EXHIBIT 99.1
Annual Shareholder Meeting
June 17, 2002
Slide 1 - Title slide
Slide 2 - Participants
I, together with Dr. Shrotriya our President and Chief Operating Officer and Mr.
Sam Gulko, our Senior Vice President Finance and Chief Financial Officer, will
now present an update on the Company.
Slide 3 - Forward Looking Statements
We will be talking about some things in our presentation today that may be
considered forward-looking and involve risks and uncertainties that could cause
actual results to differ materially. These risks are described in further detail
in the Company's reports filed with the SEC.
Slide 4 - 2002 Annual Stockholders Meeting
Today, Sam Gulko, Dr. Shrotriya and I are going to talk about where we are, and
elaborate on the broad base of technology assets we have built at
NeoTherapeutics. Dr. Shrotriya, will then discuss where we are headed and how we
intend to get there. First, I'll turn the presentation over to Sam Gulko. Thank
you Dr. Glasky and good afternoon everyone.
Slide 5 - Financial Update
Fiscal 2001 was a year of great progress in the financial area at
NeoTherapeutics. During the year we cleaned up our balance sheet, improved our
capital efficiency and, significantly reduced our net loss per share.
Slide 6 - Income Statement Data (Fiscal Year)
First, let's review our income statement for the past three years. As you can
see, the net loss per share for 2001 amounted to $27.8 million dollars. This is
down from $45 million dollars in 2000. Revenues for the year were $41,000
dollars, which reflects the amortization of the initial payments for two
licenses totaling $300,000 dollars, which were received during the year. The
decline in research and development expenses from 2001 to 2000 largely reflects
the benefit of bringing in-house, the management of our clinical trials.
Previously, our clinical trials were outsourced to a third party provider. The
increase in general and administrative expenses principally reflects the hiring
of necessary staff to support the personnel running our clinical trials as well
as higher salaries and benefits associated with the expansion of the Company.
Slide 7 - Income Statement Data (First Quarter)
For the first quarter of 2002, the Company reported a net loss of $6.3 million
dollars. Results for the first quarter continued to reflect the costs of our
pivotal study of Neotrofin in Alzheimer's disease. Now that this trial has been
completed, expenses will begin to drop over the course of the second quarter. I
will talk more about expense rates later.
Slide 8 - Balance Sheet
At the end of the first quarter of 2002, NeoTherapeutics had cash and
equivalents of $5.8 million dollars and working capital of $2.1 million dollars.
Slide 9 - 2002 Financings
So far during 2002, NeoTherapeutics has raised $7.9 million dollars through the
issuance of common stock and warrants. $6.2 million dollars were raised during
the first quarter in a placement led by the Royal Bank of Canada Investment
Management Group. So far during the second quarter, we have raised from private
institutional investors $1.66 million. Dr. Shrotriya will have more to say later
regarding our plans to access additional capital.
Slide 10 - Fully Diluted Common Shares
As of Friday, June 14, 2002, the company had approximately 33.6 million shares
outstanding. In addition, approximately 8.6 million warrants and stock options
have been issued. The average exercise price of investor warrants is $7.13 per
share and of stock options is $5.25 per share.
I also wanted to mention that we issued a press release today that we have
received notification from Nasdaq, that we are not in compliance with Nasdaq's
minimum bid price per share ($1.00) requirements for continued listing on the
Nasdaq National Market. The Company has until September 10, 2002 to regain
compliance with Nasdaq's minimum bid requirement. Under Nasdaq rules
NeoTherapeutics may demonstrate compliance by maintaining a $1.00 minimum
closing bid price per share for a minimum of 10 consecutive trading days by that
date. If the Company is unable to demonstrate compliance by that date, the
Company may appeal a determination that it be delisted from the Nasdaq National
Market, or it may decide to file an application to be transferred to the Nasdaq
Small Cap Market prior to September 10, 2002. If such an application were filed
and accepted, the Company would have another 90 days, or until December 9, 2002
to comply with the minimum bid requirement. In addition to the minimum bid
requirement, the Company must maintain compliance with certain other
quantitative standards for continued listing. The Company is currently not in
compliance with some of these standards.
