Financial Performance - The company recorded a net income of $4.2 million for the year ended December 31, 2023, due to a gain on the sale of a non-financial asset of $47.6 million[136]. - For the three months ended September 30, 2025, the company reported a net income of $8.2 million, driven by $21.5 million in revenue and a $12.5 million gain on the sale of a non-financial asset[136]. - The company has an accumulated deficit of $156.5 million as of September 30, 2025, with net losses of $38.1 million and $51.1 million for the nine months ended September 30, 2025, and 2024, respectively[138]. - Revenue for the three months ended September 30, 2025, was $21.5 million, a significant increase from $0.2 million in the same period of 2024[169]. - For the nine months ended September 30, 2025, revenue reached $21.8 million, compared to $0.9 million for the same period in 2024[169]. - $21.3 million of the total revenue for the three and nine months ended September 30, 2025, was generated from research activities performed for Novo under the Novo Collaboration Agreement[170]. - The net loss for the three months ended September 30, 2025, was $8.2 million, a decrease in loss compared to $20.5 million in the same period of 2024[168]. - The company reported a net loss of $38.1 million for the nine months ended September 30, 2025, compared to a net loss of $51.1 million in 2024, a 25.5% improvement[180]. Collaboration Agreements - The company received a one-time, non-refundable upfront payment of $195.0 million from the Novo Collaboration Agreement, recorded as deferred revenue[144]. - The company is eligible for up to approximately $498.0 million in milestone payments from the Novo Collaboration Agreement, along with tiered royalties based on global product sales[144][145]. - The company received a one-time, non-refundable upfront payment of $195.0 million in July 2025 as part of the Novo Collaboration Agreement[182]. Research and Development - The company plans to initiate a Phase 1 clinical trial for SEP-479 in the first half of 2026, pending completion of preclinical studies and regulatory submissions[131]. - The Phase 1 clinical trial for SEP-631 is expected to enroll up to approximately 150 healthy adult volunteers, with initial data anticipated in the first half of 2026[132]. - The company has incurred significant operating losses since inception, with expectations to continue incurring substantial expenditures for product development and operational activities[137]. - The company expects research and development expenses to increase substantially in absolute dollars as it continues to invest in product candidates and clinical trials[157]. - Research and development expenses for the three months ended September 30, 2025, were $24.3 million, up from $17.8 million in the same period of 2024, reflecting an increase of $6.4 million[168]. - For the nine months ended September 30, 2025, research and development expenses were $65.7 million, up from $46.0 million in 2024, marking a 42.5% increase[172]. - The company anticipates initiating a Phase 1 clinical trial for SEP-479 in the first half of 2026, following the completion of preclinical studies and regulatory submissions[173]. Operating Expenses - General and administrative expenses for the three months ended September 30, 2025, were $7.1 million, an increase of $2.2 million from $4.9 million in the same period of 2024[168]. - General and administrative expenses are also expected to increase significantly as the company expands its headcount to support business growth[162]. - General and administrative expenses rose to $7.1 million for the three months ended September 30, 2025, compared to $4.9 million in 2024, a 44.9% increase[174]. - The company recorded a gain of $12.5 million on the sale of a non-financial asset, impacting total operating expenses for the three months ended September 30, 2025[168]. Cash and Financing - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $561.6 million, expected to fund operations through at least 2029[182]. - Net cash provided by operating activities was $125.2 million for the nine months ended September 30, 2025, compared to a net cash used of $46.5 million in 2024[184]. - The company completed its IPO in October 2024, raising net proceeds of $302.8 million from the sale of 18.4 million shares[140]. - The company completed its IPO in October 2024, resulting in net proceeds of $302.8 million after total offering costs of $28.4 million[193]. - The company has historically financed operations primarily through convertible promissory notes, convertible preferred stock, and the recent IPO[193]. Accounting and Compliance - There have been no material changes to the company's critical accounting policies and estimates during the nine months ended September 30, 2025[196]. - Revenue is recognized under ASC 606 when the customer obtains control of the promised goods or services[197]. - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of new accounting standards[199]. - The company may continue to qualify as a "smaller reporting company" if certain revenue and market value thresholds are met[199]. Strategic Focus - The company is focused on establishing collaborations for favorable terms and scaling up clinical, regulatory, and manufacturing capabilities[194]. - Future commercialization activities will require expenses for sales, marketing, manufacturing, and distribution capabilities[194]. - The company has devoted resources to developing product candidates and preparing for clinical trials[193]. - The company has engaged in collaboration activities and established arrangements for the manufacture of product candidates[193].

