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Zentalis Pharmaceuticals Reports Third Quarter 2026 Financial Results and Business Updates

Lower quarterly operating expenses coincided with a wider net loss and an equity offering that added 26,450,000 shares.

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Zentalis Pharmaceuticals (Nasdaq: ZNTL) reported third-quarter financial results and updated development plans for azenosertib, its investigational treatment for ovarian cancer. Net loss widened to $28.815 million from $26.691 million a year earlier, while loss per share narrowed to $0.34 from $0.37. Cash, cash equivalents and marketable securities totaled $228.9 million; the company expects funding to last into the first half of 2028.

DENALI Part 1b median overall survival was 15.9 months in Cyclin E1-positive patients versus 7.5 months in Cyclin E1-negative patients. Zentalis expects Part 2c enrollment to finish in November 2026 and integrated Part 2 results in the first half of 2027. Phase 3 ASPENOVA and the MUIR combination trial continue enrolling. An August offering issued 26,450,000 shares. Zentalis plans FDA discussions in 2027 to assess an accelerated approval opportunity.

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19 points · 0 major

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0 major · 12 points

Hollow bars mark forward-looking points. How the balance works

Positive

  • Moderate pointAugust's completed follow-on equity offering raised funding.
  • Moderate pointCash and securities reached $228.9 million, versus $174.6 million in June and $245.9 million at year-end 2025.
  • Moderate point. Forward-looking: it has not happened yet and may not happen.Zentalis expects existing funds to cover operations and capital expenditures into the first half of 2028.
  • Minor pointDENALI Part 1b median overall survival: 15.9 months in Cyclin E1-positive patients versus 7.5 months in negative patients.
  • Minor pointDENALI response-evaluable Cyclin E1-positive patients had an updated 37.2% response rate and 5.5-month median response duration.
14 minor points
  • Minor pointDENALI Part 1b included two patients with responses exceeding 15 and 20 months.
  • Minor point. Forward-looking: it has not happened yet and may not happen.DENALI Parts 2a and 2b enrollment is complete; Part 2c completion is scheduled for November 2026.
  • Minor point. Forward-looking: it has not happened yet and may not happen.Integrated DENALI Part 2 results are expected in the first half of 2027.
  • Minor pointPhase 3 ASPENOVA enrollment and trial-site openings are advancing across multiple geographies.
  • Minor pointMUIR Part 2 is enrolling for azenosertib plus bevacizumab in platinum-sensitive ovarian cancer maintenance treatment.
  • Minor point. Forward-looking: it has not happened yet and may not happen.Zentalis is planning a combination clinical study in triple-negative breast cancer.
  • Minor pointCyclin E1 test validation demonstrated high agreement across laboratories and readers, supporting prospective trial screening.
  • Minor pointThird-quarter research and development expenses fell to $22.334 million from $22.950 million a year earlier.
  • Minor pointThird-quarter general and administrative expenses fell to $8.820 million from $10.784 million a year earlier.
  • Minor pointThird-quarter loss per share narrowed to $0.34 from $0.37 a year earlier.
  • Minor pointNine-month general and administrative expenses fell to $27.187 million from $29.812 million a year earlier.
  • Minor pointNine-month restructuring expenses were zero, versus $7.796 million a year earlier.
  • Minor pointNine-month loss per share narrowed to $1.41 from $1.42 a year earlier.
  • Minor pointTotal liabilities declined to $65.306 million from $72.763 million at December 31, 2025.

Negative

  • Moderate pointAugust's offering issued 26,450,000 common shares, diluting existing holders.
  • Minor pointThird-quarter net loss widened to $28.815 million from $26.691 million a year earlier.
  • Minor point. Forward-looking: it has not happened yet and may not happen.DENALI's accelerated approval path depends on data strength, FDA feedback and the treatment landscape.
  • Minor pointThird-quarter investment and other income fell to $2.457 million from $7.043 million a year earlier.
  • Minor pointThird-quarter income tax expense was $118,000, versus zero a year earlier.
7 minor points
  • Minor pointNine-month net loss widened to $106.453 million from $101.844 million a year earlier.
  • Minor pointNine-month research and development expenses rose to $86.213 million from $77.807 million a year earlier.
  • Minor pointNine-month investment and other income fell to $7.323 million from $13.571 million a year earlier.
  • Minor pointNine-month income tax expense was $376,000, versus zero a year earlier.
  • Minor pointWorking capital declined to $204.909 million from $216.632 million at December 31, 2025.
  • Minor pointTotal assets declined to $270.193 million from $288.967 million at December 31, 2025.
  • Minor pointShareholders' equity declined to $204.887 million from $216.204 million at December 31, 2025.

News Explained

The completed August follow-on brought Zentalis approximately $86.9 in net proceeds; because it issued common shares, the larger share count reduces existing holders’ ownership percentages absent offsetting changes.

