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AVROBIO(AVRO) - 2025 Q2 - Quarterly Results
2025-08-07 21:08
Innovating GPCR-Targeted Therapies to Reach Large Untapped Market Opportunities AUGUST 2025 DISCLAIMER Statements contained in this presentation regarding matters that are not historical facts are "foward-looking statements" within the meaning c Private Securities Litigation Reform Act of 1995, as amended. Words such as "anlicipates" "expects," "intends," "plans" "potential, "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Each of these forward-loo ...
AVROBIO(AVRO) - 2025 Q2 - Quarterly Report
2025-08-07 20:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number: 001-38537 TECTONIC THERAPEUTIC, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 81- ...
AVROBIO(AVRO) - 2025 Q1 - Quarterly Report
2025-05-08 20:20
Financial Performance - The net loss for the company was $15.906 million for the three months ended March 31, 2025, a 5% increase from a net loss of $15.221 million in the same period of 2024[108]. - Cash used in operating activities was $13.1 million for the three months ended March 31, 2025, compared to $9.3 million for the same period in 2024, reflecting ongoing investment in product development[116][117]. - Net cash provided by financing activities was $178.1 million for the three months ended March 31, 2025, primarily from the sale of shares in a Private Placement[119]. - As of March 31, 2025, the company had $306.2 million in cash and cash equivalents and an accumulated deficit of $164.5 million[114]. - The company expects to incur significant expenses and operating losses as it advances preclinical and clinical development, necessitating additional capital through equity or debt financing[113][120]. Expenses - The company reported a 21% increase in research and development expenses, totaling $13.036 million for the three months ended March 31, 2025, compared to $10.818 million in the same period of 2024[108]. - General and administrative expenses surged by 145%, reaching $5.262 million in Q1 2025, up from $2.150 million in Q1 2024[108]. - Total operating expenses increased by 41% to $18.298 million in Q1 2025, compared to $12.968 million in Q1 2024[108]. - Total research and development expenses increased by $2.2 million, or 21%, for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to increased CRO and CDMO costs related to TX2100[110]. - General and administrative expenses rose by $3.1 million, or 145%, for the three months ended March 31, 2025, driven by a 102% increase in employee-related expenses and a 266% increase in professional and consulting expenses[111]. Clinical Development - TX45 is currently being evaluated in a Phase 1b hemodynamic clinical trial, with 19 patients dosed in Part A, showing improvements in left heart function and pulmonary hemodynamics[92]. - The APEX Phase 2 clinical trial for TX45 commenced in October 2024, with topline results expected in 2026[92]. - TX2100, the second development candidate, is expected to initiate a Phase 1 clinical trial in late 2025 or early 2026, pending IND enabling study results[93]. Funding and Capital - The company completed a private placement in February 2025, raising approximately $185.0 million by issuing 3,689,465 shares of common stock[94][95]. - The merger with AVROBIO was completed on June 20, 2024, with Legacy Tectonic continuing as a wholly owned subsidiary of the surviving corporation[96]. Revenue Generation - The company has not generated any revenue since inception and does not expect to do so in the foreseeable future[97]. - The company has no approved products and has never generated revenue from product sales, relying on funding from convertible preferred stock and common stock sales[114]. - The company anticipates additional costs associated with operating as a public company and ongoing research and development activities[123]. Lease Obligations - Minimum lease payments due as of March 31, 2025, are $2.2 million in 2025, $0.5 million in 2026, and $0.1 million in 2027[127].
