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    SNPX   US87167T1025

SYNAPTOGENIX, INC.

(SNPX)
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SYNAPTOGE : SYNAPTOGENIX, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-K)

03/30/2021 | 05:08pm EDT
You should read the following discussion and analysis of our financial condition
and results of operations together with our financial statements and the related
notes appearing elsewhere in this report. In addition to historical information,
this discussion and analysis contains forward-looking statements that involve
risks, uncertainties and assumptions. Our actual results may differ materially
from those discussed below. Factors that could cause or contribute to such
differences include, but are not limited to, those identified below, and those
discussed in the section titled "Risk Factors."



The following discussion highlights our results of operations and the principal
factors that have affected our financial condition as well as our liquidity and
capital resources for the periods described, and provides information that
management believes is relevant for an assessment and understanding of the
statements of financial condition and results of operations presented herein.
The following discussion and analysis are based on the unaudited financial
statements contained in this report, which we have prepared in accordance with
United States generally accepted accounting principles. You should read the
discussion and analysis together with such financial statements and the related
notes thereto.



                                       47





Explanatory Note



On May 17, 2020, Neurotrope, Inc. (Neurotrope or Parent) announced plans for the
complete legal and structural separation of us from Neurotrope, also known as
the Spin-Off. Under the Separation and Distribution Agreement, Neurotrope
planned to distribute all of its equity interest in us to Neurotrope's
stockholders. Following the Spin-Off, Neurotrope would not own any equity
interest in us, and we would operate independently from Neurotrope. Neurotrope
Bioscience, Inc. was a wholly-owned subsidiary of Neurotrope prior to the
completion of the Spin-Off on December 7, 2020 (see below for description of
Spin-Off). Neurotrope Bioscience, Inc. represented substantially all the
business of Neurotrope.



On December 6, 2020, Neurotrope approved the final distribution ratio and
holders of record of Neurotrope common stock, Neurotrope preferred stock and
certain warrants as of November 30, 2020 received a pro rata distribution at the
rate of (i) one share of our Common Stock for every five shares of Neurotrope
common stock held, (ii) one share of our Common Stock for every five shares of
Neurotrope common stock issuable upon conversion of Neurotrope preferred stock
held and (iii) one share of our Common Stock for every five shares of Neurotrope
common stock issuable upon exercise of certain Neurotrope warrants held that
were entitled to participate in the Spin-Off pursuant to the terms thereof.


Basis of Presentation



The audited financial statements for the fiscal years and quarters ended
December 31, 2020 and 2019 include a summary of our significant accounting
policies and should be read in conjunction with the discussion below and our
financial statements and related notes included elsewhere in this annual report.
In the opinion of management, all material adjustments necessary to present
fairly the results of operations for such periods have been included in the
financial statements. All such adjustments are of a normal recurring nature.



Subsequent to the Spin-Off, the Company's financial statements as of
December 31, 2020 and for the period December 7, 2020 to December 30, 2020 are
presented on a consolidated basis as the Company became a standalone public
company on December 7, 2020. The Company's combined financial statements as of
December 31, 2019 and for the year ended December 31, 2019 as well as the period
from January 1, 2020 through December 6, 2020 that is included in the results of
operations for the year ended December 31, 2020 were derived from the
consolidated financial statements and accounting records of Neurotrope, the
former Parent. These combined financial statements reflect the historical
results of operations, financial position and cash flows of the former Parent's
Spin-Off business which was a wholly owned subsidiary of Neurotrope. Neurotrope
Bioscience, Inc. represented substantially all the business of Neurotrope. As a
result, the historical financial statements of Synaptogenix are virtually
identical to those of Neurotrope, other than capitalization.



Overview


We are a biopharmaceutical company with product candidates in pre-clinical and
clinical development. We began operations in October 2012. We are principally
focused on developing a product platform based upon a drug candidate called
bryostatin for the treatment of Alzheimer's disease, which is in the clinical
testing stage. We are also evaluating bryostatin for other neurodegenerative or
cognitive diseases and dysfunctions, such as Fragile X syndrome, Multiple
Sclerosis, and Niemann-Pick Type C disease, which have undergone pre-clinical
testing.


