PARIS, France and HEIDELBERG, Germany (Ocober 2, 2024) – SK pharmteco, a global contract development and manufacturing organization (CDMO) for small molecules and advanced therapies, and AaviGen GmbH, a preclinical stage biotechnology company focused on the development of curative gene therapies for cardiovascular and cardiopulmonary diseases, today announced a multi-year manufacturing agreement wherein SK pharmteco will be the preferred manufacturing partner for Aavigen’s lead gene therapy product AVG-101 for the treatment of heart failure.
“SK pharmteco is a key partner for AaviGen as part of our strategy to develop and commercialize innovative gene therapies against diseases of the cardiovascular and cardiovascular system,” said Patrick Most, CEO of AaviGen. “The SK pharmteco team offered the trust, competence, and understanding of how a young company like AaviGen must operate in a dynamic market from the first minute of our interactions. We look forward to the collaboration with great confidence.”
AaviGen’s proprietary heart-specific adeno-associated viral vector technology enables the development of therapies that target and reverse the underlying molecular causes of heart muscle dysfunction. By focusing on key areas such as cardioprotection, contractility, and energy metabolism, AaviGen is committed to improving patient outcomes and restoring normal cardiac function.
“We are thrilled to partner with AaviGen on their innovative gene therapy for heart failure,” said Patrick Mahieux, SK pharmteco’s President of Cell and Gene, Europe. “Our deep expertise in viral vector manufacturing and our commitment to quality and efficiency make us the ideal partner to support the development and commercialization of this promising therapy. We look forward to contributing to the advancement of this groundbreaking treatment for patients in need.”
Martin Busch, PhD., COO of AaviGen added: “SK pharmteco stands out from the global pool of suppliers because of its extensive experience in process development and manufacturing of adeno-associated viral-based gene therapies. Additionally, their recent investments in expanding manufacturing capacity provide us with exceptional support from the earliest stages of development to the commercial phase, especially for common cardiac disorders, such as chronic heart failure.”
About AaviGen
AaviGen was founded in 2019 on the understanding that successful gene therapy requires optimized delivery of therapeutic targets to the diseased heart. AaviGen’s scientific approach is documented in numerous peer-reviewed scientific publications and validated by its founders’ track record in scientific innovations for the diagnosis and treatment of cardiac diseases, including gene therapy medicinal products. For more information, please see: www.aavigen.com
About SK pharmteco
SK pharmteco is a global contract development and manufacturing organization (CDMO) with production sites, research & development facilities, and analytical laboratories across the U.S., Europe, and Korea. The company partners with biopharmaceutical companies of all sizes to manufacture Active Pharmaceutical Ingredients (API) and intermediates, cell and gene therapy technologies, registered starting materials, and analytical services for the biopharmaceutical industry worldwide. SK pharmteco is a subsidiary of SK Inc. (KRX: 034730) (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate.
Contact
SK pharmteco
Keith Bowermaster, APR, CCMP
Communications Consultant
keith.bowermaster@skpt.com
www.skpharmteco.com
AaviGen
Prof. Marc Lerchenmüller, CFO
contact@aavigen.com
www.aavigen.com
Baltimore, USA – May 11, 2024 – AaviGen, a preclinical-stage biotechnology company focused on developing curative gene therapies for cardiovascular and cardiopulmonary diseases, presented its latest developments for its cardiac-specific AAV vector portfolio and therapeutic pipeline at this year’s ASGCT meeting in Baltimore. “We have been extremely pleased with the progress our company has made over the past year in our cardiac-specific AAV vectors from our Next Cap platform and their superiority over benchmark vectors from other developments for cardiac indications,” said Dr. Martin Busch, COO of AaviGen. “AaviGen’s next-generation cardiac vectors will enable the company to tailor effective and safe therapies for both common and rare heart diseases with access to global markets,” said Prof. Dr. Marc Lerchenmüller, CFO of AaviGen.”
