Item 1. Financial Statements
Item 1. Financial Statements
Fennec Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets
(U.S. Dollars and shares in thousands)
March 31, 2021
December 31,
(unaudited)
2020
Assets
Current assets:
Cash and cash equivalents
$ 26,751
$ 30,344
Prepaid expenses
619
797
Other current assets
455
276
Total current assets
27,825
31,417
Total assets
$ 27,825
$ 31,417
Liabilities and stockholders' equity
Current liabilities:
Accounts payable
$ 2,508
$ 1,571
Accrued liabilities
384
776
Total current liabilities
2,892
2,347
Commitments and
Contingencies (Note 6)
Stockholders' equity:
Common stock, no par value; unlimited shares authorized;
26,003 shares issued and outstanding (2020-26,003)
140,733
140,733
Additional paid-in capital
49,830
49,234
Accumulated deficit
(166,873 )
(162,140 )
Accumulated other comprehensive income
1,243
1,243
Total stockholders’ equity
24,933
29,070
Total liabilities and stockholders’ equity
$ 27,825
$ 31,417
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
3
Fennec
Pharmaceuticals Inc.
Condensed Consolidated Statements of Operations
(U.S. Dollars and shares in thousands, except
per share amounts)
(Unaudited)
Three Months Ended
March 31,
March 31,
2021
2020
Revenue
$ -
$ -
Operating expenses:
Research and development
2,416
1,393
General and administrative
2,507
2,442
Total operating expenses
4,923
3,835
Loss from operations
(4,923 )
(3,835 )
Other (expense) income:
Unrealized gain on securities
182
-
Other (loss)
(8 )
(9 )
Amortization expense
-
(17 )
Interest income
16
35
Total other income, net
190
9
Net loss
$ (4,733 )
$ (3,826 )
Basic net loss per common share
$ (0.18 )
$ (0.19 )
Diluted net loss per common share
$ (0.18 )
$ (0.19 )
Weighted-average number of common shares outstanding, basic
26,003
19,896
Weighted-average number of common
shares outstanding, diluted
26,003
19,896
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
4
Fennec Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(U.S. Dollars in thousands)
(Unaudited)
Three Months Ended
March 31,
March 31,
2021
2020
Cash flows used in:
Operating activities:
Net loss
$ (4,733 )
$ (3,826 )
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of deferred issuance cost
-
17
Unrealized gain on securities
(182 )
-
Stock-based compensation - employees
587
391
Stock-based compensation - contractors
9
21
Changes in operating assets and liabilities:
Prepaid assets
178
6
Other current assets
3
6
Accounts payable
937
63
Accrued liabilities
(392 )
(427 )
Net cash used in operating activities
(3,593 )
(3,749 )
Decrease in cash and cash equivalents
(3,593 )
(3,749 )
Cash and cash equivalents - Beginning of period
30,344
13,650
Cash and cash equivalents - End of period
$ 26,751
$ 9,901
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
5
Fennec Pharmaceuticals Inc.
Condensed Consolidated Statements of Stockholders'
Equity
Three Months Ended March 31, 2021 and 2020
(U.S. dollars and shares in thousands)
(Unaudited)
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Accumulated
Comprehensive
Stockholders'
Number
(Note
4)
Amount
Capital
Deficit
Income
Equity
Balance at December 31, 2020
26,003
$ 140,733
$ 49,234
$ (162,140 )
$ 1,243
$ 29,070
Stock options issued to employees
-
-
587
-
-
587
Stock options issued to contractors
-
-
9
-
-
9
Net loss
-
-
-
(4,733 )
-
(4,733 )
Balance at March 31, 2021
26,003
$ 140,733
$ 49,830
$ (166,873 )
$ 1,243
$ 24,933
Balance at December 31, 2019
19,896
$ 106,392
$ 48,271
$ (144,031 )
$ 1,243
$ 11,875
Stock options issued to employees
-
-
391
-
-
391
Stock options issued to contractors
-
-
21
-
-
21
Net loss
-
-
-
(3,826 )
-
(3,826 )
Balance at March 31, 2020
19,896
$ 106,392
$ 48,683
$ (147,857 )
$ 1,243
$ 8,461
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
6
Fennec Pharmaceuticals Inc.
