Download Vitae Pharmaceuticals, Inc

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): June 29, 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)
502 West Office Center Drive
Fort Washington, PA 19034
(Address of Principal Executive Offices)
04-3567753
(IRS Employer Identification No.)
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):

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))
Item 8.01. Other Events.
On June 29, 2015, Vitae Pharmaceuticals, Inc. (“Vitae”) issued a press release announcing top-line clinical efficacy results from the metformin
arm of an ongoing Phase 2 proof-of-concept trail of BI187004/VTP-34072, a novel 11βHSD1 inhibitor discovered by Vitae and being
developed for the treatment of type 2 diabetes and metabolic syndrome as part of a collaboration with Boehringer Ingelheim GmbH
(“BI”). Vitae announced that primary efficacy data (fasting plasma glucose) from the metformin arm of the Phase 2 trial did not meet BI’s
pre-defined endpoint criteria. A copy of Vitae’s press release is attached hereto as Exhibit 99.1 and is hereby incorporated by reference herein.
In addition, on June 29, 2015, Vitae issued a press release announcing the initiation of a Phase 1 single ascending dose clinical trial of
VTP-43742, the company’s wholly owned and potentially first-in-class RORγt inhibitor for the treatment of autoimmune disorders, including
psoriasis, multiple sclerosis, and various arthropathies, as well as rare and orphan disorders.. This single ascending dose trial will assess the
safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-43742 in healthy human volunteers, 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 which will include patients with moderate to severe psoriasis. Top-line clinical efficacy results from this
second clinical trial are expected by the end of the year. A copy of Vitae’s press release is attached hereto as Exhibit 99.2 and is hereby
incorporated by reference herein.
Item 9.01.
(d)
Financial Statements and Exhibits.
Exhibits
Exhibit
No.
Description
99.1
Vitae Pharmaceuticals, Inc. Press Release, dated June 29, 2015.
99.2
Vitae Pharmaceuticals, Inc. Press Release, dated June 29, 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: June 29, 2015
By:
3
/s/ Jeffrey S. Hatfield
Jeffrey S. Hatfield
Chief Executive Officer
Exhibit 99.1
Vitae Pharmaceuticals Announces Top-Line Results from Metformin Arm of Ongoing Phase 2 Clinical Trial of BI187004/VTP-34072
in Overweight Type 2 Diabetics
FORT WASHINGTON, PA, June 29, 2015 — Vitae Pharmaceuticals, Inc. (NASDAQ: VTAE), a clinical-stage biotechnology company,
today 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. BI187004/VTP-34072 is a potential first-in-class
11β-hydroxysteroid dehydrogenase type 1 (11β HSD1) inhibitor that was discovered by Vitae and is currently being developed by Boehringer
Ingelheim GmbH (Boehringer Ingelheim), a leader in diabetes treatments and cardiometabolic research and development.
Safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of BI187004/VTP-34072 as monotherapy or as an add-on to metformin
background therapy are being investigated over 28 days in a randomized, double-blind, placebo-controlled study in patients with type 2
diabetes mellitus. Primary efficacy data (fasting plasma glucose) from the metformin arm did not meet Boehringer Ingelheim’s 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 Boehringer Ingelheim to determine appropriate next steps for BI187004/VTP-34072.
“The metabolically complex, overweight type 2 diabetic patient population is in need of novel mechanisms of action that can address their
overall risk profile,” said Dr. Richard Gregg, Chief Scientific Officer of Vitae. “We are anxious to learn more about BI187004/VTP-34072
when the study is completed and fully analyzed.”
About Type 2 Diabetes
Type 2 diabetes is a common and increasingly prevalent disease. According to the American Diabetes Association, in 2015, approximately 20
million Americans had a diagnosis of type 2 diabetes and another 7.7 million were undiagnosed and unaware that they had type 2 diabetes. If
the present trends continue, as many as one in three American adults are expected to have type 2 diabetes by 2050. Overall, the economic cost
of diagnosed type 2 diabetes in the United States was estimated to be $245 billion in 2012 and, of that, approximately $9.6 billion was spent on
type 2 diabetes drugs. Patients with metabolic syndrome, which affects approximately 85 percent of patients with type 2 diabetes, are
characterized by being overweight and having elevated glucose, blood pressure, cholesterol and triglycerides, while having decreased levels of
HDL-C or “good cholesterol.”
