Current Report Filing (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 THE EARLIEST EVENT REPORTED): July 21, 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 July 21, 2015, Fibrocell Science, Inc. ("Fibrocell") reported a preliminary estimate of approximately $26.9 million for cash and cash equivalents as of June 30, 2015. Fibrocell's independent registered public accounting firm, BDO USA, LLP, has not audited or reviewed, and does not express an opinion with respect to, this estimate. Fibrocell's actual cash and cash equivalents as of June 30, 2015 may differ from this estimate due to the completion of its closing procedures with respect to the second quarter ended June 30, 2015, final adjustments and other developments that may arise between now and the time the financial results for the quarter are finalized.

Item 8.01 – Other Events.

On July 21, 2015, Fibrocell issued a press release announcing the commencement of a firm commitment underwritten public offering. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. Also on July 21, 2015, Fibrocell posted an updated Corporation presentation on its website www.fibrocell.com. A copy of the presentation is attached hereto as Exhibit 99.2 and is incorporated by reference herein.

Item 9.01 – Financial Statements and Exhibits.

(d) Exhibits



Exhibit No.		Description

99.1		Press Release dated July 21, 2015
99.2		Corporate Presentation dated July 21, 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: July 21, 2015

EXHIBIT INDEX



Exhibit No.		Description

99.1		Press Release dated July 21, 2015
99.2		Corporate Presentation dated July 21, 2015

Exhibit 99.1

Fibrocell Announces Proposed Public Offering of Common Stock

EXTON, PA - July 21, 2015 - Fibrocell Science, Inc., (NASDAQ:FCSC), an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet needs, today announced that it has commenced an underwritten public offering of its common stock pursuant to its existing shelf registration statement. All of the shares in the offering are to be sold by Fibrocell.

Fibrocell intends to use the net proceeds of the proposed offering for the continued clinical and preclinical development of its product candidates and for other general corporate purposes.

Wells Fargo Securities, LLC is acting as sole book-running manager and representative of the underwriters for the offering. Roth Capital Partners and Griffin Securities are acting as co-managers for the offering. Fibrocell intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the shares of common stock sold in the public offering to cover over-allotments, if any. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The offering is being made by Fibrocell pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC), which the SEC declared effective on August 28, 2013. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement may also be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, 4th Floor, New York, NY 10152, by email at cmclientsupport@wellsfargo.com, or by calling 1-800-326-5897.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About Fibrocell Science, Inc.

Fibrocell is an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs. 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. 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 has submitted an IND application to the FDA for FCX-007, its lead orphan gene-therapy product candidate, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is in pre-clinical development of FCX-013, its second gene-therapy product candidate, for the treatment of linear scleroderma.

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. These forward-looking statements relate to a variety of matters, including, without limitation, Fibrocell’s expectations regarding the sale of shares of its common stock in the proposed public offering, its use of the proceeds from the proposed offering and other statements that are not purely statements of historical fact.

These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of Fibrocell’s control. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others: varying interpretation of research data; the outcome of regulatory review of the IND; 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, as well as those set forth under the caption “Item 1A. Risk Factors” in Fibrocell’s most recent Form 10-K filing.

Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. In addition, Fibrocell operates in a highly competitive and rapidly changing environment, and new risks may arise. Accordingly, you should not place any reliance on forward-looking statements as a prediction of actual results. Fibrocell disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statement. You are also urged to carefully review and consider the various disclosures in Fibrocell’s most recent annual report on Form 10-K, our most recent Form 10-Q as well as other public filings with the SEC since the filing of Fibrocell’s most recent annual report.

# # #

Investor Contact:

Karen Casey

Fibrocell

Tel: +1 (484) 713-6133

kcasey@fibrocellscience.com

Fibrocell Corporate Presentation 21 July 2015 1

2 Forward-Looking Statements This presentation 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. Examples of forward-looking statements include, among others, statements we make regarding our development strategy; potential advantages of our product candidates; the initiation and completion of preclinical and clinical studies and the reporting of the results thereof; the timing of regulatory submissions and actions; and all other statements relating to our plans, objectives, expectations and beliefs regarding future performance, operations, financial condition and other future events (including assumptions underlying or relating to any of the foregoing). These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of our control. Important factors that could cause our actual results and financial condition to differ materially from those indicated in forward-looking statements include, among others: uncertainties relating to the initiation and completion of preclinical and clinical studies; whether preclinical and clinical study results will validate and support the safety and efficacy of our product candidates; the outcome of regulatory reviews of our product candidates; our reliance on third parties for certain development activities; varying interpretation of research and development and market data; risks and uncertainties relating to intellectual property 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. Any forward-looking statement made by us in this presentation is based only on information currently available to us and speaks only as of the date on which it is made. In addition, we operate in a highly competitive and rapidly changing environment, and new risks may arise. Accordingly, you should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise any forward-looking statement. You are urged to carefully review and consider the various disclosures in our most recent annual report on Form 10-K, our most recent Form 10-Q and our other public filings with the SEC since the filing of our most recent annual report.

• 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 – Phase II data expected in 2Q16 • FCX-007: Novel gene-therapy drug candidate for Recessive Dystrophic Epidermolysis Bullosa (RDEB), a congenital orphan skin disease – Devastating, progressive, painful blistering disease that leads to death – Collaboration with Intrexon (NYSE: XON); IND submitted 17 Jul 2015; expect to initiate Phase I/II trial in 2H15 • FCX-013: Novel gene-therapy drug 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 Drug Candidate Recessive Dystrophic Epidermolysis Bullosa (RDEB) FCX-013 Gene-Therapy Potential Orphan Drug 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 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 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

FCX-007: Rapid Regulatory Progression to IND 12 2Q2014 • Granted Orphan Status for DEB by FDA (June 2014) 3Q2014 • Held Pre-IND Meeting with FDA (August 2014) 4Q1014 1Q2015 • Clinical Trial Protocol Cleared by NIH Recombinant DNA Advisory Committee (Feb 2015) 2Q2015 • Granted Rare Pediatric Disease Designation for RDEB by FDA (May 2015) 3Q2015 • IND Submitted on 17 July 2015 Initiate Phase I Trial 2H15

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 13

In Vitro Results Summary 14 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 Toxicity • 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 – +/- controls indicate test is valid 15

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) 16

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. 17

• Preliminary protein expression levels determined • Product Profile – Genetically-modified autologous dermal fibroblasts – Gene construct identified, target gene selected – Preparing scale-up manufacturing using lentivirus • Animal model candidate in development • Anticipated milestones – Proof-of-concept animal study data 1H16 – IND submission in 4Q16 FCX-013 Development Progressing 18

Anticipated Milestones 19 Anticipated Milestones Timing FCX-007 IND Submitted (17 July 2015) Complete FCX-007 Phase I Initiation 2H15 azficel-T sBLA Phase II Data 2Q16 FCX-013 Proof-of-Concept Data 1H16 FCX-013 IND Submission 4Q16

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 10/09/2010—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

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