Orchestra BioMed (OBIO)

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Orchestra BioMed to Showcase Transformative Potential of AVIM Therapy in Keynote Presentation on Hypertensive Heart Disease at Georgia Innovation Summit
Globenewswire· 2025-10-09 12:00
Presentation to provide comprehensive overview of AVIM Therapy clinical evidence demonstrating the potential to halt the progression of hypertensive heart diseaseOrchestra BioMed and Medtronic (NYSE: MDT) have a strategic collaboration to develop and commercialize AVIM Therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemaker, an estimated global population of over 750,000 patients annuallyAVIM Therapy has received FDA Breakthrough Device Designation for the treatment of u ...
Orchestra BioMed Presents New AVIM Therapy Clinical Data at HRX Demonstrating Substantial and Sustained Blood Pressure Reductions that are Reproducible Upon Reactivation Following Washout
Globenewswire· 2025-09-04 21:00
Core Insights - Orchestra BioMed announced new data from its AVIM therapy program, indicating sustained blood pressure-lowering effects for years after activation, with reversibility and no rebound hypertension observed [1][4][5] - The AVIM therapy has been presented at the HRX Live 2025 Meeting and published in a peer-reviewed journal, highlighting its potential as a novel treatment for uncontrolled hypertension [2][4] - The company has a strategic collaboration with Medtronic to develop and commercialize AVIM therapy, targeting an estimated global population of over 750,000 patients annually [4][6] Summary by Sections AVIM Therapy Findings - Long-term follow-up of patients treated with AVIM therapy showed sustained reductions in 24-hour ambulatory systolic blood pressure (aSBP) of 8.9 mmHg after an average of 3.6 years [5] - Upon deactivation of AVIM therapy, blood pressure returned to baseline levels without rebound hypertension, demonstrating the treatment's reversibility [5] - Reactivation of AVIM therapy resulted in a significant reduction in aSBP to 124.4 mmHg, indicating reproducibility of the treatment effect [5] Clinical and Mechanistic Data - Dr. Avi Fischer presented data supporting AVIM therapy's role in managing uncontrolled hypertension, emphasizing its sustainability and safety profile [2][4] - The BACKBEAT global pivotal study is currently investigating the efficacy and safety of AVIM therapy in patients with uncontrolled hypertension [2][8] Strategic Collaborations and Market Potential - Orchestra BioMed's partnership with Medtronic aims to commercialize AVIM therapy for patients indicated for a pacemaker, addressing a significant market need [4][6] - AVIM therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension in patients with increased cardiovascular risk, representing a potential market of over 7.7 million patients in the U.S. [4][8]
Orchestra BioMed Announces Publication of Clinical Data Demonstrating Favorable Blood Pressure and Hemodynamic Effects of AVIM Therapy in JACC: Clinical Electrophysiology
Globenewswire· 2025-08-26 11:30
Core Viewpoint - Orchestra BioMed Holdings, Inc. announced favorable hemodynamic effects of AVIM therapy for patients with uncontrolled hypertension, as published in the Journal of the American College of Cardiology: Clinical Electrophysiology [1][2][3] Group 1: AVIM Therapy Findings - AVIM therapy demonstrated statistically significant reductions in systolic blood pressure (SBP) by an average of 17.1 mmHg (RV pacing) and 19.2 mmHg (CSP), compared to 1.7 mmHg with standard pacing [6] - The therapy improved left ventricular hemodynamics, with end-diastolic volume decreasing by 12.6 mL (RV) and 18.6 mL (CSP), and end-systolic volume decreasing by 11.0 mL (RV) and 14.1 mL (CSP) [6] - AVIM therapy also significantly reduced cardiac workload, with stroke work decreasing by 1,596 mL (RV) and 1,870 mL (CSP), compared to 42 mL with standard pacing [6] Group 2: Clinical Implications - The publication of the data in a peer-reviewed journal reinforces the therapeutic rationale behind AVIM therapy, highlighting its potential to deliver differentiated clinical benefits for patients with uncontrolled hypertension [3][7] - AVIM therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension in patients with increased cardiovascular risk, estimated to be over 7.7 million patients in the U.S. [5][10] - The strategic collaboration between Orchestra BioMed and Medtronic aims to develop AVIM therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients, a population of over 750,000 patients annually [5][10] Group 3: Research and Development - The BACKBEAT global pivotal study is currently evaluating the safety and efficacy of AVIM therapy in patients with systolic blood pressure above target despite anti-hypertensive medication [10] - The MODERATO II study showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months compared to control patients [10] - AVIM therapy is compatible with standard dual-chamber pacemakers and aims to substantially and persistently lower blood pressure [10]
