Septerna, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 9 November 2026: press release. Guidance figures: 1 new, 1 kept. The quarter’s numbers.

Key takeaways

Revenue below prior-year quarter: Third-quarter revenue was $18.9 million against $21.5 million a year earlier. Nine-month revenue was $72.2 million against $21.8 million. Second-quarter revenue was $26.7 million. Source
Net loss against prior-year profit: Net loss was $26.6 million, compared with $13.0 million in the second quarter and net income of $8.2 million a year earlier. Source
R&D spend up year on year: Research and development expenses were $36.6 million, up from $35.1 million in the second quarter and $24.3 million a year earlier. Nine-month R&D expenses were $101.2 million. Source
SEP-479 Phase 1 under way: The SAD and MAD Phase 1 trial of SEP-479, an oral PTH1R agonist for hypoparathyroidism, continues in healthy volunteers. Source
SEP-204 selected as candidate: Septerna announced SEP-204 as its oral TSHR negative allosteric modulator development candidate for Graves' disease and thyroid eye disease, in conjunction with the American Thyroid Association annual meeting. Source
Cash position rises to $565.2M: Cash, cash equivalents and marketable securities were $565.2 million, up from $516.5 million at June 30, 2026. Source
Runway described as into mid-2029: Management said existing cash is expected to fund operations at least into mid-2029. The second-quarter release described the runway as at least into 2029. Source

“We are building momentum across our portfolio, with an upcoming important clinical milestone for SEP-479”
Jeffrey Finer, M.D., Ph.D., Chief Executive Officer and Co-founder of Septerna

Guidance

Area	Period	Figure	Against last quarter
SEP-479 Phase 1 SAD and MAD data Source	first quarter of 2027	first quarter of 2027	Kept
SEP-204 Phase 1 trial start Source	first quarter of 2027	first quarter of 2027	New
Cash runway Source	at least into mid-2029	at least into mid-2029

What changed from last quarter

New: SEP-204 was selected as the oral TSHR NAM development candidate. The second-quarter release had described the program as progressing toward candidate selection. Source
New: A Phase 1 trial of SEP-204 in healthy volunteers is planned to start in the first quarter of 2027. Source
New: Rajiv Patni, M.D., was appointed Chief Medical Officer in August 2026. Source
New: Novo recently assumed responsibility for a development candidate that Septerna's research team delivered, and IND-enabling toxicology studies were initiated. Source
Guidance kept: The timing for SEP-479 Phase 1 SAD and MAD data stayed at the first quarter of 2027. Source

Results and growth drivers

Revenue below prior-year quarter: Third-quarter revenue was $18.9 million against $21.5 million a year earlier. Nine-month revenue was $72.2 million against $21.8 million. Second-quarter revenue was $26.7 million. Source
Collaboration revenue composition: Quarter revenue included $2.7 million of upfront amortization from Novo Nordisk, $5.2 million of research milestones and $11.0 million of research services. Second-quarter upfront amortization was $14.6 million. Source
Net loss against prior-year profit: Net loss was $26.6 million, compared with $13.0 million in the second quarter and net income of $8.2 million a year earlier. Source
Prior-year gain on asset sale: The prior-year third quarter included a $12.5 million gain on sale of a non-financial asset. No such item appears for 2026. Source
Diluted loss per share: Diluted net loss per share was $0.57 for the quarter, against diluted earnings of $0.18 a year earlier. Nine-month diluted loss per share was $1.06. Source

Operating expenses and spend

R&D spend up year on year: Research and development expenses were $36.6 million, up from $35.1 million in the second quarter and $24.3 million a year earlier. Nine-month R&D expenses were $101.2 million. Source
G&A rose from prior quarter: General and administrative expenses were $9.6 million, against $8.5 million in the second quarter and $7.1 million a year earlier. Nine-month G&A expenses were $28.3 million. Source
Operating loss against prior-year income: Total operating expenses were $46.1 million and the loss from operations was $27.2 million. The prior-year third quarter had operating income of $2.6 million. Source
Interest income and tax provision: Interest income and other expense, net was $5.3 million, against $5.6 million a year earlier. The income tax provision was $4.6 million in the quarter and $5.9 million for nine months. Source

“we are moving closer to realizing our ambition to translate our GPCR expertise into differentiated oral medicines for patients with significant unmet needs”
Jeffrey Finer, M.D., Ph.D., Chief Executive Officer and Co-founder of Septerna

