Please ensure Javascript is enabled for purposes of website accessibility
10-Q
0001818794Q2false--12-3100018187942022-01-012022-06-300001818794dyn:OfficeAndComputerEquipmentMember2022-06-300001818794us-gaap:AdditionalPaidInCapitalMember2021-04-012021-06-300001818794dyn:TwoThousandTwentyStockIncentivePlanMemberus-gaap:RestrictedStockUnitsRSUMember2022-06-300001818794us-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:CommercialPaperMemberus-gaap:FairValueInputsLevel1Memberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:FairValueInputsLevel2Memberdyn:MarketableSecuritiesMemberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-3000018187942021-03-310001818794dyn:OfficeAndComputerEquipmentMember2021-12-310001818794us-gaap:CashAndCashEquivalentsMemberus-gaap:FairValueInputsLevel1Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:CommonStockMember2020-12-310001818794dyn:UnvestedRestrictedCommonStockMember2021-01-012021-06-300001818794us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:MoneyMarketFundsMemberus-gaap:CashAndCashEquivalentsMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:CommonStockMember2022-01-012022-03-310001818794dyn:OptionsToPurchaseCommonStockMember2022-01-012022-06-300001818794us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:ResearchAndDevelopmentExpenseMember2021-01-012021-06-300001818794us-gaap:CommonStockMember2021-04-012021-06-300001818794us-gaap:CommonStockMember2021-03-310001818794dyn:LaboratoryEquipmentMember2021-12-310001818794us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-12-310001818794us-gaap:RetainedEarningsMember2021-04-012021-06-300001818794us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-3100018187942022-09-300001818794us-gaap:AdditionalPaidInCapitalMember2020-12-310001818794us-gaap:RestrictedStockUnitsRSUMember2022-03-310001818794us-gaap:CashAndCashEquivalentsMemberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:CommonStockMember2021-06-300001818794us-gaap:CashAndCashEquivalentsMemberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:RestrictedStockMember2022-01-012022-06-3000018187942021-12-310001818794dyn:TwoThousandTwentyStockIncentivePlanMemberus-gaap:RestrictedStockUnitsRSUMember2022-01-012022-03-310001818794us-gaap:AdditionalPaidInCapitalMember2021-01-012021-03-310001818794us-gaap:CorporateDebtSecuritiesMember2021-12-3100018187942021-01-012021-06-300001818794us-gaap:RestrictedStockMember2021-12-310001818794us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-04-012021-06-300001818794us-gaap:FairValueInputsLevel2Memberdyn:MarketableSecuritiesMemberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:AdditionalPaidInCapitalMember2022-04-012022-06-300001818794dyn:OptionsToPurchaseCommonStockMember2021-01-012021-06-300001818794us-gaap:RetainedEarningsMember2022-01-012022-03-310001818794us-gaap:CommercialPaperMember2021-12-310001818794us-gaap:CommonStockMember2021-12-310001818794us-gaap:CommercialPaperMemberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-3100018187942022-06-300001818794us-gaap:RetainedEarningsMember2022-06-3000018187942022-07-310001818794us-gaap:CorporateDebtSecuritiesMemberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794dyn:TwoThousandTwentyStockIncentivePlanMember2022-06-300001818794dyn:UnvestedRestrictedCommonStockMember2022-01-012022-06-300001818794us-gaap:CommonStockMember2022-03-310001818794us-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:EmployeeStockOptionMember2022-06-300001818794us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-04-012022-06-300001818794us-gaap:CertificatesOfDepositMember2022-06-300001818794us-gaap:USTreasurySecuritiesMemberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:USTreasurySecuritiesMember2021-12-310001818794us-gaap:RetainedEarningsMember2021-01-012021-03-310001818794dyn:MarketableSecuritiesMemberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:AdditionalPaidInCapitalMember2021-06-300001818794us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-12-310001818794us-gaap:CorporateDebtSecuritiesMemberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:CommercialPaperMemberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:GeneralAndAdministrativeExpenseMember2022-01-012