Immune Design Reports Second Quarter 2018 Financial Results and Provides Corporate Update
- G100 advancing to late-stage development following
- Conference call at
1:30 pmPacific today
“We have had a solid year of progress so far at
- G100: moving forward with an ORR-based study in patients with relapsed follicular lymphoma (FL)
- G100 is a novel, synthetic TLR4 agonist for intratumoral therapy
- Based on feedback from an End of Phase 1
FDAmeeting: FDAnotes that relapsed FL patients who have failed three lines of systemic therapy represents an unmet medical need population; and
- FDA agrees that a single-arm trial to evaluate objective response rate (ORR) and duration of response (DOR) is appropriate to assess the efficacy of G100 in combination with pembrolizumab with an adaptive design that allows for an interim analysis. Immune Design is working with the
FDAon the details of the study and plans to initiate patient enrollment as soon as feasible after the protocol is finalized.
- The company intends to use this open label approach to generate data for a potential biological license application and plans to provide an update on the final study design and associated timeline after the ongoing
FDAdiscussions are complete.
- CMB305: the SYNOVATE Phase 3 trial is open for enrollment; combination with atezolizumab Phase 2 ongoing
- CMB305 is a novel prime-boost cancer vaccine targeting NY-ESO-1+ cancers in patients with soft tissue sarcoma.
- SYNOVATE study, a randomized, global Phase 3 trial evaluating CMB305 monotherapy versus placebo in synovial sarcoma patients in a post 1st line therapy maintenance setting is open for enrollment.
Immune Designis working on opening additional clinical sites throughout the United States, followed by expansion into Canada, Europeand the Asia Pacificregion.
- Combination therapy: the Phase 2 study evaluating the combination of CMB305 with atezolizumab in relapsed refractory soft-tissue sarcoma patients continues follow-up to determine overall survival after achieving an estimated 72 events.
- Research Programs
Immune Designwill shift resources to focus on later-stage programs, specifically for the development of G100 in relapsed FL and beyond. Consequently, the company is pausing further development of its preclinical programs, CA21 and intratumoral ZVex-IL12.
- This allocation of resources enables the company to run the planned G100 study at least to the interim analysis with existing capital.
- Upcoming Data Presentation
Immune Designplans to present long-term follow-up data from its CMB305 monotherapy trial in soft tissue sarcoma patients at the European Society for Medical Oncology( ESMO) 2018 Congressin October. The ESMOpresentation will be in the forms of both a poster and poster discussion session.
Immune Designended the second quarter of 2018 with $120.3 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 six months ended June 30, 2018was $27.3 million.
- Net loss and net loss per share for the second quarter of 2018 were
$13.8 millionand $0.29, respectively, compared to $13.8 millionand $0.54, respectively, for the second quarter of 2017.
- Revenue for the second quarter of 2018 was
$0.8 millionand was primarily attributable to $0.4 millionin collaboration revenue associated with the Sanofi G103 HSV2 vaccine collaboration and $0.4 millionin product sales to collaboration partners. Revenue for the second quarter of 2017 was $0.7 millionand was primarily attributable to collaboration revenue associated with the Sanofi G103 collaboration.
- Research and development expenses for the second quarter of 2018 were $11.0 million, compared to
$10.9 millionfor the same period in 2017. The $0.1 millionincrease in research and development expenses was primarily attributable to an increase in personnel-related expenses and an increase in research and development headcount to support the company’s advancing research and clinical pipeline activities. This increase was offset by a slight decrease of $0.1 millionin in-licensing royalties and fees and a $0.1 milliondecrease in research and development supplies and services.
- General and administrative expenses for the second quarter of 2018 were
$4.0 million, compared to $3.9 millionfor the same period in 2017. The $0.1 millionincrease in general and administrative expenses was primarily attributable to an increase in professional fees and services to help support our ongoing operations, which was offset by a decrease in personnel-related expenses in the form of stock-based compensation expense.
- Net loss and net loss per share for the six months ended
June 30, 2018were $27.1 millionand $0.56, respectively, compared to $26.5 millionand $1.04, respectively, for the same period in 2017.
- Revenue for the six months ended
June 30, 2018was $1.3 millionand was primarily attributable to $0.8 millionin collaboration revenue associated with the Sanofi G103 collaboration and $0.4 millionin product sales to collaboration partners. Revenue for the same period in 2017 was $6.2 millionand was primarily attributable to $5.9 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 six months ended
June 30, 2018were $21.3 millioncompared to $24.9 millionfor the same period in 2017. The $3.6 milliondecrease in research and development expenses was primarily attributable to a decrease of $4.8 millionin costs related to the timing and nature of certain contract manufacturing activities connected to the Sanofi G103 collaboration. Offsetting this decrease was an increase of $1.1 millionin personnel-related expenses, which was primarily due to an increase in compensation and benefits and an increase in research and development headcount.
- General and administrative expenses did not materially differ over the comparative periods. For the six months ended
June 30, 2018, general and administrative expenses were $8.0 millioncompared to $8.0 millionfor the same period in 2017. In February 2018, Immune Designrecouped $0.8 millionfrom the TVS settlement, which decrease in expense was offset by an increase of $0.6 millionin professional fees and services and $0.2 millionin compensation and benefits to support ongoing operations.
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 design, 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 enrollment 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||$||73,430||$||72,454|
|Total current liabilities||7,901||14,520|
|Total stockholders' equity||116,724||139,212|
|Immune Design Corp.|
|Condensed Consolidated Statements of Operations and Comprehensive Loss Data|
|(In Thousands, Except Share and Per Share Amounts)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Cost of product sales||140||18||147||55|
|Research and development||11,000||10,863||21,311||24,901|
|General and administrative||4,006||3,888||8,001||8,023|
|Total operating expenses||15,146||14,769||29,459||32,979|
|Loss from operations||(14,391||)||(14,040||)||(28,201||)||(26,785||)|
|Interest and other income||583||194||1,093||319|
|Other comprehensive loss:|
|Unrealized gain (loss) on investments||32||4||14||(19||)|
|Basic and diluted net loss per share||$||(0.29||)||$||(0.54||)||$||(0.56||)||$||(1.04||)|
|Weighted-average shares used to compute basic and diluted net loss per share||48,125,652||25,567,482||48,124,033||25,515,630|
Source: Immune Design Corp.