Notes
to Consolidated Financial Statements
(Unaudited)
Note
1 - Organization and Summary of Significant Accounting Policies
Business
Activities and Organization
Company
Overview
Processa
Pharmaceuticals, Inc. (the “Company” and formerly known as “Heatwurx” ) and its wholly-owned subsidiary,
Processa Therapeutics LLC (“Processa”), a Delaware limited liability company, acquired all the net assets of a private
company, including the rights to the CoNCERT Agreement mentioned below, Promet Therapeutics, LLC (“Promet”), a Delaware
limited liability company on October 4, 2017 in exchange for 31,745,242 shares (post reverse split) of the common stock of the
Company which, at the closing, constituted approximately 90% of the Company’s issued and outstanding common stock on a fully
diluted basis. Immediately following the closing, there were 35,272,626 shares (post reverse split) of common stock issued and
outstanding. At the closing, Processa was assigned all of the assets and operations of Promet that constituted the operating business
of Promet and Promet, which continues as an active company, received the Processa shares mentioned above and agreed to provide
the Processa shares needed if the option in the CoNCERT Agreement (see below) was exercised. Upon closing on October 4, 2017,
there was a change in control of the Company to Promet. The Company abandoned its prior business plan and adopted Promet’s
business plan focused on developing drugs to treat patients that have a high unmet medical need. Subsequent to closing and effective
October 10, 2017, the Company changed its trading symbol to “PCSA” on the OTC Pink Marketplace (“OTCQB”).
The Company effected a one-for-seven reverse split of its shares in December 2017. As a result, the 2017 consolidated financial
statements have been retrospectively adjusted to reflect shares outstanding after the one-for-seven reverse split.
The
net asset acquisition transaction was accounted for as a reverse acquisition. Prior to the acquisition, Heatwurx (subsequently
renamed Processa Pharmaceuticals, Inc.) had nominal net liabilities and operations. It was considered a non-operating public shell
corporation. Therefore, Promet was considered the accounting acquirer (and legal wholly-owned subsidiary of Heatwurx, now called
Processa Pharmaceuticals, Inc.) and Heatwurx was considered the accounting acquiree (and legal acquirer). As a result, the consolidated
financial statements of the Company reflect the financial condition, results of operations and cash flows of Promet for all periods
presented prior to October 4, 2017 and Processa for the periods subsequent to October 4, 2017. The legal capital stock (number
and type of equity interests issued) is that of Processa Pharmaceuticals, Inc., the legal parent, in accordance with guidance
on reverse acquisitions accounted for as a capital transaction instead of a business combination (See Note 2 – Basis of
Presentation and Earnings Per Share and Note 3 – Reverse Acquisition in Item 8 of the Company’s annual Report on Form
10-K filed with the SEC on April 17, 2018).).
All
references to the “Company” and Processa Pharmaceuticals, Inc. refer to Heatwurx, Inc., Processa Therapeutics, LLC,
and the net assets acquired from Promet Therapeutics, LLC, which were assigned at acquisition to Processa Therapeutics, LLC and
Promet’s operations prior to October 4, 2017.
On
March 19, 2018, Promet, Processa and CoNCERT Pharmaceuticals Inc. (“CoNCERT”) amended the Option and License Agreement
(the “Agreement”) executed in October 2017. The Agreement was assigned to Processa and Processa exercised the exclusive
option for the CTP-499 compound. The option was exercised in exchange for CoNCERT receiving (i) $8 million of common stock of
Company that was owned by Promet (or 2,090,301 shares representing 6.58% of Promet’s common stock holding or 5.93% of total
the Company’s common stock issued and outstanding), and (ii) 15% of any sublicense revenue earned by the Company for a period
equivalent to the royalty term (as defined in the Agreement) until the earliest of (a) Processa raising $8 million of gross proceeds;
and (b) CoNCERT can sell its shares of Processa common stock without restrictions pursuant to the terms of the amended Agreement.
All other terms of the Agreement remain unchanged. As a result, the Company recognized an intangible asset and additional paid-in
capital in the amount of $8 million resulting from Promet satisfying Processa’s liability to CoNCERT. There was no change
in the total shares issued and outstanding, however, Promet’s controlling interest in Processa was reduced from 90% to 84%.
Processa
Pharmaceuticals, Inc.
Notes
to Consolidated Financial Statements
(Unaudited)
Description
of Business
Processa
is an emerging pharmaceutical company focused on the clinical development of drug products that are intended to improve the survival
and/or quality of life for patients who have a high unmet medical need or who have no alternative treatment. Within this group
of pharmaceutical products, we currently are developing one product for two indications (i.e., the use of a drug to treat a particular
disease) and searching for additional products for our portfolio.
Processa’s
lead product, PCS-499 (previously known as CTP-499), is an oral tablet that is an analog of an active metabolite of an already
approved FDA drug. The advantage of PCS-499 is that it potentially may work in many conditions because it has multiple pharmacological
targets that it affects that are important in the treatment of these conditions. Based on its pharmacological activity, Processa
has identified other unmet medical need conditions where the use of PCS-499 may result in clinical efficacy. These include Necrobiosis
Lipoidica (NL) and Radiation-Induced Fibrosis (RIF) in head and neck cancer patients. Processa has met with the FDA on the NL
condition and has developed a strategy for moving the program for NL forward starting with a Phase 2 clinical trial in NL patients
in late 2018. Processa will meet with the FDA to further define the program for use of PCS-499 for the RIF condition in the next
few months.
