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2015-11-10

Peptonic Medical: Interim report January 2015 to September 2015

2015 THIRD QUARTER (Jul-Sep)

· Operating loss KSEK -2,683 (-2,713)

· Loss per share SEK -0.28 (-0.34)

FIRST NINE MONTHS 2015 (Jan-Sep)

· Operating loss KSEK -9,190 (-6,467)

· Loss per share SEK -0.97 (-0.81)

IMPORTANT EVENTS DURING THE PERIOD

· Last patient's last visit in the Phase IIb study occurred in July.
· In September the results of the Phase IIb study were announced.
Primary endpoints were not met. The Board decided to launch a
thorough investigation in to all aspects of the study before
publishing the results in more detail.

IMPORTANT EVENTS AFTER THE END OF THE PERIOD

· The Board announces that the investigation has been concluded. The
investigation found that the most probable cause of this
unsatisfactory result was that the aluminium tube used to deliver the
daily oxytocin dose, reacted with the oxytocin gel to cause a
reduction in viscosity, especially when the product was stored at
room temperature. This in turn resulted in less adherence of the
oxytocin gel to the vaginal mucosal epithelium and therefore an
inadequate daily dose of the active compound was delivered to the
tissue. Clinical observation and patient reports of leakage of the
gel prompted storage of the tubes in refrigerator temperature instead
of room temperature to preserve gel viscosity for the last 76 of 224
patients in the trial. Analysis of this sub-group, after the trial
results were known, showed a significant reduction of the most
bothersome symptom (one of three primary endpoints) compared with
placebo further supporting the notion that decreased gel viscosity
was the reason for the unexpected outcome of this study.

· The Board of Peptonic Medical has called for an extraordinary
general meeting on November 19, 2015, to seek shareholder approval
for a rights issue of approximately MSEK 22.7 (the "Offer") in order
to finance the proposed phase IIb study.

From the CEO

Vaginal atrophy is a condition affecting approximately one out of two
women during or post menopause. The symptoms e.g. vaginal dryness and
pain during intercourse, markedly reduce quality of life and
negatively impact the life in a partnership of those affected. There
is a great need for safe and effective treatments. This we have
noticed, for example, during the recruitment of patients to our
clinical studies with oxytocin (Vagitocin®). Many are seeking relief,
but do not want to or cannot use estrogen based products due to the
many serious side effects associated with their use.

Clinical studies with oxytocin up until 2013 showed good effects and
safety. The objectives of the latest study during 2014-2015 were to
make a leap towards phase 3 clinical development and to show good
efficacy of a commercially viable product. This was done by changing
the previously used glass syringe and storage in refrigerator to an
aluminium tube with a disposable applicator and storage in room
temperature. Despite good stability data for oxytocin when stored in
the aluminium tube, the results of the clinical study were
disappointing. Oxytocin treatment did not result in an improvement
compared with placebo for any of the primary endpoints.

During the course of the study, a few patients reported that they felt
that the gel was runny. This triggered a suspicion that the viscosity
of the gel was lower now than in previous studies. We decided to
issue a recommendation to the patients still to be treated to store
the gel tubes in a refrigerator during the course of the treatment
period. Analysis of the results generated after the issuance of this
recommendation showed a significant reduction of the Most Bothersome
Symptoms. Further investigations have confirmed our suspicion that
the viscosity of the gel was too low. This lead to an insufficient
adherence to the vaginal mucosa and daily oxytocin dose.

We are now planning for a repeat clinical study using both a glass
syringe and a new type of tube. This tube has shown to preserve gel
viscosity as well as glass syringes. We are confident that the
clinical endpoints can be obtained and that we can take the next
important step towards phase 3 and a subsequent commercial launch.
This study is to be concluded during 2016 and carried out as
cost-effectively and professionally as the previous one. The
physicians at the clinical sites have long experience from both
conducting clinical studies and from oxytocin. This is a guarantee
that both patients and data collection are in good hands.

The vaginal atrophy market is estimated to USD 2 billion annually.
Based on its unique properties we believe that Vagitocin® will
capture a significant share of this market and make it grow. We are
able to offer a safe and effective treatment for everyone - both to
those that do not want to use estrogens, but also to those that must
not use estrogens.

Peptonic Medical is not only focusing on Vagitocin®. There are patents
owned by the company covering many therapeutic areas of great
commercial potential such as pain, wound healing and cancer. Patent
applications for additional indications have been submitted, and more
are under development. In addition, new oxytocin formulations have
been developed for use in either existing or new indication areas.

There are many potential medical applications for oxytocin not yet
developed. It is the aim of Peptonic Medical to develop products
based on oxytocin for indications with a pronounced need for new
treatments and great market potential.

Stockholm November 11, 2015

Johan Inborr
CEO, Peptonic Medical AB

COMPANY BRIEF

Peptonic Medical AB is an innovative Swedish pharmaceutical company
developing oxytocin based products e.g. for the treatment of
menopausal symptoms, such as vaginal atrophy. Oxytocin has a long
history of safe and effective medical use and offers an alternative
to estrogen and estrogen-like acting compounds for menopausal and
postmenopausal women. Peptonic Medical AB's mission is to develop
safe and effective drugs based on the known beneficial properties of
oxytocin.

FINANCIAL INFORMATION
Net sales - Currently the company has no net sale.

Costs - Costs for the third quarter were KSEK -2,683 (-2,722). Costs
for the first nine months were KSEK -9,190 (-6,476).

Result - Loss before tax for the third quarter was KSEK -2,683
(-2,714). Loss before tax for the first nine months was KSEK -9,175
(-6,469).

Financial position and liquidity - Liquid assets was KSEK 10,537
(15,212) as of September 30, 2015. During the first six months the
company received KSEK 14,522 in a private placement.

Equity - PEPTONIC medical AB's equity amounted to KSEK 46,257 (44,119)
as of September 30, 2015, resulting in a solidity of 81 (97) percent.

Organization - The average number of employees during the period was 2
(1). At the end of the period the number of employees was 2 (2).

Share - Total numbers of shares in the company amounted to 9,441,960
as of September 30, 2015.

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http://news.cision.com/peptonic-medical/r/interim-report-january-2015-to...
http://mb.cision.com/Main/11203/9864661/442760.pdf

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