8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

___________________

FORM 8-K

___________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 5, 2015

FIBROCELL SCIENCE, INC.

(Exact Name of Registrant as Specified in its Charter)

DELAWARE	001-31564	87-0458888
(State or Other Jurisdiction of Incorporation or Organization)	(Commission File No.)	(I.R.S. Employer Identification No.)

405 EAGLEVIEW BLVD., EXTON, PA 19341

(Address of principal executive offices and zip code)

(484) 713-6000

(Registrant’s telephone number, including area code)

(Former name or former address, if changed from last report)

___________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

q	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
q	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
q	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
q	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c))

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2015, Fibrocell Science, Inc. ("Fibrocell") issued a press release announcing its financial results for the three and nine months ended September 30, 2015. A copy of the press release is furnished herewith as Exhibit 99.1.

Item 7.01 Regulation FD Disclosure.    

On November 5, 2015, Fibrocell posted an updated Corporate Presentation on its website (www.fibrocell.com). A copy of the presentation is furnished herewith as Exhibit 99.2.

Item 9.01 Financial Statements and Exhibits.

(d)    Exhibits

Exhibit No.	Description
99.1	Press release issued by Fibrocell Science, Inc. on November 5, 2015
99.2	Corporate Presentation dated November 5, 2015

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

	Fibrocell Science, Inc.
By:	/s/ Keith A. Goldan
	Keith A. Goldan
	SVP and Chief Financial Officer

Date: November 5, 2015

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press release issued by Fibrocell Science, Inc. on November 5, 2015
99.2	Corporate Presentation dated November 5, 2015

EX-99.1

Exhibit 99.1

Fibrocell Science Reports Third Quarter 2015

Financial Results and Operational Highlights

- Company to Host Conference Call and Webcast, Today at 8:30 a.m. EST -

EXTON, PA - November 5, 2015 - Fibrocell Science, Inc. (NASDAQ: FCSC), an autologous cell and gene therapy company focused on developing transformational therapies for rare and serious skin and connective tissue diseases, today reported financial results for the quarter ended September 30, 2015 and recent operational highlights. Fibrocell will host a conference call and webcast today at 8:30 a.m. EST.

“The field of gene therapy is rapidly evolving, and we are uniquely positioned as the only company developing personalized cell and gene therapies to treat rare diseases of the skin and connective tissue,” said David Pernock, Chairman and Chief Executive Officer. “We are working tirelessly to complete the steps to advance FCX-007 - our lead gene-therapy product candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) - into human clinical trials. RDEB is a devastating disease with currently no approved treatments, so to successfully develop FCX-007 and bring it to market could be transformational for patients living with RDEB, as well as their families.”

Mr. Pernock continued, “Our other programs, azficel-T for the treatment of chronic dysphonia, and FCX-013 for the treatment of linear scleroderma, continue to progress well. We expect to report Phase II data for chronic dysphonia in the second quarter of 2016, and we are on track to complete our proof-of-concept animal study for FCX-013 in the first half of next year.”

Third Quarter 2015 and Recent Highlights

• In October, data was presented at the American Society of Human Genetics (ASHG) Annual Meeting that provided additional details of positive in vivo preclinical data for FCX-007, Fibrocell’s orphan gene-therapy product candidate for the treatment of RDEB being developed in collaboration with Intrexon Corporation (NYSE: XON). In this in vivo preclinical study, FCX-007 was evaluated for toxicology and biological proof-of-concept data in RDEB and normal human skin xenografts implanted onto severe combined immunodeficiency (SCID) mice. The toxicology results for FCX-007 at two- and six-weeks post-administration showed no signs of toxicity, as observed by no test-article related findings, no tumors in the skin grafts or other organs, no statistical changes in blood chemistry and no apparent systemic distribution of the vector. Additional data supporting the biological proof-of-concept of FCX-007 was also presented at ASHG. The data showed that FCX-007 cells in a human skin xenograft model expressed type VII collagen (COL7) that localized to the basement membrane zone where anchoring fibrils are formed.

