Dyne Therapeutics第二季淨虧損1.786億美元 研發開支增逾五成

10-Q
 
 
 
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 

  
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, 2026
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 24, 2026, the registrant had 186,746,431 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

 18

 

 
 Item 3.

 Quantitative and Qualitative Disclosures About Market Risk

 31

 

 
 Item 4.

 Controls and Procedures

 31

 

 
 PART II.

 OTHER INFORMATION

 32

 

 
 Item 1.

 Legal Proceedings

 32

 

 
 Item 1A.

 Risk Factors

 32

 

 
 Item 2.

 Unregistered Sales of Equity Securities and Use of Proceeds

 96

 

 
 Item 3.

 Defaults Upon Senior Securities

 96

 

 
 Item 4.

 Mine Safety Disclosures

 96

 

 
 Item 5.

 Other Information

 96

 

 
 Item 6.

 Exhibits

 97

 

 
 Signatures

 98

 

  
 
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,” “will,” “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, design, progress and results of our research and development programs, preclinical studies and 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 timing of and our ability to submit applications for, obtain and maintain regulatory approvals for any product candidates we may develop;

•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, debt service obligations and capital expenditure requirements;

•our ability to comply with restrictive covenants under our loan agreement, or the Loan Agreement, with Hercules Capital, Inc., or Hercules;

•our ability to satisfy interest and principal payments under the Loan Agreement;

•our plans to develop and, if approved, subsequently commercialize 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; and

•our ability to establish and maintain collaborations or obtain additional funding.

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 Part II, 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:
•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 product development programs or commercialization efforts;

•our product candidates are in varying stages of preclinical and clinical development, and we have not completed clinical development of any product candidate. We do not expect to have a product candidate ready for commercialization at least until 2027, 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 and the data from the clinical trials of our product candidates may fail to demonstrate sufficient safety and efficacy to warrant further development or satisfy the 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 initial data from earlier-stage clinical trials may not be predictive of final results of clinical trials or future clinical trials and data from trials in one indication may not be predictive of results of clinical trials in other indications;

•if our product candidates cause undesirable side effects or have other unexpected adverse properties, such side effects or properties could delay or prevent us from conducting clinical trials or seeking or obtaining regulatory approval, limit the commercial potential of our product candidates or result in significant negative consequences to the extent such effects or adverse properties are observed following any marketing approval;

•our Loan Agreement contains restrictive and financial covenants that may limit our operating flexibility and our failure to comply with the covenants or other terms of the Loan Agreement, including as a result of events beyond our control, could result in a default under the Loan Agreement that could materially and adversely affect our business;

•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 certain of our product candidates are subject or 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

•even if any product candidate that we may develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success.

 

 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,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
 Assets

  

  

  

  

  

  

 

 
 Current assets:

  

  

  

  

  

  

 

 
 Cash and cash equivalents

  

 $

 676,114

  

  

 $

 893,369

  

 

 
 Marketable securities

  

  

 222,361

  

  

  

 217,193

  

 

 
 Prepaid expenses and other current assets

  

  

 39,414

  

  

  

 16,025

  

 

 
 Total current assets

  

  

 937,889

  

  

  

 1,126,587

  

 

 
 Property and equipment, net

  

  

 24,559

  

  

  

 24,029

  

 

 
 Right-of-use assets

  

  

 20,256

  

  

  

 20,742

  

 

 
 Restricted cash and other assets

  

  

 11,309

  

  

  

 15,600

  

 

 
 Total assets

  

 $

 994,013

  

  

 $

 1,186,958

  

 

 
 Liabilities and Stockholders’ Equity

  

  

  

  

  

  

 

 
 Current liabilities:

  

  

  

  

  

  

 

 
 Accounts payable

  

  

 12,153

  

  

  

 8,082

  

 

 
 Accrued expenses and other current liabilities

  

  

 46,359

  

  

  

 37,548

  

 

 
 Vendor financing arrangement

  

  

 14,151

  

  

  

 —

  

 

 
 Lease liabilities

  

  

 5,366

  

  

  

 4,995

  

 

 
 Total current liabilities

  

  

 78,029

  

  

  

 50,625

  

 

 
 Long-term debt, net

  

  

 199,328

  

  

  

 148,921

  

