FBLG

- First patients dosed in phase 1/2 clinical trial evaluating CYWC628 in diabetic foot ulcers- On track for interim results reporting in 2H 2026 HOUSTON, July 31, 2026 /PRNewswire/ -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update. Recent Highlights: Clinical Updates: Initiation of patient dosing in the Company's Phase 1/2 clinical trial evaluating CYWC628 for the treatment of diabetic foot ulcers (DFUs). Financing: Strengthened financial position through completion of a $9.0 million private placement with $3.0 million upfront and up to approximately $6.0 million of potential additional gross proceeds upon the exercise in full of warrants. Additionally, closed a $3.0 million public offering. Preclinical Progress: Reported preclinical results suggesting that topical treatment with human dermal fibroblast (HDF) spheroids may reprogram the burn wound environment by dampening harmful inflammation, reshaping immune cell behavior, and reducing markers of scar-forming activity, within just eight days of injury. Patent Portfolio: Received a notice of an allowance for a patent with the U.S. Patent and Trademark Office (USPTO) covering methods of treating and accelerating the healing of wounds by topically administering a composition comprising 3D spheroid fibroblasts together or with one or more fibroblast-derived materials. Filed a provisional patent application with the USPTO covering oral delivery systems designed to protect fibroblast-based therapeutics through the stomach and enable targeted release in the gastrointestinal tract. Conference Presentations: Presented poster presentations on the novel thymus organoid platform at the Keystone Symposia on Aging and Immunity; and preclinical data from its CYPS317 program for psoriasis at the Society for Investigative Dermatology 2026 Annual Meeting. Presented its proprietary thymus organoid technology to reboot the immune system and extend human life at the Alliance for Longevity Initiatives H-Span Summit in Washington DC. Upcoming Milestones Wound Healing: Phase 1/2 clinical trial evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients: Psoriasis: Anticipates IND clearance for the treatment of psoriasis with CYPS317, the Company's fibroblast spheroid product candidate, in the fourth quarter of 2026. Multiple Sclerosis: Plans to submit an IND application with the U.S. Food & Drug Administration (FDA) for the treatment of multiple sclerosis with FibroBiologics' fibroblast spheroid product candidate, CYMS101, in the fourth quarter of 2026. Degenerative Disc Disease: Plans to amend the IND clearance with the FDA to replace single-cell fibroblasts with fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank. Pete O'Heeron, CEO and Founder of FibroBiologics, said, "With the first patient dosed in our CYWC628 trial, FibroBiologics has entered an important stretch as a clinical-stage company. Every milestone ahead builds on this one, and every data point will speak to what fibroblasts can do for patients. We are positioned for the catalysts ahead and eager to share our initial findings this year." Financial Highlights for the Quarter Ended June 30, 2026 Research and development expenses were approximately $1.7 million for the three months ended June 30, 2026, compared to approximately $2.0 million for the same period in 2025. The decrease was primarily due to decreased CRO costs of $0.3 million as clinical validation changed to manufacturing, and certain costs were capitalized to research and development supplies. General and administrative expenses were approximately $2.4 million for both the three months ended June 30, 2026 and 2025. The primary areas of net change are decreased personnel expenses of $0.2 million; increased professional fees of $0.1 million for accounting, legal and marketing expenses; decreased facilities expenses of $0.1 million; and increased listing expenses of $0.1 million. For the three months ended June 30, 2026, FibroBiologics reported a net loss of approximately $4.1 million. The net loss for the three months ended June 30, 2026, was primarily due to research and development expenses and general and administrative expenses discussed above. Cash and cash equivalents totaled approximately $3.5 million at June 30, 2026. For more information, please visit FibroBiologics' website, email FibroBiologics at [email protected] or follow FibroBiologics on LinkedIn, YouTube, Facebook or X. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the status, timing and plans for manufacturing FibroBiologics' product candidates, the potential clinical benefits of fibroblasts and fibroblast-derived materials, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics' current and future preclinical studies, clinical trials, and research and development programs, the robustness, progress, and momentum of FibroBiologics' research and development program, the potential indications for FibroBiologics' programs, and plans for, and the timing of, regulatory filings. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections, and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of FibroBiologics' R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; (d) the ability of FibroBiologics to successfully prosecute its patent applications; (e) FibroBiologics' ability to manufacture its product candidates; (f) FibroBiologics' ability to conduct clinical trials; and (g) the Company's ability to maintain compliance with applicable Nasdaq rules. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About FibroBiologics Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 270+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com. General Inquiries:[email protected] Investor Relations:Nic JohnsonRusso Partners(212) [email protected] Media Contact:Liz PhillipsRusso Partners(347) [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/fibrobiologics-reports-second-quarter-2026-financial-results-progresses-clinical-trial-evaluating-lead-wound-care-candidate-302840401.html

