10-Q
0.18860001656536--12-31Q3false0001656536dbtx:CurrentMember2021-09-3000016565362019-12-310001656536us-gaap:EmployeeStockOptionMember2020-12-310001656536us-gaap:ResearchAndDevelopmentExpenseMember2021-01-012021-09-300001656536us-gaap:AdditionalPaidInCapitalMember2020-03-310001656536us-gaap:SeriesAPreferredStockMember2020-01-012020-09-300001656536us-gaap:CommonStockMember2021-02-052021-02-050001656536us-gaap:AdditionalPaidInCapitalMember2020-07-012020-09-300001656536dbtx:SeriesBConvertiblePreferredStockMember2020-12-310001656536us-gaap:GeneralAndAdministrativeExpenseMember2021-07-012021-09-300001656536us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001656536dbtx:SeriesAConvertiblePreferredStockMember2020-06-300001656536us-gaap:GeneralAndAdministrativeExpenseMember2020-07-012020-09-300001656536us-gaap:FairValueInputsLevel2Memberdbtx:AgencyBondsMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536dbtx:SeriesCConvertiblePreferredStockMember2021-09-300001656536dbtx:SeriesCConvertiblePreferredStockMember2021-01-012021-03-310001656536us-gaap:SeriesCPreferredStockMemberus-gaap:SubsequentEventMember2021-10-310001656536dbtx:SeriesCConvertiblePreferredStockMember2020-09-300001656536us-gaap:RetainedEarningsMember2019-12-310001656536us-gaap:CommonStockMember2020-12-3100016565362020-10-012020-10-3100016565362021-02-242021-02-240001656536dbtx:CurrentMemberus-gaap:CertificatesOfDepositMember2020-12-310001656536dbtx:SeriesDConvertiblePreferredStockMember2021-01-012021-03-3100016565362020-09-300001656536us-gaap:CommonStockMember2020-06-300001656536us-gaap:USTreasurySecuritiesMemberdbtx:NoncurrentMember2021-09-300001656536us-gaap:CommonStockMember2021-07-012021-09-300001656536us-gaap:AdditionalPaidInCapitalMember2021-01-012021-03-310001656536dbtx:UnvestedRestrictedStockMember2021-07-012021-09-300001656536dbtx:SeriesAConvertiblePreferredStockMember2021-09-300001656536us-gaap:RetainedEarningsMember2020-03-310001656536us-gaap:SubsequentEventMember2021-10-012021-10-310001656536us-gaap:ResearchAndDevelopmentExpenseMember2020-07-012020-09-300001656536dbtx:SeriesDConvertiblePreferredStockMember2020-12-3100016565362021-01-012021-09-3000016565362021-01-012021-03-3100016565362020-10-300001656536us-gaap:RetainedEarningsMember2020-09-300001656536dbtx:TwoThousandAndTwentyOneEmployeeStockPurchasePlanMember2021-09-3000016565362020-11-012020-11-300001656536us-gaap:IPOMember2021-02-170001656536us-gaap:USTreasurySecuritiesMemberdbtx:CurrentMember2021-09-300001656536us-gaap:AdditionalPaidInCapitalMember2021-09-300001656536us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536us-gaap:USTreasurySecuritiesMemberdbtx:CurrentMember2020-12-310001656536us-gaap:EmployeeStockOptionMember2021-01-012021-09-300001656536dbtx:TwoThousandAndFifteenStockIncentivePlanMember2021-09-300001656536dbtx:SeriesBConvertiblePreferredStockMember2020-03-310001656536us-gaap:RestrictedStockMember2020-12-310001656536us-gaap:RestrictedStockMember2021-09-300001656536us-gaap:RetainedEarningsMember2021-03-310001656536us-gaap:AccumulatedOtherComprehensiveIncomeMember2019-12-3100016565362020-07-012020-09-300001656536dbtx:FirstMilestonePaymentForRetentionMember2020-01-012020-03-310001656536us-gaap:EmployeeStockOptionMember2021-09-300001656536us-gaap:FairValueInputsLevel2Memberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001656536us-gaap:AdditionalPaidInCapitalMember2020-04-012020-06-300001656536us-gaap:FairValueInputsLevel2Memberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536us-gaap:EmployeeStockOptionMember2021-01-012021-09-300001656536us-gaap:CommercialPaperMemberdbtx:CurrentMember2021-09-300001656536us-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536us-gaap:RetainedEarningsMember2021-09-300001656536us-gaap:AdditionalPaidInCapitalMember2021-07-012021-09-300001656536us-gaap:AdditionalPaidInCapitalMember2020-01-012020-03-3100016565362021-07-012021-09-300001656536us-gaap:CommonStockMember2020-10-302020-