0001104659-14-059391.txt : 20140812 0001104659-14-059391.hdr.sgml : 20140812 20140811161522 ACCESSION NUMBER: 0001104659-14-059391 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20140805 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140811 DATE AS OF CHANGE: 20140811 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Ocera Therapeutics, Inc. CENTRAL INDEX KEY: 0001274644 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 631192270 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35119 FILM NUMBER: 141030731 BUSINESS ADDRESS: STREET 1: 525 UNIVERSITY AVENUE STREET 2: SUITE 610 CITY: PALO ALTO STATE: CA ZIP: 94301 BUSINESS PHONE: 6504625800 MAIL ADDRESS: STREET 1: 525 UNIVERSITY AVENUE STREET 2: SUITE 610 CITY: PALO ALTO STATE: CA ZIP: 94301 FORMER COMPANY: FORMER CONFORMED NAME: TRANZYME INC DATE OF NAME CHANGE: 20031230 8-K 1 a14-18804_18k.htm 8-K

 

 

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): August 5, 2014

 

OCERA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

DELAWARE

 

001-35119

 

63-1192270

(State or other jurisdiction

 

(Commission File Number)

 

(I.R.S. Employer

of

 

 

 

Identification No.)

incorporation)

 

 

 

 

 

525 University Avenue, Suite 610

 

 

Palo Alto, CA

 

94301

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code (650) 475-0150

 

Not applicable

(Former name or former address, if changed since last report)

 

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:

 

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 August 11, 2014, Ocera Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results and other information for the quarter ended June 30, 2014. The full text of the press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference.

 

The information under this Item 2.02, including Exhibit 99.1 attached hereto, is intended to be furnished and 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 filing.

 

Item 5.02  Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On August 5, 2014, the Company entered into an employment agreement (the “Employment Agreement”) with Rajiv Patni, M.D. pursuant to which Dr. Patni will become the Company’s Chief Development Officer effective as of September 2, 2014 (the “Effective Date”).

 

Prior to joining Ocera, Dr. Patni, age 45, served as Senior Vice President and Chief Medical Officer for Actelion US Pharmaceuticals (“Actelion”) starting in September 2010.  Prior to his time at Actelion, Dr. Patni served as Life Cycle Leader (Product Head), Executive Director and Vice President at Roche Pharmaceuticals (“Roche”) from January 2007 to September 2010. Prior to his tenure at Roche, he held leadership positions at Novartis Pharmaceuticals and Pfizer Pharmaceuticals. Dr. Patni earned his B.S. from the Sophie Davis School of Biomedical Education at the City University of New York’s accelerated BS/MD Program and received his M.D. from Mount Sinai School of Medicine.

 

Pursuant to the terms of the Employment Agreement, Dr. Patni will receive an annual base salary of $385,000 and will be eligible to receive an annual bonus based upon achievement of predefined performance objectives and corporate goals, with a target amount equal to 40% of his annual base salary.  In addition, he will receive a cash signing bonus of $25,000.  Dr. Patni will also receive stock options to purchase 250,000 shares of the Company’s common stock at an exercise price equal to the market closing price of the Company’s common stock on the date of grant.  These options will vest over four years with 25% of the options vesting on the one-year anniversary of the Effective Date and the remaining shares vesting in equal monthly installments thereafter. Dr. Patni will also receive two performance-based grants of 20,000 stock options with vesting based on specified performance criteria.  Dr. Patni will be eligible to participate in the Company’s standard employee benefit plans.

 

In the event Dr. Patni’s employment is terminated without cause (as defined in the Employment Agreement), he will be entitled to receive (i) a continuation of his base salary for six months at the rate in effect at termination, (ii) payment of COBRA premiums for six months, and (iii) acceleration of all stock options held by Dr. Patni such that as of the effective date of termination, Dr. Patni will be deemed vested in the same number of shares as if he had completed an additional six months of employment with the Company.

