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| IMM > SEC Filings for IMM > Form 10-Q on 10-Nov-2008 | All Recent SEC Filings |
10-Nov-2008
Quarterly Report
Forward Looking Statements
Certain statements contained in this quarterly report and in the documents
incorporated by reference herein constitute "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995. All
statements other than statements of historical fact may be deemed to be
forward-looking statements. Forward-looking statements frequently, but not
always, use the words "may", "intends", "plans", "believes", "anticipates" or
"expects" or similar words and may include statements concerning our strategies,
goals and plans. Forward-looking statements involve a number of significant
risks and uncertainties that could cause our actual results or achievements or
other events to differ materially from those reflected in such forward-looking
statements. Such factors include, among others described in this quarterly
report, the following: (i) we are in an early stage of product development,
(ii) the possibility that favorable relationships with collaborators cannot be
established or, if established, will be abandoned by the collaborators before
completion of product development, (iii) the possibility that we or our
collaborators will not successfully develop any marketable products, (iv) the
possibility that advances by competitors will cause our product candidates not
to be viable, (v) uncertainties as to the requirement that a drug product be
found to be safe and effective after extensive clinical trials and the
possibility that the results of such trials, if completed, will not establish
the safety or efficacy of our drug product candidates, (vi) risks relating to
requirements for approvals by governmental agencies, such as the Food and Drug
Administration, before products can be marketed and the possibility that such
approvals will not be obtained in a timely manner or at all or will be
conditioned in a manner that would impair our ability to market our product
candidates successfully, (vii) the risk that our patents could be invalidated or
narrowed in scope by judicial actions or that our technology could infringe upon
the patent or other intellectual property rights of third parties, (viii) the
possibility that we will not be able to raise adequate capital to fund our
operations through the process of commercializing a successful product or that
future financing will be completed on unfavorable terms, (ix) the possibility
that any products successfully developed by us will not achieve market
acceptance and (x) other risks and uncertainties that may not be described
herein. We undertake no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.
Results of Operations
With the exception of certain research funding agreements, license agreements
and certain grants, we have not generated any revenue from operations. For the
period from inception (October 15, 1984) to September 30, 2008, we incurred
cumulative net losses of approximately $110,289,000. We have incurred additional
losses since such date and we expect to incur additional operating losses for
the foreseeable future. We expect that our cash sources for at least the next
year will be limited to:
• payments from foundations and other collaborators under arrangements that
may be entered into in the future;
• payments from license agreement milestones;
• grants from the United States government and other governments and entities; and
• the issuance of securities or borrowing of funds or sale of the land use rights in Shenzhen, China.
The timing and amounts of grant and payment revenues, if any, will likely
fluctuate sharply and depend upon the achievement of specified milestones, and
results of operations for any period may be unrelated to the results of
operations for any other period.
Three Month Period Ended September 30, 2008 Compared with the Three Month Period
Ended September 30, 2007.
Revenues under collaborative research and development, and license agreements
were approximately $506,000 and $1,030,000 for the three month periods ended
September 30, 2008 and September 30, 2007, respectively. For the three month
period ended September 30, 2008, we recognized revenues of approximately
$487,000 related to a clinical research subcontract agreement between us and
UNC-CH and approximately $10,000 related to the Par License Agreement which has
been cancelled and $9,000 related to the BioAlliance License Agreement, while
for the three month period ended September 30, 2007, revenues recognized of
approximately $626,000 related to the abovementioned UNC-CH clinical research
subcontract, and approximately $404,000 related to the Par License Agreement.
Grant and research and development agreement revenue is recognized as completed
under the terms of the respective agreements, according to Company estimates.
Grant and research and development funds received prior to completion under the
terms of the respective agreements are recorded as deferred revenues.
Revenue from licensing arrangements is recorded when earned based on the
performance requirements of the contract. Nonrefundable upfront license fees,
for product candidates where the Company is providing continuing services
related to product development, are deferred and recognized as revenue over the
development period or as the Company provides services required under the
agreement. The timing and amount of revenue the Company recognizes from
licenses, either from upfront fees or milestones where the Company is providing
continuing services related to product development, is dependent upon the
Company's estimates of filing dates.
Research and development expenses decreased to approximately $990,000 from
$2,283,000 for the three month periods ended September 30, 2008 and
September 30, 2007, respectively. Expenses relating to the UNC-CH subcontract,
decreased to approximately $487,000 in the three month period ended
September 30, 2008 from approximately $626,000 in the three month period ended
September 30, 2007. Expenses associated with setting up operations in mainland
China were approximately $105,000 for the three month period ended September 30,
2008. Contract services relating to clinical trials and their discontinuation
decreased to approximately $190,000 in the three month period ended September
30, 2008 from approximately $1,120,000 in the three month period ended
September 30, 2007. Discovery contract research expenses decreased to
approximately $140,000 in the three month period ended September 30, 2008 from
approximately $408,000 in the three month period ended September 30, 2007.