• In July, Fibrocell filed an Investigational New Drug application (IND) for FCX-007 for the treatment of RDEB with the U.S. Food and Drug Administration (FDA). In September, Fibrocell received feedback from the FDA on the IND related to the areas of CMC, toxicology and our proposed Phase I/II clinical trial protocol. With respect to toxicology, a hybrid pharmacology/toxicology study based on the injection of FCX-007 in RDEB human skin that was xenografted onto SCID (severe combined immunodeficiency) mice was included in the IND and showed no signs of toxicity. However, the FDA requested that Fibrocell complete an additional toxicology-specific study in which FCX-007 will be injected in non-grafted SCID mice. The new toxicology study is targeted to initiate in the fourth quarter of 2015. Fibrocell expects to amend the IND in response to the FDA's feedback and to include data from the new toxicology study in the first quarter of 2016. As a result, Fibrocell expects to initiate a Phase I/II clinical trial for FCX-007 in the second quarter of 2016, subject to successful completion of the new toxicology study and addressing the FDA’s other feedback.

• Fibrocell completed an underwritten public offering of 2,974,136 shares of its common stock at a price of $5.80 per share on July 27, 2015. The offering resulted in net proceeds to Fibrocell of

approximately$15.9 million, after deducting underwriting commissions and offering expenses. Fibrocell intends to use the net proceeds from this offering for the continued preclinical and clinical development of its product candidates and for other general corporate purposes.

Financial Results for the nine months ended September 30, 2015 and 2014

For the nine months ended September 30, 2015, Fibrocell reported a basic net loss of $0.40 and diluted net loss of $0.44 per share, compared to a basic net loss of $0.55 and diluted net loss of $0.60 per share for the same period in 2014.

Total revenue was $0.4 million and $0.1 million for each of the nine months ended September 30, 2015 and 2014, respectively.  This increase was primarily due to collaboration revenue received in 2015 related to a research and development agreement that we have with an unrelated third party to investigate potential new non-pharmaceutical applications for our conditioned fibroblast media technology. This revenue relates to an upfront license fee and a proof-of-concept study currently underway. No collaboration revenue was recognized in the comparable 2014 period.

Total research and development expense decreased $2.0 million to approximately $11.9 million for the nine months ended September 30, 2015 as compared to $13.9 million for the nine months ended September 30, 2014.  The overall decrease is due primarily to $5.2 million of stock issuance costs incurred in the 2014 period related to our Ehlers-Danlos Syndrome program in connection with the second amendment to the exclusive channel collaboration agreement with Intrexon. Excluding the non-recurring stock issuance costs incurred in the 2014 period, research and development costs would have increased approximately $3.2 million in the 2015 period. This increase is due to additional spending to advance our current development programs including an increase of $0.6 million related to our clinical development program for azficel-T for the treatment of chronic dysphonia and increases of $0.8 million and $0.9 million for our preclinical development programs for FCX-007 and FCX-013, respectively. 

Selling, general and administrative expense increased by approximately $0.9 million to $9.0 million for the nine months ended September 30, 2015 as compared to $8.2 million for the same period last year.  The increase was due to a $0.5 million increase in both professional fees and compensation and related expense. The increase in professional fees was driven primarily by increased legal fees. The increase in compensation and related expense was driven by an increase in stock-based compensation and salaries and wages.

As of September 30, 2015, the Company had cash and cash equivalents of $36.9 million.

Conference Call and Webcast

To participate on the live call, please dial 855-877-0343 (domestic) or +1-678-509-8772 (international), and provide the conference code 59105396 five to ten minutes before the start of the call. The conference call will also be webcast live under the investor relations section of Fibrocell's website at www.fibrocell.com/investors/events-and-presentations, and will be archived there for 30 days following the call. Please visit Fibrocell's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

About Fibrocell Science, Inc.

Fibrocell is an autologous cell and gene therapy company focused on developing transformational therapies for rare and serious skin and connective tissue diseases.  Fibrocell’s most advanced product candidate, azficel-T, uses its proprietary autologous fibroblast technology and is in a Phase II clinical trial for the treatment of chronic dysphonia resulting from vocal cord scarring or atrophy.  In collaboration with Intrexon Corporation (NYSE:XON), a leader in synthetic biology, Fibrocell is also developing gene therapies for skin diseases using gene-modified autologous fibroblasts.  Fibrocell is in preclinical development for FCX-007, its lead orphan gene-therapy product candidate, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).  Fibrocell is also in preclinical development of FCX-013, its second gene-therapy product candidate, for the treatment of linear scleroderma. For more information, visit www.fibrocell.com.