 

The foregoing description of the Employment Agreement is a summary and does not purport to be complete. Such description is qualified in its entirety by reference to the text of the Employment Agreement, which is filed with this Current Report on Form 8-K as Exhibit 10.1, and is incorporated herein by reference.

 

2



 

In addition, Franck Rousseau, M.D., the Company’s Chief Medical and Development Officer and director, has informed the Company that he intends to resign from the Company for personal reasons.  Dr. Rousseau will remain in his position as an officer and director of Company during a transition period of approximately three months after which it is expected that he will serve as a consultant to the Company.

 

Item 8.01  Other Events.

 

On August 11, 2014, the Company issued a press release regarding the appointment of Dr. Patni.  The full text of the press release regarding the appointment is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01  Financial Statements and Exhibits.

 

(d)                                 Exhibits

 

Exhibit No.

 

Description

 

 

 

10.1

 

Employment Agreement dated August 5, 2014 by and between Ocera Therapeutics, Inc. and Rajiv Patni, M.D.

 

 

 

99.1

 

Press Release of Ocera Therapeutics, Inc. dated August 11, 2014, regarding financial results and other information, furnished hereto.

 

 

 

99.2

 

Press Release of Ocera Therapeutics, Inc. dated August 11, 2014, regarding the appointment of Dr. Patni.

 

3



 

SIGNATURES

 

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.

 

August 11, 2014

Ocera Therapeutics, Inc.

 

 

 

 

By:

/s/ Linda S. Grais, M.D.

 

Name:

Linda S. Grais, M.D.

 

Title:

President and Chief Executive Officer

 

4


EX-10.1 2 a14-18804_1ex10d1.htm EX-10.1

Exhibit 10.1

 

 

August 5, 2014

 

Rajiv Patni, MD

 

Dear Rajiv,

 

Ocera Therapeutics, Inc. (the “Company”) is pleased to offer you employment on the following terms:

 

1.                                      Position.  Your title will be Chief Development Officer, reporting to Linda Grais, CEO. This is a full-time position.  While you render services to the Company, you will not engage in any other employment, consulting or other business activity (whether full-time or part-time) that would create a conflict of interest with the Company.  By signing this letter agreement, you confirm to the Company that you have no contractual commitments or other legal obligations that would prohibit you from performing your duties for the Company.

 

2.                                      Cash Compensation.  The Company will pay you a starting salary at the rate of $385,000 per year, payable in accordance with the Company’s standard payroll schedule.  This salary will be subject to adjustment pursuant to the Company’s employee compensation policies in effect from time to time.  You will also be eligible for an annual cash bonus at a target percentage of forty percent (40%) maximum of your base wages received for the year based upon achievement of predefined performance objectives and corporate accomplishments, provided you are employed on the bonus pay-out date, and pro-rated for your initial partial year of employment. In addition, you will receive a sign on bonus of $25,000 in your first paycheck.

 

3.                                      Equity.  The Company will award you 250,000 options for the purchase of Ocera common stock upon approval by the Board of Directors, which will be priced at the market closing price on the date of grant. These options will vest over a four year period such that one-fourth of the options will vest on the first anniversary of your employment and the remaining options will vest monthly over the following three years. Vesting will commence upon the start of your employment. In addition, you will be awarded two performance-based grants of 20,000 options each, which will vest upon achievement of specific goals, as follows: The first grant of 20,000 options will fully vest if 70 patients are enrolled in the STOP-HE trial by December 31, 2014.  The second grant of 20,000 options will fully vest if 140 patients are enrolled in the STOP-HE trial by June 30, 2015.

 

3.                                      Employee Benefits.  As a regular employee of the Company, you will be eligible to participate in a number of Company-sponsored benefits, which currently include medical insurance, dental insurance, short and long-term disability and a 401(k) plan. In addition, you will be entitled to paid vacation in accordance with the Company’s prevailing vacation policy, which may change from time to time.

 

Ocera Therapeutics, Inc.