AVROBIO(AVRO) - 2025 Q1 - Quarterly Results
2025-05-08 20:07
Financial Performance - Cash and cash equivalents as of March 31, 2025, were $306.2 million, up from $141.2 million as of December 31, 2024, providing a cash runway into Q4 2028[13] - The net loss for Q1 2025 was $15.9 million, compared to a net loss of $15.2 million in Q1 2024[13] - Total operating expenses for Q1 2025 were $18.3 million, compared to $13.0 million in Q1 2024[16] Research and Development - Research and development expenses for Q1 2025 were $13.0 million, compared to $10.8 million in Q1 2024, reflecting increased costs related to the TX2100 program[13] - Interim analysis from the TX45 Phase 1b Part A trial showed a 17.9% reduction in Pulmonary Capillary Wedge Pressure and over 30% reduction in Pulmonary Vascular Resistance in a subpopulation with more severe disease[7] - Enrollment for Part B of the TX45 Phase 1b trial began in March 2025, with topline results expected in the second half of 2025[6] - Full results from the Phase 1b Part A trial will be presented on May 17, 2025, at the ESC Heart Failure Congress, involving a total of 19 patients[6] - The ongoing APEX Phase 2 trial continues to enroll patients, with topline results expected in 2026[6] Administrative Expenses - General and administrative expenses increased to $5.3 million in Q1 2025 from $2.2 million in Q1 2024, primarily due to higher professional services and stock-based compensation[13] Funding Activities - Tectonic completed a private placement in February 2025, raising approximately $185.0 million in gross proceeds[7]
AVROBIO(AVRO) - 2024 Q4 - Annual Report
2025-03-20 20:06
Financial Performance - The company has not generated any revenue since inception and does not expect to do so in the foreseeable future[470]. - The net loss for the year ended December 31, 2024, was $58.0 million, a 35% increase from the net loss of $42.8 million in 2023[485]. - Cash used in operating activities was $59.1 million in 2024, compared to $40.7 million in 2023, reflecting increased operational funding needs[494]. - The company expects to incur significant expenses and operating losses in the foreseeable future as it advances its research programs and product candidates[491]. - The company has no approved products and has never generated revenue from product sales, relying on financing to support its operations[492]. Clinical Trials and Development - TX45, the lead asset, showed favorable results in a Phase 1a trial with no severe adverse events and a favorable pharmacokinetic/pharmacodynamic relationship[463]. - The Phase 1b trial for TX45 has completed dosing of 19 patients, with preliminary data showing improvements in hemodynamics[464]. - The APEX Phase 2 clinical trial for TX45 commenced in October 2024, with topline results expected in 2026[464]. - TX2100, the second development candidate, is set to initiate a Phase 1 clinical trial in late 2025 or early 2026, pending IND enabling studies[465]. Expenses and Liabilities - Total operating expenses increased by $13.4 million, or 30%, to $58.0 million for the year ended December 31, 2024, compared to $44.6 million in 2023[485]. - Research and development expenses rose by $4.4 million, or 12%, to $41.4 million in 2024, primarily due to increased costs related to the discovery and development of TX2100[486]. - General and administrative expenses surged by $9.0 million, or 117%, to $16.7 million in 2024, driven by higher employee-related and professional consulting expenses[488]. - The company issued SAFEs for proceeds of $34.1 million, recorded as liabilities and measured at fair value until redemption[481]. - The operating lease liability and finance lease liability as of December 31, 2024, were $2.4 million and $0.9 million, respectively[518]. Cash and Financing - As of December 31, 2024, the company had $141.2 million in cash and cash equivalents and an accumulated deficit of $148.6 million[492]. - The company raised $171.7 million in net cash from financing activities in 2024, primarily from the sale of shares[498]. - As of December 31, 2024, the company had cash and cash equivalents totaling $141.2 million[517]. - Minimum lease payments are projected to be $3.0 million in 2025, $0.4 million in 2026, and $0.1 million in 2027[506]. Market and Regulatory Environment - The merger with AVROBIO was completed on June 20, 2024, with Legacy Tectonic stockholders owning approximately 38.5% of the outstanding shares post-merger[467]. - Investors in the Subscription Agreement purchased shares for an aggregate price of $96.6 million, converting into 4,163,606 shares of common stock upon merger completion[469]. - The company is classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures as long as market value remains below $250.0 million or annual revenue is less than $100.0 million[515]. Interest and Inflation - Interest income increased significantly by $3.7 million, or 633%, to $4.3 million in 2024, attributed to a rise in cash and cash equivalents following the Merger[490]. - Interest income and expenses are sensitive to changes in U.S. interest rates, but a 10% change would not materially affect the fair market value of the investment portfolio[518]. - Inflation effects on the company's results of operations and financial condition have been deemed immaterial to date[519]. Estimates and Assumptions - The company evaluates its estimates and assumptions on an ongoing basis, acknowledging that actual results may differ from these estimates[509]. - The fair value of the company's common stock is based on the closing quoted market price as reported by NASDAQ on the date of grant[512]. - The company has not experienced material adjustments to prior estimates of prepaid and accrued research and development expenses[511]. Research Agreements - The company enters into agreements for preclinical research and clinical trials that are generally cancelable without minimum purchase commitments[507].