Orchestra BioMed Announces Publication of AVIM Therapy Clinical Data in JACC: Advances Demonstrating Potential to Improve Cardiac Function in Patients with Hypertension and Diastolic Dysfunction
Globenewswire· 2025-08-14 12:00
Core Viewpoint - Orchestra BioMed announced the publication of clinical data demonstrating that AVIM therapy significantly improves cardiac function in patients with hypertension and diastolic dysfunction, which are key contributors to heart failure with preserved ejection fraction (HFpEF) [1][2]. Group 1: Clinical Data and Findings - The publication titled "Effects of AtrioVentricular Interval Modulation (AVIM) Therapy in Subjects with Hypertension and Diastolic Dysfunction" reports a retrospective treatment-blinded analysis of MODERATO II patients [2]. - AVIM therapy significantly reduced systolic blood pressure (SBP) and improved echocardiographic markers of diastolic dysfunction, which is a common comorbidity in patients with isolated systolic hypertension [2][7]. - Key findings include a reduction in office SBP by 12.1±12.8 mmHg and ambulatory SBP by 8.3±9.7 mmHg over six months, both statistically significant (p<0.01 vs baseline) [8]. Group 2: Expert Commentary - Dr. Marat Fudim emphasized the clinical link between long-standing hypertension, diastolic dysfunction, and the development of HFpEF, noting that AVIM therapy may address this unmet medical need by providing sustained blood pressure reductions and improving ventricular compliance [4]. - Dr. Avi Fischer highlighted the potential of AVIM therapy to offer a differentiated, device-based approach for earlier intervention in disease progression, targeting both elevated systolic blood pressure and impaired diastolic function [4]. Group 3: Ongoing Studies and Future Directions - AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study, which aims to support potential U.S. regulatory approval for use in pacemaker-indicated patients with uncontrolled hypertension [4][11]. - The BACKBEAT study will assess the safety and efficacy of AVIM therapy in patients with systolic blood pressure above target despite anti-hypertensive medication [11].
Orchestra BioMed Holdings, Inc. (OBIO) Reports Q2 Loss, Beats Revenue Estimates
ZACKS· 2025-08-12 20:01
Group 1: Earnings Performance - Orchestra BioMed Holdings, Inc. reported a quarterly loss of $0.5 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.51, but worse than a loss of $0.45 per share a year ago, indicating an earnings surprise of +1.96% [1] - The company posted revenues of $0.84 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 16.11%, compared to year-ago revenues of $0.78 million [2] - Over the last four quarters, the company has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Group 2: Stock Performance and Outlook - Shares of Orchestra BioMed Holdings, Inc. have declined approximately 37% since the beginning of the year, contrasting with the S&P 500's gain of 8.4% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The estimate revisions trend for the company was favorable ahead of the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Group 3: Future Estimates - The current consensus EPS estimate for the upcoming quarter is -$0.52 on revenues of $0.74 million, while for the current fiscal year, it is -$1.96 on revenues of $2.88 million [7] - The outlook for the industry, specifically the Medical - Biomedical and Genetics sector, is currently in the bottom 43% of Zacks industries, which may impact the stock's performance [8]
Orchestra BioMed Reports Second Quarter 2025 Financial Results and Highlights Recent Business Updates
Globenewswire· 2025-08-12 12:14
Core Insights - Orchestra BioMed Holdings, Inc. announced financial results for Q2 2025, highlighting significant capital raised and regulatory achievements [1][2][3] Financial Highlights - The company secured over $111 million in proceeds from strategic transactions and equity offerings, including $71 million from Medtronic and Ligand [4][5] - Cash and cash equivalents totaled $33.9 million as of June 30, 2025, with an estimated position of $101 million as of August 12, 2025, after recent financing [11] - Revenue for Q2 2025 was $0.8 million, unchanged from Q2 2024, while net loss increased to $19.4 million, or $0.50 per share, compared to a net loss of $16.0 million, or $0.45 per share, in the prior year [11][20] Regulatory Milestones - The FDA granted Breakthrough Device Designation for AVIM therapy aimed at treating uncontrolled hypertension, which