10-300001656536dbtx:SeriesBConvertiblePreferredStockMember2020-06-3000016565362020-01-012020-03-310001656536dbtx:TwoThousandAndTwentyOneEmployeeStockPurchasePlanMemberus-gaap:IPOMember2021-09-300001656536us-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001656536dbtx:SeriesAConvertiblePreferredStockMember2019-12-310001656536us-gaap:IPOMember2021-02-172021-02-170001656536us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536us-gaap:RetainedEarningsMember2021-01-012021-03-310001656536us-gaap:AdditionalPaidInCapitalMember2020-12-310001656536dbtx:SeriesAConvertiblePreferredStockMember2020-03-3100016565362021-04-012021-06-300001656536us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001656536dbtx:AgencyBondsMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-03-310001656536dbtx:SeriesCConvertiblePreferredStockMember2020-03-310001656536dbtx:SeriesCConvertiblePreferredStockMember2020-06-3000016565362021-02-170001656536dbtx:RegeneronAgreementMember2021-09-300001656536dbtx:SeriesDConvertiblePreferredStockMember2021-09-300001656536us-gaap:SeriesCPreferredStockMember2020-11-3000016565362021-06-300001656536us-gaap:CommonStockMember2020-09-300001656536us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536us-gaap:CommonStockMember2019-12-310001656536us-gaap:RetainedEarningsMember2020-06-300001656536dbtx:SeriesCConvertiblePreferredStockMember2020-12-310001656536dbtx:UnvestedRestrictedStockMember2021-01-012021-09-300001656536us-gaap:CommonStockMember2020-07-012020-09-300001656536dbtx:UnvestedRestrictedStockMember2020-07-012020-09-300001656536us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-04-012021-06-300001656536us-gaap:SeriesCPreferredStockMember2020-01-012020-09-300001656536dbtx:TwoThousandAndTwentyOneEmployeeStockPurchasePlanMemberus-gaap:IPOMember2021-01-012021-09-300001656536us-gaap:RetainedEarningsMember2021-04-012021-06-300001656536us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001656536dbtx:TwoThousandAndTwentyOneStockIncentivePlanMember2021-09-3000016565362020-04-012020-06-300001656536srt:MaximumMember2020-10-310001656536us-gaap:AdditionalPaidInCapitalMember2020-09-3000016565362021-11-010001656536dbtx:SeriesAConvertiblePreferredStockMember2020-12-310001656536us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-06-3000016565362020-03-310001656536us-gaap:FairValueInputsLevel1Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536us-gaap:FairValueInputsLevel2Memberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001656536us-gaap:RetainedEarningsMember2020-07-012020-09-300001656536us-gaap:GeneralAndAdministrativeExpenseMember2020-01-012020-09-300001656536us-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536us-gaap:FairValueInputsLevel2Memberus-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536us-gaap:SeriesCPreferredStockMember2020-10-310001656536us-gaap:CommonStockMember2020-01-012020-03-310001656536dbtx:SeriesAConvertiblePreferredStockMember2021-01-012021-03-310001656536us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-04-012020-06-300001656536us-gaap:CommercialPaperMemberdbtx:CurrentMember2020-12-310001656536us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-01-012020-03-310001656536srt:MaximumMember2021-09-300001656536dbtx:AgencyBondsMemberdbtx:CurrentMember2021-09-300001656536us-gaap:EmployeeStockOptionMember2020-01-012020-12-310001656536srt:ScenarioForecastMember2021-12-310001656536dbtx:TwoThousandAndFifteenStockIncentivePlanMember2020-12-310001656536us-gaap:AdditionalPaidInCapitalMember2021-06-300001656536us-gaap:CorporateDebtSecuritiesMemberdbtx:CurrentMember2020-12-310001656536us-gaap:FairValueInputsLevel1Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001656536us-gaap:CorporateDebtSecuritiesMemberdbtx:CurrentMember2021-09-300001656536us-gaap:GeneralAndAdministrativeExpenseMember2021-01-012021-09-300001656536us-gaap:RetainedEarningsMember2020-12-310001656536us-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