Non-cash options expense under research and development decreased to
approximately $66,000 in the three month period ended September 30, 2008 from
approximately $115,000 in the three month period ended September 30, 2007. Other
research and development expenses decreased approximately $7,000 in the three
month period ended September 30, 2008 from the three month period ended
September 30, 2007.
General and administrative expenses decreased to approximately $1,268,000 from
approximately $2,214,000 during the three month periods ended September 30,
2008, and September 30, 2007, respectively. Patent fees decreased to
approximately $61,000 in the three month period ended September 30, 2008 from
approximately $101,000 in the three month period ended September 30, 2007.
Operating expenses in Immtech Hong Kong increased to approximately $82,000 from
approximately $36,000 in the three month periods ended September 30, 2008 and
September 30, 2007, respectively. Payroll and payroll related costs decreased to
approximately $300,000 from approximately $338,000 over the same periods.
Additionally, public relation costs decreased to approximately $35,000 in the
three month period ended September 30, 2008 from approximately $188,000 in the
three month period ended September 30, 2007. Non-cash general and administrative
expenses decreased to approximately $219,000 in the three month period ended
September 30, 2008 for the expensing of options, from approximately $786,000 in
the three month period ended September 30, 2007 which includes (i) approximately
$172,000 for 50,000 warrants issued to a consultant, (ii) approximately $118,000
for 30,000 warrants issued to an investor relations firm, and
(iii) approximately $496,000 for expensing options. All other general and
administrative expenses decreased approximately $446,000 over the same periods,
primarily due to increased cost controls.
During the three month period ended September 30, 2008, the Company recorded a
non-cash asset impairment charge of approximately $693,000.
Our net loss decreased to approximately $2,435,000 from approximately $3,334,000
during the three month periods ended September 30, 2008 and September 30, 2007,
respectively.
Six Month Period Ended September 30, 2008 Compared with the Six Month Period
Ended September 30, 2007.
Revenues under collaborative research and development agreements were
approximately $1,647,000 and $1,857,000 for the six month periods ended
September 30, 2008 and September 30, 2007, respectively. For the six month
period ended September 30, 2008, we recognized revenues of approximately
$1,513,000 related to a clinical research subcontract agreement between us and
UNC-CH, approximately $67,000 related to the Par License Agreement, and
approximately $67,000 related to the BioAlliance License Agreement, while for
the six month period ended September 30, 2007, revenues recognized of
approximately $1,304,000 related to the abovementioned UNC-CH clinical research
subcontract and $553,000 related to the Par License Agreement.
Grant and research and development agreement revenue is recognized as completed
under the terms of the respective agreements, according to Company estimates.
Grant and research and development funds received prior to completion under the
terms of the respective agreements are recorded as deferred revenues.
Revenue from licensing arrangements is recorded when earned based on the
performance requirements of the contract. Nonrefundable upfront license fees,
for product candidates where the Company is providing continuing services
related to product development, are deferred and recognized as revenue over the
development period or as the Company provides services required under the
agreement. The timing and amount of revenue the Company recognizes from
licenses, either from upfront fees or milestones where the Company is providing
continuing services related to product development, is dependent upon the
Company's estimates of filing dates.
Research and development expenses decreased to approximately $2,485,000 from
$4,201,000 for the six month periods ended September 30, 2008 and September 30,
2007, respectively. Expenses relating to the UNC-CH subcontract, increased to
approximately $1,513,000 in the six month period ended September 30, 2008 from
approximately $1,221,000 in the three month period ended September 30, 2007.
Additionally, contract services relating to trials for treatment of PCP and the
subsequent termination decreased to approximately $211,000 from approximately
$2,016,000 in the same periods. Discovery contract research expenses decreased
to approximately $407,000 in the six month period ended September 30, 2008 from
approximately $606,000 in the period ended September 30, 2007. Expenses
associated with setting up operations in mainland China were approximately
$166,000 for the six month period ended September 30, 2008. Non-cash options
expense under research and development decreased to approximately $161,000 in
the six month period ended September 30, 2008 from approximately $233,000 in the
six month period ended September 30, 2007. Other research and development
expenses decreased approximately $8,000 from the six month period ended
September 30, 2007 to the six month period ended September 30, 2008.