About AaviGen
AaviGen was founded in 2019 on the understanding that successful gene therapy requires optimized delivery of therapeutic targets to the diseased heart. AaviGen’s scientific approach is documented in numerous peer-reviewed scientific publications and validated by its founders’ track record in scientific innovations for the diagnosis and treatment of cardiac diseases, including gene therapy medicinal products. For more information, please see: www.aavigen.com
AaviGen Investor and Media Contact
Prof. Dr. Marc Lerchenmüller, Chief Financial Officer and Managing Director AaviGen, Heidelberg, Germany
T: +49 6221 568900
M: +49 151 51646589
marc.lerchenmueller@aavigen.com
Heidelberg, Germany – July 26, 2023 – AaviGen GmbH, a preclinical stage biotechnology company focused on the development of curative gene therapies for cardiovascular and cardiopulmonary diseases, today announced the completion of its 17M € Series B financing round. Building on AaviGen’s proprietary portfolio of engineered cardiac-specific adeno-associated viral (AAV) capsids, the funding will enable the expansion of its preclinical programs and accelerate its lead gene therapy medicinal product (GTMP) for chronic heart failure towards the clinic. DH-LT Investments GmbH, an investment company led by Dietmar Hopp, commits the financing for the Series B to expand its existing shareholding in AaviGen.
Although current AAV-based gene therapy approaches have shown efficacy in several rare diseases, previous gene medicine developments directed against heart failure were hindered by imprecise targeting and the inability to transduce the heart effectively. AaviGen’s advanced AAV engineering platform is designed to develop differentiated AAV capsids optimized to target the diseased cardiovascular and cardiopulmonary system and to limit transduction of tissues and cell types that are not relevant to the target disease. In executing its lead GTMP program, AaviGen builds on the expertise and track record of its founders and leadership team as well as the experience and commitment of its investor: “Despite the steadily growing prevalence of heart failure, which affects more than 26 million people worldwide, there are essentially no curative therapies available targeting the underlying molecular causes. AaviGen’s therapeutic pipeline aspires to address this critical unmet need. Our highly innovative cardiac-targeted vector generation delivers therapeutic genes against the molecular and genetic foundation of acquired and hereditary heart failure with unprecedented safety and efficacy via a single intravenous injection”, commented Prof. Patrick Most, co-founder, CEO and Managing Director of AaviGen. “We are convinced that AaviGen’s innovative approach to delivering gene medicines to diseased tissues can become a game changer for the gene therapy field. Therefore, we are excited to continue supporting AaviGen in developing its therapeutic candidate for heart failure towards the clinic”, said Dietmar Hopp.
About AaviGen
AaviGen was founded in 2019 on the understanding that successful gene therapy requires optimized delivery of therapeutic targets to the diseased heart. AaviGen’s scientific approach is documented in numerous peer-reviewed scientific publications and validated by its founders’ track record in scientific innovations for the diagnosis and treatment of cardiac diseases, including gene therapy medicinal products. For more information, please see: www.aavigen.com
AaviGen Investor and Media Contact
Prof. Dr. Marc Lerchenmüller, Chief Financial Officer and Managing Director AaviGen, Heidelberg, Germany
T: +49 6221 568900
M: +49 151 51646589
marc.lerchenmueller@aavigen.com
Heidelberg, Germany – April 8, 2023 – AaviGen, a preclinical stage biotechnology company focused on the development of curative gene therapies for cardiovascular and cardiopulmonary diseases, announced the completion of its comprehensive cardiac-specific AAV vector development phase. Employing its next-generation Cardiac AAV Platform (next- CAP) that utilizes various human-relevant species, including non-human primates, AaviGen successfully engineered more than 70 proprietary capsids with the desired cardiac tropism and optimally ablated transduction propensity towards non-cardiac organs or tissues (e.g., liver, or dorsal root ganglions).
“We are extremely excited to see the achievements of our versatile cross-species next-CAP platform” said Dr. Martin Busch, COO and head of the R&D team. “Our scientific team has done an exceptional job designing a high-performance experimental/bioinformatic pipeline and successfully executing an elaborate developmental plan that addressed the challenges associated with such a complex endeavor. Our novel capsids have been engineered to target the heart specifically, which is crucial for AAV-based gene therapies that are applied systemically. This targeted approach can be further enhanced with suitable transcriptional control elements, such as cardiomyocyte-specific promoters, to optimize the expression specificity and strength of the therapeutic gene cassette, thereby countering the diverse molecular causes of either acquired or hereditary heart diseases.” Dr. Busch concluded.
