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    SNPX   US87167T1025

SYNAPTOGE

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

12/23/2020 | 05:03pm 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.



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 ("AD"), 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 ("BRNI") (which has been known as Cognitive Research
Enterprises, Inc. ("CRE") 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").



As a condition to the Mergers, Neurotrope approved a transaction (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 November 30, 2020 (the "Spin-Off Record Date") received a pro
rata distribution at the rate of (i) one share of Synaptogenix common stock for
every five shares of Neurotrope common stock held, (ii) one share of
Synaptogenix common stock for every five shares of Neurotrope common stock
issuable upon conversion of Neurotrope preferred stock held and (iii) one share
of Synaptogenix, Inc. 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") (See below for description of warrant
amendment in lieu of common stock issuance to Neurotrope warrantholders). Any
fractional shares were paid in cash.



                                       16





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 Synaptogenix, Inc.
common stock at the ratio of one share of Synaptogenix, Inc. 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 7, 2020, we filed an amended and restated certificate of
incorporation which, among other things, changed its name to Synaptogenix, Inc.
We expect that our common stock will be quoted on the OTCQB market of the OTC
Markets Group, Inc. under the symbol "SNPX" at a date to be determined in the
future. We currently trade on the OTC Pink Sheet market.



Results of Most Recent Confirmatory Phase 2 Clinical Trial




On May 4, 2018, we announced a confirmatory, 100-patient, double-blinded
clinical trial for the safe, effective 20 ?g dose protocol for advanced AD
patients not taking memantine as background therapy to evaluate improvements in
SIB scores with an increased number of patients. We engaged WCT, in conjunction
with consultants and investigators at leading academic institutions, to
collaborate on the design and conduct of the trial, which began in April 2018.
During July 2018, the first patient was enrolled in this study. Pursuant to a
Services Agreement (the "2018 Services Agreement") with WCT dated as of May 4,
2018, WCT provided services relating to the trial. The total estimated budget
for the services, including pass-through costs, drug supply and other
statistical analyses, was approximately $7.8 million. The trial was
substantially completed as of December 31, 2019. We incurred approximately $7.7
million in total expenses of which WCT has represented a total of approximately
$7.3 million and approximately $400,000 of expenses were incurred to other
trial-related vendors and consultants, resulting in a total savings for this
trial of approximately $500,000.



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 Mini Mental State Exam 2 ("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 Food and Drug
Administration ("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.



                                       17





On July 23, 2020, we entered into an additional services agreement (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,
we agreed that WCT would invoice Synaptogenix for 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, which in each case will be due within ten (10) days of
Synaptogenix's receipt of such invoice.



As of September 30, 2020, we incurred approximately $1.1 million of expenses
associated with services provided by WCT. Of those amounts, approximately
$492,000 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 $1 million. In addition, we reflected an offset to
these expenses of approximately $862,000 of amounts receivable from the NIH. As
of December 18, 2020, the NIH, pursuant to the $2.7 million award (noted above),
has reimbursed us approximately $705,000 for expenses incurred during the third
quarter 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.



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 Cooperative Research and Development
Agreement ("CRADA") with the National Cancer Institute ("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 The Nemours / Alfred I.
duPont Hospital for Children ("Nemours"), a premier U.S. children's hospital, to
initiate a clinical trial in children with Fragile X syndrome ("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.



Results of Operations


Comparison of the nine months ended September 30, 2020 and 2019

The following table summarizes our results of operations for the nine months ended September 30, 2020 and 2019:



                                                     Nine months ended
                                                       September 30,                Dollar
                                                   2020             2019            Change        % Change
Revenue                                        $          -     $          -     $          -             0 %
Operating Expenses:
Research and development expenses - Other      $  1,004,762     $  4,273,531     $ (3,268,769 )       (76.5 )%
General and administrative expenses -
Related party                                  $      7,361     $     37,500     $    (30,139 )       (80.4 )%
General and administrative expenses - Other    $  5,731,238     $  5,165,096     $    566,142          11.0 %
Stock based compensation expenses - Related
party                                          $     21,001     $    173,161     $   (152,160 )       (87.9 )%
Stock based compensation expenses - Other      $  1,428,022     $  3,173,519     $ (1,745,497 )       (55.0 )%
Other income (expense), net                    $ (1,546,695 )   $    301,620     $ (1,848,315 )      (612.8 )%
Net loss                                       $  9,739,079     $ 12,521,187     $ (2,782,108 )       (22.2 )%




                                       18





Revenues


We did not generate any revenues for the nine months ended September 30, 2020 and 2019.