may enhance future regulatory submissions and reimbursement pathways [4][6] - The BACKBEAT study protocol was updated and approved by the FDA, significantly expanding patient enrollment criteria [4][6] - IDE approval was received for the Virtue SAB U.S. pivotal trial, which will compare Virtue SAB with commercially available paclitaxel-coated balloons [4][6] Strategic Collaborations - The company has expanded its collaboration with Medtronic to develop AVIM therapy-enabled leadless pacemakers [5] - Ligand Pharmaceuticals committed $35 million for a tiered revenue interest in future royalties from AVIM therapy and Virtue SAB [5] Product Development - AVIM therapy has shown promising results in pilot studies, demonstrating significant reductions in blood pressure [12] - Virtue SAB is designed to deliver sirolimus effectively, with positive clinical data supporting its use in treating coronary in-stent restenosis [13]
Orchestra BioMed (OBIO) - 2025 Q2 - Quarterly Report
2025-08-12 12:00
[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) Orchestra BioMed's H1 2025 financials show decreased assets, a **$38.1 million** net loss, and **$32.1 million** cash used in operations [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$42.8 million** by June 30, 2025, from **$76.2 million** at year-end 2024, mainly due to reduced cash and marketable securities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $18,749 | $22,261 | | Marketable securities | $15,175 | $44,551 | | Total current assets | $35,882 | $69,171 | | **Total Assets** | **$42,825** | **$76,173** | | **Liabilities & Equity** | | | | Total current liabilities | $17,061 | $16,207 | | Total Liabilities | $42,530 | $43,215 | | Accumulated deficit | $(347,996) | $(309,878) | | **Total Stockholders' Equity** | **$295** | **$32,958** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net losses for Q2 and H1 2025 increased to **$19.4 million** and **$38.1 million**, driven by a **35% rise in R&D expenses** Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $836 | $778 | $1,704 | $1,398 | | Research and development | $13,853 | $11,126 | $27,335 | $20,238 | | Selling, general and administrative | $6,264 | $6,467 | $12,527 | $12,364 | | Loss from operations | $(19,327) | $(16,859) | $(38,248) | $(31,282) | | **Net loss** | **$(19,363)** | **$(15,980)** | **$(38,118)** | **$(29,443)** | | Net loss per share (basic and diluted) | $(0.50) | $(0.45) | $(0.99) | $(0.82) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$32.1 million** for H1 2025, with a **$3.5 million net decrease** in cash and cash equivalents Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(32,143) | $(23,320) | | Net cash provided by investing activities | $29,355 | $16,285 | | Net cash (used in) provided by financing activities | $(724) | $189 | | **Net decrease in cash and cash equivalents** | **$(3,512)** | **$(6,846)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, strategic partnerships, financing, and subsequent events, confirming sufficient capital for at least one year of operations - The company's flagship products are AVIM therapy for hypertension and Virtue SAB for atherosclerotic artery disease, developed through partnerships with Medtronic and Terumo, respectively[22](index=22&type=chunk) - Management has concluded that based on cash, cash equivalents, marketable securities as of June 30, 2025, and subsequent proceeds, there is sufficient capital to fund operations for at least one year from the issuance date of the financial statements[30](index=30&type=chunk) - The company is in a mediation procedure with Terumo to potentially resolve disagreements regarding the Virtue SAB commercialization agreement, expected to be completed by the end of Q3 2025[77](index=77&type=chunk) - Under the Medtronic agreement for AVIM therapy, the company reimburses Medtronic for certain R&D expenses, which increased significantly to approximately **$7.4 million** for H1 2025 from **$3.1 million** in H1 2024[93](index=93&type=chunk) - Subsequent to the quarter end, the company executed several major financing and strategic transactions in July and August 2025, including a revenue sharing agreement with Ligand, a loan agreement with Medtronic, a public offering, and amendments to its debt facility with Hercules[150](index=150&type=chunk)[158](index=158&type=chunk)[170](index=170&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=55&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The **29% increase in H1 2025 net loss** is due to a **35% rise in R&D expenses**, with **$76.2 million** in post-quarter financing extending the cash runway into H2 2027 [Results of Operations](index=68&type=section&id=Results%20of%20Operations) H1 2025 revenue increased **22% to $1.7 million**, but a **35% rise