525 University Ave, Suite 610

Palo Alto, CA 94301

T:650.475.0148

 



 

4.                                      Termination.  Your employment will be “at will,” meaning that the Company may terminate your employment at any time and for any or no reason, with or without Cause (as defined herein) or advance notice by giving written notice of such termination, subject to the provisions stated herein.  Similarly, you may terminate your employment with the Company at any time at your election, in your sole discretion, for any or no reason.  The “at will” nature of your employment relationship may not be modified except by a written agreement signed by the CEO.

 

(a)                                 Compensation Upon Termination By The Company Without Cause.  If the Company terminates your employment without Cause, then the Company shall pay your base salary and accrued and unused vacation earned through the date of termination.  In addition, subject to the requirements of Section 6(b) below, the Company shall provide you with the following severance benefits:

 

(i)                                    Salary Continuation.  The Company shall continue to pay your base salary as in effect on the date of termination until the end of the six month period following the termination of your employment.  Such severance payments shall be subject to standard deductions and withholdings and paid in accordance with the Company’s regular payroll policies and practices.

 

(ii)                                COBRA Coverage.  Provided that you timely elect COBRA (or Cal-COBRA, as applicable) health insurance continuation coverage, the Company shall pay such premiums on your behalf until the end of the six month period following the termination of your employment.

 

(iii)                            Accelerated Option Vesting. Vesting of your options shall be accelerated such that as of the effective date of your termination of employment you will be deemed vested in the same number of shares as if you had completed an additional 6 months of employment with the Company pursuant to this Agreement.

 

5.                                      Confidentiality and Proprietary Rights Agreement.  Like all Company employees, you will be required, as a condition of your employment with the Company, to sign the Company’s standard Confidentiality Agreement and Employee Innovations & Proprietary Rights Assignment Agreement, a copy of which is attached hereto as Exhibit A.

 

6.                                      Employment Relationship.  Employment with the Company is for no specific period of time.  Your employment with the Company will be “at will,” meaning that either you or the Company may terminate your employment at any time and for any reason, with or without cause.  Any contrary representations that may have been made to you are superseded by this letter agreement.  This is the full and complete agreement between you and the Company on this term.  Although your job duties, title, reporting relationship, compensation and benefits, as well as the Company’s personnel policies and procedures, may change from time to time at the Company’s option, the “at will” nature of your employment may only be changed in an express written agreement signed by you and a duly authorized officer of the Company (other than you).

 



 

7.                                      Taxes.  All forms of compensation referred to in this letter agreement are subject to reduction to reflect applicable withholding and payroll taxes and other deductions required by law.  You agree that the Company does not have a duty to design its compensation policies in a manner that minimizes your tax liabilities, and you will not make any claim against the Company or its Board of Directors related to tax liabilities arising from your compensation.

 

8.                                      Interpretation, Amendment and Enforcement.  This letter agreement and Exhibit A constitute the complete agreement between you and the Company, contain all of the terms of your employment with the Company and supersede any prior agreements, representations or understandings (whether written, oral or implied) between you and the Company.  This letter agreement may not be amended or modified, except by an express written agreement signed by both you and a duly authorized officer of the Company.  The terms of this letter agreement and the resolution of any disputes as to the meaning, effect, performance or validity of this letter agreement or arising out of, related to, or in any way connected with, this letter agreement, your employment with the Company or any other relationship between you and the Company will be governed by California law, excluding laws relating to conflicts or choice of law.

 

9.                                      Immigration Law Compliance/Reference Check.  As required by law, your employment with the Company is contingent upon your providing legal proof of your identity and authorization to work in the United States.  The Company also reserves the right to conduct background investigations and/or reference checks on all of its potential employees.  Your job offer, therefore, is contingent upon a clearance of such a background investigation and/or reference check, if any.

 

Rajiv, the Board and I believe you can make a major contribution to Ocera’s long term success, and we hope that you will accept our offer to join the Company.  You may indicate your agreement with these terms and accept this offer by signing and dating a copy of this letter agreement and the enclosed Proprietary Information and Inventions Agreement and returning them to me.  This offer, if not accepted, will expire at the close of business on August 6, 2014.  Your employment is also contingent upon your starting work with the Company on a mutually agreed upon timeframe.