001656536us-gaap:RestrictedStockMember2020-01-012020-09-300001656536srt:ScenarioForecastMember2021-01-012021-12-310001656536us-gaap:FairValueInputsLevel2Memberus-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001656536us-gaap:FairValueMeasurementsRecurringMember2020-12-310001656536us-gaap:CommonStockMember2020-04-012020-06-300001656536us-gaap:AdditionalPaidInCapitalMember2021-04-012021-06-300001656536us-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001656536us-gaap:CommonStockMember2021-01-012021-09-300001656536us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-12-310001656536us-gaap:ResearchAndDevelopmentExpenseMember2021-07-012021-09-3000016565362020-05-310001656536dbtx:NoncurrentMember2021-09-300001656536us-gaap:RetainedEarningsMember2021-07-012021-09-300001656536us-gaap:EmployeeStockOptionMember2020-01-012020-09-3000016565362021-04-012021-04-010001656536us-gaap:CommonStockMember2020-03-310001656536us-gaap:RetainedEarningsMember2020-04-012020-06-300001656536us-gaap:SeriesCPreferredStockMember2020-07-012020-09-300001656536us-gaap:CommonStockMember2021-04-012021-06-300001656536us-gaap:CommonStockMember2021-01-012021-03-310001656536us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-3100016565362017-11-300001656536us-gaap:RestrictedStockMember2021-01-012021-09-300001656536srt:MaximumMemberus-gaap:IPOMemberdbtx:TwoThousandAndFifteenStockIncentivePlanMember2021-09-300001656536dbtx:TwoThousandAndTwentyOneStockIncentivePlanMemberus-gaap:IPOMember2021-01-012021-09-300001656536dbtx:SeriesBConvertiblePreferredStockMember2019-12-310001656536dbtx:UnvestedRestrictedStockMember2020-01-012020-09-300001656536us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536us-gaap:SeriesAPreferredStockMember2020-07-012020-09-300001656536us-gaap:ResearchAndDevelopmentExpenseMember2020-01-012020-09-3000016565362020-01-012020-12-310001656536dbtx:SeriesBConvertiblePreferredStockMember2020-09-3000016565362021-09-3000016565362020-12-310001656536us-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536dbtx:SeriesBConvertiblePreferredStockMember2021-01-012021-03-310001656536us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-03-310001656536us-gaap:OverAllotmentOptionMember2021-02-242021-02-240001656536dbtx:SecondMilestonePaymentForRetentionMember2020-11-012020-11-300001656536us-gaap:RetainedEarningsMember2021-06-300001656536us-gaap:RetainedEarningsMember2020-01-012020-03-3100016565362021-03-310001656536us-gaap:AdditionalPaidInCapitalMember2020-06-300001656536dbtx:SeriesAConvertiblePreferredStockMember2020-09-300001656536us-gaap:SeriesBPreferredStockMember2020-07-012020-09-300001656536us-gaap:IPOMember2020-12-310001656536dbtx:CurrentMember2020-12-310001656536us-gaap:CommonStockMember2021-03-310001656536dbtx:ThirdMilestonePaymentForRetentionMember2021-01-012021-01-310001656536dbtx:SeriesCConvertiblePreferredStockMember2019-12-310001656536dbtx:TwoThousandAndTwentyOneStockIncentivePlanMemberus-gaap:IPOMember2021-09-300001656536us-gaap:CommonStockMember2021-06-3000016565362020-01-012020-09-300001656536us-gaap:CommonStockMember2021-09-300001656536us-gaap:SeriesBPreferredStockMember2020-01-012020-09-300001656536us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-01-012021-03-310001656536us-gaap:EmployeeStockOptionMember2020-07-012020-09-300001656536us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-09-300001656536us-gaap:EmployeeStockOptionMember2021-07-012021-09-300001656536us-gaap:AdditionalPaidInCapitalMember2021-03-310001656536us-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-3100016565362020-06-300001656536us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-07-012021-09-300001656536us-gaap:AdditionalPaidInCapitalMember2019-12-310001656536us-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001656536dbtx:SeriesBConvertiblePreferredStockMember2021-09-30dbtx:Investmentxbrli:puredbtx:Employeexbrli:sharesiso4217:USDxbrli:sharesiso4217:USD

