Tectonic Therapeutic (NasdaqGM:TECX) Update / briefing February 24, 2026 11:00 AM ET Company ParticipantsAlex Nackenoff - Biotechnology Equity Research AssociateAlise Reicin - President and CEODavid Risinger - Senior Managing DirectorGaurav Maini - VP of Biotech Equity ResearchHanny Al-Samkari - Associate Professor of MedicineMarcie Ruddy - Chief Medical OfficerMartin Auster - Managing DirectorPeter McNamara - Chief Scientific OfficerConference Call ParticipantsBen Burnett - AnalystLeland Gershell - Managin ...

WATERTOWN, Mass., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced it has appointed François Nader, M.D., MBA, as an independent director to its Board of Directors, effective April 1, 2026, at which time he will also assume the role of Chair of the Board. Dr. Nader bri ...

Core Insights - Tectonic Therapeutic, Inc. is hosting a virtual key opinion leader event to discuss TX2100, a GPCR antagonist aimed at treating Hereditary Hemorrhagic Telangiectasia (HHT) [1][2] Company Overview - Tectonic Therapeutic is a clinical-stage biotechnology company focused on developing therapeutic proteins and antibodies that modulate GPCR activity [9] - The company utilizes its proprietary GEODe™ technology platform to address challenges in GPCR-targeted drug discovery [9][10] Product Development - TX2100 is a potential first-in-class therapeutic candidate targeting a signaling pathway involved in pathological angiogenesis and arteriovenous malformations (AVMs) associated with HHT [3] - The company plans to initiate a Phase 1a clinical trial of TX2100 in healthy volunteers in Q1 2026 [3] Expert Involvement - Dr. Hanny Al-Samkari, an expert in hematology and a key opinion leader, will participate in the event to provide clinical context on HHT and discuss the unmet medical needs in this area [2][5][6] Disease Context - HHT is a rare inherited vascular disorder affecting approximately 75,000 people in the U.S., characterized by fragile blood vessels leading to recurrent bleeding and serious complications [8]

Core Insights - Tectonic Therapeutic, Inc. (NASDAQ:TECX) is recognized as one of the best micro-cap stocks to invest in according to analysts [1] - LifeSci Capital has reiterated a Buy rating on TECX with a price target of $88, indicating strong confidence in the stock's potential [2] Company Overview - Tectonic Therapeutic is a biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G protein-coupled receptors (GPCRs) [2][3] - The company has developed the GEODe technology platform to facilitate the discovery and development of GPCR-targeted biologic medicines [3] Product Pipeline - One of the lead product candidates is TX45, a Fc-relaxin fusion molecule that activates the RXFP1 receptor, which is the GPCR target of the hormone relaxin [3] - Tectonic is also developing TX2100, aimed at treating hereditary hemorrhagic telangiectasia, and other GPCR modulators for treating fibrosis and related conditions [3]

Summary of Tectonic Therapeutic FY Conference Call Company Overview - **Company**: Tectonic Therapeutic (NasdaqGM: TECX) - **Event**: FY Conference on December 02, 2025 Key Industry Insights - **Focus**: The conference highlighted the significance of the APEX study, which is expected to be pivotal for Tectonic in 2026, marking the beginning of a critical two-year period for the company [1][2] Core Points and Arguments 1. **Enrollment Progress**: - Tectonic met its mid-year recruitment objectives and is on track to meet its end-of-year recruitment goal. As of November, recruitment has shifted to patients with a pulmonary vascular resistance (PVR) greater than three [4][5] - 70% of the total patient population falls within the PVR greater than three category [11][13] 2. **Data Safety Monitoring**: - The last data safety monitoring committee (DSMB) meeting occurred at the end of September, with no safety signals reported. Continuous monitoring is in place [5][6] 3. **Patient Population and Study Design**: - The study is enriched for patients with chronic stable heart failure and high PVR, aiming to improve outcomes in this specific group [30][34] - The primary endpoint focuses on PVR reduction, with a previous phase 1b study showing a 30% decrease in PVR [23][24] 4. **Comparison with Competitors**: - Tectonic's TX45 is differentiated from competitors like AstraZeneca and Lilly based on patient selection and study design. Tectonic's study focuses on a more homogeneous population with specific PVR criteria [30][37] - The mechanism of action for TX45 includes vasodilation and potential antifibrotic effects, which may provide advantages over competitors [39][41] 5. **Future Development Plans**: - Tectonic is considering various options for future studies in heart failure with preserved ejection fraction (HFpEF), including standalone phase 2 or phase 2/3 studies [29][30] - The company plans to start a healthy volunteer study for TX2100 in early 2026, focusing on pharmacokinetics and safety [47] Other Important Information - **Financial Position**: Tectonic reported approximately $268 million in cash, providing a runway into the fourth quarter of 2028 [49] - **Market Context**: The discussion emphasized the complexity of the heart failure market, with multiple mechanisms and treatment options available, indicating a significant opportunity for Tectonic's therapies [43][44]

