Dyne Therapeutics, Inc. [DYN] Filings

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

10-Q 1 dyn-20240630.htm 10-Q 10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2024


☐	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.

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 August 9, 2024, the registrant had 100,400,798 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	4
Item 1.	Financial Statements (Unaudited)	4
	Condensed Consolidated Balance Sheets	4
	Condensed Consolidated Statements of Operations and Comprehensive Loss	5
	Condensed Consolidated Statements of Stockholders’ Equity	6
	Condensed Consolidated Statements of Cash Flows	7
	Notes to Unaudited Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	25
Item 4.	Controls and Procedures	25
PART II.	OTHER INFORMATION	26
Item 1.	Legal Proceedings	26
Item 1A.	Risk Factors	26
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	83
Item 3.	Defaults Upon Senior Securities	83
Item 4.	Mine Safety Disclosures	83
Item 5.	Other Information	83
Item 6.	Exhibits	84
Signatures		85

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.

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 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;

•

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; 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 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.

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.

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 several 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 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;

•

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; and

•

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.

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,
	2024			2023
Assets
Current assets:
Cash and cash equivalents	$	608,196		$	121,626
Marketable securities		170,642			1,474
Prepaid expenses and other current assets		13,482			6,275
Total current assets		792,320			129,375
Property and equipment, net		5,022			4,780
Right-of-use assets		26,615			28,612
Restricted cash		1,927			2,315
Total assets	$	825,884		$	165,082
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		1,889			22,936
Accrued expenses and other current liabilities		23,085			23,439
Lease liabilities		4,779			4,720
Total current liabilities		29,753			51,095
Lease liabilities, net of current portion		20,938			22,695
Total liabilities		50,691			73,790
Stockholders’ equity
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at June 30, 2024 and December 31, 2023		—			—
Common stock, $0.0001 par value; 200,000,000 shares authorized at June 30, 2024 and December 31, 2023; 100,119,518 and 61,468,743 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively		10			6
Additional paid-in capital		1,538,684			723,796
Accumulated other comprehensive loss		(240	)		—
Accumulated deficit		(763,261	)		(632,510	)
Total stockholders’ equity		775,193			91,292
Total liabilities and stockholders’ equity	$	825,884		$	165,082

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

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,
	2024			2023			2024			2023
Operating expenses:
Research and development	$	62,263		$	59,130		$	106,802		$	96,667
General and administrative		9,699			7,606			34,317			15,533
Total operating expenses		71,962			66,736			141,119			112,200
Loss from operations		(71,962	)		(66,736	)		(141,119	)		(112,200	)
Other income (expense):
Interest income		7,052			2,207			10,054			3,700
Other income (expense), net		(192	)		(373	)		314			(589	)
Total other income (expense), net		6,860			1,834			10,368			3,111
Net loss	$	(65,102	)	$	(64,902	)	$	(130,751	)	$	(109,089	)
Net loss per share—basic and diluted	$	(0.70	)	$	(1.08	)	$	(1.51	)	$	(1.88	)
Weighted average common shares outstanding, basic and diluted		92,507,815			59,835,087			86,777,150			58,090,142
Comprehensive loss:
Net loss	$	(65,102	)	$	(64,902	)	$	(130,751	)	$	(109,089	)
Other comprehensive loss:
Unrealized (losses) gains on marketable securities, net		(108	)		147			(240	)		515
Comprehensive loss	$	(65,210	)	$	(64,755	)	$	(130,991	)	$	(108,574	)

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

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, 2024		61,468,743	$	6	$	723,796	$	—		$	(632,510	)	$	91,292
Issuance of common stock in public offering, net of issuance costs of $21.3 million		19,722,500		2		323,849		—			—			323,851
Issuance of common stock in at-the-market offering, net of issuance costs of $3.3 million		3,800,465		1		97,870		—			—			97,871
Exercise of stock options		1,858,791		—		10,916		—			—			10,916
Stock-based compensation		—		—		19,906		—			—			19,906
Vesting of restricted stock units		239,150		—		—		—			—			—
Unrealized losses on marketable securities		—		—		—		(132	)		—			(132	)
Net loss		—		—		—		—			(65,649	)		(65,649	)
Balance at March 31, 2024		87,089,649	$	9	$	1,176,337	$	(132	)	$	(698,159	)	$	478,055
Issuance of common stock in public offering, net of issuance costs of $23.0 million		12,075,000		1		351,328		—			—			351,329
Exercise of stock options		564,904		—		4,283		—			—			4,283
Stock-based compensation		—		—		6,736		—			—			6,736
Vesting of restricted stock units		389,965		—		—		—			—			—
Unrealized losses on marketable securities		—		—		—		(108	)		—			(108	)
Net loss		—		—		—		—			(65,102	)		(65,102	)
Balance at June 30, 2024		100,119,518	$	10	$	1,538,684	$	(240	)	$	(763,261	)	$	775,193


