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2016-02-26

Peptonic Medical: Year End Report - period from January to December 2015

2015 FOURTH QUARTER (Oct-Dec)

· Operating loss KSEK -4,793 (-3,648)

· Loss per share SEK -0.25 (-0.46)

FULL YEAR 2015 (Jan-Dec)

· Operating loss KSEK -13,983 (-10,115)
· Loss per share SEK -0.73 (-1.27)

IMPORTANT EVENTS DURING THE PERIOD

· In March, the US patent office informed Peptonic Medical that the
formulation patent will be approved in the USA. Patent expiry is in
2032.

· Peptonic Medical and Swetox entered a research collaboration on
the mechanisms of action of oxytocin. The project will add new safety
data to Vagitocin®.

· In March the company raised SEK 14.4 million in a private
placement at a share price equal to the average trading price during
the three preceding months.

· Patient recruitment to Peptonic Medical's ongoing phase 2b study
was completed by the end of March.

· At the AGM in April, Mr. Anders Wiklund and Prof. Emeritus Andris
Kreicbergs were elected as new members to the Board. At the same
time, Mr. Christer Sjögren and Mr. Ingvar Wiberger resigned from the
Board.

· In April, Johan Inborr, CEO, subscribed for 160,000 warrants as
authorized by the AGM as part of an adopted incentives scheme.

· 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.

· The Board announced that the investigation had 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 called for an extraordinary general
meeting on November 19, 2015, and got shareholder approval for a
rights issue of approximately MSEK 22.7 in order to finance the
proposed phase IIb study. The rights issue was fully underwritten
through subscription undertakings, subscriptions without preferential
rights from existing shareholders (19.7 MSEK) and underwriting
commitments (3 MSEK).

· In November Mr Anders Wiklund resigned from the Board . After
Anders Wiklund's resignation, the Board consists of four members.

· In December the Company completed a directed rights issue (private
placement) in accordance with the authorisation of the Annual General
Meeting. The issue was directed to Humle Kapitalförvaltning,
resulting in net proceeds of SEK 5,000,000 to the Company.
Subscription price was SEK 3.05 per share, which corresponded to the
price of the recently closed rights issue plus 0.25 SEK. The Board
considered this to be a well-founded market price for a large
investor.

IMPORTANT EVENTS AFTER THE END OF THE PERIOD

· A total of 9 732 452 new shares have been registered per
2016-01-12 with Bolagsverket (the Swedish Companies Registration
Office) and the total number of shares in Peptonic Medical after the
rights issue amounts to 19 174 412 shares and the share capital
amounts to SEK 1 917 441.20.

· In January, an application for a new phase IIB study has been
filed for approval by Läkemedelsverket (MPA). According to the
protocol, 200 patients will be included in the double-blind
randomized placebo controlled study, with the aim to show efficacy of
Vagitocin® (400 IU oxytocin) compared with placebo. The gel, both
placebo and active, will be pre-filled into glass syringes. This to
minimize the risk of a decrease in viscosity. The last 40 patients
included in the study will get gel filled into laminate tubes. Tubes
that have been tested for stability of the API, the preservative and
viscosity. Approval by the MPA is expected in March, and the plan is
to start screening patients in April with first treatment in May.
Last patient in the head study expect to leave the study in December.

From the CEO

Last year was a roller coaster ride for Peptonic. Early in the year,
the phase 2b study progressed according to plan with a steady in-flow
of study subjects and a high proportion of them completing the
treatment and attending all follow-up visits. The results of the
study, however, were a disappointment to all concerned. When the data
was decoded in September, treatment with oxytocin did not show any
improvement compared to placebo.

A thorough investigation in to the materials, processes and management
before, during and after the study revealed that the most probable
cause for the lack of effect on the primary endpoints was related to
the viscosity of the oxytocin gel.

During the course of the study, a few subjects reported that the gel
felt runny, which triggered a suspicion that the viscosity of the gel
was lower than in previous studies. It was concluded that the
combination of the aluminium tube used and storage in room
temperature was the cause. At the time of the initial reports from
the study subjects, a recommendation was issued to the remaining
subjects to store the tubes refrigerated. Analysis of this sub-group,
after the trial results were known, showed a significant reduction of
the most bothersome symptom compared with placebo. Additional
investigations also pointed at low viscosity being the culprit. This
in turn resulted in too weak adhesion of the gel to the vaginal wall
and an insufficient oxytocin dose.

These encouraging results and a strong belief that the causes of the
low viscosity can be eliminated prompted the board to decide to
repeat the study, provided of course, that financing could be
secured. So it happened. In December a rights issue and a follow-on
private placement brought SEK 27.7 m to the company (before issues
costs). This was a clear sign by our shareholders of the strong
confidence in the competence resting in the company.

The preparations for the new study are now well under way. In the main
study (160 subjects), the gel will be stored in a glass syringe,
whereas a new tube (laminated) will be used in the pilot part of the
study (40 subjects). In stability studies the glass syringe and the
laminate tube have shown to preserve gel viscosity equally well. In
this double-blinded study subjects will be treated with a daily dose
of either 400 IU oxytocin or placebo.

We plan to start randomising subjects in to the study in May and to
present initial results before the end of the year. This, of course,
provided that plans and deadlines are met, and nothing unexpected
occurs. We feel very comfortable by the choice of clinics, suppliers
and service providers, and we have a strong belief that the study
will be successful.

The contacts with potential partners will now be re-activated with the
aim to have the partner candidates ready to move forward when the
results of the new study are published.

I want to take this opportunity to thank our shareholders, the board
members, suppliers and service providers for their support,
assistance and confidence, and my closest colleagues for the courage
and fighting spirit they have shown during the challenging times
during last year.

Stockholm, 26th of February 2016

Johan Inborr, CEO

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 fourth quarter were KSEK -4,793 (-3,649). Costs
for the full year were KSEK

-13,983 (-10,115).

Result - Loss before tax for the fourth quarter was KSEK -4,785
(-3,628). Loss before tax for the full year was KSEK -13,960
(-10,097).

Financial position and liquidity - Liquid assets was KSEK 28,431
(10,528) as of December 31, 2015. During the full year the company
received KSEK 40,564 (20,099) in new share issues.

Equity - PEPTONIC medical AB's equity amounted to KSEK 67,514 (40,910)
as of December 31, 2014, resulting in a solidity of 91 (89) percent.

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

Share - Total numbers of shares in the company amounted to 19,174,412
as of December 31, 2015. That inclusive paid shares that havn't been
registerd at Bolagsverket until the 12th of January 2016. But all of
there paid before New Year.

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http://news.cision.com/peptonic-medical/r/year-end-report---period-from-...
http://mb.cision.com/Main/11203/9925027/482169.pdf

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