in R&D expenses** led to a **$38.1 million net loss** Comparison of Six Months Ended June 30, 2025 and 2024 (in thousands) | Metric | YTD 2025 | YTD 2024 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $1,704 | $1,398 | $306 | 22% | | Research and development | $27,335 | $20,238 | $7,097 | 35% | | Selling, general and administrative | $12,527 | $12,364 | $163 | 1% | | **Net loss** | **$(38,118)** | **$(29,443)** | **$(8,675)** | **(29)%** | - The **$7.1 million (35%) increase in R&D expenses** for H1 2025 was primarily due to increased clinical development costs (**$3.0 million**), higher personnel and consulting costs (**$2.2 million**), and increased non-clinical development costs (**$1.1 million**) to advance the BACKBEAT and Virtue SAB studies[220](index=220&type=chunk) Comparison of Three Months Ended June 30, 2025 and 2024 (in thousands) | Metric | Q2 2025 | Q2 2024 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $836 | $778 | $58 | 7% | | Research and development | $13,853 | $11,126 | $2,727 | 25% | | Selling, general and administrative | $6,264 | $6,467 | $(203) | (3)% | | **Net loss** | **$(19,363)** | **$(15,980)** | **$(3,383)** | **(21)%** | [Liquidity and Capital Resources](index=73&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$33.9 million** in liquid assets, with **$76.2 million** received post-quarter and **$35 million** committed for 2026, extending the cash runway into H2 2027 - As of June 30, 2025, the company held **$18.7 million** in cash and cash equivalents and **$15.2 million** in marketable securities[239](index=239&type=chunk) - On August 4, 2025, the company received **$76.2 million** from a combination of a public offering, private placements with Medtronic and Ligand, and a revenue sharing agreement with Ligand[239](index=239&type=chunk) - The company expects to receive an additional **$35.0 million** in committed capital in 2026, consisting of **$20.0 million** from a loan agreement with Medtronic and **$15.0 million** from Ligand[239](index=239&type=chunk) - Based on current plans and recent financing, the company projects its cash runway is sufficient to fund operations into the second half of 2027[241](index=241&type=chunk) [Critical Accounting Policies and Estimates](index=77&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Critical accounting policies involve significant judgment in revenue recognition for the Terumo partnership and stock-based compensation, with estimates impacting financials - Revenue from the Terumo Agreement is recognized using a proportional performance model, relying on management's estimate of total costs to complete the performance obligation, which can affect revenue recognition timing[266](index=266&type=chunk)[268](index=268&type=chunk) - Stock-based compensation expense totaled **$6.2 million** for H1 2025, with **$16.8 million** of unrecognized expense remaining as of June 30, 2025, to be recognized over 2.3 years[282](index=282&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=87&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Quantitative and qualitative disclosures regarding market risk are not applicable for this reporting period - The company has indicated that quantitative and qualitative disclosures about market risk are not applicable[290](index=290&type=chunk) [Controls and Procedures](index=87&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[293](index=293&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the fiscal quarter ended June 30, 2025[294](index=294&type=chunk) [PART II. OTHER INFORMATION](index=87&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=87&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, nor is it aware of any pending or threatened actions - As of the filing date, the company reports no material legal proceedings[297](index=297&type=chunk) [Risk Factors](index=89&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors have occurred since the last annual and quarterly reports - The company states there are no material changes to its previously disclosed risk factors[298](index=298&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=89&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported during the period - None reported for the period[299](index=299&type=chunk) [Other Information](index=89&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the second quarter of 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the second quarter of 2025[302](index=302&type=chunk) [Exhibits](index=90&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, financing agreements, and officer certifications
Orchestra BioMed Announces Rollout of FDA-Approved BACKBEAT Global Pivotal Study Protocol Update Significantly Expanding Patient Eligibility
Globenewswire· 2025-08-08 11:00
