Tillkännagivande • Jun 21

Tectonic Therapeutic, Inc. completed the acquisition of AVROBIO, Inc. (NasdaqGS:AVRO) from a group of shareholders in a reverse merger transaction.

Tectonic Therapeutic, Inc. entered into a term sheet to acquire AVROBIO, Inc. (NasdaqGS:AVRO) from Newtyn Management, LLC, BML Capital Management, LLC, ADAR1, Atlas Venture L.P. and others for $9.2 million in a reverse merger transaction on December 13, 2023. Tectonic Therapeutic, Inc. entered into an agreement to acquire AVROBIO, Inc. (NasdaqGS:AVRO) from a group of shareholders for $9.19 million in a reverse merger transaction on January 30, 2024. Subject to the terms and conditions of the merger agreement, at the closing of the merger, (a) each then-outstanding share of Tectonic common stock will be converted into the right to receive a number of shares of 0.74458326 AVRO common stock calculated in accordance with the merger agreement exchange ratio. Under the terms of the agreement, AVROBIO will acquire 100% of the outstanding equity interests of Tectonic. Upon completion of the merger, the combined company is expected to operate under the name Tectonic Therapeutic, Inc. and trade on Nasdaq under the ticker symbol “TECX.” Upon completion of the merger, pre-Merger AVROBIO shareholders are expected to own approximately 22.3% of the combined company and pre-Merger Tectonic shareholders are expected to own approximately 40.2% of the combined company. Immediately after the merger, and prior to giving effect to the proposed private financings, AVROBIO securityholders as of immediately prior to the merger are expected to own approximately 35.6% of the outstanding shares of capital stock of the combined company, and after giving further effect to the proposed private financings, AVROBIO securityholders as of immediately prior to the merger are expected to own approximately 22.3% of the outstanding shares of capital stock of the combined company. Immediately after the merger, and prior to giving effect to the proposed private financings, former Tectonic securityholders are expected to own approximately 64.4% of the outstanding shares of capital stock of the combined company, and after giving further effect to the proposed private financings, former Tectonic securityholders are expected to own approximately 39.8% of the outstanding shares of capital stock of the combined company. Following the closing of the merger, the combined company will be led by Reicin and other members of the Tectonic management team. AVROBIO will be renamed Tectonic Therapeutic, Inc. and the corporate headquarters will be located in Watertown, Mass. The merger agreement provides that post-merger, one board member from AVROBIO will join the Board of Directors of the combined company. The agreement contains certain termination rights of each of AVRO and Tectonic. Upon termination of the agreement under specified circumstances, AVRO may be required to pay Tectonic a termination fee of $2.7125 million and/or reimburse Tectonic’s expenses up to a maximum of $0.65 million, and Tectonic may be required to pay AVRO a termination fee of $4.9 million.The merger has been approved by the Board of Directors of both companies, subject to customary closing conditions, including the approvals by the shareholders of each company, issue shares of AVRO common stock issuable in connection with the merger under the rules of The Nasdaq Stock Market LLC, Lock-Up agreement, the effectiveness of the Registration Statement, AVRO’s net cash not being less than $50 million, the closing of the private placement financing and other customary closing conditions. and is expected to close in the second quarter of 2024. In connection with the Merger, AVRO held a special meeting of its stockholders on June 11, 2024 at which AVRO’s stockholders approved effecting a reverse stock split of AVRO’s issued common stock at a ratio in the range between 1:3 and 1:30, inclusive, with the final ratio and effectiveness of all other ratios of such amendment and the abandonment of such amendment to be mutually agreed by the board of directors of AVRO and the board of directors of Tectonic prior to the effective time and closing of the merger is anticipated to take place on or around June 18, 2024. As per filling on June 18, 2024, the closing of the merger is anticipated to take place on or around June 20, 2024.Mitchell Bloom, Robert Masella, James Ding and Adam V. Johnson of Goodwin Procter LLP acted as legal advisors to AVROBIO. Marc A. Recht, Miguel J. Vega, Courtney T. Thorne and Michael Rohr of Cooley LLP acted as legal advisors to Tectonic Therapeutic. Innisfree M&A Incorporated acted as proxy solicitor to AVROBIO and will receive a fee of $50,000, plus reimbursement of out-of-pocket expenses for its services. Houlihan Lokey acted as financial advisor and fairness opinion provider to AVROBIO. Pursuant to its engagement by AVROBIO, Houlihan Lokey became entitled to an aggregate fee of $400,000 for its services, a portion of which became payable to Houlihan Lokey upon its retention by AVROBIO and the remainder of which became payable upon the delivery of its opinion. Computershare Trust Company, N.A . acted as transfer agent to AVROBIO. Deloitte & Touche LLP acted as auditor to Tectonic. Ernst & Young LLP acted as accountant to AVROBIO. TD Cowen acted as financial advisor to AVROBIO and Leerink Partners acted as financial advisor to Tectonic.Tectonic Therapeutic, Inc. completed the acquisition of AVROBIO, Inc. (NasdaqGS:AVRO) from a group of shareholders in a reverse merger transaction on June 20, 2024. The combined company will operate under the name Tectonic Therapeutic, Inc., and its shares are expected to begin trading on the Nasdaq Global Market on June 21, 2024 under the ticker symbol "TECX". Concurrent with the merger, Tectonic completed a $130.7 million private placement.

