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AVROBIO(AVRO) - 2024 Q4 - Annual Report
2025-03-20 20:06
Financial Performance - The company has not generated any revenue since inception and does not expect to do so in the foreseeable future[470]. - The net loss for the year ended December 31, 2024, was $58.0 million, a 35% increase from the net loss of $42.8 million in 2023[485]. - Cash used in operating activities was $59.1 million in 2024, compared to $40.7 million in 2023, reflecting increased operational funding needs[494]. - The company expects to incur significant expenses and operating losses in the foreseeable future as it advances its research programs and product candidates[491]. - The company has no approved products and has never generated revenue from product sales, relying on financing to support its operations[492]. Clinical Trials and Development - TX45, the lead asset, showed favorable results in a Phase 1a trial with no severe adverse events and a favorable pharmacokinetic/pharmacodynamic relationship[463]. - The Phase 1b trial for TX45 has completed dosing of 19 patients, with preliminary data showing improvements in hemodynamics[464]. - The APEX Phase 2 clinical trial for TX45 commenced in October 2024, with topline results expected in 2026[464]. - TX2100, the second development candidate, is set to initiate a Phase 1 clinical trial in late 2025 or early 2026, pending IND enabling studies[465]. Expenses and Liabilities - Total operating expenses increased by $13.4 million, or 30%, to $58.0 million for the year ended December 31, 2024, compared to $44.6 million in 2023[485]. - Research and development expenses rose by $4.4 million, or 12%, to $41.4 million in 2024, primarily due to increased costs related to the discovery and development of TX2100[486]. - General and administrative expenses surged by $9.0 million, or 117%, to $16.7 million in 2024, driven by higher employee-related and professional consulting expenses[488]. - The company issued SAFEs for proceeds of $34.1 million, recorded as liabilities and measured at fair value until redemption[481]. - The operating lease liability and finance lease liability as of December 31, 2024, were $2.4 million and $0.9 million, respectively[518]. Cash and Financing - As of December 31, 2024, the company had $141.2 million in cash and cash equivalents and an accumulated deficit of $148.6 million[492]. - The company raised $171.7 million in net cash from financing activities in 2024, primarily from the sale of shares[498]. - As of December 31, 2024, the company had cash and cash equivalents totaling $141.2 million[517]. - Minimum lease payments are projected to be $3.0 million in 2025, $0.4 million in 2026, and $0.1 million in 2027[506]. Market and Regulatory Environment - The merger with AVROBIO was completed on June 20, 2024, with Legacy Tectonic stockholders owning approximately 38.5% of the outstanding shares post-merger[467]. - Investors in the Subscription Agreement purchased shares for an aggregate price of $96.6 million, converting into 4,163,606 shares of common stock upon merger completion[469]. - The company is classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures as long as market value remains below $250.0 million or annual revenue is less than $100.0 million[515]. Interest and Inflation - Interest income increased significantly by $3.7 million, or 633%, to $4.3 million in 2024, attributed to a rise in cash and cash equivalents following the Merger[490]. - Interest income and expenses are sensitive to changes in U.S. interest rates, but a 10% change would not materially affect the fair market value of the investment portfolio[518]. - Inflation effects on the company's results of operations and financial condition have been deemed immaterial to date[519]. Estimates and Assumptions - The company evaluates its estimates and assumptions on an ongoing basis, acknowledging that actual results may differ from these estimates[509]. - The fair value of the company's common stock is based on the closing quoted market price as reported by NASDAQ on the date of grant[512]. - The company has not experienced material adjustments to prior estimates of prepaid and accrued research and development expenses[511]. Research Agreements - The company enters into agreements for preclinical research and clinical trials that are generally cancelable without minimum purchase commitments[507].
