As filed with the Securities and Exchange Commission on March 30, 2026 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Collplant Biotechnologies Ltd. (Exact name of registrant as specified in its charter) Not Applicable (Translation of Registrant's name into English) +1 302 738 6680 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) Yehiel Tal Chief Executive Officer +972 73 23 ...

Financial Performance - The company incurred a total comprehensive loss of $11.5 million for the year ended December 31, 2025, and a total comprehensive loss of $16.6 million for the year ended December 31, 2024, with an accumulated deficit of $124.8 million as of December 31, 2025[55]. - The company anticipates continuing to incur significant expenses and operating losses in the foreseeable future, with expenses expected to increase substantially due to ongoing research and development activities[57]. - Management has expressed substantial doubt about the company's ability to continue as a going concern, which may hinder its ability to obtain new financing on reasonable terms[65]. - The company has relied on revenues from product sales, licensing, and milestone payments for financing, but future revenues will depend on market acceptance and regulatory approvals[56]. Cash and Funding - As of December 31, 2025, the company's cash and cash equivalents were $5.6 million, and it has received payments under the AbbVie Development Agreement totaling $26 million in the past[60]. - The company plans to continue advancing its product candidates through preclinical and clinical development, which will require additional funding that may not be available on acceptable terms[59]. - The company has implemented a cost-cutting and workforce reduction plan to manage its financial position[60]. Product Development and Commercialization Risks - The company faces risks related to the commercialization of its products, including limited clinical data and competition from more advanced therapies[46]. - The commercial success of products will depend on market acceptance by physicians, patients, and third-party payors, which is uncertain[71]. - Limited clinical data for products may hinder acceptance by the medical community, affecting sales potential[75]. - Manufacturing capabilities for rhCollagen need improvement to meet market demand, requiring significant investment[76]. - The company has limited experience in selling and marketing its products, which may impact revenue generation[83]. - The availability of reimbursement from payors is essential for product commercialization, and lack of it could limit market success[89]. - The company operates in a competitive environment with rapid technological changes, posing risks to product commercialization[85]. Regulatory Compliance and Challenges - Regulatory compliance is critical, as failure could lead to sanctions or revocation of product approvals[80]. - The regulatory approval process for the company's novel products may be more expensive and time-consuming compared to traditional products, potentially impacting timelines[95]. - The company must navigate a complex regulatory environment, increasing the risk of potential violations[112]. - The company is subject to stringent regulations by the FDA and European regulatory authorities, which could impose penalties or restrictions if compliance is not met[118]. - The FDA has increased scrutiny of the medical device industry, which may lead to enforcement actions that could restrict manufacturing and marketing capabilities[123]. Intellectual Property and Legal Risks - The company has an extensive patent portfolio, but maintaining it is costly and non-compliance could lead to loss of patent rights, affecting competitive position[184]. - The strength of the company's intellectual property rights is uncertain, and failure to protect these rights could impair its ability to commercialize products[186]. - The company may face litigation related to intellectual property, which could be expensive and time-consuming, potentially affecting its financial resources[196]. - Third-party claims of intellectual property infringement could delay product development and commercialization efforts, leading to significant financial implications[191]. Market and Economic Conditions - Economic conditions, including inflation and geopolitical events, may negatively impact the company's operating results and growth rates, leading to delayed sales cycles and increased price competition[177]. - The company faces potential product liability claims that could result in substantial costs and negatively impact its business reputation and ability to commercialize products[166]. - Future healthcare reforms may impact reimbursement rates, affecting demand for the company's products and overall financial performance[130]. Corporate Governance and Compliance - The company is a foreign private issuer and is subject to reduced reporting requirements, which may affect the attractiveness of its ordinary shares to investors[226]. - The company may need to improve its accounting systems and controls to comply with SEC reporting requirements, which could incur significant costs[220]. - The company’s reliance on home country corporate governance practices may provide less protection to shareholders compared to U.S. domestic issuers[235]. - A loss of foreign private issuer status would result in significantly higher regulatory and compliance costs under U.S. securities laws[237].