On track for first patient dosed in phase 1/2 clinical trial evaluating CYWC628 in diabetic foot ulcers in Q2 of 2026 HOUSTON, April 30, 2026 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update. Recent Highlights Completed manufacturing of the first two batches of the CYWC628 drug product in accordance with Food & Drug Administration (FDA) Good Manufacturing Practices (cGMP) for the phase 1/2 clinical trial for the treatment of diabetic foot ulcers (DFUs). Completed site onboarding for the phase 1/2 clinical trial for CYWC628. Reported positive preclinical results for the burn program, using proprietary fibroblast spheroid technology, indicating increases in a cytokine known to support tissue repair and wound healing in skin and a significant reduction in a cytokine that is a key driver of inflammation in burn wounds. Announced positive preclinical results for a fibroblast spheroid-derived chondrocyte spheroid therapy for degenerative disc disease, demonstrating significant improvement in recovering intervertebral disc integrity versus single cell fibroblasts and fibroblast spheroids in animal models of degenerative disc disease. Raised $3M through a direct offering. Successfully regained compliance with all Nasdaq listing requirements. Expanded the patent portfolio with the issuance of a patent from the United States Patent and Trademark Office covering fibroblast cell therapy for the treatment of osteoporosis and with the Canadian Intellectual Property Office covering a novel fibroblast-based treatment for cachexia. Presented recent updates on fibroblast-based therapies for chronic disease treatments at the 9th Annual BFC Global Healthcare Business Development and Investment Conference, DealFlow Discovery Conference, and BIO Investment & Growth Summit. Upcoming Milestones Wound Healing: Phase 1/2 clinical trial evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients: GMP batch 1 clinical drug product release and shipping to Australia Dose first patient in the second quarter of 2026. Report interim results in the third quarter of 2026. Complete and report primary safety and efficacy results by the end of 2026. Psoriasis Receive IND clearance for the treatment of psoriasis with CYPS317, the Company's fibroblast spheroid product candidate, in the third quarter of 2026. Multiple Sclerosis Submit an IND application with the FDA for the treatment of multiple sclerosis with FibroBiologics’ fibroblast spheroid product candidate, CYMS101, in the second half of 2026. Degenerative Disc Disease Amend the IND clearance with the FDA to replace single-cell fibroblasts with fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank by the end of 2026. Pete O’Heeron, CEO, and Founder of FibroBiologics commented, “During the first quarter of 2026, we made important progress initiating our phase 1/2 clinical trial, including completing cGMP manufacturing of the first batch of the CYWC628 drug product and site onboarding to support dosing the first patient in the second quarter. We continued to build momentum across our pipeline, with positive preclinical data in both our burn and degenerative disc disease programs, further supporting the potential of our fibroblast-based platform. We also strengthened our cash position with additional capital. As we move into the next phase of execution, our focus is on initiating our clinical study, generating meaningful data, and advancing our pipeline programs in psoriasis and multiple sclerosis.” Financial Highlights for the Quarter Ended March 31, 2026 Research and development expenses were approximately $3.0 million for the three months ended March 31, 2026, compared to approximately $1.8 million for the same period in 2025. The increase was primarily due to increased CRO costs of $1.8 million to prepare for a clinical trial; decreased contract research costs of $0.3 million; and decreased supplies expenses of $0.3 million. General and administrative expenses were approximately $2.1 million for the three months ended March 31, 2026, compared to approximately $2.8 million for the same period in 2025. The primary areas of net change are decreased personnel expenses of $0.2 million; decreased professional fees of $0.4 million for accounting, legal and marketing expenses; decreased travel expenses of $0.1 million; and increased listing expenses of $0.1 million. For the three months ended March 31, 2026 and 2025, FibroBiologics reported a net loss of approximately $5.0 million. The net loss for the three months ended March 31, 2026, was primarily due to research and development expenses and general and administrative expenses discussed above. Cash and cash equivalents totaled approximately $1.5 million at March 31, 2026. Subsequent to March 31, 2026, the Company raised approximately $2.5 million net, in a registered direct offering. For more information, please visit FibroBiologics’ website, email FibroBiologics at [email protected] or follow FibroBiologics on LinkedIn, YouTube, Facebook or X. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the status, timing and plans for manufacturing FibroBiologics’ product candidates, the potential clinical benefits of fibroblasts and fibroblast-derived materials, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics’ current and future preclinical studies, clinical trials, and research and development programs, the robustness, progress, and momentum of FibroBiologics’ research and development program, the potential of product candidates as scalable platform technologies, the potential indications for FibroBiologics’ programs, and plans for, and the timing of, regulatory filings. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections, and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of FibroBiologics’ R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; (d) the ability of FibroBiologics to successfully prosecute its patent applications; (e) FibroBiologics’ ability to manufacture its product candidates; (f) FibroBiologics’ ability to conduct clinical trials; and (g) the Company’s ability to maintain compliance with applicable Nasdaq rules. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About FibroBiologics Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 270+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com. General Inquiries: [email protected] Investor Relations: Nic Johnson Russo Partners (212) 845-4242 [email protected] Media Contact: Liz Phillips Russo Partners (347) 956-7697 [email protected]