 

Sincerely,

 

 

 

/s/ Linda Grais

 

 

 

Linda Grais

 

CEO

 

 



 

I have read and accept this employment offer:

 

/s/ Rajiv Patni

 

Signature

 

 

Dated:  August 5, 2014

 

Start Date: September 2, 2014

 

Attachment

 

Exhibit A:  Confidentiality Agreement and Employee Innovations & Proprietary Rights Assignment Agreement

 



 

Exhibit A

 

PROPRIETARY INFORMATION AND INVENTIONS AGREEMENT

 

The following confirms and memorializes an agreement that Ocera Therapeutics, Inc. (the “Company”) and I (                  ) have had since the commencement of my employment (which term, for purposes of this agreement, shall be deemed to include any relationship of service to the Company that I may have had prior to actually becoming an employee) with the Company in any capacity and that is and has been a material part of the consideration for my employment by Company:

 

1.                                      I have not entered into, and I agree I will not enter into, any agreement either written or oral in conflict with this Agreement or my employment with Company.  I will not violate any agreement with or rights of any third party or, except as expressly authorized by Company in writing hereafter, use or disclose my own or any third party’s confidential information or intellectual property when acting within the scope of my employment or otherwise on behalf of Company.  Further, I have not retained anything containing any confidential information of a prior employer or other third party, whether or not created by me.

 

2.                                      Company shall own all right, title and interest (including patent rights, copyrights, trade secret rights, mask work rights, sui generis database rights and all other intellectual property rights of any sort throughout the world) relating to any and all inventions (whether or not patentable), works of authorship, mask works, designs, know-how, ideas and information made or conceived or reduced to practice, in whole or in part, by me during the term of my employment with Company to and only to the fullest extent allowed by California Labor Code Section 2870 (which is attached as Appendix A) (collectively “Inventions”) and I will promptly disclose all Inventions to Company.  Without disclosing any third party confidential information, I will also disclose anything I believe is excluded by Section 2870 so that the Company can make an independent assessment.  I hereby make all assignments necessary to accomplish the foregoing.  I shall further assist Company, at Company’s expense, to further evidence, record and perfect such assignments, and to perfect, obtain, maintain, enforce, and defend any rights specified to be so owned or assigned.  I hereby irrevocably designate and appoint Company as my agent and attorney-in-fact, coupled with an interest and with full power of substitution, to act for and in my behalf to execute and file any document and to do all other lawfully permitted acts to further the purposes of the foregoing with the same legal force and effect as if executed by me.  If I wish to clarify that something created by me prior to my employment that relates to Company’s actual or proposed business is not within the scope of the foregoing assignment, I have listed it on Appendix B in a manner that does not violate any third party rights or disclose any confidential information. Without limiting Section 1 or Company’s other rights and remedies, if, when acting within the scope of my employment or otherwise on behalf of Company, I use or (except pursuant to this Section 2) disclose my own or any third party’s confidential information or intellectual property (or if any Invention cannot be fully made, used, reproduced, distributed and otherwise exploited without using or violating the foregoing), Company will have and I hereby grant Company a perpetual, irrevocable, worldwide royalty-free, non-exclusive, sublicensable right and license to exploit and exercise all such confidential information and intellectual property rights.

 



 

3.                                      To the extent allowed by law, paragraph 2 includes all rights of paternity, integrity, disclosure and withdrawal and any other rights that may be known as or referred to as “moral rights,” “artist’s rights,” “droit moral,” or the like (collectively “Moral Rights”).  To the extent I retain any such Moral Rights under applicable law, I hereby ratify and consent to any action that may be taken with respect to such Moral Rights by or authorized by Company and agree not to assert any Moral Rights with respect thereto.  I will confirm any such ratifications, consents and agreements from time to time as requested by Company.