AVROBIO(AVRO) - 2024 Q4 - Annual Results
2025-03-20 20:02
Financial Performance - The net loss for Q4 2024 was $12.4 million, compared to a net loss of $7.9 million for Q4 2023[11]. - Net loss for Q4 2024 was $12,373,000, compared to a net loss of $7,869,000 in Q4 2023, representing a 57.5% increase in losses[18]. - Net loss per share for Q4 2024 was $0.84, compared to $5.01 in Q4 2023[18]. - Comprehensive loss for the year ended December 31, 2024 was $57,973,000, compared to $42,834,000 in 2023[18]. Cash and Assets - Tectonic reported cash and cash equivalents of $141.2 million as of December 31, 2024, with a private placement in February 2025 generating approximately $185.0 million, providing a cash runway into Q4'28[6]. - Cash and cash equivalents increased significantly to $141,239,000 in 2024 from $28,769,000 in 2023[20]. - Total assets grew to $152,905,000 in 2024, up from $39,399,000 in 2023[20]. - Working capital improved to $135,247,000 in 2024 from a deficit of $10,004,000 in 2023[20]. - Total stockholders' equity improved to $140,776,000 in 2024, compared to a deficit of $84,636,000 in 2023[20]. Expenses - Research and development expenses increased to $9.2 million for Q4 2024, up from $7.1 million in Q4 2023, primarily due to higher costs related to clinical trials[11]. - General and administrative expenses rose to $4.8 million for Q4 2024, compared to $2.3 million in Q4 2023, driven by increased audit, legal, and professional service costs[11]. - Total operating expenses for Q4 2024 were $13,989,000, an increase of 49.5% from $9,372,000 in Q4 2023[18]. - Research and development expenses rose to $9,155,000 in Q4 2024, up 29.3% from $7,081,000 in Q4 2023[18]. Clinical Trials and Research - The TX45 Phase 1b trial interim analysis showed a 17.9% reduction in Pulmonary Capillary Wedge Pressure (PCWP) and over 30% reduction in Pulmonary Vascular Resistance (PVR) in patients with Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF)[7]. - The APEX Phase 2 trial topline results for TX45 are expected in 2026, following positive interim results from the ongoing Phase 1b trial[6]. - The TX2100 GPCR antagonist for Hereditary Hemorrhagic Telangiectasia (HHT) is expected to initiate Phase 1 trials in Q4 2025 or Q1 2026[11]. - Tectonic's ongoing clinical trials aim to address significant unmet medical needs in pulmonary hypertension and hereditary bleeding disorders[13]. - Tectonic hosted a Key Opinion Leader webinar in December 2024 discussing the treatment landscape for patients with Group 2 PH-HFpEF[7]. - The company plans to present full results from the Phase 1b Part A trial of TX45 at a future medical meeting in 2025[7]. Interest Income - Interest income for Q4 2024 was $1,735,000, a significant increase from $132,000 in Q4 2023[18].
AVROBIO(AVRO) - 2024 Q3 - Quarterly Report
2024-11-12 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Securities registered pursuant to Section 12(b) of the Act: FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number: 001-38537 TECTONIC THERAPEUTIC, INC. (E ...
