Septerna Inc. (SEPN Proposed), a Phase 1 biotech focused on developing an oral drug to treat hypoparathyroidism, a rare endocrine disease, unveiled the terms for its $175 million IPO early today – Monday, Oct. 21, 2024. Septerna is offering 10.94 million shares at a price range of $15.00 to $17.00 to raise $175.0 million, if priced at the $16.00 mid-point of its range. The market cap would be $591.04 million, assuming pricing at the $16.00 mid-point. The IPO is expected to price later this week. (Please see the IPO Calendar for date.)
J.P. Morgan, TD Cowen, Cantor and Wells Fargo Securities are the joint book-runners.
Septerna Inc., based in San Francisco, is evaluating its lead product candidate, SEP-876, an oral small molecule agonist targeting PTH1R – parathyroid hormone 1 receptor (PTH1R) – in a Phase 1 clinical trial to treat patients with hypoparathyroidism, a rare endocrine disease. The company expects to report data from this trial in mid-2025, according to the prospectus.
“Hypoparathyroidism is a rare endocrine disease characterized by insufficient levels of parathyroid hormone (PTH) that affects approximately 70,000 patients in the United States and approximately 140,000 patients in Europe. Patients with hypoparathyroidism are at risk of both short-term and long-term complications, including muscle cramps, fatigue, cognitive dysfunction, and life-threatening complications, such as cardiac arrhythmias, seizures, and renal failure.”
Treatment is focused on relieving symptoms by restoring calcium and phosphate levels to normal with high-dose calcium supplements and activated vitamin D (calcitriol).
“Hormone replacement with injectable PTH peptides, either marketed or in clinical development, may improve blood chemistry profiles of patients via PTH1R activation but will require life-long daily injections,” Septerna said in the prospectus. “We believe there is a substantial opportunity for an oral small molecule therapy that offers convenience, improved compliance, and potentially superior efficacy.”
The company is also developing SEP-631, an oral small molecule MRGPRX2 negative allosteric modulator (NAM) to treat chronic spontaneous urticaria (CSU); this program is currently in IND-enabling studies.
“Chronic spontaneous urticaria (CSU) is a systemic inflammatory skin disease characterized by the spontaneous and persistent recurrence of itchy, painful hives, known as wheals, on the skin and angioedema, or swelling, that affects approximately 1.5 million patients in the United States,” the prospectus said.
Septerna is also developing a preclinical TSHR (thyroid stimulating hormone receptor) program to treat Graves’ disease and thyroid eye disease (TED), the prospectus said. Graves’ disease, the leading cause of hyperthyroidism, affects over 2 million patients in the U.S. In about 50 percent of Graves’ disease patients, the illness progresses to thyroid eye disease (TED), a vision-threatening autoimmune condition that can lead to eye bulging, swelling, pain and blurred or double vision.
Septerna is not profitable. For the 12 months that ended June 30, 2024, Septerna reported a net loss of $46.2 million on revenue of about $0.84 million ($840,000), according to financial statements in the prospectus.
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