0001654954-16-003338.txt : 20161102 0001654954-16-003338.hdr.sgml : 20161102 20161102074516 ACCESSION NUMBER: 0001654954-16-003338 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20161031 ITEM INFORMATION: Cost Associated with Exit or Disposal Activities ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20161102 DATE AS OF CHANGE: 20161102 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Opexa Therapeutics, Inc. CENTRAL INDEX KEY: 0001069308 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 760333165 STATE OF INCORPORATION: TX FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33004 FILM NUMBER: 161966331 BUSINESS ADDRESS: STREET 1: 2635 TECHNOLOGY FOREST BLVD. CITY: THE WOODLANDS STATE: TX ZIP: 77381 BUSINESS PHONE: (281) 272-9331 MAIL ADDRESS: STREET 1: 2635 TECHNOLOGY FOREST BLVD. CITY: THE WOODLANDS STATE: TX ZIP: 77381 FORMER COMPANY: FORMER CONFORMED NAME: PharmaFrontiers Corp. DATE OF NAME CHANGE: 20051011 FORMER COMPANY: FORMER CONFORMED NAME: PHARMAFRONTIERS CORP DATE OF NAME CHANGE: 20040816 FORMER COMPANY: FORMER CONFORMED NAME: SPORTAN UNITED INDUSTRIES INC DATE OF NAME CHANGE: 19990305 8-K 1 opxa_8k.htm CURRENT REPORT Blueprint
 
 

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): October 31, 2016
 
 

 
OPEXA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 
Texas
 
001-33004
 
76-0333165
(State or other jurisdiction ofincorporation)
 
(Commission File Number)
 
(IRS Employer Identification No.)
 
2635 Technology Forest Blvd., The Woodlands, Texas
 
77381
(Address of principal executive offices)
 
(Zip Code)
 
 
 
Registrant’s telephone number, including area code: (281) 272-9331    
N/A    
(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:
 
☐
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 2.05    Costs Associated with Exit or Disposal Activities.
 
On November 2, 2016, Opexa Therapeutics, Inc. (the “Company”) announced an approximately 40% reduction to the Company’s then-current workforce in light of the negative Phase 2b Abili-T clinical trial top-line results announced on October 28, 2016. Following further analysis of the Phase 2b Abili-T clinical trial top-line results and in order to reduce operating expenses and conserve cash resources, on October 26, 2016, the Company’s Board of Directors approved reduction of the Company’s 20 current full-time employees. The workforce reduction is effective immediately. The Company estimates that it will incur incremental aggregate cash charges of approximately $95,000 associated with this workforce reduction.
 
Item 5.02     Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
 
On October 31, 2016, Scott Seaman, a member of the Board of Directors, informed the Board of his decision to resign from the Board, effective immediately. Mr. Seaman’s resignation was not in connection with any known disagreement with the Company on any matter.
 
On November 2, 2016, the Company also announced that it had accepted the resignation of Donna Rill, the Company’s Chief Development Officer, with such resignation to be effective as of November 4, 2016.
 
Item 9.01    Financial Statements and Exhibits.
 
 A copy of the press release issued by the Company on November 2, 2016 is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
 
Cautionary Statement Relating to Forward-Looking Information for the Purpose of “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995
Statements contained in this report, other than statements of historical fact, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “expects,” “believes,” “may,” “intends,” “potential,” “should,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the reduction-in-workforce and the anticipated future reduction in operating expenses and cash conservation benefits associated therewith, and the future charges expected to be incurred, constitute forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation risks and uncertainties associated with possible changes in the magnitude of the planned workforce reduction, including as a result of changes that may occur in the Company’s operations or operating plan, or other reasons or events, possible changes in the amount of charges and cash payments associated with the workforce reduction, including the possibility that the Company may incur unanticipated charges or make cash payments that are not currently contemplated, and the Company’s ability to reduce its operating expenses and conserve cash on a net basis as a result of the workforce reduction. These and other risks are described in detail in the Company’s SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. All forward-looking statements contained in this report speak only as of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date.
 
 
2
 
 
 
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, thereunto duly authorized.
 