Neurotrope had been a party to a technology license and services agreement with
the original Blanchette Rockefeller Neurosciences Institute (which has been
known as Cognitive Research Enterprises, Inc. since October 2016), and its
affiliate NRV II, LLC, which we collectively refer to herein as "CRE," pursuant
to which we now have an exclusive non-transferable license to certain patents
and technologies required to develop our proposed products. We were formed for
the primary purpose of commercializing the technologies initially developed by
BRNI for therapeutic applications for AD or other cognitive dysfunctions. These
technologies have been under development by BRNI since 1999 and, until
March 2013, had been financed through funding from a variety of non-investor
sources (which include not-for-profit foundations, the NIH, which is part of the
U.S. Department of Health and Human Services, and individual philanthropists).
From March 2013 forward, development of the licensed technology has been funded
principally through us in collaboration with CRE.



Spin-Off from Neurotrope, Inc.




On December 1, 2020, Neurotrope, Petros Pharmaceuticals, Inc., a Delaware
corporation ("Petros"), PM Merger Sub 1, LLC, a Delaware limited liability
company and a wholly-owned subsidiary of Petros ("Merger Sub 1"), PN Merger Sub
2, Inc., a Delaware corporation and a wholly-owned subsidiary of Petros ("Merger
Sub 2"), and Metuchen Pharmaceuticals LLC, a Delaware limited liability company
("Metuchen"), consummated the transactions (the "Mergers") contemplated by that
certain Agreement and Plan of Merger by and among Neurotrope, Petros, Merger Sub
1, Merger Sub 2 and Metuchen, dated as of May 17, 2020 (the "Original Merger
Agreement"), as amended by the First Amendment to the Original Merger Agreement
(the "First Amendment"), dated as of July 23, 2020 and the Second Amendment to
the Original Merger Agreement, dated as of September 30, 2020 (the "Second
Amendment" and, together with the Original Merger Agreement and the First
Amendment, the "Merger Agreement").



                                       48







As a condition to the Mergers, Neurotrope approved the Spin-Off, which became
effective on December 7, 2020, whereby (i) any cash in excess of $20,000,000,
subject to adjustment as provided in the Merger Agreement, and all of the
operating assets and liabilities of Neurotrope not retained by Neurotrope in
connection with the Mergers were contributed to Neurotrope Bioscience, Inc. (now
known as Synaptogenix, Inc.), and (ii) holders of record of Neurotrope common
stock, Neurotrope preferred stock and certain warrants as of the Spin-Off Record
Date received a pro rata distribution at the rate of (i) one share of our Common
Stock for every five shares of Neurotrope common stock held, (ii) one share of
our Common Stock for every five shares of Neurotrope common stock issuable upon
conversion of Neurotrope preferred stock held and (iii) one share of our Common
Stock for every five shares of Neurotrope common stock issuable upon exercise of
certain Neurotrope warrants held that were entitled to participate in the
Spin-Off pursuant to the terms thereof (collectively, the "Distribution"). Any
fractional shares were paid in cash.



In addition, in connection with the Spin-Off, the holders of Neurotrope's
amended and restated warrants to purchase shares of Neurotrope common stock (the
"A&R Warrants") received warrants to purchase shares of our Common Stock at the
ratio of one share of our Common Stock for every five shares of Neurotrope
common stock issuable upon exercise of such A&R Warrants held as of the Spin-Off
Record Date (collectively, the "Spin-Off Warrants").



On December 6, 2020, we entered into the Separation and Distribution Agreement
with Neurotrope that sets forth our agreements with Neurotrope regarding the
principal transactions necessary to separate us from Neurotrope, including:
(i) the contribution of cash in excess of $20,000,000, as adjusted pursuant to
the Merger Agreement, and all of the operating assets and liabilities not
retained by Neurotrope in connection with the Merger to us and (ii) the
Distribution. The Separation and Distribution Agreement also sets forth the
other provisions that govern certain aspects of Neurotrope's relationship with
us after the completion of the Spin-Off and provides for the allocation of
assets, liabilities and obligations between us and Neurotrope in connection
with
the Spin-Off.