Operating Expenses



Overview


Total operating expenses for the nine months ended September 30, 2020 were
$8,192,384 as compared to $12,822,807 for the nine months ended September 30,
2019, a decrease of approximately 35%. 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 nine months ended September 30, 2020, we incurred $1,004,762 in research
and development expenses with non-related parties as compared to $4,273,531 for
the nine months ended September 30, 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
nine months ended September 30, 2020, $616,851 was incurred, which includes an
expense offset of $861,852 reimbursable pursuant to our NIH grant ($705,000 was
received subsequent to the end of the third quarter 2020), principally relating
to our confirmatory clinical trial and related storage of drug product, $319,128
for clinical consulting services, $22,138 of amortization of prepaid licensing
fees relating to the Stanford and Mount Sinai license agreements and $26,645 for
development of alternative drug supply with Stanford University as compared to,
for the nine months ended September 30, 2019, $3,647,450 was incurred
principally relating to our confirmatory clinical trial and related storage of
drug product, $584,745 for clinical consulting services, $20,729 of amortization
of prepaid licensing fees relating to the Stanford and Mount Sinai license
agreements and $20,607 for development of alternative drug supply with Stanford
University.


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.



General and Administrative Expenses




We incurred related party general and administrative expenses totaling $7,361
for the nine months ended September 30, 2020 as compared to $37,500 for the nine
months ended September 30, 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 $5,731,238 and $5,165,096 of general and administrative expenses for
the nine months ended September 30, 2020 and 2019, respectively, an increase of
approximately 11%. Of the amounts for the nine months ended September 30, 2020,
as compared to the comparable 2019 period: $1,381,863 was incurred primarily for
wages, bonuses, vacation pay, severance, taxes and insurance, versus $1,625,174
for the 2019 comparable period; $1,799,735 was incurred for ongoing legal
expenses versus $573,018 for the 2019 comparable period based upon work
associated with our strategic alternatives and planning for our January 2020
capital raise; $1,235,761 was incurred for outside operations consulting
services, versus $1,188,685 for the 2019 comparable period as we incurred
additional cash and non-cash expenses for investment banking consulting
services; $53,448 was incurred for travel expenses, versus $160,078 for the 2019
comparable period, which decrease is primarily attributable to limited travel
due to the COVID-19 contagion; $368,984 was incurred for investor relations
services versus $972,577 for the 2019 comparable period, which additional
expenses during the nine months ended September 30, 2019 were primarily
attributable to non-cash compensation paid to advisors and an increase in our
market exposure; $236,163 was incurred for professional fees associated with
auditing, financial, accounting and tax advisory services, versus $109,555 for
the 2019 comparable period, which additional expenses during the current period
were incurred for fees associated with our announced strategic transactions;
$457,887 was incurred for insurance, versus $361,494 for the 2019 comparable
period, which increase is primarily attributable to an increase in coverage; and
$197,397 was incurred for utilities, supplies, license fees, filing costs, rent,
advertising and other versus $174,515 for the 2019 comparable period, which
increase is primarily attributable to fees relating to document preparation and
filings for our announced strategic transactions.



                                       19




Stock Based Compensation Expenses




We incurred related party non-cash expenses totaling $21,001 and $173,161 for
the nine months ended September 30, 2020 and 2019, respectively. The decrease is
primarily attributable to the resignation of two Board members who were
affiliates of CRE and fully expensing certain options in 2019.



We incurred $1,428,022 and $3,173,519 of non-related party non-cash expenses for
the nine months ended September 30, 2020 and 2019, respectively. The decrease
for the comparable period is primarily attributable to newly issued stock
options during the first quarter of 2019, which included awards with accelerated
vesting terms.



Other Income


We recorded $1,700,000 of other, non-cash expense for the nine months ended September 30, 2020 as compared to $0 for the nine months ended September 30, 2019. The current expense is due to a charge for the amendment of investor warrants (See "Spin-Off from Neurotrope, Inc." above.)




We earned $153,305 of interest income for the nine months ended September 30,
2020 as compared to $301,620 for the nine months ended September 30, 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 and loss per share


We incurred losses of $9,739,079 and $12,521,187 for the nine months ended
September 30, 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. Earnings (losses) per common share were ($2.28)
and ($4.83) for the nine months ended September 30, 2020 and 2019, respectively.
The decrease in loss per share is primarily attributable to the decrease in our
net loss and an increase in weighted average common shares outstanding.



Basic earnings per share and weighted-average basic shares outstanding are based
on the number of shares of Neurotrope, Inc. common stock outstanding as of the
end of the period, adjusted for an assumed distribution ratio of 0.20 shares of
our Common Stock for every one share of Neurotrope, Inc. common stock held on
the record date for the Spin-Off.



