
• | Strengthened leadership team with the appointment of Gilla Kaplan, Ph.D., to the Board of Directors. Dr. Kaplan brings with her over 30 years of academic and industry experience specializing in various aspects of the host immune response to mycobacterial pathogens, including the causative agents of leprosy and tuberculosis. |
• | The Company's pipeline of novel, first-in-class compounds remains on track with all clinical development timelines and anticipates the following milestones: |
• | CERC-002: Anti-LIGHT monoclonal antibody in clinical studies for COVID-19 ARDS and severe pediatric onset Crohn’s disease. |
◦ | Completion of the multi-center, randomized, double-blinded, placebo-controlled Phase 1 proof-of-concept study of CERC-002 in cytokine storm-induced COVID-19 ARDS is anticipated by year end 2020. |
◦ | Initial data from the open-label Phase 1b clinical study designed to assess the safety, tolerability and short-term efficacy of CERC-002 in anti-TNF refractory adult subjects with moderate-to-severe Crohn’s disease is anticipated in the first quarter of 2021. |
• | CERC-007: Anti-IL-18 monoclonal antibody for the treatment of multiple myeloma (MM) and Adult-onset Still’s Disease (AOSD). |
◦ | Initial data anticipated from proof-of-concept studies for multiple myeloma in the first quarter of 2021 and in Adult-onset Still’s disease in the second quarter of 2021. |
• | CERC-006: Dual mTORC1 and mTORC2 small molecule inhibitor for complex lymphatic malformations. |
◦ | Initial data anticipated from proof-of-concept study in the first half of 2021. |
• | CERC-800 programs (CERC-801, CERC-802, and CERC-803): Restorative monosaccharide therapies for congenital disorders of glycosylation (CDGs). |
◦ | CERC-801 – data anticipated from the pivotal trial evaluating the safety and efficacy of CERC-801 in patients suffering from Phosphoglucomutase-1 deficiency related congenital disorders of glycosylation (PGM1-CDG) in 2021. |
◦ | CERC-802 – data anticipated from the pivotal trial evaluating the safety and efficacy of CERC-802 in patients suffering from Mannose phosphate isomerase deficiency related CDG (MPI-CDG) in 2021. |
◦ | CERC-803 – clearance to proceed on the Investigational New Drug Application from the FDA anticipated in the fourth quarter 2020. |
September 30, 2020 (a) | December 31, 2019 (a) | |||||||
(unaudited) | ||||||||
(in thousands) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 33,391 | $ | 3,609 | ||||
Accounts receivable, net | 1,671 | 1,002 | ||||||
Other receivables | 4,285 | 4,241 | ||||||
Inventory, net | 9 | 21 | ||||||
Prepaid expenses and other current assets | 1,544 | 707 | ||||||
Restricted cash, current portion | 132 | 17 | ||||||
Investment in Aytu | — | 7,629 | ||||||
Current assets of discontinued operations | — | 498 | ||||||
Total current assets | 41,032 | 17,724 | ||||||
Property and equipment, net | 1,708 | 1,448 | ||||||
Intangible assets, net | 1,889 | 2,426 | ||||||
Goodwill | 14,409 | 14,409 | ||||||
Restricted cash, net of current portion | 149 | 102 | ||||||
Total assets | $ | 59,187 | $ | 36,109 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,927 | $ | 2,078 | ||||
Accrued expenses and other current liabilities | 8,811 | 5,640 | ||||||
Income taxes payable | — | 552 | ||||||
Current liabilities of discontinued operations | 5,833 | 3,891 | ||||||
Total current liabilities | 16,571 | 12,161 | ||||||
Royalty obligation | 2,000 | — | ||||||
Deferred tax liability, net | 115 | 86 | ||||||
Other long-term liabilities | 1,934 | 1,112 | ||||||
Long-term liabilities of discontinued operations | — | 1,755 | ||||||
Total liabilities | 20,620 | 15,114 | ||||||