On December 6, 2020, we entered into a Tax Matters Agreement with Neurotrope
(the "Tax Matters Agreement") that generally governs the parties' respective
rights, responsibilities and obligations after the Spin-Off with respect to
taxes. Under the Tax Matters Agreement, Neurotrope will be liable for and shall
indemnify us from all taxes of Neurotrope for any taxable period and any
transfer taxes for which Neurotrope is responsible as a result of the Spin-Off.
We will be liable for and shall indemnify Neurotrope from (i) all taxes, other
than transfer taxes of Neurotrope for any pre-Spin-Off tax period to the extent
they are attributable to us (ii) all taxes, other than transfer taxes, of us for
any taxable period other than a pre-Spin-Off tax period, (iii) from all taxes,
other than transfer taxes, of Neurotrope related to the recapture of any "dual
consolidated loss" and (iv) any transfer taxes for which it is responsible
as a
result of the Spin-Off.



On December 7, 2020, we filed an amended and restated certificate of
incorporation which, among other things, changed our name to Synaptogenix, Inc.
Our Common Stock is quoted on the OTCQB market of the OTC Markets Group, Inc.
under the symbol "SNPX".


January 2021 Private Placement




On January 21, 2021, we entered into Securities Purchase Agreements (the
"Purchase Agreement") with certain accredited investors (the "Purchasers") to
issue (a) an aggregate of 9,335,533 shares of our Common stock and/or Pre-Funded
Warrants to purchase shares of Common Stock, (b) Series E Warrants to purchase
9,335,533 shares of Common Stock, with an exercise price of $2.1275 per share
(subject to adjustment), for a period of twelve months from the date of an
effective registration statement and (c) Series F Warrants to purchase up to an
aggregate of 9,335,533 shares of Common Stock, with an exercise price of $1.725
per share (subject to adjustment), for a period of five years from the date of
issuance at a combined purchase price of $1.50 per share of Common Stock and
Warrants (the "Offering"). We received total gross proceeds of approximately
$14,000,000 in Offering.



In connection with the Purchase Agreement, we entered into a Registration Rights
Agreement with the Purchasers (the "Registration Rights Agreement") on
January 21, 2021. Under the terms of the Registration Rights Agreement, we
agreed to register the shares of Common Stock and the shares of Common Stock
issuable upon exercise of the Warrants and the Pre-Funded Warrants sold to the
Purchasers pursuant to the Purchase Agreement. We are required to file a
registration statement for the resale of such securities within 30 days
following the closing date and to use its commercially reasonable efforts to
cause each such registration statement to be declared effective no later than
the earlier of (i) 120 days following the closing date (or 150 days following
the closing date if the Securities and Exchange Commission causes a delay) and
(ii) the fifth business day after we are notified that the registration
statement will not be further reviewed. We may incur liquidated damages if we do
not meet certain deadlines with respect to our registration obligations under
the Registration Rights Agreement or if certain other events occur. We also
agreed to other customary obligations regarding registration, including
indemnification and maintenance of the effectiveness of the registration
statement.



In connection with the Offering, we paid our Placement Agents (i) a cash fee
equal to ten percent (10%) of the gross proceeds from any sale of securities in
the Offering sold to Purchasers introduced by the Placement Agent and
(ii) warrants to purchase shares of Common Stock equal to ten percent (10%) of
the number of shares of Common Stock sold to Purchasers introduced by the
Placement Agent, with an exercise price of $1.725 per share and a five-year
term.



                                       49




Results of Most Recent Confirmatory Phase 2 Clinical Trial

On September 9, 2019, Neurotrope issued a press release announcing that the confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD did not achieve statistical significance on the primary endpoint, which was changed from baseline to Week 13 in the SIB total score.




An average increase in SIB total score of 1.3 points and 2.1 points was observed
for the Bryostatin-1 and placebo groups, respectively, at Week 13. There were
multiple secondary outcome measures in this trial, including the changes from
baseline at Weeks 5, 9 and 15 in the SIB total score. No statistically
significant difference was observed in the change from baseline in SIB total
score between the Bryostatin -1 and placebo treatment groups.



The confirmatory Phase 2 multicenter trial was designed to assess the safety and
efficacy of Bryostatin-1 as a treatment for cognitive deficits in patients with
moderate to severe AD - defined as a MMSE-2 score of 4-15 - who are not
currently taking memantine. Patients were randomized 1:1 to be treated with
either Bryostatin-1 20?g or placebo, receiving 7 doses over 12 weeks. Patients
on memantine, an NMDA receptor antagonist, were excluded unless they had been
discontinued from memantine treatment for a 30-day washout period prior to study
enrollment. The primary efficacy endpoint was the change in the SIB score
between the baseline and week 13. Secondary endpoints included repeated SIB
changes from baseline SIB at weeks 5, 9, 13 and 15.