Slide 11 - Actual and Projected Burn Rate
Back to expenses. Our burn rate (or monthly loss) during 2001 averages about
$2.3 million dollars per month, which is down from $4.1 million dollars per
month during 2000. We have continued our progress in reducing the burn rate so
far during 2002. During the first quarter of 2002, the monthly burn rate
averaged approximately $2.1 million dollars per month, and continues to fall. We
have indicated that we expect our burn rate to fall to $1.2 million dollars per
month this month. Last week we implemented some additional cost savings
measures, which we estimate will bring the burn rate down to less than $900,000
dollars per month for the third and fourth quarters of 2002.
Now I would like to turn the presentation back to Dr. Glasky. Thank you.
Slide 12 - NeoTherapeutics' Technology Assets
Thank you Sam. Now let's talk about the broad base of technology assets that
have been built at NeoTherapeutics.
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Slide 13 - NeoTherapeutics' Technology Assets
During 2001, we made a great deal of progress in building our base of assets at
the Company. I would like to take a few minutes to discuss and explain these
assets, and why we are so excited about their potential. These assets fall into
four basic categories: neurology, generics, functional genomics and oncology.
Slide 14 - Neurology
Let's take a look at the Company's neurology division. This is where our company
began. While many of you know about our lead neurology product, Neotrofin, we
also have some other very exciting products that I would like to discuss with
you.
Slide 15 - Neotrofin
Most of you are familiar with Neotrofin, our nerve regeneration drug that has
been under development for some time. While we are disappointed that the drug
did not meet the clinical endpoints in the Alzheimer's disease trial we
completed in April, we are encouraged by the preliminary data we reported in
Parkinson's disease, and look forward to completing the ongoing studies in
spinal cord injury and chemo-therapy induced neuropathy and reporting these
results later this year.
Slide 16 - Neotrofin in Parkinson's Disease
First let's take a look at the data we reported from our preliminary analysis of
the Parkinson's disease trial.
Slide 17 - Neotrofin in Parkinson's Disease
The design of the trial was treatment of patients for 2 weeks at 250 mg. twice
a day. During weeks 3 and 4, the dose was increased to 500 mg twice a day.
Beginning in week 5, the dose was increased to 1,000 mg twice a day. This dose
was maintained through the remaining 12 weeks of the study. Patients were
assigned to either drug treatment or placebo in a ratio of 4 to 1, that is 4
Neotrofin treated patients for every one placebo treated patient. The study was
double blind, with neither the patients nor the clinical investigation team at
each site knowing who received which treatment.
Testing for efficacy occurred at the first visit prior to treatment and again at
weeks 2, 4 and 6. At these follow-up visits, the patient took their morning
medication prior to visiting the clinic. They were tested on arrival at the
clinic, then they were given the first dose of their new medication dose. After
2-3 hours, they were retested. This allowed us to determine whether or not
Neotrofin produced a short-term benefit as well as evaluation of the cumulative
effect seen by the prior 2 weeks of treatment. The results we reported were
observed with the first 25 Neotrofin patients and the 6 placebo patients. Since
the number of placebo treated patients were so few, we conducted the statistical
analysis using each Neotrofin patient as their own control. That is, what was
the improvement in
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their performance when we analyzed it before treatment against after the various
treatments. Performance was evaluated using two recognized parameters in
Parkinson's disease patients, the Uniform Parkinson's Disease Rating Scale
(UPDRS) and a tapping test for motor function. The results I will show you are
from the UPDRS, but similar trends were seen in the Tapping Test.
Slide 18 - Graph of Parkinson's Data
While the graph may seem complicated, I would like to explain what we observed.
This graph does not show the placebo patients, there was no improvement in that
small group over any of the time periods when the continued to receive placebo.
In the Neotofin group, there was a statistically significant improvement
observed when they were observed 2-3 hours after their first dose of 250 mg.
When they returned after 2 weeks treatment at 250 mg twice a day, there was an
improvement but it did not reach statistical significance.