Planning for phase 1/2 clinical trial initiation in Australia utilizing CYWC628 to treat diabetic foot ulcers in the first half of 2026 Improved balance sheet through multiple direct offerings; completed payments of outstanding debt HOUSTON, Feb. 24, 2026 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced full year 2025 financial results and provided a corporate update. Recent Highlights Secured both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial evaluating CYWC628 for the treatment of refractory diabetic foot ulcers (DFU), enabling the enrollment of 120 patients at up to 10 sites across Australia. Filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to advance the clinical development of CYPS317 in patients with psoriasis. Raised a total of $7.2M through multiple direct offerings. Repaid all outstanding debt. Expanded the patent portfolio with the filing of a patent application with the U.S. Patent and Trademark Office (USPTO) covering a proprietary fibroblast-derived therapy platform for use in orthopedic and musculoskeletal conditions, including degenerative disc repair, cartilage repair, and joint restoration. Presented recent updates on fibroblast-based therapies for chronic disease treatments at the 2025 ThinkEquity and Bio-Europe conferences. Received a favorable determination from a Nasdaq Hearings Panel granting an extension to regain compliance for the continued listing of the Company’s common stock on The Nasdaq Capital Market. Upcoming Milestones Wound Healing: Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients Complete manufacturing of CYWC628 drug product in accordance with FDA Good Manufacturing Practices (cGMP) in Q1 2026. Complete enrollment of up to 10 clinical sites in Q1 2026. Dose first patient in the first half of 2026. Report interim results in the first half of 2026. Complete and report final results by the end of 2026. Psoriasis Receive IND clearance for the treatment of psoriasis with CYPS317, the Company's fibroblast spheroid product candidate, in the first half of 2026. Multiple Sclerosis Submit an IND application with the FDA for the treatment of multiple sclerosis with FibroBiologics’ fibroblast spheroid product candidate, CYMS101, in the first half of 2026. Degenerative Disc Disease Amend the IND clearance with the FDA to replace single-cell fibroblasts with fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank by the end of 2026. Pete O’Heeron, CEO and Founder of FibroBiologics commented, “Over the course of 2025, we focused on making steady, practical progress across the business. We advanced our fibroblast-based programs toward the clinic, expanded the intellectual property behind our platform, and improved our balance sheet. We also put key regulatory pathways in place, including approvals in Australia that allow us to rapidly move forward with our Phase 1/2 clinical study in early 2026. We are laser-focused on executing our clinical plans, initiating human studies, and advancing our IND programs for psoriasis and multiple sclerosis. We are generating the critical data needed to define where fibroblast-based therapies can make a meaningful therapeutic impact for patients with chronic diseases.” Financial Highlights for the Year Ended December 31, 2025 Research and development expenses were approximately $7.4 million for the year ended December 31, 2025, compared to approximately $4.5 million for the same period in 2024. The increase was primarily due to increased CRO costs of $2.2 million to prepare for a clinical trial; increased lab facilities expense of $0.3 million for lab rent; increased personnel related expenses of $0.3 million due to hiring additional research scientists; and increased depreciation expense of $0.1 million due to increased laboratory equipment. General and administrative expenses were approximately $9.2 million for the year ended December 31, 2025, which was equal to the same period in 2024. The primary areas of net change are increased expenses of $0.2 million for added personnel in 2025, which includes stock-based compensation expense; increased professional fees of $0.3 million for accounting, legal and marketing expenses; decreased offering and listing expenses of $0.4 million; and decreased insurance expenses of $0.1 million. For the year ended December 31, 2025, FibroBiologics reported a net loss of approximately $18.6 million compared to a net loss of approximately $11.2 million for the same period in 2024. The net loss for the year ended December 31, 2025, was primarily due to the increase in both research and development expenses and general and administrative expenses discussed above. Cash and cash equivalents totaled approximately $4.9 million at December 31, 2025. For more information, please visit FibroBiologics’ website, email FibroBiologics at [email protected] or follow FibroBiologics on LinkedIn, YouTube, Facebook or X. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the status, timing and plans for manufacturing FibroBiologics’ product candidates, the potential clinical benefits of fibroblasts and fibroblast-derived materials, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics’ current and future preclinical studies, clinical trials, and research and development programs, the robustness, progress, and momentum of FibroBiologics’ research and development program, the potential of product candidates as scalable platform technologies, the potential indications for FibroBiologics’ programs, and plans for, and the timing of, regulatory filings. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections, and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of FibroBiologics’ R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; (d) the ability of FibroBiologics to successfully prosecute its patent applications; (e) FibroBiologics’ ability to manufacture its product candidates; (f) FibroBiologics’ ability to conduct clinical trials; and (g) the Company’s ability to regain compliance with applicable Nasdaq rules. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About FibroBiologics Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 270+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com. General Inquiries: [email protected] Investor Relations: Nic Johnson Russo Partners (212) 845-4242 [email protected] Media Contact: Liz Phillips Russo Partners (347) 956-7697 [email protected]

