GeneQuine Biotherapeutics Secures More Than €9 Million in Series A Financing and Non-Dilutive Funding to Advance Gene Therapy Pipeline for Musculoskeletal Diseases

• Proceeds will facilitate development of GeneQuine’s gene therapy pipeline for musculoskeletal disorders and vector platform

• Lead gene therapy candidate GQ-303, a potentially disease-modifying treatment for osteoarthritis, will be advanced to Phase 1 clinical trial

• Gene therapy program for intervertebral disc degeneration will be accelerated

• Company is expanding with additional site and staff

Hamburg, Germany, January 26, 2021 – GeneQuine Biotherapeutics GmbH, a biotech company focused on the development of gene therapy for musculoskeletal disorders, today announced that it has raised €5.4 million in Series A financing and €3.65 million non-dilutive funding bringing the total amount raised to €9.05 million. The Series A investment round was led by Pacira BioSciences, Inc. (Nasdaq: PCRX), a specialty pharmaceutical company and the leading provider of non-opioid pain management and regenerative health solutions, headquartered in Parsippany, NJ, USA. Other investors include High-Tech Gründerfonds, Bonn, Germany, who had previously invested in GeneQuine, as well as Noshaq S.A., Liège, Belgium and Samum Vermögensverwaltungs GmbH, Hamburg, Germany. The non-dilutive funding consists of a convertible loan provided by Pacira BioSciences, Inc. and Samum Vermögensverwaltungs GmbH of in total €2.75 million and a grant by the investment bank of the state of Brandenburg (Germany) of €0.9 million.

The raised funds will be used to advance GeneQuine’s lead candidate GQ-303 for osteoarthritis (OA) to a phase 1 clinical trial, to develop new gene therapies for the treatment of intervertebral disc degeneration, to expand GeneQuine’s gene therapy vector platform and to grow the company’s operations. Last year, GeneQuine already expanded by hiring additional staff and setting up a subsidiary in Liège, Belgium. GeneQuine is headquartered in Hamburg, Germany, and operates an R&D site in Luckenwalde (greater Berlin area), Germany.

GeneQuine’s aim is to employ its gene therapy platform based on helper-dependent adenoviral (HDAd) vectors to turn tissues or organs that need to be treated into factories for local production of therapeutic proteins. Based on the concept of gene therapy, a single local injection should be sufficient to achieve multi-year protein production, avoiding the need for frequent drug administration as it is common for many conventional drugs.

GQ-303, currently at preclinical stage, is an HDAd vector expressing the protein proteoglycan 4 for local treatment of OA. Proteoglycan 4 (also known as lubricin) has been shown to have a dual mechanism of action in OA: 1) a biomechanical effect due to its lubricating properties, and 2) effects on molecular pathways leading to suppression of pain, inflammation and cartilage degeneration. Based on this unique mechanism of action, GQ-303 has the potential to be a symptomatic and disease-modifying therapeutic as demonstrated in several preclinical in vivo studies. GeneQuine is in advanced negotiations with a major contract manufacturing organization for production of GQ-303 for toxicology and clinical studies. Following production of GQ-303, GeneQuine will conduct pivotal toxicology studies in order to file an IND/clinical trial application. In 2017, GeneQuine’s then-lead gene therapy program, which is an HDAd vector expressing the protein interleukin-1 receptor antagonist (now called FX201) was acquired by the pharmaceutical company Flexion Therapeutics, Inc., Burlington, MA, USA. In 2019, Flexion initiated a Phase 1 clinical trial in knee OA and has treated several patients with FX201 at two dose levels. As GQ-303 and FX201 are both HDAd vectors and are both injected intraarticularly for treatment of knee OA, GeneQuine considers most vector-related development risks for GQ-303 minimized. While both GQ-303 and FX201 are being developed for knee OA, GQ-303 will initially target a patient population that is thought to benefit most from the unique dual mechanism of action of proteoglycan 4.

GeneQuine is also developing HDAd-based gene therapies for treatment of intervertebral disc degeneration. Despite the tremendous unmet medical need in the treatment of intervertebral disc degeneration as one of the main causes for chronic low back pain, no disease-modifying medications are currently available. GeneQuine’s data suggest that local HDAd-mediated gene therapy has great potential in the development of a symptomatic and disease-modifying drug for this disease.