General and administrative expenses decreased to approximately $2,193,000 from
approximately $3,931,000 during the six month periods ended September 30, 2008,
and September 30, 2007, respectively. Legal fees decreased to approximately
$232,000 in the six month period ended September 30, 2008 from approximately
$333,000 in the six month period ended September 30, 2007. Contact services,
including public relations, decreased to approximately $132,000 from
approximately $483,000 during the same periods. Operating expenses in Immtech
Hong Kong increased to approximately $126,000 from approximately $71,000 in the
six month periods ended September 30, 2008 and September 30, 2007, respectively.
Non-cash general and administrative expenses decreased to approximately $15,000
in the six month period ended September 30, 2008, having benefited by a reversal
of approximately $428,000 due to the change in the option forfeiture rate under
SFAS No. 123(R) upon the reduction in personnel in the first quarter of the
fiscal year, from approximately $1,161,000 in the six month period ended
September 30, 2007, which includes (i) approximately $172,000 for the 50,000
warrants issued to a consultant, (ii) approximately $118,000 for the 30,000
warrants issued to an investor relations firm, and (iii) approximately $871,000
for expensing options. Other general and administrative expenses decreased
approximately $195,000 over the same periods.
During the six month period ended September 30, 2008, the Company recorded a
non-cash asset impairment charge of approximately $693,000.
Our net loss decreased to approximately $3,692,000 from approximately $5,995,000
during the six month periods ended September 30, 2008 and September 30, 2007,
respectively.
Business Plans
AQ-13 and Other Infectious Diseases
Our clinical and regulatory staff is planning for the clinical development of
AQ-13 for the treatment of malaria and malaria prophylaxis in travelers. We have
identified and are preparing to execute additional toxicology and genotoxicology
studies, and planning the Phase I dose ranging study of AQ-13. We recently
received an Orphan Drug Designation for AQ-13 in treatment of malaria, and have
licensed exclusive rights to AQ-13 and other 4-aminoquinolines in development
from Tulane University. We are currently pursuing relationships with NGOs and
foundations to provide support for the development of AQ-13. We do not believe
that we will not develop this program unless we obtain third party funding to
cover or reduce third party and overhead expenses, and the resultant burn rate.
We expect to initiate the AQ-13 program in the first half of calendar year 2009.
We are also currently in discussions with commercial pharmaceutical
organizations and NGOs regarding providing services related to the clinical
development of proprietary compounds for infectious diseases on a
fee-for-services basis. We believe that such arrangements will result in
positive cash flow and help to reduce overall ongoing operational expenses.
Discovery Programs
We are actively working on the following long term discovery programs currently
supported by Company funds:
Hepatitis C Virus ("HCV"): Through a combination of academic collaboration and
contract services, we are advancing an HCV drug discovery effort. In June 2008,
we announced that a prototype compound belonging to this expanding class of
compounds was found to have activity against HCV under assay conditions designed
to demonstrate inhibition of the virus entry process. We are currently engaged
in new medicinal chemistry and screening efforts to optimize the lead for
potency and oral availability.
West Nile and Dengue Fever: Our understanding of mechanism of action of these
compounds has led us to investigate the application of our technology to inhibit
the virus entry process of other therapeutically important virus targets in the
flavivirus family. Two notables in this family are West Nile virus ("WNV") and
Dengue Fever virus. Screening efforts for WNV in particular have caused us to
identify a promising lead series which is currently undergoing lead optimization
through new medicinal chemistry.
The following programs are only being moved forward if third party funding is
obtained:
Antifungal and Antibiotic: We are currently evaluating potential partnership
opportunities for our antifungal and antibiotic discovery programs. We have
initiated discussions with potential collaborators who may be interested in
funding and executing additional discovery efforts in exchange for future
royalties or licensing rights.
China
Early this year, we announced the initiation of a collaboration with Beijing
Capital Medical University ("BCMU") in Beijing, one of China's leading academic
medical research centers. The Company and BCMU are considering the development
of a joint venture to provide contract research services ("CRS") in China. With
an initial focus on early-stage drug discovery, we believe that a joint venture
could be positioned to support later-stage clinical development including
coordination with research sites, data management, monitoring and reporting for
clinical research programs. We also plan to explore the potential of having
joint ventures with Chinese pharmaceutical companies that are interested in
expanding outside of China. These companies could provide funding and resources
to further develop our compounds.
Additionally, we believe that our experience in and knowledge of the Chinese
market may also permit us to explore other business development opportunities in
China.
Liquidity and Capital Resources
The accompanying financial statements have been prepared on a going concern
basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business.
