Laviv (autologous fibroblast cell therapy system) / Paragon Biosci, Precigen - LARVOL DELTA

Fibrocell Science reports fourth quarter and full year 2013 financial and operating results (Fibrocell Science Press Release) - "For the year ended December 31, 2013, Fibrocell reported a net loss of $30.6 million, or $1.03 per share, compared to a net loss of $23.2 million, or $2.59 per share, for the year ended 2012....The decrease was due to spending for the initial launch of LAVIV™ during the year ended December 31, 2012."

Commercial • Fibrosis

Study shows promise for topical application of living skin cells following laser treatment (PRWeb) - Dr. David McDaniel announced preliminary data supporting the potential for topical ‘needle free’ application of human skin fibroblast cells following fractional laser treatment; The data was presented Saturday as a “Late-Breaker” at the 2012 American Society for Laser Medicine and Surgery annual meeting in Kissimmee, FL; Pre-treatment with a 2940nm wavelength fractional skin resurfacing laser effectively enabled the topical application of fibroblast cells in a study of fresh skin samples; This laser was used to create precise microchannels in the skin to enable delivery of fibroblast cells into the skin; The Palomar LUX2940 laser is FDA cleared and is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue

Data presentation • Fibrosis

Business Update Conference Call (Fibrocell Science) - Anticipated publication of data for acne scar in 2012; Anticipated initiation of clinical research studies for stretch marks, fine lines/wrinkles in 2012; Anticipated initiation of acne scar program in 2013; Anticipated initiation of restrictive burn scar program in 2013; Anticipated completion of clinical research studies for stretch marks, fine lines/wrinkles in 2013

Anticipated clinical data • Anticipated new trial • Anticipated trial completion date • Fibrosis

Oppenheimer Healthcare Conference (Fibrocell Science) - Laviv / Fibrocell Science; Anticipated launch in China in 2012

Anticipated product launch • Fibrosis

Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for the Treatment of Vocal Fold Scarring and Age-Related Dysphonia (clinicaltrials.gov) - P2; N=20; Active, not recruiting; Sponsor: Fibrocell Technologies, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar

Fibrocell Science: Biotech Showcase (Fibrocell Science) - Anticipated initiation of P3 trial for vocal cord scars in 2016

Anticipated new P3 trial • Fibrosis

Fibrocell Science: An attractive healthcare investment (SeekingAlpha) - Anticipated P2 data for burn contracture in H2 2014; Anticipated P2 data topline for vocal cord scarring in H2 2014; "Fibrocell plans to conduct a 20-30 patient Phase II randomized, placebo-controlled study with absolute change in mucosal wave grade from baseline measured by videostroboscopy as the primary endpoint."

Anticipated new P2 trial • Anticipated P2 data • Fibrosis

IAPAM publishes its top aesthetic medicine trends for 2012 (SBwire) - The approval of LaViv & Belotero along with the FDA approval of Lip Augmentation with Restylane will enhance the use of fillers in 2012 & provide additional products to enhance patient care

Survey results • Fibrosis

Fibrocell reports fourth quarter and full year 2015 financial results and operational highlights (GlobeNewswire) - "Fibrocell completed patient dosing in its Phase II clinical trial of azficel-T for the treatment of vocal cord scarring resulting in chronic or severe dysphonia....Fibrocell expects to report primary endpoint results in the second quarter of 2016."

Anticipated P2 data • Fibrosis

Breakthrough treatment for acne scars with Laviv skin cell cloning therapy and miXto SX fractional skin laser (PRWeb) - P2/3, N=120; IT-A-008; Fibrocell Science announced the first scientific presentation of data demonstrating the efficacy of Laviv in treating moderate-to-severe depressed acne scars; The data were presented at the American Society for Dermatologic Surgery (ASDS) annual meeting in Washington, D.C; The study successfully met its two prospectively defined co-primary endpoints; According to the study results, a higher percentage of subjects responded to treatment with Laviv than with placebo, as rated by both the study investigators (58.7% vs. 42.2%; p=0.016) and pts (43.1% vs. 18.3%; p=0.000011) at the final assessment

P2/3 data • Fibrosis

Fibrocell Science: Annual Report 12 (Fibrocell Science) - Anticipated initiation of P2 trial for restrictive burn scars in Q2 2013; Anticipated initiation of P2 trial for vocal cord scars in H2 2013

Anticipated new P2 trial • Trial initiation date • Fibrosis

Fibrocell Science: Corporate Presentation (Fibrocell Science) - Anticipated completion of P3 trial for restrictive burn scars in 2016; Anticipated completion of P3 trial for vocal cord scars in 2016; Anticipated primary data from P2 trial for vocal cord scars in 2015

Anticipated P2 data • Anticipated trial completion date • Fibrosis

Fibrocell Science: Jefferies Global Healthcare Conference (Fibrocell Science) - Anticipated primary data from P2 trial for restrictive burn scars in 2015; Anticipated initiation of P3 trial for restrictive burn scars in 2016; Anticipated initiation of P3 trial for vocal cord scars in 2016

