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Tectonic Therapeutic TECX

Tectonic Therapeutic announces Q3 2026 financial results

Item 2.02 Reports results

Form
8-K
Filed
Importance
Major
  1. Cash and cash equivalents of $234.7 million as of September 30, 2026
  2. FDA granted TX2100 Fast Track designation for HHT in September 2026
  3. Dosed first patient in ALPINE Phase 2a trial of TX45 in October 2026
  4. Topline results from APEX Phase 2 trial of TX45 expected by end of January 2027

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The reading, claim by claim

  1. In its Form 8-K filed November 5, 2026, Tectonic Therapeutic, Inc. reported under Item 2.02 that it announced financial results for the third quarter ended September 30, 2026 and provided a general business update.
  2. The press release is furnished as Exhibit 99.1.
  3. The filing says the Item 2.02 information is furnished, not 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934.
  4. It is also not incorporated by reference in any Securities Act or Exchange Act filing unless a specific reference says so.
  5. Under Item 9.01, the filing lists Exhibit 99.1, the press release dated November 5, 2026, and Exhibit 104, the cover page interactive data file.
  6. Chief Financial Officer Daniel Lochner signed the report on November 5, 2026.
  7. The press release reports cash and cash equivalents of $234.7 million as of September 30, 2026.
  8. That includes approximately $22.3 million in net proceeds from an at-the-market offering for the three months ended September 30, 2026, and the company expects a cash runway into Q1 2029.
  9. The release also says the first patient was dosed in the ALPINE Phase 2a trial of TX45 in October 2026.
  10. It says topline results from the APEX Phase 2 trial of TX45 are anticipated by the end of January 2027.

10 of 11 claims matched the filing text.

Not found in the filing text

  • For context, the company's 10-Q for the quarter ended September 30, 2026 reports net income of -$21.3 million.

From the filing

Item 2.02 Results of Operations and Financial Condition.

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2026, Tectonic Therapeutic, Inc. announced its financial results for the third quarter ended September 30, 2026 and provided a general business update.1 The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.2

The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is furnished to comply with Item 2.02 of Form 8-K, and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 19343, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.4

Item 9.01 Financial Statements and Exhibits.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

99.15

Press Release of Tectonic Therapeutic, Inc. dated November 5, 20265

1045

Cover Page Interactive Data File5 (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

TECTONIC THERAPEUTIC, INC.

Date:

November 5, 2026

By:

/s/ Daniel Lochner6

Daniel Lochner6

Chief Financial Officer6

Tectonic Therapeutic Announces Third Quarter 2026 Financial Results and Recent Business Highlights

• Reported favorable safety, tolerability and pharmacokinetic ("PK") results from the single ascending-dose portion of the TX2100 Phase 1a clinical trial in healthy adult volunteers; FDA granted TX2100 Fast Track designation for Hereditary Hemorrhagic Telangiectasia ("HHT") in September 2026 and cleared the Investigational New Drug ("IND") application in August 2026 for the planned Phase 1b clinical trial • Dosed first patient in the ALPINE Phase 2a clinical trial of TX45 in pulmonary hypertension associated with interstitial lung disease ("PH-ILD") in October 2026, with interim topline results expected in the second half of 2027 • TERRA Phase 1b clinical trial of TX2100 in hematologic-support-dependent HHT expected to initiate by year-end 2026, with interim topline results expected by year-end 2027, and in parallel, the TIDAL Phase 2 clinical trial in moderate-to-severe HHT expected to initiate in early 2027 • Topline results from the APEX Phase 2 clinical trial of TX45 in pulmonary hypertension associated with heart failure with preserved ejection fraction ("PH-HFpEF") are anticipated by the end of January 202710 • Cash and cash equivalents of $234.7 million as of September 30, 20267, including approximately $22.3 million in net proceeds raised from an at-the-market offering for the three months ended September 30, 2026, is expected to provide cash runway into Q1 20298

WATERTOWN, Mass., November 5, 2026 (GLOBE NEWSWIRE)-- Tectonic Therapeutic, Inc. (NASDAQ: TECX) ("Tectonic" or the "Company"), 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 third quarter ended September 30, 2026, and provided an overview of recent business highlights.

"The favorable safety, tolerability and PK results from the single ascending-dose portion of our TX2100 Phase 1a trial in healthy adult volunteers, together with FDA Fast Track designation for HHT and IND clearance for our Phase 1b trial, support our plans to evaluate TX2100 in patients with HHT," said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic Therapeutic. "We plan to initiate an open-label Phase 1b trial in patients with hematologic-support-dependent HHT by year-end 2026 and, in parallel, a placebo-controlled Phase 2 trial in patients with moderate-to-severe HHT in early 2027. We are also approaching a critical milestone for TX45, with topline results from our APEX Phase 2 trial in PH-HFpEF anticipated by the end of January 2027."

Recent Business Highlights

• Announced Favorable Phase 1a Safety, Tolerability and PK Results for TX2100 in Healthy Adult Volunteers: In September 2026, the Company announced favorable safety, tolerability and PK results from all six planned single dose cohorts of TX2100 administered intravenously and subcutaneously in the Phase 1a Part A clinical trial in healthy adult volunteers. There were no serious adverse events or severe treatment-emergent adverse events at any dose, and no clinically significant or dose-related changes were observed in vital signs including blood pressure, or laboratory assessments. No anti-drug antibodies were detected. The PK findings support exploration of once-weekly and every-other-week subcutaneous dosing regimens in planned clinical trials. Together with nonclinical data, these findings support the approach to dose selection for planned clinical trials in patients with HHT. The Company also announced that the FDA granted TX2100 Fast Track designation for HHT and cleared the IND application for the planned Phase 1b clinical trial.

• Tectonic Presented TX2100 Poster and Related Presentations at the CureHHT 16 th HHT International Scientific Conference: In October 2026, the Company presented a TX2100 Phase 1b TERRA clinical trial design poster, a TX2100 HHT overview, TX1351 (a mouse surrogate of TX2100) preclinical studies and detailed TX2100 Phase 1a clinical trial results at the CureHHT 16 th HHT International Scientific Conference. The poster and presentations can be found under "Our Science" at the Tectonic Therapeutic website here .

• Dosed First Patient in the ALPINE Phase 2a Clinical Trial: In October 2026, Tectonic dosed the first PH-ILD patient in the TX45 ALPINE Phase 2a clinical trial.9 The trial is an open-label, multinational, 16-week clinical trial in up to 25 patients with PH-ILD designed to evaluate the safety and efficacy of TX45 administered subcutaneously (SC). Dosing of TX45 will be initiated at 300 mg SC once monthly, with the primary efficacy endpoint being change from baseline in pulmonary vascular resistance (PVR) at Week 16.

Upcoming Milestones

• TX45 APEX Phase 2 Clinical Trial Ongoing with Topline Results Expected by the end of January 2027: The global, randomized, placebo-controlled 24-week APEX Phase 2 trial is ongoing, evaluating subcutaneous TX45 in patients with PH-HFpEF, including an enriched population with combined pre- and post-capillary pulmonary hypertension (CpcPH). The primary endpoint is change in PVR from baseline in the CpcPH subgroup (PVR ≥3 Wood Units). APEX patient enrollment completed in June 2026 and, as previously disclosed, the Independent Data Monitoring Committee ("IDMC") recommended in July 2026

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Data on this page was fetched . The filing on SEC.gov is the record.