GERMANTOWN, Md., Sept. 2, 2020 /PRNewswire/ -- Seneca
Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused
on developing novel treatments for diseases of high unmet medical
need, today provided the following letter from Dr. Ken Carter, the Company's Executive
Chairman.
Dear Stakeholders,
Recently, we have received several inquiries from our
stakeholders regarding Seneca Biopharma, our legacy programs, and
current initiatives. This letter is to respond to these inquiries
and provide context regarding the path forward for our company.
Before going into detail, however, I want to assure you of the
commitment of the management team, the Board of Directors, and
myself to forging a path forward that will maximize shareholder
value.
It has been over a year and a half since I joined Seneca and one of the main driving factors for
me joining was a belief in the company's technologies and the
promise they held for patients afflicted by disease. During my
first six months as Executive Chairman, I engaged world class
consultants to provide an external review of our core technologies,
NSI-566 (Stem Cell) and NSI-189 (Small Molecule). Although
both technologies showed promise in early clinical studies, the
external review revealed that the future development for both posed
significant risks and challenges for the Company.
NSI-566
Regarding NSI-566, the result of our Phase 1 and 2 trials seemed
to indicate that our stem cell treatment could be a potential
therapy for diseases such as ALS and Stroke. I still believe
this. Unfortunately, our trials to date have been relatively
small. In order to ultimately receive approval from the FDA
to commercialize our treatment, significantly more capital would be
needed to execute and report the larger clinical trials necessary
for product registration. In addition, the time required to design,
enroll, and conduct such trials means that even if the trials were
to ultimately be successful, today our treatment would still be
several years from commercialization. These facts have impeded our
ability to raise sufficient capital to move development of NSI-566
forward in a robust fashion.
NSI-189
On July 25, 2017, we announced
top-line results from an exploratory Phase 2 clinical trial
examining the efficacy of NSI-189 compared to placebo for the
treatment of Major Depressive Disorder. The study did not meet its
primary efficacy endpoint and the market had a negative reaction to
this news. Nevertheless, the trial results seemed directionally
positive and indicated that a much larger trial might show
efficacy. However, a trial of sufficient size would require
significantly more capital than we are able access.
In addition to long lead times and a significant capital
commitment, neither NSI-566 nor NSI-189 have clear regulatory paths
to FDA approval, which significantly increases the overall risk of
both assets, especially for a company of Seneca's size.
Out-Licensing/Sales Strategy
Given the facts outlined above for our legacy programs, we first
disclosed in our 2018 Annual Report, which was filed in March of
2019, an out-licensing/sales strategy to partner or out-license our
current technologies to a partner with significantly more resources
in terms of both capital and clinical trial experience. To date, we
have conducted a broad outreach to over 100 potentially interested
development partners in the US, Europe and Asia. Over 25 companies have conducted some
level of due diligence on the programs and approximately 10 have
executed non-disclosure agreements to engage in confidential
diligence, including analysis of preclinical and clinical data,
product manufacturing and intellectual property. At the time of
this writing, we have ongoing discussions continuing with potential
partners on both programs.
A second prong of this approach is to preserve the value in both
assets thereby maximizing the value to our possible partner and
ultimately our shareholders. To this end, we have continued to: (i)
maintain the patent estates underlying both assets, (ii) conduct
and finalize ongoing trials and (iii) participate in a Type C
meeting with the FDA focused on the design of a Phase 3 clinical
study for NSI-566 in ALS patients, based on our belief that our
existing Phase 1 and 2 trial results support moving into a Phase 3
clinical trial. We believe that although we presently do not
possess the financial resources to undertake the required trials,
the actions we are taking will further enhance the value of both
NSI-189 and NSI-566 to any potential partner.
Notwithstanding the foregoing, there can be no assurance that we
will be successful in our out-licensing/sales efforts.
In-Licensing/Acquisition/Merger Initiative
Simultaneous with our out-licensing/sales strategy, we have also
begun an in-licensing/acquisition/merger initiative. The goals of
this initiative are to transform Seneca through the acquisition of novel
technologies that are less capital intensive to develop, have a
shorter time to market, and that could yield significant value to
our shareholders. We have evaluated over 50 technologies, both in
the drug development and diagnostic/screening areas. Although we
cannot be certain that we will be successful in this initiative,
management is hopeful that it will be able to complete a
transformative transaction. Successfully completing these
types of activities requires significant time, effort, and
resources. With the Covid-19 pandemic, some activities have been
even more challenging. We are sensitive to the informational needs
of our shareholders and have disclosed our initiatives in our SEC
filings, but also wanted to provide a current update as we approach
the date of our rescheduled annual shareholders meeting.
We ask that our shareholders vote as recommended by our Board of
Directors as the voting matters are important in positioning the
Company for transformation.
In closing, I would again like to assure you that I am committed
to maximizing the value of Seneca
and also thank you for your patience and continued support. In the
event of any material developments with Seneca or the initiatives and strategies
discussed above, we will make the appropriate disclosures and
filings with the SEC.
Sincerely,
Dr. Kenneth Carter
Executive Chairman
Seneca Biopharma, Inc.
Cautionary Statement Regarding Forward Looking
Information:
This news release contains "forward-looking statements" made
pursuant to the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements
relate to future, not past, events and may often be identified by
words such as "expect," "anticipate," "intend," "plan," "believe,"
"seek" or "will." Forward-looking statements by their nature
address matters that are, to different degrees, uncertain. Specific
risks and uncertainties that could cause our actual results to
differ materially from those expressed in our forward-looking
statements include risks inherent in the development and
commercialization of potential products, uncertainty of clinical
trial results or regulatory approvals or clearances, need for
future capital, dependence upon collaborators and maintenance of
our intellectual property rights. Actual results may differ
materially from the results anticipated in these forward-looking
statements. Additional information on potential factors that could
affect our results and other risks and uncertainties are detailed
from time to time in Seneca's
periodic reports filed with the Securities and Exchange Commission
(SEC), including its Annual Report on Form 10-K for the year ended
December 31, 2019, its Quarterly
Reports on Form 10-Q as well as and in other reports filed with the
SEC. We do not assume any obligation to update any forward-looking
statements.
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SOURCE Seneca Biopharma, Inc.