Notes to the Unaudited Interim Condensed Consolidated
Financial Statements
(U.S. dollars and shares in thousands, except
per share information)
1. Nature of Business and Going Concern
Fennec Pharmaceuticals Inc., a British Columbia
corporation (“Fennec,” the “Company,” “we,” “us,” or “our”), is a biopharmaceutical
company focused on the development of PEDMARK TM (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced
ototoxicity in pediatric cancer patients. We have four wholly-owned subsidiaries: Oxiquant, Inc. and Fennec Pharmaceuticals, Inc.,
both Delaware corporations, Cadherin Biomedical Inc., a Canadian company, and Fennec Pharmaceuticals (EU) Limited (“Fennec Limited”),
an Ireland company. With the exception of Fennec Pharmaceuticals, Inc., all subsidiaries are inactive.
These unaudited interim condensed consolidated
financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US
GAAP”) that are applicable to a going concern which contemplates that the Company will continue in operation for the foreseeable
future and will be able to realize its assets and discharge its liabilities in the normal course of business.
During the three months ended March 31, 2021,
the Company incurred a loss from operations of $4,923. At March 31, 2021, the Company had an accumulated deficit of $166,900 million and
had experienced negative cash flows from operating activities during the three months ended March 31, 2021 in the amount of $3,593.
On May 5, 2020, the Company announced the completion
of an underwritten public offering of 4,800,000 common shares at a public offering price of $6.25 per share. In addition, Fennec issued
an additional 660,204 common shares in connection with the partial exercise of the underwriters’ over-allotment option. The approximate
total gross proceeds from the offering were $34,100 ($32,189 net of commissions, fees and issue costs).
On February 1, 2019, the Company’s wholly
owned subsidiary Fennec Pharmaceuticals, Inc. entered into a Loan and Security Agreement (the “Loan and Security Agreement”)
with Bridge Bank, a division of Western Alliance Bank, an Arizona corporation (“Bridge Bank”), pursuant to which Bridge Bank
agreed to loan $12,500 to Fennec Pharmaceuticals, Inc., to be made available upon New Drug Application (“NDA”) approval of
PEDMARK TM by the U.S. Food and Drug Administration (“FDA”) no later than September 30, 2020. The Loan and Security
Agreement was amended on June 26, 2020 to increase the total potential amount of the loan to $18,000 and to extend the outside date to
receive NDA approval of PEDMARK TM to December 31, 2020. In connection with this facility, the Company issued Bridge Bank a
warrant to purchase up to 39,000 of the Company’s common shares at an exercise price of $6.80 per share, with an exercise period
of ten years from the date of issuance subject to certain early termination conditions .
Under Accounting Standards Codification ("ASC") 470-50, Modifications and Extinguishments, the amendment to the facility was
considered a modification. As such, the Company had been amortizing the loan fee and the value of the warrant over the remainder of the
loan term. Following receipt of the FDA’s Complete Response Letter (“CRL”) in August 2020, which identified deficiencies
in the third-party manufacturing facility that manufactures PEDMARK TM on the Company’s
behalf, the Company decided to fully amortize the remaining portions of the loan fee and the value of the warrants. The Loan and Security
Agreement expired on December 31, 2020 as a result of the Company not obtaining NDA approval of PEDMARK TM by that date, with
no amounts advanced under the facility prior to its termination. The warrant issued to Bridge Bank remains outstanding notwithstanding
termination of the facility.
The Company believes the funds raised in its May 2020
public offering provide sufficient funding for the Company to carry out its planned activities, including NDA resubmission and, if approved,
the commencement of commercialization efforts, for at least the next twelve months as it continues its strategic development of PEDMARK TM .
These financial statements do not reflect the
potentially material adjustments in the carrying values of assets and liabilities, the reported expenses, and the balance sheet classifications
used, that would be necessary if the going concern assumption were not appropriate.
7
Fennec Pharmaceuticals
Inc.
