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 9, 2017

 

Dova Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware
(State or Other Jurisdiction
of Incorporation)

 

001-38135
(Commission
File Number)

 

81-3858961
(IRS Employer
Identification No.)

 

240 Leigh Farm Road, Suite 245
Durham, North Carolina

(Address of Principal Executive Offices)

 

27707
(Zip Code)

 

Registrant’s telephone number, including area code: (919) 748-5975

 

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:

 

o     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o     Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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 x

 

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. x

 

 

 



 

Item 2.02  Results of Operations and Financial Condition.

 

On November 9, 2017, Dova Pharmaceuticals, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter and nine months ended September 30, 2017. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

 

In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, and Exhibit 99.1 hereto, 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 liability of that section, nor shall it be deemed incorporated by reference in any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

 

 

Number

 

Exhibit Description

99.1

 

Press Release, dated November 9, 2017, “Dova Pharmaceuticals Reports Third Quarter 2017 Operating and Financial Results”

 

2



 

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.

 

 

Dova Pharmaceuticals, Inc.

 

 

 

 

Date: November 9, 2017

/s/ Douglas Blankenship

 

Douglas Blankenship

 

Chief Financial Officer

 

3


Exhibit 99.1

 

 

Dova Pharmaceuticals Reports Third Quarter 2017 Operating and Financial Results

 

NDA for avatrombopag submitted to FDA

 

Conference call scheduled for 4:30 p.m. EST today

 

DURHAM, NC, November 9, 2017 — Dova Pharmaceuticals, Inc. (NASDAQ: DOVA) today reported its operating and financial results for the quarter ended September 30, 2017.

 

Third Quarter and Recent Highlights

 

·                  Submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Dova’s drug candidate, avatrombopag, for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure

 

·                  Oral presentation of the ADAPT-1 and ADAPT-2 clinical trial results at the Liver meeting of the American Association for the Study of Liver Diseases (AASLD)

 

·                  Initiated build-out of our commercial infrastructure in preparation for the anticipated U.S. launch of avatrombopag in 2018

 

·                  Continued progress towards initiation of clinical trials for avatrombopag in broader indications of thrombocytopenia, beginning potentially in the first quarter of 2018

 

Alex Sapir, President and Chief Executive Officer of Dova, commented, “The highlight of the third quarter was the submission of our NDA for avatrombopag to the FDA. This submission represents a significant milestone in the advancement of this novel therapy to become a treatment option for the more than 70,000 CLD patients with severe thrombocytopenia in the US.” Dova continues the build-out of its Medical Affairs and Commercial infrastructure including the hiring of a Medical Science Liaison team as well as an experienced Marketing and Market Access team.  In addition, Dova continues to make progress towards initiating clinical trials that explore the use of avatrombopag in broader indications including patients undergoing surgical procedures associated with a high risk of bleeding and in patients who develop thrombocytopenia after receiving chemotherapy.

 

Financial Results

 

Dova reported a net loss of $9.7 million for the third quarter of 2017, compared to a net loss of $7.2 million for the same period in 2016. Research and development expenses were $5.4 million in the third quarter of 2017, compared to $6.8 million for the same period in 2016. The decrease was primarily due to the completion of the ADAPT-1 and ADAPT-2 Phase 3 clinical trials in January 2017, partially offset by costs related to submission of the NDA.

 



 

General and administrative expenses were $4.2 million in the third quarter of 2017, compared to $0.4 million for the same period in 2016. The increase was primarily due to building our medical affairs and commercial teams to support the launch and ongoing clinical development program for avatrombopag.

 

As of September 30, 2017, Dova had $100.4 million in cash and cash equivalents compared to $28.7 million as of December 31, 2016. The increase was primarily due to Dova’s Initial Public Offering which closed in July 2017.

 

Company to Host Conference Call

 

Dova will host a conference call today, November 9, 2017 at 4:30 p.m. EST to discuss third quarter 2017 financial results and recent operational highlights. A question-and-answer session will follow Dova’s remarks.

 

To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 9965479 five to 10 minutes before the start of the call.

 

A live audio webcast of the call will also be available via the “Investor Relations” page of the Dova website, www.dova.com. Please log on through Dova’s website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on Dova’s website for 90 days following the call.

 

About Dova Pharmaceuticals, Inc.

 

Dova is a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, with an initial focus on addressing thrombocytopenia. Dova’s lead drug candidate, avatrombopag, has successfully completed two pivotal Phase 3 clinical trials for the treatment of thrombocytopenia in patients with CLD scheduled to undergo a procedure and an NDA has been submitted to the FDA for this initial indication.

 

Cautionary Note Regarding Forward-Looking Statements

 

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  These statements may be identified by words such as “anticipated”, “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Dova’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential U.S. launch for avatrombopag in patients with CLD who are scheduled to

 



 

undergo a procedure and the clinical development of avatrombopag for other indications. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, increased regulatory requirements, Dova’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Dova’s Quarterly Report on Form 10-Q for the quarter ended June 30th, 2017, filed with the U.S. Securities and Exchange Commission (SEC) on August 14, 2017, and Dova’s other periodic reports filed with the SEC.  Any forward-looking statements speak only as of the date of this press release and are based on information available to Dova as of the date of this release, and Dova assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

###

 

Contacts

 

Doug Blankenship

(919) 748-5975

dblankenship@dova.com

 

Westwicke Partners

John Woolford

(443) 213-0506

john.woolford@westwicke.com

 



 

Dova Pharmaceuticals, Inc.

 

Condensed Consolidated Statements of Operations

 

(in thousands, except share and per share amounts)

 

(Unaudited)

 

 

 

For the three months ended

 

For the nine months
ended

 

For the period from
March 24, 2016
(Inception) to

 

 

 

September 30, 2017

 

September 30, 2016

 

September 30, 2017

 

September 30, 2016

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

4,426

 

$

6,758

 

$

11,995

 

$

13,898

 

Research and development - licenses acquired

 

1,000

 

 

1,000

 

5,000

 

General and administrative

 

4,185

 

368

 

7,045

 

643

 

Total operating expenses

 

9,611

 

7,126

 

20,040

 

19,541

 

Loss from operations

 

(9,611

)

(7,126

)

(20,040

)

(19,541

)

 

 

 

 

 

 

 

 

 

 

Total other expenses, net

 

(112

)

(48

)

(614

)

(49

)

Net loss

 

$

(9,723

)

$

(7,174

)

$

(20,654

)

$

(19,590

)

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.38

)

$

(0.41

)

$

(1.03

)

$

(1.13

)

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic and diluted

 

25,290,709

 

17,332,257

 

20,014,226

 

17,297,398

 

 

Summary Balance Sheet Data

 

(in thousands)

 

(Unaudited)

 

 

 

September 30,

 

December 31,

 

 

 

2017

 

2016

 

 

 

(Unaudited)

 

 

 

Cash and cash equivalents

 

$

100,414

 

$

28,709

 

Total assets

 

$

101,447

 

$

28,746

 

Note payable, short-term and long-term, respectively

 

$

27,119

 

$

13,640

 

Total liabilities

 

$

33,836

 

$

21,951

 

Total stockholders’ equity

 

$

67,611

 

$

6,795