Processa
is looking to acquire additional drug candidates to help patients who have an unmet medical need. Processa has evaluated over
50 potential assets for acquisition and are continuing to evaluate new assets to acquire.
Our
operations are performed in the state of Maryland and are still in the organizational and research and development phase of operations.
As a result, we have a limited operating history and only a preliminary business plan from which investors may evaluate our future
prospects. We have not had any sources of revenue from inception (August 31, 2015) through March 31, 2018 and have a history of
operating losses from operations. Our ability to generate meaningful revenue from any products in the United States depends on
obtaining FDA authorization. Even if our products are authorized and approved by the FDA, we must still meet the challenges of
successful marketing, distribution and consumer acceptance.
As
of March 31, 2018, the Company had an accumulated deficit of approximately $5.0 million incurred since inception and expects to
incur substantial operating losses for the foreseeable future. Our current capital is insufficient to fully fund our total business
plan and the development of our planned product candidates for a period of one-year from the date these consolidated financial
statements are available to be issued. Our ability to achieve revenue-generating operations and, ultimately, achieve profitability
will depend on whether we can obtain additional capital when we need it, complete the development of our technology, receive regulatory
approval of our planned product candidates and any stand along development planned product candidates into new or existing drugs
which can be successfully commercialized. There can be no assurance that we will ever generate revenues or achieve profitability.
These risks and other factors could have a material adverse effect on the Company and raise substantial doubt about our ability
to continue as a going concern.
Basis
of Presentation
The
accompanying unaudited consolidated financial statements have been prepared in accordance with United States generally accepted
accounting principles (“U.S. GAAP”) for interim financial information and with the instructions of the Securities
and Exchange Commission (“SEC”) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all
of the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany accounts
and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited consolidated
financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation
of the Company’s financial position and of the results of operations and cash flows for the periods presented. These consolidated
financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the SEC on April 17, 2018. The results of operations
for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim
period or for the full year.
Processa
Pharmaceuticals, Inc.
Notes
to Consolidated Financial Statements
(Unaudited)
As
a result of the modification of the Option and License Agreement with CoNCERT and the acquisition of an exclusive license intangible
asset used in research and development activities described above, the Company adopted a new intangible asset policy and disclosure
(See Note 1 – Intangible Assets and Note 2) and recognized a deferred tax liability for the acquired temporary difference
between the financial reporting basis and the tax basis of the intangible asset (See Note 5).
Going
Concern and Management’s Plan
The
Company’s consolidated financial statements are prepared using U.S. GAAP and are based on the assumption that the Company
will continue as a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course
of business. The Company faces certain risks and uncertainties that are present in many emerging growth companies regarding product
development and commercialization, limited working capital, recurring losses and negative cash flow from operations, future profitability,
ability to obtain future capital, protection of patents, technologies and property rights, competition, rapid technological change,
navigating the domestic and major foreign markets’ regulatory and clinical environment, recruiting and retaining key personnel,
dependence on third party manufacturing organizations, third party collaboration and licensing agreements, lack of sales and marketing
activities and no customers or pharmaceutical products to sell or distribute. These risks and other factors raise substantial
doubt about our ability to continue as a going concern.
The
Company has relied exclusively on private placements with a small group of accredited investors to finance its business and operations.
We do not have any prospective arrangements or credit facilities as a source of future funds. The Company has had no revenue since
inception on August 31, 2015. The Company does not currently have any revenue under contract nor does it have any immediate sales
prospects. As of March 31, 2018, the Company had an accumulated deficit of approximately $5.0 million incurred since inception.
For the three months ended March 31, 2018, the Company incurred a net loss from continuing operations of approximately $1.1 million
and used approximately $1.1 million in net cash from operating activities from continuing operations. The Company had total cash
and cash equivalents of approximately $1.8 million as of March 31, 2018.
No
additional sources of capital have been obtained or committed through the date these consolidated financial statements were available
to be issued. We expect our operating costs to be substantial as we incur costs related to the clinical trials for our product
candidates and that we will operate at a loss for the foreseeable future.
We
are in the process of raising additional funds by potentially selling additional Senior Convertible Notes, convertible loans or
other securities. However, no assurance can be given that we will be successful in raising adequate funds needed. If we are unable
to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue
the development or commercialization of one or more of our product candidates, restrict our operations or obtain funds by entering
into agreements on unattractive terms, which would likely have a material adverse effect on our business, stock price and our
relationships with third parties with whom we have business relationships, at least until additional funding is obtained.
