Tectonic Therapeutic, Inc. (TECX)

CIK: 0001681087. SIC: 2836 Biological Products, (No Diagnostic Substances). Latest 10-K as of: 2026-02-26.

SIC breadcrumb: Manufacturing > Chemicals And Allied Products > SIC 2836 Biological Products, (No Diagnostic Substances)

SEC company page: https://www.sec.gov/edgar/browse/?CIK=1681087. Latest filing source: 0001193125-26-076793.

Selected Fundamentals

Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-02-26. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001681087.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

Flow metrics use full-year FY periods from 10-K/10-K/A filings; balance-sheet metrics use FY-end instants. Free cash flow = operating cash flow - capital expenditures. Missing metrics are omitted rather than fabricated.

Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

Financial Charts

Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-05-07. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001681087.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

Quarterly Charts

Macro Cross-References

• CPIAUCSL - Consumer Price Index for All Urban Consumers: All Items in U.S. City Average
• UNRATE - Unemployment Rate
• FEDFUNDS - Federal Funds Effective Rate
• CES0500000003 - Average Hourly Earnings of All Employees, Total Private
• DFEDTARU - Federal Funds Target Range - Upper Limit
• DFEDTARL - Federal Funds Target Range - Lower Limit
• DGS3MO - Market Yield on U.S. Treasury Securities at 3-Month Constant Maturity
• DGS2 - Market Yield on U.S. Treasury Securities at 2-Year Constant Maturity
• DGS10 - Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
• DGS30 - Market Yield on U.S. Treasury Securities at 30-Year Constant Maturity
• T10Y2Y - 10-Year Treasury Constant Maturity Minus 2-Year Treasury Constant Maturity
• CPILFESL - Consumer Price Index for All Urban Consumers: All Items Less Food and Energy
• CPIUFDSL - Consumer Price Index for All Urban Consumers: Food
• CPIENGSL - Consumer Price Index for All Urban Consumers: Energy
• CUSR0000SAH1 - Consumer Price Index for All Urban Consumers: Shelter
• PCEPI - Personal Consumption Expenditures: Chain-type Price Index
• PCEPILFE - Personal Consumption Expenditures Excluding Food and Energy: Chain-type Price Index
• PPIACO - Producer Price Index by Commodity: All Commodities
• T10YIE - 10-Year Breakeven Inflation Rate
• U6RATE - Total Unemployed, Plus All Marginally Attached Workers Plus Total Employed Part Time for Economic Reasons
• PAYEMS - All Employees, Total Nonfarm
• CIVPART - Labor Force Participation Rate
• EMRATIO - Employment-Population Ratio
• UNEMPLOY - Unemployed
• CE16OV - Employment Level
• ICSA - Initial Claims
• JTSJOL - Job Openings: Total Nonfarm
• JTSQUR - Quits: Total Nonfarm
• GDPC1 - Real Gross Domestic Product
• A191RL1Q225SBEA - Real Gross Domestic Product: Percent Change from Preceding Period
• INDPRO - Industrial Production: Total Index
• TCU - Capacity Utilization: Total Index
• HOUST - New Privately-Owned Housing Units Started: Total Units
• PERMIT - New Privately-Owned Housing Units Authorized in Permit-Issuing Places: Total Units
• RSAFS - Advance Retail Sales: Retail Trade
• PCE - Personal Consumption Expenditures
• DSPIC96 - Real Disposable Personal Income
• PSAVERT - Personal Saving Rate
• M2SL - M2
• BOPGSTB - U.S. International Trade in Goods and Services: Balance
• MSPUS - Median Sales Price of Houses Sold for the United States
• HSN1F - New One Family Houses Sold: United States
• RHORUSQ156N - Homeownership Rate in the United States
• TTLCONS - Total Construction Spending: Total Construction in the United States
• RRVRUSQ156N - Rental Vacancy Rate in the United States
• TOTALSL - Total Consumer Credit Owned and Securitized
• REVOLSL - Revolving Consumer Credit Owned and Securitized
• DRCCLACBS - Delinquency Rate on Credit Card Loans, All Commercial Banks
• GDP - Gross Domestic Product
• GPDI - Gross Private Domestic Investment
• GCE - Government Consumption Expenditures and Gross Investment
• PCEC - Personal Consumption Expenditures
• NETEXP - Net Exports of Goods and Services
• GFDEBTN - Federal Debt: Total Public Debt
• GFDEGDQ188S - Federal Debt: Total Public Debt as Percent of Gross Domestic Product
• FYFSD - Federal Surplus or Deficit
• FGRECPT - Federal Government Current Receipts
• FGEXPND - Federal Government: Current Expenditures
• MANEMP - All Employees, Manufacturing
• USCONS - All Employees, Construction
• USTRADE - All Employees, Retail Trade
• USFIRE - All Employees, Financial Activities
• USGOVT - All Employees, Government
• AWHAETP - Average Weekly Hours of All Employees, Total Private
• DGORDER - Manufacturers' New Orders: Durable Goods
• NEWORDER - Manufacturers' New Orders: Nondefense Capital Goods Excluding Aircraft
• BUSINV - Total Business Inventories
• EXPGS - Exports of Goods and Services
• IMPGS - Imports of Goods and Services
• IR - Import Price Index (End Use): All Commodities
• PPIFIS - Producer Price Index by Commodity: Final Demand

Latest quarter (10-Q)

Latest 10-Q source: 0001193125-26-212016.

