0001104659-15-055887.txt : 20150818 0001104659-15-055887.hdr.sgml : 20150818 20150804161520 ACCESSION NUMBER: 0001104659-15-055887 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20150804 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150804 DATE AS OF CHANGE: 20150804 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Vitae Pharmaceuticals, Inc CENTRAL INDEX KEY: 0001157602 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043567753 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36617 FILM NUMBER: 151025737 BUSINESS ADDRESS: STREET 1: 502 WEST OFFICE CENTER DR CITY: FORT WASHINGTON STATE: PA ZIP: 19034 BUSINESS PHONE: 215-461-2000 MAIL ADDRESS: STREET 1: 502 WEST OFFICE CENTER DR CITY: FORT WASHINGTON STATE: PA ZIP: 19034 FORMER COMPANY: FORMER CONFORMED NAME: Vitae Pharmaceuticals Inc DATE OF NAME CHANGE: 20050118 FORMER COMPANY: FORMER CONFORMED NAME: CONCURRENT PHARMACEUTICALS INC DATE OF NAME CHANGE: 20010815 8-K 1 a15-16861_18k.htm 8-K

 

 

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):  August 4, 2015

 


 

VITAE PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

 


 

Delaware
(State or Other Jurisdiction of
Incorporation)

 

001-36617
(Commission File Number)

 

04-3567753
(IRS Employer Identification No.)

 

502 West Office Center Drive
Fort Washington, PA 19034
(Address of Principal Executive Offices)

 

19034
(Zip Code)

 

Registrant’s telephone number, including area code: (215) 461-2000

 


 

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):

 

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))

 

 

 



 

Item 2.02.         Results of Operations and Financial Condition.

 

On August 4, 2015, Vitae Pharmaceuticals, Inc. (the “Company” or “Vitae”) issued a press release and is holding a conference call regarding its results of operations and financial condition for the quarter ended June 30, 2015. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

Various statements to be made during the conference call are “forward-looking statements” under the securities laws, including, but not limited to, statements regarding Vitae’s plans for its product candidates. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

 

Important factors that could cause actual results to differ materially from those reflected in Vitae’s forward-looking statements include, among others, the timing and success of preclinical studies and clinical trials conducted by Vitae and its development partners; the ability to establish and maintain development partnerships; the scope, progress, expansion, and costs of developing and commercializing Vitae’s current or future product candidates; the size and growth of the potential markets for Vitae’s current or future product candidates and the ability to serve those markets; Vitae’s expectations regarding Vitae’s expenses and revenue, the sufficiency of Vitae’s cash resources and needs for additional financing; the ability to obtain and maintain regulatory approval of Vitae’s product candidates, and the labeling for any approved products; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vitae’s Annual Report on Form 10-K for the year ended December 31, 2014 and Vitae’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Additional information will also be set forth in those sections of Vitae’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, which will be filed with the SEC in the third quarter of 2015.

 

In addition to the risks described above and in Vitae’s other filings with the SEC, other unknown or unpredictable factors could also affect Vitae’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information conveyed on the conference call is provided only as of the date of the call, and Vitae undertakes no obligation to update any forward-looking statements presented on the call on account of new information, future events, or otherwise, except as required by law.

 

The information in Item 2.02 of this Current Report on Form 8-K and the Exhibit attached 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 liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01.         Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.

 

Description

99.1

 

Press Release of Vitae Pharmaceuticals, Inc., dated August 4, 2015

 

2



 

SIGNATURE

 

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.

 

 

 

VITAE PHARMACEUTICALS, INC.

 

 

 

 

 

 

Date: August 4, 2015

By:

/s/ Jeffrey S. Hatfield

 

 

Jeffrey S. Hatfield

 

 

Chief Executive Officer

 

3


EX-99.1 2 a15-16861_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Vitae Pharmaceuticals Reports Second Quarter 2015 Operating and Financial Results

 

Multiple potential milestones in 2H 2015

 

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

 

FORT WASHINGTON, PA, August 4, 2015 — Vitae Pharmaceuticals, Inc. (NASDAQ: VTAE), a clinical-stage biotechnology company developing a robust and growing portfolio generated by its proprietary structure-based drug discovery platform, reported today its operating and financial results for the second quarter ended June 30, 2015.

 

“During the second quarter of 2015, we initiated a Phase 1 study of VTP-43742, our first-in-class RORγt candidate for the treatment of autoimmune disorders. Initiation of this study was a major accomplishment for the team, as it positions the Company well to deliver expected proof-of-concept efficacy results for the program by the end of 2015,” commented Jeff Hatfield, President and Chief Executive Officer of Vitae. “We also made progress in the development of our atopic dermatitis program, which we believe has the potential to address significant unmet medical need. We look forward to announcing multiple data milestones throughout the remainder of the year.”