Financial Performance - Revenue for the third quarter of 2025 was $21.5 million, a significant increase from $0.2 million in the same quarter of 2024[7] - Net income for the third quarter of 2025 was $8.2 million, a turnaround from a net loss of $20.5 million in Q3 2024[11] - Total stockholders' equity as of September 30, 2025, was $388.7 million, down from $420.0 million at the end of 2024[16] Expenses - Research and development expenses were $24.3 million for Q3 2025, compared to $17.8 million for Q3 2024, reflecting a 36.9% increase[11] - General and administrative expenses rose to $7.1 million in Q3 2025 from $4.9 million in Q3 2024, marking a 45.9% increase[11] Cash Position - Septerna reported a robust cash position of $561.6 million as of September 30, 2025, expected to fund operations into at least 2029[6] Clinical Trials and Research - SEP-479 was selected as the next-generation oral PTH1R agonist candidate, with a Phase 1 clinical trial planned for the first half of 2026[6] - The ongoing Phase 1 clinical trial for SEP-631 is evaluating safety and pharmacokinetics, with initial data expected in the first half of 2026[6] - The company continues to advance its TSHR NAM program, aiming for a potential treatment for Graves' disease and thyroid eye disease[6] Collaborations - Septerna's collaboration with Novo Nordisk commenced in July 2025, focusing on developing oral small-molecule therapies for obesity and type 2 diabetes[6]

Core Insights - Septerna, Inc. has selected SEP-479 as its next-generation oral PTH1R agonist development candidate for hypoparathyroidism and is currently conducting a Phase 1 clinical trial for SEP-631 targeting MRGPRX2 for mast cell-driven diseases [2][3] - The company reported a robust financial position with cash, cash equivalents, and marketable securities totaling $561.6 million, expected to support operations at least into 2029 [1][13] Business Updates - SEP-479 demonstrated robust, dose-dependent increases in serum calcium and decreases in endogenous parathyroid hormone levels in a seven-day study in healthy cynomolgus monkeys, with plans to initiate a Phase 1 clinical trial in the first half of 2026 [7][3] - The ongoing Phase 1 clinical trial for SEP-631 is evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics, with initial data expected in the first half of 2026 [4][2] - Septerna is advancing its TSHR NAM program aimed at developing a potential oral treatment for Graves' disease and thyroid eye disease [8] Financial Performance - Revenue for the quarter ended September 30, 2025, was $21.5 million, a significant increase from $0.2 million in the same quarter of 2024, driven by the amortization of the $195 million upfront payment from Novo Nordisk [13] - Research and development expenses were $24.3 million for the quarter, compared to $17.8 million in the same quarter of 2024, while general and administrative expenses rose to $7.1 million from $4.9 million [13] - The company reported a net income of $8.2 million for the quarter, a turnaround from a net loss of $20.5 million in the same quarter of 2024 [13]

Company Overview - Septerna, Inc. (SEPN) shares increased by 7% to close at $22.49, with a notable trading volume, and have gained 38% over the past four weeks [1][2] - The stock price surge is attributed to growing investor optimism regarding Septerna's clinical candidate, SEP-631, aimed at treating chronic spontaneous urticaria and other mast cell diseases [2] Financial Performance - Septerna is expected to report quarterly earnings of $0.19 per share, reflecting a year-over-year increase of 102.3% [3] - Revenue projections for the upcoming quarter stand at $75 million, indicating a significant increase of 41566.7% compared to the same quarter last year [3] Market Position and Trends - The consensus EPS estimate for Septerna has remained stable over the last 30 days, suggesting that stock price movements may not sustain without earnings estimate revisions [4] - Septerna holds a Zacks Rank of 3 (Hold), indicating a neutral outlook in the market [4] - In comparison, Gyre Therapeutics, Inc. (GYRE), a peer in the same industry, has seen a decline of 5.2% over the past month and currently holds a Zacks Rank of 4 (Sell) [4][5]