When they received their first dose of 500 mg, there was a statistically
significant improvement after 2-3 hours, which reached statistical significance.
When they returned after 2 additional weeks of treatment at 500 mg twice a day,
there was no additional improvement. Furthermore, the first dose of 1,000 mg did
not produce the short-term effect that we saw at the 250 or 500 mg doses.
While we are still collecting additional data from this study, it appears clear
that there is a rapid effect of Neotrofin in Parkinson's patients who received
250 or 500 mg. The higher dose of 1,000 mg was ineffective in producing the
short-term effect. In addition, continued treatment at 500 mg twice a day
produced no benefit over that seen at 250 mg twice a day.
I believe that this observation is very important, because it appears to be
telling us that higher doses for longer periods of treatment may not be better
than shorter term treatment at moderate dose levels. Clearly, this observation
must be replicated and validated, but it may offer an explanation for the
negative results seen in Alzheimer's disease, where we may have treated for too
long at too high a dosage.
Again, I want to repeat that these results need to be replicated but they
parallel similar observations, which have been made in many animal experiments.
If this is true, we may be able to conduct faster clinical trials to demonstrate
the efficacy of Neotrofin for the treatment of Parkinson's disease
Slide 19- Neotrofin in Chemotherapy-Induced Neuropathy
Slide 20 - Neotrofin Neuropathy Data
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In January of this year, we initiated two phase two clinical studies of
Neotrofin in chemotherapy induced neuropathy. This chart is shows some of the
data from one of several animal studies conducted by scientists outside the
Company, which led us to run human studies of Neotrofin in neuropathy.
Vincristine is an anti-cancer drug, that, when administered to humans and rats,
causes nerve damage. In this study, when animals receiving vincristine were also
given Neotrofin, these animals experienced significantly less nerve damage.
Since starting the human study in January at one site, we have increased the
number of clinical sites to six and have now enrolled eighteen patients. We hope
to have these studies completed by year-end.
Slide 21 - AIT-034/NEO-339
Besides Neotrofin, our two most advanced neurology products are AIT-034 and
NEO-339. AIT-034 is being developed for dementia, and NEO-339 is being developed
for attention deficit and mild cognitive impairment. We have been actively
seeking to license both products since late last year, and we have moved to
advanced discussions regarding licensing out or co-developing NEO-339. I would
like to show you some video of some of the pre-clinical work that has been done
on NEO-339 that has gotten us, and some of our potential partners, so interested
in this drug.
What you will be seeing is a rat in a shuttle box. There is a buzzer that comes
on prior to the animal receiving a very mild shock to his feet. This test is
commonly used to measure the animals ability to learn to respond by crossing
over into the opposite safe chamber before receiving any shock. However, if you
observe the behavior of the animal, you can see if they pay attention to the
buzzer.
Now I will show you a video of rats that are 20 months old and have been treated
with placebo or NEO 339.
Slide 22 - NEO 339 Video
The control animals did not learn as well as the treated animals, but their
attention was clearly not as focused. In addition, when tested one month later,
the control animals did not retain their learned performance, while the animals
treated with NEO-339 remembered to escape and they paid attention to the buzzer.
Slide 23 - Anti-psychotic Platform
Our newest technology in the neurology division is the anti-psychotic platform.
This platform of new compounds addresses multiple therapeutic targets that
represent a very large market opportunity, including schizophrenia, depression,
a variety of other psychosis, as well as Parkinson's disease, and pain.
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Slide 24 - Anti-psychotic Market
The anti-psychotic market is large and growing, with current product sales
exceeding $7.7 billion dollars in 2001 and market growth at 30 percent. The
leading products addressing this market are listed, and are led by Zyprexa, with
single product sales of approximately $3.1 billion dollars last year.
Slide 25 - Anti-psychotic Efficacy
The activity of this series of compounds is dependent on their action against
selective receptors for certain neurotransmitter molecules. The type of
therapeutic activity is based upon the compound's action on multiple receptor
systems and the balance of their action on dopamine and serotonin
neurotransmitter receptor systems.