022-06-300001818794us-gaap:ResearchAndDevelopmentExpenseMember2022-01-012022-06-3000018187942022-03-310001818794us-gaap:RetainedEarningsMember2021-06-3000018187942022-04-012022-06-300001818794us-gaap:MoneyMarketFundsMemberus-gaap:CashAndCashEquivalentsMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-3000018187942021-01-012021-03-310001818794dyn:FollowOnPublicOfferingMemberus-gaap:CommonStockMember2021-01-252021-01-250001818794us-gaap:RestrictedStockUnitsRSUMember2021-01-012021-06-300001818794dyn:FollowOnPublicOfferingMemberus-gaap:CommonStockMember2021-01-2500018187942021-06-300001818794us-gaap:USTreasurySecuritiesMemberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:USTreasurySecuritiesMemberus-gaap:FairValueInputsLevel1Memberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:ConstructionInProgressMember2022-06-300001818794us-gaap:FairValueInputsLevel2Memberus-gaap:CashAndCashEquivalentsMemberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:RestrictedStockUnitsRSUMember2022-07-302022-07-3000018187942022-01-012022-03-310001818794us-gaap:RestrictedStockUnitsRSUMember2022-06-300001818794us-gaap:AdditionalPaidInCapitalMember2022-03-310001818794us-gaap:AdditionalPaidInCapitalMember2022-06-300001818794us-gaap:RetainedEarningsMember2022-04-012022-06-300001818794us-gaap:CommonStockMember2021-01-012021-03-310001818794us-gaap:RetainedEarningsMember2021-12-310001818794us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-03-310001818794us-gaap:RetainedEarningsMember2020-12-310001818794us-gaap:RestrictedStockMember2022-06-300001818794us-gaap:GeneralAndAdministrativeExpenseMember2021-01-012021-06-300001818794us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:AdditionalPaidInCapitalMember2021-12-310001818794dyn:TwoThousandTwentyStockIncentivePlanMemberus-gaap:RestrictedStockUnitsRSUMember2021-12-310001818794us-gaap:CertificatesOfDepositMember2021-12-310001818794us-gaap:FairValueInputsLevel2Memberus-gaap:CashAndCashEquivalentsMemberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:ResearchAndDevelopmentExpenseMember2021-04-012021-06-300001818794us-gaap:RetainedEarningsMember2022-03-310001818794dyn:TwoThousandTwentyStockIncentivePlanMemberus-gaap:RestrictedStockUnitsRSUMember2022-01-012022-06-300001818794us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-06-300001818794us-gaap:USTreasurySecuritiesMemberus-gaap:FairValueInputsLevel1Memberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:CommercialPaperMemberus-gaap:FairValueInputsLevel1Memberdyn:MarketableSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:CashAndCashEquivalentsMemberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:CorporateDebtSecuritiesMember2022-06-300001818794us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-01-012021-03-3100018187942021-04-012021-06-300001818794us-gaap:GeneralAndAdministrativeExpenseMember2021-04-012021-06-300001818794us-gaap:CommonStockMember2022-06-300001818794us-gaap:EmployeeStockOptionMember2022-01-012022-06-300001818794us-gaap:CashAndCashEquivalentsMemberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001818794us-gaap:RetainedEarningsMember2021-03-310001818794us-gaap:ConstructionInProgressMember2021-12-310001818794dyn:MarketableSecuritiesMemberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001818794us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-06-300001818794us-gaap:AdditionalPaidInCapitalMember2022-01-012022-03-310001818794dyn:LaboratoryEquipmentMember2022-06-300001818794us-gaap:CommonStockMember2022-04-012022-06-300001818794us-gaap:AdditionalPaidInCapitalMember2021-03-3100018187942021-01-012021-12-310001818794us-gaap:GeneralAndAdministrativeExpenseMember2022-04-012022-06-300001818794us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-06-300001818794us-gaap:USTreasurySecuritiesMember2022-06-3000018187942020-12-310001818794us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-03-310001818794us-gaap:CommercialPaperMember2022-06-300001818794us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-01-012022-03-310001818794us-gaap:ResearchAndDevelopmentExpenseMember2022-04-012022-06-30xbrli:purexbrli:sharesdyn:Installmentiso4217: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 June 30, 2022

