Full Press Release Details
Tectonic Therapeutic Announces Second Quarter 2025 Financial Results and
Recent Business Highlights
WATERTOWN, Mass., August 7, 2025 (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 financial results for the second quarter ended June 30, 2025, and provided an overview of recent business highlights.
Today our team is excited to announce PH-ILD as an additional indication for TX45 that we plan to explore in a
Phase 2, proof of concept trial. PH-ILD is a devastating disease with high mortality, significant unmet medical need and limited therapeutic alternatives. TX45 s preclinical and hemodynamic data from Part
A of the Phase 1b trial in Group 2 PH-HFpEF supports expanding into PH-ILD, said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. Additionally, we have completed enrollment in
Part B of our TX45 Phase 1b trial in subjects with PH-HFrEF, with topline results expected in early Q4 2025. In parallel, enrollment continues in our global TX45 APEX Phase 2 trial in PH-HFpEF, with topline results expected in 2026.
Recent Business Highlights
Overview of Financial and Operating Results
About Group 2 Pulmonary Hypertension in
The World Health Organization has defined 5 groups of PH. Tectonic s initial focus has been on the Group 2 subtype, a condition that
develops due to left-sided heart disease, specifically PH-HFpEF. In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly
to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure, which can lead to death. PH-HFpEF is further segmented based on pulmonary hemodynamics into
Isolated post-capillary PH ( IpcPH ) and Combined pre- and post-capillary PH ( CpcPH ). CpcPH is more severe, accounts for about one third to one half of the 1.4 million PH-HFpEF
patients in the U.S. and is characterized by additional, abnormal changes to the pulmonary vasculature, leading to an increase in Pulmonary Vascular Resistance ( PVR ). Although several Group 1 PH (Pulmonary Arterial Hypertension,
PAH ) medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment.
About Group 3 Pulmonary
Hypertension and PH-ILD
The World Health Organization has defined 5 groups of PH. Group 3 is PH due
to chronic lung disease. Tectonic is focused on a Group 3 subtype, called PH-ILD where PH develops in patients who have ILD. ILD is a group of rare conditions causing inflammation and scarring in the lungs. It
is believed that a combination of factors leads to the formation of PH-ILD, including lung fibrosis, chronic hypoxia, vascular remodeling and other factors that lead to worsening exercise capacity. PH-ILD has worse survival than ILD without PH. There are currently two approved treatments for PH-ILD, both of which contain the active ingredient treprostinil administered
via nebulizer or dry powder inhaler.
About TX45, a long-acting Fc-relaxin fusion protein
TX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic
and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased
demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby.
Tectonic Therapeutic is a clinical-stage
biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. Leveraging its proprietary technology platform called
GEODe (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the
human body to modify the course of disease. Tectonic focuses 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
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are forward-looking statements. These statements may be identified by words such as aims,
anticipates, believes, could, estimates, expects, forecasts, goal, intends, may, plans, possible,
potential, seeks, will and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these
words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the design, objectives, initiation, timing, progress and results of current and future preclinical studies and clinical trials of
Tectonic s product candidates, including the ongoing Phase 1b and Phase 2 clinical trials for its lead program, TX45, in Group 2 PH-HFpEF and Group 2 PH-HFrEF and its planned Phase 2 clinical trial for TX45 in
PH-ILD; the Company s planned initiation of a Phase 1 clinical trial for TX2100; and the Company s expected cash runway. These forward-looking statements are based on Tectonic s
expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic s clinical development programs, future results or performance to differ
materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical
trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict
in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on Tectonic s business, clinical trials and financial position; unexpected safety or efficacy data observed during
preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing
competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic s actual results to differ from those
expressed or implied in the forward-looking statements in this press release are identified under the heading Risk Factors in Tectonic s quarterly report on Form 10-Q filed with
the SEC on August 7, 2025, and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein,
whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. For more information, please visit www.tectonictx.com and follow @TectonicTx on X (formerly Twitter)
Tectonic Therapeutic, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 17,185 | $ | 7,074 | $ | 30,221 | $ | 17,892 | ||||||||
| General and administrative | 5,147 | 4,347 | 10,409 | 6,497 | ||||||||||||
| Total operating expenses | 22,332 | 11,421 | 40,630 | 24,389 | ||||||||||||
| Loss from operations | (22,332 | ) | (11,421 | ) | (40,630 | ) | (24,389 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Change in fair value of SAFE liabilities | (1,535 | ) | (3,610 | ) | ||||||||||||
| Interest income | 3,389 | 318 | 5,833 | 574 | ||||||||||||
| Interest expense | (17 | ) | (28 | ) | (37 | ) | (59 | ) | ||||||||
| Other expense | (48 | ) | (5 | ) | (80 | ) | (408 | ) | ||||||||
| Total other income (expense), net | 3,324 | (1,250 | ) | 5,716 | (3,503 | ) | ||||||||||
| Loss before income tax | (19,008 | ) | (12,671 | ) | (34,914 | ) | (27,892 | ) | ||||||||
| Income tax expense | (976 | ) | (976 | ) | ||||||||||||
| Net loss | (19,984 | ) | (12,671 | ) | (35,890 | ) | (27,892 | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Foreign currency translation adjustment | (51 | ) | (8 | ) | (58 | ) | (50 | ) | ||||||||
| Comprehensive loss | $ | (20,035 | ) | $ | (12,679 | ) | $ | (35,948 | ) | $ | (27,942 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.07 | ) | $ | (4.34 | ) | $ | (2.00 | ) | $ | (12.97 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 18,680,042 | 2,919,872 | 17,923,056 | 2,150,160 |
Tectonic Therapeutic, Inc.
Select Condensed Consolidated Balance Sheet Data
| June 30, 2025 | December 31, 2024 | |||||||
| Cash and cash equivalents | $ | 287,381 | $ | 141,239 | ||||
| Working capital* | 279,487 | 135,247 | ||||||
| Total assets | 295,313 | 152,905 | ||||||
| Total stockholders equity | 283,766 | 140,776 |