Additional large-animal study with commercial-size breast implants commenced in December 2023 expected to conclude in June 2024 Cash and cash equivalents balance as of March 31, 2024, was $23.2 million Conference call and webcast to discuss its financial results and corporate updates on May 29 at 10:00 a.m. Eastern Daylight Time (details herein) REHOVOT, Israel, May 29, 2024 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ:CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived collagen for tissue regeneration and medical aesthetics, today announced results for the first quarter ended 2024 and provided a corporate update. "In December 2023 we commenced large-animal trials to evaluate commercial-size, 3D-bioprinted, regenerative breast implants. Currently, there are no commercially-available implants that allow regeneration of breast tissue," commented Yehiel Tal, CollPlant's Chief Executive Officer. "CollPlant's breast implants in development are unique in that they are designed to regenerate breast tissue as well as have inherent safety advantages. A primary goal of the large animal study is to obtain data which would support optimization of the implant design and composition. We plan to then apply this design to a pivotal large-animal study of commercial-size implants that is intended to be the subject of discussions with the FDA." Mr. Tal continued, "Also, since the beginning of the year, we have worked to finalize our first Environmental, Social and Governance, or ESG, report evaluating designated areas of focus to take measurable steps to improve towards becoming a sustainable organization. This comprehensive report highlights our commitment to sustainable practices, ethical governance, and positive social impact. It outlines our new goals in key ESG areas, reflecting our dedication to transparency and accountability. By setting these targets, we aim to create long-term value for our stakeholders while driving meaningful progress towards a more sustainable future. Q1 and Recent Program Highlights In January of 2024, CollPlant announced its initiation of a pre-clinical trial to evaluate commercial-size, 3D-bioprinted, regenerative breast implants. Currently, there are no commercial products that allow regeneration of soft tissues such as the breast and many safety issues exist with current implants. Still, the current annual market for breast implants is estimated at $2.9 billion. In the U.S. alone, hundreds of thousands of people each year experience adverse events that range from autoimmune symptoms to the very serious breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). CollPlant's breast implants, comprised of the Company's proprietary plant-derived rhCollagen and other biomaterials, are expected to regenerate breast tissue without eliciting immune response and therefore may provide a revolutionary alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients. This study follows CollPlant's first large-animal study with positive results announced in January 2023, which 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 no adverse events reported. The dermal and soft tissue filler product candidate for the medical aesthetics market is currently undergoing testing in clinical trials that are designed, planned, and executed by AbbVie, CollPlant business partner. According to the agreement between both parties, AbbVie is responsible for all the costs of the development, including the costs of the clinical trials.  Patent Updates In the fourth quarter of 2023, the U.S. Patent and Trademark Office granted CollPlant a patent that relates to its photocuring technology and serves as the basis of its photocurable dermal filler product candidate, being developed for the aesthetics market. In March 2024, the same patent application received allowance in Brazil. Patents were also granted in Israel and Australia allowing for protection until 2039 in these regions. This newly issued patent is related to CollPlant's photocuring technology within its photocurable dermal filler product candidate and represents an integral part of the Company's strategy to expand the uses for its novel, rhCollagen technology into new, high-value markets. ESG Updates During the past year, CollPlant initiated its ESG activities and set new goals in various key ESG areas. CollPlant's main ESG targets are to minimize its carbon footprint, improve the lives of the people that it interacts with, and establish a strong ethical governance mission. CollPlant's first ESG report, which is planned for publication this quarter, will highlight these goals and its current achievements. First Quarter Financial Results GAAP revenues for the first quarter ended March 31, 2024 were $98,000, a decrease of $335,000 compared to $433,000 in the first quarter ended March 31, 2023. Revenues included mainly sales of the Company's rhCollagen products. GAAP cost of revenue for the first quarter ended March 31, 2024 were $545,000, compared to $325,000 for the first quarter ended March 31, 2023. Cost of revenue mainly includes the cost of the Company's rhCollagen based products including maintenance and operation costs of its manufacturing plants, royalties to the Israeli Innovative Authorities for its sales and inventory write-off. The increase in cost of revenue in the amount of approximately $220,000 is mainly related to fixed cost of operating and maintaining the production facilities, against a quarter with relatively low revenues. GAAP gross loss for the first quarter ended March 31, 2024 was $447,000, compared to gross profit of $108,000 for the first quarter ended March 31, 2023. GAAP operating expenses for the first quarter ended March 31, 2024 were $3.9 million, compared to $3.6 million for the first quarter ended March 31, 2023. The increase of $255,000 is mainly comprised of: (i) an increase of approximately $74,000 in employees' salaries and share-based compensation expenses, including recruitment of new employees and (ii) an increase of $193,000 in research and development activities mainly related to the breast implants project. On a non-GAAP basis, the operating expenses for the first quarter ended March 31, 2024 were $3.6 million, compared to $3.1 million in the first quarter ended March 31, 2023. Non-GAAP measures exclude certain non-cash expenses. GAAP financial income, net, for the first quarter ended March 31, 2024, totaled $134,000, compared to financial expenses, net of $196,000 in the first quarter ended March 31, 2023. The increase in financial income, net, is due to the interest rates and interest received from the Company's short-term cash deposits in 2024. GAAP net loss for the first quarter ended March 31, 2024 was $4.2 million, or $0.37 basic loss per share, compared to a net loss of $3.7 million, or $0.33 basic loss per share, for the first quarter ended March 31, 2023. Non-GAAP net loss for the first quarter ended March 31, 2024 was $4.0 million, or $0.35 basic loss per share, compared to $3.3 million loss, or $0.29 basic loss per share, for the first quarter ended March 31, 2023. Balance Sheets and Cash Flow The Company's cash and cash equivalents balance as of March 31, 2024 was $23.2 million. Net cash used in operating activities was $3.3 million during the first quarter ended March 31, 2024, compared to $3.4 million during the first quarter ended March 31, 2023. Net cash used in investing activities was $82,000 during the first quarter ended March 31, 2024, compared to $145,000 during the first quarter ended March 31, 2023. The investing activities includes purchase of property and equipment. Net cash provided by financing activities was $9,000 during the first quarter ended March 31, 2024, compared to $803,000 during the first quarter ended March 31, 2023. The decrease in cash provided by financing activities is attributed to proceeds from the exercise of warrants in the first quarter of 2023. As of today, the Company has no outstanding warrants. Conference call information To participate in the conference call, please use the dial-in information below: U.S. investors:  1-877-407-9716 Investors outside of the U.S.:  1-201-493-6779 Israel investors: 1-809-406-247Conference ID:  13745964 Note, you can avoid long wait times for the operator by using the Call me™ feature and clicking the link below 15 minutes prior to the scheduled call start time: https://callme.viavid.com/viavid/?callme=true&passcode=13728588&h=true&info=company-email&r=true&B=6  Webcast information A live webcast will also be available in listen-only mode and can be accessed here or via the link to be posted on the News & Events section of the CollPlant Investor relations website. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company's website for a limited time. Submit questions to management in advance of the call and webcast To ask management a question ahead of the call, please email Dan Ferry at LifeSci Advisors LLC up until 24 hours before the event at     COLLPLANT BIOTECHNOLOGIES LTD. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands) March 31, 2024 December 31, 2023 Unaudited Audited Assets Current assets: Cash and cash equivalents $ 23,225 $ 26,674 Restricted deposit 239 241 Trade receivables, net 90 - Other accounts receivable and prepaid expenses 279 393 Inventories 645 714 Total current assets 24,478 28,022 Non-current assets: Restricted deposit 57 57 Operating lease right-of-use assets 2,979 3,070 Property and equipment, net 2,606 2,789 Intangible assets, net 173 188 Total non-current assets 5,815 6,104 Total assets $ 30,293 $ 34,126     COLLPLANT BIOTECHNOLOGIES LTD. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands, except share data) March 31, 2024 December 31,2023 Unaudited Audited Liabilities and shareholders' equity Current liabilities: Trade payables $ 1,119 $ 980 Operating lease liabilities