Immune Design Reports Second Quarter 2015 Financial Results
Corporate Update and Recent Highlights
August 10, 2015, Immune Designannounced it had entered into two clinical trial collaborations with Merck (NYSE:MRK) to evaluate two immuno-oncology investigational agents, G100 and LV305, each separately combined with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1therapy, in Phase 1 trials in patients with non-Hodgkin's lymphoma (NHL) and melanoma, respectively.
Immune Designannounced it had entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate the safety and efficacy of Immune Design'sCMB305 prime-boost immuno-oncology investigational agent combined with the investigational cancer immunotherapy, atezolizumab (MPDL3280A; anti-PD-L1), in a randomized Phase 2 trial in patients with soft tissue sarcoma.
May 2015, Immune Designannounced the presentation of positive clinical data from three immuno-oncology Phase 1 studies at the 2015 American Society of Clinical Oncology(ASCO) Annual Meeting. The three trials provide first-in-human clinical data with the company's immuno-oncology agents that are designed to generate anti-tumor immunity, LV305 and G305 which target the tumor-associated antigen, NY-ESO-1 and are the two components of CMB305 and G100, which in contrast, is a potent toll-like receptor-4 (TLR4) agonist that is being administered intratumorally to activate local and systemic immunity.
April 2015, Immune Designclosed an underwritten public offering of 3,000,000 shares of common stock at a price of $26.50per share. In May 2015, the company sold an additional 47,409 shares when the underwriters exercised a portion of their overallotment option. Immune Design received aggregate net proceeds of $75.4 million, after underwriting discounts and commissions and offering expenses totaling $5.4 million.
Financial Results and Guidance
Immune Designended the second quarter of 2015 with $129.0 millionin cash and cash equivalents, compared to $75.4 millionas of December 31, 2014.
Net loss and net loss per share for the second quarter of 2015 were
$10.5 millionand $0.54, respectively, compared to $6.1 millionand $16.57, respectively, for the second quarter of 2014.
Revenue for the second quarter of 2015 was
$1.8 millionand was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014. Revenue for the second quarter of 2014 was $1.1 millionand related primarily to license revenue associated with the company's collaboration with MedImmune.
Research and development expenses for the second quarter of 2015 were $8.5 million, compared to
$3.9 millionfor the second quarter of 2014. The $4.6 millionincrease was primarily attributable to contract manufacturing and clinical trials for LV305 and CMB305, as well as activities related to the company's HSV-2 collaboration with Sanofi Pasteur. Expenses incurred under the collaboration are predominantly reimbursed by Sanofi Pasteurand reflected in revenue. 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 Immune Design'sadvancing research and clinical pipeline. Research and development stock-based compensation (a non-cash expense), was $0.5 millionfor the current quarter compared to $0.1 millionfor the same quarter in 2014.
General and administrative expenses for the second quarter of 2015 were $3.8 million, compared to $1.9 million for the second quarter of 2014. The
$1.9 millionincrease was primarily attributable to increases in 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 $1.3 millionfor the current quarter compared to $0.1 millionfor the same quarter in 2014.
Net operating cash used in operations through
June 2015was $21.7 million, which excludes the $75.4 millionin net proceeds received from the company's follow-on offering.
Net loss and net loss per share for the six months ended
June 30, 2015were $19.9 millionand $1.10, respectively, compared to $14.3 millionand $38.81, respectively, for the same period in 2014.
Revenue for the six months ended
June 30, 2015was $3.7 millionand was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014. Revenue for the same period in 2014 was $1.1 millionrelated primarily to Immune Design'scollaboration with MedImmune.
Total operating expenses for the six months ended
June 30, 2015were $23.6 million, compared to $11.3 millionfor the same period in 2014. The increase in the current period relates primarily to contract manufacturing and clinical trials for LV305 and CMB305, as well as activities related to the company's HSV-2 collaboration with Sanofi Pasteur. Expenses incurred under the collaboration are predominantly reimbursed by Sanofi Pasteurand reflected in revenue. 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 and legal fees to support operations as a public company and to defend ongoing litigation, and in facility and office costs.
Updated Financial Guidance
In consideration of the funds raised through
Anticipate ending fiscal 2015 with a cash and investments balance of at least
Estimate net cash used in operating activities of
$36.0to $40.0 millionfor the year-ending December 31, 2015. This is an increase from beginning of the year guidance, which was an estimated range of $33.0to $37.0for net cash used in operating activities.
Conference Call Information
The live call may be accessed by dialing 844-831-3023 for domestic callers and 920-663-6275 for international callers. A live webcast of the call will be available online from the investor relations section of the company website at http://ir.immunedesign.com/events.cfm and will be archived there for 90 days. A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code: 1144304.
An archived copy of the webcast will be available on
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on
|Selected Balance Sheet Data|
|Cash and cash equivalents||$ 128,998||$ 75,354|
|Total current liabilities||6,203||11,947|
|Total stockholders' equity||125,078||66,346|
|Statements of Operation Data (unaudited)|
|(In Thousands Except Share and Per Share Amounts)|
|Three Months Ended||Six Months Ended|
|Licensing revenue||$ --||$ 1,000||$ --||$ 1,000|
|Cost of product sales||44||18||123||32|
|Research and development||8,483||3,883||15,946||7,961|
|General and administrative||3,778||1,850||7,580||3,296|
|Total operating expenses||12,305||5,751||23,649||11,289|
|Loss from operations||(10,525)||(4,687)||(19,931)||(10,200)|
|Interest and other income||8||--||8||1|
|Change in fair value of convertible preferred stock warrant liability||--||(1,439)||--||(4,150)|
|Net loss attributable to common stockholders||$ (10,517)||$ (6,126)||$ (19,923)||$(14,349)|
|Basic and diluted net loss per share attributable to common stockholders||$ (0.54)||$ (16.57)||$ (1.10)||$ (38.81)|
|Weighted-average shares used to compute basic and diluted net loss per share attributable to common stockholders||19,356,404||369,750||18,174,611||369,702|
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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