AVROBIO(AVRO) - 2024 Q4 - Annual Results
2025-03-20 20:02
Financial Performance - The net loss for Q4 2024 was $12.4 million, compared to a net loss of $7.9 million for Q4 2023[11]. - Net loss for Q4 2024 was $12,373,000, compared to a net loss of $7,869,000 in Q4 2023, representing a 57.5% increase in losses[18]. - Net loss per share for Q4 2024 was $0.84, compared to $5.01 in Q4 2023[18]. - Comprehensive loss for the year ended December 31, 2024 was $57,973,000, compared to $42,834,000 in 2023[18]. Cash and Assets - Tectonic reported cash and cash equivalents of $141.2 million as of December 31, 2024, with a private placement in February 2025 generating approximately $185.0 million, providing a cash runway into Q4'28[6]. - Cash and cash equivalents increased significantly to $141,239,000 in 2024 from $28,769,000 in 2023[20]. - Total assets grew to $152,905,000 in 2024, up from $39,399,000 in 2023[20]. - Working capital improved to $135,247,000 in 2024 from a deficit of $10,004,000 in 2023[20]. - Total stockholders' equity improved to $140,776,000 in 2024, compared to a deficit of $84,636,000 in 2023[20]. Expenses - Research and development expenses increased to $9.2 million for Q4 2024, up from $7.1 million in Q4 2023, primarily due to higher costs related to clinical trials[11]. - General and administrative expenses rose to $4.8 million for Q4 2024, compared to $2.3 million in Q4 2023, driven by increased audit, legal, and professional service costs[11]. - Total operating expenses for Q4 2024 were $13,989,000, an increase of 49.5% from $9,372,000 in Q4 2023[18]. - Research and development expenses rose to $9,155,000 in Q4 2024, up 29.3% from $7,081,000 in Q4 2023[18]. Clinical Trials and Research - The TX45 Phase 1b trial interim analysis showed a 17.9% reduction in Pulmonary Capillary Wedge Pressure (PCWP) and over 30% reduction in Pulmonary Vascular Resistance (PVR) in patients with Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF)[7]. - The APEX Phase 2 trial topline results for TX45 are expected in 2026, following positive interim results from the ongoing Phase 1b trial[6]. - The TX2100 GPCR antagonist for Hereditary Hemorrhagic Telangiectasia (HHT) is expected to initiate Phase 1 trials in Q4 2025 or Q1 2026[11]. - Tectonic's ongoing clinical trials aim to address significant unmet medical needs in pulmonary hypertension and hereditary bleeding disorders[13]. - Tectonic hosted a Key Opinion Leader webinar in December 2024 discussing the treatment landscape for patients with Group 2 PH-HFpEF[7]. - The company plans to present full results from the Phase 1b Part A trial of TX45 at a future medical meeting in 2025[7]. Interest Income - Interest income for Q4 2024 was $1,735,000, a significant increase from $132,000 in Q4 2023[18].