Trademarks

Fibrocell Science® and LAVIV® are trademarks of Fibrocell Science, Inc. and/or its affiliates. All other names may be trademarks of their respective owners.

Forward-Looking Statements

This press release contains, and our officers and representatives may from time to time make, statements that are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: our plans to address the FDA’s feedback relating to our IND for FCX-007; the initiation, design, completion and reporting of results from preclinical and clinical studies and the timing thereof; the use of proceeds from the July 2015 offering; the timing of regulatory submissions and actions; the potential advantages of our product candidates; and other statements regarding our future operations, financial performance and financial position, prospects, strategies and objectives and other future events.

Forward-looking statements are based upon management’s current expectations, intentions and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results and events to differ materially and adversely from those indicated herein including, among others:  our ability to successfully complete the additional toxicology study requested by the FDA and to adequately address the FDA’s other feedback relating to our IND for FCX-007; the outcome of the FDA’s review of our amended IND and approval to commence the Phase I/II clinical trial; varying interpretation of clinical preclinical data and the risk that results seen in preclinical studies may not be replicated in humans; uncertainties relating to the initiation and completion of clinical trials and whether clinical trial results will validate and support the safety and efficacy of our product candidates; our ability to maintain our collaboration with Intrexon; and the risks, uncertainties and other factors discussed under the caption “Item 1A. Risk Factors” in our most recent Form 10-K and Form 10-Q filings, as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the Securities and Exchange Commission. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Additionally, the forward-looking statements contained in this press release represent our views only as of the date of this release. While we may update certain forward-looking statements from time to time, we specifically disclaim any obligation to do so, whether as a result of new information, future developments or otherwise.

# # #

Investor Relations & Media Contact:

Karen Casey

Fibrocell Science, Inc.

405 Eagleview Boulevard

Exton, PA 19341

(484) 713-6133

kcasey@fibrocell.com

Fibrocell Science, Inc.

Selected Financial Information

($ in thousands, except per share and share data)

(unaudited)

Consolidated Statements of Operations	Three months ended September 30, 2015			Three months ended September 30, 2014			Nine months ended September 30, 2015			Nine months ended September 30, 2014
Revenue from product sales	$	49		$	20		$	217		$	124
Collaboration revenue	30			—			193			—
Total revenue	79			20			410			124
Cost of product sales	62			512			283			1,852
Cost of collaboration revenue	142			—			230			—
Total cost of revenue	204			512			513			1,852
Gross loss	(125		)	(492		)	(103		)	(1,728		)
Research and development expense	4,221			3,069			11,902			13,909
Selling, general and administrative expense	2,477			2,630			9,041			8,150
Operating loss	(6,823		)	(6,191		)	(21,046		)	(23,787		)
Other income:
Warrant revaluation and other finance income	5,301			177			4,240			1,135
Other income	—			—			—			370
Interest income	1			2			4			4
Loss before income taxes	(1,521		)	(6,012		)	(16,802		)	(22,278		)
Income tax benefit	—			—			—			—
Net loss	$	(1,521	)	$	(6,012	)	$	(16,802	)	$	(22,278	)
Per Share Information:
Net loss:
Basic	$	(0.04	)	$	(0.15	)	$	(0.40	)	$	(0.55	)
Diluted	$	(0.07	)	$	(0.17	)	$	(0.44	)	$	(0.60	)
Weighted average number of common shares outstanding
Basic	43,021,121			40,856,815			41,598,632			40,766,741
Diluted	43,712,918			41,300,105			41,829,231			41,045,861

	September 30, 2015		December 31, 2014
Balance Sheet Condensed Data
Cash and cash equivalents	$	36,931	$	37,495
Working capital	32,631		35,856
Total assets	43,934		45,634
Warrant liability, current and long term	6,964		11,286
Total liabilities	12,568		15,225
Stockholders' equity	31,366		30,409

