On November 6, 2024 Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported financial results for the third quarter ended September 30, 2024, and provided a business update (Press release, Nuvation Bio, NOV 6, 2024, View Source [SID1234647872]).

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David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, reflected on the quarter and stated: "In the third quarter, we continued to execute on our goal of bringing taletrectinib to people living with ROS1-positive NSCLC as quickly as possible, which has been our focus since we closed the acquisition of AnHeart Therapeutics earlier this year. In October, we completed the rolling submission of our NDA for line agnostic full approval of taletrectinib in advanced ROS1-positive NSCLC, which was supported by the pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies that we presented at ESMO (Free ESMO Whitepaper). We believe that these data – a confirmed objective response rate of 89% and median duration of response approaching four years in the TKI-naïve setting – are the strongest data seen to date in the ROS1 space and increase taletrectinib’s potential to become a best-in-class treatment option. Additionally, we are excited about the momentum of our overall pipeline, including safusidenib, our mutant IDH1 inhibitor for both low- and high-grade diffuse IDH1-mutant glioma, where we plan to make meaningful clinical progress next year, and NUV-1511, our first drug-drug conjugate, which we continue to dose escalate in the clinic."

Recent Pipeline Updates:

Taletrectinib, ROS1 inhibitor: Advanced ROS1+ NSCLC

Completed submission of an NDA for taletrectinib to the U.S. FDA for the treatment of advanced ROS1+ NSCLC (line agnostic) in October, in alignment with feedback from the U.S. FDA as part of a pre-NDA meeting.
Company expects the U.S. FDA to accept its NDA submission for full approval as early as year-end 2024, which, if approved, will allow Nuvation Bio to launch taletrectinib in the U.S. as early as mid-2025.
Taletrectinib is the only ROS1 tyrosine kinase inhibitor (TKI) currently in development that has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs (line agnostic).
Pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies were presented at the 2024 ESMO (Free ESMO Whitepaper) Congress in September. The pooled analysis supported the Company’s NDA submission for taletrectinib.
Key highlights from the pooled analysis include:
Confirmed objective responses in 89% of taletrectinib-treated patients with advanced ROS1+ NSCLC who were tyrosine kinase inhibitor (TKI)-naïve and 56% of those who were TKI-pretreated in the study.
Taletrectinib demonstrated durable responses and prolonged disease control with long-term follow up; median duration of response (DOR) and median progression-free survival (PFS) in TKI-naïve patients were 44 months and 46 months, respectively.
Taletrectinib’s safety and tolerability profile appeared favorable, including a low treatment discontinuation rate of 7%.
Data from the global, pivotal Phase 2 TRUST-II study were presented at the 2024 World Conference on Lung Cancer in September as part of the press program.
Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma

Safusidenib is a potentially best-in-class, novel, oral, brain penetrant inhibitor of mutant IDH1.
Phase 2 study of safusidenib in patients with diffuse IDH1-mutant glioma remains ongoing.
NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors

NUV-1511, the Company’s first clinical-stage DDC, fuses a targeting agent to a widely used chemotherapy agent.
Phase 1/2 dose escalation study of NUV-1511 in patients with various advanced solid tumors remains ongoing.
NUV-868, BD2-selective BET inhibitor: Advanced solid tumors

As previously announced, the Company is evaluating next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients.
Corporate Updates:

Appointed Philippe Sauvage as Chief Financial Officer in October. Mr. Sauvage brings over 20 years of global leadership experience in finance, operations, and commercialization within healthcare and biopharmaceutical organizations.
Appointed David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, as Chairman of the Board of Directors. Additionally, the Company appointed Robert Bazemore as lead independent director.
Third Quarter 2024 Financial Results

As of September 30, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of $549.1 million.

For the three months ended September 30, 2024, research and development expenses were $27.7 million, compared to $18.5 million for the three months ended September 30, 2023. The increase was primarily due to a $6.7 million increase in personnel-related costs driven by the acquisition of AnHeart, stock-based compensation and other benefits, $2.4 million increase in third-party costs related to research services and drug manufacturing as a result of clinical trial expense for taletrectinib and $0.1 million increase in amortization of assembled workforce.

For the three months ended September 30, 2024, general and administrative expenses were $19.6 million, compared to $7.8 million for the three months ended September 30, 2023. The increase was due to a $5.3 million increase in personnel-related costs as a result of the acquisition of AnHeart, $4.2 million increase in sales and marketing expense, $1.8 million increase in professional fees, $0.7 million increase in legal fees, and $0.4 million increase in occupancy expense offset by $0.4 million increase in foreign currency impact and $0.2 million decrease in insurance expense.