 

4.                                      I agree that all Inventions and all other business, technical and financial information (including, without limitation, the identity of and information relating to customers or employees) I develop, learn or obtain during the term of my employment that relate to Company or the business or demonstrably anticipated business of Company or that are received by or for Company in confidence, constitute “Proprietary Information.”  I will hold in confidence and not disclose or, except within the scope of my employment, use any Proprietary Information.  However, I shall not be obligated under this paragraph with respect to information I can document is or becomes readily publicly available without restriction through no fault of mine.  Upon termination of my employment, I will promptly return to Company all items containing or embodying Proprietary Information (including all copies), except that I may keep my personal copies of (i) my compensation records, (ii) materials distributed to shareholders generally and (iii) this Agreement.  I also recognize and agree that I have no expectation of privacy with respect to Company’s telecommunications, networking or information processing systems (including, without limitation, stored computer files, email messages and voice messages, and whether or not password-protected) and that my activity and any files or messages on or using any of those systems may be monitored at any time without notice.

 

5.                                      Until one year after the term of my employment, I will not encourage or solicit any employee or consultant of Company to leave Company for any reason (except for the bona fide firing of Company personnel within the scope of my employment).

 

6.                                      I agree that during the term of my employment with Company (whether or not during business hours), I will not engage in any activity that is in any way competitive with the business or demonstrably anticipated business of Company, and I will not assist any other person or organization in competing or in preparing to compete with any business or demonstrably anticipated business of Company.

 

7.                                      I agree that this Agreement is not an employment contract for any particular term and that I have the right to resign and Company has the right to terminate my employment at will, at any time, for any or no reason, with or without cause.  In addition, this Agreement does not purport to set forth all of the terms and conditions of my employment, and, as an employee of Company, I have obligations to Company which are not set forth in this Agreement.  However, the terms of this Agreement govern over any inconsistent terms and can only be changed by a subsequent written agreement signed by the President of Company.

 

8.                                      I agree that my obligations under paragraphs 2, 3, 4 and 5 of this Agreement shall continue in effect after termination of my employment, regardless of the reason or reasons for termination, and whether such termination is voluntary or involuntary on my part, and that Company is entitled to communicate my obligations under this Agreement to any future

 

2



 

employer or potential employer of mine.  My obligations under paragraphs 2, 3 and 4 also shall be binding upon my heirs, executors, assigns, and administrators and shall inure to the benefit of Company, it subsidiaries, successors and assigns.

 

9.                                      Any dispute in the meaning, effect or validity of this Agreement shall be resolved in accordance with the laws of the State of California without regard to the conflict of laws provisions thereof.  I further agree that if one or more provisions of this Agreement are held to be illegal or unenforceable under applicable California law, such illegal or unenforceable portion(s) shall be limited or excluded from this Agreement to the minimum extent required so that this Agreement shall otherwise remain in full force and effect and enforceable in accordance with its terms. This Agreement is fully assignable and transferable by Company, but any purported assignment or transfer by me is void. I also understand that any breach of this Agreement will cause irreparable harm to Company for which damages would not be an adequate remedy, and, therefore, Company will be entitled to injunctive relief with respect thereto in addition to any other remedies and without any requirement to post bond.

 

I HAVE READ THIS AGREEMENT CAREFULLY AND I UNDERSTAND AND ACCEPT THE OBLIGATIONS WHICH IT IMPOSES UPON ME WITHOUT RESERVATION.  NO PROMISES OR REPRESENTATIONS HAVE BEEN MADE TO ME TO INDUCE ME TO SIGN THIS AGREEMENT.  I SIGN THIS AGREEMENT VOLUNTARILY AND FREELY, IN DUPLICATE, WITH THE UNDERSTANDING THAT THE COMPANY WILL RETAIN ONE COUNTERPART AND THE OTHER COUNTERPART WILL BE RETAINED BY ME.

 

                       , 20   

Employee

 

 

 

 

 

Signature

 

 

 

 

 

 

 

Name (Printed)

 

Accepted and Agreed to:

 

Ocera Therapeutics, Inc.

