Serelaxin

Tectonic will be focused on advancing a pipeline of novel G-protein-coupled receptor (“GPCR”) targeted biologic therapies, including the lead program, TX45, a Fc-relaxin fusion. TX45 is currently being evaluated in Phase 1a/1b clinical trials as a potential treatment for Group 2 Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (“HFpEF”), a serious condition estimated to affect over 600,000 people in the U.S. alone, currently with no approved therapies. Tectonic’s second program is evaluating Hereditary Hemorrhagic Telangiectasia (“HHT”), the second-most common genetic bleeding disorder, representing a potential first-in-indication opportunity. Post-transaction cash, cash equivalents and investments of approximately $181 million, before payment of final transaction-related expenses, is expected to fund current operational plans into mid-2027, including through key Phase 1b and Phase 2 readouts for TX45, expected in 2025 and 2026, respectively and progression of the HHT program into clinical development. Shares to trade on Nasdaq under the ticker symbol "TECX" commencing on June 21, 2024. WATERTOWN, Mass.--(BUSINESS WIRE)--Tectonic Therapeutic, Inc. (“Tectonic”) (NASDAQ: TECX), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs, today announced the completion of its previously announced merger with AVROBIO, Inc. ("AVROBIO"). 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 with a syndicate of new and existing investors, including a major mutual fund, TAS Partners, 5AM Ventures, EcoR1 Capital, Polaris Partners, certain funds and accounts advised by Farallon Capital Management, Vida Ventures, the PagsGroup, and other undisclosed investors. Following these transactions, Tectonic’s cash, cash equivalents and investments of approximately $181 million at close, before payment of final transaction-related expenses, is expected to fund current operational plans into mid-2027. "It's an exciting time to be transitioning into a publicly-traded company. We expect to initiate a randomized Phase 2 clinical trial for our lead program, TX45, in Group 2 Pulmonary Hypertension in the setting of Left Heart Disease with Preserved Ejection Fraction in the second half of this year. Results from the ongoing Phase 1a clinical trial in this patient population are expected in mid-2024, to be followed by Phase 1b results expected in 2025 and results from the Phase 2 clinical trial expected in 2026. We also expect to select a potential development candidate for our second program targeting a treatment for HHT, later this year, with the start of corresponding clinical studies anticipated to commence in the fourth quarter of 2025 or the first quarter of 2026," said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. "We believe we are strongly positioned to enter the public markets at this time, with a solid financial foundation, investor syndicate and leadership team, and with several potential catalysts over the next two years, setting the stage for meaningful value creation. This transaction represents a major milestone in the evolution of Tectonic and in our efforts to bring innovative medicines to patients,” added Dr. Reicin. Tectonic’s lead program, TX000045 (“TX45”), is an Fc-relaxin fusion molecule that activates the RXFP1 receptor, the GPCR target of the hormone relaxin. Tectonic believes TX45’s pharmacological profile, the direct result of applying Tectonic’s protein engineering capabilities, has the potential to overcome the limitations that have impeded previous attempts to develop relaxin as a therapeutic protein. Tectonic’s second program addresses Hereditary Hemorrhagic Telangiectasia (“HHT”), the second-most common genetic bleeding disorder. It has been estimated that there are approximately 70,000 HHT patients in the United States. The target population for development is the 10-20% of HHT patients who are considered to have severe disease because of frequent bleeding, anemia, and in some cases, who require blood transfusions. **Transaction Details** In connection with the closing of the merger, AVROBIO enacted a 1 for 12 reverse stock split of its common stock and issued a non-transferable contingent value right (a "CVR") to AVROBIO shareholders of record immediately prior to the closing, which does not include the former holders of shares of Tectonic or the private placement investors. Holders of a CVR will be entitled to receive certain cash payments from proceeds received by Tectonic, if any, related to the dispositions of AVROBIO’s pre-transaction legacy assets. Following the reverse stock split and based on the final exchange ratio of approximately 0.5344 shares of AVROBIO common stock for each share of Tectonic common stock, at the closing of the merger, there are approximately 15,371,780 shares of the combined company's common stock outstanding on a diluted basis, with prior AVROBIO stockholders owning approximately 24.8% on a diluted basis and prior Tectonic stockholders (including investors in the private placement) holding approximately 75.2% of the combined company's outstanding common stock on a diluted basis. Leerink Partners served as exclusive financial advisor to Tectonic and Cooley LLP served as legal counsel to Tectonic. Leerink Partners and TD Cowen acted as joint placement agents for Tectonic’s private placement. Piper Sandler acted as capital markets advisor to Tectonic. TD Cowen served as lead financial advisor to AVROBIO, Houlihan Lokey served as co-financial advisor to AVROBIO, and Goodwin Procter LLP served as legal counsel to AVROBIO. **About Tectonic** Tectonic Therapeutic 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 (formerly Twitter) 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 1a/b clinical trial for its lead program, TX45, in Group 2 Pulmonary Hypertension and initiation of Phase 2 clinical trial; candidate selection for Tectonic’s second program in HHT; market opportunity and Tectonic’s anticipated cash runway. These forward-looking statements are based on Tectonic’s expectations and assumptions as of the date of this press release. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Tectonic’s control. Actual results and the timing of events could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (i) the ability of AVROBIO and Tectonic to integrate their businesses successfully and to achieve anticipated synergies; (ii) the possibility that other anticipated benefits of the merger will not be realized, including without limitation, anticipated revenues, expenses, earnings and other financial results, and growth and expansion of Tectonic’s operations, and the anticipated tax treatment of the merger; (iii) potential litigation relating to the transaction that could be instituted against Tectonic or its directors; (iv) the ability of Tectonic to retain, attract and hire key personnel; (v) potential adverse reactions or changes to relationships with customers, employees, suppliers or other parties resulting from the completion of the transaction; (vi) potential business uncertainty, including changes to existing business relationships that could affect Tectonic’s financial performance; (vii) Tectonic’s need for additional funding, which may not be available; (viii) failure to identify additional product candidates and develop or commercialize marketable products; (ix) the early stage of Tectonic’s development efforts; (x) potential unforeseen events during clinical trials could cause delays or other adverse consequences; (xi) risks relating to the regulatory approval process; (xii) interim, topline and preliminary data may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data; (xiii) 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; (xiv) Tectonic’s product candidates may cause serious adverse side effects; (xv) inability to maintain its collaborations, or the failure of these collaborations; (xvi) Tectonic’s reliance on third parties, including for the manufacture of materials for its research programs, preclinical and clinical studies; (xvii) failure to obtain U.S. or international marketing approval; (xviii) changes in expected or existing competition; (xix) the impact 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; (xx) changes in the regulatory environment; (xxi) the uncertainties and timing of the regulatory approval process; and (xxii) 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 the final prospectus on Form 424(b)(3) filed by AVROBIO with the SEC on May 3, 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.

