Welcome to the Community College Program Day

BIO 2011Washington D.C.

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Regenerative Medicine –Today and TomorrowRegenerative Medicine –Today and Tomorrow

John W. Ludlow, Ph.D.Senior Director, process Research & Assay Development

Eighth Annual Community College Program DayBIO International Convention, Washington, DC, June 2011

John W. Ludlow, Ph.D.Senior Director, process Research & Assay Development

Eighth Annual Community College Program DayBIO International Convention, Washington, DC, June 2011

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Certain statements in this presentation may constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although Tengion believes that these statements are based upon reasonable assumptions within the bounds of its knowledge of its business and operations, there are a number of factors that may cause actual results to differ from these statements.

For instance there can be no assurance that: (i) the Company's Neo-Urinary Conduit clinical trial will not be placed on clinical hold by the Food and Drug Administration, or FDA; (ii) patients enrolled in the Company's Neo-Urinary Conduit clinical trial will not experience additional adverse events, which could delay clinical trials or cause the Company to terminate the development of the Neo-Urinary Conduit; (iii) the Company will be able to successfully enroll patients in its clinical trials, including its initial clinical trial for the Neo-Urinary Conduit; (iv) the results of the clinical trial for the Neo-Urinary Conduit will support further development of that product candidate; (v) data from the Company's ongoing preclinical studies will continue to be supportive of advancing its preclinical product candidates; and (vi) the Company will be able to progress its product candidates that are undergoing preclinical testing, including the Neo-Kidney Augment, into clinical trial and (vii) the Company will be able to obtain the capital it needs to develop its product candidates and continue its operations.

For additional factors which could cause actual results to differ from expectations, reference is made to the reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward looking statements in this presentation are made only as of the date hereof and the Company disclaims any intention or responsibility for updating predictions or expectations in this presentation.

Forward Looking StatementsForward Looking Statements

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The Early History of Regenerative MedicineThe past enables the present and guides the futureThe Early History of Regenerative MedicineThe past enables the present and guides the future

Prometheus Bound

Aeschylus~458 B.C.

The Culture of Organs

Alexis Carrel & Charles Lindbergh1938

FrankensteinModern Prometheus

Mary Shelley1818

1981 Engineered skinE. Bell, et al.

1977 Allogeneic cartilageA.E. Gross, et al.

1966 Small bowel submucosa as vascular graftsT. Matsumoto, et al.

First Kidney Transplant1954

First Bone Marrow Tx1968

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Does Regenerative Medicine Have a Presence in the Present?Does Regenerative Medicine Have a Presence in the Present?

• >35,000 original papers & reviews• >50 companies with products in

clinical development Biomaterials Cells Cells + Biomaterials

• >5,000 FTEs worldwide• > 250 training institutions worldwide• > $1B in total revenue (2008)*• Products are reaching the market

Autologous chondrocytes for articular cartilage repair

Dermal patches / engineered skin for wound healing

Fibrin sealants and patches Collagen matrix for surgical repair

• Trade Organizations are growing

*www.masshightech.com (8/18/2008)

Carticel®

Dermagraft®

OASIS® Wound Matrix

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What Have we Learned?What Have we Learned?

• “The first products…just did not behave as originally intended once they entered the clinic.”

• “…the challenges of commercial-scale manufacture were considerable.”

• “…[the] biotechnology business model centered on out-licensing or partnering through joint ventures…proved wholly inappropriate…”

• “…the capital value of publicly traded tissue engineering corporations dropped by almost 90%, from US$2.5 billion at the end of 2000 to $300 million by the end of 2002.”

Kempo P. History of Regenerative Medicine:Looking backwards to move forwards. Regen Med 1(5): 653-659, 2006

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What else Have we Learned?What else Have we Learned?

“Regenerative Medicine…after a period trapped in the notorious chasm, is now just starting to climb out the other side into mainstream clinical practice…we are probably leaving the chasm by a totally different route to the one we predicted when we tumbled in.”

Mason C. Regenerative medicine 2.0. Regen Med 2(1): 11-18, 2007

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The Future is Challenging…Do we Give Up?Not a Chance!The Future is Challenging…Do we Give Up?Not a Chance!

“Change is the law of life. And those who look only to the past or present are certain to miss the future.” John F. Kennedy

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Applying our Knowledge ForwardTo increase probability of successApplying our Knowledge ForwardTo increase probability of success

• Constrain research with practical clinical and commercial limitations

• Define development pathway in close collaboration with regulatory agencies

• Strategic management of intellectual property Purposeful filing of enabled product-relevant

patents Diligent management of know-how & trade

secrets

• Structure communication for public acceptance, medical understanding, and regulator / payer interactions

• ‘Do not [complicate products] beyond necessity’ (Occam’s Razor)

Successful Clinical & Commercial Translation:

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Peripheral Artery Bypass

Tengion Product PipelineTengion Product Pipeline

Advanced CKD

Cystectomy due to Bladder Cancer

Cystectomy

Spina Bifida

Spinal Cord Injured

Esophagectomy

Short Bowel Syndrome

Coronary Artery Bypass

Vascular Access Graft

Urge Incontinence (laparascopic)

Phase IIIPhase IIPhase IINDPreclinicalOptimization

Neo-Vessel Replacement

Neo-GI Augment

Neo-Kidney Augment

Neo-Urinary Conduit

Neo-Bladder Replacement

Neo-Bladder Augment (1st gen)

Additional Platform Programs (not in active development)

Lead Programs in Development

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Biomaterials

Cel

ls

INPUTSRaw Materials

Iterative Combinatorial Approach to RegenerationDeriving the simplest effective solutionIterative Combinatorial Approach to RegenerationDeriving the simplest effective solution

Bioprocess

Delivery

PRODUCT PROTOTYPECombination ProductsStimulate Regeneration

Integrate into Host

Regenerative Template

REGENERATEDOUTCOME

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Neo-Urinary ConduitJain et al.,

TERMIS 2010

Application-specific Technology Evolutionfor translation of regenerative medicine products Application-specific Technology Evolutionfor translation of regenerative medicine products

• Bladder-derived Urothelial cells Smooth Muscle Cells

• Bladder-derived Smooth Muscle Cells

• Adipose-derived Smooth Muscle Cells

Neo-Bladder Augment Lancet 2006 367:1241

Iteration driven by operational & clinical necessity

SMC-only BladderBertram et al.,

Experimental Biology 2009

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A Future View for Regenerative MedicineSteady progress, product evolution, long-term visionA Future View for Regenerative MedicineSteady progress, product evolution, long-term vision

Targets- Cell Replacement or Structural Repair

- Functional Tissue/Organ Replacement- Total Organ Replacement

Compatibility- One “Size” fits all

- Multiple “Size” options- Personalized Medicine

Availability- Delayed Delivery

- Rapid Delivery- Point-of-Care Delivery

Composition- Assembled combination products

- More defined / integrative products- Inductive biologics

RegeneratedOutcome

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