Septerna Reports Third Quarter 2024 Financial Results and Recent Business Highlights
Deep Pipeline of GPCR Programs Focused Initially on Indications in Endocrinology, Immunology and Inflammation, and Metabolic Diseases
Phase 1 Clinical Trial Ongoing for SEP-786, Oral Small Molecule for Hypoparathyroidism, with Data Expected in Mid-2025
Well-Capitalized with Balance Sheet to Support a Planned Operating Runway into Second Half of 2027
SOUTH SAN FRANCISCO, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor $(GPCR)$ drug discovery, today reported financial results for the third quarter ended September 30, 2024 and provided a portfolio overview and business highlights.
"At Septerna, we recently celebrated two major milestones: our transition to a clinical-stage company with the initiation of our Phase 1 clinical trial for SEP-786, and our debut as a public company following a successful IPO," said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. "Our Native Complex Platform$(TM)$ has yielded a deep pipeline of oral small molecule programs, each offering a unique product profile, early clinical biomarker readouts, and substantial market potential. Leading our pipeline is SEP-786, which we believe could transform hypoparathyroidism treatment by providing full-day calcium control with a convenient, disease-modifying oral therapy. With a talented team, a pioneering platform, a robust pipeline, and a strong balance sheet, we believe we are well positioned to deliver multiple novel GPCR medicines with the potential to meaningfully improve patients' lives."
Septerna's proprietary Native Complex Platform(TM) is uniquely designed to enable targeting of GPCRs with a wide spectrum of pharmacologies to affect GPCR signaling in different ways to achieve desired therapeutic effects. Using this platform, Septerna aims to discover and develop a portfolio of oral small molecule GPCR-targeted medicines with novel mechanisms to treat diseases across multiple therapeutic areas.
Portfolio Overview
SEP-786 PTH1R Agonist Advancing in Phase 1 Clinical Trial:
-- SEP-786 is an oral small molecule Parathyroid Hormone 1 Receptor (PTH1R)
agonist in development for the treatment of hypoparathyroidism. In
preclinical studies, SEP-786 has been observed to be generally
well-tolerated and has demonstrated potent and selective activation of
PTH1R in cell-based models, and in a preclinical animal model of
hypoparathyroidism, SEP-786 controlled serum calcium levels within the
normal range over a 28-day dosing period.
-- In September 2024, Septerna initiated a Phase 1 randomized,
placebo-controlled, single-ascending dose (SAD) and multiple-ascending
dose $(MAD.AU)$ trial to assess preliminary safety, tolerability,
pharmacokinetics $(PK)$ and pharmacodynamics $(PD)$ of SEP-786 in up to 180
healthy adult participants. Data from both the SAD and MAD portions of
the trial are expected in mid-2025.
SEP-631 MRGPRX2 Negative Allosteric Modulator $(NAM.AU)$ in IND-Enabling Studies:
-- SEP-631 is a selective oral small molecule Mas-related G protein-coupled
receptor X2 (MRGPRX2) NAM in development for the treatment of chronic
spontaneous urticaria (CSU), an inflammatory skin disease. In preclinical
studies, SEP-631 demonstrated potent and long-lasting inhibition of
MRGPRX2, which is a highly and uniquely expressed receptor on mast cells
and, when activated, is believed to be a key driver of CSU.
-- SEP-631 is currently being evaluated in Investigational New Drug
$(IND.AU)$-enabling studies in anticipation of submitting for regulatory
clearance to initiate a Phase 1 clinical trial. Due to MRGPRX2's
expression on mast cells, SEP-631 has the potential to treat other mast
cell-driven diseases beyond CSU, including allergic asthma, atopic
dermatitis, and prurigo nodularis.
TSHR NAM Program for Endocrine Disorders:
-- Septerna is advancing an oral small molecule thyroid stimulating hormone
receptor (TSHR) NAM program designed to be a disease-modifying treatment
for Graves' disease and thyroid eye disease (TED). In a novel mouse model
of Graves' disease, the TSHR NAMs have demonstrated the ability to
reverse hyperthyroidism and proptosis (eye bulging effect from TED), and
in cell-based assays using primary human cells, these TSHR NAMs inhibited
several Graves' disease patient TSHR autoantibodies.
-- Septerna is progressing several TSHR NAM lead compounds towards selection
of a development candidate for future IND-enabling studies.
Incretin Receptor (GLP-1R, GIPR, GCGR) Program for Metabolic Diseases:
-- Septerna is advancing a next-generation incretin receptor program aimed
at discovering and developing oral small molecules as selective single-
or multi-acting GLP-1, GIP, or glucagon receptor agonists for the
treatment of metabolic diseases, including obesity and type 2 diabetes.
Preclinical data from incretin agonist compounds with distinct single- or
multi-acting profiles have demonstrated differential potency and
selectivity in activating GIPR, GLP-1R, and GCGR-induced intracellular
signaling. In addition, the company's mono-GIPR agonists have shown
favorable PK properties and the ability to control glucose and induce
weight loss in various mouse models.
-- Septerna is progressing several incretin receptor agonist lead compounds
towards selection of one or more development candidates for
future IND-enabling studies.
Business Highlights
-- In October 2024, Septerna completed its upsized initial public offering
$(IPO.UK)$, in which it raised net proceeds of approximately $302.6 million,
after deducting underwriting discounts and commissions and other offering
expenses.
-- In September 2024, Jae Kim, M.D., was appointed as chief medical officer
to lead an expanded team with the company's transition to a
clinical-stage organization.
Third Quarter 2024 Financial Results
-- Cash Position: Cash, cash equivalents, and marketable securities totaled
$137.5 million as of September 30, 2024. Together with net proceeds from
the company's IPO, Septerna expects its current cash position to support
its planned operations into the second half of 2027.
-- R&D Expenses: Research and development (R&D) expenses were $17.8 million
for the third quarter of 2024.
-- G&A Expenses: General and administrative (G&A) expenses were $4.9 million
for the third quarter of 2024.
-- Net Loss: Net loss totaled $20.5 million for the third quarter of 2024.
About Septerna
Septerna, Inc. is a clinical-stage biotechnology company pioneering a new era of GPCR oral small molecule drug discovery powered by its proprietary Native Complex Platform(TM). Its industrial-scale platform aims to unlock the full potential of GPCR therapies and has led to the discovery and development of its deep pipeline of product candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases. Septerna was launched by preeminent drug discovery company builders and scientific leaders in the biochemistry, structural biology, and pharmacology of GPCRs. 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 continued development and advancement of Septerna's oral small molecule GPCR-targeted programs, including the ongoing clinical trial of SEP-786 and the timing of clinical updates for SEP-786 in mid-2025; the initiation, timing, progress, and results of conducting its research and development programs and its current and future preclinical studies and anticipated clinical trials, and the release of data related thereto; its ability to demonstrate, and the timing of, preclinical proof-of-concept in vivo and ex vivo for multiple programs; its ability to advance any product candidates that it may identify and successfully complete any clinical studies; the potential of its proprietary Native Complex Platform(TM); its expectations regarding the implementation of its business model, and strategic plans for its business, product candidates, and technology; and the accuracy of its estimates regarding expenses and capital requirements, including its expected cash runway through the second half of 2027. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing," "plan," "predict," "project," "potential," "should," 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.
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