About BI187004/VTP-34072
BI187004/VTP-34072 is an 11β HSD1 inhibitor that was discovered using Vitae’s proprietary Contour® platform and is being developed by
Boehringer Ingelheim. BI187004/VTP-34072 is being studied for the treatment of type 2 diabetes and metabolic syndrome, and is Vitae’s most
advanced product candidate. In preclinical studies, BI187004/VTP-34072 had a positive impact on multiple cardiovascular and metabolic risk
factors associated with metabolic syndrome, which differentiates it from other classes of type 2 diabetes drugs. BI187004/VTP-34072 is
currently being studied in an ongoing Phase 2 proof-of-concept trial assessing efficacy and tolerability in diabetic patients on stable doses of
metformin and as monotherapy.
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 clinical development of VTP-34072. 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). 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
[email protected]
Westwicke Partners
John Woolford
(443) 213-0506
[email protected]
MEDIA:
6 Degrees PR
Tony Plohoros
(908) 940-0135
[email protected]
Exhibit 99.2
Vitae Pharmaceuticals Announces Initiation of a Phase 1 Single Ascending Dose Study of VTP-43742 in Autoimmune Disorders
FORT WASHINGTON, PA, June 29, 2015 — Vitae Pharmaceuticals, Inc. (NASDAQ: VTAE), a clinical-stage biotechnology company,
today announced the initiation of a Phase 1 single ascending dose clinical trial of VTP-43742, the Company’s wholly owned and potential
first-in-class RORγt inhibitor for the treatment of autoimmune disorders, including psoriasis, multiple sclerosis, and various arthropathies, as
well as rare and orphan disorders.
This single ascending dose trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-43742 in healthy human
volunteers, 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, which will include patients with moderate to severe psoriasis. Top-line
clinical efficacy results from this second clinical trial are expected by the end of the year.
“The initiation of this Phase 1 study of our wholly owned first-in-class RORγt inhibitor is a very important milestone both for Vitae and for
patients afflicted with autoimmune disorders,” said Dr. Richard Gregg, Chief Scientific Officer of Vitae. “We believe that VTP-43742’s unique
mechanism of action has the potential to provide patients with a safe, effective and convenient oral treatment option for a variety of
autoimmune disorders.”
About Autoimmune Disorders
Autoimmune disorders, where the immune system attacks normal tissue, make up a large number of human disorders including psoriasis,
multiple sclerosis, rheumatoid arthritis and steroid-resistant asthma, as well as rare or orphan disorders. Increased activity of a class of
lymphocytes called Th17 cells and excess production of pro-inflammatory proteins, including Interleukin 17, or IL-17, by these cells are
critical parts of the pathophysiology of many human autoimmune disorders. RORγt is a nuclear hormone receptor that is essential for the
formation and function of Th17 cells. Vitae Pharmaceuticals believes inhibition of RORγt activity in Th17 cells will be beneficial for the
treatment of multiple autoimmune disorders.
About VTP-43742
VTP-43742 is Vitae Pharmaceuticals’ wholly owned product candidate for the treatment of a variety of autoimmune disorders. In preclinical
studies, VTP-43742 demonstrated potent inhibition of IL-17 secretion from Th17 cells, was highly selective versus other ROR isotypes, and
has a predicted human oral dosing schedule of once-a-day. VTP-43742 also demonstrated superiority in an animal model of multiple sclerosis
in direct comparison to an IL-17A monoclonal antibody. Vitae has filed an Investigational New Drug Application with the U.S. Food and Drug
Administration for VTP-43742 and initiated a Phase 1 single ascending dose clinical trial in healthy human volunteers to assess safety,
tolerability, pharmacokinetics and pharmacodynamics.
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 clinical development of VTP-43742. 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). 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
[email protected]
Westwicke Partners
John Woolford
(443) 213-0506
[email protected]
MEDIA:
6 Degrees PR
Tony Plohoros
(908) 940-0135
[email protected]