Xeris Raises $55M for Glucagon Rescue Pen

Xeris Pharmaceuticals, Inc. secured $45 million in a Term Loan and Securities Agreement with Silicon Valley Bank and Oxford Finance, as well as closing a Series C financing with an additional $10 million. The Series C was led by a current investor, Merieux Developpement, with participating from Wild Basin Investments and other members of Xeris management.

The funds raised will be used to prepare a New Drug Application (NDA) and funnel into commercial preparation for its lead product candidate, a ready-to-use glucagon rescue pen to treat severe low blood sugar in diabetes patients and individuals with related disorders.

On February 15, the company announced the completion of two Phase III trials and a Human Factors usability and reliability study of the rescue pen. It also began a Phase IIIb trial. Glucagon is the standard of care for individuals having severe low blood sugar (hypoglycemic) events. Many, however, don’t carry glucagon. The company notes, "This is, in part, due to the limitations of current glucagon options all of which are powder, not ready-to-use and require a lengthy, complex, time-consuming, multi-step reconstitution and dose-calibration process, which studies have shown even trained personnel are prone to administer incorrectly."

Xeris has two proprietary formulation technology platforms. XeriSol is one of them, which is the first ready-to-use, room-temperature stable liquid glucagon. The other is XeriJect.

The products are also being evaluated for additional conditions, including post-bariatric hypoglycemia, congenital hyperinsulinism, hypoglycemia-associated autonomic failure, exercise-induced hypoglycemia, and part of a bi-hormonal artificial pancreas by way of a closed-loop pump.

"We are excited about the progress Xeris has made and continue to believe the combination of its proprietary formulation technology platforms, late-stage ready-to-use glucagon rescue product, deep pipeline, and experienced team will bring significant benefits to patients, physicians, and caregivers," said Daniel Fero of Merieux Developpement, in a statement. "We are pleased to help Xeris advance the NDA submission and commercial preparation of its investigational ready-to-use glucagon rescue pen and accelerate the development of its product pipeline."

On February 8, the U.S. Food and Drug Administration (FDA) granted the company’s glucagon product Orphan Drug Designation for Hyperinsulinemic Hypoglycemia (HH). This is when an individual’s blood sugar levels drop because of excessive insulin secretion. The approval was given partly because the mini-doses of Xeris’ ready-to-use glucagon may be safer than already approved drugs that are similar.

HH is associated with Post-Bariatric Hypoglycemia (PBH) and other diseases. There is no approved therapy for PBH, except dietary changes, off-label acarbose and a combination cocktail of other off-label therapeutics.

"Hypoglycemia can be a devastating complication of bariatric surgery," said Mary-Elizabeth Patti, of the Joslin Diabetes Center and associate professor of Medicine, Harvard Medical School, in a statement. "There is an urgent need for improved methods to treat severe hypoglycemia in this condition in order to maintain health, allow optimal nutrition, and improve safety. Having a ready-to-use, liquid, stable glucagon option may provide health care professionals and patients alike more options to treat and prevent severe hypoglycemia."

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