Xeris Pharmaceuticals Announces Third Quarter 2018 Financial Results and Highlights Pipeline Progress
Glucagon pen NDA accepted for review by
Continuing to execute commercial build and launch readiness for glucagon pen
Advancing pipeline of preclinical and clinical development-stage products
“A major achievement in the third quarter was the planned submission to the
Third Quarter 2018 Highlights and Recent Events
- Glucagon pen NDA accepted for review by
FDA : As previously announced, theU.S. Food and Drug Administration (FDA ) accepted for review the New Drug Application (NDA) of Xeris’ lead product candidate, glucagon pen, for the treatment of severe hypoglycemia in people with diabetes. TheFDA has assigned a PDUFA goal date ofJune 10, 2019 . (Severe hypoglycemia is characterized by sweating, trembling, anxiousness, confusion, and combativeness, often requiring external assistance for recovery. These events can be extremely frightening for patients and caregivers and can result in seizure or coma, and, if left untreated, death.) - Strengthened commercial organization: Xeris has hired key commercial leadership personnel in areas of U.S. Marketing and Sales, Global Commercialization and Business Development to begin market preparation, launch readiness, ex-US commercial plans and partnering.
- New Investigational New Drug (IND) application enables Phase 2 trial of ready-to-use glucagon for post-bariatric hypoglycemia (PBH): A new glucagon IND went into effect and authorized Xeris to proceed with a Phase 2 study with its ready-to-use, room-temperature stable liquid glucagon formulation for patients who experience hyperinsulinemic hypoglycemia after bariatric surgery. Xeris expects to initiate the study before the end of 2018. (PBH can begin to occur one to eight years after gastric bypass surgery. These severe hypoglycemic episodes are characterized by extreme low blood sugar levels that occur two to three hours after a meal. The etiology appears to be excessive insulin secretion in response to the meal.)
- Concluded Phase 2 clinical trial in congenital hyperinsulinism (CHI) (NCT02937558). Xeris recently concluded enrollment in the Phase 2 study and expects the randomized controlled data will support initiation of a Phase 3 program for continuous subcutaneous infusion of glucagon for the treatment of congenital hyperinsulinism. (CHI is a very rare disease that causes severe, persistent hypoglycemia in newborn babies and children. Common symptoms include irritability, sleepiness, lethargy, excessive hunger, and rapid heart rate. More severe symptoms such as seizures and coma can occur with a prolonged or extremely low blood sugar level.)
- Xeris room-temperature liquid stable glucagon used in artificial pancreas trial: In August, Xeris announced that
OHSU School of Medicine and OHSU Harold Schnitzer Diabetes Health Center inPortland, Oregon are conducting a clinical trial with a dual-hormone artificial pancreas using Xeris’ ready-to-use liquid glucagon to evaluate a new closed-loop algorithm before and after exercise. (The artificial pancreas is a technology in development to help people with diabetes automatically control their blood glucose level by providing the substitute endocrine functionality of a healthy pancreas.)
Upcoming Events
- Xeris will present three abstracts at the upcoming 18th Annual Diabetes Technology Meeting from
November 8-10, 2018 inNorth Bethesda, Maryland . - Xeris’ senior management will be participating in the following upcoming investor conferences:
Jefferies London Healthcare Conference onNovember 14-15, 2018 inLondon, UK Global Mizuho Investor Conference onDecember 3-4, 2018 inNew York, NY
Third Quarter 2018 Financial Highlights
Cash position: As of
Research and development (R&D) expenses: R&D expenses for the three months and nine months ended
General and administrative (G&A) expenses: G&A expenses for the three months and nine months ended
Net loss: For the three and nine months ended
About
Xeris is a specialty pharmaceutical company leveraging its novel 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
Media Contact
media@xerispharma.com
XERIS PHARMACEUTICALS, INC. | ||||||||||||||||
CONDENSED STATEMENTS OF OPERATIONS | ||||||||||||||||
(in thousands, except share and per share data; unaudited) | ||||||||||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Grant income | $ | 582 | $ | 170 | $ | 1,611 | $ | 1,073 | ||||||||
Service revenue | - | - | 53 | 16 | ||||||||||||
Cost of revenue | - | - | 42 | 4 | ||||||||||||
Gross profit | 582 | 170 | 1,622 | 1,085 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 10,875 | 5,725 | 28,264 | 13,588 | ||||||||||||
General and administrative | 4,650 | 2,017 | 12,388 | 4,917 | ||||||||||||
Expense from operations | 15,525 | 7,742 | 40,652 | 18,505 | ||||||||||||
Loss from operations | (14,943 | ) | (7,572 | ) | (39,030 | ) | (17,420 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 462 | 45 | 796 | 45 | ||||||||||||
Interest expense | (737 | ) | - | (1,490 | ) | (1 | ) | |||||||||
Change in fair value of warrants | 451 | - | 63 | (32 | ) | |||||||||||
Total other income (expense) | 176 | 45 | (631 | ) | 12 | |||||||||||
Net loss | $ | (14,767 | ) | $ | (7,527 | ) | $ | (39,661 | ) | $ | (17,408 | ) | ||||
Net loss per common share - basic and diluted | $ | (0.71 | ) | $ | (3.72 | ) | $ | (4.36 | ) | $ | (8.63 | ) | ||||
Weighted average common shares outstanding, basic and diluted |
20,714,475 | 2,024,355 | 9,104,491 | 2,016,112 | ||||||||||||
XERIS PHARMACEUTICALS, INC. | ||||||||
CONDENSED BALANCE SHEETS | ||||||||
(in thousands) | ||||||||
September 30, 2018 | ||||||||
December 31, 2017 | ||||||||
(unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 75,745 | $ | 42,045 | ||||
Short-term investments | 55,296 | |||||||
Accounts receivable, net | 1,731 | 1,199 | ||||||
Prepaid expenses and other current assets | 2,898 | 809 | ||||||
Total current assets | 135,670 | 44,053 | ||||||
Property and equipment, net | 1,826 | 788 | ||||||
Other assets | 95 | 157 | ||||||
Total assets | $ | 137,591 | $ | 44,998 | ||||
Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 622 | $ | 1,976 | ||||
Accrued expenses | 6,260 | 2,557 | ||||||
Warrant liabilities | 1,042 | 93 | ||||||
Deferred grant award | 284 | 234 | ||||||
Total current liabilities | 8,208 | 4,860 | ||||||
Long-term debt, net of unamortized deferred costs | 31,642 | - | ||||||
Other long-term liabilities | 2,621 | 90 | ||||||
Total liabilities | 42,471 | 4,950 | ||||||
Total convertible preferred stock | - | 97,878 | ||||||
Total stockholders' equity (deficit) | 95,120 | (57,830 | ) | |||||
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ | 137,591 | $ | 44,998 | ||||
Source: Xeris Pharmaceuticals, Inc.