• 29 Mar, 2025

COLLPLANT BIOTECHNOLOGIES REPORTS 2024 FINANCIAL RESULTS AND PROVIDES A CORPORATE UPDATE

COLLPLANT BIOTECHNOLOGIES REPORTS 2024 FINANCIAL RESULTS AND PROVIDES A CORPORATE UPDATE

CollPlant announces six-month study data from its regenerative breast implant program, which could provide a revolutionary alternative to women for aesthetic or medical purposes and aims to address a $3 billion market opportunity

Recently received a $2 million development payment from AbbVie

Conference call to be held today at 10:00 a.m. U.S. EDT

REHOVOT, Israel, March 26, 2025 -- CollPlant Biotechnologies (Nasdaq: CLGN), or "CollPlant", 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 its 2024 financial results and provided a corporate update.

"This past year to date, we have progressed on all fronts - from advancing our collaborative programs, to gaining momentum on our proprietary programs as well as our marketed products.  Specifically, we leveraged additional preclinical studies findings, refined a commercial design of our regenerative breast implants, gained an additional U.S. patent related to our photocurable dermal filler and also broadened the distribution network for our commercial product, Vergenix STR. On the aesthetic medicine front, following a development achievement we received a $2 million payment from our collaboration partner, AbbVie.  In tandem with our progress, we have also been very careful to optimize our costs. Therefore, we expect that our cash position, that has been supported by both milestone payments and incremental sales revenue, will allow us to be selective and support a capitalized path in the interest of our shareholders", commented CollPlant's Chief Executive Officer, Yehiel Tal.

Collaboration Updates 

AbbVie Collaboration

Under CollPlant's existing development and commercialization agreement with development partner, AbbVie, CollPlant has granted AbbVie a worldwide exclusive license to use CollPlant's rhCollagen technology in combination with AbbVie's proprietary technologies for the development and commercialization of dermal and soft tissue fillers.  The dermal filler product candidate is currently in the clinical phase and AbbVie is collecting data and conducting a review of interim results from the first cohort of patients enrolled under the trials initiated in 2023.  Next steps for the program are to be determined by AbbVie upon concluding their assessment.

In February 2025, following a development achievement, CollPlant received a $2 million payment from AbbVie, according to the development and commercialization agreement.

Stratasys Collaboration  

On August 19, 2024, CollPlant announced the initiation of a pre-clinical study with 200cc commercial-sized regenerative implants printed using CollPlant's bioinks and Stratasys' (Nasdaq: SSYS) Origin® 3D printer. The collaboration between CollPlant and Stratasys is currently focused on the development of a bioprinting solution for CollPlant's breast implants, in addition to finding solutions to scale-up the implant's fabrication process.

Recent Corporate Updates

Regenerative Breast Implants 

On June 6, 2024, CollPlant announced that it has successfully printed, for the first time, breast implants of 200cc, which are commercial size. These implants were printed using CollPlant's proprietary rhCollagen-based bioinks. Currently, there are no commercial products that allow regeneration of soft tissues such as the breast. The program goal is to develop and commercialize novel regenerative implants that provide a revolutionary alternative to the implants that are currently on the market.

In August 2024, CollPlant launched a preclinical study with the 200cc, clinical-sized breast implants, which were also produced with enhanced durability. The surgical protocol was refined to include implantation through a small incision while preventing implant displacement or inversion. Analysis of MRI and ultrasound data conducted in 2025 confirmed tissue integration and vascularization, offering valuable diagnostic tools for future clinical applications. At six months post-implantation, one study arm has shown promising outcomes, with the implant demonstrating vascularization and rapid tissue ingrowth within the clinical-sized implant. No complications, such as capsule formation, calcifications, and local tissue reactions were observed. Additionally, volume retention and mechanical properties were maintained in the successful study arm.

Following this study, Collplant will continue to optimize the regenerative breast implants to ensure longevity and re-modelling of the neo-vascularized tissue. 

Mr. Tal added, "CollPlant's paradigm shifting breast implants in development are unique in that they are designed to regenerate breast tissue as well as have inherent safety advantages. We have been testing implants that are commercial size after upgrading our bioprinting process and other capabilities to fabricate these implants.  We are very encouraged by the results observed so far. This is one of our lead programs that has the potential to position CollPlant as a market leader in the field of regenerative medicine."

Earlier, in 2024, three-month data showed evidence of well-developed connective tissue containing blood vessels (i.e., neovascularization) within the implant. Progressing tissue ingrowth within the implant was also observed confirming tissue regeneration. An initial biodegradation process was observed, while preserving the original structure of the 3D breast implant. No adverse tissue reaction was observed, confirming the safety profile of this novel implant in development. 

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.

In February 2025, CollPlant announced the expansion of its distribution channels for its Vergenix™ STR product, in Europe and Asia. VergenixSTR is based on the Company's rhCollagen technology and is intended for the treatment of tendinopathy by promoting healing and repair of tendon injuries in a variety of tendons including the elbow tendon (for treatment of "tennis elbow"), rotator cuffs, patellar tendons, the Achilles tendon, and hand tendons. Specifically, CollPlant recently signed distribution agreements for VergenixSTR with distributor companies located in the Netherlands, Turkey and India, for sales in the territories of the Netherlands, Belgium, Luxemburg ("Benelux"), Spain, India and Turkey.

Also in February, CollPlant announced that it had initiated a cost cutting and workforce reduction plan. CollPlant indicated that its updated allocation of resources results in a reduction of its workforce by approximately 20%, and, based on current estimates, will allow it to continue its business activities, including those related to its primary research and development programs until at least the second quarter of 2026.

Intellectual Property

RhCollagen Curable BioInks Portfolio of Products

CollPlant announced today that the Japan Patent Office (JPO) has granted a second patent on Patent Application no. 2023-101072 securing patent protection on CollPlant's portfolio of rhCollagen curable BioInks in Japan until 2038.

This newly allowed application is related to CollPlant's innovative curable Collink.3D® BioInk pipeline, consisting of the first and only line of human collagen BioInk products based on chemically modified plant-derived rhCollagen that is mass-produced with high purity and consistency. Collink.3D enables scalable and reproducible biofabrication of tissue models, tissues, and organ transplants, while perfectly mimicking the native properties of tissues and organs. Additionally, it provides the advantage of being animal-free, has the properties of optimal rheology at room temperature, supports high viability of different cell types and is biocompatible and non-immunogenic.

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