• | The FDA granted Orphan Drug Designation to CERC-801, CERC-802 and CERC-803 as therapies in development for Congenital Disorders of Glycosylation (“CDGs”) |
• | Received Fast Track Designation from the FDA for CERC-801 for the treatment of PGM1 Deficiency and for CERC-802 for the treatment of Mannose-Phosphate Isomerase Deficiency |
• | The FDA accepted the IND application for Cerecor’s investigational drugs CERC-801 for the treatment of PGM1 Deficiency and CERC-802 for the treatment of MPI-CDG |
• | Announced positive Phase I data for CERC-801 and CERC-802 in Healthy Volunteers |
• | First patient enrolled into the CDG FIRST Trial; a retrospective trial looking at the natural history of the disease and the current treatment paradigm of patients with specific CDGs |
• | Announced Company headquarters move to the pharmaceutical corridor of Rockville, Maryland |
• | Closed a $10 million Common Stock offering |
• | The Company was added to the Russell 3000 Index® |
• | Sold the pediatric portfolio and underlying commercial infrastructure to AYTU BioScience, Inc. (“AYTU”) in a deal valued in excess of $43 million and removed debt associated with Deerfield agreement on commercial assets (“Aytu Divestiture”) |
• | Signed, then subsequently closed deal in February 2020, to merge with Aevi Genomic Medicine |
• | Mike Cola announced as Chief Executive Officer and Garry Neil announced as Chief Medical Officer effective upon closing of the Aevi Merger |
• | Merger doubled the number of near-term clinical assets from the three CERC-800s programs to six total programs; honing the organizational strategy as a rare pediatric and orphan disease biotech |
◦ | CERC-002 an anti-LIGHT MAb for Pediatric-onset Crohn’s Disease |
◦ | CERC-006 a dual mTor inhibitor for complex Lymphatic Malformations |
◦ | CERC-007 an anti-IL 18 MAb for Adult-onset Still’s Disease and Multiple Myeloma |
◦ | CERC-801 D Galactose substrate replacement therapy for PGMI-CDG |
◦ | CERC-802 D Mannose substrate replacement therapy for MPI-CDG |
◦ | CERC-803 L Fucose substrate replacement therapy for (LADII), also known as SLC35C1-CDG |
December 31, | ||||||||
2019 | 2018 | |||||||
(in thousands) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 3,609 | $ | 10,646 | ||||
Accounts receivable, net | 1,002 | 822 | ||||||
Other receivables | 4,241 | 5,262 | ||||||
Inventory, net | 21 | 318 | ||||||
Prepaid expenses and other current assets | 707 | 732 | ||||||
Restricted cash, current portion | 17 | 19 | ||||||
Investment in Aytu | 7,629 | — | ||||||
Current assets of discontinued operations | 498 | 4,133 | ||||||
Total current assets | 17,724 | 21,932 | ||||||
Property and equipment, net | 1,448 | 587 | ||||||
Intangibles assets, net | 2,426 | 3,765 | ||||||
Goodwill | 14,409 | 14,409 | ||||||
Restricted cash, net of current portion | 102 | 82 | ||||||
Long-term assets of discontinued operations | — | 29,476 | ||||||
Total assets | $ | 36,109 | $ | 70,251 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,078 | $ | 1,446 | ||||
Accrued expenses and other current liabilities | 5,640 | 14,329 | ||||||
Income taxes payable | 552 | 2,032 | ||||||
Contingent consideration, current portion | — | 860 | ||||||
Current liabilities of discontinued operations | 3,891 | 7,550 | ||||||
Total current liabilities | 12,161 | 26,217 | ||||||
Contingent consideration, net of current portion | — | 397 | ||||||
Deferred tax liability, net | 86 | 69 | ||||||
License obligations | — | 1,250 | ||||||
Other long-term liabilities | 1,112 | 385 | ||||||
Long-term liabilities of discontinued operations | 1,755 | 21,025 | ||||||
Total liabilities | 15,114 | 49,343 | ||||||
