Septerna Inc. (SEPN Proposed), a Phase 1 biotech focused on developing drugs to treat thyroid and autoimmune disorders, increased its IPO’s size by 57 percent to raise $275 million – up from $175 million originally – in an S-1/A filing early today – Thursday, Oct. 24, 2024. The new terms of Septerna’s IPO are: 15.28 million shares – up from 10.94 million shares originally – at an assumed IPO price of $18.00 – $1.00 above the top of its original price range of $15.00 to $17.00. The market cap under the new terms would be $743.05 million – up from $591.04 million originally.
Septerna’s IPO is scheduled to price tonight – Thursday, Oct. 24, 2024 – to trade Friday, Oct. 25, 2024, on the NASDAQ.
J.P. Morgan, TD Cowen, Cantor and Wells Fargo Securities are the joint book-runners.
Septerna, based in San Francisco, is developing a new drug candidate, SEP-876, to treat hypoparathyroidism, a rare endocrine disease caused by low levels of the parathyroid hormone (PTH), according to the prospectus. Septerna is evaluating 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. The company plans 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.”
Targeting a Painful Skin Disease
Septerna 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.
Treating Thyroid Eye Disease
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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