Slide 26 - Anti-psychotic Series
In addition to the fact that efficacy is based upon activity towards specific
dopamine and serotonin receptor systems, the side effect profile of the drugs
can be predicted by their activity against other receptor systems. For example
activity against adrenergic receptors can produce hypotension, sedation and
restlessness. Prolonged activity against certain dopaminergic receptors can lead
to sexual dysfunction, activity against muscarinic receptors can cause dry
mouth, urinary retention, disorientation and blurred vision. Other observed side
effects are muscle spasms and dyskinesis. So we must also look at the balance
between positive therapeutic effects and the significant side effects, which
cause many patients to prematurely stop taking their medications
Slide 27 - Anti-psychotic Series
For example, in treating schizophrenia
Slide 28 - Anti-psychotic Series
With a drug like resperidone,
Slide 29 - Anti-psychotic Series
One observes the beneficial effects on dopamine D1 and D2 receptors, but also
negative effects by acting on adrenergic and histaminergic receptors, which can
produce severe weight gain.
Slide 30 - Anti-psychotic Series
For example, in treating schizophrenia with a drug like clozapine,
Slide 31 - Anti-psychotic Series
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One observes the beneficial effects on dopamine D4 and serotonin 5-HT 1A, but
also negative effects by acting on adrenergic and histaminergic like
resperidone, but also muscarinic receptors which can produce extrapyramidal or
motor side effects.
Slide 32 - Anti-psychotic Series
Olanzapine, marketed as Zyprexa
Slide 33 - Anti-psychotic Series
also has a broad range of activity against positive therapeutic receptors as
well as many of the side effect based receptors.
Slide 34 - Anti-psychotic Series
While we have a number of compounds that are active in this therapeutic area, I
will comment on only three candidate compounds. The first is NEO 392 our lead
compound.
Slide 35 - Anti-psychotic Series
Here we can see that NEO-392 has one of the broadest spectrums of activity
against the therapeutic receptor systems. It has very mild activity against a
few side effect systems, suggesting that it may indeed be a promising drug
candidate.
Slide 36 - Anti-psychotic Series
Another candidate, NEO-356
Slide 37 - Anti-psychotic Series
also has a broadest spectrum of activity against the therapeutic receptor
systems, with limited and mild activity against a single side effect system
Slide 38 - Anti-psychotic Series
The third candidate, NEO-376
Slide 39 - Anti-psychotic Series
has a unique and very specific receptor activity profile, with no activity
against the usual side effect receptor systems.
Slide 40 - Anti-psychotic Series
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Another important side effect seen with many anti-psychotic drugs is that they
impair memory function. Here we can see that clozapine in animals produces a
dose dependent inhibition in memory function. In contrast, NEO-376 does not
produce memory impairment, even at higher doses. This represents an important
additional benefit of our candidate drugs.
Slide 41 - Anti-pyschotic Technology Platform
In summary, we have selected 8 compounds and have completed an extensive
evaluation. They have shown unique receptor binding profiles, positive animal in
vivo antipsychotic activity, with no memory impairment. Their side effect
profile looks very encouraging and their toxicity profile is similarly
encouraging. These pre-clinical effects are especially important because the
animal models used in this therapeutic area have been very predictive of human
activity.
Slide 42 - Anti-pyschotic Technology Platform
We believe that our antipsychotic platform is very exciting because these
compounds represent a new generation of antipsychotic drug candidates for a
therapeutic field that is large, well-established and still has a great unmet
need based upon the currently available drugs.
Slide 43 - Functional Genomics
NeoGene Technologies uses functional genomics to identify targets for drug
development. This business is a research collaboration between NeoTherapeutics
and the University of California, Irvine, and was formed in 1999.
Slide 44 - NeoGene Highlights
During 2001, NeoGene Technologies signed two alliance agreements with Pfizer,
each covering Pfizer's use of a receptor system discovered by NeoGene to develop
pharmaceutical products. Each of the agreements calls for a total of up to $12
million in upfront and potential milestone payments. In connection with these
agreements, we received $300,000 dollars in upfront payments from Pfizer. In May
of this year, Pfizer reached the first milestone for the first agreement, which
triggered a payment to us of $250,000 dollars.