Uncertainty
concerning our ability to continue as a going concern may hinder our ability to obtain future financing, as well as adversely
affect our collaborative drug development relationships. Continued operations and our ability to continue as a going concern are
dependent on our ability to obtain additional funding in the near future and thereafter, and no assurances can be given that such
funding will be available at all or will be available in sufficient amounts or on reasonable terms. Without additional funds from
debt or equity financing, sales of assets, sales or out-licenses of intellectual property or technologies, or other transactions
yielding funds, we will rapidly exhaust our resources and will be unable to continue operations. Absent additional funding, we
believe that our cash and cash equivalents will not be sufficient to fund our operations for a period of one year or more after
the date that these consolidated financial statements are available to be issued based on the timing and amount of our projected
net loss from continuing operations and cash to be used in operating activities during that period of time.
As
a result, substantial doubt exists about the Company’s ability to continue as a going concern within one year after the
date that these consolidated financial statements are available to be issued. The accompanying consolidated financial statements
do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded assets,
or the amounts and classification of liabilities that might be different should the Company be unable to continue as a going concern
based on the outcome of these uncertainties described above.
Processa
Pharmaceuticals, Inc.
Notes
to Consolidated Financial Statements
(Unaudited)
Use
of Estimates
The
preparation of the accompanying unaudited consolidated financial statements in conformity with U.S. GAAP requires management to
make estimates and assumptions that affect the reported amounts (including assets, liabilities, revenues and expenses) and related
disclosures, including contingent assets and liabilities. Estimates have been prepared on the basis of the most current and best
available information. However, actual results could differ materially from those estimates.
Cash
and Cash Equivalents
Cash
and cash equivalents includes cash on hand and money market funds. The Company considers all highly liquid investments with a
maturity at the date of purchase of three months or less to be cash equivalents. Money market funds were $961,193 and $1,300,815
at March 31, 2018 and December 31, 2017, respectively.
Intangible
Assets
Intangible
assets acquired individually or with a group of other assets from others (other than in a business combination) are recognized
at cost, including transaction costs, and allocated to the individual assets acquired based on relative fair values and no goodwill
is recognized. Cost is measured based on cash consideration paid. If consideration given is in the form of non-cash assets, liabilities
incurred, or equity interests issued, measurement of cost is based on either the fair value of the consideration given or the
fair value of the assets (or net assets) acquired, whichever is more clearly evident and more reliably measurable. Costs of internally
developing, maintaining or restoring intangible assets that are not specifically identifiable, have indeterminate lives or are
inherent in a continuing business are expensed as incurred.
Intangible
assets purchased from others for use in research and development activities and that have alternative future uses (in research
and development projects or otherwise) are capitalized in accordance with ASC Topic 350, Intangibles – Goodwill and Other
and those that have no alternative future uses (in research and development projects or otherwise) and therefore no separate economic
value are research and development costs expensed as incurred. Amortization of intangibles used in research and development activities
is a research and development cost.
Intangibles
with a finite useful life are amortized and those with an indefinite useful life are not amortized. The useful life is the best
estimate of the period over which the asset is expected to contribute directly or indirectly to the future cash flows of the Company.
The useful life is based on the duration of the expected use of the asset by the Company and the legal, regulatory or contractual
provisions that constrain the useful life and future cash flows of the asset, including regulatory acceptance and approval, obsolescence,
demand, competition and other economic factors. If an income approach is used to measure the fair value of an intangible asset,
the Company considers the period of expected cash flows used to measure the fair value of the intangible asset, adjusted as appropriate
for Company-specific factors discussed above, to determine the useful life for amortization purposes. If no regulatory, contractual,
competitive, economic or other factors limit the useful life of the intangible to the Company, the useful life is considered indefinite.
Intangibles
with a finite useful life are amortized on the straight-line method unless the pattern in which the economic benefits of the intangible
asset are consumed or used up are reliably determinable. The Company evaluates the remaining useful life of intangible assets
each reporting period to determine whether any revision to the remaining useful life is required. If the remaining useful life
is changed, the remaining carrying amount of the intangible asset will be amortized prospectively over the revised remaining useful
life.
Intangibles
with an indefinite useful life are not amortized until its useful life is determined to be no longer indefinite. If the useful
life is determined to be finite, the intangible is tested for impairment and the carrying amount is amortized over the remaining
useful life in accordance with intangibles subject to amortization. Indefinite-lived intangibles are tested for impairment annually
and more frequently if events or circumstances indicate that it is more-likely-than-not that the asset is impaired.
Processa
Pharmaceuticals, Inc.
Notes
to Consolidated Financial Statements
(Unaudited)
Impairment
of Long-Lived Assets and Intangibles Other Than Goodwill
The
Company accounts for the impairment of long-lived assets in accordance with ASC 360, Property, Plant and Equipment and ASC 350,
Intangibles – Goodwill and Other which requires that long-lived assets and certain identifiable intangibles be reviewed
for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to expected future
undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment
to be recognized is measured as the amount by which the carrying amounts of the assets exceed the fair value of the assets based
on the present value of the expected future cash flows associated with the use of the asset. Assets to be disposed of are reported
at the lower of the carrying amount or fair value less costs to sell. Based on management’s evaluation, there was no impairment
loss recorded for the three months ended March 31, 2018 and 2017, respectively.