Notes to the Unaudited Interim Condensed Consolidated
Financial Statements
(U.S. dollars and shares in thousands, except
per share information)
2. Significant Accounting Policies
Basis of presentation
The accompanying unaudited interim condensed consolidated
financial statements have been prepared in accordance with US GAAP and are the responsibility of the Company’s management. These
unaudited interim condensed consolidated financial statements do not include all of the information and notes required by US GAAP for
annual financial statements. Accordingly, these unaudited interim condensed consolidated financial statements should be read in conjunction
with the Company's audited consolidated financial statements and notes filed with the Securities and Exchange Commission (“SEC”)
in the Company's Annual Report on Form 10-K for the year ended December 31, 2020. The Company's accounting policies are consistent with
those presented in the audited consolidated financial statements included in the Annual Report on Form 10-K for the year ended December
31, 2020. These unaudited interim condensed consolidated financial statements have been prepared in U.S. dollars. All amounts presented
are in thousands except for per share amounts.
Use of estimates
The preparation of financial statements in conformity
with US GAAP requires management to make estimates and assumptions that impact the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities as of the date of the interim condensed consolidated financial statements and the reported amounts
of expense during the reporting period. Actual results could differ from those estimates.
In the opinion of management, these unaudited
interim condensed consolidated financial statements include all adjustments, which are normal and recurring in nature, necessary for the
fair presentation of the Company’s financial position at March 31, 2021 and to state fairly the results for the periods presented.
The most significant estimates utilized during the quarter ended March 31, 2021 included estimates necessary to value grants of stock
options to employees and various contractors, disclosed in Note 4.
New accounting pronouncements
In January 2021, the FASB issued ASU No. 2021-01,
Reference Rate Reform (Topic 848). In this ASU, the FASB refines the scope of Topic 848 to clarify that certain optional expedients and
exceptions therein for contract modifications and hedge accounting apply to contracts that are affected by the discounting transition.
Specifically, modifications related to reference rate reform would not be considered an event that requires reassessment of previous accounting
conclusions. The ASU also amends the expedients and exceptions in Topic 848 to capture the incremental consequences of the scope clarification
and to tailor the existing guidance to derivative instruments affected by the discounting transition. The amendments in the ASU are effective
immediately for all entities. Entities may choose to apply the amendments retrospectively as of any date from the beginning of an interim
period that includes or is subsequent to March 12, 2020, or prospectively to new modifications from any date within an interim period
that includes or is subsequent to January 7, 2021, up to the date that financial statements are available to be issued. The Company
chose to apply amendments prospectively and concluded after evaluation that ASU 2021-01 has no significant effect on our condensed consolidated
financial statements.
Cash and cash equivalents
Cash equivalents consist of highly liquid investments with original
maturities at the date of purchase of three months or less. The Company places its cash and cash equivalents in investments held by highly
rated financial institutions in accordance with its investment policy designed to protect the principal investment. At March 31,
2021, the Company had $26,751 in cash, savings and money market accounts ($30,344 at December 31, 2020). At March 31, 2021, the Company
held $668 in cash of which $34 (as presented in U.S. dollars) was in Canadian dollars ($45 at December 31, 2020 as presented in U.S. dollars). At
March 31, 2021, the Company held $26,083 in money market investments. Money market investments typically have minimal risks. While
the Company has not experienced any loss or write-down of its money market investments, the amounts it holds in money market accounts
are substantially above the $250,000 amount insured by the FDIC and may lose value.
Financial instruments
Financial instruments recognized on the balance
sheets at March 31, 2021 and December 31, 2020 consist of cash and cash equivalents, accounts receivable, accounts payable and
accrued liabilities, the carrying values of which approximate fair value due to their relatively short time to maturity. The Company
does not hold or issue financial instruments for trading.
8
Fennec Pharmaceuticals Inc.
Notes to the Unaudited Interim Condensed Consolidated
Financial Statements
(U.S. dollars and shares in thousands, except
per share information)
The Company’s investment policy is to manage
investments to achieve, in the order of importance, the financial objectives of preservation of principal, liquidity and return on investment. Investments,
when made, are made in U.S. or Canadian bank securities, commercial paper of U.S. or Canadian industrial companies, utilities, financial
institutions and consumer loan companies, and securities of foreign banks provided the obligations are guaranteed or carry ratings appropriate
to the policy. Securities must have a minimum Dun & Bradstreet rating of A for bonds or R1 low for commercial paper.
The policy risks are primarily the opportunity
cost of the conservative nature of the allowable investments. As the main purpose of the Company is research and development, the
Company has chosen to avoid investments of a trading or speculative nature.