Pipeline progress and candidates

SEP-479 Phase 1 under way: The SAD and MAD Phase 1 trial of SEP-479, an oral PTH1R agonist for hypoparathyroidism, continues in healthy volunteers. Source
SEP-204 selected as candidate: Septerna announced SEP-204 as its oral TSHR negative allosteric modulator development candidate for Graves' disease and thyroid eye disease, in conjunction with the American Thyroid Association annual meeting. Source
SEP-204 animal data presented: Preclinical data showed potent, selective TSHR inhibition in Graves' disease animal models. SEP-204 was generally well tolerated in 28-day GLP toxicology studies, and its pharmacokinetic profile is anticipated to support once-daily oral dosing in humans. Source
SEP-631 next-phase planning: Following positive Phase 1 results reported in March 2026, the company continues evaluating development strategies for SEP-631 in mast cell-driven diseases with high unmet need. Source

Novo collaboration and discovery programs

Novo took on a development candidate: Novo recently assumed responsibility for a development candidate delivered by Septerna's research team and initiated IND-enabling toxicology studies. Source
Research milestones total $13 million: Septerna has achieved $13 million in research milestones to date under the collaboration, which began in July 2025 and covers oral small molecules for obesity, type 2 diabetes and cardiometabolic diseases. Source
Wholly owned discovery programs continue: Discovery-stage programs using the Native Complex Platform continue across several therapeutic areas, including a PTH1R agonist program for osteoporosis. Source

Leadership and appointments

Chief Medical Officer appointed: Rajiv Patni, M.D., a physician-scientist with more than 25 years leading research, development, regulatory and medical affairs organizations, was appointed in August 2026. Source

Cash, balance sheet and runway

Cash position rises to $565.2M: Cash, cash equivalents and marketable securities were $565.2 million, up from $516.5 million at June 30, 2026. Source
Runway described as into mid-2029: Management said existing cash is expected to fund operations at least into mid-2029. The second-quarter release described the runway as at least into 2029. Source
Working capital and equity rise: Working capital was $402.5 million, up from $316.8 million at June 30, 2026. Total stockholders' equity was $427.9 million, and additional paid-in capital rose to $645.4 million from $576.9 million. Source
Weighted share count rose: Weighted-average basic shares were 46.9 million for the quarter, against 45.0 million in the second quarter and 44.3 million a year earlier. Source

Upcoming milestones and timing

SEP-479 data expected next: Phase 1 SAD and MAD data for SEP-479 are expected in the first quarter of 2027. Source
SEP-204 Phase 1 start planned: Following completion of the remaining preclinical development activities, Septerna anticipates starting a Phase 1 trial of SEP-204 in healthy volunteers in the first quarter of 2027. Source
SEP-631 study timing not given: Development strategies for SEP-631 in mast cell-driven diseases are still being evaluated. The documents give no dates for these studies. Source

Coming up, as management said on 9 November 2026

SEP-479 Phase 1 data: SAD and MAD Phase 1 data for SEP-479 are expected in the first quarter of 2027. Source
SEP-204 Phase 1 trial start: A Phase 1 trial of SEP-204 in healthy volunteers is planned to start in the first quarter of 2027, after remaining preclinical work. Source
SEP-631 study strategy: The company continues to evaluate development strategies for SEP-631 in mast cell-driven diseases. No date is given for these studies. Source
Novo IND-enabling toxicology work: Novo has started IND-enabling toxicology studies on the development candidate it recently took on. No dates were given. Source

Figures management reported

Figure	Reported
R&D expense Source	$36.6 million, quarter ended September 30, 2026
Research milestone revenue Source	$5.2 million recognized in the quarter
Pipeline: SEP-479 Phase 1 Source	SAD and MAD trial ongoing; data expected first quarter of 2027
Pipeline: SEP-204 development candidate Source	Selected; Phase 1 planned for first quarter of 2027
Preclinical readout: SEP-204 Source	T4 levels restored and thyroid enlargement reduced in animal models
Pipeline: SEP-631 Phase 1 Source	Positive Phase 1 results reported March 2026

Earlier plans management reported on

Not stated: The second-quarter release set the same timing. The third-quarter release repeats it.
Not stated: The second-quarter release said at least into 2029. The third-quarter release says at least into mid-2029.
Not stated: The second-quarter release said the program was progressing toward candidate selection. The third-quarter release announces the selection of SEP-204.
Not stated: The second-quarter release said the company was evaluating capital-efficient strategies in place of a Phase 2b in CSU. The third-quarter release says it continues to evaluate them.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Septerna Highlights Business Progress and Reports Third Quarter 2026 Financial Results