AVROBIO(AVRO) - 2024 Q3 - Quarterly Results
2024-11-07 21:27
Financial Position - Cash and cash equivalents were $159.1 million as of September 30, 2024, down from $185.1 million as of June 30, 2024, providing a cash runway into mid-2027[4] - Cash and cash equivalents increased to $159,095 thousand as of September 30, 2024, up from $28,769 thousand on December 31, 2023[11] - Working capital improved to $145,278 thousand, a significant recovery from a deficit of $(10,004) thousand[11] - Total assets rose to $168,717 thousand, compared to $39,399 thousand at the end of 2023[11] - Total stockholders' equity turned positive at $150,361 thousand, recovering from a deficit of $(84,636) thousand[11] Expenses - Research and development expenses increased to $14.3 million for Q3 2024, compared to $8.1 million for Q3 2023, primarily due to higher external research costs[4] - General and administrative expenses rose to $5.3 million for Q3 2024, up from $2.0 million for Q3 2023, driven by increased personnel-related costs and professional fees[4] Net Loss - The net loss for Q3 2024 was $17.7 million, compared to a net loss of $10.1 million for Q3 2023[4] Clinical Trials - The first subject was dosed with TX000045 in the APEX Phase 2 clinical trial in early October 2024, with topline results expected in 2026[2] - Favorable Phase 1a topline trial results for TX45 were announced in September 2024, showing good tolerability and a favorable pharmacokinetic profile[2] - Development candidate TX2100 was selected for the HHT program, with plans to initiate a Phase 1 clinical trial in Q4 2025 or Q1 2026[2] - Ongoing Phase 1b hemodynamic clinical trial results for TX45 are expected in late Q1 2025 or early Q2 2025[3] - The APEX Phase 2 clinical trial is a 24-week placebo-controlled study evaluating TX45 in subjects with PH-HFpEF[2] Future Outlook - Tectonic anticipates that its current cash position will support key Phase 1b and Phase 2 readouts for TX45 and the progression of the HHT program into clinical development[4]
AVROBIO(AVRO) - 2024 Q2 - Quarterly Results
2024-08-14 20:11
Clinical Trials - TX45 has advanced into Phase 2 clinical trial for patients with Group 2 PH-HFpEF, with the first site activated and screening open in August 2024[1] - The Phase 1a clinical trial results for TX45 in healthy volunteers are expected to be reported in September 2024[5] - The ongoing Phase 1b clinical trial results for TX45 are expected in mid-2025[11] - The company anticipates topline results from the Phase 2 clinical trial of TX45 in 2026[5] Financial Performance - The company reported a net loss of $12.7 million for Q2 2024, compared to a net loss of $10.5 million for Q2 2023[7] - Net loss for the three months ended June 30, 2024, was $12,671,000, compared to a net loss of $10,455,000 for the same period in 2023, indicating a year-over-year increase of 21.3%[19] - Comprehensive loss for the three months ended June 30, 2024, was $(12,679,000), compared to $(10,455,000) for the same period in 2023, representing an increase of 11.7%[19] Expenses - Research and development expenses for Q2 2024 were $7.1 million, a decrease from $8.8 million in Q2 2023[6] - General and administrative expenses increased to $4.3 million in Q2 2024 from $1.9 million in Q2 2023, primarily due to merger-related activities[7] - Total operating expenses for the three months ended June 30, 2024, were $11,421,000, compared to $10,631,000 for the same period in 2023, representing an increase of 7.4%[19] - Research and development expenses decreased to $7,074,000 for the three months ended June 30, 2024, from $8,766,000 in the same period of 2023, a reduction of 19.3%[19] - Interest expense decreased to $(28,000) for the three months ended June 30, 2024, from $(40,000) in the same period of 2023, a reduction of 30.0%[19] Cash and Assets - As of June 30, 2024, cash and cash equivalents were $185.1 million, expected to provide a cash runway into mid-2027[6] - Total assets as of June 30, 2024, were $19,390,000, compared to $39,399,000 as of December 31, 2023, showing a significant decrease of 50.8%[20] Equity and Shares - Total stockholders' equity (deficit) improved to $(166,367,000) as of June 30, 2024, from $(84,636,000) as of December 31, 2023, indicating a worsening of 96.5%[20] - Weighted-average common shares outstanding increased to 2,919,872 for the three months ended June 30, 2024, from 1,228,778 in the same period of 2023, an increase of 138.8%[19] Mergers and Acquisitions - The company completed a reverse merger with AVROBIO in June 2024, including a concurrent private placement of $130.7 million[3] Future Plans - The company plans to select a development candidate for its second program in Hereditary Hemorrhagic Telangiectasia (HHT) in the second half of 2024[5] Interest Income - Interest income increased to $318,000 for the three months ended June 30, 2024, compared to $224,000 for the same period in 2023, reflecting a growth of 42.0%[19] Liabilities - Change in fair value of SAFE liabilities was $(1,535,000) for the three months ended June 30, 2024, with no comparable figure for the same period in 2023[19]
AVROBIO(AVRO) - 2024 Q2 - Quarterly Report
2024-08-14 20:02
Table of Contents Title of each classTrading Symbol(s)Name of each exchange on which registered Common Stock, par value $0.0001 per share TECX The Nasdaq Stock Market LLC Emerging growth company ☐ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ...