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary. Confidence: high. Filing date: 2026-05-07. Report date: 2026-03-31.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report. The following discussion contains forward-looking statements that are based upon current expectations that involve risks, uncertainties and assumptions. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors, including those discussed under “Risk Factors” and elsewhere in this Quarterly Report. Please also see the section titled “Cautionary Note Regarding Forward-Looking Statements.” All brand names or trademarks appearing in this report are the property of their respective holders.

Overview

We are a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. The discovery of biologics that can modulate GPCRs has historically been quite challenging. We have developed a proprietary technology platform called GEODe™, with the aim of addressing these challenges to enable the discovery and development of GPCR-targeted biologic medicines that can modify the course of disease. We focus on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life or extend duration of life.

Our lead product candidates are TX45, an Fc-relaxin fusion molecule that activates the RXFP1 receptor, the GPCR target of the hormone relaxin, and TX2100, a VHH-Fc fusion antagonist antibody that binds to APJ, the receptor for apelin (“APLNR”).

The ongoing APEX Phase 2 clinical trial is a global, 24-week, placebo-controlled trial designed to evaluate the safety and efficacy of TX45 administered subcutaneously (“SC”) in subjects with Pulmonary Hypertension (“PH”) in Heart Failure with Preserved Ejection Fraction (“HFpEF”), known as PH-HFpEF, enriched for combined pre- and post-capillary pulmonary hypertension (“CpcPH”). We dosed our first subject in the APEX Phase 2 clinical trial in October 2024. Subjects are being randomized to 300 mg SC (2 ml injection) once monthly of TX45, 300 mg SC once every other week of TX45, or placebo. Change from baseline in PVR in the PVR3 population is the primary endpoint of the trial. The trial is designed to enrich for patients with a PVR3 aiming for 70% of patients enrolled. In January 2026, the Independent Data Monitoring Committee (“IDMC”) met to review unblinded data from the TX45 APEX Phase 2 clinical trial. The data included safety data (adverse experiences, vital signs, plasma volume and labs) as well as efficacy data (right heart catheterization and six-minute walk distance). Based on this review the IDMC concluded that the trial could continue without any modifications. We expect topline results from the APEX clinical trial late in the fourth quarter of 2026 or early in the first quarter 2027.

In March 2026, the first patient was screened in the 16-week, open label, repeat dose, Phase 2 clinical trial to evaluate TX45’s safety and hemodynamic effects in up to 25 subjects with PH associated with Interstitial Lung Disease (“ILD”), known as PH-ILD (Group 3 PH). PH-ILD is an orphan disease with limited treatment options and a high mortality rate. We believe TX45’s mechanism is well suited to PH-ILD’s disease pathophysiology because of its pulmonary vasodilation, anti-inflammatory, beneficial remodeling and anti-fibrotic activity. In patients with PH-ILD, elevation in PVR and mean pulmonary arterial pressure (“mPAP”) has been associated with increased mortality. In the Phase 1b trial in both CpcPH-HFpEF and CpcPH-HFrEF, TX45 resulted in significant reductions in mPAP and PVR as well as improvements in other hemodynamic endpoints. The TX45 PH-ILD Phase 2 trial will initiate at a dose of TX45 300 mg every four weeks administered SC with a primary efficacy endpoint of change from baseline in PVR at Week 16.

Our second lead product candidate, TX2100, is being evaluated for the treatment of Hereditary Hemorrhagic Telangiectasia (“HHT”), the second most common genetic bleeding disorder with no approved therapy. TX2100 is a VHH-Fc fusion antagonist antibody that binds to APJ (also known as the apelin receptor; APLNR), a GPCR that mediates signaling by the pro-angiogenic peptide hormone apelin. A rodent surrogate of TX2100 demonstrated reductions in arteriovenous malformation (“AVM”) formation, bleeding, and anemia across the neonatal anti-BMP9/10 immunoblocked model and the more severe, adult inducible ALK1 knockout mouse model of HHT, supporting disease-modifying activity through APJ antagonism. TX2100 was further evaluated in non-human primates in IND-enabling GLP toxicology studies, including a 13-week repeat-dose study. In these studies, TX2100 was well tolerated at doses up to 100 mg/kg/week, with no treatment-related or target-related toxicities identified and no effects observed on cardiovascular, respiratory, neurological, renal, metabolic, or hematologic parameters. A formulation supporting subcutaneous dosing has been established, and drug substance and drug product manufacturing under Good Manufacturing Practice (“GMP”) have been completed to support initiation of a Phase 1a clinical trial. In February 2026, we randomized the first subject in the Phase 1a healthy volunteer clinical trial for TX2100. As of April 2026, four cohorts of healthy volunteers have been dosed. We expect to report topline results from the ongoing Phase 1a trial of TX2100 in healthy volunteers by the end of the third quarter of 2026. Assuming acceptable PK in the Phase 1a trial, a Phase 1b clinical trial to explore the safety and efficacy (hematological support, anemia, and epistaxis) of TX2100 in patients with hematologic-support dependent HHT and a Phase 2 clinical trial in patients with moderate to severe HHT are planned in early 2027.