Fair
Value Measurements and Disclosure
The
Company applies ASC 820, “Fair Value Measurements and Disclosures,” which expands disclosures for assets and liabilities
that are measured and reported at fair value on a recurring basis. Fair value is defined as an exit price, representing the amount
that would be received upon the sale of an asset or payment to transfer a liability in an orderly transaction between market participants.
Fair
value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset
or liability. A three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows:
Level
1 – Quoted market prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has
the ability to access at the measurement date.
Level
2 – Quoted market prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets
or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly. Fair value
determined through the use of models or other valuation methodologies.
Level
3 – Significant unobservable inputs for assets or liabilities that cannot be corroborated by market data. Fair value is
determined by the reporting entity’s own assumptions utilizing the best information available and includes situations where
there is little market activity for the asset or liability.
The
asset’s or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any
input that is significant to the fair value measurement. The Company’s policy is to recognize transfers between levels of
the fair value hierarchy in the period the event or change in circumstances that caused the transfer. There were no transfers
into or out of Level 1, 2, or 3 during the periods presented.
Net
Income (Loss) per Share
The
Company computes basic and diluted earnings per share amounts pursuant to ASC 260-10-45. Basic earnings per share is computed
by dividing net income (loss) available to common shareholders, by the weighted average number of shares of common stock outstanding
during the period, excluding the effects of any potentially dilutive securities. Diluted earnings per share is computed by dividing
net income (loss) available to common shareholders by the diluted weighted average number of shares of common stock during the
period. The diluted weighted average number of common shares outstanding is the basic weighted number of shares adjusted for any
potentially diluted debt or equity and options. The diluted computation does not assume conversion, exercise or contingent exercise
of securities since that would have an anti-dilutive effect on earnings (loss) during the three months ended March 31, 2018 and
2017.
Subsequent
Events
The
Company has evaluated subsequent events and transactions for potential recognition or disclosure through May18, 2018, the date
the financial statements were available to be issued, in accordance with ASC 855-10-50. Refer to Note 9 below for further information.
Processa
Pharmaceuticals, Inc.
Notes
to Consolidated Financial Statements
(Unaudited)
Recent
Accounting Pronouncements
From
time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting
pronouncements. Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards
Update (“ASU”). The Company has implemented all new accounting pronouncements that are in effect and that may impact
its financial statements. It has evaluated recently issued accounting pronouncements and determined that there was no material
impact on its financial position or results of operations.
From
May 2014 through March 31, 2018, the FASB issued several ASUs related to ASU 2014-09, “Revenue from Contracts with Customers
(Topic 606). The new guidance is effective for interim and annual periods beginning after December 15, 2017, although entities
may adopt one year earlier if they choose. The two permitted transition methods under the new standard are the full retrospective
method, in which case the standard would be applied to each prior reporting period presented and the cumulative effect of applying
the standard would be recognized at the earliest period shown, or the modified retrospective method, in which case the cumulative
effect of applying the standard would be recognized at the date of initial application. The Company is currently in the pre-revenue
stages of operations; therefore, we do not currently anticipate there would be any change to timing or method of recognizing revenue.
As such, the adoption of this standard did not have a material impact on our results of operations, financial condition or cash
flows.
In
February 2016 through March 31, 2018, the FASB issued several ASUs related to ASU-2016-02, “Leases (Topic 842).” The
guidance requires that a lessee recognize in the statement of financial position a liability to make lease payments (the lease
liability) and a right of use asset representing its right to use the underlying asset for the lease term. For operating leases:
the right-of-use asset and a lease liability will be initially measured at the present value of the lease payments, in the statement
of financial position; a single lease cost will be recognized, calculated so that the cost of the lease is allocated over the
lease term on a generally straight-line basis; and all cash payments will be classified within operating activities in the statement
of cash flows. The amendments in Topic 842 are effective for the Company beginning January 1, 2019. The Company’s office
lease expires September 30, 2019. Management is currently evaluating the impact of adopting the new guidance on the Company’s
consolidated financial statements.
Note
2 – Intangible Asset
Intangible
assets consist of the capitalized costs of $11,038,929, including transaction costs of $1,782, associated with the exercise of
the option to acquire the exclusive license from CoNCERT related to patent rights and know-how to develop and commercialize compounds
and products for CTP-499 (also known as the Company’s lead product PCS-499) and each metabolite thereof and the related
income tax effects. The capitalized costs include $3,037,147 associated with the initial recognition of an offsetting deferred
tax liability related to the acquired temporary difference for an asset purchased that is not a business combination and has a
tax basis of $1,782 in accordance with ASC 740-10-25-51
Income Taxes
. In accordance with ASC Topic 730,
Research and
Development
, the Company capitalized the costs of acquiring the exclusive license rights to CTP-499 as the exclusive license
rights represent intangible assets to be used in research and development activities that have future alternative uses.