Since inception, the Company has incurred accumulated net losses of
approximately $110,289,000. Management expects the Company will continue to
incur significant losses during the next several years as the Company continues
development activities, clinical trials and commercialization efforts. In
addition, the Company has various research and development agreements with third
parties and is dependent upon such parties' abilities to perform under these
agreements. There can be no assurance that the Company's activities will lead to
the development of commercially viable products. The Company's operations to
date have consumed substantial amounts of cash. The negative cash flow from
operations is expected to continue in the foreseeable future. The Company
believes it will require substantial additional funds to commercialize its drug
candidates. The Company's cash requirements may vary materially from those now
planned when and if the following become known: formation and development of
relationships with strategic partners, changes in the focus and direction of
development programs, results of research and development efforts, results of
clinical testing, responses to grant requests, competitive and technological
advances, requirements in the regulatory process and other factors. Changes in
circumstances in any results of our new global business initiatives may require
the Company to allocate substantially more funds than are currently available or
than management intends to raise.
As of September 30, 2008, cash and cash equivalents were approximately
$2,077,000.
We spent approximately $1,000 and $4,000, respectively, on equipment purchases
during the three and six month periods ended September 30, 2008. Nothing was
spent on equipment purchases during the six month period ended September 30,
2007. No significant purchases of equipment are anticipated by us during the
year ending March 31, 2009.
We periodically receive cash from the exercise of common stock options and
warrants. No options or warrants were exercised for cash during the three or six
month periods ended September 30, 2008. During the three and six month periods
ended September 30, 2007, we received approximately $296,000 from the exercise
of warrants.
Through September 30, 2008, we financed our operations with:
• proceeds from various private placements of debt and equity securities,
secondary public stock offerings, our initial public offering (our "IPO"),
and other cash contributed from stockholders, which in the aggregate
raised approximately $77,608,000;
• payments from research agreements, licensing agreements, foundation grants, and Small Business Innovation Research ("SBIR") grants and Small Business Technology Transfer program grants of approximately $36,447,000; and
• the use of stock, options and warrants in lieu of cash compensation.
Our cash resources have been used to finance, develop and begin
commercialization of drug product candidates, including sponsored research,
conducting human clinical trials, capital expenditures, expenses associated with
development of product candidates pursuant to the Consortium Agreement, and, as
contemplated by the Consortium Agreement, under the License Agreement with the
Scientific Consortium, and general and administrative expenses. Over the next
several years we expect to incur substantial additional research and development
costs, including costs related to research in pre-clinical (laboratory) and
human clinical trials, administrative expenses to support our research and
development operations and marketing expenses to launch the sale of any
commercialized product that may be developed.
Our future working capital requirements will depend upon numerous factors,
including the progress of research, development and commercialization programs
(which may vary as product candidates are added or abandoned), results of
pre-clinical testing and human clinical trials, achievement of regulatory
milestones, third party collaborators fulfilling their obligations to us, the
timing and cost of seeking regulatory approvals, the level of resources that we
devote to the engagement or development of manufacturing capabilities, our
ability to maintain existing and to establish new collaborative arrangements
with others to provide funding to support these activities, and other factors.
In any event, we will require substantial additional funds in addition to our
existing resources to develop product candidates and to otherwise meet our
business objectives.
We believe our existing unrestricted cash and cash equivalents and the grants we have received or have been awarded and are awaiting disbursement of, will be sufficient to meet our planned expenditures through at least January 2009, although there can be no assurance we will not require additional funds. As of November 1, 2008, the Company has the following cash:
Unrestricted cash and cash equivalents $ 1,776,058
Restricted funds on deposit 915,437
$ 2,691,495
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Based on forecasted monthly usage of unrestricted cash of approximately $450,000
and after consideration of payment of liabilities recorded as of November 1,
2008, we believe funding is available to continue operations through January 31,
2009. In order to maintain operations and liquidity after that date, the
following options are being pursued and are discussed below:
• sale of land use rights in Shenzhen, China;
• discussions with commercial pharmaceutical organizations and NGOs for providing development services for compounds slated for clinical development on a fee-for-services basis; and
• restrictions on staffing based on businesses to be developed and pursued.
Subsequent to September 30, 2008, the Company engaged a sales agent for the sale of the land use rights in Shenzhen, China. We believe that the proceeds from the sale of the land use rights will provide cash to fund operations through June 30, 2009. As noted in Note 2 (Long-Lived Assets), the Company has recorded an asset impairment charge of $693,073 in the second quarter of fiscal year 2009. However, due to the current uncertainty in the market, there can be no assurance that the Company will be able to realize its full carrying value. In the event the aforementioned options are unsuccessful, the Company may be unable to sustain its operations beyond January 31, 2009 due to a lack of cash resources. However, in the meantime, the Company will explore all options including fund raising, joint ventures, licensing, reducing expenses, and will consider all possibilities including merger with another company, selling the Company, ceasing operations or seeking protection under applicable laws. Management's plans for the remainder of the fiscal year, in addition to normal operations, include continuing their efforts to create joint ventures, obtain additional grants and to develop and enter into research, development and/or commercialization agreements with others.
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