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: 001-39509

 

 

Dyne Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

36-4883909

(State or other jurisdiction of

incorporation or organization)

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

1560 Trapelo Road

Waltham, Massachusetts

02451

(Address of principal executive offices)

(Zip Code)

(781) 786-8230

(Registrant’s telephone number, including area code)

 

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, $0.0001 par value per share

 

DYN

 

Nasdaq Global Select Market

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 July 31, 2022, the registrant had 51,765,370 shares of common stock, $0.0001 par value per share, outstanding.

 

 


 

Table of Contents

 

 

 

Page

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

2

PART I.

FINANCIAL INFORMATION

5

Item 1.

Financial Statements (Unaudited)

5

 

Condensed Consolidated Balance Sheets

5

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

6

 

Condensed Consolidated Statements of Stockholders’ 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

16

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

25

Item 4.

Controls and Procedures

25

PART II.

OTHER INFORMATION

25

Item 1A.

Risk Factors

25

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

81

Item 3.

Defaults Upon Senior Securities

82

Item 4.

Mine Safety Disclosures

82

Item 5.

Other Information

82

Item 6.

Exhibits

83

Signatures

84

 

 

We own or have rights to trademarks, service marks and trade names that we use in connection with the operation of our business, including our corporate name, logos and website names. The service marks and trademarks that we own include the marks Dyne Therapeutics™ and FORCE™. Other trademarks, service marks and trade names appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. Solely for convenience, some of the trademarks, service marks and trade names referred to in this Quarterly Report on Form 10-Q are listed without the ® and ™ symbols, but we will assert, to the fullest extent under applicable law, our rights to our trademarks, service marks and trade names.

1


 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q, or this Quarterly Report, contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements other than statements of historical fact, contained in this Quarterly Report, 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,” or the negative of these words or other 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 include, among other things, statements about:

the initiation, timing, progress and results of our research and development programs, preclinical studies and planned clinical trials;
the anticipated timing of the submission and clearance of investigational new drug applications, or INDs, and comparable foreign applications for any product candidates we may develop;
the impact of the ongoing COVID-19 pandemic and our response to it;
our estimates regarding expenses, future revenue, capital requirements, need for additional financing and the period over which we believe our cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements;
our plans to develop and, if approved, subsequently commercialize any product candidates we may develop;
the timing of and our ability to submit applications for, obtain and maintain regulatory approvals for any product candidates we may develop;
the potential advantages of our FORCE platform;
our commercialization, marketing and manufacturing capabilities and strategy;
our intellectual property position and our expectations regarding our ability to obtain and maintain intellectual property protection;
our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;
the impact of government laws and regulations;
our competitive position and expectations regarding developments and projections relating to our competitors and any competing therapies that are or become available;
developments and expectations regarding developments and projections relating to our competitors and our industry;
our ability to establish and maintain collaborations or obtain additional funding; and
our expectations regarding the time during which we will be an emerging growth company under the JOBS Act.

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 this Quarterly Report, particularly in Item 1A. “Risk Factors” in this Quarterly Report, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Moreover, we operate in a competitive and rapidly changing environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments we may make or enter into.

 

2


 

You should read this Quarterly Report and the documents that we have filed or incorporated by reference as exhibits to this Quarterly Report 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 are made as of the date of this Quarterly Report, 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.