On January 22, 2020, we announced the completion of an additional analysis in
connection with the confirmatory Phase 2 study, which examined moderately severe
to severe AD patients treated with Byrostatin-1 in the absence of memantine. To
adjust for the baseline imbalance observed in the study, a post-hoc analysis was
conducted using paired data for individual patients, with each patient as
his/her own control. For the pre-specified moderate stratum (i.e., MMSE-2
baseline scores 10-15), the baseline value and the week 13 value were used,
resulting in pairs of observations for each patient. The changes from baseline
for each patient were calculated and a paired t-test was used to compare the
mean change from baseline to week 13 for each patient. A total of 65 patients
had both baseline and week 13 values, from which there were 32 patients in the
Bryostatin-1 treatment group and 33 patients in the placebo group.  There was a
statistically significant improvement over baseline (4.8 points) in the mean SIB
at week 13 for subjects in the Bryostatin-1 treatment group (32 subjects),
paired t-test p < 0.0076, 2-tailed. In the placebo group (33 subjects), there
was also a statistically significant increase from baseline in the mean SIB at
week 13, for paired t-test p < 0.0144, consistent with the placebo effect seen
in the overall 203 study. Although there was a signal of Bryostatin-1's benefit
for the moderately severe stratum, the difference between the Bryostatin-1 and
placebo treatment groups was not statistically significant (p=0.2727). As a
further test of the robustness of this Moderate Stratum benefit signal, a
pre-specified trend analysis (measuring increase of SIB improvement as a
function of successive drug doses) was performed on the repeated SIB measures
over time (Weeks 0, 5, 9, and 13).  These trend analyses showed a significant
positive slope of improvement for the treatment groups in the 203 study that was
significantly greater than for the placebo group (p<.01).



In connection with the additional analysis, we also announced the approval of a
$2.7 million award from the NIH to support an additional Phase 2 clinical study
focused on the moderate stratum for which we saw improvement in the 203 study.
The grant provides for funds in the first year of approximately $1.0 million and
funding in year two of approximately $1.7 million subject to satisfactory
progress of the project. We are planning to meet with the FDA to present the
totality of the clinical data for Bryostatin-1. We are continuing to determine
how to proceed with respect to our current development programs for
Bryostatin-1.



On July 23, 2020, we entered into the 2020 Services Agreement with WCT. The 2020
Services Agreement relates to services for our Phase 2 clinical study assessing
the safety, tolerability and long-term efficacy of bryostatin in the treatment
of moderately severe AD subjects not receiving memantine treatment.  The total
estimated budget for the services, including pass-through costs, is
approximately $9.8 million. As previously disclosed on January 22, 2020, we have
received a $2.7 million award from the NIH, which award will be used to support
the 2020 Study, resulting in an estimated net budgeted cost of the 2020 Study to
us of $7.1 million. In connection with the entry into the Letter of Intent and
2020 Services Agreement, Synaptogenix paid the following advance payments:
(i) services fees of approximately $943,000; (ii) pass-through expenses of
approximately $266,000; and (iii) investigator/institute fees of approximately
$314,000.


As of December 31, 2020, we incurred approximately $1.9 million of expenses
associated with services provided by WCT. Of those amounts, approximately
$862,000 was paid utilizing prepayments on deposit with WCT (which totaled
approximately $1.5 million as detailed above), leaving a balance in prepaid
expenses of approximately $0.6 million. In addition, we reflected an offset to
these expenses of approximately $975,000 of amounts received and receivable from
the NIH. As of February 18, 2021, the NIH, pursuant to the $2.7 million award
(noted above), has reimbursed us approximately $975,000 for expenses incurred
during the third and fourth quarters of 2020. See Note 1 - Organization, Nature
of Business, and Liquidity and Note 5 - Commitments in the notes to the
condensed financial statements contained within this Quarterly Report.



                                       50





Other Development Projects



To the extent resources permit, we may pursue development of selected technology
platforms with indications related to the treatment of various disorders,
including neurodegenerative disorders such as AD, based on our currently
licensed technology and/or technologies available from third party licensors or
collaborators.