The
negotiation of the modification to the Agreement was finalized in mid-February 2018 and the legal documents were executed and
the option was exercised on March 19, 2018 in exchange for CoNCERT receiving (i) $8 million of common stock of Processa that was
owned by Promet (or 2,090,301 shares representing 6.58% of Promet’s common stock holding or 5.93% of total Processa common
stock issued and outstanding), and (ii) 15% of any sublicense revenue earned by Processa for a period equivalent to the royalty
term (as defined in the Agreement) until the earliest to occur of (a) Processa raising $8 million of gross proceeds; and (b) CoNCERT
can sell its shares of Processa common stock without restrictions pursuant to the terms of the amended Agreement. All other terms
of the Agreement remained unchanged. The license agreement was assigned to and deemed to have been exercised by the Company. As
a result of the transaction, the Company recognized an intangible asset for the fair value of the common stock consideration paid
of $8 million with an offsetting amount in additional paid-in capital resulting from Promet satisfying Processa’s liability
to CoNCERT.
Processa
Pharmaceuticals, Inc.
Notes
to Consolidated Financial Statements
(Unaudited)
The
Company estimated the fair value of the common stock issued based on the market approach and CoNCERT’s requirement to receive
shares valued at $8 million. The market approach was based on the final negotiated number of shares of stock determined on a volume
weighted average price of Processa common stock quoted on the OTCQB (principal market) over a 45 day period preceding the mid-February
2018 finalized negotiation of the modification to the option and license agreement with CoNCERT, an unrelated third party, for
the exclusive license rights to CTP-499 However, Processa has less than 300 shareholders, the volume of shares trading for Processa’s
common stock is not significant and the OTCQB is not a national exchange, therefore the volume weighted average price quotes for
the Processa stock are from markets that are not active and therefore are Level 2 inputs. The total cost recognized for the exclusive
license acquired represents the allocated fair value related to the stock transferred to CoNCERT plus the recognition of the deferred
tax liability related to the acquired temporary difference and the transaction costs incurred to complete the transaction as discussed
above.
Intangible
assets consist of the following:
|
|
March
31, 2018
|
|
|
March
31, 2017
|
|
Gross
intangible assets
|
|
|
|
|
|
|
|
|
Exclusive
license rights to CTP-499
|
|
$
|
11,038,929
|
|
|
$
|
-
|
|
Less:
Accumulated amortization
|
|
|
(25,435
|
)
|
|
|
-
|
|
Total
intangible assets, net
|
|
$
|
11,013,494
|
|
|
$
|
-
|
|
Amortization
expense was $25,435 and $0 for the three months ended March 31, 2018 and 2017, respectively. The weighted average amortization
period for the intangible asset is 14 years based on the average remaining patent lives for CTP-499 and the estimated royalty
period for a fully paid-up license under the terms of the license agreement. Amortization expense is included within research
and development expense in the accompanying consolidated statements of operations. As of March 31, 2018, the estimated future
amortization expense each year for the next five years and annual periods thereafter until fully amortized amounts to $788,495
per year.
Note
3 – Senior Convertible Notes
As
of October 4, 2017, certain entities affiliated with current shareholders had purchased $1.25 million of our senior secured convertible
notes (“Senior Notes”) in a bridge financing undertaken by us to support the Processa operations. On November 21,
2017, additional third party accredited investors contributed $1.33 million in financing proceeds. As of March 31, 2018, $2.58
million of Senior Notes were issued and outstanding.
Principal
and interest under each Senior Note is due on the earlier of (i) the mandatory and automatic conversion of the Senior Note into
the next Private Investment in Public Equity (“PIPE”) financing we undertake, provided the PIPE financing yields minimum
gross proceeds and a pre-money valuation as defined in the financing agreement or (ii) the one-year anniversary of that Senior
Note (Maturity Date). The Senior Notes bear interest at 8% per year and are payable in kind (in common stock). At the Maturity
Date, the outstanding principal and accrued interest on the Senior Note will be automatically converted into shares of common
stock of the Company equal to the lesser of (i) a pre-money valuation or (ii) any adjusted price resulting from the application
of down round pricing during the anti-dilution period through December 31, 2018 as defined in the financing agreement. There can
be no assurance that we will be successful in achieving the financing levels targeted under the Senior Convertible Notes or the
PIPE financing.
Holders
of Senior Notes (a) may elect to receive 110% of principal plus accrued interest in the event there is a change of control prior
to conversation of the Senior Notes, (b) are entitled to full ratchet anti-dilution protection in event of any sale of securities
at a net consideration per share that is less than the applicable conversion price per share to the holder, (c) are entitled to
certain registration rights for the securities underlying the Senior Notes and (d) have been granted certain preemptive rights
pro rata to their respective interests through December 31, 2018. The Senior Notes can be prepaid by the Company at any time following
the date of issuance with seven days prior written notice to the note holder.
Processa
Pharmaceuticals, Inc.
Notes
to Consolidated Financial Statements
(Unaudited)
The
Senior Notes are secured by a security interest in the assets of the Company and contain negative covenants that do not permit
the Company to incur additional indebtedness or liens on property or assets owned, repurchase common stock, pay dividends, or
enter into any transaction with affiliates of the Company that would require disclosure in a public filing with the Securities
and Exchange Commission. Upon an event of default, the outstanding principal amount of the Senior Notes, plus accrued but unpaid
interest and other amounts owing in respect thereof through the date of acceleration, shall become immediately due and payable
in cash at the holder’s election, if not cured within the cure period.