Core Insights - Tectonic Therapeutic, Inc. is a clinical-stage biotechnology company focused on developing therapeutic proteins and antibodies targeting G-protein coupled receptors (GPCRs) [4] Upcoming Conferences - Tectonic management will participate in the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, at 3:30 PM EST in New York, NY, in a fireside chat format [2] - The company will also attend the Evercore 8th Annual Healthcare Conference on December 3, 2025, in Miami, FL, conducting investor meetings [2][3] Company Overview - Tectonic utilizes its proprietary GEODe™ technology platform to enhance GPCR-targeted drug discovery, aiming to develop biologic medicines for areas with significant unmet medical needs [4] - The company is headquartered in Watertown, Massachusetts, and focuses on improving patient quality of life through innovative therapeutic options [4]

Group 1 - The article discusses Tectonic Therapeutic, Inc. (TECX) and its potential expansion of the TX45 candidate following positive interim data [2] - The author, Terry Chrisomalis, has extensive experience in the biotech sector and runs the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies [2] - The Biotech Analysis Central service includes a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2] Group 2 - The article does not provide any specific financial data or performance metrics related to Tectonic Therapeutic, Inc. or the biotech industry [1][3][4]

Clinical Trials and Product Development - TX45 achieved a 19.0% reduction in pulmonary capillary wedge pressure (PCWP) and an 18.5% improvement in cardiac output in subjects with Group 2 Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HFpEF) during the Phase 1b clinical trial[89]. - In the Phase 1b clinical trial for subjects with Heart Failure with Reduced Ejection Fraction (PH-HFrEF), TX45 demonstrated a 29.2% reduction in PCWP and a 17.3% improvement in cardiac output[90]. - The ongoing APEX Phase 2 clinical trial aims to evaluate the safety and efficacy of TX45, with topline results expected in 2026[92]. - TX2100 is being developed for Hereditary Hemorrhagic Telangiectasia (HHT), with plans to initiate a Phase 1 clinical trial in healthy volunteers in Q1 2026[94]. Financial Performance - The company has not generated any revenue since inception and does not expect to do so in the foreseeable future[97]. - Total operating expenses for the three months ended September 30, 2025, increased by $2.25 million (11%) to $21.89 million compared to $19.64 million in 2024[111]. - Research and development expenses for the three months ended September 30, 2025, rose by $2.61 million (18%) to $16.93 million, driven by increased costs related to TX2100 and employee-related expenses[112]. - Total operating expenses for the nine months ended September 30, 2025, increased by $18.5 million (42%) to $62.52 million compared to $44.02 million in 2024[116]. - Research and development expenses for the nine months ended September 30, 2025, increased by $14.94 million (46%) to $47.15 million, mainly due to increased CRO and CDMO costs for clinical trials[117]. - General and administrative expenses for the nine months ended September 30, 2025, rose by $3.56 million (30%) to $15.37 million, driven by higher employee-related expenses and professional fees[118]. - The net loss for the nine months ended September 30, 2025, was $54.9 million, up from a net loss of $45.6 million in 2024, indicating a 20% increase in losses[124][125]. Cash and Financing - In February 2025, the company raised approximately $173.1 million through a private placement of 3,689,465 shares of common stock[95]. - The net proceeds from the Private Placement in February 2025 were approximately $173.1 million[122]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $45.62 million, compared to $42.26 million in 2024[123]. - Cash used in operating activities for the nine months ended September 30, 2025, was $45.6 million, compared to $42.3 million for the same period in 2024, reflecting an increase of 7.8%[124][125]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $173.5 million, slightly higher than $172.8 million in 2024, showing a marginal increase of 0.4%[127][128]. - Existing cash and cash equivalents of $268.4 million as of September 30, 2025, are expected to fund operating expenses and capital expenditures for at least the next twelve months[139]. Operational and Administrative Expenses - Research and development expenses include costs for clinical trials, employee-related expenses, and fees paid to contract research organizations (CROs)[98]. - General and administrative expenses are expected to increase due to costs associated with operating as a public company[106]. - The company recorded a tax expense of approximately $0.9 million related to the dissolution of its Australian subsidiary, Tectonic Therapeutic Pty Ltd[109]. - Interest income for the three months ended September 30, 2025, increased by $0.95 million (49%) to $2.9 million, primarily due to higher cash and cash equivalents[111]. - Interest income for the nine months ended September 30, 2025, surged by $6.21 million (246%) to $8.73 million, attributed to an increase in cash and cash equivalents from the Merger and Private Placement[116]. Future Outlook and Risks - The company expects to incur significant commercialization expenses if marketing approval is obtained for lead product candidates TX45 and TX2100, necessitating substantial additional funding[129]. - The company anticipates ongoing costs associated with operating as a public company and may need to rely on additional financing to achieve business objectives[134]. - The company has no ongoing material financing commitments expected to affect liquidity over the next five years, aside from lease obligations[135]. - Interest rate sensitivity is a primary market risk, with cash and cash equivalents being affected by changes in U.S. interest rates, but a 10% change would not materially impact the investment portfolio[139]. - The company has entered into license agreements with milestone and royalty payment obligations contingent upon future events, which may affect financial commitments[136].