Comparison of the three months ended September 30, 2020 and 2019

The following table summarizes our results of operations for the three months ended September 30, 2020 and 2019:



                                             Three months ended
                                               September 30,                Dollar
                                            2020            2019            Change         % Change
Revenue                                 $          -     $         -     $          -              0 %
Operating Expenses:
Research and development expenses -
Other                                   $    410,292     $   845,797     $   (435,505 )        (51.5 )%
General and administrative expenses -
Related party                           $          -     $    12,500     $    (12,500 )       (100.0 )%
General and administrative expenses -
Other                                   $  1,778,187     $ 2,131,205     $   (353,018 )        (16.6 )%
Stock based compensation expenses -
Related party                           $          -     $    47,695     $    (47,177 )       (100.0 )%
Stock based compensation expenses -
Other                                   $    387,927     $   877,525     $   (489,598 )        (55.8 )%
Other income (expense), net             $ (1,693,203 )   $    90,159     $ (1,783,362 )     (1,978.0 )%
Net loss                                $  4,269,609     $ 3,824,562     $    445,047           11.6 %




Revenues



We did not generate any revenues for the three months ended September 30, 2020
and 2019.



                                       20





Operating Expenses



Overview


Total operating expenses for the three months ended September 30, 2020 were
$2,576,406 as compared to $3,914,722 for the three months ended September 30,
2019, a decrease of approximately 34%. The decrease in total operating expenses
is due primarily to a decrease in research and development expenses,
stock-based, non-cash, compensation expenses and general and administrative
expenses.



Research and Development Expenses




For the three months ended September 30, 2020, we incurred $410,292 in research
and development expenses with non-related parties as compared to $845,797 for
the three months ended September 30, 2019. These expenses were incurred pursuant
to developing the potential AD therapeutic product, specifically expenses
relating to the recently initiated follow-on Phase 2 clinical trial for AD. Of
these expenses, for the three months ended September 30, 2020, $259,729, which
includes an expense offset of $861,852 reimbursable pursuant to our NIH grant
($705,000 was received subsequent to the end of the third quarter 2020), was
incurred principally relating to our confirmatory clinical trial and related
storage of drug product, $130,887 for clinical consulting services, $7,179 of
amortization of prepaid licensing fees relating to the Stanford and Mount Sinai
license agreements and $12,497 for development of alternative drug supply with
Stanford University as compared to, for the three months ended September 30,
2019, $664,677 was incurred principally relating to our confirmatory clinical
trial and related storage of drug product, $165,033 for clinical consulting
services, $7,480 of amortization of prepaid licensing fees relating to the
Stanford and Mount Sinai license agreements and $8,607 for development of
alternative drug supply with Stanford University.



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 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.



General and Administrative Expenses




We incurred related party general and administrative expenses totaling $0 for
the three months ended September 30, 2020 versus $12,500 for the three months
ended September 30, 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 $1,778,187 and $2,131,205 of general and administrative expenses for
the three months ended September 30, 2020 and 2019, respectively, a decrease of
approximately 17%. Of the amounts for the three months ended September 30, 2020,
as compared to the comparable 2019 period: $343,774 was incurred primarily for
wages, bonuses, vacation pay, severance, taxes and insurance, versus $447,695
for the 2019 comparable period. The decrease for the three months ending
September 30, 2020 is principally based upon the resignation of our General
Counsel and Regulatory Vice President in the September 30, 2019 period; $529,855
was incurred for ongoing legal expenses versus $288,161 for the 2019 comparable
period based upon work associated with our strategic transactions; $437,180 was
incurred for outside operations consulting services, versus $764,747 for the
2019 comparable period, the decrease is attributable to additional cash and
non-cash expenses for investment banking consulting services during the prior
comparable period; $7,792 was incurred for travel expenses, versus $48,769 for
the 2019 comparable period, which decrease is primarily attributable to limited
travel due to the COVID-19 contagion; $146,593 was incurred for investor
relations services versus $350,654 for the 2019 comparable period, which
additional expenses during the three months ended September 30, 2019 were
primarily attributable to non-cash compensation paid to advisors and an increase
in our market exposure; $80,028 was incurred for professional fees associated
with auditing, financial, accounting and tax advisory services, versus $24,768
for the 2019 comparable period which increase is primarily attributable to fees
relating to document preparation for our announced strategic transactions;
$149,490 was incurred for insurance, versus $146,243 for the 2019 comparable
period; and $83,475 was incurred for utilities, supplies, license fees, filing
costs, rent, advertising and other versus $60,168 for the 2019 comparable
period.



Stock Based Compensation Expenses

We incurred related party non-cash expenses totaling $0 and $47,695 for the three months ended September 30, 2020 and 2019, respectively. The decrease is primarily attributable to the resignation of two Board members who were affiliates of CRE and fully expensing certain options in 2019.




We incurred $387,927 and $877,525 of non-related party non-cash expenses for the
three months ended September 30, 2020 and 2019, respectively. The decrease for
the comparable period is primarily attributable to newly issued stock options
during the first quarter of 2019, which included awards with accelerated vesting
terms.