Components of Our Results of Operations

Revenue

We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the

16

foreseeable future, if at all. If our development efforts for our product candidates are successful and result in regulatory approval, or if we enter collaboration or license agreements with third parties, we may generate revenue in the future from product sales or payments from collaboration or license agreements, or any combination thereof. We cannot predict if, when or to what extent we will generate revenue from the commercialization and sale of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates.

Operating Expenses

Research and Development Expenses

Research and development expenses consist of costs incurred in connection with our research activities, including discovery efforts and the preclinical and clinical development of our programs, product candidates, and platform. These expenses include:

•
employee-related expenses, including salaries, bonuses, benefits and stock-based compensation, for employees engaged in research and development functions;

•
expenses incurred in connection with research and the preclinical and clinical development of our programs and our product candidates, including fees paid to contract research organizations (“CROs”);

•
costs related to manufacturing materials for our preclinical studies and clinical trials, including fees paid to contract development and manufacturing organizations (“CDMOs”);

•
laboratory supplies, consumables and other research materials;

•
facilities, depreciation, and other expenses related to research and development activities, which include direct or allocated expenses for rent, utilities, and facility maintenance;

•
costs related to compliance with regulatory requirements; and

•
payments made under third-party licensing agreements.

We expense all research and development costs as incurred. Costs for certain development activities are recognized based on our evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and third-party service providers. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense when the goods have been delivered or the services have been performed, or when it is no longer expected that the goods will be delivered or the services rendered.

Upfront payments under license agreements are expensed upon receipt of the license. Annual maintenance fees under license agreements are expensed in the period in which they are incurred. Milestone payments under license or collaboration agreements are accrued, with a corresponding expense being recognized, in the period in which the milestone is determined to be probable of achievement and the related amount is reasonably estimable.

Costs that are deployed across multiple programs or platform activities and not directly attributable to any single program are recorded as platform development and unallocated research and development expenses, which include multi-program employee-related costs, cross-program licensing payments, laboratory supplies and related expenses, contract research, manufacturing and consulting services, facility-related and other expenses, including depreciation, and discovery efforts.

Research and development activities are central to our business. Later-stage clinical programs generally incur higher costs than early-stage programs due to the increased size and duration of trials. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We will continue to evaluate which product candidates to pursue and the allocation of funding based on preclinical and clinical results, regulatory developments, and commercial potential. We expect our research and development expenses to increase significantly as we advance our product candidates through clinical development and initiate additional clinical trials. Our future expenses may vary significantly each period based on factors such as:

•
expenses incurred to conduct preclinical studies required to advance our product candidates into clinical development;

•
per patient trial costs, based on the number of doses that patients receive;

•
the number of patients who enroll in each trial;

•
the number of trials required for approval;

•
the number of sites included in the trials;

•
the countries in which the trials are conducted;

•
the length of time required to enroll eligible patients;

17

•
the drop-out or discontinuation rates of patients;

•
potential additional safety monitoring requested by regulatory agencies;

•
the duration of patient participation in the trials and follow-up;

•
the phase of development of the product candidate;

•
third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

•
the ability to manufacture our product candidates;

•
regulators or institutional review boards requiring that we or our investigators suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; and

•
the efficacy an

[Excerpt truncated for page length; source filing is linked above.]

Latest 10-K MD&A

Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary. Confidence: high. Filing date: 2026-02-26. Report date: 2025-12-31.

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and related notes included elsewhere in this Annual Report on Form 10-K. The following discussion contains forward-looking statements that are based upon current expectations that involve risks, uncertainties and assumptions. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors, including those discussed under “Risk Factors” and elsewhere in this Annual Report on Form 10-K. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”

Unless otherwise indicated or the context otherwise requires, references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section to the Company, “we,” “us,” and “our” refer to the business and operations of Tectonic Operating Company, Inc. (previously Tectonic Therapeutic, Inc., referred to as “Legacy Tectonic”) and its consolidated subsibdiaries prior to the Merger, and the business and operations of Tectonic Therapeutic, Inc. (previously AVROBIO, Inc., referred to as “AVROBIO”) and its consolidated subsidiaries following the Merger.

Overview

We are a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. The discovery of biologics that can modulate GPCRs has historically been quite challenging. We have developed a proprietary technology platform called GEODe™, with the aim of addressing these challenges to enable the discovery and development of GPCR-targeted biologic medicines that can modify the course of disease. We focus on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life or extend duration of life.

Our lead product candidates are TX45, an Fc-relaxin fusion molecule that activates the RXFP1 receptor, the GPCR target of the hormone relaxin, and TX2100, a VHH-Fc fusion antagonist antibody that binds to the APJ receptor (“APLNR”).