 

 
 Lease liabilities, net of current portion

  

  

 14,505

  

  

  

 15,283

  

 

 
 Total liabilities

  

  

 291,862

  

  

  

 214,829

  

 

 
 Stockholders’ equity

  

  

  

  

  

  

 

 
 Preferred stock, $0.0001 par value; 10,000,000 shares authorized at June 30, 2026 and December 31, 2025

  

  

 —

  

  

  

 —

  

 

 
 Common stock, $0.0001 par value; 400,000,000 and 200,000,000 shares authorized at June 30, 2026 and December 31, 2025, respectively; 165,670,880 and 164,950,540 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively

  

  

 16

  

  

  

 16

  

 

 
 Additional paid-in capital

  

  

 2,398,040

  

  

  

 2,367,780

  

 

 
 Accumulated other comprehensive (loss) gain

  

  

 (353

 )

  

  

 475

  

 

 
 Accumulated deficit

  

  

 (1,695,552

 )

  

  

 (1,396,142

 )

 

 
 Total stockholders’ equity

  

  

 702,151

  

  

  

 972,129

  

 

 
 Total liabilities and stockholders’ equity

  

 $

 994,013

  

  

 $

 1,186,958

  

 

  
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,

  

 

 
  

  

 2026

  

  

 2025

  

  

 2026

  

  

 2025

  

 

 
 Operating expenses:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Research and development

  

 $

 152,169

  

  

 $

 99,236

  

  

 $

 253,175

  

  

 $

 205,683

  

 

 
 General and administrative

  

  

 29,492

  

  

  

 16,555

  

  

  

 53,763

  

  

  

 32,480

  

 

 
 Total operating expenses

  

  

 181,661

  

  

  

 115,791

  

  

  

 306,938

  

  

  

 238,163

  

 

 
 Loss from operations

  

  

 (181,661

 )

  

  

 (115,791

 )

  

  

 (306,938

 )

  

  

 (238,163

 )

 

 
 Other income (expense):

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Interest income

  

  

 7,788

  

  

  

 6,625

  

  

  

 16,544

  

  

  

 13,725

  

 

 
 Interest expense

  

  

 (4,595

 )

  

  

 (94

 )

  

  

 (8,797

 )

  

  

 (94

 )

 

 
 Other expense, net

  

  

 (88

 )

  

  

 (1,597

 )

  

  

 (219

 )

  

  

 (1,687

 )

 

 
 Total other income, net

  

  

 3,105

  

  

  

 4,934

  

  

  

 7,528

  

  

  

 11,944

  

 

 
 Net loss

  

 $

 (178,556

 )

  

 $

 (110,857

 )

  

 $

 (299,410

 )

  

 $

 (226,219

 )

 

 
 Net loss per share—basic and diluted

  

 $

 (1.08

 )

  

 $

 (0.97

 )

  

 $

 (1.81

 )

  

 $

 (2.02

 )

 

 
 Weighted average common shares outstanding, basic and diluted

  

  

 165,451,388

  

  

  

 113,873,126

  

  

  

 165,240,803

  

  

  

 111,900,818

  

 

 
 Comprehensive loss:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Net loss

  

 $

 (178,556

 )

  

 $

 (110,857

 )

  

 $

 (299,410

 )

  

 $

 (226,219

 )

 

 
 Other comprehensive loss:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Unrealized gains (losses) on marketable securities, net

  

  

 (216

 )

  

  

 11

  

  

  

 (828

 )

  

  

 246

  

 

 
 Comprehensive loss

  

 $

 (178,772

 )

  

 $

 (110,846

 )

  

 $

 (300,238

 )

  

 $

 (225,973

 )

 

  
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, 2026

  

  

 164,950,540

  

  

 $

 16

  

  

 $

 2,367,780

  

  

 $

 475

  

  

 $

 (1,396,142

 )

  

 $

 972,129

  

 

 
 Exercise of stock options

  

  

 88,932

  

  

  

 —

  

  

  

 1,311

  

  

  

 —

  

  

  

 —

  

  

  

 1,311

  

 

 
 Stock-based compensation

  

  

 —

  

  

  

 —

  

  

  

 13,081

  

  

  

 —

  

  

  

 —

  

  

  

 13,081

  