 

 

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 September 30, 2021

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: 001-40030

 

Decibel Therapeutics, Inc.

(Exact name of Registrant as specified in its Charter)

 

 

Delaware

46-4198709

( State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

1325 Boylston Street, Suite 500

Boston, Massachusetts

02215

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 370-8701

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common stock, par value $0.001 per share

 

DBTX

 

The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

 

 

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

As of November 1, 2021, the registrant had 24,923,363 shares of common stock, $0.001 par value per share, outstanding.

 


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

5

 

Condensed Consolidated Balance Sheets

5

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

6

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ (Deficit) Equity

7

 

Condensed Consolidated Statements of Cash Flows

8

 

Notes to Unaudited Condensed Consolidated Financial Statements

9

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

22

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

34

Item 4.

Controls and Procedures

34

 

 

 

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

36

Item 1A.

Risk Factors

36

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

86

Item 3.

Defaults Upon Senior Securities

86

Item 4.

Mine Safety Disclosures

86

Item 5.

Other Information

86

Item 6.

Exhibits

86

Signatures

87

 

 

 

i


 

Cautionary Note Regarding Forward-Looking Statements and Industry Data

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:

the initiation, timing, progress and results of our current research and development programs, preclinical studies and clinical trials;
our estimates regarding expenses, future revenue, capital requirements and need for additional financing;
our plans to develop our product candidates and programs;
the timing of and our ability to submit applications for, obtain and maintain regulatory approvals for our product candidates;
our estimates regarding the potential patient populations for our programs;
our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash, cash equivalents and available-for-sale securities;
the potential advantages of our product candidates and programs;
the potential advantages of our platform;
the rate and degree of market acceptance and clinical utility of our product candidates and programs;
our estimates regarding the potential market opportunity for our product candidates and programs;
our commercialization, marketing and manufacturing capabilities and strategy;
our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates;
the impact of government laws and regulations;
our competitive position;
developments relating to our competitors and our industry;
our ability to maintain and establish collaborations or obtain additional funding;
the potential direct or indirect impact of the COVID-19 pandemic on our business; and
our expectations regarding the time during which we will be an emerging growth company under the Jumpstart our Business Startup Acts of 2012.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q, particularly in the “Risk Factor Summary” below and in Part II, Item 1A. “Risk Factors,” that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

You should read this Quarterly Report on Form 10-Q and the documents that we reference herein and have filed or incorporated by reference hereto completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly Report on Form 10-Q, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

2


 

This Quarterly Report on Form 10-Q includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties as well as our own estimates of potential market opportunities. The market data used in this Quarterly Report on Form 10-Q involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Although we are responsible for the disclosure contained in this Quarterly Report on Form 10-Q and we believe the information from industry publications and other third-party sources included in this Quarterly Report on Form 10-Q is reliable, such information is inherently imprecise. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our estimates of the potential market opportunities for our product candidates include several key assumptions based on our industry knowledge, industry publications, third-party research and other surveys, which may be based on a small sample size and may fail to accurately reflect market opportunities. While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions.