Core Insights - Septerna, Inc. has appointed Dr. Keith Gottesdiener to its board of directors, who will chair a newly formed R&D Committee, bringing over 30 years of biotechnology experience [1][2] - Dr. Gottesdiener's expertise in advancing therapeutics and regulatory strategy is expected to support Septerna's lead programs and pipeline development [2] - The company is focused on GPCR drug discovery through its proprietary Native Complex Platform™, aiming to address unmet medical needs across various therapeutic areas [3] Company Overview - Septerna, Inc. is a clinical-stage biotechnology company specializing in GPCR therapies, with a strong team of experts and a diverse pipeline of oral small molecule drug candidates [3] - The company is advancing programs in endocrinology, immunology, inflammation, and metabolic diseases, both independently and in collaboration with partners [3] Leadership Background - Dr. Gottesdiener has held significant leadership roles, including President and CEO of Prime Medicine, Inc., and CEO of Rhythm Pharmaceuticals, Inc., where he oversaw the approval of setmelanotide for three obesity indications [2] - His previous experience includes 16 years at Merck Research Laboratories, where he was responsible for the approval of over 20 novel therapeutics and more than 200 IND submissions [2]

Financial Data and Key Metrics Changes - The company has identified a new development candidate for its parathyroid hormone receptor program, moving forward after unexpected findings with a previous compound [3][5] - The new compound, SEP-479, shows significantly improved pharmaceutical properties compared to the discontinued SEP-786, with a lower effective dose in preclinical models [9][10] Business Line Data and Key Metrics Changes - The parathyroid hormone receptor program has transitioned to SEP-479, which has demonstrated the ability to normalize serum calcium levels in preclinical models [9][10] - The MRGPRX2 program has initiated a phase one trial with a randomized, placebo-controlled design, focusing on skin-based indications [14][15] Market Data and Key Metrics Changes - The company has formed a collaboration with Novo Nordisk, which includes a $195 million upfront payment and covers all R&D costs going forward, allowing the company to expand its programs without increasing its burn rate [46][47] Company Strategy and Development Direction - The company is focused on GPCR drug discovery, utilizing its Native Complex Platform to optimize compounds quickly and effectively [2][4] - The strategic partnership with Novo Nordisk aims to leverage their expertise in the metabolic space while pursuing multiple programs in parallel [46][47] - The company is exploring additional opportunities in areas such as osteoporosis, neurology, cardiovascular diseases, and respiratory diseases [50][51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the connection between preclinical data and eventual patient data for PTH peptides, indicating a strong potential for the new compound [21][22] - The company aims to gather safety and pharmacokinetic data in phase one trials to inform future patient dosing strategies [23][24] Other Important Information - The company has completed additional studies on SEP-786 to understand its effects better, particularly regarding bilirubin metabolism [7][8] - The company is optimistic about the potential for once-daily dosing with SEP-479, which could significantly improve patient compliance [31][32] Q&A Session Summary Question: When did the company start to see issues with bilirubin in the SINOS study for SEP-786? - The company observed bilirubin issues within a couple of days in the SINOS study, similar to findings in patients [18] Question: What is the development plan for SEP-479? - The company plans to conduct a phase one study with hopes of seeing safety and pharmacokinetic properties that will inform patient dosing [20][22] Question: How does SEP-479 differ from SEP-786? - SEP-479 is a completely different structural series with no observed functional differences in assays, but it is expected to have a lower risk of off-target effects [29][30] Question: What is the expected timeline for the phase one trial? - The company anticipates starting the phase one trial in the first half of next year, with more precise timing to be communicated later [34] Question: What is the opportunity within mast cell diseases for the MRGPRX2 program? - The company sees potential in various mast cell-driven diseases, including chronic spontaneous urticaria and atopic dermatitis, and plans to pursue multiple lead indications [35][40]