FSdC demonstrated statistically significant and superior improvement in disc preservation and structural integrity compared to other treatments HOUSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced positive preclinical results for FSdC, an investigational FSdC spheroid-based therapy, demonstrating superior improvement in recovering intervertebral disc integrity and preventing degeneration in animal models of degenerative disc disease. These preclinical findings represent a major advancement for FibroBiologics’ regenerative medicine pipeline and highlight the potential of FSdC spheroids to address unmet needs in spinal health. Key results from the degenerative disc disease animal model study include: Significantly Improved Disc Height Recovery: FSdC spheroids exhibited the highest level of intervertebral disc height recovery at 12 weeks after treatment as compared to 2D fibroblasts and fibroblast spheroids, demonstrating superior long-term structural integrity. Highly Significant Statistical Superiority: Study data revealed FSdC spheroids exceptional performance in disc height recovery 12 weeks after treatment, achieving the most compelling statistical difference from vehicle control with an unadjusted p-value of 0.00015 as compared to 0.036 for 2D fibroblasts, and 0.068 for fibroblast spheroids—positioning it as the leading innovative approach. Breakthrough Potential for Spinal Health: By sustaining the highest average disc size index (%DHI) across all time points during the six disc height measuring periods of the 12 week study, FSdC spheroids significantly outperformed single cell fibroblasts and fibroblast spheroids, heralding a potential new era in regenerative therapies for the treatment of degenerative disc disease and joint-cartilage damage. “These compelling preclinical results for FSdC mark a significant step forward in our regenerative pipeline and advance our goal of bringing innovative fibroblast-based therapies to patients,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “Degenerative disc disease impacts millions who face ongoing pain and limited mobility with current options. We believe FSdC spheroids have the potential not only to enhance structural integrity but also to transform how spinal degenerative conditions are managed. This data reinforces our commitment to innovation, scientific excellence, and meaningful patient impact.” Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics, added: “Our preclinical findings indicate that FSdC spheroids leverage unique, multi-faceted regenerative activity, integrating extracellular matrix remodeling with targeted tissue support, and inflammation control which may help restore spinal disc homeostasis in degenerative states. We are enthusiastic about collaborating with regulatory authorities as we move this promising program toward clinical development.” Degenerative disc disease is a leading cause of chronic back pain and disability, affecting millions of adults in the United States and significantly impairing quality of life and productivity. Despite available treatments, unmet needs remain, particularly in achieving long-term disc preservation and regeneration with minimal invasiveness. FibroBiologics is pursuing a development program for FSdC spheroids with the goal of advancing to clinical trials. The data includes comprehensive preclinical pharmacology and efficacy assessments supporting the therapy’s mechanism of action, durability of effect, and potential for regenerative outcomes. About FibroBiologics Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 270+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com. For more information, please visit FibroBiologics' website or email FibroBiologics at: [email protected]. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the potential indications for FibroBiologics’ programs, the potential clinical benefits of fibroblasts and fibroblast-derived materials, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics’ current and future preclinical studies, clinical trials, and research and development programs, the robustness, progress, and momentum of FibroBiologics’ research and development program, and plans for, and the timing of, regulatory filings. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of FibroBiologics’ R&D efforts and preclinical studies; and (c) the unpredictable relationship between R&D and preclinical results and clinical study results. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update, or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. General Inquiries: [email protected] Investor Relations: Nic Johnson Russo Partners (212) 845-4242 [email protected] Media Contact: Liz Phillips Russo Partners (347) 956-7697 [email protected]

Advancing preparations to begin manufacturing of fibroblast-based spheroids product candidate, CYWC628, for the Phase 1/2 clinical trial evaluating CYWC628 in diabetic foot ulcers (DFU) patients Preparing to submit Investigational New Drug applications for the treatment of psoriasis with CYPS317 and the treatment of multiple sclerosis with CYMS101 HOUSTON, Oct. 31, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced third quarter 2025 financial results and provided a corporate update. Recent Highlights Announced positive IND-enabling updates from the psoriasis research program demonstrating the potential of human dermal fibroblast spheroids as a novel therapeutic approach for chronic-relapse psoriasis. Advanced the Bone Marrow Organoid platform, offering promising new treatment options for hematopoietic cancers and age-related immune decline. Filed patent application with the United States Patent and Trademark Office covering methods of generating multipotent cells from fibroblasts found in donor tissue for clinical applications. Published a leadership-authored article in the Opinion Pages presenting the scientific case for fibroblast cells' therapeutic advantages compared to stem cell therapies. Presented recent updates on fibroblast-based therapies for chronic disease treatments at the Cell & Gene Meeting on the Mesa, H.C. Wainwright 27th Annual Global Investment Conference, and the 2025 ThinkEquity Conference. Implemented cost efficient measures to reduce operating expenses and focus resources on near-term pipeline priorities. Upcoming Milestones Complete manufacturing training runs for CYWC628 and confirm sterility of the manufacturing process by the end of 2025. Complete the manufacturing of CYWC628 in accordance with FDA Good Manufacturing Practices (cGMP). Initiate Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in diabetic foot ulcers (DFU) patients in the first quarter of 2026. Complete Phase 1/2 clinical trial in Australia in DFU patients in the third quarter of 2026. Complete pre-clinical IND-enabling studies for the treatment of psoriasis with CYPS317, FibroBiologics’ fibroblast spheroid product candidate, and submit IND. Complete pre-clinical IND-enabling studies for the treatment of multiple sclerosis with CYMS101, FibroBiologics’ fibroblast spheroid product candidate, and submit IND. “This quarter brought our strategy into greater focus,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “We are efficiently moving our most advanced product candidates towards the clinic while laying the groundwork to demonstrate that fibroblasts can be a scalable platform and not simply a single-asset bet. Our fibroblast platform will enter the clinic with our Phase 1/2 trial in diabetic foot ulcer patients in the first quarter next year, as we execute against defined