Risk Factor Summary

 

Our business is subject to a number of risks of which you should be aware before making an investment decision. Below we summarize what we believe to be the principal risks facing our business, in addition to the risks described more fully in Item 1A, “Risk Factors” of Part II of this Quarterly Report on Form 10-Q and other information included in this report. The risks and uncertainties described below are not the only risks and uncertainties we face. Additional risks and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations.

 

If any of the following risks occurs, our business, financial condition and results of operations and future growth prospects could be materially and adversely affected, and the actual outcomes of matters as to which forward-looking statements are made in this report could be materially different from those anticipated in such forward-looking statements.

 

We have incurred significant losses since our inception, have no products approved for sale and we expect to incur substantial losses for the foreseeable future and may never achieve or maintain profitability;

 

We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our research and development programs or commercialization efforts;

 

The COVID-19 pandemic has disrupted our ongoing Phase 1b clinical trial of DB-020 and has affected and may in the future affect our ability to initiate and complete preclinical studies, delay the initiation of our planned clinical trials or future clinical trials, disrupt regulatory activities, disrupt our manufacturing and supply chain or have other adverse effects on our business and operations. In addition, this pandemic has caused substantial disruption to global supply chains and may adversely impact economies worldwide, both of which could result in adverse effects on our business, operations and ability to raise capital;

 

Our limited operating history may make it difficult for stockholders to evaluate the success of our business to date and to assess our future viability;

 

We are very early in our development efforts. Our business is dependent on our ability to advance our lead gene therapy product candidate, DB-OTO, and our other current and future product candidates through preclinical studies and clinical trials, obtain marketing approval and ultimately commercialize them. If we are unable to complete preclinical and clinical development, obtain regulatory approval for or commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed;

 

Clinical development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate;

 

Gene therapy is an emerging field of drug development that poses many risks. We have only limited prior experience in gene therapy research and no prior experience in gene therapy clinical development. Our lack of experience and the limited patient populations for our gene therapy programs may limit our ability to be successful or may delay our development efforts;

 

3


 

If we experience delays or difficulties in participant enrollment for clinical trials, our research and development efforts and the receipt of necessary regulatory approvals could be significantly delayed or prevented;

 

Our product candidates or the process for administering our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval;

 

The manufacture of gene therapy products is complex and difficult and is subject to a number of scientific and technical risks, some of which are common to the manufacture of drugs and biologics and others of which are unique to the manufacture of gene therapies. We could experience manufacturing problems that result in delays in our gene therapy development or commercialization programs;

 

We rely, and expect to continue to rely, on third parties to conduct some or all aspects of our product manufacturing, research, preclinical and clinical testing, and these third parties may not perform satisfactorily;

 

We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do; and

 

Our rights to develop and commercialize any product candidates are subject and may in the future be subject, in part, to the terms and conditions of licenses granted to us by third parties. If we fail to comply with our obligations under our current or future intellectual property license agreements or otherwise experience disruptions to our business relationships with our current or any future licensors, we could lose intellectual property rights that are important to our business.

4


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

DECIBEL THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands, except share and per share data)

 

 

 

September 30,
2021

 

 

December 31,
2020

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

51,413

 

 

$

27,742

 

Available-for-sale securities

 

 

92,477

 

 

 

26,568

 

Accounts receivable from related party

 

 

3,142

 

 

 

1,237

 

Prepaid expenses and other current assets

 

 

2,835

 

 

 

2,281

 

Total current assets

 

 

149,867

 

 

 

57,828

 

Available-for-sale securities, long-term

 

 

28,494

 

 

 

 

Property and equipment, net

 

 

5,798

 

 

 

6,337

 

Other assets

 

 

1,128

 

 

 

3,120

 

Total assets

 

$

185,287

 

 

$

67,285

 

Liabilities, Convertible Preferred Stock and Stockholders’ (Deficit) Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,814

 

 

$

2,131

 

Accrued expenses and other current liabilities

 

 

7,552

 

 

 

5,665

 

Deferred collaboration liability, current

 

 

6,459

 

 

 

10,968

 

Deferred rent and lease incentive obligation, current

 

 

674

 

 

 

610

 

Total current liabilities

 

 

16,499

 

 

 

19,374

 