Summary of Septurna (SEPN) 2025 Conference Call Company Overview - **Company**: Septurna - **Event**: 2025 Cantor Healthcare Conference - **CEO**: Jeff Feiner introduced the company and its updates on drug discovery platforms and lead programs [1][2] Industry and Market Context - **Industry**: Biopharmaceuticals focusing on G protein-coupled receptors (GPCRs) - **Market Opportunity**: GPCRs are a significant target class in drug discovery, with over 70% of approved GPCR drugs targeting just six subfamilies [6] Key Programs and Developments 1. Lead Programs - **SEP-479**: Next-generation parathyroid hormone receptor small molecule agonist for hyperparathyroidism, announced as a new development candidate [4][20] - **SEP-631**: Focused on MRGPRAX2 for mast cell-driven diseases, recently started Phase 1 trials [5][33] 2. Drug Discovery Platform - **Native Complex Platform**: A novel approach to drug discovery that allows for the isolation of fully functional GPCRs, enhancing the ability to design effective small molecules [3][7] - **Structural Biology**: Utilizes cryo-electron microscopy for rapid structure determination, enabling efficient structure-based design [9][10] 3. Therapeutic Areas - **Focus Areas**: Endocrinology, immunology, inflammation, metabolic diseases, and early-stage efforts in neurology [11][12] Clinical Insights SEP-479 - **Mechanism**: Aims to replace traditional injectable therapies for hypoparathyroidism with an oral small molecule [17] - **Efficacy**: Demonstrated effectiveness in animal models at significantly lower doses compared to previous compounds [25][26] - **Safety Profile**: No observed UGT1A1 inhibition, which was a concern with the previous candidate SEP-786 [32] SEP-631 - **Target**: MRGPRAX2, involved in mast cell activation pathways, with a focus on chronic spontaneous urticaria [34] - **Profile**: Designed as a negative allosteric modulator with a slow off-rate, showing promise in preclinical models [35][38] Collaborations and Financials - **Novo Nordisk Collaboration**: Involves five targets with an upfront payment of $195 million, significantly reducing Septurna's R&D costs [46] - **Financial Position**: Well-capitalized with operating capital projected to last until at least 2029 [4][48] Management and Governance - **Experienced Team**: Led by a seasoned management team and supported by a strong board of directors and advisory board [47] Conclusion - **Outlook**: Septurna is positioned for growth with a robust pipeline and strategic collaborations, focusing on innovative therapies for significant unmet medical needs [48]

Core Insights - Septerna, Inc. is a clinical-stage biotechnology company focused on G protein-coupled receptor (GPCR) drug discovery [1][2] - The company will participate in two upcoming investor conferences in September 2025, showcasing its commitment to engaging with investors [1] Company Overview - Septerna is advancing GPCR therapies to address significant unmet medical needs, utilizing its proprietary Native Complex Platform™ for drug discovery [2] - The company has developed a diverse pipeline of novel oral small molecule drug candidates across various therapeutic areas, including endocrinology, immunology, inflammation, and metabolic diseases [2]

Core Insights - Septerna, Inc. has initiated the Phase 1 clinical trial for SEP-631, a selective oral small molecule MRGPRX2 negative allosteric modulator aimed at treating chronic spontaneous urticaria (CSU) and other mast cell-driven diseases [1][2][4] Company Overview - Septerna is a clinical-stage biotechnology company focused on G protein-coupled receptor (GPCR) drug discovery, utilizing its proprietary Native Complex Platform™ to develop novel oral small molecule drug candidates [5] - The company aims to address significant unmet medical needs in various therapeutic areas, including endocrinology, immunology, inflammation, and metabolic diseases [5] Clinical Trial Details - The Phase 1 clinical trial will consist of a single-ascending dose (SAD) and multiple-ascending dose (MAD) study, enrolling approximately 150 healthy adult volunteers to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SEP-631 [3] - The SAD portion is currently underway, focusing on escalating oral doses, while the MAD portion will assess the safety and tolerability over a treatment period [3] Disease Context - Mast cell-driven diseases, such as CSU, affect millions globally and often result in inadequate symptom relief from existing therapies, highlighting the need for new treatment options [2] - CSU is characterized by spontaneous and persistent hives and angioedema, with mast cell