Immune Design Reports First Quarter 2018 Financial Results and Provides Corporate Update
- The higher dose of CMB305 was deemed safe and cleared for the pivotal Phase 3
- The 20ug dose of G100 shows a two-fold increase in TILs, higher than that seen at the 10ug dose
- Conference call at
1:30 pmPacific today
“The plan to start patient enrollment by mid-year in our pivotal Phase 3 of CMB305 in synovial sarcoma is on track. Moreover, G100 is emerging as an exciting, active immunotherapeutic molecule with great potential,” said
- CMB305: novel prime-boost targeting NY-ESO-1+ cancers
-- The higher dose of CMB305 (4x the vector component compared to earlier clinical studies) was found to be safe by a data monitoring committee and cleared to move forward into the planned pivotal Phase 3 trial in frontline maintenance in synovial sarcoma patients.
- G100: novel, synthetic TLR4 agonist for intratumoral therapy
-- Updated data in follicular lymphoma patients show that a higher dose of G100 (20ug, 2x the dose studied in the ongoing randomized study with pembrolizumab) has increased activity, as defined by a two-fold increase in tumor infiltrating lymphocytes (TILs) pre- vs. post-G100 treatment.
Immune Designis planning to interact with the FDAregarding next steps for development of G100.
Immune Designended the first quarter of 2018 with $131.0 millionin cash and cash equivalents, short-term investments, and other receivables compared to $144.2 millionas of December 31, 2017. Net cash used in operations for the three months ended March 31, 2018was $16.4 million.
- Net loss and net loss per share for the first quarter of 2018 were
$13.3 millionand $0.28, respectively, compared to 12.6 million and $0.50, respectively, for the first quarter of 2017.
- Revenue for the first quarter of 2018 was
$0.5 millionand was primarily attributable to the Sanofi G103 HSV2 vaccine collaboration. Revenue for the first quarter of 2017 was $5.5 millionand was primarily attributable to $5.2 millionin collaboration revenue associated with the Sanofi G103 collaboration and $0.3 millionin product sales to other third parties.
- Research and development expenses for the first quarter of 2018 were $10.3 million, compared to
$14.0 millionfor the same period in 2017. The $3.7 milliondecrease was primarily attributable to a decrease of $4.8 millionin contract manufacturing costs related both internal and collaboration programs. Offsetting this decrease was an increase of $1.1 millionin personnel-related and other research and development expenses.
- General and administrative expenses for the first quarter of 2018 were
$4.0 million, relatively consistent with general and administrative expenses of $4.1 millionrecorded in the first quarter of 2017.
Based on current expectations,
Conference Call Information
The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the
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,” “target,” “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 Immune Design’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Immune Design’s clinical development programs, future results or performance to differ significantly from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, scope and results of clinical trials, the association of data with treatment outcomes, the timing and likelihood of obtaining regulatory approval of Immune Design’s product candidates and timing estimates of cash remaining to fund operations. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrolment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause Immune Design’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Immune Design’s filings with the
|Immune Design Corp.|
|Selected Balance Sheet Data|
|Cash and cash equivalents||$||72,172||$||72,454|
|Total current liabilities||6,351||14,520|
|Total stockholders' equity||128,858||139,212|
|Immune Design Corp.|
|Condensed Consolidated Statements of Operations and Comprehensive Loss Data|
|(In Thousands Except Share and Per Share Amounts)|
|Three Months Ended|
|Cost of product sales||7||37|
|Research and development||10,311||14,038|
|General and administrative||3,995||4,135|
|Total operating expenses||14,313||18,210|
|Loss from operations||(13,810||)||(12,745||)|
|Interest and other income||510||125|
|Other comprehensive loss:|
|Unrealized loss on investments||(18||)||(23||)|
|Basic and diluted net loss per share||$||(0.28||)||$||(0.50||)|
|Weighted-average shares used to compute basic and diluted net loss per share||48,122,396||25,463,202|
Source: Immune Design Corp.