Tillkännagivande • Dec 08

AVROBIO, Inc. Announces New Positive Clinical Data and Outlines Clinical Development Plan Following Regulatory Discussions for Its Gaucher Disease Gene Therapy

AVROBIO, Inc. announced new interim pharmacokinetic, pharmacodynamic and clinical efficacy data, showing stabilization or reversal of multiple clinically relevant measures in five patients with Gaucher disease after they received a single dose of AVR-RD-02, an investigational hematopoietic stem cell (HSC) gene therapy. In addition, following positive discussions with regulators, AVROBIO plans to initiate a global, registrational Phase 2/3 clinical trial in Gaucher disease type 3 (GD3) in the second half of 2023. Gaucher disease is the largest, most common lysosomal disorder. Even on enzyme replacement therapy (ERT) – the current standard of care – people with Gaucher disease type 1 (GD1) typically have a shortened life expectancy and may experience debilitating symptoms that significantly reduce their quality of life. GD3 is a more severe, progressive form of Gaucher disease, which presents with more widespread systemic manifestations, typically refractory to standard of care treatment, as well as neurological signs and symptoms. AVR-RD-02 for GD3: First pediatric patient dosed with investigational AVR-RD-02: An 11-year-old patient was dosed at the University of Manchester, U.K., on a named patient basis; Fifteen months post gene therapy, the patient has normalized peripheral glucocerebrosidase (GCase) enzyme activity and plasma chitotriosidase, a marker of activated macrophages, and remains off enzyme replacement therapy (ERT) and substrate reduction therapy (SRT); Patient’s albumin levels increased 33% eight months post gene therapy, reflecting improvements in lymphadenopathy and enteropathy?. This patient was previously refractory to maximal and multimodal medical therapy, including ERT, SRT, enteral steroids, dietary restrictions and intermittent albumin infusions;? Additionally, the patient did not develop any new lesions on MRI assessments post gene therapy, on a background of rapidly developing lesions, and had no clinically detectable change in neurological status or new neurological manifestations 15 months post gene therapy; Safety data from this patient indicate no adverse events (AEs) related to drug product. All AEs observed were related to myeloablative conditioning, stem cell mobilization, underlying disease or pre-existing conditions. AVR-RD-02 for GD1: Clinically meaningful reductions in organomegaly and improvements from baseline ERT levels in plasma lyso-Gb1 and chitotriosidase activity: All four adult GD1 patients in the Guard clinical trial who have been infused with investigational AVR-RD-02 to date saw sustained engraftment with vector copy numbers (VCN) between 0.54 to 0.86 per diploid genome 14 weeks to two years post gene therapy, and reconstitution of GCase enzyme activity both in plasma and peripheral blood leukocytes within the normal range; Glucosylsphingosine (lyso-Gb1) decreased 21% to 70% (21%, 21%, 30% and 70%, respectively) below ERT baseline levels for all four patients 12 weeks to two years post gene therapy. A downstream metabolic product of glucocerebroside, lyso-Gb1, is considered a sensitive and specific biomarker used for disease monitoring; The metabolite chitotriosidase was reduced in the two patients with evaluable samples to date, reflecting a reduction in macrophage activation and inflammation. Patient 1's chitotriosidase level has almost completely normalized, declining from a high of 145.8 µmol/L/h prior to gene therapy treatment to 42.4 µmol/L/h (=38.1 µmol/L/h is considered normal range) two years post gene therapy. Patient 2, who was in the normal range before gene therapy treatment, still decreased from 24.3 µmol/L/h at baseline to 19.2 µmol/L/h at week 52;3 Importantly, three of the four patients dosed demonstrate a reduction in liver and spleen volume below their own ERT baseline. Patient 4 is not yet out far enough post gene therapy to be scanned for liver or spleen volume: Patient 1 data showed a clinically significant 24% reduction in liver volume at 104 weeks post gene therapy (patient underwent a splenectomy during childhood); Patient 2 data showed a clinically significant 11% reduction in liver volume and 23% reduction in spleen volume at 52 weeks post gene therapy; Patient 3 data showed a 4% reduction in liver volume and a 19% reduction in spleen volume, at 26 weeks post gene therapy; Safety data from the four patients dosed to date indicate no AEs related to drug product. All AEs observed were related to myeloablative conditioning, stem cell mobilization, underlying disease or pre-existing conditions. The majority of AEs were mild or moderate and resolved without clinical sequelae.? Additionally, hemoglobin and platelet levels, a core feature of successful Gaucher disease treatment, remain in normal range following gene therapy; The ongoing Guard1 clinical trial (NCT04145037) is a multinational, open-label study to assess the safety and efficacy of investigational AVR-RD-02 in approximately eight to 16 participants (male or female) who are =18 and =50 years of age with a confirmed diagnosis of GD1. Planning first ever, randomized controlled clinical trial for GD3 in 2023: The company plans to initiate a Phase 2/3 pediatric clinical trial for investigational AVR-RD-02 in GD3 in the second half of 2023, following constructive meetings with the U.S. Food and Drug Administration (FDA) and U.K. Medicines and Healthcare products Regulatory Agency (MHRA); Global, open label, parallel-arm and randomized controlled clinical trial designed to evaluate the efficacy and safety of investigational AVR-RD-02. The trial is expected to include approximately 40 GD3 participants (male or female) who will be randomized 1:1 to receive HSC gene therapy or continue to receive standard of care ERT. Following the observation period, eligible participants who received ERT can cross over into the active arm and receive HSC gene therapy; Planned primary efficacy endpoint is a novel, multi-domain endpoint to reflect the systemic and heterogeneous nature of Gaucher disease, including ataxia (impaired coordination), breathing ability and liver and spleen volume. A key secondary efficacy measure will examine substrate levels in cerebrospinal fluid (CSF), which reflects the impact of the HSC gene therapy in the central nervous system; ? Overall, data from both the Guard1 and planned global Phase 2/3 GD3 clinical trials are expected to further development of this investigational gene therapy?, leveraging the similar underlying pathophysiology for both types of Gaucher disease.