3


 

RISK FACTOR SUMMARY

 

Our business is subject to a number of risks that, if realized, could materially affect our business, prospects, operating results and financial condition. These risks are discussed more fully in the “Risk Factors” section of this Quarterly Report. These risks include, but are not limited to, the following:

our limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability;
we are early in our development efforts. Our product candidates are in varying stages of preclinical and clinical development, and we have not completed a clinical trial of any product candidate. As a result, it will be many years before we commercialize a product candidate, if ever. If we are unable to advance product candidates through preclinical studies and clinical trials, obtain marketing approval and ultimately commercialize them, or experience significant delays in doing so, our business will be materially harmed;
we may encounter substantial delays in commencement, enrollment or completion of our clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, which could prevent us from commercializing any product candidates we determine to develop on a timely basis, if at all;
our approach to the discovery and development of product candidates based on our FORCE platform is unproven, and we may not be successful in our efforts to develop our product candidates;
the outcome of preclinical studies and earlier-stage clinical trials may not be predictive of future results or the success of later preclinical studies and clinical trials;
if our product candidates cause undesirable side effects or have other unexpected adverse properties, such side effects or properties could delay or prevent regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval;
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 us or more successfully than we do;
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 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;
if we or our licensors are unable to obtain, maintain and defend patent and other intellectual property protection for any product candidates or technology, or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully develop and commercialize our product candidates or our technology may be adversely affected due to such competition; and
the COVID-19 pandemic may affect our ability to initiate and complete preclinical studies, delay the initiation of our planned clinical trials or future clinical trials, disrupt regulatory activities, or have other adverse effects on our business and operations. In addition, this pandemic has caused substantial disruption to supply chains and may adversely impact economies worldwide, which could negatively impact our operations.

 

4


 

PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements (Unaudited)

Dyne Therapeutics, Inc.

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands, except share and per share data)

 

 

 

June 30,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

135,980

 

 

$

200,825

 

Marketable securities

 

 

155,858

 

 

 

175,746

 

Prepaid expenses and other current assets

 

 

6,096

 

 

 

5,821

 

Total current assets

 

 

297,934

 

 

 

382,392

 

Property and equipment, net

 

 

5,483

 

 

 

4,678

 

Right-of-use assets

 

 

34,294

 

 

 

36,282

 

Restricted cash and other assets

 

 

2,315

 

 

 

2,311

 

Total assets

 

$

340,026

 

 

$

425,663

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

 

6,972

 

 

 

4,031

 

Accrued expenses and other current liabilities

 

 

13,161

 

 

 

20,799

 

Lease liabilities

 

 

5,489

 

 

 

3,893

 

Total current liabilities

 

 

25,622

 

 

 

28,723

 

Lease liabilities, net of current portion

 

 

27,345

 

 

 

28,743

 

Total liabilities

 

 

52,967

 

 

 

57,466

 

Stockholders’ equity

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized at June 30, 2022 and December 31, 2021

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 shares authorized at June 30, 2022 and December 31, 2021; 51,741,334 and 51,607,522 shares issued and 51,734,361 and 51,569,381 shares outstanding at June 30, 2022 and December 31, 2021, respectively

 

 

6

 

 

 

6

 

Additional paid-in capital

 

 

604,570

 

 

 

596,934

 

Accumulated other comprehensive loss

 

 

(1,156

)

 

 

(269

)

Accumulated deficit

 

 

(316,361

)

 

 

(228,474

)

Total stockholders’ equity

 

 

287,059

 

 

 

368,197

 

Total liabilities and stockholders’ equity

 

$

340,026

 

 

$

425,663

 

 

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

 

 

5


 

Dyne Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

46,664

 

 

$

23,872

 

 

$

74,899

 

 

$

42,496

 

General and administrative

 

 

6,091

 

 

 

6,293

 

 

 

13,638

 

 

 

12,802

 

Total operating expenses

 

 

52,755

 

 

 

30,165

 

 

 

88,537

 

 

 

55,298

 

Loss from operations

 

 

(52,755

)

 

 

(30,165

)

 

 

(88,537

)

 

 

(55,298

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

441

 