Revenue
The Company's revenue is generated
through sales of intellectual property (“IP”). The Company generates its revenue through one segment and the revenue
recognized under each of the Company's arrangements during the current period is described below. The terms of these agreements may contain
multiple promised goods or services or optional goods and services, including licenses to product candidates, referred to as exclusive
licenses, as well as research and development activities to be performed by the Company on behalf of the collaboration partner related
to the licensed product candidates.
Revenue recognition
Revenue is recognized when control
of the promised goods or services are transferred to customers in an amount that reflects the consideration the Company expects to be
entitled to in exchange for transferring those goods or providing services. The Company accounts for a contract when it has approval and
commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance
and collectability of consideration is probable.
When determining whether the customer
has obtained control of the goods or services, the Company considers the point at which the customer may benefit from the goods or services.
For sale of IP to, revenue is recognized upon grant or transfer of the IP, as the Company's IP is considered functional in nature.
Performance obligations
A performance obligation is a
promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC 606. A contract’s
transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation
is satisfied. The Company's contracts may contain multiple performance obligations if a promise to transfer goods or services is separately
identifiable from other promises in a contract and, therefore, is considered distinct. For contracts with multiple performance obligations,
the Company determines the standalone selling price of each performance obligation and allocates the total transaction price using the
relative selling price basis. The Company recognizes performance obligations based on their nature.
Significant payment terms
The Company’s revenue arrangements
include payments to the Company of one or more of the following: a non-refundable, upfront payment; milestone payments and royalties on
commercial sales of IP product candidates, if any. To date, the Company has received upfront payments and several milestone payments but
has not received any license or option fees or earned royalty revenue as a result of product sales.
Under ASC 606, the Company estimates
the amount of consideration to which it will be entitled in exchange for satisfying performance obligations. Based on the Company’s
current contracts, variable consideration primarily exists in the following forms: development and regulatory milestones, royalties and
sales-based milestones. The Company utilizes the "most likely amount" variable consideration method for estimating development
and regulatory milestone consideration to include in the transaction price. The Company only includes an amount of variable consideration
in the transaction price to the extent it is probable that a significant reversal in the cumulative revenue recognized will not occur
when the uncertainty associated with the variable consideration is subsequently resolved. The Company refers to this as the variable consideration
constraint.
9
Fennec Pharmaceuticals Inc.
Notes to the Unaudited Interim Condensed Consolidated
Financial Statements
(U.S. dollars and shares in thousands, except
per share information)
Due
to the uncertainty associated with the occurrence of the underlying events which would trigger development and regulatory milestone consideration
under its revenue arrangements, with the exception of certain initial conditions precedent milestones ,
the Company has concluded the variable consideration associated with all development and regulatory milestones to be fully constrained
as of the ASC 606 transition date and as of March 31, 2021, and therefore has not included such consideration in the transaction
price for any of its revenue arrangements. The Company will reassess this conclusion at each subsequent reporting period and will only
include amounts associated with regulatory or development milestones in the transaction price when, or if, the variable consideration
is determined to be released from the constraint.
In accordance with ASC 606, the
Company is required to adjust the transaction price for the effects of the time value of money if the timing of payments agreed to by
the parties to the contract, explicitly or implicitly, provides the Company or its customer with a significant benefit of financing the
transfer of goods or services. The Company concluded that its licensing and collaboration arrangements do not contain a significant financing
component because the payment structure of its agreements arise from reasons other than providing a significant benefit of financing.
Contract assets
The Company did not have
a contract asset as of March 31, 2021 or December 31, 2020.
Contract liabilities
The Company did not have
a contract liability as of March 31, 2021 or December 31, 2020.
Revenue arrangements
Elion
In May 2016, the Company sold Eniluracil
to Elion Oncology, LLC (“Elion”). The agreement called for $40,000 in cash and 5% royalties to be paid to Fennec for any income
derived from the sale of Eniluracil. The agreement was for the sale, not license of IP. In addition, the agreement did not call for any
additional good or service beyond the transfer of IP and related assets (e.g. “all information and know-how”, documentation, etc.).
