prvl-8k_20200514.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):

May 14, 2020

 

Prevail Therapeutics Inc.

 

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

Delaware

 

001-38939

 

82-2129632

(state or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

 

430 East 29th Street, Suite 1520

New York, New York

 

10016

(Address of principal executive offices)

 

(Zip Code)

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

(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:

 

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, par value $0.0001 per share

PRVL

The Nasdaq Stock Market LLC

 

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 12b2 of the Securities Exchange Act of 1934 (§ 240.12b2 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 May 14, 2020, Prevail Therapeutics Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2020. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed to be “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 in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, except as otherwise expressly stated in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit 

No.

 

Description

 

 

99.1

 

Press Release dated May 14, 2020.

 

 

 

 

 



SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

PREVAIL THERAPEUTICS INC.

 

 

By:

 

/s/ Brett Kaplan, M.D.

 

 

Brett Kaplan, M.D.

Chief Financial Officer

Dated: May 14, 2020

prvl-ex991_6.htm

Exhibit 99.1

 

Prevail Therapeutics Reports First Quarter 2020 Financial Results and Business Highlights

 

Phase 1/2 Trial of PR001 for Parkinson’s Disease with GBA1 Mutations Ongoing; Study Startup Activities Progressing for Phase 1/2 Trials of PR001 for Type 2 Neuronopathic Gaucher Disease and PR006 for Frontotemporal Dementia with GRN Mutations

 

Data Presentations Highlight Potential of AAV Gene Therapy Approach to

Slow or Stop Neurodegenerative Disease Progression in Preclinical Models

 

 

NEW YORK, May 14, 2020 -- Prevail Therapeutics Inc. (Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today reviewed recent business highlights and reported financial results for the first quarter ended March 31, 2020.

 

“We are excited to continue the clinical development of PR001 and are on track to report interim data for a subset of patients from our Phase 1/2 clinical trial of PR001 for Parkinson’s disease with GBA1 mutations (PD-GBA) later this year. In addition, we are advancing our AAV gene therapy-based pipeline, with the planned mid-year initiation of Phase 1/2 clinical trials of PR001 for Type 2 neuronopathic Gaucher disease (nGD) and PR006 for frontotemporal dementia with GRN mutations (FTD-GRN).” said Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail. “In addition, at ASGCT and AAT-AD/PD, we presented or will present data that validate the potential of these products for neurodegenerative disease patients with urgent unmet needs, and detailed our ongoing and planned clinical trials.”

 

Recent Business Highlights and Updates:

 

 

Data and Clinical Trial Designs Presented or to be Presented for PR001 in nGD and PR006 in FTD-GRN at the 2020 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting: In separate presentations, Prevail described the design of two planned clinical trials: the PROVIDE Phase 1/2 clinical trial of PR001 for the treatment of patients with Type 2 nGD, and the PROCLAIM Phase 1/2 clinical trial of PR006 for the treatment of FTD-GRN. Preclinical data serving as the basis for the company’s clinical programs, including PR001 for nGD and PD-GBA and PR006 for FTD-GRN, will also be presented.

 

 

Data and Clinical Trial Design Presented for PR001 in PD-GBA and PR006 in FTD-GRN at the AAT-AD/PD Focus Meeting 2020: Advances in Alzheimer’s and Parkinson’s Therapies: Presentations at the AAT-AD/PD Focus Meeting included details on the design of Prevail’s PROPEL Phase 1/2 clinical trial to evaluate the safety and efficacy of PR001 in patients with PD-GBA, and preclinical data related to PR001 for PD-GBA and PR006 for FTD-GRN.

 

 

Clinical Development of PR001: As announced in March 2020, Prevail initiated dosing for the PROPEL Phase 1/2 trial of PR001 for patients with PD-GBA. As previously reported, in response to the COVID-19 pandemic, trial sites had temporarily suspended patient screening and enrollment activity. Prevail now expects patient screening to resume by the end of the second


 

quarter of 2020 at certain clinical sites. The Company remains on track to report interim data on a subset of patients in the second half of 2020.

 

In addition, study startup activities are continuing for the PROVIDE Phase 1/2 clinical trial of PR001 for Type 2 nGD, and the Company intends to initiate dosing in mid-2020. Prevail also continues to expect to initiate the PROGRESS Phase 1/2 clinical trial of PR001 for Type 3 nGD in the second half of 2020. The timelines for PR001 are subject to any delays related to the COVID-19 pandemic.

 

Clinical Development of PR006: Study startup activities are also underway for the PROCLAIM Phase 1/2 clinical trial of PR006 for FTD-GRN patients, which is planned to initiate in mid-2020, subject to any delays related to the COVID-19 pandemic.

 

First Quarter 2020 Financial Results

 

 

Cash Position: Cash and cash equivalents were $149.6 million as of March 31, 2020, as compared to $168.1 million as of December 31, 2019. As previously guided, the Company expects its current cash position to be sufficient to fund operating expenses into the first half of 2022.