EX-99.2

Corporate Presentation November 5, 2015 1

2 Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the potential advantages of our product candidates; the initiation, design and timing of preclinical and clinical studies and the reporting of the results thereof; the timing of regulatory submissions and actions; anticipated milestones; and all other statements regarding our objectives, strategies, prospects, future operations, future financial performance, future financial position and other future events (including our assumptions relating thereto). Forward-looking statements are based upon our current expectations, intentions and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially and adversely from those expressed or implied by such statements. Factors that could cause or contribute to such differences include, among others: our ability to successfully complete the additional toxicology study requested by the FDA and to adequately address the FDA’s other feedback relating to our IND for FCX-007; the outcome of the FDA’s review of the amended IND for FCX-007 and approval to commence the Phase I/II trial; varying interpretation of clinical and preclinical data; the risk that results seen in preclinical studies may not be replicated in humans; uncertainties relating to the initiation and completion of clinical trials and whether the results will validate and support the safety and efficacy of our product candidates; our ability to maintain our collaboration with Intrexon; and the other factors discussed under the caption “Item 1A. Risk Factors” in our most recent annual report on Form 10-K and our most recent quarterly report on Form 10-Q, which are available through the “Investors & Media—SEC filings” page of our website at www.fibrocell.com. As a result, you should not place undue reliance on forward-looking statements. The forward-looking statements made during this presentation represent our views only as of the date of this presentation (or any earlier date indicated in such statement). While we may update certain forward-looking statements from time to time, we specifically disclaim any obligation to do so, whether as a result of new information, future developments or otherwise.

• Fibrocell is the leader of autologous fibroblast therapy for skin and connective tissue diseases – Developing a pipeline of cell and gene therapies for orphan skin diseases using autologous fibroblasts to deliver a targeted gene • Phase II azficel-T sBLA program: autologous fibroblasts for Chronic Dysphonia – Significant voice impairment due to severe vocal cord scarring or atrophy – Phase II data expected in 2Q16 • FCX-007: Novel gene-therapy product candidate for Recessive Dystrophic Epidermolysis Bullosa (RDEB), a congenital orphan skin disease – Devastating, progressive, painful blistering disease that leads to death – Granted rare pediatric disease designation by FDA – Collaboration with Intrexon Corporation (NYSE: XON); expect to initiate Phase I/II trial in 2Q16 • FCX-013: Novel gene-therapy product candidate for Linear Scleroderma – Autoimmune disease causes debilitating, painful linear scars and skin thickening that can lead to pain, reduced joint mobility and deformity – Collaboration with Intrexon; proof-of-concept expected 1H16; IND planned 4Q16 Company Highlights 3

Autologous Fibroblasts as a Therapy • Fibroblasts repair tissue infrastructure by producing extracellular matrix proteins including collagen and growth factors • Most common cell in skin and connective tissue • Key advantages of our autologous fibroblast/gene-therapy approach: ‐ Monogenic (one gene) disorder with a known mechanism of action ‐ Fibroblasts are genetically-modified ex vivo, with safety testing prior to administration ‐ Protein target characterized by multiple assays ‐ Localized injection (avoids systemic delivery) ‐ Reduced rejection concern • We are using our proprietary technology to create personalized biologics 4

Gene Therapy Product Engine integrates Intrexon’s synthetic biology FCX-007, FCX-013 Autologous Fibroblast Product Engine azficel-T BLA* Two Product Engines – Multiple Therapeutics in Development Collection Culture Local Administration Vector Preparation Gene Packaging Gene Transduction Personalized Biologics Approach 5 * azficel-T BLA currently approved as LAVIV® for the treatment of nasolabial fold wrinkles in adults

Personalized Biologics Indication Pre-Clinical Development Phase 1 Phase 2 Phase 3 azficel-T sBLA* Chronic Dysphonia FCX-007 Gene-Therapy Orphan Product Candidate Recessive Dystrophic Epidermolysis Bullosa (RDEB) FCX-013 Gene-Therapy Potential Orphan Product Candidate Linear Scleroderma Development Pipeline 6 * azficel-T BLA currently approved as LAVIV® for the treatment of nasolabial fold wrinkles in adults

Disease Current Treatments Epidemiology Damage to the fibroblast layer causes scarring and edema which limits air flow and results in severe and significant limitations in voice quality, often loss of voice • Current treatments only address symptoms • Voice therapy • Surgery - Injection (collagen, fat, calcium, hyaluronic acid) - Implant (PTFE, silastic) Prevalence of ~125,000 (U.S.) suffering with chronic dysphonia caused by benign vocal fold lesions1 Chronic Dysphonia 7

Positive Phase I clinical trial results published in peer-reviewed journal2 • Injection of azficel-T into scarred fold 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 8 Clinical Data Support Our Approach in Chronic Dysphonia

