Form 8-K Vitae Pharmaceuticals, For: Mar 31

 

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):  March 31, 2015

 

 

VITAE PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

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 March 31, 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 and year ended December 31, 2014. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 which is on file with the Securities and Exchange Commission (the “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 Annual Report on Form 10-K for the year ended December 31, 2014, which will be filed with the SEC in the first 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 8.01. Other Events.

 

On March 31, 2015, the Company announced that its 2015 Annual Meeting of Stockholders will be held on Thursday, May 28, 2015 at the Ritz-Carlton, Philadelphia, 10 Avenue of the Arts, Philadelphia, Pennsylvania 19102. The meeting will be the Company’s first annual meeting since becoming a public company in the third quarter of 2014.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Press Release of Vitae Pharmaceuticals, Inc.

 

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: March 31, 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.

 

4

Exhibit 99.1

 

 

Vitae Pharmaceuticals Reports Fourth Quarter and Full Year 2014 Operating and Financial Results

 

Conference call scheduled for 8:30 a.m. EDT today

 

FORT WASHINGTON, PA, March 31, 2015 — Vitae Pharmaceuticals, Inc. (NASDAQ: VTAE), a clinical-stage biotechnology company, reported today its operating and financial results for the fourth quarter and full year ended December 31, 2014.

 

“We continue to make significant progress in advancing our RORgt program with our lead proprietary candidate, VTP-43742 for the treatment of autoimmune disorders, towards initiation of a Phase 1 single ascending dose study,” said Jeffrey Hatfield, President and Chief Executive Officer of Vitae. “In addition, we recently completed a successful follow-on offering, providing us with the capital to further the development of our wholly-owned portfolio of potential first-in-class programs.”

 

Quarterly and Recent Highlights

 

Since September 30, 2014, Vitae has experienced the following:

 

Pipeline Updates:

 

·                  Continued to advance VTP-43742, Vitae’s product candidate to treat autoimmune diseases, toward an anticipated filing of an Investigational New Drug Application (IND), with Phase 1 clinical trials commencing thereafter. Vitae has completed the GMP manufacture of API to support the Phase 1 studies, and completed the safety pharmacology studies and gene toxicity studies. In addition, the Company is currently working to complete the 28- day GLP toxicity studies and continues to expect to initiate a Phase 1 trial during the second quarter of 2015.

·                  Boehringer Ingelheim (BI) has decided to move forward with the development of BI 1147560, a structurally different compound from BI 1181181. In the fourth quarter of 2014, Vitae announced positive top-line results with BI 1181181 for the treatment and prevention of Alzheimer’s disease as part of the BACE collaboration with BI. Subsequently, as announced in February 2015, in a Phase 1 clinical trial of BI 1181181, skin reactions were observed in some patients, prompting BI to place the compound on a voluntary clinical hold while the finding was investigated. BI has completed its analysis and concluded that skin reactions are an obstacle for further development. Therefore, BI has decided to move forward with the development of a structurally different compound, BI 1147560, which was also discovered and advanced through preclinical development as part of the BACE

 

Vitae Pharmaceuticals, Inc.		Tel: (215) 461-2000
502 West Office Center Drive		Fax: (215) 461-2006
Fort Washington, PA 19034		www.vitaepharma.com

 

 

collaboration. BI currently expects to start the initial Phase 1 clinical trial of BI 1147560 by the end of 2015.

 

Corporate Updates:

 

·                  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 over-allotment option, at a price of $11.90 per share less underwriting fees and expenses, for aggregate net proceeds of approximately $37.8 million.

·                  Added to the Russell 2000® and Russell 3000® indexes.

 

Financial Results:

 

·                  Revenue. Collaborative revenues for the fourth quarter of 2014 were $0.2 million, compared with $15.2 million for the fourth quarter of 2013. Revenue for the fourth quarter of 2013 included a $14.0 million milestone payment from BI related to Vitae’s BACE program.

·                  Operating Expense. Total operating expenses for the fourth quarter of 2014 were $7.3 million, compared with $5.2 million for the fourth quarter of 2013.

·                  Research and development expenses were $5.1 million for the fourth quarter of 2014, compared with $3.8 million for the fourth quarter of 2013. The increase was largely attributable to expenses related to the RORγt program, including VTP-43742.