Key Figures

Cash, cash equivalents and marketable securities: $228.9 million Cash runway: Into the first half of 2028 Median overall survival: 15.9 months vs. 7.5 months +5 more
Cash, cash equivalents and marketable securities
$228.9 million
As of September 30, 2026, compared with $174.6 million as of June 30, 2026
Cash runway
Into the first half of 2028
Company estimate based on existing cash, cash equivalents and marketable securities
Median overall survival
15.9 months vs. 7.5 months
DENALI Part 1b; Cyclin E1-positive patients (n=48) vs. Cyclin E1-negative patients (n=46)
Overall response rate
37.2%
Response-evaluable Cyclin E1-positive patients
Median duration of response
5.5 months
Response-evaluable Cyclin E1-positive patients
Research and development expenses
$22.3 million vs. $23.0 million
Three months ended September 30, 2026 vs. September 30, 2025
Total operating expenses
$31.2 million vs. $33.7 million
Three months ended September 30, 2026 vs. September 30, 2025
Net loss
$28,815 thousand vs. $26,691 thousand
Three months ended September 30, 2026 vs. September 30, 2025

Previous Earnings Reports

1 past event · Latest: Aug 06
Same Type 1 event
  1. Aug 06

    2Q earnings

    24h Move
    -15.6%

    Q2 cash of $174.6 million and runway into late 2027 preceded the current higher balance.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

wee1 inhibitor, accelerated approval, immunohistochemistry, progression-free survival, +1 more
5 terms
wee1 inhibitor medical
"a clinical oncology innovator advancing late-stage development of an investigational, potentially first-in-class WEE1 inhibitor"
A Wee1 inhibitor is a drug that blocks the Wee1 protein, which normally acts like a safety brake that pauses damaged cells before they divide. By removing that brake, cancer cells with DNA damage are forced into division and often die, making the approach useful for targeting tumors. Investors track Wee1 inhibitors because their clinical trial success, safety profile and use with other therapies can greatly affect a biotechnology company's value.
accelerated approval regulatory
"we plan to discuss the DENALI data with the FDA in 2027 to assess the accelerated approval opportunity"
Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.
immunohistochemistry medical
"based on Zentalis' proprietary immunohistochemistry cutoff"
Immunohistochemistry is a laboratory method that uses labelled antibodies to highlight specific proteins inside thin slices of tissue, producing visible color where those proteins are present—like using colored highlighters to mark words on a page. Investors care because it provides concrete evidence about whether a drug hits its intended target, whether a diagnostic test works, and how a treatment affects tissues, all of which can affect clinical success, regulatory approval, and market value.
progression-free survival medical
"The primary endpoint is progression-free survival (PFS)"
Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.
overall response rate medical
"key secondary endpoints include overall survival (OS) and overall response rate (ORR)"
Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.

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  • DENALI Part 1b survival data strengthen azenosertib's position as the potential first-in-class oral, non-chemotherapy, non-ADC therapy in pivotal development for Cyclin E1-positive PROC
  • DENALI Part 2c enrollment scheduled to complete in November 2026, with an integrated topline readout expected in 1H 2027
  • $228.9 million in cash, cash equivalents and marketable securities as of September 30, 2026 provides runway into 1H 2028 to support execution of key milestones

SAN DIEGO, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of an investigational, potentially first-in-class WEE1 inhibitor, azenosertib, as a biomarker-driven treatment approach for ovarian cancer, today announced financial results for the third quarter ended September 30, 2026, and highlighted recent business updates.

"Overall survival data from DENALI Part 1b presented at ESMO reinforce our confidence in azenosertib to offer a differentiated oral treatment for patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC), if approved," said Julie Eastland, Chief Executive Officer of Zentalis Pharmaceuticals. "We designed complementary paths through DENALI and ASPENOVA to support our goal of bringing azenosertib to patients as quickly as possible. In light of an evolving landscape in PROC, we plan to discuss the DENALI data with the FDA in 2027 to assess the accelerated approval opportunity. Meanwhile, we continue to advance ASPENOVA at full speed, ensuring we are well positioned to support our regulatory strategy under either an accelerated or full approval pathway. With DENALI Part 2c enrollment completing this month, we expect a topline readout from DENALI in the first half of 2027 — a key potential value-creating catalyst ahead of ASPENOVA.

Ms. Eastland continued: "Alongside our PROC program, our strategy includes advancing azenosertib as a combination therapy where we see meaningful therapeutic and scientific rationale. MUIR, evaluating azenosertib in combination with bevacizumab in platinum-sensitive ovarian cancer, is enrolling. Additionally, we are actively planning a combination clinical study in triple-negative breast cancer. Collectively, this strategy positions azenosertib to realize its full potential, both as the first targeted option for patients with Cyclin E1-positive PROC and through combinations across tumor types where WEE1 inhibition may enhance the benefit of standard-of-care therapies, including ADCs and other agents.

