- Further protection granted in key territory applying to the significant and growing aesthetic and reconstructive markets - REHOVOT, Israel, June 4, 2025 /PRNewswire/ -- CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived, rhCollagen for tissue regeneration and medical aesthetics, today announced that the European Patent and Trademark Office has allowed a patent application related to CollPl ...

REHOVOT, Israel, May 30, 2025 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived, rhCollagen for tissue regeneration and medical aesthetics, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 1,200,002 of the Company's ordinary shares at a purchase price of $3.00 per share in a registered direct offering priced at-the- ...

- In Q1 following a development achievement, CollPlant received a $2 million payment from AbbVie – Collaboration Updates AbbVie Collaboration In February 2025, following a key development milestone, CollPlant received a $2 million milestone payment from its partner, AbbVie, pursuant to the existing development and commercialization agreement. Under this agreement, CollPlant granted AbbVie a worldwide exclusive license to use its recombinant human collagen (rhCollagen) technology in combination with AbbVie's ...

Core Viewpoint - CollPlant's rhCollagen BioInks align with the FDA's initiative to phase out animal testing for drug development, offering innovative alternatives for tissue regeneration and medical aesthetics [1][2][6] Group 1: FDA Announcement and Industry Impact - The FDA announced a plan on April 10, 2025, to phase out animal testing as a requirement for preclinical development of monoclonal antibodies and other drugs, aiming for a transition within 3-5 years [6][7] - This shift is intended to enhance drug safety, reduce development timelines, and promote ethical research practices [7] Group 2: CollPlant's Solutions - CollPlant's Collink.3D BioInks are designed for biofabrication of tissue-on-a-chip and organ-on-a-chip systems, which can replace traditional animal testing methods [1][2] - The BioInk products are compatible with in-vitro human-based systems, facilitating drug discovery and regenerative medicine applications [2] - CollPlant has developed Computational Modeling and Simulation (CM&S) methodologies to predict the behavior of regenerative implants, further reducing the need for animal studies [2] Group 3: Product Features and Applications - CollPlant's Collink.3D BioInk is the first and only line of human collagen BioInk products based on chemically modified plant-derived rhCollagen, produced with high purity and consistency [3][4] - The BioInk supports 3D bioprinting of tissues and organs, enabling real-time assessment of immune responses and tissue remodeling [4][5] - The product is characterized by optimal rheology at room temperature, high cell viability, biocompatibility, and non-immunogenic properties [5] Group 4: Company Overview - CollPlant focuses on regenerative and aesthetic medicine, utilizing 3D bioprinting technologies for tissue repair and organ manufacturing [8] - The company has a partnership with Allergan, an AbbVie company, for the development and commercialization of dermal and soft tissue fillers [9]