The
Company retained Boustead Securities Ltd. (“Boustead”), a registered broker-dealer, as its exclusive financial adviser
and has agreed to pay Boustead (i) six percent (6%) of gross proceeds received by the Company and (ii) warrants to purchase securities
in the amount of three percent (3%) of the equity issued or issuable in connection with the Senior Notes bridge financing. These
warrants will be issued upon achieving certain financing levels under the next PIPE financing we undertake. No additional funds
have been raised since the November 21, 2017 financing proceeds. As a result, no warrants are issuable, and none have been issued
as of March 31, 2018.
The
Company incurred $154,800 in debt issuance costs on the Senior Notes with Boustead, which were reported as a reduction of the
carrying amount of the Senior Convertible Notes on the face of the consolidated balance sheets. The debt issuance costs are amortized
to interest expense using the interest method over the term of the Senior Convertible Notes. The effective interest rate on the
Senior Notes was 7.72%before debt issuance costs since no payments of interest are due until maturity and 13.96%including the
debt issuance costs based on the repayment terms of the Senior Notes.
Debt
and accrued interest at March 31, 2018 and interest expense for the three months ended March 31, 2018 are as follows:
|
|
|
|
|
Unamortized
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior
|
|
|
Debt
|
|
|
Senior
|
|
|
|
|
|
|
|
|
|
Convertible
|
|
|
Issuance
|
|
|
Convertible
|
|
|
Accrued
|
|
|
Interest
|
|
|
|
Notes
|
|
|
Costs
|
|
|
Notes,
Net
|
|
|
Interest
|
|
|
Expense
|
|
Balance,
December 31, 2017
|
|
$
|
2,580,000
|
|
|
$
|
(131,430
|
)
|
|
$
|
2,448,570
|
|
|
$
|
35,693
|
|
|
$
|
59,063
|
|
Accrued
interest
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
51,600
|
|
|
|
51,600
|
|
Amortize
debt issuance costs
|
|
|
-
|
|
|
|
36,140
|
|
|
|
36,140
|
|
|
|
-
|
|
|
|
36,140
|
|
Balance,
March 31, 2018
|
|
|
2,580,000
|
|
|
|
(95,290
|
)
|
|
|
2,484,710
|
|
|
|
87,293
|
|
|
$
|
87,740
|
|
Current
portion
|
|
|
(2,580,000
|
)
|
|
|
95,290
|
|
|
|
(2,484,710
|
)
|
|
|
(87,293
|
)
|
|
|
|
|
Long-term
portion
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
Note
4 – Stockholders’ Equity
On
March 19, 2018, Promet, Processa and CoNCERT amended the Agreement executed in October 2017. The Agreement was assigned to Processa
and Processa exercised the exclusive option for the CTP-499 compound (see Note 1 – Company Overview and Note 2 – Intangible
Asset) in exchange for CoNCERT receiving, in part, $8 million of common stock of the Company that was owned directly by Promet
(or 2,090,301 shares at $3.83 per share representing 6.58% of Promet’s common stock holding or 5.93% of total the Company’s
common stock issued and outstanding) in satisfaction of the obligation due for the exclusive license for CTP-499 acquired by Processa.
There was no change in the total shares issued and outstanding of 35,272,626, however, Promet’s controlling interest was
reduced from 90% to 84%. Promet contributed the payment of the obligation due for the exclusive license to the Company without
consideration paid to them. As a result of the transaction, the Company recognized an exclusive license intangible asset with
a fair value of $8 million and an offsetting increase in additional paid-in capital resulting from Promet satisfying Processa’s
liability to CoNCERT.
There
were no changes in or issuances of preferred stock, stock options or warrants from December 31, 2017.
Processa
Pharmaceuticals, Inc.
Notes
to Consolidated Financial Statements
(Unaudited)
Note
5 – Income Taxes
The
Company accounts for income taxes in accordance with ASC Topic 740,
Income Taxes.
Deferred income taxes are recorded for
the expected tax consequences of temporary differences between the tax basis of assets and liabilities for financial reporting
purposes and amounts recognized for income tax purposes. The Company records a valuation allowance to reduce the Company’s
deferred tax assets to the amount of future tax benefit that is more likely than not to be realized.
As
required under ASC 740-270,
Interim Financial Reporting
, the Company has estimated its annual effective tax rate for the
full fiscal year and applied that rate to its year-to-date consolidated pre-tax ordinary loss before income taxes in determining
its benefit for income taxes. The Company recorded a benefit for income taxes of approximately $282,000 and $0 for the three-month
period ended March 31, 2018 and 2017, respectively.
As
of March 31, 2018, and December 31, 2017, the Company maintained a valuation allowance equal to the full recorded amount of the
Company’s net deferred tax assets related to intangible start-up costs since it is more likely than not that such benefits
will not be realized. The valuation allowance is reviewed quarterly and is maintained until sufficient positive evidence exists
to support its reversal.