“With $228.9 million on the balance sheet providing an anticipated runway into the first half of 2028, we believe we are well resourced to support key DENALI milestones, full enrollment in ASPENOVA and combination trials in ovarian cancer and triple-negative breast cancer,” Ms. Eastland concluded.

Business Updates

Clinical Development

  • DENALI Part 2 Enrollment Completing: Enrollment in DENALI Parts 2a and 2b is complete, and enrollment in Part 2c is scheduled to complete in November 2026.
  • DENALI Part 2 Topline Readout: Zentalis expects to provide a topline readout in the first half of 2027, which will reflect an integrated dataset across Parts 2a, 2b, and 2c.
  • ASPENOVA Phase 3 Enrolling: We continue to execute on the global Phase 3 ASPENOVA study, with trial site initiations and enrollment advancing across multiple geographies.
  • MUIR Phase 1b Enrolling: Enrollment in Part 2 is ongoing for azenosertib in combination with bevacizumab as the maintenance treatment for second-line platinum-sensitive ovarian cancer.
  • Triple-Negative Breast Cancer Combination Study Planning: Zentalis is actively planning a combination clinical study of azenosertib in triple-negative breast cancer.

Congresses and Publications

  • European Society for Medical Oncology (ESMO) 2026: In October 2026, the following were presented:
    • DENALI Part 1b Overall Survival Analysis: Meaningful overall survival data from DENALI Part 1b were presented at the ESMO Annual Meeting, further supporting the biomarker-driven development strategy. In Cyclin E1-positive PROC patients (n=48), median OS was 15.9 months (95% CI, 8.7–21.2), versus 7.5 months (95% CI, 5.8-12.3) in Cyclin E1-negative patients (n=46). Updated ORR in response-evaluable Cyclin E1-positive patients was 37.2%, with a median DOR of 5.5 months, including two patients with responses exceeding 15 and 20 months. The safety profile was consistent with prior reporting; median relative dose intensity was 84.6%.
    • ASPENOVA Trial-in-Progress: An overview of the ongoing Phase 3 ASPENOVA trial evaluating azenosertib in patients with Cyclin E1-positive PROC.
  • College of American Pathologists Annual Meeting — Cyclin E1 IHC Assay Validation: In October 2026, Zentalis scientists presented analytical validation data for a laboratory-developed IHC test for Cyclin E1 detection in high-grade serous ovarian cancer, demonstrating high concordance across laboratories and readers and supporting prospective biomarker screening in ongoing clinical trials.

Corporate

  • Follow-on Equity Offering: In August 2026, completed a follow-on offering of 26,450,000 shares of common stock, raising approximately $86.9 in net proceeds.

Third Quarter 2026 Financial Results

  • Cash Position: Cash, cash equivalents and marketable securities were $228.9 million as of September 30, 2026, compared to $174.6 million as of June 30, 2026, including net proceeds from the August 2026 follow-on offering. Zentalis believes that existing cash, cash equivalents and marketable securities will be sufficient to fund operating expenses and capital expenditure requirements into the first half of 2028.
  • Research and Development Expenses: Research and development expenses for the three months ended September 30, 2026 were $22.3 million, compared to $23.0 million for the three months ended September 30, 2025. The $0.7 million decrease was primarily attributable to a $6.2 million decrease in clinical trial expenses for certain studies that reached or are near completion, partially offset by a $3.8 million increase in expenses for ongoing clinical trials open for enrollment, a $0.8 million increase in companion diagnostic development expenses and a $0.9 million increase in personnel-related expenses and allocated overhead.
  • General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2026 were $8.8 million, compared to $10.8 million for the three months ended September 30, 2025. The $2.0 million decrease was primarily attributable to a $2.7 million decrease in personnel-related expenses partially offset by a $0.7 million increase primarily related to consulting and outside services.
  • Total Operating Expenses: Total operating expenses were $31.2 million for the three months ended September 30, 2026, compared to $33.7 million for the three months ended September 30, 2025.

About Azenosertib 
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive PROC. There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment.

Azenosertib has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.​

About DENALI Clinical Trial 
DENALI is a multi-part Phase 2 clinical trial (NCT05128825) studying azenosertib in PROC patients.

Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2. Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis' proprietary immunohistochemistry cutoff.

Part 2, in total, was designed to support an accelerated approval pathway in the Cyclin E1-positive patient population, subject to the strength of the data, FDA feedback and the treatment landscape at the time of regulatory action.

  • Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.
  • Part 2b: Enrollment expansion at the selected 400mg QD 5:2 dose up to approximately 100 patients, including patients at this dose in Part 2a. This cohort has completed enrollment.
  • Part 2c: Broadening study population to include patients previously treated with a taxane-containing regimen for PROC. The enrollment in this cohort is scheduled to complete in November 2026.