AVROBIO(AVRO) - 2024 Q1 - Quarterly Results
2024-06-20 20:25
Financial Performance - Net loss for the three months ended March 31, 2024, was $15,221,000, compared to a net loss of $14,445,000 for the same period in 2023, indicating an increase in loss of about 5.4%[6] - The company reported a comprehensive loss of $15,271,000 for the three months ended March 31, 2024, compared to a comprehensive loss of $14,445,000 for the same period in 2023, reflecting an increase of about 5.7%[6] - The total net loss attributable to common stockholders was $15,221,000, compared to a net loss of $14,445,000 for the same period in 2023, representing an increase of approximately 5.4%[81] Assets and Liabilities - Total current assets decreased from $30,884,000 as of December 31, 2023, to $20,558,000 as of March 31, 2024, representing a decline of approximately 33.5%[3] - Total liabilities increased from $43,408,000 as of December 31, 2023, to $50,102,000 as of March 31, 2024, an increase of about 15.3%[3] - Total stockholders' deficit increased from $84,636,000 as of December 31, 2023, to $99,574,000 as of March 31, 2024, an increase of about 17.6%[3] - Cash and cash equivalents decreased from $28,769,000 as of December 31, 2023, to $18,748,000 as of March 31, 2024, a reduction of approximately 34.9%[3] - Cash and cash equivalents decreased to $19.3 million as of March 31, 2024, down from $25.5 million at the end of 2023, representing a decrease of approximately 24%[12] - The aggregate liquidation preference of convertible preferred stock remained at $87,459,000 as of March 31, 2024, consistent with December 31, 2023[3] Research and Development - Research and development expenses for the three months ended March 31, 2024, were $10,818,000, down from $12,985,000 for the same period in 2023, a decrease of approximately 16.8%[6] - The company expects to continue incurring operating losses and negative cash flows as it develops its product candidates[16] - The company’s proprietary GEODe™ platform is currently in development, focusing on therapeutic proteins and antibodies targeting GPCRs[14] - The company anticipates needing to raise additional capital to fund its operations as it continues its research and development efforts[16] Cash Flow and Operating Activities - The company utilized $9.3 million in cash from operating activities during the first quarter of 2024, an improvement from $10.8 million used in the same period of 2023[12] - The Company paid $381,000 in operating cash flows for operating leases during the three months ended March 31, 2024, compared to $370,000 in the same period of 2023[53] Equity and Stock - The weighted-average common shares outstanding increased from 2,222,800 for the three months ended March 31, 2023, to 2,608,740 for the same period in 2024, an increase of approximately 17.3%[6] - The Company has issued a total of 6,825,483 shares of Preferred Stock with a carrying value of $80,627,000 as of March 31, 2024[57] - The Company has authorized the issuance of up to 11,947,558 shares of common stock, with 2,637,120 shares issued and outstanding as of March 31, 2024[67] - The 2019 Equity Incentive Plan allows for the issuance of up to 1,991,264 shares of common stock, with stock options being the only equity awards issued to date[68] - The total stock-based compensation expense for the three months ended March 31, 2024, was $321,000, up from $275,000 in 2023, indicating a year-over-year increase of approximately 16.7%[77] Mergers and Acquisitions - The company completed a merger with AVROBIO, Inc. on June 20, 2024, receiving $77.3 million in cash and completing the sale of $96.6 million in common stock[16] - The company entered into a merger agreement with AVROBIO on January 30, 2024, with the merger closing on June 20, 2024, treating AVROBIO as the acquired company for financial reporting purposes[91] - Concurrently with the merger, certain investors purchased 7,790,889 shares of the company's common stock for an aggregate purchase price of approximately $96.6 million[92] Fair Value and Liabilities - The company incurred a change in the fair value of SAFE liabilities amounting to a loss of $2,075,000 for the three months ended March 31, 2024[6] - As of March 31, 2024, the SAFE liabilities were valued at $32.59 million, up from $30.52 million as of December 31, 2023, reflecting a fair value adjustment of $2.08 million[31] - The fair value of the SAFEs issued in October 2023 was recognized at $10.4 million, with subsequent measurement