• Fully enrolled 20+ subjects • Double-blind, randomized, placebo-controlled • Validated scales with a 4-month efficacy endpoint • Dosing expected to be complete by year-end 2015 • Expect to report primary endpoint results in 2Q16 Chronic Dysphonia - Phase II Trial 9

Providing Hope for RDEB Patients 10 RDEB patients do not produce type VII collagen (COL7) due to mutation in COL7A1 gene ‐ Main component of anchoring fibrils that connect skin layers FCX-007 is an autologous human dermal fibroblast transduced with a lentiviral (LV) vector containing the gene for COL7A1 ‐ Simple, local injection to the papillary dermis

Disease Current Treatments Epidemiology • Devastating, progressive, painful blistering disease that leads to death • Diagnosed at infancy • High mortality rate • Cause: A mutation in the COL7A1 gene which encodes for COL7 • Current treatments only address symptoms • Bandaging & antibiotics – bandaging alone can exceed $10,000 per month3 • Feeding tubes • Surgery, including hand and esophageal Dystrophic EB (DEB) ~5,500 – 12,500 US4 • RDEB ~1,100 – 2,500 US5 Recessive Dystrophic Epidermolysis Bullosa 11

COL7 Expression Confirmation COL7 Trimer COL7 FORMATION 290kDa ~900kDa Culture supernatant evaluated for COL7 expression: • ELISA assay indicates virus dose-dependent protein expression • Trimeric form of COL7 produced by RDEB patient fibroblasts transduced with LV-COL7 ~ 900kDa 12

FCX-007 In Vitro Results Summary 13 Study Results: Results Suggest: Production of LV-COL7 was demonstrated Ability to successfully make the vector FCX-007 was produced by expanding LV-COL7-transduced RDEB patient fibroblasts from a biopsy sample Ability for full-scale FCX-007 production The integrated transgene copy number per cell was dependent on the virus dose Full gene integration into cell genome The COL7 expression from the FCX-007 was confirmed by qRT- PCR, immunofluorescence staining, and ELISA COL7 is being produced from FCX-007 The structure of the COL7 expressed by FCX-007 was confirmed to be predominantly trimeric by immunoprecipitation/SDS- PAGE/Western blot analysis COL7 produced from FCX-007 is the correct size and structure The COL7 produced from FCX-007 was demonstrated to be functional by binding to Laminin 332 in an in vitro binding assay and by correction of the hypermotility phenotype of RDEB cells in an in vitro migration assay COL7 produced from FCX-007 is functional Results replicated over two additional FCX-007 cultures Study results are reproducible

Positive Pre-Clinical Results & Next Steps Toxicity • Hybrid pharmacology/toxicology study with SCID mice grafted with normal human skin graft & injected with FCX-007 to determine toxicity and systemic distribution of vector • Results: – No adverse observations at 2 and 6 weeks post-injection – No apparent vector distribution based on qPCR of organ samples Proof-of-Concept • SCID mice grafted with human RDEB skin substitutes & injected with FCX-007 • Results: – Production of COL7 observed in vivo – COL7 detected in the dermal-epidermal junction Next Steps • Perform toxicology-specific mouse study in non-grafted SCID mice • Amended IND with new toxicology data expected in 1Q 2016 • Expect to initiate Phase I/II trial in 2Q2016 14

FCX-007 Proposed Clinical Trial Design Title A Phase I/II Trial of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Statement of Purpose The purpose of this study is threefold: 1) To evaluate the safety of FCX-007 2) To evaluate COL7 expression and the presence of anchoring fibrils resulting from FCX-007 3) To analyze wound healing as a result of FCX-007 administration Objectives Primary 1) The primary objective of this protocol is to evaluate the safety of FCX-007 Secondary 1) To evaluate mechanism of action of FCX-007 at weeks 4,12, 25, 52, and unscheduled visits through the evaluation of skin biopsies for COL7 expression and the presence of anchoring fibrils 2) To evaluate the efficacy of FCX-007 through an intra-subject paired analysis of target wound area at weeks 4, 8, 12, 25, 52, and unscheduled visits, comparing FCX-007 treated wounds to untreated wounds in Phase I and to wounds administered sterile saline in Phase II through the evaluation of digital imaging of wounds # of Subjects Nine (three adults in Phase I followed by six pediatrics in Phase II) 15