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $164,000, a decrease from $299,000 in Q4 2023, primarily due to lower sales of RH collagen products [16] - GAAP revenue for the full year 2024 was $515,000, significantly down from $11 million in 2023, largely due to a $10 million milestone payment received in 2023 from AbbVie [16][21] - GAAP gross loss for Q4 2024 was $108,000 compared to a gross loss of $474,000 in Q4 2023, while the gross loss for the full year 2024 was $1.1 million compared to a gross profit of $9 million in 2023 [18][21] - GAAP net loss for Q4 2024 was $3.9 million or $0.34 per share, compared to a net loss of $4.7 million or $0.41 per share in Q4 2023; for the full year, the net loss was $16.6 million or $1.45 per share, compared to a net loss of $7 million or $0.62 per share in 2023 [21] Business Line Data and Key Metrics Changes - The photocurable dermal filler candidate is in the preclinical phase, targeting a market valued at approximately $6.3 billion with a 10% CAGR [8] - The regenerative breast implant program is advancing preclinical testing with promising outcomes observed in tissue integration and vascularization [12][13] - Collaboration with AbbVie is ongoing, with AbbVie currently reviewing interim results from clinical trials initiated in 2023 [10][29] Market Data and Key Metrics Changes - The market potential for the VerGenix STR product, aimed at treating tendon injuries, is estimated to be between 1% to 3% of the population [33] - The company is establishing distribution networks in Europe and Asia for the VerGenix product, with expectations for market penetration following regulatory approvals [33][34] Company Strategy and Development Direction - The company aims to be a leader in regenerative medicine, focusing on proprietary programs and potential collaborations [6][8] - Plans include launching clinical trials for the photocurable dermal filler within two years and optimizing the regenerative breast implant for clinical readiness [43] - Expansion of the distribution network for VerGenix STR and broadening product offerings for bioinks are also key strategic initiatives [44] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of transparency regarding upcoming catalysts and the stability of the company's cash position, which is expected to support operations through Q2 2026 [40][41] - The company is aware of macroeconomic conditions affecting share price but maintains a stable operational outlook [41] Other Important Information - Cash and cash equivalents as of December 31, 2024, were $11.9 million, with an additional $2 million received from AbbVie in February 2025 [22][23] - The company has implemented cost reduction plans that do not materially impact main development programs [39] Q&A Session Summary Question: When will there be an update from AbbVie on the studies and potential milestone payments in 2025? - AbbVie is currently collecting data and reviewing interim results from clinical trials; the timeline for updates is controlled by AbbVie [29][30] Question: What is the market potential for the VerGenix product and expected revenue flow? - The VerGenix product targets tendon injuries with a market potential of 1% to 3% of the population; the company is in the initial stages of establishing distribution networks [33][34] Question: What is the company's cash flow situation and burn rate? - The company has $11.9 million in cash, with a cash runway expected to last through Q2 2026; cost reductions are in place without impacting key development programs [39][40]

