Immune Design Reports Third Quarter 2015 Financial Results
Corporate Update and Recent Highlights
Immune Designannounced the dosing of the first patient in the randomized Phase 2 trial of CMB305, the company's "prime boost" immuno-oncology product candidate, combined with Genentech'sinvestigational cancer immunotherapy, atezolizumab (MPDL3280A; anti-PD-L1) in patients with soft tissue sarcoma. The trial is being conducted pursuant to a clinical collaboration with Genentech, a member of the Roche Group, which will provide atezolizumab.
November 5, Immune Designannounced that preclinical research on G100, the company's intratumoral TLR4 agonist-based product candidate, will be presented in an oral presentation at the 57th American Society of Hematology (ASH) Annual Meeting taking place December 5-8, 2015in Orlando, Florida.
November 3, Immune Designannounced new preclinical data showing that each of G100, which contains a potent synthetic TLR4 agonist, and a dendritic-cell targeting hybrid lentiviral vector from its ZVex™ immunotherapy platform synergize with immune check point inhibitors and demonstrate potent local and systemic anti-tumor activity in cancer models. These data were presented at the 30th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) Conference.
Immune Designhighlighted the application of its GLAASTM discovery platform in MedImmune'sPhase 2 clinical trial of MEDI7510. MEDI7510 is an investigational agent for the prevention of respiratory syncytial virus (RSV) under development by MedImmune, the global biologics research and development arm of AstraZeneca.
Immune Designannounced the establishment of clinical collaborations with each of Merckand Genentech, a member of the Roche group, covering three clinical trials. In the first collaboration, Merckwill contribute KEYTRUDA® (pembrolizumab), its anti-PD-1 therapy, to both Immune Design'splanned G100 Phase 1b/2 clinical trial in patients with Non-Hodgkin's Lymphoma, as well as anLV305 Phase 1 expansion arm in melanoma patients who have an inadequate response to anti-PD1 therapy. Genentechis providing atezolizumab, its investigational anti-PD-L1 therapy, to Immune Design'srandomized Phase 2 trial for patients with selected soft tissue sarcomas expressing NY-ESO-1. Immune Designis the sponsor of these three clinical trials, and none of the parties to these arrangements have transferred any rights to their products to the other.
Financial Results and Guidance
Immune Designended the third quarter of 2015 with $120.5 millionin cash and cash equivalents, compared to $75.4 millionas of December 31, 2014.
Net loss and net loss per share for the third quarter of 2015 were
$7.4 millionand $0.37, respectively, compared to $6.7 millionand $0.55, respectively, for the third quarter of 2014.
Revenue for the third quarter of 2015 was
$4.7 millionand was attributable primarily to $3.5 millionin license revenue associated with Immune Design'scollaborations with MedImmuneand Sanofi, $0.8 millionin product sales, and $0.3 millionin collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014. Revenue for the third quarter of 2014 was $3.5 millionand related to license revenue associated with the company's collaboration with Sanofi.
Research and development expenses for the third quarter of 2015 were $8.3 million, compared to
$6.0 millionfor the third quarter of 2014. The $2.3 millionincrease was primarily attributable to research and development and contract manufacturing of Immune Design'sG103 HSV-2 investigational agent, which is almost completely paid for under the Sanofi Pasteur G103 collaboration agreement, and for contract manufacturing and clinical trials for LV305 and CMB305. Additionally, there was an increase in personnel-related expenses, including stock-based compensation, as a result of growth in research and development headcount to support the company's advancing research and clinical pipeline. Research and development stock-based compensation (a non-cash expense), was $0.5 millionfor the current quarter and $0.2 millionfor the same quarter in 2014.
General and administrative expenses for the third quarter of 2015 were $3.5 million, compared to $4.1 million for the third quarter of 2014. This decrease was partially offset by increases in facility-related costs and personnel-related expenses, including stock-based compensation, primarily related to an increase in administrative headcount to support the growth and expansion of the business. General and administrative expenses for stock-based compensation (a non-cash expense), was
$0.9 millionfor the current quarter and $0.2 millionfor the same quarter in 2014.
Net operating cash used in operations through
September 2015was $30.3 million, which excludes the $75.4 millionin net proceeds received from the company's follow-on offering in April 2015.
Net loss and net loss per share for the nine months ended
September 30, 2015were $27.3 millionand $1.45, respectively, compared to $21.0 millionand $4.85, respectively, for the same period in 2014.
Revenue for the nine months ended
September 30, 2015was $8.4 millionand was attributable primarily to $3.9 millionin collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014, $3.5 millionin license revenue associated with the company's collaborations with MedImmuneand Sanofi, and $0.9 millionin product sales. Revenue for the same period in 2014 was $4.6 millionand was primarily attributable to $4.5 millionin license revenue associated with Immune Design'scollaborations with Sanofi and MedImmune.
Total operating expenses for the nine months ended
September 30, 2015were $35.7 million, compared to $21.4 millionfor the same period in 2014. The increase in the current period relates primarily to an increase in activities to support research and development and contract manufacturing of G103, which is almost completely paid for under the Sanofi Pasteur G103 collaboration, and for contract manufacturing and clinical trials for LV305 and CMB305. Additionally, there was an increase in personnel-related expenses, including stock-based compensation, as a result of growth and expansion of the business following Immune Design'sinitial public offering in July 2014, in professional service fees to support operations as a public company and in facility and office costs. These increases were partially offset by a decrease in legal services related to defending ongoing litigation, patents and corporate legal services.
Conference Call Information
The live call may be accessed by dialing 844-831-3023 for domestic callers and 920-663-6275 for international callers. A live webcast of the call will be available online from the investor relations section of the company website at http://ir.immunedesign.com/events.cfm and will be archived there for 90 days. A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code: 70749704.
An archived copy of the webcast will be available on
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on
|Selected Balance Sheet Data|
|Cash and cash equivalents||$ 120,490||$ 75,354|
|Total current liabilities||6,679||11,947|
|Total stockholders' equity||119,169||66,346|
|Statements of Operation Data (unaudited)|
|(In Thousands Except Share and Per Share Amounts)|
|Three Months Ended||Nine Months Ended|
|Licensing revenue||$ 3,500||$ 3,500||$ 3,500||$ 4,500|
|Cost of product sales||298||31||421||63|
|Research and development||8,263||5,988||24,209||13,949|
|General and administrative||3,506||4,082||11,086||7,378|
|Total operating expenses||12,067||10,101||35,716||21,390|
|Loss from operations||(7,414)||(6,557)||(27,345)||(16,757)|
|Interest and other income||7||2||15||3|
|Change in fair value of convertible preferred stock warrant liability||--||(127)||--||(4,277)|
|Net loss attributable to common stockholders||$ (7,407)||$ (6,682)||$ (27,330)||$ (21,031)|
|Basic and diluted net loss per share attributable to common stockholders||$ (0.37)||$ (0.55)||$ (1.45)||$ (4.85)|
|Weighted-average shares used to compute basic and diluted net loss per share attributable to common stockholders||20,131,260||12,128,810||18,822,517||4,332,480|
CONTACT: Media Contact
Julie Rathbun Rathbun Communicationsjulie@rathbuncomm.com 206-769-9219 Investor Contact Shari Annes Annes Associatessannes@annesassociates.com 650-888-0902
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