AVROBIO(AVRO) - 2024 Q3 - Quarterly Report
2024-11-12 21:01
Financial Performance - The company reported net losses of $17.7 million for Q3 2024, compared to $10.1 million for Q3 2023, and $45.6 million for the nine months ended September 30, 2024, compared to $35.0 million for the same period in 2023[63]. - Net loss for Q3 2024 was $17.7 million, a 76% increase from a net loss of $10.1 million in Q3 2023[75]. - Net cash used in operating activities was $42.3 million for the nine months ended September 30, 2024, compared to $29.0 million in 2023[85]. - The company does not expect to generate revenue from product sales in the foreseeable future and will need substantial additional funding to support ongoing operations[68]. Cash and Funding - As of September 30, 2024, the company had an accumulated deficit of $136.2 million and cash and cash equivalents of $159.1 million, which is expected to fund operations for at least the next twelve months[61]. - The company has raised an aggregate of $288.6 million since inception through various financing methods, including the sale of convertible preferred stock and common stock[61]. - Net cash provided by financing activities was $172.8 million for the nine months ended September 30, 2024, primarily from the sale of shares and proceeds from the Merger[89]. - The company anticipates needing additional capital to fund ongoing operations and research and development activities[84]. Expenses - Research and development expenses increased by 76% to $14.3 million in Q3 2024 from $8.1 million in Q3 2023[75]. - General and administrative expenses rose by 169% to $5.3 million in Q3 2024 compared to $2.0 million in Q3 2023[78]. - Total operating expenses for Q3 2024 were $19.6 million, a 94% increase from $10.1 million in Q3 2023[75]. - General and administrative expenses for the nine months ended September 30, 2024, were $11.8 million, a 115% increase from $5.5 million in the same period of 2023[79]. Clinical Trials and Development - The Phase 1a trial for the lead asset TX45 showed favorable results, with no severe adverse events and a favorable pharmacokinetic/pharmacodynamic relationship[61]. - The Phase 1b hemodynamic clinical trial for TX45 is enrolling ahead of plan, with topline results expected in late Q1 or early Q2 2025[61]. - The APEX Phase 2 clinical trial for TX45 commenced in October 2024, with topline results anticipated in 2026[61]. - The company plans to initiate a Phase 1 clinical trial for TX2100 in Q4 2025 or Q1 2026, pending IND enabling studies[61]. Merger and Financing - The merger with AVROBIO was completed on June 20, 2024, resulting in Legacy Tectonic securityholders owning approximately 38.5% of the outstanding shares on a diluted basis[65]. - Concurrently with the merger, the company raised $96.6 million through a Subscription Agreement at a price of $12.40 per share[66]. - The company issued SAFEs for proceeds of $34.1 million in October and December 2023, recorded as liabilities at fair value[73]. Obligations and Commitments - As of September 30, 2024, the company's total contractual obligations and commitments amount to $3.788 million, with $2.163 million due within one year[92]. - The company has a one-time license fee obligation of $170,000 to Harvard, payable in equal installments over three years, with the final installment made in July 2024[94]. - The company is obligated to pay up to $8.5 million in milestone payments for products granted FDA marketing authorization under the Harvard License Agreement[94]. - The company has a license agreement with Alloy Therapeutics, which includes total milestone payments of $4.8 million and annual commercial payments in the low seven digits for the first six years of sales[95]. Interest Income and Financial Sensitivity - Interest income surged by 1,912% to $1.9 million in Q3 2024 from $97,000 in Q3 2023, primarily due to increased cash and cash equivalents[75]. - Interest income increased by $2.0 million for the nine months ended September 30, 2024, primarily due to an increase in cash and cash equivalents resulting from the Merger[83]. - The company’s financial condition is sensitive to interest rate changes, but a 10% change in market interest rates would not materially affect the fair market value of its investment portfolio[102].