For example, we have entered into a CRADA with NCI on January 29, 2019 for the
research and clinical development of Bryostatin-1. Under the CRADA, we will
collaborate with the NCI's Center for Cancer Research, Pediatric Oncology Branch
("POB") to develop a Phase 1 clinical trial testing the safety and toxicity of
Bryostatin-1 in children and young adults with CD22 + leukemia and B-cell
lymphoma. In the growing era of highly effective immunotherapies targeting
cell-surface antigens (e.g., CAR-T cell therapy), and the recognition that
antigen modulation plays a critical role in evasion of response to
immunotherapy, the ability for Bryostatin-1 to upregulate CD22 may serve a
synergistic role in enhancing the response to a host of CD22 targeted therapies.
Under the CRADA, Bryostatin-1 is expected to be tested in the clinic to evaluate
its ability to modulate CD22 in patients with relapsed/refractory CD22+ disease,
while evaluating safety, toxicity and overall response. In connection with the
Transfer Agreement, we agreed to assign and transfer to BryoLogyx all of our
right, title and interest in and to the CRADA, subject to the receipt of NCI's
consent.



Nemours Agreement


On September 5, 2018, we announced a collaboration with Nemours, a premier U.S.
children's hospital, to initiate a clinical trial in children with Fragile X. In
addition to the primary objective of safety and tolerability, measurements will
be made of working memory, language and other functional aspects such as
anxiety, repetitive behavior, executive functioning, and social behavior. As of
December 31, 2020, the Company continues to pursue its development of a
therapeutic to possibly treat Fragile X thru future clinical trials.



Impact of COVID-19



In January 2020, the World Health Organization ("WHO") announced a global health
emergency because of a new strain of coronavirus originating in Wuhan, China
(the "COVID-19 outbreak") and the risks to the international community. In
March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the
rapid increase in exposure globally. As a result of the COVID-19 pandemic, which
continues to rapidly evolve, "shelter in place" orders and other public health
guidance measures have been implemented across much of the United States, Europe
and Asia, including in the locations of our offices, key vendors and partners. .



We continue to monitor our operations and applicable government recommendations,
and we have made modifications to our normal operations because of the COVID-19
pandemic, including requiring most office-based employees to work remotely.
Notwithstanding these measures, the COVID-19 pandemic could affect the health
and availability of our workforce as well as those of the third parties we rely
on taking similar measures. If members of our management and other key personnel
in critical functions across our organization are unable to perform their duties
or have limited availability due to COVID-19, we may not be able to execute on
our business strategy and/or our operations may be negatively impacted. We may
also experience limitations in employee resources, including because of sickness
of employees or their families or the desire of employees to avoid contact with
individuals or large groups of people. In addition, we have experienced and will
continue to experience disruptions to our business operations resulting from
quarantines, self-isolations and other restrictions on the ability of our
employees to perform their jobs.



The Company also faces the ongoing risk that the coronavirus pandemic may slow,
for an unforeseeable period, the conduct of the Company's trial. In order to
prioritize patient health and that of the investigators at clinical trial sites,
we will monitor enrollment of new patients in our Phase 2 clinical trial of
Bryostatin-1 for the treatment of patients with Alzheimer's disease. In
addition, some patients may be unwilling to enroll in our trials or be unable to
comply with clinical trial protocols if quarantines or travel restrictions
impede patient movement or interrupt healthcare services. These and other
factors outside of our control could delay our ability to conduct clinical
trials or release clinical trial results. In addition, the effects of the
ongoing coronavirus pandemic may also increase non-trial costs such as insurance
premiums, increase the demand for and cost of capital, increase loss of work
time from key personnel, and negatively impact our key clinical trial vendors
and supplier of API. The full extent to which the COVID-19 pandemic impacts the
clinical development of Bryostatin-1, the Company's suppliers and other
partners, will depend on future developments that cannot be predicted at this
time.



In light of the COVID-19 outbreak, the FDA has issued a number of new guidance
documents. Specifically, as a result of the potential effect of the COVID-19
outbreak on many clinical trial programs in the US and globally, the FDA issued
guidance concerning potential impacts on clinical trial programs, changes that
may be necessary to such programs if they proceed, considerations regarding
trial suspensions and discontinuations, the potential need to consult with or
make submissions to relevant ethics committees, Institutional Review Board
("IRBs"), and the FDA, the use of alternative drug delivery methods, and
considerations with respect the outbreak's impacts on endpoints, data
collection, study procedures, and analysis. Such developments may result in
delays in our development of Bryostatin-1.