·                  Selling, general and administrative expenses were $2.2 million for the fourth quarter of 2014, compared with $1.4 million for the same period in 2013.

·                  Net Loss/Income. Vitae reported a net loss of $7.3 million for the fourth quarter of 2014, compared with net income of $9.7 million for the fourth quarter of 2013.

·                  Cash position. As of December 31, 2014, Vitae had $65.3 million in cash, restricted cash and marketable securities, compared to $32.5 million as of December 31, 2013. The increase was primarily a result of the completion of the Company’s IPO in the third quarter of 2014. In the first quarter 2015, Vitae raised aggregate net proceeds of approximately $37.8 million in a follow-on public offering, as mentioned above, and retired its outstanding term note with Silicon Valley Bank and Oxford Finance Corporation.

 

Upcoming Milestones

 

Vitae reaffirmed the following previously disclosed potential development milestones for its programs currently expected in 2015:

 

·                  VTP-34072 (11β HSD1) - Top-line results from the Phase 2 proof of concept trial in type 2 diabetic patients in the second quarter of 2015.

·                  VTP-43742 (RORγt) — 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 in mid-year 2015.

 

 

·                  VTP-43742 (RORγt) — Initiation and completion of a multiple ascending dose Phase 1 study in psoriatic patients in the second half of 2015.

·                  VTP-38543 (LXRβ partial agonist) — Initiation of a Phase 1 safety and PK trial in the second half of 2015.

·                  BI 1147560 (BACE) — Initiation of a Phase 1 clinical trial by the end of 2015.

 

Company to Host Conference Call

 

Vitae will host a conference call today, March 31, 2015, at 8:30 a.m. EDT to discuss the company’s financial results for the quarter ended December 31, 2014, 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 8012202, 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. The company is developing a robust and growing portfolio of novel product candidates generated by Contour®, its 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” 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 final prospectus filed under Rule 424(b)(1) with the Securities and Exchange Commission (SEC) in connection with Vitae’s follow-on public offering. Additional factors may also be set forth in those sections of Vitae’s Annual Report on Form 10-K for the year ended December 31, 2014 to be filed with the 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]

 

 

Vitae Pharmaceuticals, Inc.

Statement of Operations (unaudited)

 

		Three Months Ended						Twelve Months Ended
		December 31,						December 31,
		2014			2013			2014			2013
Collaborative revenues		$	161,673		$	15,198,155		$	8,668,786		$	22,512,683
Operating expenses:
Research and development		5,080,317			3,804,311			19,304,843			14,916,562
General and administrative		2,189,157			1,409,291			7,913,847			5,405,769
Total operating expenses		7,269,474			5,213,602			27,218,690			20,322,331
(Loss) / income from operations		(7,107,801		)	9,984,553			(18,549,904		)	2,190,352
Other (expenses) income:
Other income		—			23,500			343,318			327,391
Interest income		27,223			12,056			63,932			69,497
Interest expense		(194,360		)	(314,364		)	(960,752		)	(1,425,342		)
Total other (expenses) income		(167,137		)	(278,808		)	(553,502		)	(1,028,454		)
Net (loss) income		$	(7,274,938	)	$	9,705,745		$	(19,103,406	)	$	1,161,898
Per share information:
Net (loss) income per common share:
Basic		$	(0.40	)	$	0.77		$	(3.61	)	$	—
Diluted		$	(0.40	)	$	0.74		$	(3.61	)	$	—
Weighted-average number of common shares:
Basic		18,113,997			583,653			5,290,534			563,136
Diluted		18,113,997			975,795			5,290,534			563,136

 

Vitae Pharmaceuticals, Inc.

Selected Balance Sheet Data (unaudited)

 

		As of December 31,		As of December 31,
		2014		2013
Cash, Cash Equivalents and Marketable securities		65,318,300		32,454,453
Working Capital		57,970,386		23,905,376
Current Liabilities		8,864,107		9,517,419
Convertible Preferred Stock		—		125,869,931
Common Stock and APIC		188,737,768		3,983,281
Total Stockholder’s equity / (deficit)		58,718,051		(106,894,151	)