 

By

 

 

 

 

 

Name

 

 

 

 

 

Title

 

 

 

3



 

APPENDIX A

 

California Labor Code Section 2870.  Application of provision providing that employee shall assign or offer to assign rights in invention to employer.

 

(a)                                 Any provision in an employment agreement which provides that an employee shall assign, or offer to assign, any of his or her rights in an invention to his or her employer shall not apply to an invention that the employee developed entirely on his or her own time without using the employer’s equipment, supplies, facilities, or trade secret information except for those inventions that either:

 

(1)                                 Relate at the time of conception or reduction to practice of the invention to the employer’s business, or actual or demonstrably anticipated research or development of the employer; or

 

(2)                                 Result from any work performed by the employee for his employer.

 

(b)                                 To the extent a provision in an employment agreement purports to require an employee to assign an invention otherwise excluded from being required to be assigned under subdivision (a), the provision is against the public policy of this state and is unenforceable.

 



 

APPENDIX B

 

PRIOR MATTER

 


EX-99.1 3 a14-18804_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Ocera Reports Second Quarter 2014 Financial Results

 

PALO ALTO, Calif., August 11, 2014 — Ocera Therapeutics, Inc. (Nasdaq:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced its financial results for the second quarter ended June 30, 2014. Net loss for the period was $7.2 million, compared to a net loss of $2.1 million in the same period of 2013. As of June 30, 2014, Ocera had cash, cash equivalents and investments of $38.1 million.

 

Ocera Clinical Trial Update

 

During the second quarter, Ocera continued patient enrollment in its “Stop HE” Phase 2b study of OCR-002, or ornithine phenlyacetate, for the treatment of acute hepatic encephalopathy (HE).  This study is a placebo-controlled, double blind trial evaluating the efficacy, safety and pharmacokinetics of intravenously administered OCR-002 reducing the severity of HE symptoms in hospitalized patients with liver cirrhosis and an acute episode of HE.

 

“Acute HE remains a serious neurological disorder with few treatment options”, said Linda Grais, M.D., chief executive officer of Ocera. “We believe that OCR-002 has the potential to significantly improve upon the standard of care for HE. While we are still relatively early in the trial, we continue to expect to complete enrollment in mid-2015.”

 

Ocera Second Quarter 2014 Financial Results

 

On July 15, 2013, Ocera Therapeutics, Inc., a private company (Private Ocera), consummated a reverse merger with Tranzyme, Inc. (Tranzyme). The resulting public entity became Ocera Therapeutics, Inc. (Ocera).  As private Ocera was the accounting acquirer, Ocera’s financial statements with respect to periods prior to the closing of the merger reflect only the financial statements of Private Ocera.

 

Upon the restructuring of Tranzyme Pharma Inc. and disposal of related assets, the operations and cash flows of this component were eliminated from ongoing operations of Ocera. As a result, Ocera has classified the results of operations of Tranzyme Pharma Inc., related restructuring costs, assets and liabilities as discontinued operations.

 

Net loss for the three and six months ended June 30, 2014 was $7.2 million and $11.3 million, respectively. Net loss for the three and six months ended June 30, 2013 was $2.1 million and $2.8 million, respectively. Basic and diluted net loss per share for the three and six months ended June 30, 2014 was $0.46 and $0.73, respectively. Basic and diluted net loss per share for the three and six months ended June 30, 2013 was $3.24 and $4.40, respectively.

 

Revenue for three and six months ended June 30, 2014 was $33,000 and $78,000, respectively. No revenue was reported in the three and six months ended June 30, 2013. Revenue in the 2014 periods consisted of royalty revenue generated from a license agreement acquired in connection with the reverse merger with Tranzyme in July 2013.

 

Research and development expense for three months ended June 30, 2014 was $4.8 million,

 



 

compared to $0.4 million for the same period in 2013.  Research and development expense for the six months ended June 30, 2014 was $7.3 million, compared to $0.4 million for the same period in 2013.  The increase in research and development expense for both periods was due primarily to costs associated with Ocera’s clinical development of OCR-002, and increases in headcount and stock-based compensation expense.