                                       51





On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief,
and Economic Security Act ("CARES Act"). The CARES Act, among other things,
includes provisions relating to refundable payroll tax credits, deferment of
employer side social security payments, net operating loss carryback periods,
alternative minimum tax credit refunds, modifications to the net interest
deduction limitations, increased limitations on qualified charitable
contributions, and technical corrections to tax depreciation methods for
qualified improvement property. The Company evaluated the provisions of the
CARES Act and does not anticipate the associated impacts, if any, will have a
material effect on the Company's provision for income taxes.



Results of Operations


Comparison of the years ended December 31, 2020 and 2019




The following table summarizes our results of operations for the years ended
December 31, 2020 and 2019:



                                               Years ended
                                              December 31,                 Dollar
                                          2020             2019            Change         % Change
Revenue                               $          -     $          -     $          -               0 %
Operating Expenses:
Research and development expenses     $  3,069,034     $  5,670,013     $ (2,600,979 )         (45.9 )%
General and administrative expenses
- Related party                       $     28,362     $    270,856     $  

(242,494 ) (89.5 )% General and administrative expenses $ 8,059,014 $ 9,572,588 $ (1,513,574 )

           4.3 %
Other income (expense), net           $ (1,546,787 )   $    378,707     $ (1,925,494 )        (508.4 )%
Net loss attributable to common
shareholders                          $ 15,130,197     $ 15,123,750     $     (4,553 )           0.0 %




Revenues


We did not generate any revenues for the years ended December 31, 2020 and 2019.




Operating Expenses



Overview



Total operating expenses for the years ended December 31, 2020 were $11,156,410
as compared to $15,513,457 for the year ended December 31, 2019, a decrease of
approximately 28%. The decrease in total operating expenses is due primarily to
a decrease in research and development expenses and stock-based, non-cash,
compensation expenses offset by an increase in our general and administrative
expenses.


Research and Development Expenses




For the year ended December 31, 2020, we incurred $3,069,034 in research and
development expenses as compared to $5,670,013 for the year ended December 31,
2019. These expenses were incurred pursuant to developing the potential AD
therapeutic product, specifically expenses relating to the recently concluded
confirmatory Phase 2 clinical trial plus the recently initiated Phase 2 clinical
trial for AD. Of these expenses, for the years ended December 31, 2020,
$1,884,769 was incurred, which includes an expense offset of $975,066 reimbursed
and reimbursable pursuant to our NIH grant ($127,445 was received subsequent to
the end of the fourth quarter 2020), principally relating to our confirmatory
clinical trial and related storage of drug product, $460,353 for clinical
consulting services, $29,698 of amortization of prepaid licensing fees relating
to the Stanford and Mount Sinai license agreements, $43,108 for development of
alternative drug supply with Stanford University and 651,106 of non-cash stock
options compensation expense as compared to, for the year ended December 31,
2019, $3,862,697 was incurred principally relating to our confirmatory clinical
trial and related storage of drug product, $622,911 for clinical consulting
services, $28,291 of amortization of prepaid licensing fees relating to the
Stanford and Mount Sinai license agreements, $27,048 for development of
alternative drug supply with Stanford University and 1,129,066 of non-cash
stock
options compensation expense.


We expect our research and development expenses to substantially increase, in
the short term, as our current Phase 2 clinical trial for AD was recently
initiated. Other development expenses might increase, as our resources permit,
in order to advance our potential products. We are continuing to determine how
to proceed with respect to our other current development programs for
Bryostatin-1.



                                       52




General and Administrative Expenses




We incurred related party general and administrative expenses totaling $28,362
for the year ended December 31, 2020 as compared to $270,856 for the year ended
December 31, 2019. The decrease is attributable to the resignation of two
members of Neurotrope's board of directors in February 2020, who are affiliates
of CRE.