For physician and patient information about the DENALI trial, please visit www.denalitrial.com.

About ASPENOVA Clinical Trial
ASPENOVA is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive PROC. The trial is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator's choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The primary endpoint is progression-free survival (PFS); key secondary endpoints include overall survival (OS) and overall response rate (ORR). ASPENOVA is intended to support approvals in the U.S. and major ex-U.S. markets, based on alignment with U.S. and EU regulators.

About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.​

For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential for azenosertib to be first-in-class; the continued development of azenosertib; the clinical and therapeutic potential of azenosertib, including the potential for azenosertib to be a differentiated oral treatment option for patients with Cyclin E1-positive platinum resistant ovarian cancer or other indications; the Company’s biomarker-driven strategy for azenosertib; the Company’s anticipated milestones and the timing thereof, including the anticipated enrollment completion of DENALI Part 2, the topline readout from DENALI Part 2, and the design, conduct and timing of our confirmatory ASPENOVA Phase 3 trial, MUIR Phase 1b trial and our potential clinical study of azenosertib in triple-negative breast cancer; the potential to advance research on additional areas of opportunity for azenosertib as maintenance therapy in ovarian cancer, triple-negative breast cancer and additional tumor types; the Company’s anticipated cash runway; and the Company’s planned regulatory strategy for azenosertib and the timing thereof, including the potential for an accelerated approval in light of the evolving treatment landscape. The terms “anticipate,” “advance,” “believe,” “complete,” “continue,” “design,” “develop,” “ensuring,” “expect,” “focus,” “future,” “goal,” “intend,” “may,” “plan,” “position,” “potential,” “provides,” “runway,” “scheduled,” “strategy,” “support,” “target,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of a companion diagnostic; risks relating to the regulatory approval process or ongoing regulatory obligations; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; our product candidates may cause serious adverse side effects; the interim, initial, “topline,” and preliminary data from our clinical trials may change as more patient data becomes available, and are subject to audit and verification procedures that could result in material changes in the final data; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release. 

Contact:
Aron Feingold
VP, Investor Relations & Corporate Communications
ir@zentalis.com


Zentalis Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
 
 Three Months Ended September 30,Nine Months Ended September 30,
2026
2025
2026
2025
Operating Expenses    
Research and development$22,334 $22,950 $86,213 $77,807 
General and administrative 8,820  10,784  27,187  29,812 
Restructuring —  —  —  7,796 
Total operating expenses 31,154  33,734  113,400  115,415 
Loss from operations (31,154) (33,734) (113,400) (115,415)
Investment and other income, net 2,457  7,043  7,323  13,571 
Net loss before income taxes (28,697) (26,691) (106,077) (101,844)
Income tax expense 118  —  376  — 
Net loss$(28,815)$(26,691)$(106,453)$(101,844)
Net loss per common share, basic and diluted$(0.34)$(0.37)$(1.41)$(1.42)
Common shares used in computing net loss per share, basic and diluted 84,612  72,139  75,453  71,938 
             


Zentalis Pharmaceuticals, Inc.
Selected Condensed Consolidated Balance Sheet Data
(Unaudited)
(In thousands)
 
 As of September 30, 2026As of December 31, 2025
Cash, cash equivalents and marketable securities$228,893$245,893
Working capital 1 204,909 216,632
Total assets 270,193 288,967
Total liabilities 65,306 72,763
Total Zentalis equity$204,887$216,204
1 Zentalis defines working capital as current assets less current liabilities.



FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Zentalis expect DENALI Part 2 results?

Zentalis expects topline results in the first half of 2027, integrating DENALI Parts 2a, 2b and 2c. Parts 2a and 2b have completed enrollment, while Part 2c enrollment is scheduled to finish in November 2026.

What were Zentalis ZNTL's third-quarter 2026 financial results?

Zentalis recorded a $28.815 million net loss, or $0.34 per share, compared with a $26.691 million loss, or $0.37 per share, a year earlier. Total operating expenses were $31.154 million, down from $33.734 million.

How is Zentalis's ASPENOVA trial designed?

ASPENOVA is a randomized Phase 3 trial comparing azenosertib alone with investigator-selected single-agent chemotherapy in Cyclin E1-positive platinum-resistant ovarian cancer. Expected enrollment is approximately 420 patients. The primary endpoint is progression-free survival, the time patients live without disease worsening; secondary endpoints include overall survival and response rate.

Which patients are included in Zentalis's DENALI Part 2c?

DENALI Part 2c broadens enrollment to include patients previously treated with a taxane-containing regimen for platinum-resistant ovarian cancer. DENALI Part 2 prospectively enrolls patients with Cyclin E1 protein overexpression, identified using Zentalis's proprietary tissue-staining cutoff.

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