SEC Filing | Dyne Therapeutics, Inc.

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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 September 30, 2022


☐	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 October 31, 2022, the registrant had 52,126,892 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	26
Item 4.	Controls and Procedures	26
PART II.	OTHER INFORMATION	26
Item 1A.	Risk Factors	26
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	82
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;

•

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.

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 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 progress of our ongoing clinical trials or the initiation of 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.

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)


	September 30,			December 31,
	2022			2021
Assets
Current assets:
Cash and cash equivalents	$	144,901		$	200,825
Marketable securities		103,241			175,746
Prepaid expenses and other current assets		10,092			5,821
Total current assets		258,234			382,392
Property and equipment, net		5,742			4,678
Right-of-use assets		33,386			36,282
Restricted cash and other assets		2,317			2,311
Total assets	$	299,679		$	425,663
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		919			4,031
Accrued expenses and other current liabilities		17,826			20,799
Lease liabilities		4,576			3,893
Total current liabilities		23,321			28,723
Lease liabilities, net of current portion		26,614			28,743
Total liabilities		49,935			57,466
Stockholders’ equity
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2022 and December 31, 2021		—			—
Common stock, $0.0001 par value; 200,000,000 shares authorized at September 30, 2022 and December 31, 2021; 51,909,235 and 51,607,522 shares issued and 51,906,773 and 51,569,381 shares outstanding at September 30, 2022 and December 31, 2021, respectively		6			6
Additional paid-in capital		608,467			596,934
Accumulated other comprehensive loss		(983	)		(269	)
Accumulated deficit		(357,746	)		(228,474	)
Total stockholders’ equity		249,744			368,197
Total liabilities and stockholders’ equity	$	299,679		$	425,663

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 September 30,						Nine Months Ended September 30,
	2022			2021			2022			2021
Operating expenses:
Research and development	$	34,670		$	36,510		$	109,570		$	79,007
General and administrative		7,609			6,256			21,247			19,058
Total operating expenses		42,279			42,766			130,817			98,065
Loss from operations		(42,279	)		(42,766	)		(130,817	)		(98,065	)
Other (expense) income:
Interest income		903			184			1,575			560
Other income (expense), net		(9	)		—			(30	)		—
Total other (expense) income, net		894			184			1,545			560
Net loss	$	(41,385	)	$	(42,582	)	$	(129,272	)	$	(97,505	)
Net loss per share—basic and diluted	$	(0.80	)	$	(0.83	)	$	(2.50	)	$	(1.92	)
Weighted-average common shares outstanding used in net loss per share—basic and diluted		51,795,446			51,320,940			51,692,899			50,676,668
Comprehensive loss:
Net loss	$	(41,385	)	$	(42,582	)	$	(129,272	)	$	(97,505	)
Other comprehensive loss:
Unrealized gains (losses) on marketable securities, net		173			7			(714	)		(7	)
Comprehensive loss	$	(41,212	)	$	(42,575	)	$	(129,986	)	$	(97,512	)

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, 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
Exercise of stock options		19,354		—		70		—			—			70
Stock-based compensation		—		—		3,827		—			—			3,827
Vesting of restricted shares		4,511		—		—		—			—			—
Vesting of restricted stock units		148,547		—		—		—			—			—
Unrealized gains on marketable securities		—		—		—		173			—			173
Net loss		—		—		—		—			(41,385	)		(41,385	)
Balance at September 30, 2022		51,906,773	$	6	$	608,467	$	(983	)	$	(357,746	)	$	249,744


	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 gains 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
Exercise of stock options		99,679		—		457		—			—			457
Stock-based compensation		—		—		3,638		—			—			3,638
Vesting of restricted shares		63,977		—		—		—			—			—
Vesting of restricted stock units		87,646		—		—		—			—			—
Unrealized gains on marketable securities		—		—		—		7			—			7
Net loss		—		—		—		—			(42,582	)