0001104659-15-037271.txt : 20150512 0001104659-15-037271.hdr.sgml : 20150512 20150512161058 ACCESSION NUMBER: 0001104659-15-037271 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20150512 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150512 DATE AS OF CHANGE: 20150512 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: 15854574 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 a15-11348_18k.htm 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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 12, 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

(I.R.S. Employer Identification Number)

 

502 West Office Center Drive

Fort Washington, PA 19034

(215) 461-2000

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)

 


 

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 May 12, 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 March 31, 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 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 which is 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 March 31, 2015, which will be filed with the SEC in the second 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 May 12, 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: May 12, 2015

By:

/s/ Jeffrey S. Hatfield

 

 

Jeffrey S. Hatfield

 

 

Chief Executive Officer

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press Release of Vitae Pharmaceuticals, Inc., dated May 12, 2015

 

4


EX-99.1 2 a15-11348_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Vitae Pharmaceuticals Reports First Quarter 2015 Operating and Financial Results

 

Multiple impending 2Q inflection points supported by enhanced cash position

 

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

 

FORT WASHINGTON, PA, May 12, 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 first quarter ended March 31, 2015.

 

“During the first quarter, we continued to execute on our plans to deliver important near-term value drivers for shareholders that we hope will ultimately result in meaningful new treatments for patients suffering from a variety of serious diseases,” commented Jeff Hatfield, President and Chief Executive Officer of Vitae. “We made solid progress in the development of our diabetes and autoimmune programs, remained committed to advancing our Alzheimer’s program, and extended our expected cash runway through 2016.  We look forward to a continued steady stream of activity during the remainder of 2015, including multiple data milestones we expect to achieve this year.”

 

Quarterly and Recent Highlights

 

Pipeline Updates:

 

VTP-34072 in Type 2 Diabetes

 

·                  Boehringer Ingelheim (BI) completed the dosing phase of VTP-34072 in the metformin arm of the ongoing Phase 2 proof-of-concept trial; top-line clinical efficacy results for this arm are expected to be announced this quarter.  This trial is a randomized, double-blind, placebo controlled clinical trial with the endpoints being glucose lowering, safety and tolerability.  The monotherapy arm of the trial remains ongoing due to slower patient enrollment; the top-line clinical efficacy results for this arm are expected to be announced in the second half of 2015.

 

BI-1147560 in Alzheimer’s Disease

 

·                  BI will advance BI-1147560 for the treatment of Alzheimer’s disease; clinical studies expected to begin by year-end. As disclosed in detail earlier this year, BI placed the previous lead compound, BI-1181181, on a voluntary clinical hold due to skin reactions, and subsequently decided to move forward with the development of BI-1147560.  —560 is a

 

Vitae Pharmaceuticals, Inc.

Tel: (215) 461-2000

502 West Office Center Drive

Fax: (215) 461-2006

Fort Washington, PA 19034

www.vitaepharma.com

 



 

structurally different compound that has successfully completed all IND enabling studies.  In preclinical studies, -560 was shown to lower amyloid beta levels comparably with -1181.  Vitae is eligible to receive a $7 million milestone upon dosing of the first subject in the Phase 1 trial.

 

VTP-43742 in Autoimmune Disorders

 

·                  Vitae continued to advance VTP-43742, its potential first-in-class product candidate for the treatment of autoimmune disorders. Vitae has completed the 28-day GLP toxicity studies and expects to initiate a Phase 1 clinical trial during the second quarter.

 

·                  Vitae made several presentations of preclinical data for VTP-43742 at scientific meetings, including the Keystone Symposia on Mechanisms of Pro-Inflammatory Diseases and the AAI’s Immunology 2015 conference.  One of the key data sets presented demonstrates that VTP-43742 achieved a superior clinical response in an animal model of multiple sclerosis in comparison to an IL-17A monoclonal antibody.

 

Other Pipeline Programs

 

·                  Vitae presented preclinical efficacy data for VTP-38543, which is being developed for atopic dermatitis, at the Society for Investigational Dermatology.

 

·                  Vitae presented preclinical efficacy data for VTP-38443, which is being developed for acute coronary syndrome, at the Arteriosclerosis, Thrombosis and Vascular Biology Meeting.

