Decibel Therapeutics, Inc.

2022 Q4 Form 10-Q Financial Statement

#000095017022023819 Filed on November 09, 2022

View on sec.gov

Income Statement

Concept 2022 Q4 2022 Q3 2021 Q3

Balance Sheet

Concept 2022 Q4 2022 Q3 2021 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $104.6M $111.9M $143.9M
YoY Change -29.71% -22.2% 2667.12%
Cash & Equivalents $34.61M $36.68M $51.41M
Short-Term Investments $69.95M $75.26M $92.48M
Other Short-Term Assets $3.469M $4.340M $2.835M
YoY Change -14.18% 53.09% 89.0%
Inventory
Prepaid Expenses
Receivables $0.00 $10.00M $3.142M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $108.0M $126.3M $149.9M
YoY Change -34.2% -15.73% 2136.82%
LONG-TERM ASSETS
Property, Plant & Equipment $4.526M $4.553M $5.798M
YoY Change -19.34% -21.47% -12.15%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $0.00 $0.00 $28.49M
YoY Change -100.0% -100.0%
Other Assets $924.0K $1.060M $1.128M
YoY Change -18.09% -6.03% -24.8%
Total Long-Term Assets $15.34M $15.99M $35.42M
YoY Change -24.37% -54.86% 331.95%
TOTAL ASSETS
Total Short-Term Assets $108.0M $126.3M $149.9M
Total Long-Term Assets $15.34M $15.99M $35.42M
Total Assets $123.4M $142.3M $185.3M
YoY Change -33.12% -23.21% 1143.54%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.064M $3.031M $1.814M
YoY Change -73.48% 67.09% 51.17%
Accrued Expenses $11.98M $11.92M $7.552M
YoY Change 55.29% 57.79% 84.2%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $19.00K $74.00K
YoY Change
Total Short-Term Liabilities $22.44M $23.37M $16.50M
YoY Change 9.27% 41.67% 37.49%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $1.906M $1.761M $1.785M
YoY Change 18.31% -1.34% -86.05%
Total Long-Term Liabilities $1.906M $1.761M $1.785M
YoY Change 18.31% -1.34% -86.05%
TOTAL LIABILITIES
Total Short-Term Liabilities $22.44M $23.37M $16.50M
Total Long-Term Liabilities $1.906M $1.761M $1.785M
Total Liabilities $41.58M $45.46M $31.13M
YoY Change -2.82% 46.02% 25.03%
SHAREHOLDERS EQUITY
Retained Earnings -$277.5M -$261.6M -$201.6M
YoY Change 29.36% 29.75%
Common Stock $359.5M $358.9M $355.8M
YoY Change 0.9% 0.88%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $81.79M $96.81M $154.2M
YoY Change
Total Liabilities & Shareholders Equity $123.4M $142.3M $185.3M
YoY Change -33.12% -23.21% 1143.54%

