Ampio Pharmaceuticals Reports Full-Year 2011 Financial Results and Milestone Highlights for 2011
GREENWOOD VILLAGE, Colo., Feb. 9, 2012 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) (“Ampio” or the “Company”), a company that discovers and develops new uses for previously approved drugs and new molecular entities (“NMEs”), today announced financial results for the year ended December 31, 2011, and offered a summary of the milestones during 2011.
Financial Results
Total revenues recognized for the year ended December 31, 2011, were $18,750, reflecting the amortized portion of the $500,000 licensing upfront payment from the Company’s agreement with a major Korean pharmaceutical company for South Korean rights to Ampio’s Zertane(TM). The Company did not report any revenues for the year ended December 31, 2010.
Total operating expenses for the full-year periods ended December 31, 2011 and 2010, were $11,152,891 and $6,704,405, respectively. Research and development expenses for the full year 2011 were $6,648,397, compared to $1,972,134 for the full year 2010. The 237% growth in research and development costs during 2011 primarily reflects the increased focus on the Company’s multiple clinical trials and proof-of-concept studies. Specifically, the Company invested significantly in the Phase 2 Ampion(TM) in the Knee study and the Phase 2 Optina(TM) study evaluating the product’s ability to prevent diabetic macular edema (DME) and in a $2,000,000 fee paid to obtain a product technology license associated with Zertane(TM).
General and administrative expenses for the full-year period of 2011 were $4,504,494, compared to $4,732,271 in the full-year period of 2010. Other expenses were $7,142,593 in the full-year period of 2011, compared to $1,348,990 in the corresponding 2010 period. The increase in other expenses primarily reflects the $5,585,422 of non-cash changes in the fair value of Ampio’s debentures prior to their conversion to common stock in February 2011. This change in value stemmed primarily from the increase in Ampio’s common stock price between December 31, 2010, and February 28, 2011.
For the year ended December 31, 2011, Ampio reported a net loss of $18,359,234, or $0.71 per share, compared to a net loss of $8,053,395, or $0.49 per share, for the same period in 2010. Non-cash expenses accounted for $9,170,000, or approximately 50%, of the total loss in 2011. Research and development represented 36% of the reported loss. Non-cash expenses in the 2010 period were $4,426,000, or approximately 55%, of the reported loss.
At December 31, 2011, Ampio had cash and cash equivalents of $11,362,325, compared with $671,279 as of December 31, 2010.
Milestone Highlights for 2011
Financings
----------
--December 21, 2011. Sold 2,220,255 of shares of common stock at
$4.25 per share in a registered direct offering from which Ampio
received gross proceeds of approximately $9.436 million, before
deducting placement agents' fees and estimated offering expenses.
There were no investor warrants or convertible securities associated
with this financing.
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--March and April 2011. Sold 5,092,880 shares of common stock at a
price of $2.50 per share in a private placement from which Ampio
received gross proceeds of $12.732 million, before deducting
placement's agents' fees and estimated offering expenses. There were
no investor warrants or convertible securities associated with this
financing.
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Corporate Achievements
----------------------
-- June 16, 2011. Announced Ampio was being included in the U.S.
broad-market Russell 3000 index on June 24.
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--May 20, 2011. Announced Ampio common stock was now trading on the
NASDAQ Capital Market under the ticker symbol "AMPE".
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--March 23, 2011. Ampio acquired all of the outstanding stock of DMI
BioSciences, Inc. whose principal asset consisted of the worldwide
rights to Zertane(TM), including 32 issued patents and 31 pending
applications.
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Clinical Trials
---------------
-- October 26, 2011. Announced Ampion(TM) would be tested as a
stand-alone therapy, which was not previously permitted by the
regulators. This trial was in progress at December 31, 2011.
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The
progression
to the
second
part of
the
Phase 2
study
was
based
upon
positive
results
from the
first
dosing
cohort
in the
Phase 2
Ampion(TM)-
In-Knee
(AIK)
clinical
trial.
The
results
were
generated
from 40
patients
randomized
equally
into two
separate
study
arms.
Enrolled
patients
with
moderately
severe
osteoarthritis
of the
knee
were
assessed
for the
difference
in pain
relief
from
their
own
established
baseline.