	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, 2023		55,636,505	$	6	$	649,502	$	(571	)	$	(396,573	)	$	252,364
Issuance of common stock in public offering, net of issuance costs of $1.0 million		2,335,150		—		28,186		—			—			28,186
Exercise of stock options		232,292		—		587		—			—			587
Stock-based compensation		—		—		4,617		—			—			4,617
Vesting of restricted stock units		101,533		—		—		—			—			—
Unrealized gains on marketable securities		—		—		—		368			—			368
Net loss		—		—		—		—			(44,187	)		(44,187	)
Balance at March 31, 2023		58,305,480	$	6	$	682,892	$	(203	)	$	(440,760	)	$	241,935
Issuance of common stock in public offering, net of issuance costs of $0.8 million		2,173,913		—		24,184		—			—			24,184
Exercise of stock options		432,626		—		764		—			—			764
Stock-based compensation		—		—		4,749		—			—			4,749
Vesting of restricted stock units		101,967		—		—		—			—			—
Unrealized gains on marketable securities		—		—		—		147			—			147
Net loss		—		—		—		—			(64,902	)		(64,902	)
Balance at June 30, 2023		61,013,986	$	6	$	712,589	$	(56	)	$	(505,662	)	$	206,877

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

Dyne Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)


	Six Months Ended June 30,
	2024			2023
Cash flows from operating activities:
Net loss	$	(130,751	)	$	(109,089	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		26,642			9,366
Depreciation and amortization expense		785			843
Non-cash lease expense		298			454
Accretion of premium on marketable securities		(1,792	)		(543	)
Loss on sale of marketable securities		—			23
Loss (gain) on disposal of property and equipment		(2	)		118
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(7,207	)		4,175
Accounts payable and other liabilities		(21,378	)		(7,897	)
Net cash used in operating activities		(133,405	)		(102,550	)
Cash flows from investing activities:
Purchases of property and equipment		(1,048	)		(480	)
Purchases of marketable securities		(207,691	)		(34,684	)
Maturities of marketable securities		40,076			77,629
Sales of marketable securities		—			1,829
Net cash (used in) provided by investing activities		(168,663	)		44,294
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of issuance costs		675,180			—
Proceeds from issuance of common stock in at-the-market offering, net of issuance costs		97,871			52,370
Proceeds from exercise of stock options		15,199			1,351
Net cash provided by financing activities		788,250			53,721
Net increase (decrease) in cash, cash equivalents and restricted cash		486,182			(4,535	)
Cash, cash equivalents and restricted cash, beginning of period		123,941			174,466
Cash, cash equivalents and restricted cash, end of period	$	610,123		$	169,931
Supplemental disclosures of cash flow information:
Purchase of property and equipment in accounts payable	$	—		$	10

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

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 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 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.

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. 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.

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 5, 2024. The results for the three and six months ended June 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, 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 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:


	June 30,
	2024		2023
Options to purchase common stock		8,363,280		9,162,462
Unvested restricted stock units		2,828,836		1,555,356
Total		11,192,116		10,717,818

Recently Issued Accounting Pronouncements Not Yet Adopted

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280). The amendments in this update expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment among other disclosure requirements. This update is effective for the Company in the consolidated financial statements for the year ending December 31, 2024, and interim periods beginning on January 1, 2025. The adoption of this standard only impacts disclosures and is not expected to have a material impact on the Company’s consolidated financial statements.

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.