Räntetäckningsgrad	n/a
Kontanter	US$90.48m
Eget kapital	US$88.84m
Summa skulder	US$3.51m
Totala tillgångar	US$92.35m

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2024/06/20 06:22
Aktiekurs vid dagens slut	2024/06/20 00:00
Intäkter	2024/03/31
Årlig intjäning	2023/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Yun Zhong	Brean Capital Historical (Janney Montgomery)
Yun Zhong	BTIG
Whitney Ijem	Guggenheim Securities, LLC

This company is no longer active

AVROBIO Balansräkning Hälsa

Finansiell hälsa kriterier kontrolleras 6/6

Viktig information

Nya uppdateringar om finansiell hälsa

AVROBIO Receives Written Notice from The Nasdaq Stock Market Regarding Minimum Bid Price Requirement

Here's Why We're Watching AVROBIO's (NASDAQ:AVRO) Cash Burn Situation

We're Keeping An Eye On AVROBIO's (NASDAQ:AVRO) Cash Burn Rate

Here's Why We're Not Too Worried About AVROBIO's (NASDAQ:AVRO) Cash Burn Situation

We Think AVROBIO (NASDAQ:AVRO) Can Afford To Drive Business Growth

Recent updates

Tectonic Therapeutic, Inc. completed the acquisition of AVROBIO, Inc. (NasdaqGS:AVRO) from a group of shareholders in a reverse merger transaction.

Investor sentiment improves as stock rises 1,043%

New major risk - Revenue and earnings growth

New major risk - Revenue and earnings growth

New minor risk - Shareholder dilution

AVROBIO, Inc. (NasdaqGS:AVRO) entered into an agreement to acquire Tectonic Therapeutic, Inc.

No longer forecast to breakeven

Price target decreased by 16% to US$3.00

New major risk - Revenue and earnings growth

Chief Business Officer notifies of intention to sell stock

Novartis Pharma AG and Novartis Pharmaceuticals Corporation entered into an Asset Purchase Agreement to acquire Cystinosis Gene Therapy Program from AVROBIO, Inc. (NasdaqGS:AVRO) for $87.5 million.

Price target decreased by 8.5% to US$3.58

Co- Founder exercised options to buy US$104k worth of stock.