For the three months ended September 30, 2024, Nuvation Bio reported a net loss of $41.2 million, or $(0.15) per share. This compares to a net loss of $19.6 million, or $(0.09) per share, for the comparable period in 2023.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.

Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1+ NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC. Based on pooled results of the TRUST-I and TRUST-II clinical studies, Nuvation Bio submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with advanced ROS1+ NSCLC (line agnostic, full approval). Based on results of the TRUST-I clinical study, China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs.

On November 5, 2024 PharmaMar Group (MSE: PHM) has received a $10 million payment from Janssen Products LP (Janssen), a subsidiary of Johnson & Johnson, upon reaching a commercial milestone established in the licensing agreement for Yondelis (trabectedin) in the United States (Press release, PharmaMar, NOV 5, 2024, View Source [SID1234647674]).

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In August 2019, PharmaMar signed a new licensing agreement with Johnson & Johnson that replaced the 2001 agreement under which Johnson & Johnson reserved the right to exclusively sell and distribute trabectedin in the United States.

Currently, trabectedin is approved in more than 70 countries for the treatment of soft tissue sarcoma and also in some of these countries for ovarian cancer.

On November 5, 2024 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported financial results for the third quarter ended Sept. 30, 2024 and provided a business update (Press release, AnaptysBio, NOV 5, 2024, View Source [SID1234647702]).

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"We remain confident in the potential best-in-class profiles of our programs targeting BTLA and PD-1 co-inhibitory receptors to drive differentiated results as we approach multiple clinical catalysts and value drivers for Anaptys, including top-line Phase 2b data in AD for ANB032, our BTLA agonist, in December. We’ve also completed enrollment for the Phase 2b trial of rosnilimab, our PD-1 agonist, in RA and are narrowing our guidance for top-line data to February 2025," said Daniel Faga, president and chief executive officer of Anaptys. "Additionally, enrollment in healthy volunteers has commenced for the Phase 1 trial for ANB033, our anti-CD122 antagonist, and we look forward to disclosing the Phase 1b indication in 2025. Looking to the end of the year, we are on track to have four programs in clinical development."

Updates on Wholly Owned ICM Pipeline

ANB032 (BTLA agonist antibody)

Top-line Week 14 data for global Phase 2b trial in moderate-to-severe AD anticipated in December 2024
Enrolled approximately 200 patients in a placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI-75 and IGA 0/1
Enrollment included approximately 15% of patients with Dupixent/anti-IL-13 treatment experience
Presented analyses that characterize a BTLA transcriptomic signature in AD at the European Academy of Dermatology and Venerology (EADV) Congress in September 2024
Poster presentation is available here
Rosnilimab (PD-1 agonist antibody)

Top-line Week 12 data for global Phase 2b trial in moderate-to-severe RA anticipated in February 2025
Completed enrollment of approximately 420 patients in a placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70
At Week 14, rosnilimab-treated patients who achieve low disease activity, defined as CDAI<=10, are eligible to be dosed for an additional 16-week all-active treatment period and then followed for a three-month off-drug follow-up period
Enrollment ongoing for global Phase 2 trial in moderate-to-severe ulcerative colitis (UC)
132-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission
Rosnilimab and placebo-treated patients who achieved clinical response on mMS are eligible to continue on their assigned treatment for an additional 12 weeks, while patients on placebo who are non-responders will be crossed over to the high-dose rosnilimab treatment arm, in an all-active treatment period and then followed for a three-month off-drug follow-up period
In October 2024, an optional 26-week, blinded treatment extension period (TEP) was implemented for patients who remain in clinical response at Week 24 in the U.S.; EU implementation anticipated in early 2025
Top-line Week 12 data anticipated in Q1 2026
Presented data evaluating the PD-1 depletion and agonism mechanisms of rosnilimab in vitro with UC patient-derived PBMCs and a mouse model of colitis at the 2024 United European Gastroenterology Week (UEGW) in October 2024
Poster presentation is available here
ANB033 (anti-CD122 antagonist antibody)

Phase 1 trial initiated in healthy volunteers in October 2024
Phase 1b indication to be disclosed in 2025
ANB101 (BDCA2 modulator antibody)

Submitted investigational new drug (IND) application and plan to initiate enrollment for Phase 1 trial in healthy volunteers in Q1 2025
Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing

Presented full data from the Phase 3 GEMINI-1 and GEMINI-2 trials of imsidolimab (IL-36R) in generalized pustular psoriasis (GPP) at the EADV Congress in September 2024
Poster presentation is available here
Intend to out-license imsidolimab in 2024
GSK Immuno-Oncology Financial Collaboration

GSK anticipates top-line data in H1 2025 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
GSK anticipates top-line data in Q4 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer
Cash Runway