AVROBIO(AVRO) - 2024 Q3 - Quarterly Results
2024-11-07 21:27
Financial Position - Cash and cash equivalents were $159.1 million as of September 30, 2024, down from $185.1 million as of June 30, 2024, providing a cash runway into mid-2027[4] - Cash and cash equivalents increased to $159,095 thousand as of September 30, 2024, up from $28,769 thousand on December 31, 2023[11] - Working capital improved to $145,278 thousand, a significant recovery from a deficit of $(10,004) thousand[11] - Total assets rose to $168,717 thousand, compared to $39,399 thousand at the end of 2023[11] - Total stockholders' equity turned positive at $150,361 thousand, recovering from a deficit of $(84,636) thousand[11] Expenses - Research and development expenses increased to $14.3 million for Q3 2024, compared to $8.1 million for Q3 2023, primarily due to higher external research costs[4] - General and administrative expenses rose to $5.3 million for Q3 2024, up from $2.0 million for Q3 2023, driven by increased personnel-related costs and professional fees[4] Net Loss - The net loss for Q3 2024 was $17.7 million, compared to a net loss of $10.1 million for Q3 2023[4] Clinical Trials - The first subject was dosed with TX000045 in the APEX Phase 2 clinical trial in early October 2024, with topline results expected in 2026[2] - Favorable Phase 1a topline trial results for TX45 were announced in September 2024, showing good tolerability and a favorable pharmacokinetic profile[2] - Development candidate TX2100 was selected for the HHT program, with plans to initiate a Phase 1 clinical trial in Q4 2025 or Q1 2026[2] - Ongoing Phase 1b hemodynamic clinical trial results for TX45 are expected in late Q1 2025 or early Q2 2025[3] - The APEX Phase 2 clinical trial is a 24-week placebo-controlled study evaluating TX45 in subjects with PH-HFpEF[2] Future Outlook - Tectonic anticipates that its current cash position will support key Phase 1b and Phase 2 readouts for TX45 and the progression of the HHT program into clinical development[4]
AVROBIO(AVRO) - 2024 Q2 - Quarterly Results
2024-08-14 20:11
Clinical Trials - TX45 has advanced into Phase 2 clinical trial for patients with Group 2 PH-HFpEF, with the first site activated and screening open in August 2024[1] - The Phase 1a clinical trial results for TX45 in healthy volunteers are expected to be reported in September 2024[5] - The ongoing Phase 1b clinical trial results for TX45 are expected in mid-2025[11] - The company anticipates topline results from the Phase 2 clinical trial of TX45 in 2026[5] Financial Performance - The company reported a net loss of $12.7 million for Q2 2024, compared to a net loss of $10.5 million for Q2 2023[7] - Net loss for the three months ended June 30, 2024, was $12,671,000, compared to a net loss of $10,455,000 for the same period in 2023, indicating a year-over-year increase of 21.3%[19] - Comprehensive loss for the three months ended June 30, 2024, was $(12,679,000), compared to $(10,455,000) for the same period in 2023, representing an increase of 11.7%[19] Expenses - Research and development expenses for Q2 2024 were $7.1 million, a decrease from $8.8 million in Q2 2023[6] - General and administrative expenses increased to $4.3 million in Q2 2024 from $1.9 million in Q2 2023, primarily due to merger-related activities[7] - Total operating expenses for the three months ended June 30, 2024, were $11,421,000, compared to $10,631,000 for the same period in 2023, representing an increase of 7.4%[19] - Research and development expenses decreased to $7,074,000 for the three months ended June 30, 2024, from $8,766,000 in the same period of 2023, a reduction of 19.3%[19] - Interest expense decreased to $(28,000) for the three months ended June 30, 2024, from $(40,000) in the same period of 2023, a reduction of 30.0%[19] Cash and Assets - As of June 30, 2024, cash and cash equivalents were $185.1 million, expected to provide a cash runway into mid-2027[6] - Total assets as of June 30, 2024, were $19,390,000, compared to $39,399,000 as of December 31, 2023, showing a significant decrease of 50.8%[20] Equity and Shares - Total stockholders' equity (deficit) improved to $(166,367,000) as of June 30, 2024, from $(84,636,000) as of December 31, 2023, indicating a worsening of 96.5%[20] - Weighted-average common shares outstanding increased to 2,919,872 for the three months ended June 30, 2024, from 1,228,778 in the same period of 2023, an increase of 138.8%[19] Mergers and Acquisitions - The company completed a reverse merger with AVROBIO in June 2024, including a concurrent private placement of $130.7 million[3] Future Plans - The company plans to select a development candidate for its second program in Hereditary Hemorrhagic Telangiectasia (HHT) in the second half of 2024[5] Interest Income - Interest income increased to $318,000 for the three months ended June 30, 2024, compared to $224,000 for the same period in 2023, reflecting a growth of 42.0%[19] Liabilities - Change in fair value of SAFE liabilities was $(1,535,000) for the three months ended June 30, 2024, with no comparable figure for the same period in 2023[19]
