Download vitae pharmaceuticals, inc. - corporate

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:
/s/ Jeffrey S. Hatfield
Jeffrey S. Hatfield
Chief Executive Officer
3
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]