Cash and investments of $458.0 million as of September 30, 2024 and reiterating cash runway through year-end 2026
Third Quarter Financial Results

Cash, cash equivalents and investments totaled $458.0 million as of September 30, 2024, compared to $417.9 million as of December 31, 2023, for an increase of $40.1 million due primarily to the $100.0 million underwritten registered direct offering completed in Q3 and $50.0 million received from the Sagard royalty monetization in Q2 offset by operating activities.
Collaboration revenue was $30.0 million and $48.2 million for the three and nine months ended September 30, 2024, compared to $3.3 million and $8.2 million for the three and nine months ended September 30, 2023. The increase in non-cash revenue is due to a $15.0 million commercial milestone earned for annual Jemperli sales exceeding $250.0 million and increased royalties recognized for sales of Jemperli.
Research and development expenses were $42.2 million and $121.3 million for the three and nine months ended September 30, 2024, compared to $30.9 million and $98.8 million for the three and nine months ended September 30, 2023. The increase was due primarily to development costs for rosnilimab, ANB032, ANB033 and ANB101 offset by a decrease in development costs for imsidolimab. The R&D non-cash, stock-based compensation expense was $4.0 million and $10.9 million for the three and nine months ended September 30, 2024 as compared to $2.2 million and $7.7 million in the same period in 2023.
General and administrative expenses were $10.6 million and $32.2 million for the three and nine months ended September 30, 2024, compared to $10.2 million and $31.7 million for the three and nine months ended September 30, 2023. The G&A non-cash, stock-based compensation expense was $4.2 million and $14.9 million for the three and nine months ended September 30, 2024 as compared to $5.6 million and $17.4 million in the same period in 2023.
Net loss was $32.9 million and $123.4 million for the three and nine months ended September 30, 2024, or a net loss per share of $1.14 and $4.46, compared to a net loss of $37.3 million and $121.4 million for the three and nine months ended September 30, 2023, or a net loss per share of $1.41 and $4.49.

On November 5, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the Company generated revenue of $709 million for the third quarter ended September 30, 2024, compared to $628 million for the same period of 2023 (Press release, Exact Sciences, NOV 5, 2024, View Source [SID1234647724]).

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"The Exact Sciences’ team is helping eradicate cancer while strengthening our platform and growing our business efficiently," said Kevin Conroy, chairman and CEO. "During the third quarter, we delivered test results to more patients than ever before, improved profitability, and achieved key milestones in our pipeline of innovative cancer diagnostics. While we have made progress, our execution during the third quarter and updated outlook for the full year don’t reflect our full potential. We plan to accelerate growth in 2025, and our long-term outlook remains strong."

Third-quarter 2024 financial results

For the three-month period ended September 30, 2024, as compared to the same period of 2023 (where applicable):

Total revenue was $709 million, an increase of 13 percent on a reported and core revenue basis
Screening revenue was $545 million, an increase of 15 percent
Precision Oncology revenue was $164 million, an increase of 5 percent on a reported and core revenue basis
Gross margin including amortization of acquired intangible assets was 69 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 72 percent
Other operating income was $3 million compared to $72 million, which included a gain related to the sale of the Oncotype DX Genomic Prostate Score Test in third-quarter 2023
Net loss was $38 million, or $0.21 per basic and diluted share, a reduction of $39 million, or $0.21 per basic and diluted share
Adjusted EBITDA was $99 million an increase of $42 million, and adjusted EBITDA margin was 14 percent, an increase of 500 basis points
Operating cash flow was $139 million and free cash flow was $113 million, increases of $114 million and $113 million, respectively
Cash, cash equivalents, and marketable securities were $1.02 billion at the end of the quarter
Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX and therapy selection tests.

Platform and pipeline advancements

The Company’s ExactNexus technology platform allows Exact Sciences to connect electronically with patients, health systems, healthcare professionals, and payers. The digital tools and data embedded within the ExactNexus platform enable personalized customer experiences, creating a streamlined process for accessing information, enhancing patient engagement, and improving health outcomes. This approach contributed to strong growth in Cologuard test utilization among rescreen patients and within care gap programs during the third quarter.

Exact Sciences received FDA approval for the Cologuard Plus test, its next-generation Cologuard test. The Cologuard Plus test detects cancers and precancerous polyps with even greater sensitivity than the Cologuard test while reducing false positives by more than 30 percent. This advancement enhances the Company’s screening capabilities and reinforces its commitment to delivering high-quality, non-invasive options for patients. With the Cologuard Plus test, the Company expects to secure a higher price through an established Medicare pathway.