Phase 1 Clinical Trial for PTH1R Agonist SEP-479 Ongoing; SAD / MAD Data Expected in Q1 2027

Plans to Initiate Phase 1 Clinical Trial of Newly Selected Oral TSHR NAM Development Candidate SEP-204 in Q1 2027

Cash Position of $565.2 Million Expected to Support Operating Plans at Least into mid-2029

SOUTH SAN FRANCISCO, Calif. - November 09, 2026 - Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted pipeline progress and anticipated milestones and reported financial results for the third quarter ended September 30, 2026.

“We are building momentum across our portfolio, with an upcoming important clinical milestone for SEP-479, our oral PTH1R agonist for hypoparathyroidism, and the selection of SEP-204 as our oral TSHR NAM development candidate for Graves’ disease and thyroid eye disease,” said Jeffrey Finer, M.D., Ph.D., Chief Executive Officer and Co-founder of Septerna. “With Phase 1 data for SEP-479 and the initiation a Phase 1 trial of SEP-204 expected in the first quarter of 2027, we are moving closer to realizing our ambition to translate our GPCR expertise into differentiated oral medicines for patients with significant unmet needs.”

Recent Portfolio Progress and Anticipated Milestones

SEP-479 PTH1R Agonist for Hypoparathyroidism:

Septerna’s Phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) clinical trial of SEP-479, an oral small molecule PTH1R agonist in development for hypoparathyroidism, is ongoing in healthy volunteers, with data expected in the first quarter of 2027.

SEP-204 TSHR NAM for Graves’ Disease and Thyroid Eye Disease:

In conjunction with last week’s American Thyroid Association (ATA) annual meeting, Septerna announced the selection of SEP-204 as its oral TSHR negative allosteric modulator (NAM) development candidate as a potential disease-modifying treatment for Graves’ disease and thyroid eye disease.

Preclinical data presented at ATA demonstrated that SEP-204 potently and selectively inhibited TSHR, restored normal thyroid hormone T4 levels and reduced thyroid enlargement and orbital proptosis in Graves’ disease animal models. SEP-204 was generally well tolerated in 28-day GLP toxicology studies and demonstrated a favorable pharmacokinetic profile anticipated to support once-daily oral dosing in humans. Additional details are available in the data release.

Following the successful completion of the remaining preclinical development activities, Septerna anticipates initiating a Phase 1 clinical trial for SEP-204 in healthy volunteers in the first quarter of 2027.

SEP-631 MRGPRX2 NAM for Mast Cell-Driven Diseases:

Following positive Phase 1 results reported in March 2026, Septerna continues to evaluate capital-efficient, signal-finding clinical studies of SEP-631 in mast cell-driven diseases with high unmet need.

Additional Programs:

Under its global collaboration with Novo, initiated in July 2025, Septerna and Novo are advancing oral small molecule programs for obesity, type 2 diabetes and other cardiometabolic diseases. Novo recently assumed responsibility for a development candidate delivered by Septerna’s research team and initiated IND-enabling toxicology studies. To date, Septerna has achieved a total of $13 million in research milestones under the collaboration.

Septerna also continues to advance wholly owned discovery-stage programs utilizing its Native Complex Platform® across multiple therapeutic areas, including a PTH1R agonist program for osteoporosis.

Corporate Announcements

In August 2026, Septerna announced the appointment of Rajiv Patni, M.D., as Chief Medical Officer. Dr. Patni is a physician-scientist and accomplished biopharmaceutical executive with more than 25 years of experience leading research, development, regulatory, and medical affairs organizations.

Third Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities totaled $565.2 million as of September 30, 2026. Septerna expects its existing cash runway to fund operations at least into mid-2029.

Revenue: Revenue was $18.9 million for the quarter ended September 30, 2026, compared to $21.5 million for the quarter ended September 30, 2025. Revenue for the quarter ended September 30, 2026 included the amortization of $2.7 million of the $195.0 million upfront payment from Novo Nordisk, and $5.2 million from the achievement of research milestones, in addition to $11.0 million for research services associated with the collaboration.

R&D Expenses: Research and development (R&D) expenses were $36.6 million for the quarter ended September 30, 2026, compared to $24.3 million for the quarter ended September 30, 2025.