AVROBIO(AVRO) - 2024 Q2 - Quarterly Report
2024-08-14 20:02
Financial Performance - The company has incurred net losses of $12.7 million and $10.5 million for the three months ended June 30, 2024 and 2023, respectively, and $27.9 million and $24.9 million for the six months ended June 30, 2024 and 2023, respectively[93]. - The net loss for Q2 2024 was $12.7 million, representing a 21% increase compared to a net loss of $10.5 million in Q2 2023[116]. - The company incurred a net loss of $27.9 million for the six months ended June 30, 2024, compared to a net loss of $24.9 million for the same period in 2023[136]. - The company used $22.7 million and $20.5 million in operations for the six months ended June 30, 2024 and 2023, respectively[146]. Cash and Capital - The company had $185.1 million in cash and cash equivalents as of June 30, 2024, which is expected to fund operations for at least the next twelve months[92]. - The company had $185.1 million in cash and cash equivalents as of June 30, 2024, with an accumulated deficit of $118.5 million[132]. - The company has received $288.6 million in capital contributions since inception, primarily from sales of preferred stock and proceeds from the merger[92]. - Net cash provided by financing activities was $179.1 million for the six months ended June 30, 2024, primarily due to proceeds from the sale of shares and the Merger[139]. Expenses - Research and development expenses include costs related to employee salaries, clinical trials, and compliance with regulatory requirements[105]. - Research and development expenses for Q2 2024 were $7.1 million, a decrease of 19% from $8.8 million in Q2 2023[119]. - Research and development expenses for the six months ended June 30, 2024, totaled $17.9 million, down 18% from $21.8 million in the same period of 2023[125]. - General and administrative expenses increased by 133% to $4.3 million in Q2 2024 from $1.9 million in Q2 2023, primarily due to higher personnel and professional fees[120]. - General and administrative expenses increased to $6.5 million for the six months ended June 30, 2024, compared to $3.4 million in the same period of 2023, marking a 90% increase[129]. - The company anticipates a significant increase in general and administrative expenses in the future due to costs associated with operating as a public company[111]. Research and Development - The company plans to continue the clinical development of its lead product candidate TX45 and expand its clinical product pipeline[93]. - The company is focused on developing biologics to address GPCRs, which represent over 30% of all approved drugs[88]. - The proprietary GEODe™ technology platform aims to overcome challenges in GPCR-targeted drug discovery[89]. - The company expects to incur significant expenses and operating losses as it advances its research programs and product candidates, necessitating additional capital[131]. Merger and Corporate Structure - The merger with AVROBIO was completed on June 20, 2024, resulting in Legacy Tectonic securityholders owning approximately 38.5% of the outstanding shares on a diluted basis[99]. - The increase in professional and consultant fees in Q2 2024 was primarily related to merger-related activities, which rose by 489% to $2.5 million[120]. Liabilities and Obligations - Total contractual obligations and commitments as of June 30, 2024, amount to $3.724 million, including finance leases of $1.243 million and operating leases of $2.481 million[148]. - The company has a one-time license fee of $170,000 under the Harvard License Agreement, with installments due over three years[150]. - The company is obligated to pay up to $8.5 million in milestone payments for products granted FDA marketing authorization under the Harvard License Agreement[152]. - The company has a total of $4.8 million in milestone payments under the Alloy Therapeutics License Agreement for clinical trial advancements[154]. - The SAFE liabilities loss was $3.6 million due to the remeasurement of the SAFE liabilities to fair value during the six months ended June 30, 2024[130]. Interest Income - Interest income increased by 42% to $318,000 in Q2 2024 compared to $224,000 in Q2 2023, driven by higher interest rates[116]. - Interest income increased by $0.2 million for the six months ended June 30, 2024, attributed to rising interest rates[130]. Market Conditions - An immediate 10% change in market interest rates would not have a material effect on the fair market value of the company's investment portfolio[167].