Xeris Pharmaceuticals Announces Second Quarter 2019 Financial Results and Highlights
“The second quarter saw several important highlights including the active enrollment in a number of Phase 2 clinical programs that will keep us on track to report data before the end of the year, the progress of additional preclinical programs in new therapeutic areas, and our continuing commercial preparation in advance of the FDA’s decision on our Gvoke™ NDA,” said
Second Quarter 2019 Highlights and Recent Events
- Xeris released favorable data from a Phase 1 study of XeriSol™ formulated diazepam and, based on these results, anticipates initiating a Phase 2 weight-based dosing study by year-end.
- Xeris announced that the
FDA had extended its PDUFA goal date toSeptember 10, 2019 for Gvoke. If approved, the Company anticipates launching Gvoke late in the fourth quarter of 2019. - Xeris reported positive outcomes from a global Phase 3 study of Gvoke. This additional data will support the Marketing Authorization Application (MAA), which the Company anticipates submitting to EMA by year-end 2019.
- Xeris announced that it dosed the first subject in a Phase 2 study of ready-to-use (RTU) glucagon in patients who experience hypoglycemic episodes following bariatric surgery (NCT03770637). This randomized, placebo-controlled, double-blind study will evaluate the efficacy, safety, and tolerability of the Xeris RTU glucagon in treating symptomatic postprandial hypoglycemia among patients with post-bariatric hypoglycemia initially during two in-patient clinical research center visits and then ongoing as part of a 12-week outpatient phase. Based on planned enrollment rates, Xeris anticipates reporting data from the in-clinic portion of the study in the second half of 2019.
- Data was presented at American Diabetes Association’s 79th Scientific Sessions (ADA), which included preclinical data of our XeriSol™ pramlintide-insulin co-formulation and regular insulin and lispro insulin, clinical data summarizing combined safety and efficacy of Gvoke, as well as clinical data using Xeris’ RTU glucagon in a dual hormone, closed-loop pump system.
Second Quarter and Year-to-Date 2019 Financial Highlights
Cash position: As of
Research and development (R&D) expenses: R&D expenses for the three and six months ended
Selling, general and administrative (SG&A) expenses: SG&A expenses for the three and six months ended
Net loss: For the three months ended
About
Xeris is a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use, room-temperature stable injectable and infusible drug formulations. The Company’s proprietary XeriSol™ and XeriJect™ formulation technologies are being evaluated for the subcutaneous (SC) and intramuscular (IM) delivery of highly-concentrated, non-aqueous, ready-to-use formulations of peptides, small molecules, proteins, and antibodies using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps. XeriSol™ and XeriJect™ have the potential to offer distinct advantages over existing formulations of marketed and development-stage products, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. These attributes may lead to products that are easier to use by patients, caregivers, and health practitioners and reduce costs for payers and the healthcare system. Further information about Xeris can be found at www.xerispharma.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.
Investor Contact
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
312-736-1237
XERIS PHARMACEUTICALS, INC. | |||||
CONDENSED BALANCE SHEETS | |||||
(in thousands) | |||||
June 30, 2019 | |||||
December 31, 2018 | |||||
(unaudited) | |||||
Assets | |||||
Current assets: | |||||
Cash and cash equivalents | $ | 66,669 | $ | 45,716 | |
Short-term investments | 57,841 | 66,917 | |||
Accounts receivable, net | 826 | 2,869 | |||
Prepaid expenses and other current assets | 813 | 2,397 | |||
Total current assets | 126,149 | 117,899 | |||
Property and equipment, net | 7,677 | 2,034 | |||
Other assets | 68 | 95 | |||
Total assets | $ | 133,894 | $ | 120,028 | |
Liabilities and Stockholders' Equity | |||||
Current liabilities: | |||||
Accounts payable | $ | 1,840 | $ | 866 | |
Accrued expenses | 15,609 | 8,214 | |||
Current portion of long-term debt | 3,000 | - | |||
Warrant liabilities | 403 | 860 | |||
Deferred grant awards | 156 | 232 | |||
Total current liabilities | 21,008 | 10,172 | |||
Long-term debt, net of unamortized deferred costs | 29,403 | 31,890 | |||
Other long-term liabilities | 8,692 | 2,560 | |||
Total liabilities | 59,103 | 44,622 | |||
Total stockholders' equity | 74,791 | 75,406 | |||
Total liabilities and stockholders' equity | $ | 133,894 | $ | 120,028 | |
XERIS PHARMACEUTICALS, INC. | |||||||||||||||
CONDENSED STATEMENTS OF OPERATIONS | |||||||||||||||
(in thousands, except share and per share data; unaudited) | |||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Grant income | $ | 314 | $ | 819 | $ | 529 | $ | 1,029 | |||||||
Service revenue | 6 | - | 39 | 53 | |||||||||||
Cost of revenue | 23 | - | 23 | 42 | |||||||||||
Gross profit | 297 | 819 | 545 | 1,040 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 19,333 | 8,677 | 32,500 | 17,389 | |||||||||||
Selling, general and administrative | 15,024 | 4,499 | 27,542 | 7,738 | |||||||||||
Expense from operations | 34,357 | 13,176 | 60,042 | 25,127 | |||||||||||
Loss from operations | (34,060 | ) | (12,357 | ) | (59,497 | ) | (24,087 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest and other income | 845 | 238 | 1,516 | 334 | |||||||||||
Interest expense | (1,062 | ) | (562 | ) | (2,125 | ) | (753 | ) | |||||||
Change in fair value of warrants | (108 | ) | (306 | ) | 444 | (388 | ) | ||||||||
Total other income (expense) | (325 | ) | (630 | ) | (165 | ) | (807 | ) | |||||||
Net loss | $ | (34,385 | ) | $ | (12,987 | ) | $ | (59,662 | ) | $ | (24,894 | ) | |||
Net loss per common share - basic and diluted | $ | (1.28 | ) | $ | (3.07 | ) | $ | (2.36 | ) | $ | (7.76 | ) | |||
Weighted average common shares outstanding, basic and diluted |
26,889,398 | 4,231,054 | 25,234,489 | 3,205,998 | |||||||||||
Source: Xeris Pharmaceuticals, Inc.