resulting in total SAFE liabilities fair value of $32.6 million recorded in the statement of operations[87] Commitments and Expenses - The Company has commitments for annual maintenance fees and royalty payments under its agreements with Harvard and Alloy Therapeutics, which may total in the low seven digits annually[42][46] - The Company has a remaining installment of $56,668 due to Harvard in July 2024 as part of a license agreement[42] - Total lease costs for the three months ended March 31, 2024, amounted to $921,000, an increase of 4.3% compared to $883,000 for the same period in 2023[52] Depreciation and Fair Value Adjustments - Depreciation expense for the three months ended March 31, 2024, was $0.3 million, compared to $0.2 million for the same period in 2023[36] - The company recorded a change in the fair value of SAFE liabilities amounting to $2.1 million for the first quarter of 2024[12] Tax Assets - The company has maintained a full valuation allowance against its net deferred tax assets as of March 31, 2024, due to cumulative net losses and the likelihood of not realizing the benefits of these assets[79]
Why Is Avrobio (AVRO) Stock Moving Today?
Investor Place· 2024-06-20 12:26
Group 1 - Avrobio is preparing for a merger with Tectonic Therapeutic, which is set to take place today after investor approval [1] - A one-for-12 reverse stock split will occur after market close today, with shares trading on a split-adjusted basis starting tomorrow [2] - The stock ticker will change from AVRO to TECX following the merger, with Tectonic Therapeutic becoming a wholly-owned subsidiary of Avrobio [2] Group 2 - AVRO stock experienced slight increases in the morning, but there were reports of a significant drop in pre-market trading, possibly due to merger and reverse stock split plans [2]
AVROBIO(AVRO) - 2024 Q1 - Quarterly Report
2024-05-09 20:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38537 AVROBIO, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 81-0710585 (State or other jurisdiction of in ...
AVROBIO(AVRO) - 2023 Q4 - Annual Report
2024-03-13 16:00
Merger and Ownership Structure - AVROBIO securityholders are expected to own approximately 22.3% of the combined company, while former Tectonic securityholders are expected to own approximately 39.8%[61]. - The merger agreement includes an exchange ratio based on AVROBIO's net cash at closing, anticipated to be between $65.0 million and $75.0 million[61]. - If AVROBIO's net cash is below $65.0 million, the exchange ratio will be adjusted, resulting in a smaller ownership percentage for AVROBIO stockholders[61]. - The merger cannot be consummated without the approval of certain proposals by AVROBIO stockholders[63]. - Following the merger, AVROBIO stockholders are expected to own approximately 22.3% of the combined company, while former Tectonic stockholders are expected to own approximately 39.8%[67]. - AVROBIO anticipates its net cash at closing will be between $65.0 million and $75.0 million, with ownership percentages based on an assumption of $65.0 million[67]. - If the merger is not completed, AVROBIO may be required to pay Tectonic a termination fee of $2,712,500, or Tectonic may owe AVROBIO $4,900,000[67]. - The completion of the merger is subject to various conditions, including approval from both AVROBIO and Tectonic stockholders[75]. Financial Performance and Capital Requirements - AVROBIO incurred a net loss of $105.9 million for the year ended December 31, 2022, and a net income (loss) of $12.2 million for the year ended December 31, 2023[78]. - AVROBIO has received a cash payment of $87.5 million from Novartis for the sale of its cystinosis gene therapy program, which has allowed the company to pay off all outstanding amounts under its Term Loan Agreement[78]. - The combined company may need to raise additional capital, potentially causing significant dilution to existing shareholders[64]. - AVROBIO's future capital requirements will depend on various factors, including the costs associated with drug discovery, clinical trials, and potential regulatory reviews[82]. - The company may need additional funding to resume development of its product candidates, which may not be available on acceptable terms[82]. - AVROBIO's exploration of strategic alternatives may involve entering into acquisitions or mergers, which could result in dilution for existing stockholders[83]. Strategic Alternatives and Operational Focus - In July 2023, AVROBIO announced a comprehensive