Disease Epidemiology • Excess production of extracellular matrix characterized by skin fibrosis and linear scars • The linear areas of skin thickening may extend to underlying tissue and muscle in children which may impair growth in affected legs and arms or forehead • Lesions appearing across joints impair motion and may be permanent • Localized Scleroderma ~200,000 sufferers US6 comprised of many different sub-types - Linear Scleroderma Initial target for FCX-013 is a group of ~40,000 patients who have scleroderma over a major joint and exhibit severe joint pain7 Current Treatments • Current treatments only address symptoms • Systemic or topical corticosteroids • UVA light therapy • Physical therapy Linear Scleroderma Photo: © 2015 American College of Rheumatology. Used with permission. 16

• Demonstrated protein expression • Product Profile – Genetically-modified autologous dermal fibroblasts – Gene construct identified, target gene selected – Preparing scale-up manufacturing using lentivirus • Animal model in development • Anticipated milestones – Proof-of-concept animal study data 1H16 – IND submission in 4Q16 FCX-013 Development Progressing 17

Anticipated Milestones & Corporate Info 18 • Cash = $36.9 million at 30 Sept 2015 • 43.9 million common shares of FCSC outstanding at 30 Sept 2015 – 5.9 million warrants; 3.2 million options • Analyst research – Wedbush Securities – David Nierengarten, PhD – Griffin Securities – Keith Markey, PhD Anticipated Milestones Timing FCX-007 Phase I/II Trial Initiation 2Q16 azficel-T sBLA Phase II Data 2Q16 FCX-013 Proof-of-Concept Data 1H16 FCX-013 IND Submission 4Q16

• Fibrocell is the leader of autologous fibroblast therapy for skin and connective tissue diseases – Developing a pipeline of cell and gene therapies for orphan skin diseases using autologous fibroblasts to deliver a targeted gene • Phase II azficel-T sBLA program: autologous fibroblasts for Chronic Dysphonia – Significant voice impairment due to severe vocal cord scarring or atrophy – Phase II data expected in 2Q16 • FCX-007: Novel gene-therapy product candidate for Recessive Dystrophic Epidermolysis Bullosa (RDEB), a congenital orphan skin disease – Devastating, progressive, painful blistering disease that leads to death – Granted rare pediatric disease designation by FDA – Collaboration with Intrexon Corporation (NYSE: XON); expect to initiate Phase I/II trial in 2Q16 • FCX-013: Novel gene-therapy product candidate for Linear Scleroderma – Autoimmune disease causes debilitating, painful linear scars and skin thickening that can lead to pain, reduced joint mobility and deformity – Collaboration with Intrexon; proof-of-concept expected 1H16; IND planned 4Q16 Company Highlights 19

References 1Data on file. Fibrocell Science, Inc. 2Chhetri, Dinesh, Injection of Cultured Autologous Fibroblasts for Human Vocal Fold Scars. The Laryngoscope 121(4):785-792, 2011. 3 The Dystrophic Epidermolysis Research Association of America (DebRA). DEB brochure, page 6: http://www.debra.org/pdfs/Debra-of-America-Brochure.pdf; accessed 07/20/15. 4 DEBRA International. What is EB Infographic: http://www.debra-international.org/epidermolysis-bullosa.html.; accessed 10/06/2014. 5Petrof G., et. al. Fibroblast cell therapy enhances initial healing in recessive dystrophic epidermolysis bullosa wounds: results of a randomised, vehicle-controlled trial. Brit J Dermatol. 2013 Nov;169(5):1025-33. 6The Scleroderma Foundation. What is Scleroderma? http://www.scleroderma.org/site/PageServer?pagename=patients_whatis#.VaUwk7BFBMw, paragraph 6; accessed 10/09/2014—states, “It’s estimated that about 300,000 Americans have scleroderma. About one third of those people have the systemic form of scleroderma (i.e., 200,000 have a form of localized scleroderma).“ 7The Scleroderma Foundation. “Localized Scleroderma” brochure, pages 4, 6-7: http://www.scleroderma.org/site/DocServer/Localized.pdf?docID=317; accessed 07/20/15—states, “Some patients with localized scleroderma, an estimated 10 to 20 percent (20% of 200,000 = 40,000 patients), develop joint pain (arthralgia) during the course of their disease.” 20