Immune Design Reports Third Quarter 2014 Financial Results and Provides Corporate Update
Third Quarter 2014 Highlights and Corporate Update
Immuno-oncology Clinical Trials
- Continued progress on clinical trial enrollment. Enrollment for all ongoing clinical trials continues per plan. Within the company's Specific Antigen approach targeting NY-ESO-1-expressing tumors, the LV305 and G305 Phase 1 studies in five types of cancer are on schedule to complete enrolment by year-end, with data available to the company by the end of the first quarter of 2015. In the Endogenous Antigen approach, the G100 Phase 1 study continues to enroll Merkel cell carcinoma patients and should complete enrollment in the first half of 2015.
CMB305 IND cleared. The
FDAhas cleared Immune Designto proceed with the first clinical study of CMB305, the prime-boost approach combining LV305 and G305, and the next stage in the Specific Antigen approach. The company expects to begin enrolling patients in the first quarter of 2015.
Multiple new studies planned for 2015. In addition to starting the CMB305 Phase 1 study, in the latter part of 2015,
Immune Designintends to begin two CMB305 Phase 2 studies in two tumor types, as well as an expansion study of LV305 at the maximum tolerated dose from its Phase 1 study in the first quarter of 2015. In the second quarter of 2015, the company also intends to start a G100 Phase 1 study in a second tumor, a type of non-Hodgkin lymphoma.
Non-oncology Strategy Update
Immune Designcontinued to execute on its near-term strategy to partner in non-oncology indications with the announcement of two partnerships leveraging the GLAAS™ Platform:
License to Sanofi to Explore Novel Approach to Treat Food Allergy: In
August 2014, Immune Designgranted Sanofi an exclusive license to discover, develop and commercialize products to treat a selected food allergy, for which the company received an upfront payment and will be eligible to receive development and commercialization milestones totaling $168.0 million, as well as tiered royalties on sales of approved products.
Broad Collaboration for the Development of a Herpes Simplex Virus Therapy with
Sanofi Pasteur: In October 2014, Immune Designentered into a broad collaboration for the development of a herpes simplex virus (HSV) therapy with Sanofi Pasteur, the vaccines division of Sanofi. The two companies will each contribute product candidates and develop them jointly through Phase 2 clinical trials, at which point Sanofi Pasteurintends to continue development of the most promising candidate. Sanofi Pasteurwill bear the costs of all preclinical and clinical development, as well as commercial costs, with Immune Designproviding a specific formulation of GLA from the GLAAS platform at its cost through Phase 2 studies. Immune Designwill be eligible to receive future milestone and royalty payments on any product developed from the collaboration.
- License to Sanofi to Explore Novel Approach to Treat Food Allergy: In
Initial Public Offering Completed: In
July 2014, Immune Designcompleted its initial public offering (IPO) of 5,410,564 shares, at a public offering price of $12.00per share, resulting in aggregate gross proceeds of approximately $64.9 million, before underwriting discounts, commissions and expenses.
Third Quarter 2014 Financial Highlights and 2014 Guidance
Immune Designended the third quarter of 2014 with $83.4 millionin cash and cash equivalents compared to $18.0 millionat the end of the second quarter. Proceeds from the IPO and the exercise of warrants provided net cash from financing activities during the quarter of $67.3 million, which was offset by approximately $1.9 millionnet cash used for operating activities during the quarter.
Research and development expenses for the third quarter of 2014 were $6.0 million, compared with $2.9 million for the third quarter of 2013. The increase of
$3.1 millionwas primarily due to increased manufacturing of our clinical trial materials and the clinical trial costs for three ongoing Phase 1 studies in the current quarter.
General and administrative expenses for the third quarter of 2014 were $4.1 million, compared to $1.1 million for the third quarter of 2013. The
$3.0 millionincrease was driven primarily by the increased costs required to operate as a public company and increased legal fees.
Net loss for the third quarter of 2014 was
$6.7 million, compared to $4.0 millionfor the third quarter 2013.
Immune Designexpects full-year 2014 net cash used in operating activities to be less than $20.0 million, estimates ending 2014 with approximately $75.0 millionin cash and equivalents, and expects to have cash to fund operations for approximately three years, without entering into any additional collaboration agreements or receiving any future milestone payments.
Conference Call Information
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Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on
|Selected Balance Sheet Data (unaudited)|
|Cash and cash equivalents||$ 83,388||$ 30,387|
|Total Current liabilities||5,955||1,975|
|Convertible preferred stock||--||81,394|
|Total stockholders' equity (deficit)||78,996||(55,834)|
|Statements of Operation Data|
|(In Thousands Except Per Share Amounts)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Licensing revenue||$ 3,500||$ 13||$ 4,500||$ 717|
|Cost of product sales||31||70||63||532|
|Research and development||5,988||2,920||13,949||8,819|
|General and administrative||4,082||1,132||7,378||2,827|
|Total operating expenses||10,101||4,122||21,390||12,178|
|Loss from operations||(6,557)||(3,993)||(16,757)||(10,603)|
|Interest and other income (expense)||2||(1)||3||34|
|Change in fair value of convertible preferred stock warrant liability||(127)||—||(4,277)||—|
|Net loss attributable to common stockholders||$ (6,682)||$ (3,994)||$ (21,031)||$ (10,569)|
|Basic and diluted net loss per share attributable to common stockholders||$ (0.55)||$ (10.81)||$ (4.85)||$ (28.81)|
|Weighted-average shares used to compute basic and diluted net loss per share attributable to common stockholders||12,128,810||369,460||4,332,480||366,854|
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