On Target Laboratories and Mauna Kea Technologies Announce a Novel Clinical Research and Product Development Collaboration

The collaboration will explore and establish the value of molecular image-guided procedures for the identification and diagnosis of pulmonary cancers during interventional bronchoscopy, leveraging two complementary technologies

PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News:

On Target Laboratories, Inc. (‘On Target’) a privately-held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery and Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA, ‘Mauna Kea’) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announced a novel clinical research and product development collaboration in the field of molecular image-guided procedures.

The collaboration was created to further develop the combined clinical and technological capabilities of both companies, with an initial focus on interventional pulmonology and lung cancer, and the opportunity to expand into additional indications.

Lung cancer is the world’s leading cause of cancer deaths and its diagnosis remains challenging, despite significant advancements in diagnostic and treatment technologies. The number of lung nodules identified on chest CTs continues to rise with one study estimating that, in the U.S. alone, nearly 1.6 million people who underwent a chest CT had a pulmonary nodule identified¹. Determining if a suspicious pulmonary nodule is malignant or benign can be challenging and time-consuming, often requiring multiple biopsy attempts and/or invasive procedures which can result in inconclusive results and complications. One study reported it can take up to 6 months to diagnose a lung nodule and the majority were diagnosed at advanced stages of the disease, underscoring the need for earlier and more accurate diagnoses².

Molecular imaging is a growing field of technology for interventional and surgical procedures to detect cancer cells for easier and more precise visualization. On Target’s imaging agents target and bind to cancer cells, providing healthcare professionals with a tool to detect cancer for removal. Mauna Kea’s Cellvizio platform provides the ability to image tissues at the cellular level, including the identification of cancer cells through a non-invasive bronchoscopy procedure³. Combining the two technologies has the potential to create a novel category of medical procedures – Molecular Image-guided Procedures (MIP) – which would provide real-time visualization of cancer at the cellular level. The use of MIP during bronchoscopic lung biopsy may improve the diagnostic accuracy of biopsies while reducing the number of procedures, time, and complications associated with obtaining a diagnosis.

“We are guided by our mission to illuminate cancer intraoperatively. This collaboration with Mauna Kea has the potential to expand the benefits of intraoperative molecular imaging to interventional pulmonology,” said Chris Barys, President and Chief Executive Officer of On Target Laboratories. “We look forward to seeing the meaningful difference these two transformational technologies could bring to patients fighting cancer.”

“This collaboration underscores our company’s commitment to the field of interventional pulmonology and brings together two powerful and complementary technologies in the molecular imaging market,” said Nicolas Bouvier, Interim Chief Executive Officer of Mauna Kea Technologies. “Through this collaboration, On Target and Mauna Kea can develop and validate a new class of diagnostic options for patients with cancer, making a transformative change in how physicians manage their patients.”

About On Target Laboratories

On Target Laboratories discovers and develops targeted fluorescent imaging agents to illuminate cancer during surgery so cancerous tissue can be identified for removal. Their fluorescent imaging technology, based on the pioneering work of Philip S. Low, PhD, Purdue University's Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry, aims to reduce the uncertainty associated with finding and removing cancerous tissue during surgical procedures, helping surgeons to provide a more precise and complete surgical resection. CYTALUX, the Company's first product, is being studied in the investigational Phase 3 ELUCIDATE Trial for lung cancer in the US. For more information visit www.ontargetlabs.com.

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit www.maunakeatech.com.

Disclaimer

Mauna Kea Technologies

This press release contains forward-looking statements concerning Mauna Kea Technologies and its activities. All statements other than statements of historical fact included in this press release, including, without limitation, those regarding Mauna Kea Technologies’ financial condition, business, strategies, plans and objectives of management for future operations are forward-looking statements. Such forward looking statements are based on assumptions that Mauna Kea Technologies considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties, including the risks set forth in Chapter 3 of the 2020 Universal Registration Document of Mauna Kea Technologies registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on June 17, 2021 under number D-21-0566 and the amendment to the 2020 Universal Registration Document filed with the AMF on September 17, 2021, which are both available on the Company's website (www.maunakeatech.com), and risks relating the economic situation, financial markets, and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this release are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Mauna Kea Technologies that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for, Mauna Kea Technologies shares in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. The distribution of this document may, in certain jurisdictions, be restricted by local regulations. Persons who come into possession of this document are required to observe all applicable local regulations relating to this document.

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¹ Gould MK, Tang T, Liu IL, Lee J, Zheng C, Danforth KN, Kosco AE, Di Fiore JL, Suh DE. Recent Trends in the Identification of Incidental Pulmonary Nodules. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1208-14. doi: 10.1164/rccm.201505-0990OC. PMID: 26214244.

² Gildea TR, DaCosta Byfield S, Hogarth DK, Wilson DS, Quinn CC. A retrospective analysis of delays in the diagnosis of lung cancer and associated costs. Clinicoecon Outcomes Res. 2017;9:261-269. doi.org:10.2147/CEOR.S132259

³ Kramer T, Wijmans L, de Bruin M, et al Bronchoscopic needle-based confocal laser endomicroscopy (nCLE) as a real-time detection tool for peripheral lung cancer Thorax Published Online First: 25 June 2021. doi: 10.1136/thoraxjnl-2021-216885