A
deferred tax liability was recorded when CoNCERT sold its license and “Know-How” to Processa for stock in an Internal
Revenue Code Section 351 transaction on March 19, 2018 (see Note 1 – Company Overview and Note 2 – Intangible Asset).
A Section 351 transaction treats the acquisition of the license and Know-How for stock as a tax-free exchange. As a result, under
ASC 740-10-25-51
Income Taxes
, Processa recorded a deferred tax liability of $3,037,147 for the acquired temporary difference
between the financial reporting basis of approximately $11,038,929 and the tax basis of approximately $1,782. The deferred tax
liability may be offset by the deferred tax assets resulting from 2017 and 2018 taxable net operating losses. Thus, a partial
release of valuation allowance occurred in Q1 2018 as it relates to the NOL. There remains a valuation allowance on intangible
start-up costs. Under ACS 740-270
Income Taxes – Interim Reporting
, the Company is required to project its 2018 federal
and state effective income tax rate and apply it to the March 31, 2018 operating loss before income taxes. Based on the projection,
the Company expects to recognize the tax benefit from the 2017 net operating loss carryover and the projected 2018 taxable loss,
which resulted in the recognition of a deferred tax benefit shown in the consolidated statements of operations for 2018.
As
discussed in Note 2 – Income Taxes in the consolidated financial statements included in Item 8 of the 2017 Form 10-K filed
with the SEC on April 17, 2018, the historical information presented in the consolidated financial statements prior to October
4, 2017 is that of Promet in accordance with Accounting Standards Codification (“ASC”) 805-40-45,
Business Combinations
– Reverse Acquisitions
. Prior to the closing of the asset purchase transaction on October 4, 2017, Promet was treated
as a partnership for federal income tax purposes and thus was not subject to income tax at the entity level. Therefore, no provision
or liability for income taxes has been included in these consolidated financial statements through the date of the asset purchase
on October 4, 2017.
The
Company expects to be in an overall taxable loss position for 2018. However, the Company expects to recognize a deferred tax benefit
in 2018 to the extent the 2017 net operating loss carryover and the 2018 net operating losses can be used to offset the deferred
tax liability related to the intangible asset. No current income tax expense is expected for the foreseeable future as the Company
expects to generate taxable net operating losses.
Note
6 – Net Loss per Share of Common Stock
The
Company has preferred stock authorized but no preferred stock issued and outstanding at March 31, 2018 and 2017. There were no
outstanding options or warrants issued at March 31, 2018 and 2017.
The
Company has reported a loss from continuing operations and a loss from continuing operations available to common stockholders
for all periods presented. As a result, there is no assumed conversion, exercise or contingent exercise of potential common shares
included in the computation of the diluted per share amounts since it would have an antidilutive effect, therefore, basic and
diluted loss per share are computed by dividing net loss applicable to common stockholders by the weighted-average number of shares
of common stock outstanding.
The
weighted-average shares of common stock used in calculating basic and diluted loss per share for the 2018 calculation uses the
total shares issued and outstanding of 35,272,626. There has been no change in total shares issued and outstanding since December
31, 2017. The weighted-average shares of common stock used in calculating basic and diluted loss per share for the 2017 calculation
uses the 31,745,242 shares issued to Promet in the asset purchase transaction for the period from January 1, 2017 through the
acquisition date of October 4, 2017 in accordance with ASC 805-40-45,
Business Combinations – Reverse Acquisitions
.
All shares were restated for the one-for-seven reverse split.
The
calculation of the numerator and denominator for basic and diluted net loss per common share is shown in the following table.
|
|
For the three months ended
|
|
|
|
March 31,
|
|
|
|
2018
|
|
|
2017
|
|
|
|
|
|
|
|
|
Net loss from continuing operations applicable to common stockholders - basic and diluted
|
|
$
|
(1,096,798
|
)
|
|
$
|
(232,442
|
)
|
|
|
|
|
|
|
|
|
|
Total common shares issued and outstanding
|
|
|
35,272,626
|
|
|
|
31,745,242
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding used in calculating net loss per common share - basic and diluted
|
|
|
35,272,626
|
|
|
|
31,745,242
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share - basic and diluted
|
|
$
|
(0.03
|
)
|
|
$
|
(0.01
|
)
|
Note
7 – Related Party Transactions
A
shareholder, Corlyst, LLC, reimburses the Company for shared costs related to payroll, health care insurance and rent based on
actual costs incurred and recognized as a reduction of the general and administrative operating expenses being reimbursed in the
Company’s consolidated statements of operations. The reimbursed amounts totaled $26,684 and $29,430 for the three months
ended March 31, 2018 and 2017, respectively. The receivable balances due from Corlyst at March 31, 2018 and December 31, 2017
were $26,684 and $62,709, respectively.
During
2016 and 2017, Corlyst paid certain operating expenses on behalf of the Company and the Company reimbursed Corlyst based on actual
costs incurred at later dates. The accounts payable amounts due to Corlyst at March 31, 2018 and December 31, 2017 were $336 and
$336, respectively. In addition, there was $100 due to an officer included in due to related parties as of March 31, 2018 and
December 31, 2017.
