimod in pulmonary sarcoidosis in the third quarter of this year."

"The second quarter is shaping up to be an important period, as we prepare to present the clinical data for the Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis at the upcoming American Thoracic Society (ATS) International Conference and anticipate the potential publication of a related manuscript. We are focused on preparation for the planned registrational study so that the balance of the year may center upon initiating the study in the U.S. and Europe and supporting our partner Kyorin Pharmaceutical with the anticipated launch of the study in Japan."

First Quarter 2022 and Subsequent Period Highlights

Announced posters accepted for presentation for efzofitimod in pulmonary sarcoidosis at the upcoming ATS 2022 International Conference. The posters will present clinical data from the recently completed Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety, tolerability and consistent dose response for efzofitimod on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.
Announced a company reception at the upcoming ATS 2022 International Conference in San Francisco, CA, on Monday, May 16, 2022. The event, which will convene sarcoidosis medical experts, principal investigators, advocacy organizations, analysts and investors, will review results from the Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis and discuss an outlook for the planned registrational study that the company expects to initiate in the third quarter of 2022.
Received FDA orphan drug designation for efzofitimod for the treatment of systemic sclerosis (SSc, or scleroderma), a chronic, progressive autoimmune disease in which many patients may develop associated ILD, known as SSc-ILD. Orphan drug designation is granted to support the development of medicines for patients with unmet needs for rare disorders affecting fewer than 200,000 people in the U.S. and provides certain benefits, including the potential for seven years of market exclusivity following regulatory approval. The company expects to explore the potential expansion of its efzofitimod clinical program into other forms of ILD with high unmet medical need.
Presented preclinical research in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting characterizing the effects of ATYR2810, the company’s lead anti-Neuropilin-2 (NRP2)/VEGF antibody and IND candidate, in highly aggressive tumor subtypes, including triple-negative breast cancer. The findings suggest that ATYR2810 reduces metastasis and enhances chemosensitivity by downregulating key genes linked to these processes. The company expects to initiate a phase 1 study of ATYR2810 in cancer patients in the second half of 2022.
First Quarter 2022 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents and investments as of March 31, 2022, were $98.7 million.
R&D Expenses: Research and development expenses were $8.9 million for the first quarter of 2022, which consisted primarily of product development and manufacturing costs for the efzofitimod and ATYR2810 programs.
G&A Expenses: General and administrative expenses were $3.5 million for the first quarter of 2022.
Shares Outstanding: Common shares outstanding were 28,056,249 as of March 31, 2022.
Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. EDT / 2:00 p.m. PDT to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the U.S., or 209-905-5951 internationally and using conference ID 9273437. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: View Source An audio replay will be available for at least 90 days following the event.

About Efzofitimod

aTyr is developing efzofitimod as a potential therapeutic for patients with fibrotic lung disease. Efzofitimod, a fusion protein comprised of the immunomodulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates innate and adaptive immune response in inflammatory disease states. aTyr’s lead indication for efzofitimod is pulmonary sarcoidosis, a major form of interstitial lung disease. Clinical proof-of-concept for efzofitimod was recently established in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety and a consistent dose response and trends of benefit of efzofitimod compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms and inflammatory biomarkers. aTyr intends to initiate a planned registrational study of efzofitimod in pulmonary sarcoidosis in the third quarter of 2022.

On May 9, 2022 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported partnerships with prominent next generation sequencing (NGS) providers and leaders in genomic testing and profiling, including Foundation Medicine, Tempus and others (Press release, Aadi Bioscience, MAY 9, 2022, View Source [SID1234614205]). We expect these collaborations to expedite patient identification for the ongoing PRECISION 1 trial of nab-sirolimus in patients harboring tumors with inactivating alterations in TSC1 or TSC2 genes.

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Neil Desai, PhD, Founder, President and Chief Executive Officer of Aadi, stated, "We are very pleased to have these leading NGS partnerships in place. Recently published data project an incidence of approximately 12,000 advanced cancer patients with TSC1 or TSC2 definite impact alterations in the US. These collaborations should help physicians to identify patients who may be candidates for nab-sirolimus in our PRECISION 1 registrational trial. We expect to report preliminary data from this trial in the first half of next year."