In September 2024, we announced favorable results from a Phase 1a clinical trial evaluating safety, tolerability and pharmacokinetic (“PK”) and pharmacodynamic (“PD”) properties for TX45. In this clinical trial, TX45 was well-tolerated with no drug-related severe adverse events, no observed immunogenicity and demonstrated a favorable PK/PD relationship. Renal plasma flow was measured in each patient at several time points as a PD marker. This data was used to develop an exposure-response model which enabled the selection of doses for the APEX Phase 2 clinical trial.

In May 2025, we announced the complete results from Part A of the Phase 1b hemodynamic clinical trial of TX45 in subjects with Group 2 Pulmonary Hypertension (“PH”) in Heart Failure with Preserved Ejection Fraction (“HFpEF”), known as PH-HFpEF. Part A of the TX45 Phase 1b clinical trial was a single dose IV, open-label clinical trial evaluating the safety, tolerability and hemodynamic effects of TX45 over an 8-hour period in subjects with PH-HFpEF. The complete data from Part A confirmed the tolerability and hemodynamic effects of TX45 in subjects with PH-HFpEF previously reported in the interim data in January 2025. Based on the complete dataset, TX45 was well-tolerated in subjects with PH-HFpEF with no serious or severe adverse events. In the overall study population of the complete dataset, TX45 achieved a 19.0% reduction in pulmonary capillary wedge pressure (“PCWP”), an endpoint reported to correlate with exercise capacity, morbidity and mortality in patients with heart failure, and an 18.5% improvement in cardiac output. In the subpopulation with combined pre- and post-capillary pulmonary hypertension (“CpcPH”) who have an elevated Pulmonary Vascular Resistance (“PVR”) and more severe disease, TX45 demonstrated 30% reduction in PVR, which along with PCWP is correlated to exercise capacity and mortality in this patient population.

In October 2025, we announced the topline results from Part B of the Phase 1b hemodynamic clinical trial of TX45 in subjects with Group 2 PH in Heart Failure with Reduced Ejection Fraction (“PH-HFrEF”). Part B of the TX45 Phase 1b clinical trial had a similar design as the Phase 1b Part A, assessing hemodynamic effects of TX45 but was conducted in subjects with PH-HFrEF. Based on the topline results, TX45 was well-tolerated in subjects with PH-HFrEF with no serious or severe adverse events. In the overall study population, TX45 achieved a 29.2% reduction in PCWP, an endpoint reported to correlate with exercise capacity, morbidity and mortality in patients with heart failure, and a 17.3% improvement in cardiac output. In the subpopulation with CpcPH who have an elevated PVR and more severe disease, TX45 demonstrated a 19.7% reduction in PVR in patients with a PVR equal to or greater than 3 Wood Units and a 10.3% reduction in PVR in patients with a PVR equal to or greater than 2 Wood Units. PVR along with PCWP is correlated to exercise capacity and mortality in this patient population.

The ongoing APEX Phase 2 clinical trial is a global, 24-week, placebo-controlled trial designed to evaluate the safety and efficacy of TX45 administered subcutaneously (“SC”) in subjects with PH-HFpEF, enriched for CpcPH. We dosed our first subject in the APEX Phase 2 clinical trial in October 2024. Subjects are being randomized to 300 mg SC (2 ml injection) once monthly of TX45, 300 mg SC once every other week of TX45, or placebo. Change from baseline in PVR in the PVR3 population is the primary endpoint of the trial. The trial is designed to enrich patients with a PVR3 aiming for 70% of patients enrolled. We expect topline results from the APEX clinical trial in 2026.

77

In February 2026, the first site was activated and opened for screening in the 16-week, open label, repeat dose, Phase 2 clinical trial to evaluate TX45’s safety and hemodynamic effects in up to 25 subjects with PH associated with Interstitial Lung Disease (“ILD”), known as PH-ILD (Group 3 PH). PH-ILD is an orphan disease with limited treatment options and a high mortality rate. We believe TX45’s mechanism is well suited to PH-ILD’s disease pathophysiology because of its pulmonary vasodilation, anti-inflammatory, remodeling and anti-fibrotic activity. In patients with PH-ILD, elevation in PVR and mean pulmonary arterial pressure (“mPAP”) has been associated with increased mortality. In the Phase 1b trial in both CpcPH-HFpEF and CpcPH-HFrEF, TX45 resulted in significant reductions in mPAP and PVR as well as improvements in other hemodynamic endpoints. The TX45 PH-ILD Phase 2 trial will initiate at a dose of TX45 300 mg every four weeks administered SC with a primary efficacy endpoint of change from baseline in PVR at Week 16.

