- Entering field of RNA therapeutics through acquisition of Trasir Therapeutics, Inc.
- Trasir’s innovative peptide-based OligoPhoreTM platform designed to enable extrahepatic delivery of oligonucleotides
- Trasir’s founder, Dr. Samuel Wickline, joining leadership team as Chief Scientific Officer
- Strategic repositioning around RNA therapeutics and plans for spin-off or divestiture of existing programs in medium term
- Extraordinary general meeting of shareholders to vote on change of Company’s name to Altamira Therapeutics Ltd. and election of Margrit Schwarz as new Board member
- Conference call and webcast today at 8 am EDT
Hamilton, Bermuda, June 3, 2021 – Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders, today announced the acquisition of privately held Trasir Therapeutics, Inc. (“Trasir”), based in Tampa, FL, a pioneer in extrahepatic oligonucleotide delivery. The purchase price comprises 0.77 million common shares of the acquiring Company, the assumption of certain selling shareholders’ cash outlays as well as a future share-based payment contingent on reaching a specific development milestone. The transaction, which closed on June 1, 2021, is the starting point for a strategic repositioning under which the Company intends to focus on the development of RNA therapeutics while in the medium term aiming to spin off or divest its existing assets in neurotology, rhinology and allergology. Dr. Samuel Wickline, Trasir’s founder and Professor of Medicine, has been appointed Chief Scientific Officer and joined the Company’s leadership team.
Repositioning the Company to focus on emerging RNA therapeutic opportunities
“Following a thorough review of various strategic options, we are very excited to enter with the Trasir acquisition the field of oligonucleotide delivery, which we believe will provide us with a new range of RNA-based therapeutics with disruptive potential”, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “The global market for RNA therapeutics has been growing fast, exceeding $1 billion in 2020. However, appropriate delivery technologies have remained a key rate-limiting step for unlocking their potential. Trasir’s groundbreaking OligoPhore technology allows for effective delivery of RNA payloads to tissues beyond the liver, which is inadequately addressed with current delivery approaches. We look forward to applying OligoPhore for the development of truly innovative RNA therapeutics and advancing them to clinical proof of concept.” He added: “Although we continue to believe that our existing business holds great promise, we acknowledge investors’ preferences for highly focused company strategies. Therefore, we will prepare for its separation either through a divestiture or a spin-off to shareholders within the next 12-18 months. Through the strategic repositioning and transformation of the Company, we aim to unlock and create significant shareholder value.”
Overcoming key challenges in RNA delivery
Trasir was founded in 2014 by Dr. Wickline based on extensive NIH-sponsored research on technologies that enable safe and effective oligonucleotide delivery to extrahepatic tissues at Washington University, St. Louis MO. Its core technology is the proprietary peptide polyplex platform OligoPhoreTM that can engage any type of RNA in rapid self-assembly. OligoPhoreTM allows for safe and effective systemic delivery of oligonucleotide payloads with efficient cellular uptake and full endosomal release. Importantly, OligoPhoreTM enables delivery to target tissues outside the liver, creating the potential for developing RNA-based therapies for a range of indications with substantial unmet need.
In various murine models of disease, OligoPhoreTM has been shown to protect the RNA payload (siRNA and/or mRNA) from degradation in the circulation, while enabling pH-dependent nucleotide endosomal escape and cytoplasmic delivery. Proof-of-concept for efficient delivery and target knockdown has been demonstrated for targets in the NF-kB family, various members of the ETS transcription factor family, and targets in the JNK and TAM pathways, enabling a preclinical development pathway for several oncology indications, rare diseases, as well as rheumatoid and osteoarthritis and inflammatory pathologies such as atherosclerosis.
Based on the extensive work of Dr Wickline and collaborators, the Company intends to initiate under project code AM-401 the preclinical development of the first pipeline program in an oncology or rare disease indication. The submission of an IND is targeted for the end of 2022. In parallel, the Company will explore further potential applications of the OligoPhoreTM platform for delivery of siRNA, mRNA and gene editing constructs, and seek to leverage the platform’s potential through strategic partnering.
Proposed change of Company name to reflect new strategic focus
To reflect the Company’s strategic repositioning, the Board of Directors of Auris Medical Holding Ltd. intends to call an extraordinary general meeting of shareholders to propose to change its corporate name to Altamira Therapeutics Ltd. Upon approval of the proposed name change, the Company’s shares will start trading under the ticker symbol “CYTO” – the word root for cell in ancient Greek – instead of “EARS”. In addition, the Board intends to propose the election of Margrit Schwarz, PhD, MBA, as an additional Board member. Margrit Schwarz brings with her 25 years of experience in drug discovery and development across multiple indications and modalities, acquired in the global biopharmaceutical industry (Amgen, Boehringer Ingelheim, Roche, Genevant) and in international academic research settings.
Conference Call & Webcast
Auris Medical's management team will host a live conference call and webcast to present and discuss the Trasir Therapeutics acquisition and its business implications at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial +1-877-870-9135 (US, toll free) or +44-2071-928-338 (international), and enter passcode 4581447. A live webcast of the conference call can be accessed in the Investor Relations section of the Auris Medical website at www.aurismedical.com. A replay will be available approximately two hours following the live call.
About Auris Medical
Auris Medical is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of oligonucleotides for extrahepatic therapeutic targets (OligoPhoreTM platform; preclinical), nasal sprays for protection against airborne viruses and allergens (BentrioTM; pre-commercial) or the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®, Phase 3). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol “EARS.”
This press release may contain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Auris Medical’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may”, “might”, “will”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “projects”, “potential”, “outlook” or “continue”, or the negative of these terms or other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval and timing of commercialization of AM-301, Auris Medical’s need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Auris Medical’s product candidates, the clinical utility of Auris Medical’s product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical’s intellectual property position and Auris Medical’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical’s capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s Annual Report on Form 20-F for the year ended December 31, 2020, and in Auris Medical's other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.