milestones to validate its biology, the technology, and the regulatory and commercial path forward.” Financial Highlights for the Nine Months Ended September 30, 2025 Research and development expenses were approximately $6.6 million for the nine months ended September 30, 2025, compared to approximately $3.1 million for the same period in 2024. The increase was primarily due to increased contract research costs of $0.4 million for cell manufacturing activities; increased CRO costs of $2.1 million to prepare for a clinical trial; increased lab facilities expense of $0.2 million for lab rent; increased personnel related expenses of $0.3 million due to hiring additional research scientists; and increased research materials and supplies expenses of $0.5 million due to increased laboratory personnel and preclinical studies. General and administrative expenses were approximately $7.4 million for the nine months ended September 30, 2025, compared to approximately $6.9 million for the same period in 2024. The increase was primarily due to increased expenses of $0.7 million for added personnel in 2025, which includes stock-based compensation expense; increased professional fees of $0.2 million for accounting, legal and marketing expenses; increased travel expenses of $0.1 million; and decreased Direct Listing related expenses of $0.4 million. For the nine months ended September 30, 2025, FibroBiologics reported a net loss of approximately $15.4 million compared to a net loss of approximately $8.1 million for the same period in 2024. The net loss for the nine months ended September 30, 2025, was primarily due to the increase in both research and development expenses and general and administrative expenses discussed above. Cash and cash equivalents totaled approximately $4.9 million at September 30, 2025. For more information, please visit FibroBiologics’ website or email FibroBiologics at [email protected]. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the status, timing and plans for manufacturing FibroBiologics’ product candidates, the potential clinical benefits of fibroblasts and fibroblast-derived materials, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics’ current and future preclinical studies, clinical trials, and research and development programs, the robustness, progress, and momentum of FibroBiologics’ research and development program, the potential of product candidates as scalable platform technologies, the potential indications for FibroBiologics’ programs, and plans for, and the timing of, regulatory filings. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections, and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of FibroBiologics’ R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; (d) the ability of FibroBiologics to successfully prosecute its patent applications; (e) FibroBiologics’ ability to manufacture its product candidates; and (f) FibroBiologics’ ability to conduct clinical trials. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About FibroBiologics Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 270+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com. General Inquiries: [email protected] Investor Relations: Nic Johnson Russo Partners (212) 845-4242 [email protected] Media Contact: Liz Phillips Russo Partners (347) 956-7697 [email protected]

HOUSTON, July 31, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced second quarter 2025 financial results and provided a corporate update. Recent Highlights Successfully closed third $5 million tranche of a $25 million total financing, with proceeds used to advance research and development efforts and support the upcoming Phase 1/2 clinical trial in diabetic foot ulcers (DFUs). Strengthened leadership team with the appointment of Jason D. Davis, CPA, as Chief Financial Officer, who brings over 25 years of experience in building and leading organizations. Presented pre-clinical evidence at the Society for Investigative Dermatology Annual Meeting supporting the potential of fibroblast spheroids to reduce psoriasis severity. Findings showcased the fibroblast-based candidate’s ability to enable sustained remission and reduce relapse, accompanied by a significantly lower adverse side effects profile. Highlighted potential of fibroblast-based therapies for chronic disease treatments at the BIO International Convention 2025. Confirmed the use of the CYWC628 master cell bank for the manufacturing of CybroCell™, FibroBiologics’ investigational intradiscal administered allogeneic fibroblast cell-based therapy in development for degenerative disc disease. Upcoming Milestones Initiate Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients in the first quarter of 2026. Complete Phase 1/2 clinical trial in Australia in DFU patients in the third quarter of 2026. Complete pre-clinical IND-enabling studies for the treatment of psoriasis with CYPS317, FibroBiologics’ fibroblast spheroid product candidate, by the end of 2025. Pete O'Heeron, Founder and Chief Executive Officer of FibroBiologics, said, “Backed by our strong research and development efforts, we are continuing to progress toward entering the clinic with our Phase 1/2 trial evaluating CYWC628 in diabetic foot ulcer patients, while simultaneously advancing IND-enabling studies for CYPS317 in psoriasis. Our robust intellectual property portfolio, which now includes more than 275 issued or pending patents, is reinforced by the growing pre-clinical evidence supporting the potential of our fibroblast-based therapies. We believe this expanding IP position enhances our competitive advantage and supports our long-term strategy for innovation. As always, we remain focused on executing our clinical milestones and delivering meaningful value to both patients and shareholders as we advance toward our goal of transforming chronic disease treatments.” Financial Highlights for the Six Months Ended June 30, 2025 Research and development expenses were approximately $3.8 million for the six months ended June 30, 2025, compared to approximately $1.9 million for the same period in 2024. The increase was primarily due to increased chemistry, manufacturing and control costs of $0.2 million for cell manufacturing activities; increased CRO costs of $0.9 million to prepare for a clinical trial; increased personnel related expenses of $0.3 million due to hiring additional research scientists; and increased research materials and supplies expenses of $0.5 million due to increased laboratory personnel and preclinical studies. General and administrative expenses were approximately $5.2 million for