 

 
 Vesting of restricted stock units

  

  

 161,857

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

 

 
 Unrealized losses on marketable securities

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (612

 )

  

  

 —

  

  

  

 (612

 )

 

 
 Net loss

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (120,854

 )

  

  

 (120,854

 )

 

 
 Balance at March 31, 2026

  

  

 165,201,329

  

  

 $

 16

  

  

 $

 2,382,172

  

  

 $

 (137

 )

  

 $

 (1,516,996

 )

  

 $

 865,055

  

 

 
 Exercise of stock options

  

  

 75,658

  

  

  

 —

  

  

  

 892

  

  

  

 —

  

  

  

 —

  

  

  

 892

  

 

 
 Stock-based compensation

  

  

 —

  

  

  

 —

  

  

  

 14,976

  

  

  

 —

  

  

  

 —

  

  

  

 14,976

  

 

 
 Vesting of restricted stock units

  

  

 393,893

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

 

 
 Unrealized losses on marketable securities

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (216

 )

  

  

 —

  

  

  

 (216

 )

 

 
 Net loss

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (178,556

 )

  

  

 (178,556

 )

 

 
 Balance at June 30, 2026

  

  

 165,670,880

  

  

 $

 16

  

  

 $

 2,398,040

  

  

 $

 (353

 )

  

 $

 (1,695,552

 )

  

 $

 702,151

  

 

 
  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

 

 
  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

 

 
  

  

 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, 2025

  

  

 102,318,629

  

  

 $

 10

  

  

 $

 1,579,750

  

  

 $

 6

  

  

 $

 (949,928

 )

  

 $

 629,838

  

 

 
 Issuance of common stock in at-the-market offering, net of issuance costs of $4.4 million

  

  

 10,660,159

  

  

  

 1

  

  

  

 140,652

  

  

  

 —

  

  

  

 —

  

  

  

 140,653

  

 

 
 Exercise of stock options

  

  

 89,835

  

  

  

 —

  

  

  

 588

  

  

  

 —

  

  

  

 —

  

  

  

 588

  

 

 
 Stock-based compensation

  

  

 —

  

  

  

 —

  

  

  

 13,020

  

  

  

 —

  

  

  

 —

  

  

  

 13,020

  

 

 
 Vesting of restricted stock units

  

  

 565,159

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

 

 
 Unrealized gains on marketable securities

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 235

  

  

  

 —

  

  

  

 235

  

 

 
 Net loss

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (115,361

 )

  

  

 (115,361

 )

 

 
 Balance at March 31, 2025

  

  

 113,633,782

  

  

 $

 11

  

  

 $

 1,734,010

  

  

 $

 241

  

  

 $

 (1,065,289

 )

  

 $

 668,973

  

 

 
 Exercise of stock options

  

  

 488,457

  

  

  

 —

  

  

  

 2,795

  

  

  

 —

  

  

  

 —

  

  

  

 2,795

  

 

 
 Stock-based compensation

  

  

 —

  

  

  

 —

  

  

  

 10,523

  

  

  

 —

  

  

  

 —

  

  

  

 10,523

  

 

 
 Vesting of restricted stock units

  

  

 216,371

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

 

 
 Unrealized gains on marketable securities

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 11

  

  

  

 —

  

  

  

 11

  

 

 
 Net loss

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (110,857

 )

  

  

 (110,857

 )

 

 
 Balance at June 30, 2025

  

  

 114,338,610

  

  

 $

 11

  

  

 $

 1,747,328

  

  

 $

 252

  

  

 $

 (1,176,146

 )

  

 $

 571,445

  

 

  
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,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
 Cash flows from operating activities:

  

  

  

  

  

  

 

 
 Net loss

  

 $

 (299,410

 )

  

 $

 (226,219

 )

 

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

  

  

  

  

  

  

 

 
 Stock-based compensation expense

  

  

 28,057

  

  

  

 23,543

  

 

 
 Depreciation and amortization expense

  

  

 1,110

  

  

  

 1,005

  

 

 
 Non-cash lease expense

  

  

 206

  

  

  

 32

  

 

 
 Non-cash interest expense

  

  

 167

  

  

  

 2

  

 

 
 Accretion of premium on marketable securities

  

  

 (504

 )