Our lead product candidate, TX2100, is being evaluated for the treatment of Hereditary Hemorrhagic Telangiectasia (“HHT”), the second most common genetic bleeding disorder with no approved therapy. TX2100 is a VHH-Fc fusion antagonist antibody that binds to APJ (also known as the apelin receptor; APLNR), a GPCR that mediates signaling by the pro-angiogenic peptide hormone apelin. A rodent surrogate of TX2100 demonstrated reductions in arteriovenous malformation (“AVM”) formation, bleeding, and anemia across the neonatal anti-BMP9/10 immunoblocked model and the more severe, adult inducible ALK1 knockout mouse model of HHT, supporting disease-modifying activity through APJ antagonism. TX2100 was further evaluated in non-human primates in IND-enabling GLP toxicology studies, including a 13-week repeat-dose study. In these studies, TX2100 was well tolerated at doses up to 100 mg/kg/week, with no treatment-related or target-related toxicities identified and no effects observed on cardiovascular, respiratory, neurological, renal, metabolic, or hematologic parameters. A formulation supporting subcutaneous dosing has been established, and drug substance and drug product manufacturing under Good Manufacturing Practice (“GMP”) have been completed to support initiation of a Phase 1a clinical trial. In February 2026, we randomized the first subject in the Phase 1a healthy volunteer clinical trial for TX2100. We are also planning a Phase 1b clinical trial to explore the safety and efficacy (epistaxis, anemia, and hematological support) of TX2100 in patients with severe HHT. In addition, subject to positive Phase 1a results, we plan to initiate a Phase 2 clinical trial for TX2100 in early 2027.

Private Placement

In February 2025, we entered into a securities purchase agreement (the “Private Placement”) pursuant to which we issued an aggregate of 3,689,465 shares of common stock, at a price of $50.00 per share to institutional accredited investors and $54.14 per share to individual accredited investors that are either an officer or director of the Company. The net proceeds from the Private Placement were approximately $173.1 million.

Merger with AVROBIO

On June 20, 2024, we completed our previously announced merger transaction in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of January 30, 2024 (the “Merger Agreement”) with AVROBIO, Inc. (“AVROBIO”), pursuant to which Alpine Merger Subsidiary, Inc., a wholly owned subsidiary of AVROBIO, merged with and into the entity formerly known as Tectonic Therapeutic, Inc., now known as Tectonic Operating Company, Inc. (“Legacy Tectonic”), with Legacy Tectonic continuing as a wholly owned subsidiary of the surviving corporation of AVROBIO (the “Merger”).

Components of our Results of Operations

Revenue

We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the foreseeable future, if at all. If our development efforts for our product candidates are successful and result in regulatory approval, or if we enter collaboration or license agreements with third parties, we may generate revenue in the future from product sales or payments from collaboration or license agreements, or any combination thereof. We cannot predict if, when or to what extent we will generate revenue from the commercialization and sale of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates.

Operating Expenses

Research and Development Expenses

Research and development expenses consist of costs incurred in connection with our research activities, including discovery efforts and the preclinical and clinical development of our programs, product candidates, and platform. These expenses include:

•
employee-related expenses, including salaries, bonuses, benefits and stock-based compensation, for employees engaged in research and development functions;

•
expenses incurred in connection with research and the preclinical and clinical development of our programs and our product candidates, including fees paid to contract research organizations (“CROs”);

78

•
costs related to manufacturing materials for our preclinical studies and clinical trials, including fees paid to contract development and manufacturing organizations (“CDMOs”);

•
laboratory supplies, consumables and other research materials;

•
facilities, depreciation, and other expenses related to research and development activities, which include direct or allocated expenses for rent, utilities, and facility maintenance;

•
costs related to compliance with regulatory requirements; and

•
payments made under third-party licensing agreements.

We expense all research and development costs as incurred. Costs for certain development activities are recognized based on our evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and third-party service providers. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense when the goods have been delivered or the services have been performed, or when it is no longer expected that the goods will be delivered or the services rendered.

Upfront payments under license agreements are expensed upon receipt of the license. Annual maintenance fees under license agreements are expensed in the period in which they are incurred. Milestone payments under license or collaboration agreements are accrued, with a corresponding expense being recognized, in the period in which the milestone is determined to be probable of achievement and the related amount is reasonably estimable.

Costs that are deployed across multiple programs or platform activities and not directly attributable to any single program are recorded as platform development and unallocated research and development expenses, which include multi-program employee-related costs, cross-program licensing payments, laboratory supplies and related expenses, contract research, manufacturing and consulting services, facility-related and other expenses, including depreciation, and discovery efforts.

Research and development activities are central to our business. Later-stage clinical programs generally incur higher costs than early-stage programs due to the increased size and duration of trials. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We will continue to evaluate which product candidates to pursue and the allocation of funding based on preclinical and clinical results, regulatory developments, and commercial potential. We expect our research and development expenses to increase significantly as we advance our product candidates through clinical development and initiate additional clinical trials. Our future expenses may vary significantly each period based on factors such as:

•
expenses incurred to conduct preclinical studies required to advance our product candidates into clinical development;

•
per patient trial costs, based on the number of doses that patients receive;

•
the number of patients who enroll in each trial;

•
the number of trials required for approval;

•
the number of sites included in the trials;

•
the countries in which the trials are conducted;

•
the length of time required to enroll eligible patients;

•
the drop-out or discontinuation rates of patients;

•
potential additional safety monitoring requested by regulatory agencies;

•
the duration of patient participation in the trials and follow-up;

•
the phase of development of the product candidate;

•
third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

•
the ability to manufacture our product candidates;

79

•
regulators or institutional review boards requiring that we or our investigators suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; and

•
the efficacy and safety profile of our product candidates.