About AaviGen
AaviGen was founded in 2019 on the understanding that successful gene therapy requires optimized delivery of therapeutic targets to the diseased heart. AaviGen’s scientific approach is documented in numerous peer-reviewed scientific publications and validated by its founders’ track record in scientific innovations for the diagnosis and treatment of cardiac diseases, including gene therapy medicinal products. For more information, please see: www.aavigen.com
AaviGen Investor and Media Contact
Prof. Dr. Marc Lerchenmüller, Chief Financial Officer and Managing Director AaviGen, Heidelberg, Germany
T: +49 6221 568900
M: +49 151 51646589
marc.lerchenmueller@aavigen.com
AaviGen’s Forward-Looking Statements
This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections of the company regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the
company’s strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.
Heidelberg, Germany – January 24, 2023 – AaviGen, a preclinical stage biotechnology company focused on the development of curative gene therapies for cardiovascular and cardiopulmonary diseases, announced that the strategic partnership with the German Primate Center (DPZ) successfully enabled the development of heart-specific adeno-associated viral (AAV) capsids in non-human primates via AaviGen’s next-generation Cardiac AAV Platform (next-CAP).
“We are excited to work side-by-side with our internationally renowned partner and expert in cardiovascular gene therapy development Prof. Dr. Rabea Hinkel and her experienced team at the DPZ to develop therapeutic solutions for yet incurable rare and common cardiac diseases” explains Prof. Dr. Patrick Most, AaviGen’s CEO. “Working with AaviGen at the forefront of heart-directed gene therapy concepts in human-relevant model systems advances our translational capabilities with access to a novel class of engineered therapeutic vector systems that are key for future effective, safe and easy to administer precision gene therapies against cardiac disorders” replied Prof. Dr. Rabea Hinkel, Director of the DPZ Laboratory Animal Science Unit.
AaviGen and the DPZ will continue their innovative collaborative work on next-generation cardiac gene therapy medicinal product development in human-relevant model systems and accelerate the path to clinical solutions by the creation of synergies.
About AaviGen
AaviGen was founded in 2019 on the understanding that successful gene therapy requires optimized delivery of therapeutic targets to the diseased heart. AaviGen’s scientific approach is documented in numerous peer-reviewed scientific publications and validated by its founders’ track record in scientific innovations for the diagnosis and treatment of cardiac diseases, including gene therapy medicinal products. For more information, please see: www.aavigen.com
About DPZ
The German Primate Center GmbH (DPZ) – Leibniz Institute for Primate Research conducts biological and biomedical research on and with primates in the fields of infection research, neuroscience and primate biology. The DPZ also maintains four field stations in the tropics and is a reference and service center for all aspects of primate research. The DPZ is one of the 97 research and infrastructure facilities of the Leibniz Association.
AaviGen Investor and Media Contact
Prof. Dr. Marc Lerchenmüller, Chief Financial Officer and Managing Director AaviGen, Heidelberg, Germany
T: +49 6221 568900
M: +49 151 51646589
marc.lerchenmueller@aavigen.com
AaviGen’s Forward-Looking Statements
This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections of the company regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the company’s strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.
Heidelberg, Germany – December 14, 2022 – For the first time, AaviGen presented data on its novel heart-specific adeno-associated viral (AAV) vector portfolio generated by its next- generation Cardiac AAV Platform (next-CAP) to an international audience. The invited presentation took place at the Cell & Gene Therapy Meeting (December 14 – 15, 2022) hosted by the Economic Partnership Initiative between Baden-Württemberg and United Kingdom. In addition, AaviGen showcased its dual-organ engineered AAV capsids suited, e.g., for neurological or muscular diseases with secondary involvement of the heart, such as Friedreich Ataxia or Muscular dystrophies. The meeting (https://cell-and-gene- therapy.b2match.io/home) is jointly organized by BIOPRO Baden-Württemberg, the UK Department for International Trade, Scottish Development International, Welsh Government, London & Partners and the cluster MedCity as well as the Northern Health Science Alliance.
“AaviGen‘s proprietary novel engineered AAV capsids are key to our comprehensive strategy to develop broadly applicable curative AAV-based gene therapies for rare and common heart diseases.” stated Dr. Martin Busch, COO of AaviGen. “The further expanding engineered AAV vector portfolio is the foundation to develop our therapeutic products and build partnerships in the rapidly growing field of DNA- and RNA-based treatments of cardiovascular and cardiopulmonary disorders” explicated Prof. Marc Lerchenmüller, AaviGen’s CFO. “We are extremely excited to see the growing results of our continued innovative work and the forward-looking investment made by Dietmar Hopp. 2023 will be a decisive part in AaviGen’s innovative journey.” said Prof. Patrick Most and Prof. Hugo Katus, CEO and CMO of AaviGen.