In August 2020, Elion entered into a license
agreement with Processa Pharmaceuticals, Inc. (“Processa”). The license agreement called for equity and cash upon satisfying
the Condition Precedent, along with development and regulatory milestone payments, Sales Milestone Payments, and Product Royalties. The
grant of the license was conditioned upon the “Condition Precedent” which was defined as (i) Processa’s closing
of a public offering by October 30, 2020 in which Processa raised at least $15M and (ii) Processa’s shares being listed
on NASDAQ. Upon satisfying the Condition Precedent, which occurred in October 2020, Elion was entitled to receive $100,000 in cash and
825,000 in shares of Processa of which the Company is entitled to 5%. As a result, in January 2021, the Company received $5,000 in
cash and 41,250 restricted shares of Processa common shares.
The agreement between Elion and
Processa entitles Elion to the payments outlined in the table below. Fennec would be eligible to receive 5% of the following based on
future milestone events:
Milestone Event
Milestone Payment ($)
1st Year Anniversary of Effective Date
100,000 Restricted Shares
2nd Year Anniversary of Effective Date
100,000 Restricted Shares
1st Patient in Dose Confirmation Study
100,000 Restricted Shares
NDA Submission
300,000 Restricted Shares
1st FDA Approval in US
$5,000,000
2nd FDA Approval in US
$3,000,000
1st Regulatory Approval Outside US
$2,000,000
2nd Regulatory Approval Outside US
$2,000,000
Since the Condition Precedent was achieved, and
only the passage of time must occur in order for the 1 st and 2 nd Year Anniversary payments to become due, the Company
concluded the 1 st and 2 nd Year Anniversary milestone payments are also probable of coming to fruition and thus were
included in the transaction price during the 4 th quarter of 2020 along with the aforementioned Condition Precedent payments.
10
Fennec Pharmaceuticals Inc.
Notes to the Unaudited Interim Condensed Consolidated
Financial Statements
(U.S. dollars and shares in thousands, except
per share information)
The arrangement with Elion contains
consideration that is variable based on the Processa’s achievement of the above referenced development and regulatory milestones.
The next milestone payment the Company may be entitled to receive is 5,000 restricted shares for 1 st patient in Dose Confirmation
Study and then another 15,000 restricted shares for the NDA submission. These are considered variable consideration that is fully constrained
due to the uncertainty associated with the achievement of the development milestone. The considerations related to royalties (first and
second FDA approval in US and first and second regulatory approval outside of US) are also variable consideration that are fully constrained
in accordance with the royalty recognition constraint. The variable consideration related to royalties will be recognized in the period
the products are sold by Processa and the Company has a present right to payment.
The Company recognized $0.2
million in revenue associated with the aforementioned cash and shares it became entitled to for the year ended December 31,
2020. Due to the one year lockup provision on the Processa shares, the Company deemed it reasonable to apply a liquidity discount of 20%
to the valuation of the shares associated with the achievement of the Condition Precedent. Shares associated with the one- and two-year
anniversary milestones had a 30% and 40% liquidity discount applied to their fair market valuations. Recognizing the passage of time,
the Company adjusted its liquidity discount to the original shares of 15% and then 25 and 30% for the one- and two-year anniversary tranches.
Subsequent changes to the fair
value of the underlying securities are recognized as unrealized gains or losses on marketable equity securities within the consolidated
statement of operations and comprehensive loss. During the quarter ended March 31, 2021, the Company reported $182 in unrealized gain
on the fair value of the underlying Processa shares.
3. Loss per Share
Earnings per common share is presented under two
formats: basic earnings per common share and diluted earnings per common share. Basic earnings per common share is computed by dividing
net income attributable to common shareholders by the weighted average number of common shares outstanding during the period. Diluted
earnings per common share is computed by dividing net income by the weighted average number of common shares outstanding during the period,
plus the potentially dilutive impact of common stock equivalents (i.e. stock options and warrants). Dilutive common share equivalents
consist of the incremental common shares issuable upon exercise of stock options and warrants. The following table sets forth the computation
of basic and diluted net loss per share:
Three Months Ended March 31,
2021
2020
Numerator:
Net (loss)
$ (4,733 )
$ (3,826 )
Denominator:
Weighted-average common shares, basic
26,003
19,896
Dilutive effect of stock options
-
-
Dilutive effect of warrants
-
-
Incremental dilutive shares
-
-
Weighted-average common shares, dilutive
26,003
19,896
Net (loss) per share, basic and diluted
$ (0.18 )
$ (0.19 )
The following outstanding options and warrants
were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have
had an anti-dilutive effect:
Three Months Ended March 31,
2021
2020
Options to purchase common stock
2,952
3,088
Warrants to purchase common stock
39
39
11
Fennec Pharmaceuticals Inc.