We incurred $8,059,014 and $9,572,588 of general and administrative expenses for
the years ended December 31, 2020 and 2019, respectively, a decrease of
approximately 15.8%. Of the amounts for the year ended December 31, 2020, as
compared to the comparable 2019 period: $1,808,733 was incurred primarily for
wages, bonuses, vacation pay, severance, taxes and insurance, versus $2,172,287
for the 2019 comparable period. The decrease is primarily attributable to the
hiring of a Chief Operating Officer in 2019 who was terminated in 2020;
$2,208,968 was incurred for legal expenses versus $701,433 for the 2019
comparable period. The increase for 2020 is based upon work associated with our
strategic alternatives, planning, restructuring and spin-off of
Synaptogenix, Inc.; $1,395,849 was incurred for outside operations consulting
services, versus $1,771,850 for the 2019 comparable period as, for 2019, we
incurred additional investment banking consulting services; $58,499 was incurred
for travel expenses, versus $184,749 for the 2019 comparable period, which
decrease is primarily attributable to limited travel due to the COVID-19
contagion; $489,833 was incurred for investor relations services versus
$1,038,730 for the 2019 comparable period, which additional expenses during 2019
were primarily attributable to non-cash compensation paid to advisors and an
increase in our market exposure; $278,577 was incurred for professional fees
associated with auditing, financial, accounting and tax advisory services,
versus $129,355 for the 2019 comparable period, which additional expenses during
the current period were incurred for fees associated with our strategic
transactions; $671,292 was incurred for insurance, versus $515,634 for the 2019
comparable period, which increase is primarily attributable to an increase in
coverage; $117,994 was incurred for utilities, supplies, license fees, filing
costs, rent, advertising and other versus $226,472 for the 2019 comparable
period, and 1,029,269 was recorded as non-cash stock options compensation
expense versus 2,832,078 for the 2019 comparable period.



Other Income / Expense



We recorded $1,700,000 of other, non-cash expense for the year ended
December 31, 2020 as compared to $0 for the year ended December 31, 2019.  The
current expense is due to a charge for the amendment of investor warrants (See
"Spin-Off from Neurotrope, Inc." above.)



We earned $153,213 of interest income for the year ended December 31, 2020 as
compared to $378,707 for the year ended December 31, 2019 on funds deposited in
interest bearing money market accounts.  The decrease is primarily attributable
to the decrease in money market interest income rates.



Net loss



We incurred losses of $15,130,197 and $15,134,750 for the years ended
December 31, 2020 and 2019, respectively. The decreased loss was primarily
attributable to the decrease in net research and development expenses associated
with completing our most recent Phase 2 confirmatory clinical trial and a
decrease in non-cash stock-based compensation expenses offset by the increase in
our general and administrative expenses and one-time charges associated with the
amendment of investor warrants and the issuance of Common Stock and Warrants
associated with our spin-off totaling approximately $2,427,000.



Financial Condition, Liquidity and Capital Resources



Cash and Working Capital



Since inception, we have incurred negative cash flows from operations. As of
December 31, 2020, we had working capital of $5,116,300 as compared to working
capital of $17,397,094 as of December 31, 2019. The $12,280,794 decrease in
working capital was primarily attributable to providing $20 million to Petros
Pharmaceuticals, Inc. pursuant to the merger of Neurotrope and Metuchen which
closed on December 1, 2020, our net loss, excluding non-cash compensation and
consulting expenses, non-cash warrant amendment expense and depreciation of
$8,796,209, plus capital expenditures of $5,413, offset by an increase in cash
of approximately $16.5 million as a result of net transfers from our Parent
prior to the Spin-Off.



As of December 31, 2020, we had approximately $5.8 million in cash and cash
equivalents as compared to $17.4 million at December 31, 2019. The approximately
$11.6 million decrease in cash is attributable to transferring approximately $20
million to Petros Pharmaceuticals, Inc. pursuant to the merger of Neurotrope and
Metuchen which closed on December 1, 2020, and cash used for operating
activities during the year 2020, offset by the aforementioned net transfers from
our Parent prior to the Spin-Off.



We expect that our current cash and cash equivalents of approximately $15
million which includes the $12.54 million of net proceeds received under the
January 2021 Private Placement and the remaining cash expected to be received
from the NIH of approximately $1.7 million, will be sufficient to support our
projected operating requirements for at least the next 12 months from the
Form 10-K filing date, which would include the continuing development and
current Phase 2 clinical trial, of bryostatin, our novel drug targeting the
activation of PKC epsilon.