Long-term liabilities:

 

 

 

 

 

 

Deferred collaboration liability, long term

 

 

8,459

 

 

 

4,177

 

Deferred rent and lease incentive obligation, long term

 

 

4,389

 

 

 

4,901

 

Other long-term liabilities

 

 

1,785

 

 

 

523

 

Total liabilities

 

 

31,132

 

 

 

28,975

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

Series A convertible preferred stock, $0.001 par value; no shares authorized, issued and
   outstanding at September 30, 2021;
57,758,734 shares authorized, issued and outstanding at
   December 31, 2020; aggregate liquidation preference of $
40,284 at December 31, 2020

 

 

 

 

 

16,176

 

Series B convertible preferred stock, $0.001 par value; no shares authorized, issued and
   outstanding at September 30, 2021;
12,500,000 shares authorized, issued and outstanding at
   December 31, 2020; aggregate liquidation preference of $
16,334 at December 31, 2020

 

 

 

 

 

5,700

 

Series C convertible preferred stock, $0.001 par value; no shares authorized, issued and
   outstanding at September 30, 2021;
37,528,581 shares authorized, issued and outstanding at
   December 31, 2020; aggregate liquidation preference of $
45,457 at December 31, 2020

 

 

 

 

 

16,759

 

Series D convertible preferred stock, $0.001 par value; no shares authorized, issued and
   outstanding at September 30, 2021;
47,610,763 shares authorized, 31,740,554 shares issued
   and outstanding at December 31, 2020; aggregate liquidation preference of $
55,509
   at December 31, 2020

 

 

 

 

 

54,456

 

Stockholders’ (deficit) equity:

 

 

 

 

 

 

Preferred stock, $0.001 par value; 5,000,000 shares authorized, no shares issued
   and outstanding at September 30, 2021;
no shares authorized, issued and outstanding
   at December 31, 2020

 

 

 

 

 

 

Common stock, $0.001 par value; 200,000,000 shares authorized, 24,920,599 shares
   issued and
24,899,200 outstanding at September 30, 2021; 115,000,000 shares authorized,
   
573,793 shares issued and 521,052 shares outstanding at December 31, 2020

 

 

25

 

 

 

1

 

Additional paid-in capital

 

 

355,731

 

 

 

107,908

 

Accumulated other comprehensive income (loss)

 

 

8

 

 

 

(1

)

Accumulated deficit

 

 

(201,609

)

 

 

(162,689

)

Total stockholders’ equity (deficit)

 

 

154,155

 

 

 

(54,781

)

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

 

$

185,287

 

 

$

67,285

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

5


 

DECIBEL THERAPEUTICS, INC.

CONDENSED conSOLIDATED Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands, except share and per share data)

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

9,020

 

 

$

4,691

 

 

$

21,867

 

 

$

17,426

 

General and administrative

 

 

5,680

 

 

 

2,397

 

 

 

15,462

 

 

 

9,130

 

Total operating expenses

 

 

14,700

 

 

 

7,088

 

 

 

37,329

 

 

 

26,556

 

Loss from operations

 

 

(14,700

)

 

 

(7,088

)

 

 

(37,329

)

 

 

(26,556

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

33

 

 

 

2

 

 

 

141

 

 

 

103

 

Other income, net

 

 

 

 

 

(25

)

 

 

 

 

 

 

Total other income, net

 

 

33

 

 

 

(23

)

 

 

141

 

 

 

103

 

Net loss before provision for income taxes

 

 

(14,667

)

 

 

(7,111

)

 

 

(37,188

)

 

 

(26,453

)

Provision for income taxes

 

 

(1,732

)

 

 

 

 

 

(1,732

)

 

 

 

Net loss

 

$

(16,399

)

 

$

(7,111

)

 

$

(38,920

)

 

$

(26,453

)

Cumulative dividends on convertible preferred stock

 

 

 

 

 

(2,779

)

 

 

(2,309

)

 

 

(8,277

)

Net loss attributable to common stockholders

 

$

(16,399

)

 

$

(9,890

)

 

$

(41,229

)