exploration of strategic alternatives to maximize stockholder value, including a proposed merger with Tectonic announced in January 2024[79]. - AVROBIO's management and employees are currently focused on the merger, which may divert attention from day-to-day operations[74]. - The company has halted further development of its programs and conducted reductions in force while evaluating strategic alternatives[82]. - AVROBIO's cash conservation activities may lead to unintended consequences, including employee attrition and reduced morale[78]. - The company has implemented workforce reductions to conserve capital expenditures, but may not realize the anticipated savings or operational efficiencies from these restructuring efforts[87]. Clinical Development and Regulatory Challenges - AVROBIO's clinical development has been halted, and the commercially-scalable plato platform has been used in only two clinical trials[96]. - The company has limited experience in preparing and submitting regulatory filings, having never completed a pivotal or registrational clinical trial[92]. - The regulatory approval process for AVROBIO's novel product candidates may be more expensive and time-consuming compared to other therapies, with limited prior approvals in the HSC gene therapy space[90]. - AVROBIO's ability to conduct clinical trials may be impacted by changes in hospital policies, government regulations, and disruptions in third-party services[89]. - The company may face significant delays in resuming clinical trials due to challenges in patient enrollment, particularly for rare diseases[94]. Intellectual Property and Competitive Landscape - AVROBIO's ability to compete effectively depends on maintaining proprietary technology and manufacturing processes[129]. - The company may face substantial litigation expenses and resource diversion if claims of patent infringement arise[128]. - AVROBIO's reliance on trade secrets and confidentiality agreements poses risks, as these can be difficult to enforce[129]. - Changes in U.S. patent law, particularly the Leahy-Smith America Invents Act, could increase uncertainties and costs related to patent applications and enforcement, potentially adversely affecting AVROBIO's business[130]. - AVROBIO's ability to protect its intellectual property may be compromised if it cannot secure patent term extensions or data exclusivity for its product candidates, which could lead to reduced revenue[132]. Market and Economic Conditions - The market price of AVROBIO common stock is subject to significant fluctuations, particularly in the context of the merger's completion[66]. - AVROBIO's stock price may decline if the market assumes the merger will not be completed[73]. - The company is subject to provisions in its charter and bylaws that could delay or prevent a change in control, including the authorization of "blank check" preferred stock and a classified board of directors[138]. - AVROBIO's financial condition could be adversely affected by unfavorable global economic conditions, including the impacts of the COVID-19 pandemic and geopolitical events[141]. - The company has faced cybersecurity threats in the past, including a cyberattack in 2017 that led to the theft of funds, which could disrupt operations if similar incidents occur in the future[141]. Compliance and Regulatory Risks - AVROBIO is subject to various U.S. and foreign healthcare laws, and non-compliance could result in substantial penalties and reputational harm[120]. - Compliance with data protection laws, including GDPR, is critical, as violations could result in fines up to 4% of global revenues or €20 million[122]. - The company may need to enhance its business processes and systems to support future growth and ensure compliance with regulatory requirements[120]. - AVROBIO's suppliers have not undergone FDA approval processes, which poses risks for the company's ability to meet regulatory requirements[109]. Employee and Management Issues - AVROBIO has implemented workforce reductions, including a 50% reduction in July 2023 and further cuts in October, November, and December 2023, impacting employee morale and retention[118]. - The company is currently led by an interim CEO following the resignation of the former President and CEO on May 1, 2023, with no timeline for hiring a permanent replacement[118]. - AVROBIO's ability to retain key personnel is critical for its future success, with a competitive landscape for skilled employees in the biotechnology sector[118].