 

Quarterly and Recent Highlights

 

Pipeline Updates:

 

VTP-43742 in Autoimmune Disorders

 

·                  Vitae initiated a Phase 1 single ascending dose clinical trial of VTP-43742, its first-in-class RORyt product candidate for the treatment of autoimmune disorders. This trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-43742 in approximately 56 healthy human volunteers over several cohorts, with results expected in the second half of 2015. The Company also intends to initiate an overlapping Phase 1 multiple ascending dose, proof-of-concept clinical trial of VTP-43742 in the third quarter of 2015, which will be a double-blind, placebo-controlled trial of approximately 48 healthy volunteers and approximately 60 patients with moderate to severe psoriasis. Top-line clinical efficacy results from the proof-of-concept trial are expected by the end of 2015.

 

Vitae Pharmaceuticals, Inc.

Tel: (215) 461-2000

502 West Office Center Drive

Fax: (215) 461-2006

Fort Washington, PA 19034

www.vitaepharma.com

 



 

VTP-38543 in Atopic Dermatitis

 

·                  Vitae continued to advance VTP-38543, its first-in-class product candidate for the treatment of atopic dermatitis. Vitae plans to initiate a Phase 1 clinical trial in the second half of 2015. Phase 1 efficacy proof-of-concept results are expected in 2016.

 

Partnered Programs:

 

·                  Vitae announced top-line clinical efficacy results from the metformin arm of an ongoing Phase 2 proof-of-concept clinical trial of BI187004/VTP-34072 in the treatment of overweight type 2 diabetic patients. Primary efficacy data (fasting plasma glucose) from the metformin arm did not meet Boehringer Ingelheim’s (BI) predefined endpoint criteria. Data from the placebo-controlled monotherapy arm of the trial, which is still ongoing, are expected to be reported later this year. Together, these data sets will be used by BI to determine appropriate next steps for BI187004/VTP-34072.

 

·                  Vitae recently announced the end of the research collaboration and license agreement for beta secretase (BACE) inhibitors. Termination of the agreement by BI for strategic business reasons will be effective October 21, 2015. In connection with the termination of the agreement, Vitae expects to receive the rights to the BACE program, including BI 1147560/VTP-36951. Under the BACE agreement, no material payments are required to be made by or to the Company in connection with the termination of the agreement. Vitae plans to assess the program and revise its operating plan accordingly after determining the appropriate next steps.  The Company will provide an update for the BACE program in the second half of 2015.

 

Financial Results:

 

·                  Operating Expense. Total operating expenses for the second quarter of 2015 were $10.0 million, compared with $6.2 million for the second quarter of 2014.

 

·                  Research and development expenses were $7.8 million for the second quarter of 2015, compared with $4.9 million for the same period in 2014. The increase was largely attributable to expenses related to the RORγt program, including VTP-43742, Vitae’s atopic dermatitis program and discovery efforts.

·                  General and administrative expenses were $2.3 million for the second quarter of 2015, compared with $1.4 million for the same period in 2014. The change was primarily due to increased costs relating to being a public company.

 

·                  Net Loss. Vitae reported a net loss of $9.8 million for the second quarter of 2015, compared with a net loss of $5.1 million for the second quarter of 2014.

 

·                  Cash Position. As of June 30, 2015, Vitae had $80.3 million in cash, cash equivalents and marketable securities, compared to $65.3 million as of December 31, 2014. The increase in

 



 

cash position was primarily a result of the completion of the Company’s follow-on public offering in the first quarter of 2015. Based on the Company’s current operating plan, which as of now does not include any expenses relating to further development of the BACE program, the Company believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its projected operating requirements through the end of 2016.

 

Expected Milestones

 

·                  VTP-43742 in Autoimmune Disorders — Initiation of a Phase 1 multiple ascending dose proof-of-concept trial in healthy volunteers and patients with moderate to severe psoriasis.

 

·                  VTP-43742 in Autoimmune Disorders — Results from the single ascending dose Phase 1 clinical trial assessing safety, tolerability, pharmacokinetics and pharmacodynamics in the second half of 2015.

 

·                  VTP-43742 in Autoimmune Disorders — Top-line clinical efficacy results from the Phase 1 multiple ascending dose proof-of-concept trial by the end of 2015.

 

·                  VTP-38543 in Atopic Dermatitis — Initiation of a Phase 1 clinical trial in the second half of 2015.

 

·                  VTP-34072 in Type 2 Diabetes — Top-line data from the remaining placebo-controlled monotherapy arm of the Phase 2a proof-of-concept trial in the second half of 2015.

 

·                  VTP-36951 in Alzheimer’s disease — An update on plans for the program after the BI collaboration and license agreement termination is complete in the second half of 2015.