At each
study
time
point (6
hours,
24
hours,
72
hours),
the
reduction
in pain
scores
was
greater
in the
20
patients
receiving
Ampion(TM),
steroids
and
lidocaine
than the
20
patients
treated
with
steroids
and
lidocaine.
The
group
receiving
Ampion
achieved
a 37%
improvement
at 72
hours
for the
Ampion(TM)
group.
This
trend
toward
efficacy
was more
pronounced
over
time.
-- October 18, 2011. Announced a randomized, vehicle-
controlled, double-blinded study conducted at Centers for Allergy
and Asthma in Denver, Colorado which indicates intranasal danazol
has an impact on allergic rhinitis, a clinical condition in which
increases in vascular permeability and edema are hallmark signs.
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-- September 26, 2011. Announced positive results from a 12-
week open-label extension study, which was performed at the
conclusion of the Phase 3 trials for Zertane(TM) in patients with
premature ejaculation. No treatment-related serious adverse
events and very few adverse events were recorded during the open-
label extension period, when all subjects received active
treatment, even though the mean extent of exposure (approximately
0.26 to 0.31 tablets per day) appeared to increase modestly
compared to the double-blind treatment period (approximately 0.24
to 0.26 tablets per day). The average use by patients during this
12-week period remained less than 3 pills per week. Six subjects
experienced an adverse event (5.9%) with only one treatment-
related adverse event (anxiety/erectile dysfunction),
demonstrating that even the higher dose of Zertane(TM) is safe with
longer-term dosing. There were no reports of dependency or
tolerability issues.
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-- June 27, 2011. Announced positive results from its Phase 3,
randomized, double-blind, placebo-controlled, multicenter study
to evaluate the efficacy and safety of two doses of Zertane(TM) for
the treatment of premature ejaculation (PE). The study was
conducted in 61 sites in 11 countries in Eastern and Western
Europe and included 604 intent-to-treat patients.
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Licensing of Distribution
-------------------------
--September 8, 2011. Licensed exclusive rights to market
Zertane(TM) to Daewoong Co., Ltd. of South Korea for the treatment
of premature ejaculation (PE) and for a combination drug,
utilizing Zertane(TM) and another erectile dysfunction drug (PDE5
inhibitors and others), to simultaneously treat premature
ejaculation and erectile dysfunction (ED).
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New Intellectual Property
-------------------------
-- December 22, 2011. Received notification of the granting of
a Canadian patent with broad claims directed to compositions
containing either DA-DKP, a cyclic dipeptide diketopiperazine,
which is the active ingredient of Ampion(TM), but also extends to
many other diketopiperazines.
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-- December 7, 2011. Received notification of the granting of a
European patent with broad claims directed to "METHOD OF USING
DIKETOPIPERAZINES AND COMPOSITION CONTAINING THEM". The
protected compositions containing DA-DKP, a cyclic dipeptide
diketopiperazine, which is the active ingredient of Ampion (TM). The
patent also includes claims for these compositions that target
clinical treatments for inflammation and inflammatory diseases
and conditions, such as arthritis and allergies.
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--December 5, 2011. Purchased, for $2 million, certain worldwide
rights relating to a patented orally disintegrating tablet (ODT)
drug delivery technology. Ampio intends to utilize this
technology to elevate the market acceptance of Zertane(TM) for
premature ejaculation. This acquisition provides additional
intellectual property to protect Zertane(TM) ODT's unique
formulation, over and above the many method of use claims for
Zertane(TM) contained in patents Ampio already owns. The Company
indicated it expects this technology will facilitate Ampio's
filing of marketing authorization applications for Zertane(TM).
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--November 16, 2011. Received PTO notification of the allowance
of two important U.S. patents. The first patent is directed to a
unique class of compounds that combine elements of
diketopiperazines (same class as Ampion(TM)) and methylphenidate
derivatives. The second patent is directed to novel derivatives
of methylphenidate (Ritalin). Both patents contain not only use
claims for these novel compounds, and pharmaceutical compositions
containing them, but also composition of matter claims.
