dyn-8k_20201105.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): November 5, 2020

 

Dyne Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

Delaware

001-39509

36-4883909

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

 

 

 

830 Winter Street

Waltham, Massachusetts

 

02451

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (781) 786-8230

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

Common stock, $0.0001 par value per share

 

DYN

 

Nasdaq Global Select Market

 

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 November 5, 2020, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 2020. 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

  

Press Release issued by Dyne Therapeutics, Inc. on November 5, 2020

 

 


 

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: November 5, 2020

 

By:

 

/s/ Joshua Brumm

 

 

 

 

Name:

 

Joshua Brumm

 

 

 

 

Title:

 

President and Chief Executive Officer

 

 

dyn-ex991_24.htm

Exhibit 99.1

 

 

Dyne Therapeutics Reports Third Quarter 2020 Financial Results and
Recent Highlights

- Successful Financings, including $268 Million Initial Public Offering and $116 Million Series B Expected to Fund Through Proof of Concept Data in Co-lead Programs, Myotonic Dystrophy Type 1 and Duchenne Muscular Dystrophy -

WALTHAM, Mass., November 5, 2020 Dyne Therapeutics, Inc. (Nasdaq: DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the third quarter 2020 and recent business highlights.

“We made important progress across the business in the third quarter, including securing significant funding through multiple financings culminating with our IPO, continuing to attract exceptional leaders to Dyne with expertise in muscle and rare diseases, and generating platform-validating preclinical data that is creating momentum for our pipeline,” said Joshua Brumm, president and chief executive officer of Dyne. “We expect we have the cash resources to support our planned IND submissions for our three programs between the fourth quarter of 2021 and the fourth quarter of 2022, and to achieve proof-of-concept data for two of those – our myotonic dystrophy type 1 and Duchenne muscular dystrophy programs. Following this exciting third quarter, Dyne is well positioned to pursue our goal of becoming the world’s leading muscle disease company.”

Recent Highlights

On September 21, 2020, Dyne completed its IPO of 14,089,314 shares of its common stock, including the full exercise by the underwriters of their option to purchase 1,837,736 additional shares, at an IPO price of $19.00 per share. Gross proceeds of the offering, before deducting the underwriting discount and commissions and offering expenses, were $267.7 million.

The Company continued to generate preclinical data during the quarter for its myotonic dystrophy type 1 (DM1) program:

 

o

The importance of Transferrin 1 receptor (TfR1), which is highly expressed on muscle cells, is foundational to Dyne’s FORCE platform and approach to developing modern oligonucleotide therapeutics for serious muscle diseases. To accelerate its work across its platform and programs, Dyne developed a preclinical model for DM1 which expresses the human TfR1 receptor rather than the murine TfR1 receptor. In a preclinical study utilizing this model, two doses of the FORCE conjugate targeting TfR1 resulted in significant reductions in cytoplasmic wild type DMPK RNA in the tibialis anterior, gastrocnemius, heart and diaphragm muscles.

 

o

In a separate study of DM1 patient cells, a single dose of Dyne’s FORCE conjugate reduced nuclear DMPK foci by approximately 40 percent as determined through a fluorescence in situ hybridization analysis.

In August 2020, Dyne completed its Series B preferred stock financing, raising gross proceeds of $115.7 million.


 

In August 2020, Dyne appointed Susanna High, MBA, as its chief operating officer (COO). Ms. High has more than two decades of experience leading corporate strategy, portfolio management, business planning and operations for biotechnology companies. Prior to joining Dyne, her most recent position was COO of bluebird bio, and previously she held roles of increasing responsibility at Alnylam Pharmaceuticals, including as senior vice president, strategy and business integration.

In July 2020, the Company appointed pediatric neurologist Francesco Muntoni, FRCPCH, FMedSci, to its Scientific Advisory Board. Dr. Muntoni is a global leader in clinical research into neuromuscular disease, with particular expertise in clinical care, clinical trial design and drug development for Duchenne muscular dystrophy.

Romesh Subramanian, Ph.D., chief scientific officer, reviews Dyne’s novel approach to developing modern oligonucleotides for serious muscle diseases at TIDES Europe: Oligonucleotide & Peptide Therapeutics in a presentation that is available on demand for registered attendees at https://informaconnect.com/tides-europe/. Dr. Subramanian will also participate in a panel discussion, “Oligonucleotide Delivery Beyond Liver and Targeted Delivery,” during the virtual conference on Wednesday, November 11, 2020 at 9:45 am ET.

Third Quarter 2020 Financial Results

Cash and cash equivalents: Cash and cash equivalents were $379.6 million as of September 30, 2020 compared to $14.6 million as of December 31, 2019.

Research and development (R&D) expenses: R&D expenses were $9.7 million for the third quarter 2020 compared to $3.0 million for the third quarter of 2019.

General and administrative (G&A) expenses: G&A expenses were $3.8 million during the third quarter of 2020 compared to $0.6 million for the third quarter of 2019.

Net loss: Net loss was $13.9 million or $2.01 per common share for the third quarter 2020 compared to $5.9 million, or $2.36 per common share for the third quarter 2019.

About Dyne Therapeutics

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. The Company utilizes its proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on TwitterLinkedIn 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, plans, objectives of management, the expected timeline for submitting investigational new drug applications and achieving proof-of-concept data readouts and the sufficiency of its cash resources, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,”

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“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 conduct of research activities, the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies; the timing of and Dyne’s ability to submit and obtain regulatory approval for investigational new drug applications; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; Dyne’s ability to obtain sufficient cash resources to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; the impact of the COVID-19 pandemic on Dyne’s business and operations; 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-Q 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.

Contact:

Dyne Therapeutics

Amy Reilly

areilly@dyne-tx.com

857-341-1203

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Dyne Therapeutics, Inc.

Condensed Statement of Operations (Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

9,679

 

 

$

2,982

 

 

$

23,102

 

 

$

6,781

 

General and administrative

 

 

3,841

 

 

 

647

 

 

 

6,945

 

 

 

1,575

 

Total operating expenses

 

 

13,520

 

 

 

3,629

 

 

 

30,047

 

 

 

8,356

 

Loss from operations

 

 

(13,520

)

 

 

(3,629

)

 

 

(30,047

)

 

 

(8,356

)

Other (expense income)

 

 

(400

)

 

 

(2,242

)

 

 

(741

)

 

 

(1,100

)

Net loss

 

$

(13,920

)

 

$

(5,871

)

 

$

(30,788

)

 

$

(9,456

)

Net loss per sharebasic and diluted

 

$

(2.01

)

 

$

(2.36

)

 

$

(7.51

)

 

$

(3.94

)

Weighted-average common shares outstanding used in net

   loss per share—basic and diluted

 

 

6,920,008

 

 

 

2,491,487

 

 

 

4,100,504

 

 

 

2,401,039

 

 

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Dyne Therapeutics, Inc.

Condensed Balance Sheet Data (Unaudited)

(in thousands)

 

 

 

September 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

379,606

 

 

$

14,632

 

Other assets

 

 

1,866

 

 

 

1,804

 

Total assets

 

$

381,472

 

 

$

16,436

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

 

 

Liabilities

 

 

14,627

 

 

 

2,400

 

Stockholders' equity

 

 

366,845

 

 

 

14,036

 

Total liabilities and stockholders' equity

 

$

381,472

 

 

$

16,436

 

 

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