CollPlant Biotechnologies Ltd.

Greetings and welcome to Coal Plant Biotechnology's third quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Dori Kurowski, with LifeSci. Thank you. You may begin.

Good morning. I would like to welcome everyone to Coal Plant Biotechnology's Financial Results Conference Call for the third quarter ended September 30th, 2023 and Corporate Business Update. With us on the call today from Coal Plant are Yahil Tal, Chief Executive Officer, who will provide an overview of the company's programs and forthcoming updates, and Aaron Rotem, Deputy CEO and Chief Financial Officer who will provide a summary of COPLAN's financial results for the third quarter ending September 30, 2023. Before we get started, I would like to remind everyone that the statements made on this conference call may include forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors including those set forth in the Risk Factors section of Coal Plant's filings with the Securities and Exchange Commission. These filings can be found at www.sec.gov or on Coal Plant's website at www.coalplant.com. In addition, any forward-looking statements made on this call represent Coal Plant's views only as of today, November 29, 2023, and should not be relied upon as representing the company's views as of any subsequent date. Coal Plant Management specifically disclaims any obligation to update or revise any of these forward-looking statements. Finally, Coal Plant Management will refer to certain financial measures not reported in accordance with GAAP on this call. You can find reconciliations of these non-GAAP financial measures to the GAAP financial measures in the earnings press release that Coal Plant published earlier today. and which is available on Coal Plant's website at ire.coalplant.com. With that, let me turn the call over to Yahil Tal, Chief Executive Officer of Coal Plant Biotechnologies. Please go ahead, sir.

Good morning, everyone, and thank you for joining us today on Coal Plant's investor conference call to discuss our third quarter 2023 financial results and corporate developments. As you know, Israel has been in a state of war since October 7. First and foremost, I want to communicate to you about how we have been managing coal plants during this time. So it has very unfortunately been a significant part of our daily life. When the war started, coal plants management team implemented two key objectives. The first one was maintain company operations including R&D and general operations in support of the company's objectives and the second objective was to maintain employee safety and security. At the beginning of the war we established a crisis team comprised of management members that are closely monitoring all aspects of our company operations. This team is charged with key responsibilities, including maintaining ongoing communication with business partners, critical suppliers, major shareholders, analysts, bankers, and others, as well as strengthening ties with Cold Plants employees. In addition, approximately 10% of Cold Plants employees were drafted to the Army at the beginning of the war, and of course, we keep in touch with them. As of today, we can report that Cold Plant's production plan and main development programs have been minimally affected as a result of the war. Specifically, we can say that collagen production continues according to plan and that we continue to maintain an ongoing dialogue with our partners. The moral of our employees these days is reasonable according to the circumstances and their desire to come to the site and contribute to Cold Plant is commendable and at a good level. As Iran will expand upon later, we also took the initiative to make the necessary adjustments to the company's budget to accommodate the current challenging market conditions as well as the situation that Israel is in today. The company is now focusing on advancing its key programs that I will discuss shortly. We all pray that the war which was imposed upon us will end soon and life will get back to normal so that we can continue to contribute to our part to make life better and longer. Cortland is developing collagen technology and regenerative medicine products to improve and prolong lives. We have historically remained steadfast in the use of our cash and very conservative about utilizing the capital markets. We will continue to direct very careful focus on our core programs and our supportive partners in order to continue in this manner. Our goal is to create products that enable the regeneration of tissues and organs using our novel proprietary recombinant human collagen technology. Our collagen, which is produced in genetically engineered tobacco plants, is differentiated from the other types of collagen by its regenerative properties and also because it is xeno-tissue-free. Now, on to our development programs. On this slide is the dermal filler product candidate that we are partnered with AbbVie on. This product candidate, which is in clinical phase now, has the potential to create a paradigm shift in the fillers market, since in addition to tissue filling, it would provide regenerative properties for new skin growth. This program is our top focus and as planned, AbbVie continues to advance this filler program towards commercialization. Last quarter, we announced the achievement of a very important company milestone related to this product, Candidate, which triggered a $10 million payment to Coldplant in the third quarter. Coldplant has the potential to receive additional milestone payments as well as future royalties in accordance to its long-term collaboration with AVI for this dermal filler. This month, we announced that a U.S. patent was granted related to our photocurable dermal filler product candidate being developed by ColdPlant for the aesthetics market. The patent is related to our method of use and application, and we believe that this patent will strengthen our position in the aesthetic market for many years to come. Now I will discuss our other in-house development programs that are our core focus. The next leading program is our regenerative breast implants. Based on three years of development, we are now establishing the infrastructure for the next large animal study, which we plan to begin in December. The upcoming study will be conducted with clinically relevant commercial size implants and will serve as the basis for the pivotal large animal study. This study follows the completion of our first large animal study, the result of which were announced in January of this year. The first preclinical study demonstrated progressive stages of tissue regeneration after three months as highlighted by the formation of maturing connective tissue and neovascular networks within the implants with, importantly, no adverse events reported. We have previously stated, according to the FDA, patients with breast implants have an increased risk of developing breast implant-associated anaplastic loud cell lymphoma. This is a very serious risk. In the US alone, hundreds of thousands of people per year experience adverse events that range from autoimmune symptoms to this more serious side effect. Cold plant breast implants are comprised of its proprietary plant-derived RH collagen and other biomaterials and therefore are not expected to pose such a risk. Further, our breast implants are expected to regenerate breast tissue without eliciting immune response and thus may provide a revolutionary alternative for aesthetic and reconstructive procedures. The additional safety and efficacy data that we will generate from the large animal studies that I mentioned will be used to optimize the development of the regenerative breast implant and to support future regulatory submissions and clinical studies. Here is an example of a breast implant printed with our collaborators at Stratasys using ColdPlant's Rh-collagen-based bioinks. We look forward to reporting initial results from this study by the second half of next year. Last but not least is our Gut on a Chip program. This is an area where we have an opportunity to disrupt the market in terms of drug discovery and personalized medicine. We are developing a 3D bioprinted gut tissue model that is intended to evaluate the therapeutic response in patients suffering from ulcerative colitis. This model is designed to mimic the tissue of the human intestine to acid drug response metabolism and other factors in humans. A device as this would allow medical professionals to identify drug targets and personalized therapeutic responses that could lead to improved patient outcomes by providing a predictive, personalized platform in medicine. Tissue-on-a-chip devices are typically comprised of plastic chambers or channels that aim to recapitulate the distinct compartments and structures of the targeted tissue or organ. The multi-chip arrays that we are developing will be charged with our microfluidic chips that contain the bioprinted scaffolds and is intended to support high throughput therapy screening. Our system being developed is designed to enhance the physiological environment of the human intestine tissue and enable us to provide a predictive personalized platform. ColdPlant mimics the gut structure by 3D printing the gut tissue geometry in high resolution using its unique RH collagen-based bioink formulation. Recently, the ColdPlant team managed to successfully grow epithelial cells on the 3D bioprinted scaffolds. In many ulcerative colitis patients, failure to respond to a specific therapy can be determined only after three months of treatment. This is a significant amount of time to remain in therapy with an unknown outcome, which, of course, is not ideal for the patient. In addition to delaying what could be the initiation of an effective treatment, this option also bears the risk of exposing the patient to unjustified adverse events. With the large and growing inflammatory diseases market and the many new biological treatments being launched to address the needs of these patients, it is important to note that a need also exists for a reliable screening tool to provide a personalized prediction of treatment response. In various areas of personalized medicine, we expect that this approach could be a groundbreaking improvement over the existing use of animal models for drug developments. This could be a sustainable means for drug development and patient diagnosis without the use of animals. And we remind you, this program is also very much in line with our ESG initiatives. Recently, we have made strides in blustering our ESG environmental, social, and governance initiatives. After approving our company's sustainability roadmap for the upcoming year, we have initiated a range of projects aimed at reducing coal plants' carbon footprint and aligning with our vision and mission related to sustainability. Being able to communicate our planned initiatives was a mandate for us after we conducted a formal analysis of our current operations and identified what we are doing correctly or where we can further improve. In our commitment to advancing sustainability and ESG principles at Coal Plant, we produced a ranked list of material topics forming the foundation of our ESG strategy. These priorities were reviewed and approved by our senior leadership and board of directors. One of our key initiatives in the forthcoming publication in 2024 of our inaugural ESG report for 2023, which will outline for the first time precise ESG objectives. In September, Copeland proudly announced its participation in the United Nations Global Compact, the world's largest initiative for sustainable and responsible corporate governance. This alliance unites over 23,000 companies and 4,000 non-business signatories across 166 countries and more than 62 local networks. By joining this voluntary leadership platform, Kotland reaffirms its unwavering dedication to sustainable practices and further blusters its mission to provide sustainable alternatives to existing regenerative and aesthetics medicine products and technologies. This concludes my initial remarks about our core programs that we remain very excited about in terms of their prospects. Now, I will turn the call over to our Deputy CEO and Chief Financial Officer, Yaron Rotem, to provide a recap of the financial results. Yaron?