                                       53





Sources and Uses of Liquidity



Since inception, we have satisfied our operating cash requirements from
transfers of cash from Neurotrope, which was raised by Neurotrope through the
private placement of equity securities sold principally to outside investors. We
expect to continue to incur expenses, resulting in losses and negative cash
flows from operations, over at least the next several years as we may continue
to develop AD and other therapeutic products. We anticipate that this
development may include clinical trials in addition to our current ongoing
clinical trial and additional research and development expenditures.



                                                    Years Ended December 31,
                                                      2020             2019
Cash used in operating activities                 $  8,102,398     $ 

11,886,809

Cash used in investing activities                        5,413            

5,214

Cash (used in) provided by financing activities (3,479,172 ) 419,843

Net Cash Used in Operating Activities




Cash used in operating activities was $8,102,398 for the year ended December 31,
2020, compared to $11,886,809 for the year ended December 31, 2019. The
$3,784,411 decrease primarily resulted from the decreased net loss of
approximately $2.4 million, which current year loss also included non-cash
warrant revaluation expense of $1.7 million and by the increase in payables of
approximately $3.3 million, offset by a decrease in non-cash stock-based
compensation expenses of approximately $3.3 million and by a decrease in prepaid
expenses of approximately $0.3 million, for the year ended December 31, 2020.



Net Cash Used in Investing Activities




Net cash used in investing activities was $5,413 for the year ended December 31,
2020 compared to $5,214 for the year ended December 31, 2019. The cash used in
investing activities for both periods was for capital expenditures.



Net Cash Used in Financing Activities




Net cash used in financing activities was $3,479,172 for the year ended
December 31, 2020 compared to cash provided by financing activities of $419,843
for the year ended December 31, 2019. The change in net cash used in financing
activities from 2019 to 2020 was the result of net transfers from our Parent of
approximately $16.5 million offset by transferring approximately $20 million to
Petros Pharmaceuticals, Inc. pursuant to the merger of Neurotrope and Metuchen.



As of December 31, 2020, we had approximately $5.8 million in cash, cash equivalents and marketable investment securities. In addition, as mentioned above, we received approximately $16.5 million from net transfers from our Parent, Neurotrope.




We expect that our existing capital resources, including approximately $12.5
million of net proceeds from our January 2021 Offering, will be sufficient to
support our projected operating requirements over at least the next 12 months
from the Form 10-K filing date, including the potential continued development of
bryostatin, our novel drug targeting the activation of PKC epsilon. The future
course of our operations and research and development activities will be
contingent upon the further analysis of results from our recently completed
trial.



We expect to require additional capital in order to initiate, pursue and
complete all potential AD clinical trials, including the development of
bryostatin for other potential product applications, or in connection with any
strategic alternatives that we may pursue. Additional funding may not be
available to us on acceptable terms, or at all. If we are unable to access
additional funds when needed, we may not be able to initiate, pursue and
complete all planned clinical trials or continue the development of our product
candidates or we could be required to delay, scale back or eliminate some or all
of our development programs and operations. Any additional equity financing, if
available, may not be available on favorable terms, would most likely be
significantly dilutive to our current stockholders and debt financing, if
available, and may involve restrictive covenants. If we are able to access funds
through collaborative or licensing arrangements, we may be required to
relinquish rights to some of our technologies or product candidates that we
would otherwise seek to develop or commercialize on our own, on terms that are
not favorable to us. Our ability to access capital when needed is not assured
and, if not achieved on a timely basis, will materially harm our business,
financial condition and results of operations.



Off-Balance Sheet Arrangements

We did not engage in any "off-balance sheet arrangements" (as that term is defined in Item 303(a)(4)(ii) of Regulation S-K) as of December 31, 2020.




                                       54

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Financials (USD)
Sales 2020 - - -
Net income 2020 -12,7 M - -
Net cash 2020 5,80 M - -
P/E ratio 2020 -0,50x
Yield 2020 -
Capitalization 28,1 M 28,1 M -
EV / Sales 2019 -
EV / Sales 2020 -
Nbr of Employees 4
Free-Float -
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Managers and Directors
NameTitle
Alan J. Tuchman Chief Executive Officer & Director
Daniel L. Alkon President, Director & Chief Science Officer
Robert Weinstein Chief Financial Officer, Secretary & Treasurer
Joshua Nathaniel Silverman Chairman
William S. Singer Vice Chairman