Financial Performance - The company incurred a total comprehensive loss of $16.6 million for the year ended December 31, 2024, and a total comprehensive loss of $7.0 million for the year ended December 31, 2023, with an accumulated deficit of $113.4 million as of December 31, 2024[56]. - The company has incurred recurring losses from operations and negative operating cash flows since its inception, except for a total comprehensive income of $0.2 million in the year ended December 31, 2021[62]. - The company anticipates significant expenses and operating losses in the foreseeable future, particularly as it continues research and clinical development, seeks marketing approvals, and expands manufacturing processes[58]. - Future operating expenses may fluctuate significantly, potentially leading to cash shortfalls due to various uncontrollable factors[69]. - The company incurs significant costs associated with being a public company, which may impact its financial resources and management focus[209]. Cash and Funding - As of December 31, 2024, the company's cash and cash equivalents were $11.9 million, and it has received payments under the AbbVie Development Agreement totaling $26 million since February 2021[62]. - The company plans to continue advancing the development of its products and product candidates, which will require additional funding that may not be available on acceptable terms[61]. - The company is subject to various risks related to its financial position, including the need for additional funding and the potential impact of unfavorable economic conditions[46]. Market and Competition - The company expects to rely on third-party collaborators, distributors, and resellers for a significant portion of its sales, which may impact its revenue generation capabilities[52]. - The company faces competition and rapid technological change, which could impair its ability to successfully commercialize its products[52]. - The company faces competition from major pharmaceutical and biotechnology companies, which may have greater resources and market presence[86]. - The company heavily relies on the future success of its medical aesthetics, 3D-bioprinting product candidates, and bioink products for revenue generation and profitability[94]. Regulatory and Compliance Risks - Regulatory compliance is critical; failure to maintain it could result in sanctions from authorities, including refusal of product approvals[81]. - The availability of reimbursement from third-party payors is essential for product commercialization; lack of adequate coverage could limit market success[90]. - The company is subject to stringent regulations from various government agencies, including the FDA and European regulatory authorities, which could materially affect its financial condition and business operations[119]. - Regulatory compliance failures could lead to significant penalties, including civil or criminal fines, suspension of clinical trials, or withdrawal of product approvals[120]. - The company must establish and maintain strategic partnerships, such as the AbbVie Development Agreement, to support product development and marketing[99]. Clinical Development and Trials - Patient enrollment in clinical trials is critical, and difficulties in recruiting patients could delay or prevent trials from proceeding[100]. - Clinical trials are expensive and uncertain, with a high failure rate for medical devices and drugs, which could impact the company's ability to generate revenue[109]. - The company has limited clinical data to support sales of its products, which may hinder market acceptance by physicians and patients[48]. - Manufacturing capabilities for rhCollagen need improvement to meet future clinical study and commercialization standards[77]. Intellectual Property and Legal Risks - The company has an extensive patent portfolio, but maintaining it incurs high costs and requires compliance with various regulations[177]. - The strength of the company's patents in regenerative medicine is uncertain, and challenges to their validity could impair exclusivity[179]. - The company may face claims regarding the inventorship or ownership of its patents, which could lead to litigation and loss of valuable intellectual property rights[196]. - Legal proceedings related to intellectual property claims may lead to substantial operating losses and divert resources from development activities[199]. Operational Challenges - The company has implemented a cost-cutting and workforce reduction plan to manage its financial resources more effectively[62]. - The company currently has 57 employees and may need to expand its workforce, which could lead to operational challenges if not managed effectively[155]. - Any disruption in manufacturing operations could significantly impair the ability to meet commercial demand for products[82]. - The company experienced a mechanical failure at its Yessod Hama'ala facility in 2024, leading to a temporary shutdown of manufacturing operations[160]. Economic and Geopolitical Factors - Economic conditions, including inflation and geopolitical events, may negatively impact the company's operating results and financial condition[170]. - Political and military instability in Israel may adversely impact the company's results of operations and financial condition[226]. - The company has taken precautionary measures to close its facility in Yessod Hama'ala due to proximity to conflict zones, which could materially impact operations[229]. Shareholder and Governance Issues - As of March 15, 2025, senior management and directors own approximately 33% of the company's ordinary shares, allowing them to exert significant influence over shareholder decisions[210]. - The company is subject to Israeli law regarding corporate governance, which may provide less protection to shareholders compared to U.S. domestic issuers[223]. - Shareholder rights and responsibilities are governed by Israeli law, which may differ materially from those of U.S. corporations, including duties of good faith and fairness[235].