the six months ended June 30, 2025, compared to approximately $4.7 million for the same period in 2024. The increase was primarily due to increased expenses of $0.5 million for added personnel in 2025, which includes stock-based compensation expense; increased professional fees of $0.3 million for accounting, legal and marketing expenses; increased travel expenses of $0.1 million; and decreased Direct Listing related expenses of $0.4 million. For the six months ended June 30, 2025, FibroBiologics reported a net loss of approximately $9.6 million compared to a net loss of approximately $7.6 million for the same period in 2024. The net loss for the six months ended June 30, 2025, was primarily due to the increase in both research and development expenses and general and administrative expenses discussed above. Cash and cash equivalents totaled approximately $8.8 million at June 30, 2025. For more information, please visit FibroBiologics’ website or email FibroBiologics at [email protected]. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the potential of fibroblast spheroids to reduce psoriasis severity, the potential of fibroblast-based therapies for chronic disease treatments, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics’ clinical trials, and the robustness, progress, timing, and momentum of FibroBiologics’ research and development program. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections, and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of FibroBiologics’ R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; (d) the ability of FibroBiologics to successfully prosecute its patent applications; and (e) FibroBiologics’ ability to manufacture its product candidates. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About FibroBiologics Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 275+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com. General Inquiries: [email protected] Investor Relations: Nic Johnson Russo Partners (212) 845-4242 [email protected] Media Contact: Liz Phillips Russo Partners (347) 956-7697 [email protected]

Preparations for Phase 1/2 clinical trial in Australia utilizing fibroblast-based spheroids product candidate, CYWC628, to treat diabetic foot ulcers are proceeding with plans to initiate in the third quarter of 2025 HOUSTON, May 14, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 240+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced first quarter 2025 financial results and provided a corporate update. Recent Highlights Announced the completion of FibroBiologics’ proprietary master cell bank that will support upcoming clinical trials. Manufactured in accordance with FDA Good Manufacturing Practices (cGMP), the cell bank has successfully passed all required safety testing. Announced the opening of a new laboratory facility in Houston that will expand the company’s ability to pioneer additional candidates for chronic disease-focused indications leveraging its novel fibroblast-based technology. Announced a significant advancement in neurodegenerative disease research. Leveraging the well-established Cuprizone animal model, FibroBiologics has demonstrated that intravenous fibroblasts can facilitate remyelination. FibroBiologics’ Cuprizone animal model study demonstrated a statistically significant increase in myelin expression within seven and nine weeks after both single and multiple dose fibroblast treatments. This confirms FibroBiologics’ previous report of remyelination with the Experimental Autoimmune Encephalomyelitis (EAE) animal model. Presented at a number of investor and science conferences including the ThymUS 2025 Meeting, The Cell & Gene Meeting on the Mediterranean, and The German-Nordic Joint Extracellular Matrix Meeting. Announced the filing of a patent application with the United States Patent and Trademark Office covering methods employing fibroblasts to improve mitochondrial performance in cells. Upcoming Milestones Initiate Phase 1/2 clinical trial in Australia utilizing fibroblast-based spheroids product candidate, CYWC628, in diabetic foot ulcer (DFU) patients in the third quarter of 2025. Complete Phase 1/2 clinical trial in Australia in DFU patients in the first quarter of 2026. Determine the potential of using the CYWC628 master cell bank for use with the manufacturing of CybroCell™, FibroBiologics’ investigational intradiscal administered allogeneic fibroblast cell-based therapy in development for degenerative disc disease. Complete pre-clinical IND-enabling studies for the treatment of psoriasis with FibroBiologics’ fibroblast spheroid product candidate, CYPS317, by the end of 2025. “In the first quarter of 2025, we achieved a major operational milestone: the completion of the CYWC628 master cell bank with Charles River. This sets the foundation for our upcoming Phase 1/2 clinical trial in DFU wound healing, which we’re on track to launch in the second half of the year,” said Pete O’Heeron, Founder & CEO. “We’ve also made a strategic move to strengthen our competitive advantage by filing a new patent that leverages our fibroblast platform to target mitochondrial activity—a key driver in a range of diseases. We believe the increasing visibility we’re gaining across investor and scientific forums reflects not just interest, but belief in the disruptive potential of our platform and the velocity building across our pipeline.” Financial Highlights for the Quarter Ended March 31, 2025 Research and development expenses were approximately $1.8 million for the quarter ended March 31, 2025, compared to approximately $1.0 million for the same period in 2024. The increase was primarily due to increased drug product expenses and other expenses to prepare for the Phase 1/2 clinical trial in DFU patients, and the hiring of additional research personnel. General and administrative expenses were approximately $2.8 million for the quarter ended March 31, 2025, compared to approximately $2.5 million for the same period in 2024. The increase was primarily due additional personnel. For the quarter ended March 31, 2025, FibroBiologics reported a net loss of approximately $5.0 million compared to a net loss of approximately $8.5 million for the same period in 2024. The decrease in net loss for the quarter ended March 31, 2025, was primarily due to the change in the fair value of the warrant liability, partially offset by increases in research and development expenses and general and administrative expenses. Cash and cash equivalents totaled approximately $8.7 million at March 31, 2025. For more information, please visit FibroBiologics' website or email FibroBiologics at [email protected]. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the benefits of the new laboratory facility, plans for, and the anticipated timing of the initiation of, FibroBiologics’ clinical trials, and the robustness, progress, timing, and momentum of FibroBiologics’ research and development program. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections, and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of FibroBiologics’ R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; (d) the ability of FibroBiologics to successfully prosecute its patent applications; (e) FibroBiologics’ ability to maintain the master services agreement with Charles River and enter into statements of work for CDMO services; and (f) FibroBiologics' ability to maintain the master services agreement with Southern Star Research. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About FibroBiologics Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 240+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com. General Inquiries:  [email protected] Investor Relations:  Nic Johnson  Russo Partners  (212) 845-4242  [email protected] Media Contact:  Liz Phillips  Russo Partners  (347) 956-7697  [email protected]

HOUSTON, April 02, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics”), a clinical-stage biotechnology company with 240+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced a significant advancement in neurodegenerative disease research. Leveraging the well-established Cuprizone animal model, FibroBiologics has demonstrated that intravenous fibroblasts can facilitate remyelination. FibroBiologics’ Cuprizone animal model study demonstrated a statistically significant increase in myelin expression within seven weeks after both single and multiple dose fibroblast treatments. This confirms FibroBiologics’ previous report of remyelination with the Experimental Autoimmune Encephalomyelitis (EAE) animal model. Myelin sheath, the insulating layer around nerve fibers, is critical for proper nerve function and is often damaged in neurodegenerative diseases like multiple sclerosis. In the brain, the myelin sheath plays a critical role in speeding up communications between neurons. This is especially important in the brain, where rapid and precise signaling is needed for functions like thinking, memory, movement, and coordination. “This confirmation by our talented team of researchers demonstrates that fibroblasts can support the regeneration of myelin sheath, marking a potentially significant step in the utilization of a cell-based therapeutic in regenerative medicine,” said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics. “Our team’s findings advance our understanding of fibroblasts’ regenerative capabilities,” said Pete O'Heeron, Founder & Chief Executive Officer of FibroBiologics. “Confirming remyelination in a second validated animal model is an important step in our research and development efforts, offering fresh hope for patients with demyelinating diseases, including multiple sclerosis. These findings advance our mission to develop transformative fibroblast-based therapies that address the root causes of chronic disease, not just their symptoms, and reflect our dedication to pushing the frontiers of regenerative medicine." For more information, please visit FibroBiologics' website or email FibroBiologics at: [email protected]. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the potential of fibroblasts to facilitate remyelination and to address demyelinating diseases, including multiple sclerosis. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections, and beliefs, as well as a number of assumptions concerning future events. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of our R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; and (d) the ability of FibroBiologics to successfully prosecute its patent applications. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update, or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About FibroBiologics Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 240+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com. General Inquiries:[email protected] Investor Relations:Nic Johnson Russo Partners(212) [email protected] Media Contact:Liz PhillipsRusso Partners(347) [email protected]

Proprietary master cell bank of fibroblast-based spheroids product candidate, CYWC628, completed in accordance with Good Manufacturing Practices after successfully passing all required safety testing Preparations for Phase 1/2 clinical trial in Australia utilizing CYWC628 to treat diabetic foot ulcers are proceeding with plans to initiate in the second quarter of 2025 Cash and cash equivalents of approximately $14.0 million at December 31, 2024 HOUSTON, March 31, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 240+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced full year 2024 financial results and provided a corporate update. Recent Highlights Established a master services agreement with Charles River Laboratories to develop and manufacture FibroBiologics’ therapeutic master cell bank, working cell bank, and fibroblast-based spheroids product, CYWC628, for utilization in a Phase 1/2 clinical trial to treat diabetic foot ulcers (DFUs). Completed FibroBiologics’ proprietary master cell bank that will support upcoming clinical trials. Manufactured in accordance with FDA Good Manufacturing Practices (cGMP), the cell bank has successfully passed all required safety testing. Engaged Southern Star Research to provide clinical research organization (CRO) services in Australia in connection with FibroBiologics’ planned Phase 1/2 clinical trial utilizing CYWC628 to treat DFUs. Presented at a number of investor and science conferences including the 2024 Jones Healthcare and Innovation Conference, HC Wainright Global Investment Conference, 2024 Maxim Virtual Summit, BIO San Diego, Cell and Gene Meeting on the Mesa, ThinkEquity Conference, BIO CEO Conference, and The Extracellular Matrix Pharmacology Congress, Copenhagen, Denmark. Announced early-stage research and development efforts in FibroBiologics’ human longevity program covering potential extension of life applications including recovery of lost thymic functionality by using transplanted artificial thymic organoids in animal models, which has demonstrated the generation of a diverse array of mature T-cells, and 60+ days of vascularization and persistence at the transplantation site. Moved discovery phase project, CYPS317, to the product candidate pipeline for the treatment