G&A Expenses: General and administrative (G&A) expenses were $9.6 million for the quarter ended September 30, 2026, compared to $7.1 million for the quarter ended September 30, 2025.

Net (Loss) Income: Net loss was $26.6 million for the quarter ended September 30, 2026, compared to net income of $8.2 million for the quarter ended September 30, 2025.

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. Septerna intends to use its Investor Relations website and LinkedIn as means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Septerna’s Investor Relations website and follow https://www.linkedin.com/company/septernainc on LinkedIn, in addition to following Septerna’s press releases, SEC filings, public conference calls, presentations, and webcasts.

Forward-Looking Statements

Forward-looking statements notice

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 translating of SEP-479, SEP-204, SEP-631 and any future preclinical data into similar clinical findings; the availability of SEP-479 Phase 1 clinical data; SEP-479’s potential as a differentiated once-daily oral therapy for patients with hypoparathyroidism; advancing SEP-204 into a Phase 1 clinical trial and timing thereof; SEP-204’s potential as a disease-modifying treatment for Graves’ disease and thyroid eye disease; continuing to advance programs under the Novo collaboration and achieving milestones thereunder; the potential of its proprietary Native Complex Platform®; the continued advancement of SEP-631, including plans to evaluate development strategies for capital-efficient, signal-finding clinical trials; the role of MRGPRX2 in mast cell-driven diseases; SEP-631’s potential to provide a convenient oral treatment option for patients with mast cell-driven diseases; the advancement of its discovery-stage programs across multiple therapeutic areas; the size and growth potential of the markets for its current and future product candidates; its strategic plans for its business, product candidates, and technology; its uses of capital, expenses and financial results, including its expected cash runway at least into mid-2029; 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; among others. 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.

Forward-looking statements notice

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, risks associated with: Septerna’s product candidates successfully entering and advancing through clinical trials (including those for SEP-479, SEP-204 and SEP-631) including uncertainties related to opening investigational new drug applications (INDs) and obtaining other regulatory approvals; risks related to clinical development outcomes including unexpected safety or efficacy findings; the results of preclinical studies including the long-term toxicology studies for SEP-479, SEP-204, and SEP-631, or preclinical studies or clinical trials not being predictive of future clinical outcomes; risks related to the timing of initiating clinical studies and future availability of clinical data; the scope of protection Septerna is able to establish and maintain for intellectual property rights covering its Native Complex Platform® and its product candidates; and Septerna’s ability to identify and enter into future license agreements and collaborations; and general economic, industry and market conditions; among others. 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 September 30, 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.

Condensed Statements of Operations

(In thousands, except for share and per share data)

(Unaudited)

	Three Months Ended September 30,		Nine Months Ended September 30,
	2026	2025	2026	2025
Revenue	$18,881	$21,495	$72,150	$21,833
Operating expenses (income):
Research and development	36,556	24,264	101,223	65,723
General and administrative	9,554	7,117	28,292	20,884
Gain on sale of non-financial asset	-	(12,500)	-	(12,500)
Total operating expenses	46,110	18,881	129,515	74,107
(Loss) income from operations	(27,229)	2,614	(57,365)	(52,274)
Interest income and other expense, net	5,260	5,559	15,035	14,133
Provision for income taxes	(4,621)	-	(5,931)	-
Net (loss) income	$(26,590)	$8,173	$(48,261)	$(38,141)
Net (loss) income per share, basic	$(0.57)	$0.18	$(1.06)	$(0.86)
Net (loss) income per share, diluted	$(0.57)	$0.18	$(1.06)	$(0.86)
Weighted-average shares outstanding, basic	46,914,946	44,343,085	45,579,174	44,150,041
Weighted-average shares outstanding, diluted	46,914,946	45,602,099	45,579,174	44,150,041

SEPTERNA, INC.

Condensed Balance Sheets

(In thousands)

(Unaudited)

	September 30, 2026	December 31, 2025
Cash, cash equivalents and marketable securities	$565,188	$548,658
Working capital	402,486	324,033
Total assets	619,404	596,187
Total liabilities	191,475	214,261
Additional paid-in capital	645,441	548,517
Accumulated deficit	(215,514)	(167,253)
Total stockholders’ equity	$427,929	$381,926

1. Working capital is defined as total current assets less total current liabilities. See our financial statements and the related notes thereto included in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 for further details regarding our current assets and current liabilities.

Contacts
Renee Leck, THRUST renee@thrustsc.com
Carly Scaduto, THRUST carly@thrustsc.com
SEPTERNA, INC.