                                       21





Other Income



We recorded $1,700,000 of other, non-cash expense for the three months ended
September 30, 2020 as compared to $0 for the three months ended September 30,
2019.  The current expense is due to a charge for the amendment of investor
warrants (See "Spin-Off from Neurotrope, Inc." above.)



We earned $6,797 of interest income for the three months ended September 30,
2020 as compared to $90,159 for the three months ended September 30, 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 and loss per share


We incurred losses of $4,269,609 and $3,824,563 for the three months ended
September 30, 2020 and 2019, respectively. The increased loss was primarily
attributable to the recording of non-cash warrant amendment expenses offset by
the decrease in research and development expenses associated with the ramp up of
our current Phase 2 confirmatory clinical trial, a decrease in our general and
administrative expenses and a decrease in non-cash stock-based compensation
expenses. Earnings (losses) per common share were ($0.90) and ($1.48) for the
three months ended September 30, 2020 and 2019, respectively. The decrease in
loss per share is primarily attributable to an increase in weighted average
common shares outstanding partially offset by the increase in our net loss.



Basic earnings per share and weighted-average basic shares outstanding are based
on the number of shares of Neurotrope, Inc. common stock outstanding as of the
end of the period, adjusted for an assumed distribution ratio of 0.20 shares of
our Common Stock for every one share of Neurotrope, Inc. common stock held on
the record date for the Spin-Off.



Financial Condition, Liquidity and Capital Resources



Cash and Working Capital



Since inception, we have incurred negative cash flows from operations. As of
September 30, 2020, we had working capital of $27,825,991 as compared to working
capital of $17,397,094 as of December 31, 2019. The $10,428,897 increase in
working capital was primarily attributable to an increase in cash of
approximately $16.5 million as a result of net transfers from our Parent prior
to the Spin-Off, offset by our net loss, excluding non-cash compensation and
consulting expenses, non-cash warrant amendment expense and depreciation, of
$6,085,678 plus capital expenditures of $5,413.



As of September 30, 2020, we had approximately $27.0 million in cash and cash
equivalents as compared to $17.4 million at December 31, 2019. The increase in
cash is attributable to the aforementioned issuance of preferred stock and
warrants pursuant to a registered direct offering in January 2020 by Neurotrope,
partially offset by cash used for operating activities during the 2020 period.
On December 2, 2020, we transferred approximately $19.4 million to Petros
Pharmaceuticals, Inc, pursuant to the merger of Neurotrope, Inc. and Metuchen
Pharmaceuticals, Inc. which closed on December 1, 2020.



We expect that our current cash and cash equivalents will be sufficient to
support its projected operating requirements for at least the next 12 months
from the Form 10-Q filing date, which would include the continuing development
of bryostatin, our novel drug targeting the activation of PKC epsilon.



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 new clinical trials and additional research and
development expenditures. We are continuing to determine how to proceed with
respect to our current development programs for Bryostatin-1.



                                              Nine Months Ended September 30,
                                                  2020                 2019
Cash used in operating activities           $      6,896,751       $  

10,367,137

Cash used in investing activities                      5,413              

5,214

Cash provided by financing activities             16,519,988             419,843




                                       22




Net Cash Used in Operating Activities

Cash used in operating activities was $6,896,751 for the nine months ended
September 30, 2020, compared to $10,367,137 for the nine months ended September
30, 2019. The $3,470,386 decrease primarily resulted from the decreased net loss
of approximately $2.8 million, the increase in non-cash warrant revaluation
expense of $1.7 million and by the decrease in payables of approximately $3.0
million, offset by a decrease in non-cash stock-based compensation expenses of
approximately $2.7 million and by a decrease in prepaid expenses of
approximately $1.3 million, for the nine months ended September 30, 2020.



Net Cash Used in Investing Activities

Net cash used in investing activities was $5,413 for the nine months ended
September 30, 2020 compared to $5,214 for the nine months ended September 30,
2019. The cash used in investing activities for both periods was for capital
expenditures.


Net Cash Provided by Financing Activities




Net cash provided by financing activities was $16,519,988 for the nine months
ended September 30, 2020 compared to $419,843 for the nine months ended
September 30, 2019. The change in net cash provided by financing activities from
2019 to 2020 was the result of a change in net transfers from our Parent.



As of September 30, 2020, we had approximately $27.0 million in cash, cash
equivalents and marketable investment securities. We transferred approximately
$19.4 million to Petros Pharmaceuticals, Inc, pursuant to the merger of
Neurotrope, Inc. and Metuchen Pharmaceuticals, Inc. which closed on December 1,
2020.


We expect that our existing capital resources will be sufficient to support our
projected operating requirements over at least the next 12 months from the Form
10-Q 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.

© Edgar Online, source Glimpses

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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 24,6 M 24,6 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