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 |
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001-36617 (Commission File Number) |
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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 Vitaes 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 Vitaes 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 Vitaes product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Vitaes product candidates; the size and growth of the potential markets for Vitaes product candidates and the ability to serve those markets; Vitaes expectations regarding Vitaes expenses and revenue, the sufficiency of Vitaes cash resources and needs for additional financing; Vitaes ability to attract or retain key personnel; and other factors that are described in the Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations sections of Vitaes 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 SECs website at www.sec.gov. Additional information will also be set forth in those sections of Vitaes 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 Vitaes other filings with the SEC, other unknown or unpredictable factors could also affect Vitaes 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. |
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Description |
99.1 |
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Press Release of Vitae Pharmaceuticals, Inc., dated May 12, 2015 |
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.
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VITAE PHARMACEUTICALS, INC. | |
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Date: May 12, 2015 |
By: |
/s/ Jeffrey S. Hatfield |
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Jeffrey S. Hatfield |
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Chief Executive Officer |
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 Alzheimers 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 Alzheimers Disease
· BI will advance BI-1147560 for the treatment of Alzheimers 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 AAIs 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 underwriters 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 Companys 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 Alzheimers 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 companys financial results for the quarter ended March 31, 2015, and recent operational highlights. A question and answer session will follow Vitaes 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 Vitaes website approximately 10 minutes prior to the scheduled start time. A replay of the webcast will be archived on Vitaes 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, Alzheimers disease, autoimmune disorders, atopic dermatitis and acute coronary syndrome. This robust and growing portfolio of novel product candidates is generated by Contour®, Vitaes proprietary structure-based drug discovery platform.
For additional information, please visit the companys 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 Vitaes 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 Vitaes product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Vitaes product candidates; the size and growth of the potential markets for Vitaes product candidates and the ability to serve those markets; Vitaes expectations regarding Vitaes expenses and revenue, the sufficiency of Vitaes cash resources and needs for additional financing; Vitaes ability to attract or retain key personnel; and other factors that are described in the Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations sections of Vitaes 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 Vitaes 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 Vitaes other filings with the SEC, other unknown or unpredictable factors also could affect Vitaes 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)
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Three Months Ended |
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March 31, |
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2015 |
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2014 |
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Collaborative revenues |
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$ |
150,239 |
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$ |
1,173,451 |
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Operating expenses: |
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Research and development |
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7,505,916 |
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4,548,012 |
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General and administrative |
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2,111,056 |
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1,259,897 |
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Total operating expenses |
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9,616,972 |
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5,807,909 |
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Loss from operations |
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(9,466,733 |
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(4,634,458 |
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Other (expenses) income: |
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Other income |
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13,375 |
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Interest income |
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74,193 |
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17,559 |
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Interest expense |
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(107,864 |
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(285,362 |
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Loss on debt extinguishment |
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(206,678 |
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Total other (expenses) income |
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(240,349 |
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(254,428 |
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Net loss |
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$ |
(9,707,082 |
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$ |
(4,888,886 |
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Per share information: |
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Net loss per common share: |
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Basic |
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$ |
(0.47 |
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$ |
(8.24 |
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Diluted |
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$ |
(0.47 |
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$ |
(8.24 |
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Weighted average number of common shares: |
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Basic |
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20,826,647 |
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593,206 |
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Diluted |
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20,826,647 |
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593,206 |
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Vitae Pharmaceuticals, Inc.
Selected Balance Sheet Data (unaudited)
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As of March |
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As of |
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31, |
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December 31, |
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2015 |
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2014 |
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Cash, cash equivalents and marketable securities |
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88,693,190 |
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65,318,300 |
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Working capital |
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67,800,388 |
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57,970,386 |
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Current liabilities |
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5,438,036 |
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8,864,107 |
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Common stock and APIC |
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225,368,097 |
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188,737,768 |
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Total stockholders equity |
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85,649,375 |
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58,718,051 |
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