 

Corporate Updates:

 

·                  Vitae completed a follow-on public offering in January 2015. Vitae issued and sold an aggregate of 3.45 million shares of common stock, including the shares sold upon the exercise of the underwriter’s option to purchase additional shares, at a price of $11.90 per share less underwriting fees and expenses, for aggregate net proceeds of approximately $38.0 million.

 

·                  Vitae retired its remaining venture debt facility. In February 2015, Vitae paid off in full its outstanding venture debt facility of $4.3 million, including applicable prepayment fees.

 

Financial Results:

 

·                  Operating Expense. Total operating expenses for the first quarter of 2015 were $9.6 million, compared with $5.8 million for the first quarter of 2014.

 



 

·                  Research and development expenses were $7.5 million for the first quarter of 2015, compared with $4.5 million for the first quarter of 2014. The increase was largely attributable to expenses related to the RORγt program, including VTP-43742, and the LXRβ program.

·                  Selling, general and administrative expenses were $2.1 million for the first quarter of 2015, compared with $1.3 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 $9.7 million for the first quarter of 2015, compared with a net loss of $4.9 million for the first quarter of 2014.

 

·                  Cash Position. As of March 31, 2015, Vitae had $88.7 million in cash, cash equivalents and marketable securities, compared to $65.3 million as of December 31, 2014. The increase was primarily a result of the completion of the Company’s follow-on public offering in the first quarter of 2015.

 

Expected Milestones

 

·                  VTP-34072 in Type 2 Diabetes — Top-line clinical efficacy results from the metformin arm of the Phase 2 proof-of-concept trial in type 2 diabetic patients in the second quarter, and top-line clinical efficacy results from the monotherapy arm in the second half of 2015.

 

·                  VTP-43742 in Autoimmune Disorders — Initiation of a single dose Phase 1 safety and pharmacokinetic (PK) clinical trial in healthy human volunteers in the second quarter of 2015, with completion and results mid-year 2015.

 

·                  VTP-43742 in Autoimmune Disorders — Initiation and completion of a multiple ascending dose proof-of-concept trial in psoriatic patients, with top-line clinical efficacy results in the second half of 2015.

 

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

 

·                  BI-1147560 in Alzheimer’s Disease — Initiation of a Phase 1 clinical trial by the end of 2015, with Vitae eligible to earn a $7 million milestone payment upon first dosing.

 

Company to Host Conference Call

 

Vitae will host a conference call today, May 12, 2015, at 4:30 p.m. EDT to discuss the company’s financial results for the quarter ended March 31, 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 40302906, 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 novel, small molecule drugs for diseases in which there are 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 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 clinical development of BI 1181181 and any back up compounds. 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 which has 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 March 31, 2015 to be filed with the SEC in the second 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

 

 

 

March 31,

 

 

 

2015

 

2014

 

Collaborative revenues

 

$

150,239

 

$

1,173,451

 

Operating expenses:

 

 

 

 

 

Research and development

 

7,505,916

 

4,548,012

 

General and administrative

 

2,111,056

 

1,259,897

 

Total operating expenses

 

9,616,972

 

5,807,909

 

Loss from operations

 

(9,466,733

)

(4,634,458

)

Other (expenses) income:

 

 

 

 

 

Other income

 

 

13,375

 

Interest income

 

74,193

 

17,559

 

Interest expense

 

(107,864

)

(285,362

)

Loss on debt extinguishment

 

(206,678

)

 

Total other (expenses) income

 

(240,349

)

(254,428

)

Net loss

 

$

(9,707,082

)

$

(4,888,886

)

Per share information:

 

 

 

 

 

Net loss per common share:

 

 

 

 

 

Basic

 

$

(0.47

)

$

(8.24

)

Diluted

 

$

(0.47

)

$

(8.24

)

Weighted average number of common shares:

 

 

 

 

 

Basic

 

20,826,647

 

593,206

 

Diluted

 

20,826,647

 

593,206

 

 

Vitae Pharmaceuticals, Inc.

Selected Balance Sheet Data (unaudited)

 

 

 

As of March

 

As of

 

 

 

31,

 

December 31,

 

 

 

2015

 

2014

 

Cash, cash equivalents and marketable securities

 

88,693,190

 

65,318,300

 

Working capital

 

67,800,388

 

57,970,386

 

Current liabilities

 

5,438,036

 

8,864,107

 

Common stock and APIC

 

225,368,097

 

188,737,768

 

Total stockholder’s equity

 

85,649,375

 

58,718,051

 

 


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