Stockholders’ equity: | ||||||||
Common stock—$0.001 par value; 200,000,000 shares authorized at September 30, 2020 and December 31, 2019; 74,900,047 and 44,384,222 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 75 | 44 | ||||||
Preferred stock—$0.001 par value; 5,000,000 shares authorized at September 30, 2020 and December 31, 2019; 1,257,143 and 2,857,143 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 1 | 3 | ||||||
Additional paid-in capital | 200,639 | 135,239 | ||||||
Accumulated deficit | (162,148 | ) | (114,291 | ) | ||||
Total stockholders’ equity | 38,567 | 20,995 | ||||||
Total liabilities and stockholders’ equity | $ | 59,187 | $ | 36,109 | ||||
(a) The condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019 have been derived from the reviewed and audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. | ||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2020 (a) | 2019 (a) | 2020 (a) | 2019 (a) | |||||||||||||
(in thousands, except per share data) | (in thousands, except per share data) | |||||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 1,111 | $ | 2,101 | $ | 5,202 | $ | 6,070 | ||||||||
License and other revenue | — | 100 | — | 100 | ||||||||||||
Total revenues, net | 1,111 | 2,201 | 5,202 | 6,170 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of product sales | 77 | 132 | 221 | (612 | ) | |||||||||||
Research and development | 8,872 | 1,744 | 19,556 | 8,858 | ||||||||||||
Acquired in-process research and development | — | — | 25,549 | — | ||||||||||||
General and administrative | 4,573 | 2,638 | 13,350 | 7,654 | ||||||||||||
Sales and marketing | 462 | 214 | 1,792 | 936 | ||||||||||||
Amortization expense | 404 | 335 | 1,238 | 1,004 | ||||||||||||
Change in fair value of contingent consideration | — | — | — | (1,256 | ) | |||||||||||
Total operating expenses | 14,388 | 5,063 | 61,706 | 16,584 | ||||||||||||
Loss from continuing operations | (13,277 | ) | (2,862 | ) | (56,504 | ) | (10,414 | ) | ||||||||
Other income: | ||||||||||||||||
Change in fair value of Investment in Aytu | — | — | 5,208 | — | ||||||||||||
Other income, net | 19 | 53 | 447 | 83 | ||||||||||||
Total other income, net from continuing operations | 19 | 53 | 5,655 | 83 | ||||||||||||
Loss from continuing operations before taxes | (13,258 | ) | (2,809 | ) | (50,849 | ) | (10,331 | ) | ||||||||
Income tax expense (benefit) | 3 | 121 | (2,607 | ) | 306 | |||||||||||
Loss from continuing operations | $ | (13,261 | ) | $ | (2,930 | ) | $ | (48,242 | ) | $ | (10,637 | ) | ||||
(Loss) income from discontinued operations, net of tax | (198 | ) | (1,086 | ) | 385 | (7,057 | ) | |||||||||
Net loss | $ | (13,459 | ) | $ | (4,016 | ) | $ | (47,857 | ) | $ | (17,694 | ) | ||||
Net (loss) income per share of common stock, basic and diluted: | ||||||||||||||||
Continuing operations | $ | (0.16 | ) | $ | (0.05 | ) | $ | (0.68 | ) | $ | (0.19 | ) | ||||
Discontinued operations | (0.01 | ) | (0.02 | ) | 0.00 | (0.12 | ) | |||||||||
Net loss per share of common stock, basic and diluted | $ | (0.17 | ) | $ | (0.07 | ) | $ | (0.68 | ) | $ | (0.31 | ) | ||||
Net (loss) income per share of preferred stock, basic and diluted: | ||||||||||||||||
Continuing operations | $ | (0.82 | ) | $ | (0.26 | ) | $ | (3.40 | ) | $ | (0.94 | ) | ||||
Discontinued operations | (0.01 | ) | (0.09 | ) | 0.02 | (0.62 | ) | |||||||||
Net loss per share of preferred stock, basic and diluted | $ | (0.83 | ) | $ | (0.35 | ) | $ | (3.38 | ) | $ | (1.56 | ) | ||||
(a) The unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2020 and 2019 have been derived from the reviewed financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. | ||||||||||||||||