of psoriasis. Entered into a Standby Equity Purchase Agreement (SEPA) with YA II PN LTD. (Yorkville), an investment fund managed by Yorkville Advisors Global, LP. The agreement allows FibroBiologics, subject to customary conditions, to sell up to $25.0 million in the aggregate of its common stock to Yorkville over the course of two years. Yorkville advanced FibroBiologics the first $10.0 million available under the agreement in December 2024 and FibroBiologics expects Yorkville to advance another $5.0 million available under the agreement following receipt of shareholder approval in satisfaction of Nasdaq rules at FibroBiologics’ 2025 annual meeting of stockholders in June 2025. FibroBiologics can sell an additional $10.0 million of its common stock to Yorkville under the agreement, subject to Yorkville’s consent and other conditions. Expanded patent portfolio in the area of manufacturing and manipulation of the cellular microenvironment and with: (i) the issuance of a patent from the European Patent Office covering methods and compositions for the treatment of cancer utilizing fibroblasts that have been modified to enhance their ability to deliver one or more anti-cancer agents to an individual, (ii) the filing of a patent application with the United States Patent and Trademark Office covering methods employing fibroblasts or other Tissue Factor (TF)-expressing cells to prevent IBMIR-mediated blood clotting, (iii) the filing of a patent application covering methods for treatment of splenomegaly using a cell-based therapeutic approach, and (iv) the filing of a patent application with the USPTO covering methods employing fibroblasts to improve mitochondrial performance in cells. Upcoming Milestones Initiate Phase 1/2 clinical trial in Australia utilizing fibroblast-based spheroids product candidate, CYWC628, in DFU patients in the second quarter of 2025. Complete Phase 1/2 clinical trial in Australia in DFU patients by the end of 2025. Determine timeline for Phase 1 clinical trial for CybroCell™, FibroBiologics’ investigational allogeneic fibroblast cell-based therapy in development for degenerative disc disease, through discussion with the U.S. Food and Drug Administration (FDA). FibroBiologics received IND clearance from the FDA in 2018, conditional upon approval of our master cell bank, to evaluate this candidate in a planned clinical trial. Complete pre-clinical IND-enabling studies for the treatment of psoriasis with FibroBiologics’ fibroblast spheroid product candidate, CYPS317, by the end of 2025. "We entered 2025 with $14 million in cash and cash equivalents and access to additional financing, which enables us to continue to push forward our clinical programs and explore new opportunities," said Pete O'Heeron, CEO and Co-founder of FibroBiologics. "We are focused on starting our Phase 1/2 clinical trial in Australia utilizing CYWC628 in DFU patients in the second quarter of 2025 and expect to have early results by year-end. Our team will continue its ongoing efforts to tackle diseases at their root causes rather than just managing symptoms, which should create real value for patients and our shareholders alike." Financial Highlights for the Year Ended December 31, 2024 Research and development expenses were approximately $4.5 million for the year ended December 31, 2024, compared to approximately $2.4 million for the same period in 2023. The increase was primarily due to increased drug product expenses and other expenses to prepare for the Phase 1/2 clinical trial in DFU patients, and the hiring of additional research personnel. General and administrative expenses were approximately $9.2 million for the year ended December 31, 2024, compared to approximately $6.5 million for the same period in 2023. The increase was primarily due to the costs associated with FibroBiologics’ Direct Listing and operating as a public company and additional personnel. For the year ended December 31, 2024, FibroBiologics reported a net loss of approximately $11.2 million compared to a net loss of approximately $16.5 million for the same period in 2023. The decrease in net loss for the year ended December 31, 2024, was primarily due to the change in the fair value of the warrant liability, partially offset by increases in research and development expenses and general and administrative expenses. Cash and cash equivalents totaled approximately $14.0 million at December 31, 2024. For more information, please visit FibroBiologics' website or email FibroBiologics at [email protected]. This communication shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of the securities discussed herein, in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning plans for, and the anticipated timing of the initiation of, FibroBiologics’ clinical trials, the robustness, progress, timing, and momentum of FibroBiologics’ research and development program and our positioning to accelerate progress in delivering treatments to patients, CDMO services to be provided under the master services agreement with Charles River, our relationship with Charles River, CRO services to be provided under the master services agreement with Southern Star Research, our relationship with Southern Star Research, the funding of the advances under the SEPA, FibroBiologics’ ability to sell additional shares under the SEPA, FibroBiologics’ ability to complete clinical trials and IND-enabling studies and to develop its other programs and indications, potential discussions with the FDA, the potential and capabilities of fibroblasts and artificial thymus organoids to persist and function post-transplantation, with vascularization and the generation of a diverse array of mature T cells, and potential value creation of ongoing efforts. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections, and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of FibroBiologics’ R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; (d) the ability of FibroBiologics to successfully prosecute its patent applications; (e) FibroBiologics’ ability to maintain the master services agreement with Charles River and enter into statements of work for CDMO services; and (f) FibroBiologics' ability to maintain the master services agreement with Southern Star Research. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About FibroBiologics Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 240+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com. General Inquiries:[email protected] Investor Relations:Nic JohnsonRusso [email protected] Media Contact:Liz PhillipsRusso Partners(347) [email protected]