Anticipated new P3 trial • Anticipated P2 data • Fibrosis

FibroCell Science: Jefferies Global Healthcare Conference (Fibrocell Science) - “Positive Phase I clinical trial results published in peer-reviewed journal”; “All patients completed the clinical trial, successive injections of autologous fibroblasts were well-tolerated, and no serious adverse events reported; n=5”; “Statistically significant and sustained improvement: Efficacy analysis for wave grade improvements was significant starting in month 3 of the 12 month clinical trial (p=0.04), Voice Handicap Index and Voice Quality assessments showed an improvement in voice quality overall for the duration of the clinical trial”

P1 data • Fibrosis

Fibrocell Science: Annual Report 2013 (Fibrocell Science) - Anticipated expiry of patent in US of method of use in treatment of restrictive burn scars and vocal cord scars in July 2015; Anticipated expiry of patents in US, Australia, Canada, China, Europe, India, Japan and South Korea of frozen dosage formulations for injection for the treatment of restrictive burn scars and vocal cord scars in 2030 and 2031; Anticipated expiry of patents in US related to topical formulations of autologous dermal fibroblasts in 2031

Anticipated patent expiry • Fibrosis

Fibrocell highlights recent pipeline accomplishments (GlobeNewswire) - P2, N=20; NCT02120781; "Fibrocell completed patient dosing in its Phase II clinical trial of azficel-T for the treatment of vocal fold scarring resulting in chronic or severe dysphonia....Fibrocell continues to expect to report these primary endpoint results in the second quarter of 2016."

Anticipated P2 data • Enrollment closed • Fibrosis

Fibrocell Science autologous fibroblast injections show improvement in facial acne scar appearance (Businesswire) - P2/3, N=120; NCT00642642; "Fibrocell Science...announced that its Phase 2 study to evaluate the safety and efficacy of azficel-T (LAVIV®) for the treatment of patients with moderate-to-severe acne scars has been accepted for publication in Dermatologic Surgery...The findings demonstrated that azficel-T treatment was associated with clinically meaningful improvement in acne scar appearance and was judged safe and superior to control treatment."

P2 data • Fibrosis

Fibrocell Science: Rodman & Renshaw Global Investment Conference (Fibrocell Science) - Anticipated initiation of P2 trial for burn scars in H2 2013; Anticipated publication of primary data from P2 trial for burn scars in H2 2014; Anticipated initiation of P3 trial for burn scars in H1 2015; Anticipated publication of data from P3 trial for burn scars in H1 2016; Anticipated initiation of P2 trial for vocal fold scars in H2 2013; Anticipated publication of primary data from P2 trial for vocal fold scars in H2 2014; Anticipated initiation of P3 trial for vocal fold scars in H1 2015; Anticipated publication of data from P3 trial for vocal fold scars in H1 2016

Anticipated P2 data • Anticipated P3 data • Anticipated trial initiation date • Fibrosis

Fibrocell Science: Barclays Global Healthcare Conference (Fibrocell Science) - Anticipated BLA submission for restrictive burn scars in H2 2016; Anticipated BLA submission for vocal cord scars in H2 2016

Anticipated BLA • Fibrosis

Fibrocell Sciences: Corporate Presentation (Fibrocell Science) - "Positive Phase I clinical trial results published in peer-reviewed journal"; "Injection of azficel-T into scarred cord lamina propria layer was found to be safe and well-tolerated in trial (n=5): All patients completed the trial, No serious adverse events reported"; "Positive trend of sustained improvement: Sustained improvement from month 3 through month 12 was noted in a majority of patients in the mucosal wave grade assessment, voice handicap index and patient-assessed voice quality, Primary endpoint data summary (n=5)"

P1 data • Fibrosis

Fibrocell Science: Q1 2014 Results (Fibrocell Science) - Anticipated enrollment completion of 20 subjects in P2 trial for vocal cord scars by Q3 2014; Anticipated top-line efficacy read out from P2 trial for vocal cord scars in Q3 2015; Anticipated enrollment completion of 21 subjects in P2 trial for restrictive burn scars by Q3 2014

Anticipated enrollment status • Anticipated P2 data • Fibrosis

Fibrocell announces last patient visit for primary endpoint analysis in Phase II clinical trial of azficel-T for the treatment of vocal cord scarring (GlobeNewswire) - P2, N=20; NCT02120781; "Fibrocell Science...today announced that the last patient visit for primary endpoint analysis has been completed in its Phase II clinical trial of azficel-T for the treatment of vocal cord scarring resulting in chronic or severe dysphonia....Fibrocell expects to report primary endpoint results for this Phase II trial in the second quarter of 2016."

Anticipated P2 data • Enrollment closed • Fibrosis

Fibrocell Science expands potential medical applications for Azficel-T (Fibrocell Science) - "Fibrocell Science...announced today the initiation of a Phase II trial for azficel-T...for the treatment of restrictive burn scars (RBS)...study will enroll 21 participants with burn scars that restrict range of motion of jointed areas such as elbows, shoulders and fingers."

Trial initiation date • Fibrosis

Investor Presentation (Fibrocell Science) - "Reports anecdotally suggest 75-82% of patients demonstrate treatment benefit 9 and 12 months following treatment"

P2 data • Fibrosis

Fibrocell Science: Annual Report 2015 (Fibrocell Science) - Anticipated expiry of patent in US in July 2020; Anticipated expiry of patents in US, Australia, Canada, China, Europe, India, Japan, Hong Kong and South Korea of frozen dosage formulations for injection for the treatment of restrictive burn scars and vocal cord scars in 2030 and 2031

Anticipated patent expiry • Fibrosis