Milan (Italy), 12 November 2012 – The Board of Directors of MolMed S.p.A. (MLM.MI), chaired by Prof. Claudio Bordignon, today reviewed and approved the interim financial report at 30 September 2012. The most important elements were:

1. MolMed Board of Directors approves the
interim financial report at 30 September 2012
Milan (Italy), 12 November 2012 – The Board of Directors of MolMed S.p.A.
(MLM.MI), chaired by Prof. Claudio Bordignon, today reviewed and approved
the interim financial report at 30 September 2012. The most important
elements were:
● The analysis of the clinical trial progress: in particular the positive
interim data of the randomised Phase II data of NGR-hTNF in
combination with doxorubicin in soft tissue sarcomas;
● The increase of revenues to € 2.8 million from the development of new
cell and gene therapy treatments for third parties;
● Approval of balance sheet and income statement pursuant to Art. 2446
of the Italian Civil Code.
Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented:
"The interim analysis of the randomised Phase II study of NGR-hTNF in
soft tissue sarcomas shows a statistically significant superiority of the arm
treated with the dose of 0.8 µg/sqm administered weekly in combination with
doxorubicin. According to protocol design the study will continue enrolling
patients only in this arm that has demonstrated superior progression free
survival. These results confirm that the low dose administered weekly in
combination with chemotherapy represents the most efficacious dose and
schedule. This schedule is also being tested in the ongoing pivotal Phase III
trial in mesothelioma and will be explored in the ongoing randomised Phase II
study in ovarian cancer".

2. Key achievements in the first nine months of 2012
Research & Clinical Development activities
In the first nine months of 2012, the Company’s activities were mainly focused
on clinical development of its two investigational anticancer therapeutics: NGR-
hTNF for the treatment of a panel of solid tumours and TK for the treatment of
high-risk leukaemia.
With regard to NGR-hTNF, main progress achieved included:

3. ● Progress of patient recruitment in the randomised pivotal
Phase III trial for the treatment of relapsed malignant pleural
mesothelioma (trial NGR015): over 300 patients were enrolled in
more than 40 centres located in nine European countries, the United
States, Canada and Egypt, with accrual completion expected by the end
of 2012. The primary analysis of data is expected in 2H 2013;
● Presentation at ASCO (June 2012) and ESMO (October 2012) of
long-term survival data in a randomised Phase II trial in non-
small cell lung cancer (NSCLC, trial NGR014), confirming the
potential clinical benefit in NSCLC patients with squamous cell histology.
The extension of overall survival was the most common clinical benefit
observed also in three other Phase II trials presented – in mesothelioma,
ovarian cancer and small-cell lung cancer;
● Presentation of two analyses on potential predictors of efficacy.
The results of the first analysis show in all indications a positive
correlation between Grade 1 and 2 infusion-related adverse reactions
(transient chills) and patients’ overall response to the therapy,
which is in line with analogous findings observed with other anti-
angiogenic or biological drugs. The second analysis shows a negative
correlation between circulating TNF receptors and therapeutic response -
consistently with the hypothesised mechanism of action of the drug - and
also clarifies why low doses of NGR-hTNF are more efficacious than high
doses.
Updates with regard to NGR-hTNF after 30 September 2012:
● Positive interim data from a randomised Phase II trial of NGR-
hTNF in patients affected by soft tissue sarcomas (trial NGR016).
The results from this four-arm trial, with a pick-the-winner design,
confirm that low-dose NGR-hTNF (0.8 µg/sqm) administered weekly
in combination with doxorubicin provides the highest clinical benefit
to patients. With this schedule, the progression free survival resulted
significantly prolonged, as compared to weekly high-dose NGR-hTNF
(either in combination with doxorubicin or as monotherapy), and weekly
low-dose NGR-hTNF as monotherapy. For this reason the trial will
continue including new patients only in the treatment arm with low-
doses of NGR-hTNF in combination with doxorubicin. These results
further confirm that the dose of 0.8 µg/sqm administered weekly, tested
also in the ongoing pivotal Phase III trial in mesothelioma, represents
the optimal dose and schedule. Complete trial results are expected in 2H
2013;