General and Administrative Expenses

General and administrative expenses consist primarily of employee-related costs, including salaries, bonuses, benefits and stock-based compensation, for our personnel in executive, finance and information technology, and other administrative functions. General and administrative expenses also include professional fees for legal, accounting, and consulting services, insurance costs, facilities and information technology expenses, investor relations and public company compliance costs, and other general corporate overhead. As a clinical-stage company, our general and administrative expenses are driven in part by the costs required to support our research and development activities and to operate as a public company.

Other Income (Expense)

Interest Income

Interest income primarily consists of interest earned on money market funds, which are included in cash and cash equivalents on the Consolidated Balance Sheet.

Loss on Issuance of SAFE Liabilities and Change in Fair Value of SAFE Liabilities

In October and December 2023, Legacy Tectonic issued SAFEs for proceeds of $34.1 million. The SAFEs were recorded as liabilities in the Consolidated Balance Sheets at their fair value on the issuance dates. Until redemption on June 20, 2024, the SAFEs were measured at a fair value on a recurring basis, with subsequent changes in fair value recorded in other income and expenses on the Consolidated Statement of Operations and Comprehensive Loss.

Income Tax Expense

During the year ended December 31, 2025, we recorded income tax expense of approximately $1.2 million related to the dissolution of our wholly owned Australian subsidiary, Tectonic Therapeutic Pty Ltd. This entity is being dissolved as part of a broader corporate initiative intended to streamline operations and reduce administrative costs. The dissolution triggered a taxable event under Australian tax law due to the deemed disposition of certain assets at fair market value. As a result, we recognized a tax liability based on the difference between the carrying amount of these assets for financial reporting purposes and their tax basis. The dissolution does not have a significant impact on our effective tax rate for the period, but it did result in a discrete item within the period. We do not expect material ongoing tax consequences from this dissolution.

Results of Operations

Comparison of the Years Ended December 31, 2025 and 2024

The following tables summarize our results of operations for the years ended December 31, 2025 and 2024 (in thousands, except percentages):

Year Ended December 31,

2025

2024

$ Change

% Change

Operating expenses:

Research and development

$

63,489

$

41,364

$

22,125

53

%

General and administrative

20,547

16,651

3,896

23

%

Total operating expenses

84,036

58,015

26,021

45

%

Loss from operations

(84,036

)

(58,015

)

(26,021

)

45

%

Other income (expense):

Interest income

11,297

4,261

7,036

165

%

Interest expense

(63

)

(107

)

44

(41

%)

Change in fair value of the SAFE liabilities

—

(3,610

)

3,610

(100

%)

Other expense

(119

)

(511

)

392

(77

%)

Total other income, net

11,115

33

11,082

33,582

%

Loss before income tax

(72,921

)

(57,982

)

(14,939

)

26

%

Income tax expense

(1,230

)

—

(1,230

)

100

%

Net loss

$

(74,151

)

$

(57,982

)

$

(16,169

)

28

%

80

Research and Development Expenses

Year Ended December 31,

2025

2024

$ Change

% Change

Direct research and development expenses by program:

TX45

$

24,327

$

15,324

$

9,003

59

%

TX2100

12,494

4,417

8,077

183

%

Platform development and unallocated expenses:

Employee-related expenses, including stock-based compensation

17,455

12,317

5,138

42

%

Contract research, manufacturing and consulting services

1,163

1,159

4

0

%

Laboratory supplies and related expenses

3,274

3,653

(379

)

(10

%)

Facility related and other expenses, including depreciation

4,776

4,494

282

6

%

Total platform development and unallocated expenses

26,668

21,623

5,045

23

%

Total research and development expenses

$

63,489

$

41,364

$

22,125

53

%

Total research and development expenses increased by $22.1 million for the year ended December 31, 2025 compared to the year ended December 31, 2024.

Direct research and development program expenses increased primarily due to advancement of our preclinical and clinical programs. TX45 expenses increased by $9.0 million, primarily attributable to CRO costs related to the ongoing Phase 2 clinical trial. TX2100 expenses increased by $8.1 million, as the program progressed further through discovery and development.

Platform development and unallocated expenses increased by $5.0 million, primarily driven by higher employee-related expenses. The increase in employee-related expenses was primarily due to an increase in stock-based compensation expense related to the ongoing issuance of equity awards and increase in the weighted-average fair value of the awards granted. In addition, we expanded our research and development team to support our programs, resulting in higher payroll and related costs.

General and Administrative Expenses

Year Ended December 31,

2025

2024

$ Change

% Change

Employee-related expenses, including stock-based compensation

$

11,550

$

7,862

$

3,688

47

%

Professional and consulting expenses

7,371

7,009

362

5

%

 Facility related and other expenses, including depreciation

1,626

1,780

(154

)

(9

%)

Total general and administrative expenses

$

20,547

$

16,651

$

3,896

23

%

General and administrative expenses increased by $3.9 million for the year ended December 31, 2025 compared to the year ended December 31, 2024, primarily due to higher employee-related expenses, including stock-based compensation, which increased by $3.7 million. The increase in stock-based compensation expense was primarily attributable to the ongoing issuance of equity awards and increase in the weighted-average fair value of the awards granted.