 

$

(34,730

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.66

)

 

$

(20.28

)

 

$

(2.00

)

 

$

(74.11

)

Weighted average shares of common stock outstanding, basic and diluted

 

 

24,874,738

 

 

 

487,658

 

 

 

20,661,879

 

 

 

468,641

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(16,399

)

 

$

(7,111

)

 

$

(38,920

)

 

$

(26,453

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on available-for-sale securities, net of tax of $0

 

 

3

 

 

 

 

 

 

9

 

 

 

(10

)

Total other comprehensive income (loss)

 

 

3

 

 

 

 

 

 

9

 

 

 

(10

)

Comprehensive loss

 

$

(16,396

)

 

$

(7,111

)

 

$

(38,911

)

 

$

(26,463

)

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

6


 

DECIBEL THERAPEUTICS, INC.

CONDENSED CONSOLIDATED Statements of CONVERTIBLE PREFERRED STOCK AND Stockholders’ (Deficit) EQUITY

(Unaudited)

(In thousands, except share data)

 

 

 

Series A
Convertible Preferred
Stock

 

 

Series B
Convertible Preferred
Stock

 

 

Series C
Convertible Preferred
Stock

 

 

Series D
Convertible Preferred
Stock

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’
(Deficit)

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

(Loss) Income

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2019

 

 

57,758,734

 

 

$

57,682

 

 

 

12,500,000

 

 

$

24,957

 

 

 

27,528,581

 

 

$

55,005

 

 

 

 

 

$

 

 

 

 

434,942

 

 

$

 

 

 

1,546

 

 

$

10

 

 

$

(123,352

)

 

$

(121,796

)

Vesting of restricted common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

21,872

 

 

 

 

 

 

11

 

 

 

 

 

 

 

 

 

11

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

225

 

 

 

 

 

 

 

 

 

225

 

Unrealized loss on available-for-sale
   securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9

)

 

 

 

 

 

(9

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,535

)

 

 

(11,535

)

Balance at March 31, 2020

 

 

57,758,734

 

 

$

57,682

 

 

 

12,500,000

 

 

$

24,957

 

 

 

27,528,581

 

 

$

55,005

 

 

 

 

 

$

 

 

 

 

456,814

 

 

$

 

 

 

1,782

 

 

$

1

 

 

$

(134,887

)

 

$

(133,104

)

Vesting of restricted common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

20,324

 

 

 

 

 

 

16

 

 

 

 

 

 

 

 

 

16

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

179

 

 

 

 

 

 

 

 

 

179

 

Unrealized loss on available-for-sale
   securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

(1

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,807

)

 

 

(7,807

)

Balance at June 30, 2020

 

 

57,758,734

 

 

$

57,682

 

 

 

12,500,000

 

 

$

24,957

 

 

 

27,528,581

 

 

$

55,005

 

 

 

 

 

$

 

 

 

 

477,138

 

 

$

 

 

 

1,977

 

 

$

 

 

$

(142,694

)

 

$

(140,717

)

Vesting of restricted common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

16,279

 

 

 

 

 

 

5

 

 

 

 

 

 

 

 

 

5

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

185

 

 

 

 

 

 

 

 

 

185

 

Unrealized loss on available-for-sale
   securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,111

)

 

 

(7,111

)

Balance at September 30, 2020

 

 

57,758,734

 

 

$

57,682

 

 

 

12,500,000

 

 

$

24,957

 

 

 

27,528,581

 

 

$

55,005

 

 

 

 

 

$

 

 

 

 

493,417

 

 

$

 

 

 

2,167

 

 

$

 

 

$

(149,805

)

 

$

(147,638

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2020

 

 

57,758,734

 

 

$

16,176

 

 

 

12,500,000

 

 

$

5,700

 

 

 

37,528,581

 

 

$

16,759

 

 

 

31,740,554

 

 

$

54,456

 

 

 

 

521,052

 

 

$

1

 

 

$

107,908

 

 

$

(1

)

 

$

(162,689

)

 

$

(54,781

)

Issuance of common stock upon
   exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,773