 

 

210

 

 

 

671

 

 

 

375

 

Other income (expense), net

 

 

10

 

 

 

 

 

 

(21

)

 

 

 

Total other (expense) income, net

 

 

451

 

 

 

210

 

 

 

650

 

 

 

375

 

Net loss

 

$

(52,304

)

 

$

(29,955

)

 

$

(87,887

)

 

$

(54,923

)

Net loss per share—basic and diluted

 

$

(1.01

)

 

$

(0.58

)

 

$

(1.70

)

 

$

(1.09

)

Weighted-average common shares outstanding used in net loss per share—basic and diluted

 

 

51,679,536

 

 

 

51,216,254

 

 

 

51,640,706

 

 

 

50,349,193

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(52,304

)

 

$

(29,955

)

 

$

(87,887

)

 

$

(54,923

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gains (losses) on marketable securities, net

 

 

(226

)

 

 

27

 

 

 

(887

)

 

 

(14

)

Comprehensive loss

 

$

(52,530

)

 

$

(29,928

)

 

$

(88,774

)

 

$

(54,937

)

 

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

6


 

Dyne Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

(in thousands, except share data and issuance costs)

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Comprehensive Loss

 

 

Deficit

 

 

Equity

 

Balance at January 1, 2022

 

 

51,569,381

 

 

$

6

 

 

$

596,934

 

 

$

(269

)

 

$

(228,474

)

 

$

368,197

 

Exercise of stock options

 

 

9,583

 

 

 

 

 

 

18

 

 

 

 

 

 

 

 

 

18

 

Stock-based compensation

 

 

 

 

 

 

 

 

4,488

 

 

 

 

 

 

 

 

 

4,488

 

Vesting of restricted shares

 

 

20,504

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of restricted stock units

 

 

49,955

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized losses on marketable securities

 

 

 

 

 

 

 

 

 

 

 

(661

)

 

 

 

 

 

(661

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(35,583

)

 

 

(35,583

)

Balance at March 31, 2022

 

 

51,649,423

 

 

$

6

 

 

$

601,440

 

 

$

(930

)

 

$

(264,057

)

 

$

336,459

 

Exercise of stock options

 

 

32,367

 

 

 

 

 

 

99

 

 

 

 

 

 

 

 

 

99

 

Stock-based compensation

 

 

 

 

 

 

 

 

3,031

 

 

 

 

 

 

 

 

 

3,031

 

Vesting of restricted shares

 

 

10,664

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of restricted stock units

 

 

41,907

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized losses on marketable securities

 

 

 

 

 

 

 

 

 

 

 

(226

)

 

 

 

 

 

(226

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(52,304

)

 

 

(52,304

)

Balance at June 30, 2022

 

 

51,734,361

 

 

$

6

 

 

$

604,570

 

 

$

(1,156

)

 

$

(316,361

)

 

$

287,059

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other

 

 

Accumulated

 

 

Stockholders’

 

(in thousands, except per share data)

 

Shares

 

 

Amount

 

 

Capital

 

 

Comprehensive Loss

 

 

Deficit

 

 

Equity

 

Balance at January 1, 2021

 

 

45,076,574

 

 

$

5

 

 

$

421,572

 

 

$

(27

)

 

$

(79,183

)

 

$

342,367

 

Issuance of common stock upon follow-on public offering, net of issuance costs of $0.7 million

 

 

6,000,000

 

 

 

1

 

 

 

157,236

 

 

 

 

 

 

 

 

 

157,237

 

Exercise of stock options

 

 

11,163

 

 

 

 

 

 

13

 

 

 

 

 

 

 

 

 

13

 

Stock-based compensation

 

 

 

 

 

 

 

 

3,652

 

 

 

 

 

 

 

 

 

3,652

 

Vesting of restricted shares

 

 

70,539

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized losses on marketable securities

 

 

 

 

 

 

 

 

 

 

 

(41

)