About AaviGen
AaviGen was founded in 2019 on the understanding that successful gene therapy requires optimized delivery of therapeutic targets to the diseased heart. AaviGen’s scientific approach is documented in numerous peer-reviewed scientific publications and validated by its founders’ track record in scientific innovations for the diagnosis and treatment of cardiac diseases, including gene therapy medicinal products. For more information, please see: www.aavigen.com
AaviGen Investor and Media Contact
Prof. Dr. Marc Lerchenmüller, Chief Financial Officer and Managing Director AaviGen, Heidelberg, Germany
T: +49 6221 568900
M: +49 151 51646589
marc.lerchenmueller@aavigen.com
AaviGen’s Forward-Looking Statements
This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections of the company regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the company’s strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.
Heidelberg, Germany – June 6, 2022 – AaviGen GmbH, a preclinical stage biotechnology company focused on the development of curative gene therapies for cardiovascular and cardiopulmonary diseases, today announced the appointment of Prof. Walther J. Koch as a member of the scientific advisory board. “At AaviGen, we seek to translate excellent basic cardiovascular science into the next generation of a novel class of cardiovascular and cardiopulmonary adeno-associated viral based gene therapies. The exceptional expertise Prof. Koch contributes as a pioneer in the cardiac gene therapy field and world-wide leader in molecular and translational cardiovascular science will be decisive for AaviGen’s ability to transform molecular discoveries into clinical concepts” says Prof. Patrick Most, CEO of AaviGen GmbH. Prof. Koch said, “Through its versatile vector development platform, AaviGen moved into an ideal position to provide easy-to-use and highly effective gene therapies for common and rare diseases of the cardiovascular system that were previously inaccessible to this novel treatment. I look forward to contributing my experience in basic and translational cardiovascular gene therapy research to aid in navigating AaviGen towards successful completion of its innovative programs.”
About AaviGen
AaviGen was founded in 2019 on the understanding that successful gene therapy requires optimized delivery of therapeutic targets to the diseased heart. AaviGen’s scientific approach is documented in numerous peer-reviewed scientific publications and validated by its founders’ track record in scientific innovations for the diagnosis and treatment of cardiac diseases, including gene therapy medicinal products. For more information, please see: www.aavigen.com
AaviGen Investor and Media Contact
Prof. Dr. Marc Lerchenmüller, Chief Financial Officer and Managing Director AaviGen, Heidelberg, Germany
T: +49 6221 568900
M: +49 151 51646589
marc.lerchenmueller@aavigen.com
AaviGen’s Forward-Looking Statements
This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions, or projections of the company regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the company’s strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking
statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.
Heidelberg, Germany – December 13, 2021 – AaviGen GmbH, a preclinical stage biotechnology company focused on the development of curative gene therapies for cardiovascular and cardiopulmonary diseases, today announced the appointment of Eric Goossens as a member of the scientific advisory board. “We are very pleased that Eric Goossens will advise AaviGen GmbH in the multifaceted process of gene therapy medicinal product development. His comprehensive expertise and many years of experience in large and medium sized bioindustrial and R&D companies in the areas of biotechnology and particularly adeno-associated viral vector manufacturing will further strengthen AaviGen’s position in terms of process development and vector manufacturing” commented Dr. Martin Busch, COO of AaviGen GmbH. “I am excited to support AaviGen in achieving its goals to provide curative therapies in the targeted unmet medical need. AaviGen is moving in the forefront of heart directed gene therapy and I am proud to share my expertise with AaviGen’s leadership team to fulfill their mission to help patients.”.
About AaviGen
AaviGen was founded in 2019 on the understanding that successful gene therapy requires optimized delivery of therapeutic targets to the diseased heart. AaviGen’s scientific approach is documented in numerous peer-reviewed scientific publications and validated by its founders’ track record in scientific innovations for the diagnosis and treatment of cardiac diseases, including gene therapy medicinal products. For more information, please see: www.aavigen.com
AaviGen Investor and Media Contact
Prof. Dr. Marc Lerchenmüller, Chief Financial Officer and Managing Director AaviGen, Heidelberg, Germany
T: +49 6221 568900
M: +49 151 51646589
marc.lerchenmueller@aavigen.com
AaviGen’s Forward-Looking Statements
This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections of the company regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the company’s strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks,
uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.