Cashflow Statement

Concept 2022 Q4 2022 Q3 2021 Q3

Facts In Submission

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us-gaap Increase Decrease In Prepaid Deferred Expense And Other Assets
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872000
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3137000
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170000
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1420000
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152359000
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159000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
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52541000
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11485000
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CapitalExpendituresIncurredButNotYetPaid
187000
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us-gaap Nature Of Operations
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<p style="text-indent:0.0%;font-size:10.0pt;margin-top:12.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">1. Nature of the Business</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">Decibel Therapeutics, Inc. (the “Company”) was formed on November 26, 2013. The Company is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments for hearing and balance disorders, one of the largest areas of unmet need in medicine. The Company aims to restore and improve hearing and balance through the restoration and regeneration of functional hair cells and non-sensory support cells within the inner ear.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">On February 5, 2021, the Company’s board of directors approved a </span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;"><span style="-sec-ix-hidden:F_23ccd603-5a9c-48c6-aa75-fb1aef64bdc5;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">1-for-5.3</span></span></span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> reverse stock split of the Company’s common stock.</span></span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> All share and per share amounts in the condensed consolidated financial statements and notes thereto have been retroactively adjusted for all periods presented to give effect to the reverse stock split.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">On February 17, 2021, the Company completed an initial public offering (“IPO”), issuing and selling </span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">7,062,000</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> shares of common stock at a public offering price of $</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">18.00</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> per share, and on February 24, 2021, the Company issued and sold an additional </span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">600,000</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> shares pursuant to the underwriters’ partial exercise of their option to purchase additional shares. The aggregate net proceeds received by the Company from the offering were $</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">125.0</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million. Upon closing of the Company’s IPO, all outstanding shares of convertible preferred stock automatically converted into shares of common stock.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">In March 2022, the Company filed a universal shelf registration statement on Form S-3 to register for sale from time to time up to $</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">200.0</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million of common stock, preferred stock, debt securities, warrants and/or units in one or more offerings. Further, in March 2022, the Company entered into an Open Market Sale Agreement</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;vertical-align:super;font-size:6.7pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">SM</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) pursuant to which, from time to time, the Company may offer and sell shares of its common stock. Sales of common stock through Jefferies may be made by any method that is deemed an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">Jefferies is entitled to compensation at a rate equal to </span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">3.0</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">% of the gross proceeds from any shares of common stock sold under the Sales Agreement. In August 2022, the Company filed a prospectus supplement under its universal shelf registration for the offer and sale of shares of its common stock having an aggregate offering price up to $</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">50.0</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million pursuant to the Sales Agreement. As of September 30, 2022, the Company had </span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">no</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">t sold any shares of common stock pursuant to the Sales Agreement.</span></p><p style="margin-left:2.253%;text-indent:0.0%;font-size:10.0pt;margin-top:18.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;">Liquidity</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">Since its inception, the Company’s operations have been focused on organizing and staffing, business planning, raising capital, establishing the Company’s intellectual property portfolio and performing research and development of its product candidates, programs and platform.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including but not limited to, risks associated with completing preclinical studies and clinical trials, obtaining regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Programs currently under development will require significant additional research and development efforts, including preclinical and clinical testing and will need to obtain regulatory approval prior to commercialization.</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:9.0pt;font-family:&quot;Arial&quot;, sans-serif;min-width:fit-content;"> </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">As of September 30, 2022, the Company had cash, cash equivalents and available-for-sale securities of </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">$</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">111.9</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">. The Company has determined that its existing capital resources will be sufficient to meet its projected operating expenses and capital expenditure requirements for at least twelve months from the date of issuance of these condensed consolidated financial statements. The Company expects to experience negative cash flows from operations and net losses for the foreseeable future as it continues to invest significantly in research and development of its product candidates, preclinical and clinical development and platform. Management’s conclusion with respect to its ability to fund its operations is based on estimates that are subject to risks and uncertainties that may prove to be incorrect. If actual results differ from management’s estimates, the Company may be required to seek additional funding or curtail planned activities to reduce operating expenses, which may have an adverse impact on the Company’s ability to achieve its business objectives.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="margin-left:2.253%;text-indent:0.0%;font-size:10.0pt;margin-top:18.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;">Impact of the COVID-19 Pandemic</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">The worldwide COVID-19 pandemic has affected and may affect in the future the Company’s ability to initiate and complete preclinical studies, delay the initiation and completion of the Company’s current and planned clinical trials, disrupt regulatory activities or have other adverse effects on the Company’s business, results of operations, financial condition and prospects. In addition, the pandemic has caused substantial disruption to global supply chains and may adversely impact economies worldwide, both of which could adversely affect the Company’s business, operations and ability to raise funds to support its operations.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">The Company is following, and plans to continue to follow, recommendations from federal, state and local governments regarding workplace policies, practices and procedures. In response to the COVID-19 pandemic and in accordance with direction from state and local governmental authorities, the Company previously restricted access to its facility to those individuals who must perform critical research, translational medicine and laboratory support activities that must be completed on site, limited the number of such people that can be present at its facility at any one time, and required that most of its employees work remotely. In February 2022, the Company re-opened its facility to all of its employees. Screening and enrollment in the Company’s ongoing Phase 1b clinical trial of DB-020 in Australia and the United States had been adversely impacted by the COVID-19 pandemic. Patient screening and enrollment were paused in the second quarter of 2020 in both Australia and the United States, and screening for enrollment did not resume until early in the third quarter of 2020 in Australia and early in the fourth quarter of 2020 in the United States. The Company experienced delays in site start-up and the withdrawal of some sites in the United States. In addition, the Company and the third-party manufacturers, contract research organizations (“CROs”), and academic collaborators that it engages have faced in the past and may face in the future disruptions that could affect its ability to initiate and complete preclinical studies or clinical trials. This includes disruptions in procuring items and providing adequate resources that are essential for its research and development activities, such as, for example, raw materials used in the manufacture of its product candidates, laboratory supplies for its preclinical studies and clinical trials, or animals that are used for preclinical testing, in each case, for which there may be shortages because of ongoing efforts to address the COVID-19 pandemic, including supply chain disruptions. For example, due to increased quarantine mandates in China, the receipt of shipments and data from some of the Company's vendors and CROs were more difficult and unpredictable during the first half of 2022. This caused some delays in preclinical studies for the Company's gene therapy programs.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">The Company cannot be certain what the overall impact of the COVID-19 pandemic will be on its business. The extent of the impact of COVID-19 on its business will depend on the length and severity of the pandemic, including the extent there is any resurgence of the COVID-19 virus or any variant strains of the virus, the availability and effectiveness of vaccines and the impact of the foregoing on its preclinical studies, current and planned clinical trials, employees and vendors, which is uncertain and cannot be predicted. The pandemic has the potential to adversely affect its business, financial condition, results of operations and prospects.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:12.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p>
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<p style="margin-left:2.253%;text-indent:0.0%;font-size:10.0pt;margin-top:18.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;">Use of Estimates</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these condensed consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to the estimated cost to perform research which is an input into the measurement of research and development expenses recognized under the Company’s license and collaboration agreement (the “Regeneron Agreement”) </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">with Regeneron Pharmaceuticals, Inc. (“Regeneron”) as described below, the accrual of research and development expenses, stock-based compensation expenses, leases and income taxes. Estimates are periodically reviewed considering changes in circumstances, facts and historical experience. Actual results may differ from the Company’s estimates.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p>
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