We anticipate that our general and administrative expenses will continue to increase in the future as we continue to invest in infrastructure and personnel to support the advancement of our clinical programs and operation as a public company. We also expect to incur additional intellectual property-related expenses as we file patent applications to protect innovations arising from our research and development activities.

Other Income (Expense)

Interest Income

Interest income increased by $7.0 million for the year ended December 31, 2025 compared to the year ended December 31, 2024 primarily due to an increase in cash and cash equivalents as a result of the Merger and Private Placement.

Change in Fair Value of SAFE Liabilities

The SAFE liabilities loss of $3.6 million resulted from the remeasurement of the SAFE liabilities to fair value during the year ended December 31, 2024.

81

Income Tax Expense

Income tax expense of approximately $1.2 million was recorded during the year ended December 31, 2025, related to the dissolution of Tectonic Therapeutic Pty Ltd.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical and clinical development of our research programs and product candidates. We expect that our research and development and general and administrative costs will increase in connection with conducting additional preclinical studies and clinical trials for our current and future research programs and product candidates, contracting with CROs and CDMOs to support preclinical studies and clinical trials, expanding our intellectual property portfolio, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements or other sources.

We do not currently have any approved products and have never generated any revenue from product sales. We have funded our operations primarily through the sale and issuance of common stock, convertible equity instruments, and the Merger. In February 2025, we sold shares of our common stock under the Private Placement in exchange for net proceeds of approximately $173.1 million. We currently have an effective shelf registration statement on Form S-3 filed with the SEC, which we may use to offer from time to time any combination of common stock, preferred stock, debt securities, and warrants up to an aggregate amount of $400 million. Of this amount, we have the ability to sell up to $100 million of additional shares of our common stock to the public through an at the market offering (“ATM”). During the year ended December 31, 2025, we did not sell any shares under the ATM program. As of December 31, 2025, the full $100 million remained available for issuance under the ATM program.

As of December 31, 2025, we had $253.8 million in cash and cash equivalents and an accumulated deficit of $222.7 million. Based on our current business plans, management believes that our cash, cash equivalents and marketable securities on hand at December 31, 2025 are sufficient to meet our operating requirements for at least the next 12 months from the issuance of the consolidated financial statements included in this Annual Report on Form 10-K. However, our estimates are based on assumptions that may prove to be incorrect, and we could exhaust our capital resources sooner than expected. We may require additional funding to support our research programs, clinical development, and general operations. There can be no assurance that additional financing, whether through public or private equity, debt, collaborations, or licensing arrangements, will be available on acceptable terms, or at all.

Cash Flows

The following table shows a summary of our cash flows for the years ended December 31, 2025 and 2024:

Year Ended December 31,

2025

2024

Net cash used in operating activities

$

(60,078

)

$

(59,080

)

Net cash used in investing activities

(138

)

(156

)

Net cash provided by financing activities

173,355

171,714

Effect of exchange rate changes on cash and cash equivalents

(95

)

(8

)

Net increase in cash, cash equivalents and restricted cash

$

113,044

$

112,470

Operating Activities

Net cash used in operating activities was $60.1 million for the year ended December 31, 2025. Cash used in operations was primarily used to fund our operations in developing our product candidates, resulting in a net loss of $74.2 million, partially offset by non-cash charges of $14.1 million. Changes in operating assets and liabilities, including the timing of vendor payments and lease repayments, had a minimal net effect of $0.1 million on cash used in operating activities.

Net cash used in operating activities was $59.1 million for the year ended December 31, 2024. Cash used in operating activities was primarily used to fund our operations to develop our product candidates resulting in a net loss of $58.0 million and $10.3 million of changes in operating assets and liabilities related to accrued expenses, timing of vendor payments and lease repayments offset by non-cash charges of $9.2 million.

82

Investing Activities

Net cash used in investing activities during the year ended December 31, 2025 and 2024 was nominal and related to the purchase and sale of property and equipment.

Financing Activities

Net cash provided by financing activities was $173.4 million for the year ended December 31, 2025, primarily due to net proceeds of $173.1 million from the sale of shares pursuant to the Private Placement and $1.2 million in proceeds from the exercise of stock options.

Net cash provided by financing activities was $171.7 million for the year ended December 31, 2024, primarily due to net proceeds of $94.6 million from the sale of shares pursuant to the Subscription Agreement, $76.0 million of net cash acquired in connection with the Merger, and $1.6 million in proceeds from the exercise of stock options.