Core Insights - CollPlant Biotechnologies reported significant advancements in its regenerative and aesthetic medicine initiatives, including financial results for 2025 and updates on corporate developments [1] Financial Performance - GAAP revenues for 2025 were $2.4 million, a substantial increase from $515,000 in 2024, primarily due to a $2 million milestone payment from AbbVie [20] - GAAP gross profit for 2025 was $1.5 million, compared to a gross loss of $1.1 million in 2024 [22] - GAAP net loss for 2025 was $11.5 million, or $0.94 per share, an improvement from a net loss of $16.6 million, or $1.45 per share, in 2024 [25] Corporate Developments - The company achieved a development milestone in aesthetic medicine, triggering a $2 million payment from AbbVie [2][10] - CollPlant expanded its distribution network into North America through a partnership with a U.S.-based logistics center [8] - The company launched BioFlex, a ready-to-print rhCollagen-based kit for 3D bioprinting applications, aimed at drug discovery and tissue engineering [5][6] Product Innovations - CollPlant's rhCollagen platform was utilized to create a fully humanized 3D bioprinted skin model at Mayo Clinic, providing an alternative to animal testing [4][7] - The company refined its regenerative breast implants based on new preclinical data, showing promising outcomes in tissue integration and vascularization [11][13] Intellectual Property - CollPlant secured U.S. Patent No. 12,186,449 for its photocurable dermal filler product candidate, expected to remain in force until 2039 [14] - The company received patent allowances in South Korea and Japan for its photocurable dermal filler technology and rhCollagen-based BioInks, respectively [15][16] Cost Management - CollPlant implemented a cost-reduction plan, resulting in a 25% reduction in workforce and a decrease in operating expenses from $16.1 million in 2024 to $13.0 million in 2025 [19][23]

Core Viewpoint - CollPlant Biotechnologies has launched a redesigned corporate website aimed at enhancing transparency and accessibility for investors and stakeholders, reflecting the company's advancements in regenerative medicine and aesthetics [2][4]. Company Overview - CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, utilizing its proprietary plant-derived recombinant human collagen (rhCollagen) technology [4]. - The company addresses various indications in tissue repair, aesthetics, and organ manufacturing, marking a new era in regenerative and aesthetic medicine [4]. Website Features - The new website includes expanded sections on the company's technology platform, product pipeline, strategic collaborations, and corporate governance [2][7]. - It serves as a central source of information regarding CollPlant's scientific platform, clinical and preclinical programs, and corporate updates [2][7]. Strategic Collaborations - In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, which is a leader in the dermal filler market [5].

Core Insights - CollPlant Biotechnologies has secured a patent for its photocurable dermal filler technology in South Korea, which is significant for its aesthetic market strategy [1] Group 1: Company Developments - The Korean Patent Office has allowed a patent application that covers key aspects of CollPlant's dermal filler technology [1] - The patent application includes a polymerizable solution and its application in tissue augmentation, indicating advancements in regenerative medicine [1] Group 2: Market Implications - The allowed patent positions CollPlant favorably in one of the largest target markets for its products, enhancing its competitive edge in the aesthetic medicine sector [1]

Core Insights - CollPlant Biotechnologies is strategically positioning its photocurable dermal filler platform to address facial volume loss associated with GLP-1 weight-loss therapies, targeting a growing market of patients experiencing facial fat depletion due to rapid weight loss [1][2] Group 1: Product Development - The photocurable dermal filler is designed to restore facial volume while providing a supportive regenerative matrix that integrates with surrounding tissue [1] - This technology aims to provide immediate structural restoration and support tissue integration, potentially improving skin quality and elasticity over time [1] - CollPlant's filler technology is currently in the preclinical stage, as part of a broader strategy to develop next-generation regenerative aesthetic solutions based on recombinant human collagen (rhCollagen) [1] Group 2: Market Opportunity - The rapid global adoption of GLP-1 therapies is driving increased demand for aesthetic solutions that address changes in facial structure following significant weight loss [1] - There is a growing interest in non-surgical treatments that restore volume while maintaining natural facial dynamics, indicating a shift in patient preferences [1] - CollPlant's regenerative biomaterial platform positions the company to meet this emerging clinical and aesthetic need [1] Group 3: Strategic Partnerships - In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, which is a leader in the dermal filler market [1]

