- In April, Celladon announced that its Phase 2b CUPID2 trial did not meet its primary or secondary endpoints. CUPID2 is a randomized, double-blind, placebo-controlled, multinational trial evaluating a single, one-time, intracoronary infusion of the cardiovascular gene therapy agent MYDICAR® (AAV1/SERCA2a) versus placebo added to a maximal, optimized heart failure drug and device regimen.
- In June, Celladon confirmed its plans to suspend further research or development of its MYDICAR (AAV1/SERCA2a) program and its other programs including the Stem Cell Factor (mSCF) gene therapy and SERCA2b small molecule programs.
- In the second quarter of 2015, Celladon's Board of Directors approved an approximately 70% reduction of Celladon's workforce in order to reduce operating expenses and conserve cash resources as the Company evaluates strategic alternatives in light of the negative CUPID2 data.
- In June, Celladon announced the engagement of Wedbush PacGrow Healthcare as its exclusive financial advisor and a strategic plan pursuant to which the Company immediately commenced a process to seek a merger or sale. This process is ongoing and could include the sale of the Company or some or all of its assets, and/or a liquidation and distribution of the remaining cash to its shareholders. Celladon estimates that if a merger, sale or liquidation transaction were to be completed in the second half of 2015, its net cash immediately prior to the transaction and/or available for distribution to shareholders, after paying current obligations and commitments, would be approximately $25-$30 million. This projection is based on Celladon's current expectations and assumptions, and the actual amount of net cash could differ materially from the Company's current estimate.
Second Quarter 2015 Financial Results
- Cash Position: Cash, cash equivalents and investments as of June 30, 2015 were $58.0 million. On August 3, 2015, the Company prepaid the outstanding amounts due under its loan agreement. The aggregate prepayment amount, including an end of term charge, was $11.8 million.
- Research and Development Expenses: Research and development expenses were $9.5 million and $5.0 million, respectively, for the second quarter of 2015 and 2014.
- General and Administrative Expenses: General and administrative expenses were $3.5 million and $2.0 million, respectively, for the second quarter of 2015 and 2014.
- Other Expense/Income, Net: Other expense, net was $450 thousand and other income was $13 thousand for the second quarter of 2015 and 2014, respectively.
- Consolidated Net Loss: Consolidated net loss was $16.5 million and $7.0 million for the second quarter of 2015 and 2014, respectively.
|Condensed Consolidated Statements of Operations|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$ 9,501||$ 4,981||$ 21,019||$ 10,199|
|General and administrative||3,493||2,024||8,272||3,730|
|Total operating expenses||16,075||7,005||32,372||13,929|
|Loss from operations||(16,075)||(7,005)||(32,372)||(13,929)|
|Other income (expense), net||(450)||13||(899)||(225)|
|Consolidated net loss||$ (16,525)||$ (6,992)||$ (33,271)||$ (14,154)|
|Condensed Consolidated Balance Sheets|
|June 30,||December 31,|
|Cash and cash equivalents||$ 50,041||$ 14,435|
|Prepaid expenses and other assets||1,165||3,135|
|Total current assets||59,210||88,083|
|Property and equipment, net||616||763|
|Total assets||$ 59,953||$ 89,110|
|Liabilities, preferred stock and stockholders' deficit|
|Accounts payable and accrued expenses||$ 3,446||$ 5,803|
|Accrued restructuring charges||2,392||—|
|Accrued clinical expenses||342||731|
|Current portion of long-term obligations||10,587||1|
|Total current liabilities||16,836||6,606|
|Long-term obligations, net of discount||10||10,102|
|Total liabilities, preferred stock and stockholders' equity||$ 59,953||$ 89,110|
CONTACT: Fredrik Wiklund Vice President, Corporate Development and Investor Relations (858) 432-7215