AVROBIO, Inc. Announces New Positive Clinical Data and Outlines Clinical Development Plan Following Regulatory Discussions for Its Gaucher Disease Gene Therapy

Price target decreased to US$4.14

Insufficient new directors

Avrobio Receives Rare Pediatric Disease Designation from the U.S. FDA for First-In-Class Gene Therapy for Gaucher Disease

AVROBIO, Inc. Announces Completion of Patient Dosing in First Gene Therapy Clinical Trial for Cystinosis

AVROBIO, Inc. announces U.K. Medicines and Healthcare products Regulatory Agency grant an Innovation Passport under the Innovative Licensing and Access Pathway

Avrobio rises as gene therapy for Gaucher disease gets ILAP designation in UK

AVROBIO, Inc. Reports Favorable Data on Use of Combined State-Of-The-Art in Vitro Cell-Based Assays to Identify Potential Genotoxicity Risk of Integrating Vectors During Preclinical Development

AVROBIO Receives Written Notice from The Nasdaq Stock Market Regarding Minimum Bid Price Requirement

AVROBIO, Inc. Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for First Gene Therapy in Development for Cystinosis

Avrobio stock rises as kidney disease gene therapy gets FDA rare pediatric disease status

AVROBIO Inc. Announces Neuronopathic Mucopolysaccharidosis Type II or Hunter Syndrome Clinical Trial Application Accepted by U.K. Regulatory Agency to Initiate Pediatric Phase 1/2 Gene Therapy Trial

AVROBIO granted FDA’s orphan drug designation for metabolic disorder therapy

AVROBIO, Inc.(NasdaqGS:AVRO) dropped from Russell 2500 Index

AVROBIO, Inc. Announces Preclinical Data Demonstrating the Efficacy and Safety of AVR-RD-03 Gene Therapy in A Mouse Model of Infantile Onset Pompe Disease

Avrobio Reports Positive Data from Phase 1/2 Clinical Trial of Investigational Gene Therapy for Cystinosis, Including New Interim Data on Neurocognitive Measures

Price target decreased to US$6.29

Insufficient new directors

AVROBIO, Inc. Reports Interim Data from Phase 1/2 Clinical Trial of Investigational Gene Therapy for Cystinosis

Insufficient new directors

Insufficient new directors

AVROBIO, Inc. Announces the Appointment of Sean O’Bryan as Chief Regulatory Officer

AVROBIO, Inc. Announces New Data from Phase 2 Fab-Gt Clinical Trial Show Variable Engraftment

AVROBIO, Inc Presents Clinician Experience with FAB-GT Clinical Trial and Updated Safety Data for Investigational Gene Therapies in Fabry Disease and Gaucher Disease Type 1

Price target decreased to US$22.88

Price target increased to US$25.14

Here's Why We're Watching AVROBIO's (NASDAQ:AVRO) Cash Burn Situation

We're Keeping An Eye On AVROBIO's (NASDAQ:AVRO) Cash Burn Rate

AVROBIO, Inc.(NasdaqGS:AVRO) dropped from Russell 2500 Growth Index

AVROBIO, Inc. Provides Regulatory Update on Investigational AVR-RD-01 for Fabry Disease

AVROBIO, Inc. Announces Two Oral Presentations and Two Posters Featuring Data from Its Pipeline of Lysosomal Disorder Gene Therapy

Here's Why We're Not Too Worried About AVROBIO's (NASDAQ:AVRO) Cash Burn Situation

Price target lowered to US$34.50

AVROBIO, Inc. Receives Orphan Drug Designation from the European Commission for AVR-RD-04, an Investigational Gene Therapy for Cystinosis

AVROBIO, Inc. Announces 100% Kidney Substrate Reduction at 12 Months Post-Gene Therapy in First Patient Dosed with plato Gene Therapy Platform in Fabry Disease Phase 2 Trial

New 90-day high: US$17.11

Avrobio Appoints Diana M. Escolar as Chief Medical Officer

AVROBIO, Inc. Appoints Diana M. Escolar as Chief Medical Officer

We Think AVROBIO (NASDAQ:AVRO) Can Afford To Drive Business Growth

AVROBIO, Inc. Avrobio Announces New Positive Clinical Data and Preclinical Data, as Well as Expanded Leading Lysosomal Disorder Gene Therapy Pipeline

Price target raised to US$38.50

Avrobio, Inc. Enters into Agreement with University of Manchester, England

Avrobio, Inc. Receives Orphan Drug Designation from the European Medicines Agency for Avr-Rd-02, an Investigational Gene Therapy for Gaucher Disease

New 90-day low: US$15.00

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