 

 

R&D Expenses: R&D expenses were $11.4 million for the three months ended March 31, 2020, compared to $8.4 million for the three months ended March 31, 2019. The increase was primarily related to the Company’s development programs, specifically as a result of increased clinical trial activities, and headcount.

 

 

G&A Expenses: G&A expenses were $7.9 million for the three months ended March 31, 2020, compared to $1.9 million for the three months ended March 31, 2019. The increase was primarily due to an increase in professional services fees associated with the ongoing arbitration matter, personnel costs resulting from increased headcount, and other corporate and public company-related expenses.

 

 

Net Loss: Net loss was $18.6 million, or $0.56 loss per share, for the three months ended March 31, 2020, compared to $9.9 million, or $1.73 loss per share, for the three months ended March 31, 2019.

 

About Prevail Therapeutics

Prevail is a gene therapy company leveraging breakthroughs in human genetics with the goal of developing and commercializing disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases. The company is developing PR001 for patients with Parkinson’s disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease; PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN); and PR004 for patients with certain synucleinopathies.

 

Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson’s with GBA and OrbiMed, and is headquartered in New York, NY.

 

 

 


Forward-Looking Statements Related to Prevail

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the potential impact of COVID-19 on Prevail’s ongoing and planned clinical trials, business and operations; the potential of Prevail’s gene therapies to modify the course of neurodegenerative diseases; the anticipated timing of Prevail’s clinical trials of PR001 in PD-GBA and in nGD and Prevail’s clinical trial of PR006, including resuming of delayed trials and initiation of new trials; the expected timing of reporting of interim data for a subset of patients from Prevail’s Phase 1/2 clinical trial of PR001; and expectations regarding Prevail’s cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Prevail’s novel approach to gene therapy makes it difficult to predict the time, cost and potential success of product candidate development or regulatory approval; Prevail’s gene therapy programs may not meet safety and efficacy levels needed to support ongoing clinical development or regulatory approval; the regulatory landscape for gene therapy is rigorous, complex, uncertain and subject to change; the fact that gene therapies are novel, complex and difficult to manufacture; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

 

These and other risks are described more fully in Prevail’s filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2020, filed with the SEC on or about May 14, 2020, the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the SEC on March 26, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Prevail undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

 

Prevail Therapeutics Inc.

Statements of Operations

(Unaudited)

(in thousands, except share and per share data)

 

 

 

 

Three Months Ended March 31,

 

 

 

 

2020

 

 

2019

 

Operating Expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

 

$

11,417

 

 

$

8,411

 

General and administrative

 

 

 

7,862

 

 

 

1,885

 

Total operating loss

 

 

 

(19,279

)

 

 

(10,296

)

Other income

 

 

 

210

 

 

 

 

Interest income

 

 

 

494

 

 

 

351

 

Total other income

 

 

 

704

 

 

 

351

 

Net loss

 

 

$

(18,575

)

 

$

(9,945

)

Net loss per share, basic and diluted

 

 

$

(0.56

)

 

$

(1.73

)

Weighted average shares outstanding, basic and diluted

 

 

 

33,267,342

 

 

 

5,740,874

 


Balance Sheets

(in thousands, except share and per share data)

 

 

 

March 31,

2020

 

 

December 31,

2019

 

 

 

(unaudited)

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

149,580

 

 

 

168,051

 

Prepaid expenses and other current assets

 

 

4,909

 

 

 

6,410

 

Total current assets

 

 

154,489

 

 

 

174,461

 

Property and equipment, net

 

 

2,725

 

 

 

2,549

 

Operating lease right-of-use assets

 

 

9,682

 

 

 

10,001

 

Other long-term assets

 

 

1,817

 

 

 

 

Restricted cash

 

 

91

 

 

 

91

 

TOTAL ASSETS

 

$

168,804

 

 

$

187,102

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

Accounts payable

 

 

3,943

 

 

$

5,162

 

Accrued expenses and other current liabilities

 

 

5,452

 

 

 

5,330

 

Operating lease liabilities

 

 

1,395

 

 

 

1,341

 

Total current liabilities

 

 

10,790

 

 

 

11,833

 

Long-term operating lease liabilities

 

 

9,553

 

 

 

9,927

 

TOTAL LIABILITIES

 

 

20,343

 

 

 

21,760

 

COMMITMENTS AND CONTINGENCIES (Note 12)

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

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

as of March 31, 2020 and December 31, 2019, respectively;

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

 

 

 

 

 

 

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

shares authorized as of March 31, 2020 and December 31, 2019,

respectively, 34,196,456 and 34,138,750 shares issued and outstanding

as of March 31, 2020 and December 31, 2019, respectively

 

 

3

 

 

 

3

 

Additional paid-in capital

 

 

251,135

 

 

 

249,441

 

Accumulated deficit

 

 

(102,677

)

 

 

(84,102

)

Total stockholders’ equity

 

 

148,461

 

 

 

165,342

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

168,804

 

 

$

187,102

 



Media Contact:

Mary Carmichael

Ten Bridge Communications

mary@tenbridgecommunications.com

617-413-354

 

Investor Contact:

investors@prevailtherapeutics.com