“We are very excited that we have raised this financing round, and are eager to put these funds to work to bring GQ-303 to the clinic, accelerate the development of gene therapy for intervertebral disc degeneration and build out our HDAd vector platform. We thank all the investors that participated in this financing round for their support. It is especially exciting to have Pacira as an investor on board given their expertise in clinical drug development in the musculoskeletal space” said Kilian Guse, CEO of GeneQuine.

“Our equity investment in GeneQuine represents a significant opportunity to participate in the development of what we believe is an exciting disease-modifying gene therapy for osteoarthritis. GeneQuine is conducting preclinical work to support the initiation of human studies in approximately two years. In addition to our confidence in this transaction as a sound investment, we enthusiastically look forward to the maturation of data and for further opportunity to participate in GeneQuine’s successful preclinical program and entry into the clinic. Importantly, this investment is consistent with our mission to advance innovative pain management and regenerative health solutions,” said Ron Ellis, DO, senior vice president, corporate strategy and business development at Pacira.

“We are proud that we have attracted GeneQuine to Wallonia and that they set up a subsidiary in the region to advance their lead gene therapy program in collaboration with other local companies and academic partners in our life science ecosystem. GeneQuine develops unique gene therapies for treatment of musculoskeletal disorders and we look forward to seeing GeneQuine bring their lead candidate GQ-303 for osteoarthritis to clinical stage” said Gaetan Servais, CEO of Noshaq.

Martin Pfister, principal at High-Tech Gründerfonds (HTGF), comments: “GeneQuine is a great example of what we believe is a typical HTGF investment: An exciting technology at the very forefront of scientific development when we first invested in 2012 combined with a strong team that is capable of advancing gene therapy towards the clinic in a most efficient manner. We are looking forward, together with our co-investors and the know-how of Pacira, to supporting GeneQuine with the clinical translation of their promising pipeline.”

About GeneQuine Biotherapeutics GmbH

GeneQuine Biotherapeutics GmbH is a biotech company focused on the development of innovative gene therapies for treatment of musculoskeletal disorders. GeneQuine’s aim is to use its gene therapy platform to established sustained production of therapeutic proteins locally in the tissues or organs where they are needed. The lead candidate GQ-303 is being developed as a locally administered treatment for osteoarthritis and has demonstrated the potential to be a symptomatic and disease-modifying treatment in several animal models. In 2017, Flexion Therapeutics, Inc. acquired GeneQuine’s then-lead program for osteoarthritis, which is based on the same gene therapy vector technology as GQ-303 and is currently in clinical Phase 1 testing. GeneQuine is headquartered in Hamburg, Germany and has sites at Luckenwalde (greater Berlin area), Germany and Liège, Belgium.
Further information is available at: www.genequine.com

About Pacira

Pacira BioSciences, Inc. (Nasdaq: PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company’s long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves.
To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com

About Noshaq S.A.

Noshaq is a Belgian investment fund and project developer with a portfolio of 464 companies and 600 million euros of resources. Noshaq is the reference financial partner for the creation and development of SMEs in the Liège Region (Wallonia). Over the years, Noshaq has developed a range of financing vehicles in line with the needs and trends of the market and its strategy. Each service offered by Noshaq (capital - loan - leasing) is always determined according to the demand and needs of the owner-investor. The objective is always to have a leverage effect on the company's development.
Further information is available at: www.noshaq.be

About High-Tech Gründerfonds

The seed investor High-Tech Gründerfonds (HTGF) finances technology start-ups with high potential for growth. With a volume of around 900 million euros spread over three funds and an international partner network, the HTGF has supported almost 600 start-ups since 2005. Its team of experienced investment managers and start-up experts supports the young companies with know-how, entrepreneurial spirit and passion. The focus is on high-tech start-ups in the fields of digital tech, industrial tech, life sciences, chemistry and related business areas. To date, external investors have invested more than 2.6 billion euros in the HTGF portfolio in more than 1,600 follow-up financing rounds. The fund has also successfully sold shares of more than 100 companies. Investors in the public-private partnership include the Federal Ministry of Economics and Energy, KfW Capital, the Fraunhofer-Gesellschaft and 32 companies.
Our investors: www.htgf.de/en/about-us/fund-investors
Further information is available at: www.htgf.de/en

(Image by GeneQuine)