Financial Performance - Tectonic reported a net loss of $19.0 million for Q3 2025, compared to a net loss of $17.7 million in Q3 2024, reflecting an increase in operational expenses[14] - Total operating expenses for Q3 2025 were $21.9 million, compared to $19.6 million in Q3 2024[18] - Net loss per share for Q3 2025 was $1.02, compared to $1.20 in Q3 2024[18] Research and Development - Research and development expenses increased to $16.9 million in Q3 2025 from $14.3 million in Q3 2024, primarily due to the development of TX2100 and increased employee-related costs[14] - Tectonic plans to initiate the TX2100 Phase 1 clinical trial in healthy volunteers in Q1 2026 as a potential treatment for Hereditary Hemorrhagic Telangiectasia[6] - A Phase 2 clinical trial for TX45 in patients with Pulmonary Hypertension associated with Interstitial Lung Disease is planned for 2026, targeting up to 25 patients[7] - The ongoing TX45 APEX Phase 2 clinical trial is over 50% enrolled, with topline results expected in 2026[7] Clinical Trial Results - Positive topline results from Part B of the TX45 Phase 1b clinical trial showed a 29.2% reduction in pulmonary capillary wedge pressure and a 17.3% improvement in cardiac output[4] - TX45 demonstrated a 19.7% reduction in pulmonary vascular resistance in patients with a PVR ≥ 3 Wood Units during the Phase 1b trial[4] Cash and Assets - Cash and cash equivalents were $268.4 million as of September 30, 2025, down from $287.4 million as of June 30, 2025, providing a cash runway into Q4 2028[14] - Cash and cash equivalents increased to $268.435 million as of September 30, 2025, up from $141.239 million on December 31, 2024, representing an increase of 90.1%[20] - Working capital rose to $263.868 million, compared to $135.247 million at the end of 2024, indicating a growth of 95.0%[20] - Total assets grew to $277.001 million, up from $152.905 million, reflecting an increase of 81.3%[20] - Total stockholders' equity increased to $267.528 million, compared to $140.776 million, marking a rise of 90.0%[20]

Core Insights - The conference call focuses on the top line results from Part B of the Phase Ib clinical trial evaluating TX45 for patients with pulmonary hypertension associated with reduced ejection fraction heart failure (PH-HFrEF) [2][3] Group 1: Clinical Trial Overview - The clinical trial involved 14 patients and aimed to assess the safety and tolerability of TX45 in the PH-HFrEF patient population [3] - The trial also sought to explore the hemodynamic effects of TX45, with expectations of observing effects similar to previous studies [3]