Company Quick10K Filing
Prevail Therapeutics
Price12.32 EPS-1
Shares34 P/E-12
MCap420 P/FCF-23
Net Debt-183 EBIT-35
TEV237 TEV/EBIT-7
TTM 2019-09-30, in MM, except price, ratios
10-Q 2020-06-30 Filed 2020-08-11
10-Q 2020-03-31 Filed 2020-05-14
10-K 2019-12-31 Filed 2020-03-26
10-Q 2019-09-30 Filed 2019-11-12
10-Q 2019-06-30 Filed 2019-08-14
S-1 2019-05-24 Public Filing
8-K 2020-09-09 Officers, Regulation FD, Exhibits
8-K 2020-08-11 Earnings, Regulation FD, Exhibits
8-K 2020-06-17
8-K 2020-05-14
8-K 2020-03-26
8-K 2020-03-02
8-K 2020-01-13
8-K 2020-01-09
8-K 2019-12-26
8-K 2019-11-15
8-K 2019-11-12
8-K 2019-10-08
8-K 2019-09-10
8-K 2019-08-15
8-K 2019-08-14
8-K 2019-06-24

PRVL 10Q Quarterly Report

Part I - Financial Information
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
Part II - Other Information
Item 1. Legal Proceedings.
Item 1A. Risk Factors.
Item 2.
Item 3. Defaults Upon Senior Securities
Item 4. Mine Safety Disclosures
Item 5. Other Information
Item 6. Exhibits
EX-5.1 prvl-ex51_386.htm
EX-10.1 prvl-ex101_532.htm
EX-31.1 prvl-ex311_6.htm
EX-31.2 prvl-ex312_7.htm
EX-32.1 prvl-ex321_8.htm

Prevail Therapeutics Earnings 2020-06-30

Balance SheetIncome StatementCash Flow

10-Q 1 prvl-10q_20200630.htm 10-Q prvl-10q_20200630.htm

 

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, 2020    

 

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: 001-38939

 

Prevail Therapeutics Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

82-2129632

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

 

430 East 29th Street, Suite 1520

New York, New York 10016

10016

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (917) 336-9310

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol

Name of exchange on which registered

Common Stock, par value $0.0001 per share

PRVL

The Nasdaq Stock Market LLC

 

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 August 5, 2020, the registrant had 34,214,851 shares of common stock, par value $0.0001 per share, outstanding.

 

 

 


Table of Contents

 

 

 

Page

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

1

 

 

 

PART I.

FINANCIAL INFORMATION

2

 

 

 

Item 1.

Financial Statements (Unaudited)

2

 

Balance Sheets

2

 

Statements of Operations and Comprehensive Loss

3

 

Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Deficit

4

 

Statements of Cash Flows

5

 

Notes to Unaudited Financial Statements

6

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

19

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

29

Item 4.

Controls and Procedures

29

 

 

 

 

 

 

PART II.

OTHER INFORMATION

30

 

 

 

Item 1.

Legal Proceedings

30

Item 1a.

Risk Factors

30

Item 2.

Recent Sales of Unregistered Securities

78

Item 3.

Defaults Upon Senior Securities

78

Item 4.

Mine Safety Disclosures

78

Item 5.

Other Information

78

Item 6.

Exhibits

79

 

SIGNATURES

80

 

 


SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements, including statements about:

 

our expectations regarding the initiation, timing, scope and results of our development activities, including our planned clinical trials;

 

 

the timing of and plans for regulatory filings;

 

our plans to obtain and maintain regulatory approvals of our product candidates in any of the indications for which we plan to develop them;

 

 

the potential benefits of our product candidates and technologies;

 

our expectations regarding our ability to identify additional gene therapy product candidates;

 

the market opportunities for our product candidates and our ability to maximize those opportunities;

 

our business strategies and goals;

 

estimates of our expenses, capital requirements and need for additional financing;

 

our expectations regarding potentially establishing manufacturing capabilities;

 

the performance of our third-party suppliers and manufacturers,

 

our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and our ability to operate our business without infringing on the intellectual property rights of others;

 

 

our expectations regarding any claims, arbitrations or litigation against us or our employees, including, for example, the arbitration hearings with Alector, Inc.;

 

 

our expectations regarding developments and projections relating to our competitors and any competing therapies that are or become available;

 

 

our ability to identify, recruit and retain key personnel;

 

the effects of the current COVID-19 pandemic on our business, operations and clinical development timelines and plans;

 

regulatory development in the United States and foreign countries; and

 

our expectations regarding the uses of the net proceeds from our initial public offering, or IPO; and

 

 

the sufficiency our existing cash and cash equivalents to fund our operations.