Financial Performance - GAAP revenues for the year ended December 31, 2024, were $515,000, a significant decrease from $11.0 million in 2023, primarily due to a $10.0 million milestone payment received in 2023[19] - GAAP net loss for the year ended December 31, 2024, was $16.6 million, or $1.45 basic loss per share, compared to a net loss of $7.0 million, or $0.62 basic loss per share, for the year ended December 31, 2023[24] - Revenues for the year ended December 31, 2024, were $515,000, a significant decrease of 95.3% compared to $10,959,000 in 2023[39] - Gross profit for 2024 was a loss of $1,110,000, compared to a gross profit of $8,968,000 in 2023[39] - Total operating loss for 2024 increased to $17,251,000, compared to a loss of $7,512,000 in 2023[39] - Net loss for 2024 was $16,609,000, which is a 136.7% increase from the net loss of $7,019,000 in 2023[39] - Basic and diluted net loss per ordinary share for 2024 was $1.45, compared to $0.62 in 2023[39] - Non-GAAP net loss for 2024 was $14,889,000, compared to $5,193,000 in 2023, indicating a worsening financial position[45] Cash and Liabilities - The cash and cash equivalents balance as of December 31, 2024, was $11.9 million, down from $26.7 million in 2023[25] - Total current liabilities decreased to $2,970,000 in 2024 from $3,251,000 in 2023, a reduction of 8.6%[37] - Total liabilities decreased to $5,245,000 in 2024 from $5,786,000 in 2023, a reduction of 9.3%[37] - Cash and cash equivalents at the end of 2024 were $11,909,000, down from $26,674,000 at the end of 2023, a decrease of 55.3%[41] Research and Development - The company reported a significant increase in research and development expenses, totaling $10,515,000 in 2024, slightly up from $10,484,000 in 2023[39] - CollPlant successfully printed 200cc breast implants using its proprietary rhCollagen-based bioinks, marking a significant advancement in its regenerative breast implant program[6] - The company has been granted a second patent in Japan for its rhCollagen curable BioInks, securing protection until 2038[14] - CollPlant's breast implants are designed to regenerate breast tissue without eliciting immune response, addressing a $3 billion market opportunity[1] Strategic Initiatives - The company has initiated a cost-cutting and workforce reduction plan, resulting in a reduction of approximately 20% of its workforce[12] - CollPlant received a $2 million development payment from AbbVie in February 2025, following a development achievement[4] - The company expanded its distribution channels for its Vergenix™ STR product in Europe and Asia, signing agreements in the Netherlands, Turkey, and India[11] Future Outlook - CollPlant reported a significant increase in revenue, achieving $X million in the last quarter, representing a Y% growth compared to the previous quarter[53] - The company highlighted a user base expansion, with an increase of Z% in active users year-over-year[53] - Future outlook indicates projected revenue growth of A% for the next fiscal year, driven by new product launches and market expansion strategies[53] - CollPlant is investing in R&D for innovative technologies, with a budget allocation of $B million aimed at enhancing product offerings[53] - The company plans to enter new markets, targeting a C% increase in market share within the next two years[53] - Recent acquisitions are expected to contribute an additional $D million in annual revenue, enhancing overall business capabilities[53] - The management provided guidance for the upcoming quarter, forecasting revenue between $E million and $F million[53] - New product developments are on track, with expected launch dates set for Q1 of next year, anticipated to drive further growth[53] - Strategic partnerships are being explored to enhance distribution channels, aiming for a G% increase in reach[53] - The company emphasized a commitment to sustainability, with initiatives expected to reduce operational costs by H% over the next five years[53]

Core Insights - CollPlant Biotechnologies has announced six-month study data from its regenerative breast implant program, which targets a $3 billion market opportunity and aims to provide a revolutionary alternative for women [1][12] - The company received a $2 million development payment from AbbVie, indicating progress in its collaboration efforts [1][5] Financial Performance - For the year ended December 31, 2024, CollPlant reported GAAP revenues of $515,000, a significant decrease from $11.0 million in 2023, primarily due to a milestone payment of $10 million received in 2023 [21] - The GAAP net loss for 2024 was $16.6 million, or $1.45 basic loss per share, compared to a net loss of $7.0 million, or $0.62 basic loss per share in 2023 [26] - Cash and cash equivalents as of December 31, 2024, were $11.9 million, down from $26.7 million in 2023 [27] Product Development and Collaborations - CollPlant's regenerative breast implants, printed using proprietary rhCollagen-based bioinks, have shown promising results in six-month studies, including vascularization and tissue integration [9][11] - The company has initiated a preclinical study with Stratasys for the development of bioprinting solutions for its breast implants [6] - Under the collaboration with AbbVie, a worldwide exclusive license has been granted for the use of CollPlant's rhCollagen technology in dermal and soft tissue fillers, which are currently in clinical trials [4] Market Strategy and Distribution - CollPlant has expanded its distribution channels for its Vergenix™ STR product in Europe and Asia, signing agreements with distributors in the Netherlands, Turkey, and India [13] - The company is focused on optimizing costs and has implemented a workforce reduction plan of approximately 20% to support its primary research and development programs [14] Intellectual Property - CollPlant has secured a second patent in Japan for its rhCollagen curable BioInks, extending protection until 2038 [15] - A U.S. patent related to its photocurable dermal filler product candidate has also been granted, which will expire in 2039 [18]

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].