In the third quarter, the Company also presented data for its blood-based colorectal cancer screening test, showcasing a sensitivity of 88% for colorectal cancer and 31% for advanced precancerous lesions at 90% specificity. These results show the potential of the Company’s novel marker panel to detect advanced precancerous lesions and cancers at an attractive cost profile. This innovation is expected to provide average-risk patients with another screening option, reinforcing the power of the Company’s unique scientific approach.

Exact Sciences secured acceptance from a peer-reviewed journal for its first publication on the Oncodetect test, its molecular residual disease and recurrence monitoring test. These data are currently under embargo and are expected to be shared in January 2025. With nearly 6 million cancer survivors in the U.S. who could benefit from residual and recurrent disease testing, the need is urgent – yet less than 5% are currently receiving the vital testing today. This recognition highlights the scientific rigor behind the product and positions the Oncodetect test as a leading solution for monitoring residual disease and cancer recurrence.

The Company also shared evidence supporting its blood-based multi-cancer screening test, assessing organ-specific performance of methylation and protein biomarkers in a prospectively collected cohort of samples from its ASCEND 2 study. The analysis indicated an overall sensitivity of 55% in cancers without standard-of-care screening options (excluding lung), and 64% in the six most aggressive cancers with the shortest survival rates, with a specificity of 98.5%. These findings highlight the potential clinical value of using multiple biomarkers to detect various cancer types, including the most aggressive and those without recommended screening options.

2024 outlook

The Company has updated its full-year 2024 revenue and adjusted EBITDA guidance:

Prior guidance

November 5 update

Total revenue

$2.810 – $2.850 billion

$2.730 – $2.750 billion

Screening

$2.155 – $2.175 billion

$2.080 – $2.095 billion

Precision Oncology

$655 – $675 million

$650 – $655 million

Adjusted EBITDA

$335 – $355 million

$310 – $320 million

Third-quarter 2024 conference call & webcast

Company management will host a conference call and webcast on Tuesday, November 5, 2024, at 5 p.m. ET to discuss third-quarter 2024 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608. A replay of the webcast will be available at exactsciences.com. The webcast, conference call, and replay are open to all interested parties.

On November 5, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that data from its Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML) will be presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, which is being held on December 7 –10, 2024, in San Diego, California (Press release, Sellas Life Sciences, NOV 5, 2024, View Source;Exposition-2024/default.aspx [SID1234647741]).

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"We are excited to have SLS009 featured at the 2024 ASH (Free ASH Whitepaper) meeting and are pleased with the very promising safety and efficacy results from the Phase 2a trial in r/r AML," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Treatment with SLS009 in combination with azacitidine and venetoclax was well tolerated and led to a 50% response rate in the selected optimal dose. Clinical activity was even higher in patients with AML-myelodysplasia-related changes (AML-MRC) and in particular those with ASXL1 mutations, suggesting that this subset of patients may exhibit preferential sensitivity to SLS009. These findings contribute to the growing evidence supporting the potential of SLS009 to address unmet needs in difficult-to-treat populations, and future development efforts will focus on further exploring its impact in patients with AML-MRC."

Poster presentation details:

Title: Phase 2a Study of SLS009, a Highly Selective CDK9 Inhibitor, In Combination with Azacitidine and Venetoclax for Relapsed/Refractory Acute Myeloid Leukemia After Prior Venetoclax Treatment

Session Date and Time: Sunday, December 8, 2024, 6:00 PM – 8:00 PM PST

Session Title: Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II

Location: San Diego Convention Center, Halls G-H

Lead Author: Joshua F. Zeidner, MD, University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC

Abstract Number: 2877

The study enrolled 30 patients across three dosing levels (DLs) of SLS009:45 mg IV QW, DL2: 60 mg IV QW, and DL3: 30 mg IV BIW. SLS009 was well-tolerated across the DLs tested with no dose-limiting toxicities (DLTs) observed. Among 29 evaluable pts, 16 (55%) had ≥50% reduction in bone marrow (BM) blasts compared to baseline (DL1: 60%; DL2: 33%; DL3: 80%). Nine (31%) patients achieved an overall response (i.e., CR+CRi+MLFS), including 5 (17%) who achieved CR/CRi. The response rates per dose level were 10% in DL1, 33% in DL2, and 50% in DL3. All 9 responders had AML- Myelodysplasia Related (AML-MR) (9/23 of AMLMR pts responded) and 8/15 pts (53%) with somatic MR mutations responded. Among those with ASXL1 mutations, 5/9 (56%) achieved an overall response. 2/9 (22%) with TP53 mutations achieved a response including one patient with concomitant TP53 and ASXL1 mutation who had an ongoing response at data cut-off. Fifteen patients were still alive at the time of the data cutoff and the median OS for the trial has not been reached.

For more information on the study, visit clinicaltrials.gov identifier NCT04588922.