Core Insights - CollPlant Biotechnologies reported financial results for Q3 2025, showing significant growth in revenue and advancements in its product development pipeline [1][15][24]. Financial Performance - GAAP revenues for Q3 2025 were $77,000, up from $4,000 in Q3 2024, primarily due to increased sales of rhCollagen-based products [15]. - For the nine months ended September 30, 2025, GAAP revenues reached $2.3 million compared to $351,000 for the same period in 2024 [16]. - The company reported a GAAP net loss of $3.5 million for Q3 2025, an improvement from a net loss of $4.3 million in Q3 2024 [24]. Product Development and Innovation - CollPlant is advancing its dermal filler program and has achieved a key milestone in collaboration with AbbVie, receiving a $2 million payment [3][17]. - The company’s rhCollagen-based bioink, Collink.3D™, has shown superior performance compared to Matrigel® in supporting structured tissue formation, indicating a potential market opportunity of approximately $100 million with an annual growth rate of over 10% [2][15]. - A fully humanized bioprinted skin model developed at Mayo Clinic using rhCollagen offers an ethical alternative to animal testing, broadening the application of CollPlant's technology in medical and pharmaceutical research [2][16]. Strategic Initiatives - CollPlant has initiated a cost reduction plan, including a workforce reduction of approximately 25%, to extend its cash runway [5][21]. - The company is expanding its distribution capabilities in North America through a new logistics partnership, enhancing support for its rhCollagen and BioInk product lines [7][12]. - Plans are in place to actively seek a strategic partner for the continued development of its novel regenerative breast implant product candidate [6]. Market Expansion - CollPlant has expanded its international distribution network for its tendon-repair product, Vergenix™ STR, entering seven new markets in 2025, with plans for further expansion in Europe and Asia in 2026 [13][14]. - The company appointed Bowman Bagley as Vice President, Commercial North America, to lead its commercial strategy and execution across the region [16]. Balance Sheet and Cash Flow - As of September 30, 2025, cash and cash equivalents were $8.5 million, with cash used in operating activities amounting to $6.5 million for the nine months ended September 30, 2025 [26]. - The company reported a decrease in cash used in investing activities to $12,000 from $481,000 in the same period of 2024, primarily due to reduced purchases of property and equipment [27].

Company Overview - CollPlant Biotechnologies is a regenerative and aesthetics medicine company focused on developing innovative technologies and products based on non-animal-derived rhCollagen for tissue regeneration and medical aesthetics [1][2] - The company specializes in 3D bioprinting of tissues and organs, tissue repair, and medical aesthetics, utilizing proprietary plant-based genetic engineering technology to produce rhCollagen [2] Financial Reporting - CollPlant will report its financial results for the third quarter of 2025 on November 26, 2025, before the opening of U.S. financial markets [1] Strategic Partnerships - In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, a subsidiary of AbbVie and a leader in the dermal filler market [3]

Core Insights - CollPlant Biotechnologies is expanding its distribution capabilities in North America by establishing a new logistics center in the U.S. to support its rhCollagen and BioInk product lines [1][3][4] Group 1: Expansion and Infrastructure - The new logistics center will provide cGMP-compliant storage and distribution services, enhancing logistical efficiencies for CollPlant's operations in the U.S. and Canada [1][2] - The facility features advanced infrastructure, including a cloud-based temperature monitoring system, AI-powered security, and remote inventory management, ensuring reliable and secure distribution [2] Group 2: Strategic Commitment - The establishment of the U.S. logistics center reflects CollPlant's long-term commitment to the North American market and is seen as a significant milestone in advancing its regenerative medicine products [3] - By maintaining local inventory, the company aims to improve efficiency and reduce shipping times, thereby enhancing customer access to its products [3] Group 3: Company Overview - CollPlant focuses on regenerative and aesthetic medicine, utilizing its proprietary recombinant human collagen technology for various applications, including tissue repair and organ manufacturing [4] - The company has previously entered into a global commercialization agreement for dermal and soft tissue fillers with Allergan, a leader in the dermal filler market [5]

Core Insights - CollPlant Biotechnologies announced positive results from a comparative study of its rhCollagen-based bioink, Collink.3D™, which outperformed Matrigel® in supporting structured tissue formation [1][8]. Company Overview - CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, tissue repair, and medical aesthetics, utilizing proprietary plant-based genetic engineering technology to produce rhCollagen [9]. Product Details - Collink.3D™ is a recombinant human type I collagen methacrylamide bioink, produced without animal-derived substances, designed to mimic the native properties of human tissues and organs [6][7]. - The bioink enables scalable and reproducible biofabrication of 3D tissue and organ models, supporting drug screening and therapeutic research [7]. Study Findings - The study conducted by the Levenberg Lab at Technion demonstrated that Collink.3D™ exhibited enhanced mechanical strength, elasticity, and stability compared to Matrigel®, suggesting it may serve as a next-generation, animal-free extracellular matrix [3][5]. Market Insights - The global market for basement membrane matrices, including Matrigel and similar products, was valued at approximately $96 million in 2024 and is projected to reach $201 million by 2031, growing at a CAGR of 11.2% [4].