 

Company to Host Conference Call

 

Vitae will host a conference call today, August 4, 2015, at 4:30 p.m. EDT to discuss the company’s financial results for the quarter ended June 30, 2015, and recent operational highlights. A question and answer session will follow Vitae’s remarks. To participate on the live call, please dial 844-423-9893 (domestic) or +1-716-247-5808 (international), and provide the conference ID 94533069, approximately five to 10 minutes ahead of the start of the call.

 

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

 



 

About Vitae Pharmaceuticals

 

Vitae Pharmaceuticals is a clinical-stage biotechnology company focused on discovering and developing first-in-class, small molecule drugs for difficult-to-drug disease targets that can potentially address significant unmet medical needs, including disclosed programs in diabetes, Alzheimer’s disease, autoimmune disorders, atopic dermatitis and acute coronary syndrome. This robust and growing portfolio of novel product candidates is generated internally by Contour®, Vitae’s proprietary structure-based drug discovery platform.

 

For additional information, please visit the company’s website at www.vitaepharma.com.

 

Safe Harbor Statement

 

This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the pre-clinical and clinical development of the product candidates in its portfolio and the use and sufficiency of the Company’s cash position. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan” “impending” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward- looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties Vitae is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Vitae’s forward-looking statements include, among others, the timing and success of preclinical studies and clinical trials conducted by Vitae and its collaborative partners; the ability to obtain and maintain regulatory approval of Vitae’s product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Vitae’s product candidates; the size and growth of the potential markets for Vitae’s product candidates and the ability to serve those markets; Vitae’s expectations regarding Vitae’s expenses and revenue, the sufficiency of Vitae’s cash resources and needs for additional financing; Vitae’s ability to attract or retain key personnel; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vitae’s Annual Report on Form 10-K for the year ended December 31, 2014 and Vitae’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 which have been filed with the Securities and Exchange Commission (SEC). Additional factors may also be set forth in those sections of Vitae’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 to be filed with the SEC in the third quarter of 2015. In addition to the risks described above and in Vitae’s other filings with the SEC, other unknown or unpredictable factors also could affect Vitae’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Vitae undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

 



 

INVESTORS:

 

Vitae Pharmaceuticals, Inc.

Richard S. Morris, CPA

Chief Financial Officer

(215) 461-2000

rmorris@vitaerx.com

 

Westwicke Partners

John Woolford

(443) 213-0506

john.woolford@westwicke.com

 

MEDIA:

 

6 Degrees PR

Tony Plohoros     
(908) 940-0135

tplohoros@6degreespr.com

 



 

Vitae Pharmaceuticals, Inc.

Statement of Operations (unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

Collaborative revenues

 

$

161,588

 

$

1,155,496

 

$

311,827

 

$

2,328,947

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

7,772,822

 

4,877,246

 

15,278,738

 

9,425,258

 

General and administrative

 

2,259,358

 

1,368,394

 

4,370,414

 

2,628,291

 

Total operating expenses

 

10,032,180

 

6,245,640

 

19,649,152

 

12,053,549

 

Loss from operations

 

(9,870,592

)

(5,090,144

)

(19,337,325

)

(9,724,602

)

Other income (expenses):

 

 

 

 

 

 

 

 

 

Other income

 

1,430

 

204,399

 

1,430

 

217,774

 

Interest income

 

107,820

 

11,256

 

182,013

 

28,815

 

Interest expense

 

 

(255,675

)

(107,864

)

(541,037

)

Loss on debt extinguishment

 

 

 

(206,678

)

 

Total other income (expenses)

 

109,250

 

(40,020

)

(131,099

)

(294,448

)

Net loss

 

$

(9,761,342

)

$

(5,130,164

)

$

(19,468,424

)

$

(10,019,050

)

Per share information:

 

 

 

 

 

 

 

 

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.45

)

$

(8.50

)

$

(0.91

)

$

(16.74

)

Diluted

 

$

(0.45

)

$

(8.50

)

$

(0.91

)

$

(16.74

)

Weighted-average number of common shares:

 

 

 

 

 

 

 

 

 

Basic

 

21,837,676

 

603,868

 

21,315,094

 

598,567

 

Diluted

 

21,837,676

 

603,868

 

21,315,094

 

598,567

 

 

Vitae Pharmaceuticals, Inc.

Selected Balance Sheet Data

 

 

 

As of
June 30,

 

As of
December 31,

 

 

 

 

 

 

 

2015

 

2014

 

 

 

 

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

80,338,022

 

$

65,318,300

 

 

 

 

 

Working capital

 

64,218,894

 

57,970,386

 

 

 

 

 

Current liabilities

 

7,026,199

 

8,864,107

 

 

 

 

 

Common stock and APIC

 

225,934,216

 

188,737,768

 

 

 

 

 

Total stockholder’s equity

 

76,433,631

 

58,718,051

 

 

 

 

 

 


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