1. FOR DISCLOSURE AND FOOTNOTE INFORMATION, REFER
TO THE JMP FACTS AND DISCLOSURES SECTION
INVESTMENT HIGHLIGHTS
• Solid progress as CLI Phase III trial gets underway; reiterate Market Outperform rating and
$6 price target. Aastrom announced that it has initiated the Phase III REVIVE trial, evaluating
the company's autologous cell therapy, ixmyelocel-T for the treatment of patients with critical limb
ischemia (CLI). The timing of this news is in line with our expectations and we anticipate that
enrollment could be completed with approximately 18 months, with data read out in 2H14. We
continue to believe that the SPA-backed Phase III trial has a higher than average probability of
success based on the impressive results from the randomized Phase IIb RESTORE CLI trial as
well as the design and powering assumptions for Phase III. Additionally, we anticipate the
emergence of further value-driving catalysts in 2012 as we gain more visibility on advancing
ixmyelocel-T in broader CLI patient populations and indications (e.g. dilated cardiomyopathy),
currently not included in our valuation. Our $6 price target is derived by applying a 5x multiple to
our projection for ixmyelocel-T sales of $571MM in 2018, discounted by 35% per year.
• Phase III designed to optimize likelihood of success. The Phase III REVIVE trial is expected to
enroll 594 "no option" CLI patients at 80 clinical sites in the U.S. These are the most severe CLI
patients who would not benefit from revascularization procedures and have pre-existing tissue loss.
We note that, in our view, the selection of clinical site only in the U.S. is positive, minimizing the
potential for geographical variability seen with previous trials in this indication (i.e. Sanofi's
TAMARIS trial). The primary endpoint of the trial is amputation-free survival 12 months following
treatment. We believe the statistical powering assumptions are another strength of this Phase III
trial ,as they are supported by the results from the Phase IIb trial in the same patient population.
• Confidence in Phase III success driven by Phase IIb results and in-depth product
characterization. In our view, the REVIVE trial has been de-risked by the efficacy and safety
results of the Phase IIb RESTORE CLI trial. Recall that these results, presented in November 2011
at the American Heart Association annual meeting, demonstrated a statistically significant benefit in
the primary endpoint of time to treatment failure (p=0.032). Moreover, in the subset of patients
(>60%) with pre-existing wounds (the population being enrolled in Phase III), the greatest benefit of
treatment was observed for both the time to treatment failure and amputation free survival
endpoints. We also note that we view ixmyelocel-T and its manufacturing processes to be well
characterized and validated, attributes we see as pivotal for achieving regulatory success.
Biotechnology - Company Report March 1, 2012
Aastrom Biosciences, Inc. (1)
Execution Remains Focus with CLI Phase III Trial Now Underway
MARKET OUTPERFORM ASTM $1.79
Price $1.79 FY Dec 2010A 2011E 2012E
Target Price $6.00 Revenue (M) 1Q -- $0.0A 0.0
52-Wk Range $1.75 - $3.47 2Q -- $0.0A 0.0
Shares Out. (M) 39 3Q -- $0.0 0.0
Market Cap. (M) $69 4Q -- $0.0 0.0
Average Daily Vol. (000) 215 FY $0.1 $0.0 0.0
Float (M) $38.4
2010A 2011E 2012E
LT Debt (M) 0.049 EPS 1Q -- ($0.13)A ($0.16)
Cash (M) $12 2Q -- ($0.26)A ($0.16)
Enterprise Value (M) $57 3Q -- ($0.05) ($0.17)
Cash/Share $0.31 4Q -- ($0.15) ($0.17)
FY ($0.65) ($0.59) ($0.66)
P/E NM NM NM
Previous FY -- -- --
CY ($0.65) ($0.59) ($0.66)
PE NA NA NA
NC indicates no change to previous estimate. NE indicates no previous estimate.
Source: Company reports and JMP Securities
Jason N. Butler, PhD
jbutler@jmpsecurities.com
(212) 906-3505
2. 2
• Cash overhang remains, however data support further investment. The primary near-term
overhang for ASTM shares remains the need to fully fund the ixmyelocel-T Phase III program. In
our view, the data seen to date for the product in this indication and dilated cardiomyopathy, as well
as the extensive development and expertise that have been generated for this cell therapy
platform, provide ample support for further investment in what we already believe is an undervalued
asset. We continue to believe that management has a clear understanding of how to execute on a
capital efficient clinical development program, while maintaining a focus on the steps necessary
optimize the probability of clinical and regulatory success.
INVESTMENT RISKS
Clinical risk. Aastrom's development candidates could fail to generate expected results in current or
future clinical trials.
Regulatory risk. The FDA, and/or other ex-U.S. regulatory agencies, could reject any of the firm's, or its
partners', future regulatory filings or require additional studies prior to granting approval. We note that
no product has been previously approved for the treatment of critical limb ischemia in the U.S.
Commercial risk. If successfully developed, Aastrom's products may face competition both from
approved products and also potentially from new product candidates in development by biotechnology
and pharmaceutical companies.
Balance sheet risk. The expenses associated with drug development are high. It is possible that the
company will return to the capital markets to secure additional financing to fund current or future
development programs. As of September 30th, 2011, Aastrom had approximately $12MM in cash and
equivalents, which we do not believe will be sufficient to fund operations through profitability.
COMPANY DESCRIPTION
Aastrom is a biopharmaceutical company focused on the development of cellular therapies for the
treatment of severe, chronic cardiovascular diseases. The company's lead candidate is ixmyelocel-T, an
autologous, bone marrow-derived cell therapy product that is being developed for the treatment of
critical limb ischemia (CLI) and dilated cardiomyopathy (DCM). The company announced positive top-
line results from a randomized, placebo controlled Phase IIb trial for ixmyelocel-T in CLI this summer,
and full results are expected to be presented in November at the American Heart Association annual
meeting. Furthermore, in August, Aastrom agreed to a Special Protocol Assessment (SPA) with the
FDA for a Phase III trial of ixmyelocel-T in CLI, and this trial is expected to begin in 4Q11. The second
indication for ixmyelocel-T is DCM, and based on positive Phase II results presented in September at
the Heart Failure Society of American annual meeting, we expect the company to collaborate with the
FDA to determine the appropriate development path forward. Aastrom has core expertise in the
manufacture and engineering of cell therapy products and has capacity at its cGMP facility in Ann Arbor
to support clinical development and early commercialization of ixmyelocel-T.
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