Septerna to Present Preclinical Characterization of SEP-479, an Oral PTH1R Agonist for Hypoparathyroidism, at 2026 ENDO Annual Meeting

Key Terms

g protein-coupled receptor medical

A G protein-coupled receptor is a protein on a cell’s surface that acts like an antenna: it detects signals such as hormones, neurotransmitters or drugs outside the cell and passes that message inside to change cell behavior. Investors care because roughly a third of marketed medicines act on these receptors, so a company’s success in targeting or modulating a specific receptor can determine the value of drug candidates, regulatory risk, and future revenue potential.

gpcr medical

G protein-coupled receptors (GPCRs) are a large family of proteins on cell surfaces that act like locks sensing chemical signals — when the right key binds, they trigger internal cell responses. They matter to investors because GPCRs are the target of many marketed drugs and experimental therapies; success or failure in developing a GPCR-targeting drug can change a company’s revenue prospects, clinical progress, and licensing value, much like winning control of a widely used distribution channel.

pth1r agonist medical

A PTH1R agonist is a drug that activates the parathyroid hormone 1 receptor, a protein on certain cells that controls calcium handling and bone remodeling. Think of the receptor as a light switch and the agonist as the hand that turns it on; for investors this matters because activating that pathway can increase bone formation or change calcium levels, making such drugs relevant for treating osteoporosis, fracture healing and related markets.

hypoparathyroidism medical

A disorder in which small glands in the neck fail to make enough of a hormone that keeps blood calcium at the right level, causing low calcium with symptoms such as muscle cramps, tingling or fatigue. For investors, it matters because chronic, hard-to-manage conditions like this create demand for medicines, medical devices and diagnostic tests, shaping clinical trial needs, regulatory review and potential market opportunity much like a persistent mechanical problem creates ongoing demand for repairs.

in vitro medical

In vitro describes laboratory tests performed on cells, tissues, or biological molecules outside a living body—literally “in glass,” such as in test tubes or dishes. For investors, in vitro results are an early sign that a drug or technology has a desired effect under controlled conditions, but they don’t guarantee it will work or be safe in animals or people; think of them as a prototype tested on a bench rather than in real-world use.

in vivo medical

In vivo describes tests or experiments performed inside a living organism, such as an animal or human, to observe how a drug, device or biological process behaves in a real, functioning body. Investors care because in vivo results reveal safety, effectiveness and possible side effects that lab tests cannot, much like road-testing a prototype car in traffic rather than only on a bench — outcomes can strongly influence regulatory approval, clinical success and a company’s valuation.

phase 1 medical

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

single-ascending dose medical

A single-ascending dose (SAD) study is an early-stage clinical test where small groups of volunteers each receive one single dose of a drug, with each subsequent group getting a higher dose if the previous dose is safe. Think of it like stepping up a staircase one step at a time to check stability; investors watch SAD results because they reveal initial safety, how the body handles the drug, and the safe dose range, all of which affect development risk and timelines.

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced that the first detailed preclinical characterization of SEP-479 has been accepted for an oral presentation at the 2026 Endocrine Society’s Annual Meeting (ENDO 2026), taking place June 13-16, 2026, in Chicago.

The presentation will highlight the pharmacologic profile of SEP-479, a potent, selective small molecule PTH1R agonist being developed for the treatment of hypoparathyroidism, including robust in vitro and in vivo activity supporting its potential as an oral therapy. SEP-479 is currently being evaluated in an ongoing Phase 1 single-ascending dose and multiple-ascending dose study in healthy volunteers, with data expected in late 2026 or early 2027.

“SEP-479 highlights the ability of our Native Complex Platform^® to discover novel oral small molecules directed towards challenging GPCR targets,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “The preclinical data that will be presented at ENDO further characterize SEP-479 and support its potential to functionally replace PTH with a once-daily oral therapy. We believe this approach has the potential to redefine the treatment landscape for patients with hypoparathyroidism, and we look forward to further evaluating SEP-479 in the clinic as we advance our ongoing Phase 1 study.”

Presentation Details:

Title: Characterization of SEP-479, a Novel Oral Small Molecule PTH1R Agonist for the Treatment of Hypoparathyroidism
Abstract Number: ORF16-05
Session: Parathyroid Disease – Bone and Mineral Metabolism-02
Presenter: Jun Zhang, Ph.D., Senior Director of Translational Biology
Session Date and Time: June 13, 2026, 2:15-2:30 p.m. CT
Location: McCormick Place West, Room W187

About SEP-479

Septerna is developing SEP-479, a potent oral small molecule parathyroid hormone 1 receptor (PTH1R) agonist, for the treatment of patients with hypoparathyroidism. In preclinical studies, SEP-479 demonstrated activity comparable to PTH peptides in cell-based assays and in vivo models, normalized serum calcium in a rat model of hypoparathyroidism and increased serum calcium with reductions in endogenous PTH in a non-human primate PK/PD study. SEP-479 was generally well tolerated in 28-day GLP toxicology studies in rats, dogs and non-human primates.

About Septerna

Septerna, Inc. is a clinical-stage biotechnology company with a world-class team of GPCR experts and drug developers advancing cutting-edge science to unlock the full potential of GPCR therapies for patients with significant unmet needs. The company’s proprietary Native Complex Platform^® is designed to enable new approaches to GPCR drug discovery and has led to the development of a diverse pipeline of novel oral small molecule drug candidates. Septerna is advancing programs in endocrinology, immunology and inflammation, metabolic diseases and additional therapeutic areas, both independently and with partners. For more information, please visit www.septerna.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Septerna’s beliefs and expectations regarding: the potential of SEP-479 preclinical data to translate into similar clinical safety, pharmacokinetic, and pharmacodynamic findings; the estimated availability of SEP-479 Phase 1 clinical data in late 2026 or early 2027; the potential for SEP-479 to be a differentiated once-daily oral therapy for patients with hypoparathyroidism; the potential of its proprietary Native Complex Platform^® to discover novel oral small molecules; the size and growth potential of the markets for its current and future product candidates; its expectations regarding strategic plans for its business, product candidates, and technology; and the scope of protection it is able to establish and maintain for intellectual property rights covering its Native Complex Platform^® and its product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: the risk that SEP-479 preclinical data does not turn out to be predictive of future clinical outcomes for SEP-479; risks related to clinical development outcomes for SEP-479 including unexpected safety, pharmacokinetic, or pharmacodynamic findings; risks related to the actual timing of future availability of clinical data for SEP-479 including that the actual timing of enrollment and completion of the study may differ from management’s current estimates; the scope of protection Septerna is able to establish and maintain for intellectual property rights covering its Native Complex Platform^® and its product candidates (including SEP-479); and general economic, industry and market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Septerna’s Quarterly Report on Form 10-Q for the three months ended March 31, 2026, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Septerna’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Septerna explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260608910791/en/

Investor Contact:
Renee Leck, THRUST
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Media Contact:
Carly Scaduto, THRUST
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Source: Septerna, Inc.