Heidelberg, Germany – December 13, 2021 – AaviGen GmbH, a preclinical stage biotechnology company focused on the development of curative gene therapies for cardiovascular and cardiopulmonary diseases, today announced the appointment of Dr. Robert W. Makuch as a member of the scientific advisory board. “At AaviGen, we constantly strive for optimal regulatory and clinical strategies in a versatile global market to bring our innovative therapeutics most efficiently to our patients. The profound expertise Dr. Makuch is making available to AaviGen from his extensive work in biopharmaceuticals with regulatory authorities in the US, China and Europe will be key to effectively meet the differing requirements across the major markets” says Prof. Hugo Katus, CMO of AaviGen GmbH. Dr. Makuch said, “Through its inventive scientific research endeavors, AaviGen is poised to identify a number of curative gene therapies aimed at addressing global challenges in the treatment of cardiovascular and cardiopulmonary diseases. I look forward to contributing my expertise in regulatory affairs science and the assessment of complex scientific evidence to help guide AaviGen towards successful completion of its research programs.”
About AaviGen
AaviGen was founded in 2019 on the understanding that successful gene therapy requires optimized delivery of therapeutic targets to the diseased heart. AaviGen’s scientific approach is documented in numerous peer-reviewed scientific publications and validated by its founders’ track record in scientific innovations for the diagnosis and treatment of cardiac diseases, including gene therapy medicinal products. For more information, please see: www.aavigen.com
AaviGen Investor and Media Contact
Prof. Dr. Marc Lerchenmüller, Chief Financial Officer and Managing Director AaviGen, Heidelberg, Germany
T: +49 6221 568900
M: +49 151 51646589
marc.lerchenmueller@aavigen.com
AaviGen’s Forward-Looking Statements
This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions, or projections of the company regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the company’s strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place
undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.
Heidelberg, Germany – December 22, 2020 – AaviGen GmbH, a preclinical stage biotechnology company focused on the development of curative gene therapies for cardiovascular and cardiopulmonary diseases, today announced the completion of its initiating 5 million € first financing round. The fundraising adds DH-LT Investments GmbH, an investment company owned and led by SAP co-founder Dietmar Hopp, to AaviGen’s shareholders. The proceeds of the financing will enable the development of precision gene therapies for heart failure, a highly prevalent disease affecting 26 million people worldwide. AaviGen was advised by Mayer Brown LLP, under the lead of Dr. Jan Streer, on the legal aspects of the fundraising.
AaviGen’s lead program employs heart-specific recombinant adeno-associated viruses to bring therapeutic genes with unprecedented ease, safety, precision, and personalization to the diseased heart via a single intravenous injection. In executing its program, AaviGen builds on the expertise and track record of its founders and leadership team as well as the experience and commitment of its investor: “Despite the steadily growing prevalence of heart failure, there are essentially no curative therapies available targeting the molecular causes of the disease. AaviGen aspires to address this critical unmet need with a highly innovative vector engineering technology and gene therapy platform. AaviGen’s new program builds on our experience gained in our late-stage preclinical biotechnology company InoCard”, commented Prof. Patrick Most, co-founder, CEO and Managing Director of AaviGen. “The AaviGen team has proven expertise in advancing scientific innovations in healthcare. I am excited to support AaviGen in launching its development program”, said Dietmar Hopp.
About AaviGen
AaviGen was founded in 2019 on the understanding that successful gene therapy requires optimized delivery of therapeutic targets to the diseased heart. AaviGen’s scientific approach is documented in numerous peer-reviewed scientific publications and validated by its founders’ track record in scientific innovations for the diagnosis and treatment of cardiac diseases, including gene therapy medicinal products. For more information, please see: www.aavigen.com
AaviGen Investor and Media Contact
Prof. Dr. Marc Lerchenmüller, Chief Financial Officer and Managing Director AaviGen, Heidelberg, Germany
T: +49 6221 568900
M: +49 151 51646589
marc.lerchenmueller@aavigen.com
AaviGen’s Forward-Looking Statements
This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections of the company regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the company’s strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.