Our objective at NeoGeneis to expand to number of development agreements with
additional companies and to expand the type of alliances we establish. We
currently are critically evaluating the best strategy to achieve these
objectives. This includes re-negotiation of the level of financial commitment by
NeoTherapeutics as well as M & A possibilities.
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Now, I would like to invite Dr. Shrotriya to the podium to discuss our oncology
and generic drug opportunities, and to talk about where we go from here and how
we intend to get there.
Thank you Dr. Glasky and good afternoon everyone. First, I would like to thank
you for coming today and I would also like to thank you for your support of
NeoTherapeutics.
In addition to neuroscience and functional genomics, we have added two more
dimensions and a number of new drugs to our pipeline since my joining the
Company. During the next 15 minutes or so, I will talk about our oncology
portfolio and the joint venture that we finalized just last month.
Slide 45 - NEO JB
NeoJB was formed in May of this year after many months of discussions between
NeoTherapeutics and JB Chemicals and Pharmaceuticals. The mission of NeoJB is to
gain regulatory approvals and facilitate the marketing and sale of products
manufactured by JB in India.
JB Chemicals is an internationally known pharmaceutical company headquartered in
Bombay, India. Today, its products are sold in over 50 countries and it has 12
manufacturing facilities producing high quality drugs for domestic use and as a
supplier to other pharmaceutical. They also manufacture and sell generic drugs
and herbal products.
Slide 46 - Generic Drugs
These three generic drugs are among the products that we are focusing on for
seeking regulatory approvals. Each of these drugs addresses major markets, and
with JB's low-cost and high quality manufacturing capabilities, we are hopeful
that we can gain a piece of their market share.
Slide 47 - NEO JB Strategy
Importantly, our joint-venture with JB is not a significant cash drain on the
Company. We are using our skills in the regulatory and development area to help
JB gain approvals for marketing its products in the United States. Once these
approvals are received, then we will benefit from a portion of the revenues that
might come from these products.
Slide 48 - NeoOncoRx
About 18 months ago, we decided to form an oncology division at NeoTherapeutics
in order to take advantage of the many opportunities that exist and to leverage
the skills of many at NeoTherapeutics, especially those of Dr. Gino Lenaz, the
President of NeoOncoRx. Dr. Lenaz spent more than 20 years at Bristol Myers and
has been credited with much of their success in oncology. Our oncology strategy
is to identify and in-
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license late stage anti-cancer drugs. We now have three late stage products
where significant amounts of capital have already been invested, and clinical
results support further development. This lessens the risk of development for
us, and given that our threshold for potential revenue is much lower than the
major pharmaceutical companies, there are plenty of appealing prospects
available.
Slide 49 - Oncology Products
During the first twelve months of its existence, our oncology division
identified and in-licensed, three products: satraplatin, Neoquin and
elsamitrucin. Now we plan to expand our efforts to the development of these
products, while we continue to evaluate additional promising candidates for
in-licensing.
Slide 50 - Elsamitrucin
Late last year, we in-licensed Elsamitrucin from Bristol Myers-Squibb.
Elsamitrucin has shown activity in a phase 2 study of non-Hodgkin's lymphoma -
the sixth leading cause of cancer death.
Slide 51 - Elsamitrucin Trials
While elsamitrucin was tested in a number of cancer types, its revenue potential
was not sufficient to meet Bristol's minimum marketing requirements. Our revenue
requirements for drugs are - not surprisingly - a bit lower, and we believe that
the drug's multi-hundred million dollar revenue potential, could have a
meaningful impact on the value of NeoTherapeutics.
Slide 52 - Elsamitrucin - Non-Hodgkin's Lymphoma
Our first area of focus for Elsamitrucin will be non-Hodgkin's Lymphoma. A phase
2 study of elsamitrucin in non-Hodgkin's lymphoma patients who had tried and
failed other drug treatments looks encouraging. Approximately 25 percent of the
31 patients in this study, who took elsamitrucin, showed an objective response
to the drug. Our intention is to run a larger phase 2 study in non-Hodgkin's
lymphoma patients who have failed other treatments to see if these results can
be confirmed. FDA approval for oncology products that are effective in patients
who have failed other treatments is generally accelerated.