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


	June 30,		December 31,
(in thousands)	2024		2023
Cash and cash equivalents	$	608,196	$	121,626
Restricted cash		1,927		2,315
Total	$	610,123	$	123,941

4. Fair Value Measurements

The following tables set forth marketable securities for the periods presented:


	As of June 30, 2024
(in thousands)	Amortized Cost		Unrealized Gains		Unrealized Losses			Total
Commercial paper		35,211		—		(28	)		35,183
Corporate debt securities		114,383		28		(222	)		114,189
Certificates of deposit		14,075		1		(9	)		14,067
U.S. treasury notes		7,203		1		(1	)		7,203
Total	$	170,872	$	30	$	(260	)	$	170,642


	As of December 31, 2023
(in thousands)	Amortized Cost		Unrealized Gains		Unrealized Losses		Total
Corporate debt securities		1,474		—		—		1,474
Total	$	1,474	$	—	$	—	$	1,474

The following tables set forth by level, within the fair value hierarchy (see Note 2), the assets carried at fair value on a recurring basis for the periods presented:


	Fair value measurements as of June 30, 2024
(in thousands)	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents
Money market funds	$	179,220	$	—	$	—	$	179,220
Corporate debt securities		—		6,081		—		6,081
Marketable securities
Commercial paper		35,183		—		—		35,183
Corporate debt securities		—		114,189		—		114,189
Certificates of deposit		—		14,067		—		14,067
U.S. treasury notes		7,203		—		—		7,203
Total	$	221,606	$	134,337	$	—	$	355,943


	Fair Value Measurements as of December 31, 2023
(in thousands)	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents
Money market funds	$	66,179	$	—	$	—	$	66,179
U.S. treasury notes		18,689		—		—		18,689
Marketable securities
Corporate debt securities		—		1,474		—		1,474
Total	$	84,868	$	1,474	$	—	$	86,342

The fair value of U.S. government treasury notes, money market funds and commercial paper were determined by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. Certificates of deposit and corporate debt securities were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy.

There were no transfers between Level 1, Level 2, or Level 3 during the periods presented.

The following table summarizes the scheduled maturity for the Company's marketable securities for the periods presented:


(in thousands)	June 30, 2024
Maturing in one year or less	$	155,058
Maturing after one year through two years		15,584
Maturing after two years		—
Total	$	170,642

Financial instruments not recorded at fair value

The carrying values of cash, cash equivalents, accounts payable and accrued expenses that are reported on the balance sheets approximate their fair value due to the short-term nature of these assets and liabilities.

5. Property and Equipment

Property and equipment consisted of the following:


	June 30,			December 31,
(in thousands)	2024			2023
Laboratory equipment	$	7,940		$	7,546
Office and computer equipment		2,138			2,091
Construction in process		1,016			431
Property and equipment—at cost		11,094			10,068
Less accumulated depreciation and amortization		(6,072	)		(5,288	)
Property and equipment—net	$	5,022		$	4,780

Depreciation and amortization expense for the three and six months ended June 30, 2024 was $0.4 million and $0.8 million, respectively. Depreciation and amortization expense for the three and six months ended June 30, 2023 was $0.4 million and $0.8 million, respectively.

6. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:


	June 30,		December 31,
(in thousands)	2024		2023
Payroll and benefits	$	8,178	$	10,498
Consulting services		1,098		423
Legal services		1,094		397
Research and development		12,715		12,121
Total	$	23,085	$	23,439

7. Stockholders' Equity

Common Stock

In November 2021, the Company entered into an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies") as the Company's sales agent, and filed a universal shelf registration statement on Form S-3 (the "2021 Shelf Registration Statement") that included a prospectus relating to the Sales Agreement and pursuant to which, from time to time, the Company could offer and sell shares of its common stock having an aggregate offering price of up to $150.0 million in an "at-the-market" offering. On January 4, 2024, the Company notified Jefferies that it was suspending and terminating the prospectus filed under the 2021 Shelf Registration Statement relating to the Sales Agreement for the Company's "at-the-market" offering program.

On March 5, 2024, the Company filed a universal shelf registration statement on Form S-3 with the SEC, (the “2024 Shelf Registration Statement”) that included a prospectus relating to the Sales Agreement (the “2024 ATM Prospectus”). Under the 2024 Shelf Registration Statement, the Company may offer and sell debt securities, common stock, preferred stock, units and/or warrants from time to time at an indeterminate aggregate offering price in one or more offerings. Under the

2024 ATM Prospectus, in accordance with the Sales Agreement, the Company may offer and sell shares of its common stock having an aggregate offering price of up to $200.0 million in an “at-the-market” offering.