activation playing a critical role in symptom development [2][4]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Unaudited H1 2025 financials reveal decreased assets to $415.2 million, a widened net loss of $46.3 million, and increased operating cash outflow [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $415.2 million from $456.6 million, primarily due to a drop in cash, while equity declined Condensed Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $189,311 | $238,196 | | Total current assets | $334,141 | $356,824 | | **Total assets** | **$415,231** | **$456,554** | | **Liabilities & Equity** | | | | Total current liabilities | $15,127 | $12,849 | | **Total liabilities** | **$37,674** | **$36,507** | | **Total stockholders' equity** | **$377,557** | **$420,047** | | Accumulated deficit | $(164,688) | $(118,374) | [Condensed Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for H1 2025 widened to $46.3 million from $30.6 million, driven by increased R&D and G&A expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $338 | $687 | | Research and development | $41,459 | $28,188 | | General and administrative | $13,767 | $6,054 | | **Total operating expenses** | **$55,226** | **$34,242** | | Loss from operations | $(54,888) | $(33,555) | | **Net loss** | **$(46,314)** | **$(30,607)** | | Net loss per share | $(1.05) | $(13.40) | [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $43.6 million in H1 2025, with minimal financing cash compared to prior year Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(43,630) | $(29,698) | | Net cash used in investing activities | $(5,660) | $(2,565) | | Net cash provided by financing activities | $405 | $74,952 | | **Net (decrease) increase in cash** | **$(48,885)** | **$42,689** | [Notes to Unaudited Condensed Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes detail the company's IPO, a major collaboration with Novo Nordisk, and confirm sufficient capital for 12 months - The company is a biotechnology firm focused on GPCR oral small molecule drug discovery using its proprietary Native Complex Platform™[31](index=31&type=chunk) - In October 2024, the company completed its IPO, raising net proceeds of **$302.8 million**[35](index=35&type=chunk) - The company believes its cash, cash equivalents, and marketable securities of **$379.2 million** as of June 30, 2025, are sufficient to fund operations for at least **12 months**[40](index=40&type=chunk) - In May 2025, the company entered into a collaboration with Novo Nordisk, effective July 1, 2025, receiving a **$195.0 million** upfront payment in July 2025 and eligible for up to **$498.0 million** in milestones per R&D program, plus tiered royalties[52](index=52&type=chunk)[54](index=54&type=chunk) - A milestone related to the 2023 asset purchase agreement with Vertex was achieved in July 2025, resulting in a **$12.5 million** payment received in August 2025[57](index=57&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the GPCR platform, increased H1 2025 operating losses, and the Novo Nordisk collaboration, projecting funding into 2029 [Overview and Pipeline](index=29&type=section&id=Overview%20and%20Pipeline) Septerna, a biotechnology company, pioneers GPCR oral small molecule drug discovery with its Native Complex Platform™ and a pipeline in endocrinology, immunology, and metabolic diseases - The company's proprietary Native Complex Platform™ replicates the natural structure and function of GPCRs, enabling an industrialized, structure-based drug design approach[100](index=100&type=chunk) Development Pipeline Summary | Program / Target | Therapeutic Area | Development Status | | :--- | :--- | :--- | | **Wholly-Owned Programs** | | | | PTH1R Program | Endocrinology | Discovery | | SEP-631 (MRGPRX2) | Immunology and Inflammation | Discovery | | TSHR Program | Endocrinology | Discovery | | **Partnered Programs** | | | | Metabolic Programs (GLP-1R, etc.) | Obesity & Cardiometabolic | Partnered (Novo) | [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Net loss increased to $46.3 million in H1 2025, driven by a $13.3 million rise in R&D expenses and a $7.7 million increase in G&A expenses Comparison of Results of Operations (in thousands) | Line Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $338 | $687 | $(349) | | Research and development | $41,459 | $28,188 | $13,271 | | General and administrative | $13,767 | $6,054 | $7,713 | | **Net loss** | **$(46,314)** | **$(30,607)** | **$(15,707)** | Research and Development