Slide 53 - Neoquin
Neoquin was the first drug in-licensed by NeoOncoRx, and the first drug to begin
clinical trials. Late last year we initiated a clinical study in the United
Kingdom to evaluate the safety, determine the dose-limiting toxicity, and
measure the efficacy of Neoquin in superficial bladder cancer. We also have
filed for orphan drug status in the United States. In addition to showing
promise as a treatment for superficial bladder cancer, Neoquin has potential as
a radiation sensitizer.
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Slide 54 - Satraplatin
Our lead drug at NeoOncoRx is satraplatin. In September of last year we
in-licensed satraplatin from Johnson-Matthey - an $8 billion market
capitalization company based in the United Kingdom, that specializes in precious
metals. One of those precious metals is platinum, and Johnson-Matthey has
developed a number of "platinum-compounds" for the treatment of cancer. The
first was cisplatin and the second was carboplatin - both developed by Dr. Lenaz
when he was at Bristol Myers Squibb. Satraplatin is a third-generation platinum
compound - an improvement over carboplatin, just as carboplatin was an
improvement over cisplatin.
Our first target indication for satraplatin is prostate cancer. Prostate cancer
is the number two killer of men in terms of cancer - second only to lung cancer.
There are currently no specifically approved chemotherapeutic treatments for
prostate cancer. Satraplatin has shown efficacy in human studies to date in this
indication - including in a phase 3 study. In July of this year we have a
meeting with the FDA to discuss our phase 3 protocol for prostate cancer, and we
hope to begin that study during the second half of 2002. Assuming positive data,
we would hope to file an NDA within the next 2 to 3 years. Satraplatin has the
potential to follow in the foot-steps of carboplatin, which has sales in excess
of $500 million.
Slide 55 - Satraplatin Advantages
As I mentioned, satraplatin is the third-generation platinum compound - a son of
carboplatin and grandson of cisplatin. Let's see how they compare: Efficacy of
the three compounds is similar, however satraplatin has some advantage in terms
of safety and it is orally available. Cisplatin and carboplatin have to be
administered intravenously and in a hospital due to the need to hydrate patients
because of potential kidney toxicity. Satraplatin does not have this type of
toxicity, and can be taken orally - at home. Satraplatin has shown some efficacy
advantages in animal models where there is resistance to cisplatin and
carboplatin, but this has yet to be established in humans. Our development plan
with Satraplatin, is to seek approval for prostate cancer first and then to run
studies in lung cancer and other cancers where carboplatin and cisplatin are
used to expand the drug's potential.
Slide 56 - Satraplatin Prostate Cancer Survival
This graph shows increased survival for patients treated with satraplatin versus
the standard treatment. This is why we in-licensed and are excited about
developing this drug. Bristol Myers had been developing satraplatin - while Dr.
Lenaz was there - but their marketing group scrapped its development. Their
marketing rationale was that prostate cancer would be treated by surgery,
radiation and hormones, not chemotherapy. While this was true at the time, the
recent trend is leading to the use of chemotherapy. Prior to their decision, a
phase 3 study had been started. At the time of cancellation of the development
program, 50 patients had been enrolled in the phase 3 study. They were allowed
to complete the study even though the development of satraplatin had been
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discontinued. The data from these 50 patients is graphed. The green line
represents patients on satraplatin and shows a clear survival advantage to
patients receiving prednisone alone - the current standard of care. If this data
is extrapolated out to the targeted study size of 300 patients, the study would
have shown statistically significant survival advantage for satraplatin, which
would have gotten the drug approved.
Slide 57 - NeoTherapeutics' Patents
Importantly, the assets that we have discussed are protected by numerous
patents.
Slide 58 - NeoTherapeutics' US Patents
We currently hold 16 patents, with one additional patent allowed and 21 more
pending. Corresponding foreign patents have been issued or applied for.
Slide 59 - Summary of Technology Assets
I hope you can see that we have a broad base of assets at NeoTherapeutics.