Stockholders’ equity: | ||||||||
Common Stock—$0.001 par value; 200,000,000 shares authorized at December 31, 2019 and 2018; 44,384,222 and 40,804,189 shares issued and outstanding at December 31, 2019 and 2018, respectively | 44 | 41 | ||||||
Preferred Stock—$0.001 par value; 5,000,000 shares authorized at December 31, 2019 and 2018; 2,857,143 shares issued and outstanding at December 31, 2019 and 2018, respectively | 3 | 3 | ||||||
Additional paid-in capital | 135,239 | 119,082 | ||||||
Accumulated deficit | (114,291 | ) | (98,218 | ) | ||||
Total stockholders’ equity | 20,995 | 20,908 | ||||||
Total liabilities and stockholders’ equity | $ | 36,109 | $ | 70,251 | ||||
The condensed consolidated balance sheets at December 31, 2019 and 2018 have been derived from the 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 |
Year Ended December 31, | ||||||||
2019 | 2018 | |||||||
(in thousands, except per share data) | ||||||||
Revenues | ||||||||
Product revenue, net | $ | 6,650 | $ | 6,572 | ||||
Sales force revenue | — | 456 | ||||||
License and other revenue | 100 | — | ||||||
Total revenues, net | 6,750 | 7,028 | ||||||
Operating expenses: | ||||||||
Cost of product sales | (567 | ) | 3,261 | |||||
Research and development | 11,764 | 5,786 | ||||||
Acquired in-process research and development | — | 18,724 | ||||||
General and administrative | 10,124 | 10,511 | ||||||
Sales and marketing | 1,484 | 545 | ||||||
Amortization expense | 1,339 | 1,828 | ||||||
Impairment of intangible assets | — | 1,862 | ||||||
Change in fair value of contingent consideration | (1,256 | ) | (111 | ) | ||||
Total operating expenses | 22,888 | 42,406 | ||||||
Loss from continuing operations | (16,138 | ) | (35,378 | ) | ||||
Other (expense) income: | ||||||||
Change in fair value of Investment in Aytu | 54 | — | ||||||
Change in fair value of warrant liability and unit purchase option liability | (4 | ) | 25 | |||||
Other (expense) income, net | (24 | ) | 13 | |||||
Interest income, net | 121 | 16 | ||||||
Total other income, net from continuing operations | 147 | 54 | ||||||
Loss from continuing operations before taxes | (15,991 | ) | (35,324 | ) | ||||
Income tax expense (benefit) | 280 | (49 | ) | |||||
Loss from continuing operations | $ | (16,271 | ) | $ | (35,275 | ) | ||
Income (loss) from discontinued operations, net of tax (inclusive of gain on sale) | 198 | (4,778 | ) | |||||
Net loss | $ | (16,073 | ) | $ | (40,053 | ) | ||
Net (loss) income per share of common stock, basic and diluted: | ||||||||
Continuing operations | $ | (0.28 | ) | $ | (1.06 | ) | ||
Discontinued operations | 0.00 | $ | (0.14 | ) | ||||
Net loss per share of common stock, basic and diluted | $ | (0.28 | ) | $ | (1.20 | ) | ||
Net (loss) income per share of preferred stock, basic and diluted: | ||||||||
Continuing operations | $ | (1.42 | ) | |||||
Discontinued operations | 0.01 | |||||||
Net loss per share of preferred stock, basic and diluted | $ | (1.41 | ) | |||||
The condensed consolidated statements of operations for the years ended December 31, 2019 and 2018 have been derived from the 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. |
• | CERC-800s (CERC-801, CERC-802 and CERC-803) anticipate initial data readout from the CDG-FIRST Trial within the 1 Half of 2020 |
• | CERC-002 (anti-LIGHT mAb) being developed for Pediatric-onset Crohn’s Disease expects initial data readout 2 Half 2020 |
• | CERC-007 (anti-IL-18 mAb) being developed for auto-inflammatory diseases (AOSD, MM) is expecting initial data readout Q4 2020 to Q1 2021 |
• | CERC-006 (dual mTOR inhibitor) being developed for complex Lymphatic Malformations anticipates initial data readout 1 Half 2021 |