UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
|
|
||
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s telephone number, including area code: (
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading symbol(s) |
|
Name of each exchange on which registered |
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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.
Item 2.02 Results of Operations and Financial Condition.
On March 5, 2024, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the year ended December 31, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filling.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
|
Description |
|
|
|
99.1 104 |
|
Press Release issued by Dyne Therapeutics, Inc. on March 5, 2024 Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
|
|
|
DYNE THERAPEUTICS, INC. |
||||
|
|
|
||||
Date: March 5, 2024 |
|
By: |
|
/s/ Joshua Brumm |
||
|
|
|
|
Name: |
|
Joshua Brumm |
|
|
|
|
Title: |
|
President and Chief Executive Officer |
Exhibit 99.1
Dyne Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights
- Positive Initial Clinical Data from ACHIEVE Trial in DM1 Patients and DELIVER Trial in DMD Patients Demonstrated Proof-of-Concept, Validating the Promise of the FORCE™ Platform and Targeted Delivery to Muscle -
- Strengthened Balance Sheet with $345 Million Public Offering Extending Projected Cash Runway Through 2025 -
WALTHAM, Mass., March 5, 2024 – Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the fourth quarter and full year 2023 and recent business highlights.
“We’ve had an exciting start to 2024 highlighted by Dyne’s first clinical data demonstrating proof-of-concept in our DM1 and DMD programs that validated the promise of the FORCE™ platform in developing targeted therapeutics for people living with rare muscle diseases. We were thrilled to see dose-dependent results in our ACHIEVE trial in DM1 as well as meaningful improvement in myotonia at the lowest dose, and in our DELIVER trial to exceed the level of dystrophin production reported for the standard of care for DMD exon 51 with a fraction of the dose. The strength of these data formed the foundation of the $345 million offering we completed in January 2024, which has extended our projected cash runway through 2025,” said Joshua Brumm, president and chief executive officer of Dyne. “In 2024, we are focused on leveraging the favorable safety profiles for both DYNE-101 and DYNE-251 and the adaptive nature of our ACHIEVE and DELIVER trials to optimize dose and dose regimen. We plan to provide an update from both trials in the second half of 2024, including reporting data from multiple, higher dose cohorts. We also continue to pursue expedited regulatory pathways as part of our commitment to move with a sense of urgency to deliver potentially transformative therapies for the DM1 and Duchenne communities.”
Highlights from Clinical Programs
Phase 1/2 ACHIEVE Trial of DYNE-101 in DM1
1
Phase 1/2 DELIVER Trial of DYNE-251 in DMD
Other Business Highlights
Upcoming Events & Key 2024 Milestones
2
Fourth Quarter and Full Year 2023 Financial Results
Cash position: Cash, cash equivalents and marketable securities were $123.1 million as of December 31, 2023. In January 2024, the Company completed an underwritten public offering of 19,722,500 shares of its common stock for net proceeds of approximately $323.9 million. The Company expects that its cash, cash equivalents and marketable securities as of December 31, 2023, together with the net proceeds from the January 2024 underwritten public offering, will be sufficient to fund its operations through 2025.
Research and development (R&D) expenses: R&D expenses were $58.8 million and $33.2 million for the quarters ended December 31, 2023 and 2022, respectively. R&D expenses were $210.8 million and $142.8 million for the years ended December 31, 2023 and 2022, respectively.
General and administrative (G&A) expenses: G&A expenses were $8.8 million and $7.0 million for the quarters ended December 31, 2023 and 2022, respectively. G&A expenses were $31.4 million and $28.2 million for the years ended December 31, 2023 and 2022, respectively.
Net loss: Net loss for the quarter ended December 31, 2023 was $66.6 million, or $1.09 per basic and diluted share. This compares with a net loss of $38.8 million, or $0.74 per basic and diluted share, for the quarter ended December 31, 2022. Net loss for the year ended December 31, 2023 was $235.9 million, or $3.95 per basic and diluted share. This compares with a net loss of $168.1 million, or $3.23 per basic and diluted share, for the year ended December 31, 2022.