Expense Breakdown (in thousands) | Program | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | PTH1R | $6,733 | $4,746 | $1,987 | | SEP-631 (MRGPRX2) | $3,765 | $874 | $2,891 | | Other programs | $9,996 | $2,153 | $7,843 | | Unallocated costs | $20,965 | $20,415 | $550 | | **Total R&D Expense** | **$41,459** | **$28,188** | **$13,271** | [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) With $379.2 million in cash as of June 30, 2025, bolstered by $195.0 million from Novo and $12.5 million from Vertex, the company projects funding into 2029 - The company historically financed operations through convertible notes, preferred stock, and its October 2024 IPO, which raised **$302.8 million** in net proceeds[143](index=143&type=chunk) - Management projects that its cash position of **$379.2 million** as of June 30, 2025, combined with the **$195.0 million** from Novo and **$12.5 million** from Vertex, will fund operations into **2029**[144](index=144&type=chunk) Summary of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(43,630) | $(29,698) | | Net cash used in investing activities | $(5,660) | $(2,565) | | Net cash provided by financing activities | $405 | $74,952 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Septerna, Inc. is not required to provide the information requested under this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide quantitative and qualitative disclosures about market risk[161](index=161&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Based on an evaluation as of the end of the period, the Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[163](index=163&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[164](index=164&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings deemed probable to have a material adverse effect on its business - The company is not currently involved in any litigation or legal proceedings expected to have a material adverse effect on its business, financial condition, or results of operations[168](index=168&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors include potential FDA disruptions, unfavorable global economic conditions, geopolitical instability, and healthcare legislative reforms impacting drug pricing - Risks include potential disruptions at the FDA and other agencies due to staffing reductions, funding shortages, or government shutdowns, which could delay product development and approval[170](index=170&type=chunk)[171](index=171&type=chunk) - Unfavorable global economic conditions, political instability, and geopolitical events such as military conflicts and trade tariffs could adversely affect the business, financial condition, and stock price[172](index=172&type=chunk)[173](index=173&type=chunk) - Healthcare legislative reforms, including the Inflation Reduction Act (IRA) and recent Executive Orders, may negatively impact the business by containing healthcare costs and affecting drug pricing and reimbursement[176](index=176&type=chunk)[179](index=179&type=chunk)[180](index=180&type=chunk) - Recent changes to U.S. tax law, such as the One Big Beautiful Bill Act (H.R.1), could materially affect the company's business and cash flow, particularly regarding the capitalization and amortization of R&D expenses[186](index=186&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales occurred; IPO proceeds of $302.8 million are reallocated to advance other pipeline candidates after discontinuing the SEP-786 program - The company's October 2024 IPO generated net proceeds of **$302.8 million**[189](index=189&type=chunk) - The planned use of IPO proceeds has changed due to the discontinuation of the SEP-786 product candidate; funds will now advance other programs, including a next-generation PTH1R agonist and SEP-631[190](index=190&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable - No defaults upon senior securities were reported[192](index=192&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - No mine safety disclosures were required[193](index=193&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading plans during the fiscal quarter ended June 30, 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading plan or other similar trading arrangement during the quarter[194](index=194&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, the Novo Collaboration Agreement, and certifications - The list of exhibits includes the Novo Collaboration Agreement, CEO/CFO certifications, and XBRL data files[196](index=196&type=chunk)