 

General and administrative expense for three months ended June 30, 2014 was $2.4 million, compared to $1.7 million for the same period in 2013. General and administrative expense for the six months ended June 30, 2014 was $5.2 million, compared to $2.2 million for the same period in 2013.  The increase in general and administrative expense for both periods was due primarily to an increase in legal and accounting fees, headcount and stock-based compensation expense. These increases were partially offset by a decrease in costs related to preparatory activities associated with the reverse merger with Tranzyme in July 2013.

 

Public Offering

 

On July 10, 2014, Ocera raised gross proceeds of $25.2 million in an underwritten public offering of 4.2 million shares of common stock at $6.00 per share. Ocera intends to use these proceeds to continue Ocera’s clinical development of OCR-002 and for working capital and other general corporate purposes.

 

Financial Guidance

 

Ocera continues to expect a net use of cash for 2014 to be approximately $30 million (net use of cash is the difference between the anticipated balances of cash and cash equivalents plus investments at December 31, 2014, excluding the proceeds generated from the July 2014 public offering, and the actual balances at December 31, 2013). In addition, Ocera expects that it has sufficient cash to cover its operations through 2016.

 

Conference Call

 

Ocera will host a conference call at 4:30 p.m. Eastern Time (1:30 pm Pacific Time) today to discuss its financial results and provide an update on its business. To access the conference call via the Internet, go to www.ocerainc.com. To access the live conference call via phone, dial 1-877-317-6789. International callers may access the live call by dialing 1-412-317-6789. The reference name to enter the call is Ocera Therapeutics, Inc.

 

The replay of the conference call may be accessed later today after 8:00 p.m. Eastern Time (5:00 pm Pacific Time) via the Internet, at www.ocerainc.com, or via phone at 1-877-344-7529 for domestic callers, or 1-412-317-0088 for international callers. The replay will be available for approximately one month. The reference number to enter the replay of the call is 10050051.

 

About Ocera

 

Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate). OCR-002 is an ammonia scavenger and has been granted orphan drug designation and Fast Track status by the

 



 

U.S. Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant hepatic encephalopathy in patients with acute liver failure and acute-on-chronic liver disease. For additional information, please see www.ocerainc.com.

 

Financial Information

 

Condensed consolidated financial information has been presented in accordance with GAAP.  The information set forth below is not necessarily indicative of our results of future operations.

 

Forward-Looking Statements

 

This press release contains “forward-looking” statements, including, without limitation, all statements related to the OCR-002 clinical development program, including but not limited to the potential benefits of OCR-002, expected completion of enrollment of its “Stop HE” study, as well as expected use of proceeds from its public offering in July 2014 and cash projections. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “expected,” “hope,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Ocera’s current expectations. Forward-looking statements involve risks and uncertainties and Ocera’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including those risks and uncertainties discussed under the heading “Risk Factors” in Ocera’s Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent filings with the SEC. All information in this press release is as of the date of the release, and Ocera undertakes no duty to update this information unless required by law.

 



 

Ocera Therapeutics, Inc.

Condensed Consolidated Statement of Operations

(Unaudited, in thousands, except per share data)

 

 

 

Three-Months Ended June 30,

 

Six-Months Ended June 30,

 

 

 

2014

 

2013

 

2014

 

2013

 

Royalty revenue

 

$

33

 

$

—

 

$

78

 

$

—

 

Total revenue

 

33

 

—

 

78

 

—

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

4,826

 

365

 

7,292

 

434

 

General and administrative

 

2,421

 

1,652

 

5,154

 

2,223

 

Amortization of intangibles

 

41

 

—

 

82

 

—

 

Total operating expenses

 

7,288

 

2,017

 

12,528

 

2,657

 

Loss from operations

 

(7,255

)

(2,017

)

(12,450

)

(2,657

)

Net interest income (expense)

 

12

 

(77

)

25

 

(173

)

