UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 7, 2024, Tectonic Therapeutic, Inc. announced its financial results for the three and nine months ended September 30, 2024 and provided a general business update. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
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 1934, 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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99.1 |
Press Release of Tectonic Therapeutic, Inc. dated November 7, 2024 |
104 |
Cover Page Interactive Data File (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.
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TECTONIC THERAPEUTIC, INC. |
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Date: |
November 7, 2024 |
By: |
/s/ Daniel Lochner |
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Daniel Lochner |
Exhibit 99.1
Tectonic Therapeutic Announces Third Quarter 2024 Financial Results and Recent Business Highlights
WATERTOWN, MA, November 7, 2024 (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 its financial results for the third quarter ending September 30, 2024, and provided an overview of recent business highlights.
“During the third quarter we continued to make excellent progress advancing our novel pipeline. We initiated the APEX Phase 2 clinical trial and continued better than expected enrollment in our Phase 1b hemodynamic, proof of concept clinical trial for TX45,” commented Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “Additionally, today we are announcing the selection of TX2100 as our development candidate for Tectonic’s second program targeting HHT, and we are looking forward to discussing our Phase 1a trial results for TX45 this month at the American Heart Association followed by topline results for the Phase 1b trial expected in late Q1’2025 or early Q2’2025.”
Recent Business Highlights
Upcoming Milestones
Overview of Financial and Operating Results
About TX45, a long-acting Fc-relaxin fusion protein
Tectonic’s lead program, TX45, is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the GPCR target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women. 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 is evaluating TX45 in an ongoing Phase 1b hemodynamic, proof-of-concept study and a Phase 2 clinical proof-of-concept study; both studies are being conducted in patients with PH-HFpEF.
About Group 2 Pulmonary Hypertension in HFpEF
The World Health Organization has defined five groups of PH. Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically pulmonary hypertension secondary to left heart failure with preserved ejection fraction (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. 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 TX2100
TX2100 is a GPCR-targeting biotherapeutic that is being developed to treat HHT, the second most common genetic bleeding disorder. In HHT, loss-of-function mutations in the BMP9/10-Endoglin-ALK1-SMAD4 signaling pathway lead to increased expression of factors that promote abnormal blood vessel formation. The abnormal blood vessel formations found in HHT, also known as telangiectasias and arterio-venous malformations or “AVMs”, are prone to spontaneous recurrent and severe bleeding episodes that can be life-threatening, yet there are no approved therapies to treat these patients. The target GPCR for TX2100 is a receptor for an angiogenic factor known to be upregulated in animal models of HHT. By blocking the signaling of this receptor, Tectonic anticipates it can reduce bleeding resulting from the abnormal blood vessel formation seen in HHT.
About Tectonic
Tectonic 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). 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 life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit www.tectonictx.com and follow @TectonicTx on X and LinkedIn.
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; the proposed initiation of a Phase 1 clinical trial for its development candidate for a second program in HHT, including its preclinical studies and anticipated endpoints; 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 November 7, 2024, 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) and LinkedIn.
Contacts:
Investors:
Dan Ferry
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576
Media:
Barbara Yates
The Yates Network
Barbara@theyatesnetwork.com
(781) 258-6153
Tectonic Therapeutic, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
(unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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$ |
14,317 |
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$ |
8,134 |
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$ |
32,208 |
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$ |
29,774 |
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General and administrative |
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5,320 |
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1,980 |
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11,816 |
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5,500 |
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Total operating expenses |
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19,637 |
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10,114 |
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44,024 |
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35,274 |
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Loss from operations |
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(19,637 |
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(10,114 |
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(44,024 |
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(35,274 |
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Other income (expense), net: |
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Change in fair value of SAFE liabilities |
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— |
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— |
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(3,610 |
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— |
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Interest income |
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1,952 |
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97 |
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2,526 |
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448 |
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Interest expense |
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(25 |
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(36 |
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(85 |
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(118 |
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Other expense |
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(7 |
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(1 |
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(416 |
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(10 |
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Total other income (expense), net |
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1,920 |
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60 |
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(1,585 |
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320 |
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Net loss |
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(17,717 |
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(10,054 |
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(45,609 |
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(34,954 |
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Net loss per share attributable to common stockholders, basic and |
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$ |
(1.20 |
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$ |
(7.62 |
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$ |
(7.16 |
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$ |
(28.06 |
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Weighted-average common shares outstanding, basic and diluted |
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14,729,018 |
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1,319,147 |
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6,373,717 |
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1,245,745 |
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Other comprehensive loss: |
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Foreign currency translation adjustment |
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(16 |
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— |
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(66 |
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— |
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Comprehensive loss |
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$ |
(17,733 |
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$ |
(10,054 |
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$ |
(45,675 |
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$ |
(34,954 |
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Tectonic Therapeutic, Inc.
Select Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
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September 30, |
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December 31, |
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Cash and cash equivalents |
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$ |
159,095 |
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$ |
28,769 |
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Working capital* |
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145,278 |
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(10,004 |
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Total assets |
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168,717 |
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39,399 |
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Total stockholders’ equity (deficit) |
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150,361 |
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(84,636 |
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*Working capital is defined as current assets less current liabilities