Funding Requirements

We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue or initiate clinical trials of, and seek marketing approval for, our product candidates including our lead product candidates TX45 and TX2100. In addition, if we obtain marketing approval for TX45, TX2100 or any of our other product candidates, we expect to incur significant commercialization expenses related to program sales, marketing, manufacturing and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Furthermore, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

We expect our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least the next twelve months. Our future capital requirements will depend on many factors, including:

•
the scope, progress, results and costs of product discovery, preclinical studies and clinical trials;

•
the scope, prioritization and number of our research and development programs;

•
the costs, timing and outcome of regulatory review of our product candidate;

•
our ability to access sufficient additional capital on a timely basis and on favorable terms;

•
the costs and timing of process development and manufacturing scale-up activities associated with our product candidates and other programs as we advance them through preclinical and clinical development;

•
our ability to establish and maintain collaborations on favorable terms, if at all;

•
the achievement of milestones or occurrence of other developments that trigger payments under the license agreements and any other collaboration agreements we enter into;

•
the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under collaboration agreements, if any;

•
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

•
the extent to which we acquire or in-license other product candidates and technologies;

•
the costs of securing manufacturing arrangements for commercial production;

•
the costs of operating as a publicly traded company;

•
the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our product candidates; and

•
the macroeconomic environment, including inflation and interest rates.

Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of product candidates that we do not expect to be commercially available for many years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. Until such time, if

83

ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

We expect to incur additional costs associated with operating as a public company. In addition, we anticipate that we will need substantial additional funding in connection with our continuing operations. Our projections of operating capital requirements are based on our current operating plan, which includes several assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect.

We currently have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years.

Contractual Obligations & Commitments

We have entered into license agreements under which we are obligated to make specified milestone and royalty payments. The payment obligations under these agreements are contingent upon future events, such as our achievement of specified development, regulatory, and sales milestones, or generating product sales. Generally, the timing or likelihood of achieving these milestones or generating future product sales are not determinable. For further details regarding our significant contracts, and the commitments and contractual obligations contained within each contract, please refer to Note 11, License Agreements, and Note 12, Commitments and Contingencies, and to our consolidated financial statements included in this Annual Report on Form 10-K, which is incorporated herein by reference.

We have lease obligations for certain laboratory equipment and office and laboratory space under non-cancelable operating and finance leases. In September 2025, we entered into a non-cancelable operating lease for office and laboratory space in Watertown, Massachusetts. As of December 31, 2025, this lease had not commenced; accordingly, no right-of-use asset or lease liability has been recorded on the Consolidated Balance Sheet. The lease will be recognized upon commencement in January 2026, at which time a right-of-use asset and corresponding lease liability will be recorded based on the present value of lease payments over the lease term.

The leases, including the Watertown lease, expire at various times through 2029. Minimum lease payments under these agreements are $2.5 million in 2026, $1.9 million in 2027, $2.0 million in 2028, and $0.2 million in 2029. These amounts reflect enforceable obligations under non-cancelable contracts and do not include commitments that can be terminated without significant penalty.

In addition, we enter into agreements in the normal course of business with vendors for preclinical research studies, clinical trials and other services and products for operating purposes. These contracts do not contain any minimum purchase commitments and are generally cancelable upon written notice. Payments due upon cancellation consist only of payments for services provided and expenses incurred up to the date of cancellation.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). The preparation of the consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities in our consolidated financial statements and the reported amounts of expenses during the reporting periods. We base our estimates on historical experience, known trends and events, and various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities and recorded expenses that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Actual results may differ from these estimates.

While our significant accounting policies are described in Note 2, Summary of Significant Accounting Policies and Basis of Presentation, to our financial statements included elsewhere in this Annual Report, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

84

Research and Development Expenses

As part of the process of preparing our consolidated financial statements, we are required to estimate our research and development expenses, primarily related to services performed by third parties such as CROs and CDMOs. This process involves estimating the level of service performed and the associated cost incurred for the services when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make judgments and estimates of our research and development expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time, which includes corroboration of these estimates with the service providers. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust accrued expenses or prepaid expenses accordingly, which impact research and development expenses. Changes in these estimates that result in material changes to our accrued costs could materially affect our results of operations. To date, we have not experienced any material adjustments to our prior estimates of prepaid and accrued research and development expenses.

Stock-Based Compensation Expense

We recognize stock-based compensation expense for employee and non-employee equity awards, including stock options and restricted stock units, over the requisite service period in accordance with ASC 718. Stock options are measured at fair value on the grant date using the Black-Scholes option pricing model, which requires assumptions regarding expected volatility, expected term, risk-free interest rates, and expected dividend yield. The grant date fair value of our common stock is based on the closing quoted market price of our common stock as reported by the NASDAQ Global Market on the date of grant. Stock-based compensation is recorded in either research and development expense or general and administrative expenses depending on the roles of the recipients.

Recent Accounting Pronouncements

Recent accounting pronouncements are addressed in Note 2, Summary of Significant Accounting Policies and Basis of Presentation, in the Notes to the Consolidated Financial Statements included herein.

Smaller Reporting Company Status

We are a “smaller reporting company” as defined in the Exchange Act. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as the market value of the common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of the common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

As a result, the information in this Annual Report on Form 10-K and that we provide to our investors in the future may be different than what you might receive from other public reporting companies.