 

 

 

 

 

(41

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(24,968

)

 

 

(24,968

)

Balance at March 31, 2021

 

 

51,158,276

 

 

$

6

 

 

$

582,473

 

 

$

(68

)

 

$

(104,151

)

 

$

478,260

 

Exercise of stock options

 

 

10,088

 

 

 

 

 

 

25

 

 

 

 

 

 

 

 

 

25

 

Stock-based compensation

 

 

 

 

 

 

 

 

4,239

 

 

 

 

 

 

 

 

 

4,239

 

Vesting of restricted shares

 

 

63,977

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

 

 

27

 

 

 

 

 

 

27

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(29,955

)

 

 

(29,955

)

Balance at June 30, 2021

 

 

51,232,341

 

 

$

6

 

 

$

586,737

 

 

$

(41

)

 

$

(134,106

)

 

$

452,596

 

 

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

7


 

Dyne Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(87,887

)

 

$

(54,923

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

7,519

 

 

 

7,891

 

Depreciation and amortization expense

 

 

885

 

 

 

487

 

Non-cash lease expense

 

 

2,183

 

 

 

(15

)

Amortization of premium on marketable securities

 

 

1,011

 

 

 

1,146

 

Loss on sale of marketable securities

 

 

21

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(656

)

 

 

(21,393

)

Other assets

 

 

 

 

 

(578

)

Accounts payable and other liabilities

 

 

(4,724

)

 

 

2,842

 

Net cash used in operating activities

 

 

(81,648

)

 

 

(64,543

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(1,662

)

 

 

(747

)

Purchases of marketable securities

 

 

(89,530

)

 

 

(156,562

)

Maturities of marketable securities

 

 

104,740

 

 

 

22,500

 

Sales of marketable securities

 

 

2,759

 

 

 

 

Net cash provided by (used in) investing activities

 

 

16,307

 

 

 

(134,809

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from follow-on public offering of common stock, net of issuance costs

 

 

 

 

 

157,237

 

Proceeds from exercise of stock options

 

 

117

 

 

 

38

 

Net cash provided by financing activities

 

 

117

 

 

 

157,275

 

Net decrease in cash and cash equivalents

 

 

(65,224

)

 

 

(42,077

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

203,519

 

 

 

303,153

 

Cash, cash equivalents and restricted cash, end of period

 

$

138,295

 

 

$

261,076

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

Purchase of property and equipment in accounts payable

 

$

230

 

 

$

383

 

 

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

8


 

Dyne Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Unaudited)

 

1. Nature of Business and Basis of Presentation

Dyne Therapeutics, Inc. (the “Company”) is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. The Company was incorporated in Delaware on December 1, 2017 and has a principal place of business in Waltham, Massachusetts.

 

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for its product candidates, fluctuations in operating results, compliance with government regulations, the ability to establish clinical- and commercial-scale manufacturing processes, the impact of the COVID-19 pandemic and the ability to secure additional capital to fund operations. Product candidates and programs currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization of a product. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

 

On January 25, 2021, the Company completed a follow-on public offering of common stock pursuant to which it issued and sold 6,000,000 shares of its common stock at a public offering price of $28.00 per share, resulting in net proceeds of $157.2 million, after deducting underwriting discounts and commissions and offering expenses.

 

The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. Since inception, the Company has funded its operations with proceeds from the sales of preferred stock and common stock, including its initial public offering ("IPO") completed in September 2020 and the follow-on offering completed in January 2021. The Company expects to continue to generate operating losses for the foreseeable future. The Company expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance of these condensed consolidated financial statements.