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--September 28, 2011. Received notification of allowance of its
two patent applications on Zertane(TM) combinations with erectile
dysfunction (ED) drugs in Canada. This allowances includes
claims directed to the use of Zertane(TM) with a class of drugs
called phosphodiesterase type 5 (PDE5) inhibitors commonly used
for the treatment of ED to address concurrent premature
ejaculation (PE) and ED. The allowed claims also include
composition of matter claims, such as claims directed to a
pharmaceutical composition or a kit containing Zertane(TM) and a
PDE5 inhibitor.
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Full financial results are available in the Company’s Form 10-K, which was filed with the Securities and Exchange Commission on February 9, 2012.
About Ampion(TM)
Ampion(TM) is a non-steroidal anti-inflammatory drug that appears to have a significant role in the homeostasis of inflammation, so that it has the potential to be used in a broad array of inflammatory conditions which impact millions of patients. Ampion(TM) is a molecule produced by humans in response to injury and is protected globally by composition of matter and use patents including means of synthetically manufacturing the molecule and method of extraction from commercial albumin preparations.
About Zertane(TM)
Zertane(TM) is an oral drug to treat premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners. The active ingredient in Zertane(TM) has multiple mechanisms of actions that can delay ejaculation. This drug also has an excellent safety record established during 30 years of human use. These unique pharmaceutical qualities, exceptional human safety record, and a distinctive non-standard dosage not available in generic form, differentiate Zertane(TM) from other treatments for premature ejaculation. Zertane(TM) is taken as needed before sexual activity, and is not required on a daily basis.
About Optina(TM)
Optina(TM) is an existing oral drug being developed as a new treatment for diabetic retinopathy and diabetic macular edema. Diabetic retinopathy is damage to the retina caused by complications of diabetes mellitus. Macular edema is often an early form of diabetic retinopathy that causes significant vision loss in adults. Almost all Type 1 diabetics and more than 60% of Type 2 diabetics develop retinopathy. There is no effective daily drug treatment for diabetic retinopathy other than general measures, such as controlling blood sugar, hypertension, blood lipids, etc. Effective non-surgical drug treatment of diabetic retinopathy is a high unmet medical need due to the global diabetes epidemic. Based on its extensive human safety record, a phase 2 clinical development program is currently underway using Optina(TM) for the treatment of diabetic macular edema.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities (“NMEs”). By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio’s product development programs. For more information about Ampio, please visit our website, www.ampiopharma.com.
Forward-Looking Statements
Ampio’s statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Contact: Investor Relations, Ampio Pharmaceuticals, Inc. 720-437-6500
AMPIO PHARMACEUTICALS, INC., AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
Twelve Months Ended
December 31,
------------
2011 2010
---- ----
License revenue $18,750 $--
Expenses:
Research and development 6,614,384 1,883,150
Research and development - related party 34,013 88,984
General and administrative 4,504,494 4,732,271
--------- ---------
Total operating expenses 11,152,891 6,704,405
---------- ---------
Other (expense) income
Interest income 6,684 815
Interest expense (8,358) (19,545)
Unrealized loss on fair value of debt
instruments (5,585,422) 37,511
Derivative expense (1,555,497) (1,367,771)
---------- ----------
Total other expense (7,142,593) (1,348,990)
---------- ----------
Net loss, before income tax (18,276,734) (8,053,395)
Foreign tax expense 82,500 --
Net loss $(18,359,234) $(8,053,395)
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Weighted-average number of common shares
outstanding 26,013,838 16,288,468
Basic and diluted net loss per common share $(0.71) $(0.49)
AMPIO PHARMACEUTICALS, INC., AND SUBSIDIARIES
(A Development Stage Company)
SELECTED CONSOLIDATED BALANCE SHEET DATA
December 31, December 31,
2011 2010
---- ----
Cash and cash equivalents $11,362,325 $671,279
Total assets 19,482,599 737,524
Total current liabilities 1,291,533 4,745,960
Deficit accumulated in the
development stage (28,177,552) (9,818,318)
Total stockholders' equity
(deficit) 17,759,816 (4,008,436)
Total liabilities and
stockholders' equity $19,482,599 $737,524
SOURCE Ampio Pharmaceuticals, Inc.