Change in fair value of warrant liability

 

—

 

7

 

—

 

12

 

Net loss from continuing operations

 

(7,243

)

(2,087

)

(12,425

)

(2,818

)

Net income from discontinued operations

 

20

 

—

 

1,137

 

—

 

Net loss

 

$

(7,223

)

$

(2,087

)

$

(11,288

)

$

(2,818

)

Net loss per share from continuing operations-basic and diluted

 

$

(0.46

)

$

(3.24

)

$

(0.80

)

$

(4.40

)

Net loss per share from discontinued operations-basic and diluted

 

—

 

—

 

0.07

 

—

 

Net loss per share-basic and diluted

 

$

(0.46

)

$

(3.24

)

$

(0.73

)

$

(4.40

)

Shares used to compute net loss per share-basic and diluted

 

15,539,053

 

643,674

 

15,480,469

 

640,465

 

 

Ocera Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited, in thousands)

 

 

 

June 30,
2014

 

December 31,
2013

 

Cash, cash equivalents and investments

 

$

38,118

 

$

47,213

 

Working capital

 

35,485

 

42,605

 

Total assets

 

39,796

 

51,820

 

Accumulated deficit

 

(92,774

)

(81,486

)

Total stockholders’ equity (deficit)

 

$

36,495

 

$

45,132

 

 

CONTACT:

Michael Byrnes

Ocera Therapeutics, Inc.

Communications@ocerainc.com

650-475-0150

 


EX-99.2 4 a14-18804_1ex99d2.htm EX-99.2

Exhibit 99.2

 

Ocera Announces Appointment of Rajiv Patni, M.D. as Chief Development Officer

 

PALO ALTO, Calif., August 11, 2014 — Ocera Therapeutics, Inc. (Nasdaq:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced that Rajiv Patni, M.D. has been appointed as the Company’s Chief Development Officer. Dr. Patni will commence his employment with Ocera on September 2, 2014.

 

“I am delighted to have Rajiv join our management team and expect that he will make significant contributions to the development of OCR-002,” said Linda Grais, M.D., Chief Executive Officer of Ocera. “Rajiv has been involved in over 15 clinical development programs, across several therapeutic areas, including acute care indications. Rajiv also served as an academic physician and trained in internal medicine and cardiology. Rajiv’s experience both in the clinic and in industry will be an invaluable asset to Ocera.”

 

“Based on my review of the available clinical data on OCR-002 as well as the ongoing STOP-HE protocol, I am very excited to join the Ocera team and advance the clinical development of OCR-002 for the potential treatment of acute hepatic encephalopathy.  My near-term focus will be the completion of STOP-HE, which represents one of the largest randomized, placebo-controlled studies ever done in acute hepatic encephalopathy,” said Dr. Patni.

 

Prior to joining Ocera, Dr. Patni served as Senior Vice President for Actelion U.S. Prior to his time at Actelion, Dr. Patni served as Vice President at Roche as well as in leadership positions at Novartis and Pfizer. Dr. Patni received his M.D. from Mount Sinai School of Medicine and served as Attending Physician at the Albert Einstein College of Medicine, both in New York City.

 

About Ocera

 

Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate). OCR-002 is an ammonia scavenger and has been granted orphan drug designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant hepatic encephalopathy in patients with acute liver failure and acute-on-chronic liver disease. For additional information, please see www.ocerainc.com.

 

Forward-Looking Statements

 

This press release contains “forward-looking” statements, including, without limitation, all statements related to the OCR-002 clinical development program. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “expected,” “hope,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Ocera’s current expectations. Forward-looking statements involve risks and uncertainties and Ocera’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and

 



 

uncertainties, including those risks and uncertainties discussed under the heading “Risk Factors” in Ocera’s Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent filings with the SEC. All information in this press release is as of the date of the release, and Ocera undertakes no duty to update this information unless required by law.

 

CONTACT:

Michael Byrnes

Ocera Therapeutics, Inc.

Communications@ocerainc.com

650-475-0150

 


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