4. ● Completion of patient enrolment in a randomised Phase II trial
in platinum-resistant/refractory ovarian cancer patients (trial
NGR018). The study is evaluating low-dose NGR-hTNF (administered
once every three weeks) in combination with the standard treatment
(doxorubicin or pegylated liposomal doxorubicin) versus standard
treatment alone. Based on the positive results obtained in the trial in
soft tissue sarcomas, the Company has decided to assess the efficacy
of weekly low-dose NGR-hTNF in combination with doxorubicin versus
doxorubicin alone, and thus to extend the sample size by enrolling 30
additional patients, therefore bringing the total to 130. Preliminary trial
results are expected in 2H 2013.
With regard to TK:
● With the aim to provide additional clinical benefit to patients, the
Company implemented two important changes in the protocol
design of Phase III trial TK008. The first change consists in
broadening the enrolment criteria to include patients in leukaemic
relapse, in addition to those in disease remission; the second change
provides for the introduction of a further treatment option in the control
arm, based on the use of an unmanipulated transplant followed by
cyclophosphamide administration during the post-transplantation
period. The Company estimates that those modifications double the
number of eligible patients for each centre, and hopes that this will
significantly increase the potential number of participating centres. First
two prestigious U.S. centres have been authorised and are ready to start
enrolment. Moreover, the new version of the protocol has already been
implemented in the majority of centres involved in the trial;
● Efficacy data gathered so far led the Company to prepare a request for
market approval through an accelerated procedure (Conditional
Marketing Authorisation). This request is based on the favourable
risk/benefit rate, the demonstration of safety and clinical efficacy and the
rarity of the indication (TK has obtained the Orphan Drug designation).
The Company expects to file this request to the European authorities in
mid-2013.
Development and GMP production for third parties
Development and production of new cell and gene therapy treatments
performed for third parties are consolidating the company's technological
leadership in this field, and are also generating a significant increase in
revenues (as described in the Comments to financials). During the first nine
months of 2012, work continued under two major agreements signed in

5. 2011, respectively with Telethon Foundation and GlaxoSmithKline, for the
development and production of investigational gene therapies for a total of
seven rare diseases. In addition, work has been carried out to upgrade and
optimise the GMP production facility.
The official Corporate Financial Reporting Manager of MolMed S.p.A., Enrico
Cappelli, herewith attests, pursuant to Article 154-bis, paragraph 2 of the
Italian Consolidated Law on Finance (Legislative Decree 58/1998), that the
accounting disclosure contained in this press release matches documentary
evidence, corporate books, and accounting records.
In this press release, use is made of “alternative performance indicators” which
are not provided for under European IFRS, and whose significance and content
- in line with Recommendation CESR/05-178b published on 3 November 2005 -
are illustrated below:
● Operating Result: defined as the difference between sales revenues and
other income and costs for materials, costs of services received, costs for
use of third-party assets, personnel costs and amortisation, depreciation
& write downs. It represents the profit before financial flows and taxes;
● Net Financial Position: is the algebraic sum of cash, cash equivalents,
financial receivables and other financial assets, and current and non-
current financial debt.
This press release is written in compliance with public disclosure obligations
established by CONSOB (Italian securities & exchange commission) resolution
no. 11971 of 14.5.1999, as subsequently amended.
About MolMed
MolMed S.p.A. is a biotechnology company focused on research, development
and clinical validation of novel anticancer therapies. MolMed’s pipeline includes
two novel therapeutics in clinical development: TK, a cell-based therapy
enabling bone marrow transplants from partially compatible donors, in Phase
III in high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent
(VTA), in Phase III in malignant pleural mesothelioma and in Phase II in
six more indications: colorectal, lung (small-cell and non-small-cell), liver
and ovarian cancer, and soft tissue sarcomas. MolMed also offers top-level
expertise in cell and gene therapy to third parties to develop, conduct and
validate projects from preclinical to Phase III trials, including scale-up and
cGMP production of clinical-grade viral vectors, and manufacturing of patient-
specific genetically engineered cells. MolMed is headquartered at the San
Raffaele Biomedical Science Park in Milan, Italy. The Company’s shares are
listed on the Milan Stock Exchange, at the Standard segment (class I) of the
MTA managed by Borsa Italiana. (Ticker Reuters: MLMD.MI)

6. FONTE : MOLMED