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) May 12, 2016
GlobeImmune, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 001-35642 | 84-1353925 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
1450 Infinite Drive Louisville, CO |
80027 | |
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (303) 625-2700
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations 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)) |
Section 2 Financial Information
Item 2.02. | Results of Operations and Financial Condition. |
On May 12, 2016, GlobeImmune, Inc., a Delaware corporation, issued a press release providing an update on its business and clinical programs, and announcing financial results for the first quarter of 2016. The press release is attached hereto as Exhibit 99.1, which is furnished under Item 2.02 of this report and shall not be deemed to be 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, regardless of any general incorporation language in such filing.
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits |
Exhibit |
Description | |
99.1 | Press Release titled GlobeImmune Announces Updates and Financial Results for First Quarter 2016 dated May 12, 2016. |
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.
GlobeImmune, Inc. | ||||||
Dated: May 12, 2016 | ||||||
By: | /s/ Timothy C. Rodell | |||||
Timothy C. Rodell | ||||||
Chief Executive Officer and President |
INDEX TO EXHIBITS
(d) | Exhibits |
Exhibit |
Description | |
99.1 | Press Release titled GlobeImmune Announces Updates and Financial Results for First Quarter 2016 dated May 12, 2016. |
Exhibit 99.1
For Immediate Release
GlobeImmune Announces Updates and Financial Results
for First Quarter 2016
LOUISVILLE, CO(Marketwired May 12, 2016) GlobeImmune, Inc. (NASDAQ: GBIM) today provided an update on the Companys business and clinical programs and announced financial results for the first quarter 2016.
The Company continues to seek potential strategic transactions. Cantor Fitzgerald & Co. has been retained by the Company to assist in reviewing ways to maximize stockholder value. There is not a defined timeline for the strategic review process and the review may not result in any specific action or transaction.
The Company has three ongoing clinical trials being conducted by the Companys corporate collaborators, Gilead Sciences, Inc. and Celgene Corporation. GS-US-330-1401, the GS-4774 Phase 2 clinical trial in patients with chronic HBV infection who are currently not receiving treatment, is fully enrolled and the 48-week results are projected to be available in the second half of 2016. The 24-week results for this trial did not show a statistical difference between control and treatment arms. The results from a GI-6207 Phase 2 trial in subjects with medullary thyroid cancer are projected to be available in the second half of 2016. A Phase 2 clinical trial designed to investigate the safety and efficacy of evaluating GI-6301 in combination with radiation therapy in patients with chordoma is still enrolling patients.
Financial Results First Quarter Ended March 31, 2016
GlobeImmune reported a net loss of $0.9 million for the three months ended March 31, 2016 compared to $1.6 million for the same period in 2015. The decrease in net loss for 2016 was due to lower compensation expense due to layoffs in research and development and general and administrative expenses. GlobeImmune reported a loss applicable to common stockholders of $0.15 per share, for three months ended March 31, 2016 compared to loss applicable to common stockholders of $0.27 per share for the same period in 2015.
Research and development for proprietary programs expense for the three months ended March 31, 2016 was $0.3 million compared to $0.4 million for the same period in 2015, a decrease of $0.1 million. The decrease was primarily due to a decrease in salary expense due to layoffs in 2015. Costs of manufacturing services for the three months ended March 31, 2016 were $0 compared to $0.2 million for the same period in 2015. The decrease was primarily due to a decrease in expenses relating to manufacturing services for Gilead for the Phase 2 HBV trial. Costs of collaboration license and services for the three months ended March 31, 2016 was $0.5 million compared to $0.9 million for the same period in 2015, a decrease of $0.4 million. The decrease was primarily due to a decrease in expenses related to the clinical trial for GS-4774 and reduction in salary expense due to layoffs in 2015. General and administrative expense for the three months ended March 31, 2016 was $0.9 million compared to $1.2 million for the same period in 2015, a decrease of $0.3 million. The decrease was due to a reduction in salary expense due to layoffs in 2015.
At March 31, 2016, GlobeImmune had cash and equivalents of $8.7 million. The Company believes it has sufficient cash to operate the company as a going concern through the middle of 2017 as it continues to evaluate strategic alternatives. If a strategic alternative is not found in the near future, we could decide to wind down the operations of the Company which will consume cash faster than currently planned as a going concern.
About GlobeImmune
GlobeImmune is a biopharmaceutical company focused on developing products for the treatment of cancer and infectious diseases based on its proprietary Tarmogen® platform. Tarmogens activate the immune system by stimulating cellular immunity, known as T cell immunity, in contrast to traditional vaccines that predominately stimulate antibody production. To date, Tarmogen product candidates have been generally well tolerated in clinical trials for multiple disease indications and are efficient to manufacture. In 2009, the Company entered into a worldwide strategic collaboration and option agreement with Celgene Corporation focused on the discovery, development and commercialization of product candidates intended to treat cancer. Under this agreement, Celgene exercised their option to take an exclusive worldwide license to the GI-6300 and GI-6200 Tarmogen product series targeting brachyury and CEA, respectively. In 2011, the Company entered into a worldwide, strategic collaboration with Gilead Sciences, Inc., to develop Tarmogens intended for the treatment of chronic hepatitis B infection. For additional information, please visit the companys website at www.globeimmune.com.
Safe Harbor Statement
This press release contains forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the adequacy of the Companys capital to fund its ongoing operations, the Companys ability to enter into and complete any strategic transaction, the potential for Tarmogens to treat or prevent any disease, potential Tarmogen side effect profiles, the Company and its collaborators abilities to successfully complete clinical trials, timing and eventual prospects for completion of clinical trials and any approval to market any of the Companys products and the prospects for the Companys collaborations. Such statements are based on managements current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Companys financial resources and whether they will be sufficient to meet the Companys business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by the Companys intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. The Companys forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning GlobeImmunes business are described in additional detail in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2015, and the Companys other Periodic and Current Reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Tarmogen is a registered trademark of GlobeImmune, Inc.
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GLOBEIMMUNE CONTACT:
Timothy C. Rodell M.D.
President and Chief Executive Officer
T: 303-625-2820
information@globeimmune.com
GLOBEIMMUNE INVESTOR CONTACT:
Susan Noonan
S.A. Noonan Communications
T: 212-966-3650
susan@sanoonan.com