Slide 60 - Where are We Going?
As you have seen, we believe we have created a great deal of potential at
NeoTherapeutics during the past eighteen months.
Unfortunately, the failure of our pivotal trial of Neotrofin in Alzheimer's
disease and our relatively modest cash balances have put pressure on our stock
price.
Market conditions and the fact that biotech companies are out of favor with the
market right now have made things even more difficult.
We have some great products, which represent great opportunities, and we have
great people, who I believe can accomplish much. The key questions are, given
the challenges we face, where do we go from here and how do we get there?
Slide 61 - Where are We Going?
Let me answer them briefly. First, where are we going?
Given our success at in-licensing oncology drugs, discovering new neurology
drugs and identifying new indications for Neotrofin, we have a lot of projects
facing us today. Given the choices, and our financial resources, we have
designed a strategy that we believe should allow us to move forward on many
fronts.
First, as far as Neotrofin is concerned, let me repeat that we will not initiate
any additional studies of Neotrofin in Alzheimer's disease, unless we find a
development partner who is willing to fund the studies. We have three ongoing
studies in other
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indications that we expect to complete within the next six months or so.
Decisions to move forward in these trials will be made once data from each study
is analyzed. We are also pursuing potential licensing and/or co-development
opportunities for Neotrofin.
Second, we are very excited about several compounds that are in the pre-clinical
development stage. Our plan for these compounds, NEO-339 and our anti-psychotic
platform, is to out-license them or sign co-development agreements with
companies that have the cash resources necessary to take these drugs into human
clinical studies and ultimately to the FDA. Discussions on these compounds began
late last year, and have progressed during the course of this year.
Finally, we would like to devote capital to the development of our phase 3
anti-cancer drug, satraplatin. Within the next few weeks we will meet with the
FDA to discuss our phase 3 protocol for satraplatin. Once we have the FDA's
buy-in for our protocol and for our regulatory strategy, we would like to begin
this trial. Our goal is to get the trial started during the second half of this
year, but the launch will be dependent on our ability to raise the necessary
capital.
Slide 62 - 2002 Annual Stockholders Meeting
Now let me address the second question: How will we get there?
Slide 63 - What are our strategic plans going forward?
The key to our future success is getting access to capital. We have good
products, we have talented, experienced people and there is money available for
promising investment opportunities. The capital we need could come from a
variety of sources, and we are actively pursuing each of these avenues. First,
we are looking within the pharmaceutical industry. There are many mid-sized and
large pharmaceutical companies with significant amounts of cash and large
budgets for drug development, who are short potential products to develop. We
have been actively pursuing licensing and co-development arrangements with
pharmaceutical companies for most of our drugs over the past six months. We have
made some progress in our discussions and these negotiations are continuing as
we speak. This will remain our highest priority.
There are also opportunities, where again, we have peers who have cash, but are
not satisfied with their drug development candidates. We also have some unique
skills resident in our employee and management teams that are attractive to
these other companies. As with licensing discussions, efforts to identify and
discuss a potential merger or sale of one of our divisions or sale of the entire
company have been ongoing and will continue.
Finally, we have the option of accessing capital through the sale of common
stock or other securities. We would prefer to raise capital without issuing
stock at current prices, but we prudently must pursue this option so that we
have a backup strategy to the first
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two I discussed. While we don't like the idea of dilution, we must ensure that
the Company has adequate cash resources to move our products forward.
Getting where we want to go won't be easy, but we are committed to doing it, and
we have a very capable team of people charged with the task.
I'd now like to turn the presentation back to Dr. Glasky for some concluding
remarks and questions.
Thank you, Dr. Shrotriya.
Slide 64 - Summary
In summary
Slide 65 - Summary
It has been a tough quarter, but the upside potential of the NeoTherapeutics'
portfolio remains...
Slide 66 - Summary
There is real value in our technology and product platforms
Slide 67 - Summary
Our challenge is to gain realization and recognition of this value in the
marketplace.
Thank you for your attention and continued interest in NeoTherapeutics.
I would now like to open the meeting to your questions.
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