About Dyne Therapeutics
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Dyne’s strategy, future operations, prospects and plans, objectives of management, the potential of the FORCE platform, the trial design of the DYNE-101 and DYNE-251 clinical trials, the anticipated timelines for reporting data from the DYNE-101 and DYNE-251 clinical trials and initiating registrational cohorts, plans to optimize dose and dose regimen for DYNE-101 and DYNE-251 and the sufficiency of Dyne's cash resources for the period anticipated, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,”
3
“expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Dyne may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; the timing of and Dyne’s ability to initiate and enroll patients in clinical trials; whether results from preclinical studies and initial data from early clinical trials will be predictive of the final results of the clinical trials or future trials; whether Dyne’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Dyne’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-K and in subsequent filings Dyne may make with the SEC. In addition, the forward-looking statements included in this press release represent Dyne’s views as of the date of this press release. Dyne anticipates that subsequent events and developments will cause its views to change. However, while Dyne may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Dyne’s views as of any date subsequent to the date of this press release.
1. Safety data as of December 6, 2023
2. No head-to-head trials have been conducted comparing DYNE-251 to eteplirsen. Eteplirsen data may not be directly comparable due to differences in trial protocols, dosing regimens and patient populations. Accordingly, these cross-trial comparisons may not be reliable. Eteplirsen data from J Neuromuscul Dis. 2021; 8(6): 989–1001
Dyne Therapeutics, Inc. |
|
||||||||||||||
Condensed Consolidated Statement of Operations |
|
||||||||||||||
(in thousands, except share and per share data) |
|
||||||||||||||
|
Three Months Ended |
|
|
Year Ended |
|
||||||||||
|
December 31, |
|
|
December 31, |
|
||||||||||
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
$ |
58,843 |
|
|
$ |
33,191 |
|
|
$ |
210,762 |
|
|
$ |
142,760 |
|
General and administrative |
|
8,846 |
|
|
|
6,955 |
|
|
|
31,400 |
|
|
|
28,202 |
|
Total operating expenses |
|
67,689 |
|
|
|
40,146 |
|
|
|
242,162 |
|
|
|
170,962 |
|
Loss from operations |
|
(67,689 |
) |
|
|
(40,146 |
) |
|
|
(242,162 |
) |
|
|
(170,962 |
) |
Other (expense) income, net |
|
1,050 |
|
|
|
1,319 |
|
|
|
6,225 |
|
|
|
2,863 |
|
Net loss |
$ |
(66,639 |
) |
|
$ |
(38,827 |
) |
|
$ |
(235,937 |
) |
|
$ |
(168,099 |
) |
Net loss per share, basic and diluted |
$ |
(1.09 |
) |
|
$ |
(0.74 |
) |
|
$ |
(3.95 |
) |
|
$ |
(3.23 |
) |
Weighted average common shares outstanding, basic and diluted |
|
61,393,409 |
|
|
|
52,817,413 |
|
|
|
59,683,851 |
|
|
|
51,976,343 |
|
4
Dyne Therapeutics, Inc. |
|
|||||||
Condensed Consolidated Balance Sheet Data |
|
|||||||
(in thousands) |
|
|||||||
|
|
December 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Assets |
|
|
|
|
|
|
||
Cash, cash equivalents and marketable securities |
|
$ |
123,100 |
|
|
$ |
256,012 |
|
Other assets |
|
|
41,982 |
|
|
|
50,313 |
|
Total Assets |
|
$ |
165,082 |
|
|
$ |
306,325 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
||
Liabilities |
|
|
73,790 |
|
|
|
53,961 |
|
Stockholders' equity |
|
|
91,292 |
|
|
|
252,364 |
|
Total liabilities and stockholders' equity |
|
$ |
165,082 |
|
|
$ |
306,325 |
|
Contacts:
Investors
Amy Reilly
areilly@dyne-tx.com
857-341-1203
Media
Stacy Nartker
snartker@dyne-tx.com
781-317-1938
5