During the six months ended June 30, 2024, the Company issued and sold an aggregate of 3,800,465 shares of common stock pursuant to the Sales Agreement for aggregate net proceeds of $97.9 million, after deducting fees and offering expenses payable by the Company. The Company sold such shares at a weighted average price of $26.86 per share.

In January 2024, the Company completed a follow-on public offering, pursuant to which the Company issued and sold 19,722,500 shares of the Company’s common stock. The Company received net proceeds of $323.9 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.

Forbion Capital Fund IV Cooperatief U.A. and related affiliated entities (collectively, “Forbion”) were a beneficial owner of more than 5.0% of the Company's outstanding common stock as of June 30, 2024. Two members of the Company's board of directors are partners at Forbion. In the January 2024 offering, the Company issued and sold 1,714,285 shares of common stock that Forbion and related affiliated entities purchased at the public offering price of $17.50 per share for aggregate gross proceeds of $30.0 million. The shares were purchased on the same terms as the other shares that were offered and sold in the offering.

In May 2024, the Company completed a follow-on public offering, pursuant to which the Company issued and sold 12,075,000 shares of the Company's common stock. The Company received net proceeds of $351.3 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.

2020 Stock Incentive Plan

In August 2020 the Company’s board of directors adopted and the Company’s stockholders approved the 2020 Stock Incentive Plan, (the "2020 Plan"), which became effective on September 16, 2020. The 2020 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards to employees, directors, consultants and advisors of the Company. The 2020 Plan is administered by the Company’s board of directors or by a committee appointed by the board of directors. Upon the effectiveness of the 2020 Plan, the Company ceased granting awards under the 2018 Stock Incentive Plan.

As of June 30, 2024, 4,894,073 shares remained available for future issuance under the 2020 Plan.

2024 Inducement Stock Incentive Plan

In March 2024, the Company's board of directors adopted the 2024 Inducement Stock Incentive Plan (the "2024 Inducement Plan"). The 2024 Inducement Plan provides for the grant of nonstatutory stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards with respect to an aggregate of 900,000 shares of Common Stock (subject to adjustment as provided in the 2024 Inducement Plan). Awards under the 2024 Inducement Plan may only be granted to new employees who were not previously an employee or director of the Company or are commencing employment with the Company following a bona fide period of non-employment, in either case, as an inducement material to the individual’s entering into employment with the Company and in accordance with the requirements of Nasdaq Stock Market Rule 5635(c)(4).

As of June 30, 2024, 220,147 shares remained available for future issuance under the 2024 Inducement Plan.

Stock option valuation

The fair value of stock option grants is estimated using the Black-Scholes option-pricing model. The fair value is determined based upon the quoted price of the Company’s common stock. The Company lacks company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected

dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.

The assumptions that the Company used to determine the grant-date fair value of options granted were as follows:


	Six Months Ended June 30,
	2024		2023
Expected volatility	66%		67%
Risk-free interest rate	3.98% — 4.65%		3.42% — 4.22%
Expected term (in years)	6		6
Expected dividend yield		—		—

Stock option activity

A summary of the Company’s stock option activity and related information for the six months ended June 30, 2024 is as follows:


(in thousands, except share and per share data)	Options		Weighted Average Exercise Price		Weighted Average Remaining Life (in years)		Aggregate Intrinsic Value
Outstanding as of January 1, 2024		9,914,719	$	10.48		7.7	$

Dyne Therapeutics, Inc. [DYN] Filings
10-Q	[2024-08-12]
10-Q	[2024-05-02]
10-K	[2024-03-05]
10-Q	[2023-10-30]
10-Q	[2023-08-03]
10-Q	[2023-05-11]
10-K	[2023-03-02]
10-Q	[2022-11-03]
10-Q	[2022-08-04]
10-Q	[2022-05-02]
10-K	[2022-03-10]
10-Q	[2021-11-04]
10-Q	[2021-08-05]
10-Q	[2021-05-06]
10-K	[2021-03-04]
S-1	[2021-01-19]
10-Q	[2020-11-05]
S-1	[2020-08-25]