 
Dated: November 2, 2016   
OPEXA THERAPEUTICS, INC.
 
 
 
 
 
 
By:  
/s/  Neil K. Warma
 
 
 
Neil K. Warma
 
 
 
President, Chief Executive Officer and Acting Chief Financial Officer
 
 
 
 
 3

 
 
 EX-99.1 2 opxa_ex991.htm PRESS RELEASE Untitled Document
 
EXHIBIT 99.1
 
Opexa Announces Reduction in Workforce in Light of Top-Line Results from Phase 2b Abili-T Trial of Tcelna® (imilecleucel-T) in Secondary Progressive Multiple Sclerosis
 
THE WOODLANDS, Texas (November 2, 2016) – Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing personalized immunotherapies for autoimmune disorders, including multiple sclerosis (MS) and neuromyelitis optica (NMO), today announced that it was implementing an approximately 40% reduction to the Company’s current workforce in order to reduce operating expenses and conserve cash resources. The move comes as the Company recently announced that the Phase 2b Abili-T clinical trial designed to evaluate the efficacy and safety of Tcelna® (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS) did not meet its primary endpoint of reduction in brain volume change (atrophy), nor did it meet the secondary endpoint of reduction of the rate of sustained disease progression.
The Company estimates that it will incur incremental aggregate cash charges of approximately $95,000 associated with this current workforce reduction. Moreover, the Company expects that additional restructuring will occur by year-end.
Additionally, the Company has accepted the resignations of Ms. Donna Rill, Opexa’s Chief Development Officer, and Mr. Scott Seaman, a member of the Company’s Board of Directors. Ms. Rill, who is leaving to pursue other career opportunities, will depart as of November 4, 2016.
“This reduction in force is a difficult but necessary step as a result of the disappointing results of our lead product candidate, Tcelna, announced last week,” said Neil K. Warma, President and Chief Executive Officer of Opexa. “I would like to personally express my appreciation to each of the employees impacted by this decision for their commitment to Tcelna and Opexa. The Opexa team has endeavored to increase the understanding of secondary progressive multiple sclerosis, and we hope our work will contribute to the development of a safe and effective therapy for this devastating disease. I would also like to thank Scott Seaman for his long-time service as a Director of Opexa and note our special heartfelt appreciation of Donna Rill who has dedicated over 15 years to Opexa.”
About Opexa Therapeutics
Opexa Therapeutics is a biopharmaceutical company developing personalized immunotherapies based on ImmPath®, its proprietary T-cell technology, with the potential to treat autoimmune diseases. Opexa’s staff of cell therapy experts operates in a stand-alone facility located on one acre in the Woodlands, Texas. The facility is comprised of over 10,000 sq. ft. of state of the art space for cGMP manufacturing suites, a quality control laboratory, a research and development laboratory, quality assurance, specialized flow cytometry, a microscopy lab and clinical and regulatory affairs, as well as warehouse space for materials management. Opexa’s patent estate is currently comprised of over 160 issued patents (domestic and international).
For more information, please visit Opexa Therapeutics’ website at www.opexatherapeutics.com or follow company news on Twitter via @OpexaCEO or LinkedIn.
Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995
Statements contained in this report, other than statements of historical fact, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “expects,” “believes,” “may,” “intends,” “potential,” “should,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the reduction-in-workforce and the anticipated future reduction in operating expenses and cash conservation benefits associated therewith, and the future charges expected to be incurred, constitute forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation risks and uncertainties associated with possible changes in the magnitude of the planned workforce reduction, including as a result of changes that may occur in the Company’s operations or operating plan, or other reasons or events, possible changes in the amount of charges and cash payments associated with the workforce reduction, including the possibility that the Company may incur unanticipated charges or make cash payments that are not currently contemplated, and the Company’s ability to reduce its operating expenses and conserve cash on a net basis as a result of the workforce reduction. These and other risks are described in detail in the Company’s SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. All forward-looking statements contained in this report speak only as of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date.
 
Company Contact:
Neil K. Warma
Opexa Therapeutics, Inc.
Chief Executive Officer
281-775-0600
 
 
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