DUBLIN, March 1, 2024 /PRNewswire/ -- The "Acute Heart Failure (AHF) Therapeutics: Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. Global Acute Heart Failure (AHF) Therapeutics Market to Reach $2.9 Billion by 2030 The global market for Acute Heart Failure (AHF) Therapeutics estimated at US$599.7 Million in the year 2022, is projected to reach a revised size of US$2.9 Billion by 2030, growing at a CAGR of 21.7% over the analysis period 2022-2030. Cardiac Glycosides, one of the segments analyzed in the report, is projected to record a 22.3% CAGR and reach US$762.4 Million by the end of the analysis period. Taking into account the ongoing post pandemic recovery, growth in the B-Blockers segment is readjusted to a revised 25.1% CAGR for the next 8-year period. The acute heart failure (AHF) market has been significantly impacted by the COVID-19 pandemic and the looming global recession. Despite the challenges, diuretics and vasodilators remain the first-line therapy for AHF, although the efficacy of other known drugs for AHF is limited, hindering their widespread use. Market insights and trajectories indicate a complex landscape influenced by these factors, with varying degrees of competitive market presence among players worldwide in 2022. Recent market activity reflects ongoing efforts to size the AHF market and adapt to the evolving healthcare landscape. Looking ahead, the market outlook suggests continued focus on addressing the challenges posed by COVID-19 and economic uncertainties while exploring opportunities for innovation and growth in AHF therapeutics. The U.S. Market is Estimated at $163.4 Million, While China is Forecast to Grow at 30.4% CAGR The Acute Heart Failure (AHF) Therapeutics market in the U.S. is estimated at US$163.4 Million in the year 2022. China, the world's second largest economy, is forecast to reach a projected market size of US$841.2 Million by the year 2030 trailing a CAGR of 30.4% over the analysis period 2022 to 2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 16.3% and 18.4% respectively over the 2022-2030 period. Within Europe, Germany is forecast to grow at approximately 17.1% CAGR. Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach US$433.4 Million by the year 2030. MARKET OVERVIEW Influencer Market Insights World Market Trajectories Market Outlook Recent Market Activity Sizing the AHF Market Acute Heart Failure - An Overview of the Disease and Available Therapeutics Diuretics and Vasodilators - The First Line Therapy for AHF Other Known Drugs for AHF - Lower Efficacy Thwarts Use Acute Heart Failure (AHF) Therapeutics - Global Key Competitors Percentage Market Share in 2022 (E) Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2022 (E) Impact of Covid-19 and a Looming Global Recession MARKET TRENDS & DRIVERS Conventional Therapies Leave Considerable Unmet Needs Novel Treatments Offer a Ray of Hope Key AHF Therapeutics in the Pipeline Serelaxin Nears Trial Readout form RELAX-AHF-2 Ularitide - A Novel Drug in Development for AHF The Litany of Drug Failures Expands, Emphasis on Prevention Grows Other Promising Drugs under Development Research Findings Kidney Dysfunction - Predictor of Acute Heart failure Genetic Influence on Heart Disease among African Americans Higher Body Mass Index - A Key Risk Factor for AHF Supplemental Oxygen Therapy May not be for All Cases of AHF Macro Growth Drivers Alarming Levels of Cardiovascular Disease (CVD) Prevalence: Key Growth Driver for AHF Therapeutics Ballooning Elderly Population: The Vital Growth Driver for AHF Therapeutics FOCUS ON SELECT PLAYERS (Total 93 Featured) Bayer AG (Germany) Bristol-Myers Squibb Company (USA) Cardiorentis AG (Switzerland) CVie Therapeutics Limited (Taiwan) Cytokinetics, Inc. (USA) Merck & Co. (USA) Novartis AG (Switzerland) Orion Corporation (Finland) PhaseBio Pharmaceuticals, Inc. (USA) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets