Core Viewpoint - CollPlant Biotechnologies is expanding its distribution channels for its Vergenix™ STR product in Europe and Asia, targeting the treatment of tendon injuries through innovative rhCollagen technology [1][3]. Group 1: Product Overview - VergenixSTR is designed for treating tendinopathy, promoting healing and repair of various tendon injuries, including tennis elbow and Achilles tendonitis [1][2]. - The product combines cross-linked rhCollagen with Platelet-rich plasma (PRP), facilitating a controlled release of growth factors to enhance healing [4]. Group 2: Distribution Expansion - CollPlant has signed distribution agreements for VergenixSTR with companies in the Netherlands, Turkey, and India, aiming to sell in the Benelux region, Spain, and Turkey [1][2]. - The new distributor for Benelux and Spain specializes in medical device sales focused on orthopedics, with the first shipment made in February 2025 [2]. Group 3: Market Potential - The CEO of CollPlant expressed optimism about the market potential for VergenixSTR as the company expands its distribution network in Europe and Asia-Pacific [3]. - The company plans to take further steps in 2025 to broaden its distribution reach for VergenixSTR [3].

Core Viewpoint - CollPlant has been granted U.S. Patent No. 12,186,449 for its photocurable dermal filler product, which is based on modified recombinant human collagen and hyaluronic acid, expiring on May 2, 2039 [1][2]. Dermal Filler Program - CollPlant has an exclusive licensing agreement with AbbVie for the use of its rhCollagen technology in dermal and soft tissue fillers [3]. - AbbVie is currently reviewing interim results from clinical trials initiated in 2023, with next steps to be determined after complete assessment [4]. Financial Developments - CollPlant received a contingent payment of $2 million from AbbVie related to its rhCollagen technology as per their agreement [4]. - The company has initiated a cost-cutting plan, reducing its workforce by approximately 20%, which is expected to sustain business activities until at least Q2 2026 [5]. Future Focus - In 2025, CollPlant plans to advance its product candidate pipeline, including the development of a regenerative breast implant towards clinical phases [6]. Company Overview - CollPlant specializes in regenerative and aesthetic medicine, focusing on 3D bioprinting of tissues and organs, with products based on its proprietary rhCollagen technology [7].

Financial Data and Key Metrics Changes - GAAP revenues for Q3 2024 were $4,000, a decrease from $43,000 in Q3 2023, primarily due to no deliveries planned for the largest customer [17] - GAAP revenues for the nine months ended September 30, 2024, were $351,000 compared to $10.7 million for the same period in 2023, with the decrease attributed to a $10 million milestone payment received in 2023 [18] - GAAP net loss for Q3 2024 was $4.3 million or $0.38 basic loss per share, compared to a net loss of $4.4 million or $0.38 basic loss per share for Q3 2023 [23] - Cash and cash equivalents as of September 30, 2024, were $15.4 million, expected to sustain operations until at least the end of 2025 [25] Business Line Data and Key Metrics Changes - The regenerative breast implant program is advancing with a preclinical study involving 200 cc commercial-sized implants, showing good results in terms of vascularization and tissue integration [7][10] - The collaboration with AbbVie focuses on developing a dermal and soft tissue filler product, with the filler market valued at approximately $5.5 billion and expected to grow by 10% annually [15] Market Data and Key Metrics Changes - The global breast implant market is estimated at approximately $3 billion and projected to grow to about $6.5 billion by 2033, indicating significant market potential for regenerative breast implants [13] Company Strategy and Development Direction - The company aims to be a leader in regenerative medicine, focusing on advancing the development of its breast implant and dermal filler programs while seeking additional collaborations to enhance its rhCollagen technology [38][39] - The strategy includes securing non-dilutive cash through partnerships and streamlining operations to reduce the annual burn rate [15] Management Comments on Operating Environment and Future Outlook - Management highlighted the challenges in developing breast implants, including ensuring natural filling, safety, and ease of administration, while expressing optimism about the ongoing preclinical study results [30][31] - The company is in discussions with various companies regarding its collagen technology, with a goal to sign another agreement in 2025 [36] Other Important Information - The company showcased its technology at the Annual Meeting of the International Society for Biofabrication, which generated interest and potential collaboration opportunities [16] Q&A Session Summary Question: Can you elaborate on the meaning of the results you have reported from your pre-clinical studies? - Management discussed the challenges in developing breast implants, including the need for natural filling, safety, and ease of administration, and reported significant vascularization and tissue ingrowth observed in the study [30][33] Question: Can you elaborate and estimate when will we see another agreement announced? - Management indicated ongoing dialogues with companies interested in collagen technology and expressed a goal to sign another agreement during 2025, though timing is uncertain [36]

Financial Performance - GAAP revenues for Q3 2024 were $4,000, a decrease from $43,000 in Q3 2023, primarily due to no deliveries planned for the largest customer[8]. - GAAP revenues for the nine months ended September 30, 2024, were $351,000, down approximately $10.3 million from $10.7 million in the same period in 2023, largely due to a milestone payment of $10 million received in 2023[9]. - GAAP net loss for Q3 2024 was $4.3 million, or $0.38 basic loss per share, compared to a net loss of $4.4 million, or $0.38 basic loss per share, in Q3 2023[17]. - GAAP net loss for the nine months ended September 30, 2024, was $12.7 million, or $1.11 basic loss per share, compared to a net loss of $2.3 million, or $0.20 basic loss per share, for the same period in 2023[18]. - Total revenues for the nine months ended September 30, 2024, were $351 million, a decrease from $10,660 million in the same period of 2023[32]. - The net loss for the nine months ended September 30, 2024, was $12,731 million, compared to a net loss of $2,330 million for the same period in 2023[32]. - Non-GAAP net loss for the nine months ended September 30, 2024, was $11,497 million, compared to a non-GAAP net loss of $1,239 million in 2023[38]. - Basic and diluted net loss per ordinary share for the nine months ended September 30, 2024, was $1.11, compared to $0.20 in 2023[38]. - The company reported a total operating loss of $13,277 million for the nine months ended September 30, 2024, compared to a loss of $2,444 million in 2023[32]. - The company experienced a net cash used in operating activities of $10,629 million for the nine months ended September 30, 2024, compared to $418 million in 2023[34]. Cash Position - Cash and cash equivalents as of September 30, 2024, were $15.4 million, providing a runway for operations until at least the end of 2025[20]. - Cash and cash equivalents at the end of the period were $15,371 million, down from $28,981 million at the end of the same period in 2023[34]. Research and Development - Research and development expenses for the nine months ended September 30, 2024, were $7,972 million, up from $7,371 million in 2023, reflecting a 8.2% increase[32]. - Operating expenses for Q3 2024 were $4.3 million, a slight decrease from $4.4 million in Q3 2023, with increased R&D costs related to breast implants[13]. - Significant progress in preclinical studies for the 3D-printed rhCollagen-based breast implants, showing promising results in vascularization and tissue ingrowth[3]. - The company is focused on 3D bioprinting of tissues and organs, utilizing its proprietary rhCollagen technology for regenerative and aesthetic medicine[39]. Collaborations and Partnerships - The collaboration with AbbVie has resulted in $24 million received to date, with potential total payments of up to $50 million for the development of a dermal filler product[6]. - The company entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, indicating a strategic partnership in the market[40]. - The company is prioritizing raising non-dilutive cash through collaborations in the medical and aesthetics fields[3]. Assets - Total assets as of September 30, 2024, were $22.4 million, down from $34.1 million as of December 31, 2023[28].

Core Insights - CollPlant Biotechnologies has achieved promising results in preclinical studies for its rhCollagen-based regenerative breast implants, indicating significant vascularization and tissue integration [1][4] - The company is targeting a $3.0 billion market opportunity with its innovative breast implant technology [1] - As of September 30, 2024, CollPlant reported cash and cash equivalents of $15.4 million, providing a runway for operations into 2025 [19] Company Developments - The CEO of CollPlant, Yehiel Tal, expressed optimism about advancing the breast implant program into human studies following successful preclinical trials [2] - The company has adjusted its development plans to ensure sufficient capitalization for at least one year and is focusing on raising non-dilutive cash through collaborations [2] - CollPlant is collaborating with Stratasys to develop a bioprinting solution for its breast implants, which could revolutionize the current market offerings [3] Financial Performance - For Q3 2024, CollPlant reported GAAP revenues of $4,000, a decrease from $43,000 in Q3 2023, primarily due to a lack of deliveries to its largest customer [9] - For the nine months ended September 30, 2024, GAAP revenues were $351,000, down from $10.7 million in the same period in 2023, largely due to a milestone payment received in 2023 under the AbbVie agreement [10] - The company reported a GAAP net loss of $4.3 million for Q3 2024, compared to a net loss of $4.4 million in Q3 2023 [17] Collaborations and Partnerships - CollPlant's collaboration with AbbVie is focused on developing a dermal and soft tissue filler product, with the potential for up to $50 million in payments to CollPlant [5] - As of now, CollPlant has received $24 million from AbbVie under this agreement [5] Research and Development - The company is prioritizing research and development activities related to its breast implants, which have shown significant promise in preclinical trials [14] - Operating expenses for R&D increased in Q3 2024, reflecting the company's commitment to advancing its innovative technologies [14][15] Market Context - The breast implant market represents a significant opportunity for CollPlant, with the company positioned to address unmet needs in aesthetic and reconstructive plastic surgery [2][32] - The innovative nature of CollPlant's products, based on non-animal-derived collagen, aligns with current trends towards biocompatibility in medical aesthetics [2][32]

Group 1 - CollPlant Biotechnologies will report its financial results for Q3 2024 on November 27, 2024, before U.S. market opening [1] - A conference call and webcast will be held on the same day at 10:00 a.m. EST to discuss the financial results and corporate updates [1] - The company specializes in regenerative and aesthetic medicine, focusing on non-animal-derived collagen for tissue regeneration and medical aesthetics [1][5] Group 2 - CollPlant's products are based on rhCollagen, produced through proprietary plant-based genetic engineering technology, addressing tissue repair, aesthetics, and organ manufacturing [5] - In 2021, CollPlant entered a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, a leader in the dermal filler market [6]

Core Viewpoint - CollPlant Biotechnologies and Stratasys Ltd. have initiated a preclinical study to develop 200cc regenerative breast implants using Stratasys' 3D printing technology, aiming to provide a natural alternative to traditional implants [1][2]. Company Overview - CollPlant specializes in regenerative and aesthetic medicine, focusing on rhCollagen-based technologies for tissue regeneration and organ production [3]. - Stratasys is a leader in polymer 3D printing solutions and has modified its Origin printer for this collaboration [3]. Study Details - The preclinical study will evaluate the implants' ability to grow natural breast tissue and fully degrade over time [2][4]. - Initial results from the study are expected in the first half of 2025 [3]. Market Potential - CollPlant's innovative breast implants are positioned to capture a significant share of the $3 billion global breast implant market, offering a groundbreaking alternative for reconstructive and cosmetic procedures [5][6]. - Traditional breast augmentation procedures typically use synthetic silicone implants, which carry risks of complications [6]. Price Performance - Year-to-date, CollPlant's shares have decreased by 24.1%, contrasting with a 0.2% rise in the industry and a 17.7% increase in the S&P 500 [7].

Financial Data and Key Metrics Changes - GAAP revenues for Q2 2024 were $249,000, a significant decrease from $10.2 million in Q2 2023, primarily due to a $10 million milestone payment received in 2023 from AbbVie [14] - GAAP gross loss for Q2 2024 was $287,000, compared to a gross profit of $9.6 million in Q2 2023 [14] - GAAP net loss for Q2 2024 was $4.2 million, or $0.37 basic loss per share, compared to a net income of $5.8 million, or $0.51 basic income per share, for Q2 2023 [15] - Cash and cash equivalents as of June 30, 2024, were $18.9 million, providing a runway expected to satisfy operational requirements until at least the end of 2025 [16] Business Line Data and Key Metrics Changes - The breast implant program has progressed to testing 200 cc volume implants in preclinical studies, with the potential to address a $3 billion global breast implant market projected to grow to $6.5 billion by 2033 [6][7] - The dermal filler product, co-developed with AbbVie, is in the clinical phase, with a milestone payment of $10 million received last year [9][14] Market Data and Key Metrics Changes - The dermal filler market experienced a recent slowdown but has shown signs of recovery, evidenced by merger and acquisition activity [10] - The breast implant market is currently underserved in terms of safety and performance, with existing materials posing risks such as immunogenicity [7] Company Strategy and Development Direction - The company aims to lead in regenerative medicine through innovative collagen technology, focusing on the development of regenerative breast implants and dermal fillers [12][35] - The company has released its first environmental, social, and governance (ESG) report, emphasizing its commitment to sustainability and health [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the regenerative breast implant's potential to revolutionize aesthetic and reconstructive procedures, addressing safety concerns associated with current implants [6][8] - The company plans to advance the dermal filler program with AbbVie and generate additional safety and efficacy data for the breast implants [35] Other Important Information - The company is avoiding the use of growth factors in its scaffold technology to prevent regulatory complications, instead relying on collagen and other biomaterials [27] - The degradation of the scaffold is controlled through enzymatic degradation, hydrolysis, and oxidation, with a degradation time of six to twelve months [28] Q&A Session Summary Question: Differences between breast implants and dermal fillers - The breast implants are 3D bioprinted scaffolds that degrade and are replaced by naturally grown tissue, while dermal fillers require repeat injections and serve different purposes [18][19] Question: Key findings in the preclinical study for breast implants - The studies aim to optimize formulations, design, performance, safety, and efficacy, with a focus on fat tissue regeneration and implant degradation kinetics [21][22] Question: Next steps in the AbbVie collaboration - The dermal filler product is in clinical studies, with expectations of reaching commercialization milestones totaling $26 million, plus royalties upon approval [24] Question: Growth factors in the scaffold - The company does not use growth factors to avoid regulatory issues, relying instead on collagen's cell-binding properties to attract surrounding tissue cells [27] Question: Predictiveness of animal models - The company has developed a reliable animal model and a computational biomechanics discipline to predict scaffold behavior in humans, which will support FDA submissions [30]

Financial Performance - Total revenues for the six months ended June 30, 2024, were $347 million, compared to $249 million for the same period in 2023, representing a 39.5% increase[36]. - Total revenues for the six months ended June 2024 were $347,000, compared to $10,617,000 for the same period in 2023, indicating a significant decrease[89]. - Revenues from the sales of goods for the three months ended June 2024 were $249,000, down from $184,000 in the same period of 2023[89]. - Revenues from milestones for the six months ended June 2024 were $30,000, consistent with the previous year[89]. - Total revenues for the three months ended June 2024 were $249,000, compared to $10,184,000 for the same period in 2023, showing a substantial decline[89]. Net Loss and Earnings - The net loss for the period was $8,405 million, compared to a net income of $2,047 million for the same period in 2023[36]. - Basic net loss per ordinary share for the six months ended June 30, 2024, was $(0.73), compared to a profit of $0.18 per share for the same period in 2023[36]. - As of June 30, 2024, the company reported a net loss of $8,405,000, with an accumulated deficit of $105,146,000[69]. - The basic net loss per share for the six months ended June 30, 2024, was $(0.73), compared to a net income per share of $0.18 for the same period in 2023[73]. Assets and Liabilities - Current assets decreased to $20,335,000 as of June 30, 2024, from $28,022,000 as of December 31, 2023, reflecting a decline of approximately 27.6%[33]. - Total assets decreased to $26,566,000 as of June 30, 2024, from $34,126,000 as of December 31, 2023, indicating a reduction of approximately 22.2%[33]. - Total liabilities as of June 30, 2024, were $5,837 million, slightly up from $5,786 million as of December 31, 2023[35]. - Total shareholders' equity decreased to $20,729 million as of June 30, 2024, from $28,340 million as of December 31, 2023, indicating a decline of 26.8%[35]. Cash Flow and Liquidity - Cash and cash equivalents at the end of the period were $18,920 million, down from $22,366 million at the end of the same period in 2023, a decrease of 15.8%[47]. - The company's cash and cash equivalents as of June 30, 2024, totaled $18,920,000, providing sufficient funds to support operations for more than 12 months[69]. - The company incurred negative cash flows from operating activities amounting to $7,181,000 for the six months ended June 30, 2024[69]. - The company anticipates future net losses and will need to raise additional cash to support its operations until profitability is achieved[51]. Research and Development - Research and development expenses increased to $5,103 million for the six months ended June 30, 2024, from $4,676 million in the same period of 2023, reflecting an increase of 9.1%[36]. - Research and development expenses for the six months ended June 30, 2024, were $410,000, compared to $307,000 for the same period in 2023[86]. Stock Options and Compensation - During the six months ended June 30, 2024, the company granted options totaling 41,500, with a weighted average exercise price of $5.34[19]. - The fair value of options granted during the six months ended June 30, 2024, was $169,000, compared to $505,000 for the same period in 2023[19]. - As of June 30, 2024, the company had 1,764,005 options outstanding, with a weighted average exercise price of $5.78[19]. - The total incremental fair value of options granted to employees was $197,000, based on the Black-Scholes pricing model[76]. - As of June 30, 2024, there was $2,213,000 of unrecognized compensation expense related to unvested RSUs and options, expected to be recognized over a weighted-average period of 1.9 years[86]. - The company granted 261,000 restricted share units (RSUs) with a weighted average grant date fair value of $5.13 during the six months ended June 30, 2024[77]. Inventory Management - As of June 30, 2024, total inventories decreased to $439,000 from $714,000 as of December 31, 2023, representing a decline of approximately 38.5%[2]. - The company recorded approximately $268,000 for write-down of inventories under cost of revenues during the six months ended June 30, 2024[28]. Business Development - The company achieved a milestone in June 2023 related to the clinical phase dermal filler product, resulting in a $10,000 payment from AbbVie, received in July 2023[9]. - The company is focused on the development and commercialization of its products, including BioInk for 3D bioprinting and rhCollagen for medical aesthetics[50]. - The company has not commenced operations for its wholly-owned subsidiary, CollPlant Inc., established in November 2021[68].

Core Viewpoint - CollPlant Biotechnologies has initiated a pre-clinical trial for its 200cc rhCollagen-based regenerative breast implants, targeting a $3.0 billion market opportunity, while reporting significant financial results for Q2 2024 [1][2][7]. Company Developments - The company has launched a pre-clinical trial for its 200cc breast implants printed with Stratasys' Origin® 3D printer, marking a significant milestone as there are currently no other commercial products for soft tissue regeneration like these implants [2][3]. - CollPlant has released its first ESG and Sustainability report, outlining its commitment to sustainability and health improvement through innovative collagen technology [2][5][6]. Financial Performance - For Q2 2024, GAAP revenues were $249,000, a decrease from $10.2 million in Q2 2023, primarily due to a milestone payment received from AbbVie in 2023 [7][8]. - The company reported a GAAP net loss of $4.2 million for Q2 2024, compared to a net income of $5.8 million in Q2 2023 [16]. - Cash and cash equivalents as of June 30, 2024, were $18.9 million, providing a runway for operations until at least the end of 2025 [18]. Research and Development - CollPlant has made notable progress in its regenerative breast implant program, with encouraging pre-clinical results related to tissue regeneration and vascularization [2][4]. - The collaboration with Stratasys focuses on developing a bioprinting solution for the breast implants and scaling up the fabrication process [3]. ESG and Sustainability Initiatives - The inaugural ESG report details initiatives for enhancing plant-based production, reducing emissions, and delivering safe medical solutions, reflecting the company's commitment to sustainability [5][6].