 

In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target” or “will” or the negative of these terms or other similar expressions intended to identify statements about the future. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently, uncertain and investors are cautioned not to unduly rely upon these statements.

You should read the section titled “Risk Factors” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Moreover, we operate in an evolving 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. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report on Form 10-Q will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

You should read this Quarterly Report on Form 10-Q, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

 

1


PART I—FINANCIAL INFORMATION

Prevail Therapeutics Inc.

Balance Sheets

(Unaudited)

(in thousands, except share and per share data)

 

 

 

June 30,

2020

 

 

December 31,

2019

 

 

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

111,065

 

 

$

168,051

 

Investments

 

 

6,458

 

 

 

 

Prepaid expenses and other current assets

 

 

4,620

 

 

 

6,410

 

Total current assets

 

 

122,143

 

 

 

174,461

 

Property and equipment, net

 

 

2,698

 

 

 

2,549

 

Investments

 

 

13,674

 

 

 

 

Operating lease right-of-use assets

 

 

9,355

 

 

 

10,001

 

Other long-term assets

 

 

2,730

 

 

 

 

Restricted cash

 

 

91

 

 

 

91

 

TOTAL ASSETS

 

$

150,691

 

 

$

187,102

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,981

 

 

$

5,162

 

Accrued expenses and other current liabilities

 

 

9,435

 

 

 

5,330

 

Operating lease liabilities

 

 

1,447

 

 

 

1,341

 

Total current liabilities

 

 

12,863

 

 

 

11,833

 

Long-term operating lease liabilities

 

 

9,173

 

 

 

9,927

 

TOTAL LIABILITIES

 

 

22,036

 

 

 

21,760

 

COMMITMENTS AND CONTINGENCIES (Note 13)

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Preferred stock - $0.0001 par value, 10,000,000 shares authorized

as of June 30, 2020 and December 31, 2019, respectively;

no shares issued as of June 30, 2020 and December 31, 2019, respectively

 

 

 

 

 

 

Common stock - $0.0001 par value, 200,000,000 shares authorized

   as of June 30, 2020 and December 31, 2019, respectively,

   34,214,851 and 34,138,750 shares issued and outstanding as

   of June 30, 2020 and December 31, 2019, respectively

 

 

3

 

 

 

3

 

Additional paid-in capital

 

 

253,430

 

 

 

249,441

 

Accumulated deficit

 

 

(124,777

)

 

 

(84,102

)

Accumulated other comprehensive loss

 

 

(1

)

 

 

 

Total stockholders’ equity

 

 

128,655

 

 

 

165,342

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

150,691

 

 

$

187,102

 

 

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

2


Prevail Therapeutics Inc.

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,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

12,943

 

 

$

11,955

 

 

$

24,360

 

 

$

20,366

 

General and administrative

 

 

9,208

 

 

 

3,713

 

 

 

17,070

 

 

 

5,598

 

Operating expenses

 

 

(22,151

)

 

 

(15,668

)

 

 

(41,430

)

 

 

(25,964

)

Other income

 

 

 

 

 

 

 

 

210

 

 

 

 

Interest income, net

 

 

51

 

 

 

565

 

 

 

545

 

 

 

916

 

Total other income

 

 

51

 

 

 

565

 

 

 

755

 

 

 

916

 

Net loss

 

$

(22,100

)

 

$

(15,103

)

 

$

(40,675

)

 

$

(25,048

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Net unrealized loss on investments

 

 

(1

)

 

 

 

 

 

(1

)

 

 

 

Total other comprehensive loss

 

 

(1

)

 

 

 

 

 

(1

)

 

 

 

Comprehensive loss

 

$

(22,101

)

 

$

(15,103

)

 

$

(40,676

)

 

$

(25,048

)

Net loss per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

$

(0.66

)

 

$

(0.58

)

 

$

(1.22

)

 

$

(1.05

)

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

 

33,467,346

 

 

 

26,212,356

 

 

 

33,367,344

 

 

 

23,945,198

 

 

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


 

3


Prevail Therapeutics Inc.

Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(Unaudited)

(in thousands except share data)

 

 

 

Series Seed

 

 

Series A

 

 

Series B

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred Stock

 

 

Preferred Stock

 

 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Accumulated Deficit

 

 

Accumulated Other Comprehensive Loss

 

 

Total Stockholders' Equity

 

For the three months ended June 30, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31, 2020

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

34,196,456

 

 

$

3

 

 

$

251,135

 

 

$

(102,677

)

 

$

 

 

$

148,461

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,249

 

 

 

 

 

 

 

 

 

2,249

 

Exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

18,395

 

 

 

 

 

 

46

 

 

 

 

 

 

 

 

 

46

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,100

)

 

 

 

 

 

(22,100

)

Net unrealized loss on investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1

)

 

 

(1

)

Balance at June 30, 2020

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

34,214,851

 

 

$

3

 

 

$

253,430

 

 

$

(124,777

)

 

$

(1

)

 

$

128,655

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the three months ended June 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31, 2019

 

 

6,480,000

 

 

$

3,524

 

 

 

8,997,085

 

 

$

76,186

 

 

 

3,958,046

 

 

$

49,834

 

 

 

7,209,000

 

 

$

1

 

 

$

3,108

 

 

$

(30,859

)

 

$

 

 

$

(27,750

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,109

 

 

 

 

 

 

 

 

 

1,109

 

Conversion of convertible preferred stock into common stock upon the closing of initial public offering

 

 

(6,480,000

)

 

 

(3,524

)

 

 

(8,997,085

)

 

 

(76,186

)

 

 

(3,958,046

)

 

 

(49,834

)

 

 

19,435,131

 

 

 

1

 

 

 

129,542

 

 

 

 

 

 

 

 

 

129,543

 

Issuance of common stock upon closing

of initial public offering, net of issuance

costs of $3,016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,353,000

 

 

 

1

 

 

 

113,235

 

 

 

 

 

 

 

 

 

113,236

 

Exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

24,063

 

 

 

 

 

 

4

 

 

 

 

 

 

 

 

 

4

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,103

)

 

 

 

 

 

(15,103

)

Balance at June 30, 2019

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

34,021,194

 

 

$

3

 

 

$

246,998

 

 

$

(45,962

)

 

$

 

 

$

201,039

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the six months ended June 30, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2019

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

34,138,750

 

 

$

3

 

 

$

249,441

 

 

$

(84,102

)

 

$

 

 

$

165,342

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,881

 

 

 

 

 

 

 

 

 

3,881

 

Exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

76,101

 

 

 

 

 

 

108

 

 

 

 

 

 

 

 

 

108

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(40,675

)

 

 

 

 

 

(40,675

)

Net unrealized loss on investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1

)

 

 

(1

)

Balance at June 30, 2020

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

34,214,851

 

 

$

3

 

 

$

253,430

 

 

$

(124,777

)

 

$

(1

)

 

$

128,655

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the six months ended June 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2018

 

 

6,480,000

 

 

$

3,524

 

 

 

8,997,085

 

 

$

76,186

 

 

 

 

 

$

 

 

 

7,209,000

 

 

$

1

 

 

$

2,496

 

 

$

(20,914

)

 

$

 

 

$

(18,417

)

Issuance of Series B Preferred Stock,

net of issuance costs of $166

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,958,046

 

 

 

49,834

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,721

 

 

 

 

 

 

 

 

 

1,721

 

Conversion of convertible preferred stock

into common stock upon the closing of

initial public offering

 

 

(6,480,000

)

 

 

(3,524

)

 

 

(8,997,085

)

 

 

(76,186

)

 

 

(3,958,046

)

 

 

(49,834

)

 

 

19,435,131

 

 

 

1

 

 

 

129,542

 

 

 

 

 

 

 

 

 

129,543

 

Issuance of common stock upon closing

of initial public offering, net of issuance

costs of $3,016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,353,000

 

 

 

1

 

 

 

113,235

 

 

 

 

 

 

 

 

 

113,236

 

Exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

24,063

 

 

 

 

 

 

4

 

 

 

 

 

 

 

 

 

4

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(25,048

)

 

 

 

 

 

(25,048

)

Balance at June 30, 2019

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$