Loretta Itri, M.D., Chief Medical Officer of Aadi, stated, "We are excited to announce partnerships with the leading molecular diagnostic companies, including Foundation Medicine, Tempus and others. Many of our clinical trial sites had already been utilizing the NGS reports provided by these companies. Now our partnerships will allow us to also leverage their established patient enrollment programs, which we believe will significantly augment our efforts to identify and recruit patients with TSC1 and TSC2 alterations for our PRECISION 1 registrational trial. We are pleased with our progress to-date and remain confident we will meet our enrollment goals."

These partners will collect and analyze clinical and molecular data to determine which patients may be eligible to participate in Aadi’s PRECISION 1 clinical trial. The goals are to increase patient match rate, reduce screen failure rate and increase speed of enrollment into the trial.

About the PRECISION 1 Trial

The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic pivotal study, of nab-sirolimus designed as a basket trial that will evaluate approximately 120 adult and adolescent patients with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. The trial will have two independent arms of 60 patients each to separately evaluate patients with either TSC1 or TSC2 inactivating alterations. Aadi has received Fast Track designation to evaluate nab-sirolimus in this indication from the FDA. The first patient on the PRECISION 1 trial was dosed in March 2022.

On MAY 9, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, reported that, in connection with the $50 million share buyback programme announced on 5 May 2022, it is now commencing purchases of the Company’s ordinary shares of one pence each ("Ordinary Shares") (the "Programme") (Press release, PureTech Health, MAY 9, 2022, View Source [SID1234613864]). The Programme will be carried out in tranches and is in line with the Company’s previously announced capital allocation strategy to balance investment in the continued growth of its business with potential returns of capital to shareholders.1

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PureTech plans to execute the buyback in two tranches. In respect of the first tranche, PureTech announces that it has entered into an irrevocable non-discretionary instruction with Jefferies International Limited ("Jefferies") in relation to the purchase by Jefferies, acting as principal during the period commencing on 9 May 2022 and ending on the earlier of exhaustion of funds associated with the first tranche or 8 May 2023 (subject to any regulatory objections or concerns), of Ordinary Shares for an aggregate consideration (excluding expenses) of no greater than $25 million and the simultaneous on-sale of such Ordinary Shares by Jefferies to PureTech. Jefferies will make its trading decisions in relation to the Ordinary Shares independently of, and uninfluenced by, the Company. Purchases may continue during any close period to which the Company is subject. It is anticipated that the second tranche, subject to a separate instruction, will commence promptly on completion of the first tranche, subject to renewal of the requisite authority at the 2022 AGM.

The maximum number of Ordinary Shares that can be purchased under the first tranche of the Programme is 28,589,874 Ordinary Shares (being the maximum number of shares the Company is authorised to purchase pursuant to the authority granted by shareholders at the Company’s annual general meeting held on May 27, 2021).

The purpose of the Programme is to return capital to shareholders in line with the Company’s capital allocation strategy and to enable the Company to meet obligations arising from employee share option programmes, or other allocations of shares to employees of the Company or to members of the administrative, management or supervisory bodies of the Company, or an associate of the Company. Any shares repurchased for this purpose will be held in treasury.

Any purchase of Ordinary Shares under the first tranche of the Programme will be carried out on the London Stock Exchange and any other UK recognised investment exchange which may be agreed, in accordance with pre-set parameters and in accordance with, and subject to limits, including those limits related to daily volume and price, prescribed by the Company’s general authority to repurchase Ordinary Shares granted by its shareholders at its most recent annual general meeting on May 27, 2021, Chapter 12 of the Financial Conduct Authority’s UK Listing Rules, Article 5(1) of Regulation (EU) No. 596/2014 (as incorporated into UK domestic law by the European Union (Withdrawal) Act 2018) and Commission Delegated Regulation (EU) 2016/1052 (as incorporated into UK domestic law by the European Union (Withdrawal) Act 2018).

PureTech will announce any market repurchases of Ordinary Shares no later than 7.30 a.m. BST on the business day following the calendar day on which the repurchase occurred.