Core Viewpoint - Orchestra BioMed Holdings, Inc. announced a significant update to the BACKBEAT study protocol, approved by the FDA, which expands patient eligibility criteria for evaluating AVIM therapy in patients with uncontrolled hypertension who require pacemakers [1][5]. Summary by Relevant Sections Patient Eligibility Expansion - The updated protocol increases the eligible patient pool by more than 24-fold compared to the original protocol, supporting the company's target for mid-2026 completion of enrollment [2][5]. - New eligibility criteria include hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or Astra™ pacemaker, including device replacements [5][6]. Clinical Implications - The expanded criteria align the study population with the characteristics of the FDA Breakthrough Device Designation for AVIM therapy, potentially representing millions of U.S. patients needing better options for managing elevated systolic blood pressure [3][4]. - AVIM therapy is designed specifically for older, higher-risk hypertensive patients who may also require a pacemaker, reflecting its transformative potential [3][8]. Company Overview - Orchestra BioMed focuses on accelerating high-impact biomedical technologies through partnerships with leading medical device companies, with AVIM therapy as its lead product candidate for uncontrolled hypertension [4]. - The company has received four Breakthrough Device Designations from the FDA for its core programs, indicating significant potential to address unmet needs in cardiovascular care [4].
Orchestra BioMed Secures Over $111 Million in Proceeds and Committed Capital Following Completion of Strategic Transactions and Concurrent Public and Private Equity Offerings
Globenewswire· 2025-08-05 11:00
Core Viewpoint - Orchestra BioMed Holdings, Inc. has successfully completed strategic transactions and equity offerings totaling an expected $111.2 million to advance its late-stage AVIM therapy and Virtue SAB clinical programs [1][2]. Financial Summary - The $111.2 million in expected gross proceeds includes $56.2 million from a public offering and private placements, with net proceeds of approximately $51.8 million after expenses [2][4]. - Medtronic and Ligand have committed a total of $55 million in royalty-based, non-dilutive investments, with Ligand contributing $35 million and Medtronic $20 million [3][4]. Use of Proceeds - The net proceeds will fund significant value-creating catalysts, including the completion of enrollment and follow-up for the BACKBEAT study and substantial enrollment of the Virtue Trial [3][5]. Clinical Programs - AVIM therapy aims to treat uncontrolled hypertension and has shown promising results in pilot studies, with reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure [9]. - Virtue SAB is designed to deliver sirolimus for treating coronary in-stent restenosis and has demonstrated positive three-year clinical data in prior studies [10]. Strategic Partnerships - The company has established collaborations with Medtronic for AVIM therapy and Terumo for Virtue SAB, enhancing its potential for successful commercialization [7]. - The partnerships reflect confidence in the transformative potential of the company's therapeutic programs [2]. Market Position - Orchestra BioMed focuses on high-impact technologies in the biomedical sector, addressing significant unmet needs in cardiovascular care [7]. - The company has received four Breakthrough Device Designations from the FDA for its core programs, indicating the high potential of its technologies [7].
Orchestra BioMed Announces Pricing of $40 Million Public Offering
Globenewswire· 2025-08-01 11:59
Core Viewpoint - Orchestra BioMed Holdings, Inc. announced a public offering of 9,413,637 shares at $2.75 per share, along with pre-funded warrants for 5,136,363 shares at $2.7499 each, aiming to raise approximately $40 million before expenses [1][2]. Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 2,182,500 shares at the public offering price [1]. - The expected closing date for the offering is August 4, 2025, subject to customary conditions [1]. Group 2: Use of Proceeds - The net proceeds will fund the atrioventricular interval modulation (AVIM) therapy program, the BACKBEAT study, and the Virtue Sirolimus AngioInfusion Balloon (SAB) program, along with general corporate purposes [2]. Group 3: Company Overview - Orchestra BioMed focuses on high-impact biomedical technologies through partnerships with leading medical device companies [6]. - The company’s lead product candidate, AVIM therapy, targets hypertension, while Virtue SAB addresses atherosclerotic artery disease [6]. - The company has strategic collaborations with Medtronic and Terumo for the development and commercialization of its key therapies [6].