A
director of the Company is the manager of the JMW Fund, LLC, the San Gabriel Fund, LLC, and the Richland Fund, LLC, collectively
known as the “Funds”. In addition, the Funds own $1 million in Senior Convertible Notes at March 31, 2018 and December
31, 2017.
Entities
affiliated with the Chairman of the Board of Directors, Chief Executive Officer and Interim Chief Financial Officer of the Company
own $250,000 in Senior Convertible Notes at March 31, 2018 and December 31, 2017.
Note
8 – Commitments and Contingencies
Purchase
Obligations
The
Company enters into contracts in the normal course of business with contract research organizations and subcontractors to further
develop its products. The contracts are cancellable, with varying provisions regarding termination. If a contract with a specific
vendor were to be terminated, the Company would only be obligated for products or services that it received as of the effective
date of the termination and any applicable cancellation fees. The Company had purchase obligations of approximately $1,006,000
and $896,000 at March 31, 2018 and December 31, 2017, respectively.
Processa
Pharmaceuticals, Inc.
Notes
to Consolidated Financial Statements
(Unaudited)
Cybersecurity
Fraud
In
January 2018, the Company incurred a loss of $144,200 due to fraud from a cybersecurity breach. As a result, we have implemented
certain review and approval procedures internally and with our banks; our technology consultants have implemented system changes;
and, we reported the fraud to our banks and the Federal Bureau of Investigation Cyber Crimes Unit. The Company does not have insurance
coverage against the type of fraud that occurred, therefore, recovery of the loss is remote. While we are taking steps to prevent
such an event from reoccurring, we cannot provide assurance that similar issues will not reoccur. Failure of our control systems
to prevent or detect and correct errors or fraud could have a material and adverse effect on our financial condition. The loss
is included in general and administrative expenses in the consolidated statement of operations for the three months ended March
31, 2018.
Note
9 – Subsequent Events
On
May 15, 2018 Processa Pharmaceuticals (the “Company”) entered into Subscription and Purchase Agreements (the “Purchase
Agreements”) with certain accredited investors and conducted a closing pursuant to which the Company sold 1,112,656 shares
of the Company’s Common Stock, par value $0.001 per share (the “Common Stock”), at a purchase price of $2.27
per share. In addition, each investor received a warrant to purchase one share of Common Stock for each Common Stock purchased
by such investor at an exercise price equal to $2.724, subject to adjustment thereunder. The closing is the initial closing (the
“Initial Closing”) of the Company’s previously announced private placement (the “Private Placement”)
of up to $8 million of Common Stock (the Maximum Offering Amount”).
The
Company received total gross proceeds of approximately $2.5 million from the Initial Closing, prior to deducting placement agent
fees and estimated expenses payable by the Company associated with the Initial Closing. The Company currently intends to use the
proceeds of the Private Placement to fund research and development of its lead product candidate, PCS-499, including clinical
trial activities, and for general corporate purposes. Pursuant to the Purchase Agreements, the Company may periodically conduct
additional closings until the earlier of June 29, 2018 or the Company has sold the Maximum Offering Amount.
The
Securities were sold in a private placement pursuant to exemptions from the registration requirements of the Securities Act of
1933, as amended (the “Securities Act”), afforded by Rule 506 of Regulation D promulgated thereunder.
Boustead
Securities acted as placement agent The placement agent received approximately $128,056 in connection with the Initial Closing
and a Placement Agent Warrant to purchase up to 33,380 shares of Common Stock at an exercise price equal to $2.724.
Anti-Dilution
Protection
The
Common Stock, but not the Warrants, will have full ratchet anti-dilution protection rather than weighted-average anti-dilution
protection. Except as provided, until the Company has issued equity securities or securities convertible into equity securities
for a total of an additional $20.0 million in cash or assets, including the proceeds from the exercise of the Warrants issued
in the Offering, in the event the Company issues additional equity securities or securities convertible into equity securities
at a purchase price less than $2.27 per share of Common Stock, the Purchase Price shall be adjusted and new shares of Common Stock
issued as if the Purchase Price was such lower amount (or, if such additional securities are issued without consideration, to
a price equal to $0.01 per share).
The
following issuances shall not trigger anti-dilution adjustment: (i) shares of Common Stock issued in the Private Placement and
securities issuable upon exercise of the Warrants; (ii) securities issued upon the conversion of any outstanding debenture, warrant,
option, or other convertible security; (iii) Common Stock issuable upon a stock split, stock dividend, or any subdivision of shares
of Common Stock, provided that such securities have not been amended since the date of the Agreement to increase the number of
such securities or to decrease the exercise price, exchange price or conversation price of such securities (other than in connection
with stock splits or combinations) or to extend the term of such securities; (iv) shares of Common Stock (or options to purchase
such shares of Common Stock) issued or issuable to employees or directors of, or consultants to, the Company pursuant to any plan
approved by the Company’s Board of Directors and (v) securities issued pursuant to acquisitions or strategic transactions
approved by a majority of the disinterested directors of the Company, provided that such issuance shall only be to a person (or
to the equity holders of a person) which is, itself or through its subsidiaries, believed by the Company to be an operating company
or an owner of an asset in a business synergistic with the business of the Company.