 

To continue its development efforts, the Company will need to obtain substantial additional funding through public or private equity offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements in order to fund its research and development and ongoing operating expenses. The Company may not be able to obtain financing on acceptable terms, when needed or at all, and the Company may not be able to enter into collaborations, strategic alliances or licensing arrangements. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. Any collaborations, strategic alliances or licensing arrangements may require the Company to relinquish rights to certain of its technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to the Company. If the Company is unable to obtain funding, the Company could be forced to delay, limit, reduce or eliminate some or all of its research and development programs, pipeline expansion or future commercialization efforts or grant rights to develop and market product candidates, which could adversely affect its business prospects. Although management will continue to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations when needed or at all.

 

To date, the Company has not experienced material business disruptions, including with its vendors, as a result of the COVID-19 pandemic. The Company expects to continue to take actions as may be required or recommended by government authorities or as it determines are in the best interests of its employees and other business partners. The Company is continuing to monitor the potential impact of the pandemic, but cannot be certain what the overall impact will be on its business, financial condition, results of operations and prospects.

9


 

2. Summary of Significant Accounting Policies

The accompanying financial statements have been prepared in conformity with generally accepted accounting principles (“GAAP”) in the United States of America. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

The financial statements of the Company included herein have been prepared, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The unaudited interim financial statements have been prepared on the same basis as audited annual financial statements, except certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. In the opinion of management, the interim financial information reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair representation of the results for the reported periods. Accordingly, these financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s annual report on Form 10-K filed with the SEC on March 10, 2022. The results for the six months ended June 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022, any other interim periods, or any future year or period.

 

Fair value measurements

Certain assets and liabilities are carried at fair value. Fair value is defined as the amount that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

Level 1—Unadjusted quoted prices in active markets that are accessible to the reporting entity at the measurement date for identical assets and liabilities.
Level 2—Inputs other than quoted prices in active markets for identical assets and liabilities that are observable either directly or indirectly for substantially the full term of the asset or liability. Level 2 inputs include the following:
quoted prices for similar assets and liabilities in active markets;
quoted prices for identical or similar assets or liabilities in markets that are not active;
observable inputs other than quoted prices that are used in the valuation of the asset or liabilities (e.g., interest rate and yield curve quotes at commonly quoted intervals); and
inputs that are derived principally from or corroborated by observable market data by correlation or other means.
Level 3—Unobservable inputs for the assets or liability (i.e., supported by little or no market activity). Level 3 inputs include management’s own assumptions about the assumptions that market participants would use in pricing the asset or liability (including assumptions about risk).

 

Net loss per share

Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. Diluted net loss is computed by adjusting net loss to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net loss per share is computed by dividing the diluted net loss by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares assuming the dilutive effect of common stock equivalents.

 

The following potentially dilutive common stock equivalents, presented based on amounts outstanding at each period end, were excluded from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:

 

10


 

 

 

June 30,

 

 

 

2022

 

 

2021

 

Options to purchase common stock

 

 

8,088,441

 

 

 

7,160,650

 

Unvested restricted common stock

 

 

6,973

 

 

 

209,567

 

Unvested restricted stock units

 

 

1,017,273

 

 

 

548,465

 

Total

 

 

9,112,687

 

 

 

7,918,682

 

 

3. Cash, Cash Equivalents and Restricted Cash

Cash includes cash in readily available checking accounts and cash equivalents include money market funds that invest in U.S. treasury securities and all highly liquid investments maturing within 90 days from the date of purchase.

Amounts included in restricted cash represent amounts pledged as collateral for letters of credit required for security deposits on the Company’s leased facilities. Restricted cash totaled $2.3 million and $2.7 million at June 30, 2022 and December 31, 2021, respectively. These amounts are classified as a component of other current assets and as restricted cash on the Company’s condensed consolidated balance sheets.

 

Cash, cash equivalents and restricted cash consisted of the following:

 

 

 

June 30,

 

 

December 31,

 

(in thousands)

 

2022

 

 

2021

 

Cash and cash equivalents

 

$

135,980

 

 

$

200,825

 

Short term restricted cash included in other current assets

 

 

 

 

 

383

 

Restricted cash

 

 

2,315

 

 

 

2,311

 

Total

 

$

138,295