  

  

 (1,079

 )

 

 
 Gain on sale of marketable securities

  

  

 (39

 )

  

  

 (14

 )

 

 
 Loss on disposal of property and equipment

  

  

 30

  

  

  

 95

  

 

 
 Changes in operating assets and liabilities:

  

  

  

  

  

  

 

 
 Prepaid expenses and other current assets

  

  

 (23,363

 )

  

  

 2,795

  

 

 
 Other non-current assets

  

  

 4,379

  

  

  

 —

  

 

 
 Accounts payable and other liabilities

  

  

 14,159

  

  

  

 (756

 )

 

 
 Net cash used in operating activities

  

  

 (275,208

 )

  

  

 (200,596

 )

 

 
 Cash flows from investing activities:

  

  

  

  

  

  

 

 
 Purchases of property and equipment

  

  

 (1,735

 )

  

  

 (1,041

 )

 

 
 Purchases of marketable securities

  

  

 (107,064

 )

  

  

 (106,903

 )

 

 
 Maturities of marketable securities

  

  

 58,190

  

  

  

 107,708

  

 

 
 Sales of marketable securities

  

  

 43,422

  

  

  

 8,468

  

 

 
 Net cash (used in) provided by investing activities

  

  

 (7,187

 )

  

  

 8,232

  

 

 
 Cash flows from financing activities:

  

  

  

  

  

  

 

 
 Proceeds from exercise of stock options

  

  

 2,048

  

  

  

 2,560

  

 

 
 Proceeds from issuance of long-term debt, net of issuance costs paid

  

  

 49,450

  

  

  

 98,802

  

 

 
 Proceeds from vendor financing arrangement

  

  

 18,034

  

  

  

 —

  

 

 
 Repayments under vendor financing arrangement

  

  

 (3,904

 )

  

  

 —

  

 

 
 Payment of debt issuance costs

  

  

 (30

 )

  

  

 —

  

 

 
 Payment of issuance costs from public offering of common stock

  

  

 (424

 )

  

  

 —

  

 

 
 Proceeds from issuance of common stock in at-the-market offering, net of issuance costs

  

  

 —

  

  

  

 140,653

  

 

 
 Net cash provided by financing activities

  

  

 65,174

  

  

  

 242,015

  

 

 
 Net (decrease) increase in cash, cash equivalents and restricted cash

  

  

 (217,221

 )

  

  

 49,651

  

 

 
 Cash, cash equivalents and restricted cash, beginning of period

  

  

 895,740

  

  

  

 437,391

  

 

 
 Cash, cash equivalents and restricted cash, end of period

  

 $

 678,519

  

  

 $

 487,042

  

 

 
 Supplemental disclosures of cash flow information:

  

  

  

  

  

  

 

 
 Cash paid for interest

  

 $

 11,460

  

  

 $

 —

  

 

 
 Right-of-use assets acquired under operating leases

  

  

 1,580

  

  

  

 —

  

 

 
 Debt issuance costs included in accounts payable or accrued expenses

  

  

 56

  

  

  

 506

  

 

 
 Proceeds from employee stock option exercises in other current assets

  

  

 155

  

  

  

 823

  

 

 
 Purchase of property and equipment in accounts payable

  

  

 —

  

  

  

 364

  

 

  
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 a clinical-stage neuromuscular disease company focused on delivering functional improvement for people living with genetically driven neuromuscular 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 clinical-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 and the ability to secure additional capital to fund operations. Product candidates and programs currently under development require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s development efforts are successful and product candidates receive regulatory approval, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
 
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 equity securities, and its term loan with Hercules Capital, Inc. (“Hercules”). 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, debt service obligations 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.

2. Summary of Significant Accounting Policies 
The accompanying condensed consolidated financial statements reflect the operations of the Company and the Company’s wholly-owned subsidiary, Dyne Therapeutics Securities Corporation. Intercompany balances and transactions have been eliminated in consolidation. The accompanying condensed consolidated 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 

  
9

 
  

 financial statements and notes thereto included in the Company’s Annual Report on Form 10-K filed with the SEC on March 2, 2026. The results for the three and six months ended June 30, 2026 are not necessarily indicative of results to be expected for the year ending December 31, 2026, 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 exchange price 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 ful