Notes to the Unaudited Interim Condensed Consolidated
Financial Statements
(U.S. dollars and shares in thousands, except
per share information)
4. Stockholders'
Equity
Authorized capital stock
The Company’s authorized capital stock consists
of an unlimited number of common shares, no par value per share.
Warrants
to Purchase Common Stock
During the three months ended March 31, 2021 and
2020, there were no warrants issued or exercised. Outstanding warrants have a weighted average life of 7.85 years on March 31, 2021. The
following tables detail the Company’s warrant activity for the three months ended March 31, 2021 and 2020, respectively:
Investor Warrants
Common Shares Issuable Upon Exercise of Outstanding Warrants
Weighted-Average Exercise Price $USD
Outstanding December 31, 2020
39
6.80
Issued
-
-
Outstanding March 31, 2021
39
6.80
Total
39
6.80
Investor Warrants
Common Shares Issuable Upon Exercise of Outstanding Warrants
Weighted-Average Exercise Price $USD
Outstanding December 31, 2019
39
6.80
Issued
-
-
Outstanding March 31, 2020
39
6.80
Total
39
6.80
Stock option plan
Equity Incentive Plan
The Compensation Committee of the Board of Directors
administers the Company’s equity incentive plan (the “Plan”). The Compensation Committee designates eligible participants
to be included under the Plan and approves the number of options to be granted from time to time under the Plan. Currently, the maximum
number of option shares issuable under the Plan, together with the Company’s prior stock option plan, is twenty-five percent (25%)
of the total number of issued and outstanding common shares. Based upon the current shares outstanding, a maximum of 6,501 shares
of common stock are authorized for issuance pursuant to stock options or other equity awards granted under the Plan. For all options
issued under the Plan, the exercise price is the fair value of the underlying shares on the date of grant. All options vest within
three years or less and are exercisable for a period of ten years from the date of grant. The Plan allows the issuance of Canadian
and U.S. dollar grants. The table below outlines recognized contractor and employee expense from option awards for the three month
periods ended March 31, 2021 and 2020.
Three Months Ended March 31,
2021
2020
Contractor options expense recognized
$ 9
$ 21
Employee options expense recognized
587
391
Total option expense recognized
$ 596
$ 412
Stock option activity
The following is a summary of option activity
for the three months ended March 31, 2021 and 2020 for stock options denominated in U.S. and Canadian dollars. As of August 2020, there
were no Canadian denominated options outstanding.
Number of
Weighted-Average
US Denominated Options
Options (thousands)
Exercise Price $USD
Outstanding December 31, 2020
2,952
$
4.82
Granted
-
-
Exercised
-
-
Outstanding at March 31, 2021
2,952
$
4.82
12
Fennec Pharmaceuticals Inc.
Notes to the Unaudited Interim Condensed Consolidated
Financial Statements
(U.S. dollars and shares in thousands, except
per share information)
Number of
Weighted-Average Exercise
US Denominated Options
Options (thousands)
Price $USD and $CAD
Outstanding December 31, 2019
3,088
$
3.59
(1)
Granted
-
-
Exercised
-
-
Outstanding at March 31, 2020
3,088
$
3.56
(2)
1. Figure represents 2,440 US denominated with a weighted average price of $4.05, and 648 $CAD denominated
options with a weighted average price of $1.87 translated at $CAD/$USD 0.768174.
2.
Figure represents 2,440 US denominated with a weighted average price of $4.05, and 648 $CAD denominated options with a weighted
average price of $1.72 translated at $CAD/$USD 0.70978.
During the three month periods ended March 31,
2021 and 2020, there was no US denominated option activity. Of the 2,952 options granted and outstanding at March 31, 2021, 2,154 are
fully vested and exercisable.
5.
Fair Value Measurements
The Company has adopted ASC 820 the Fair Value
Measurements and Disclosure Topic of the FASB. This Topic applies to certain assets and liabilities that are being measured and reported
on a fair value basis. The Fair value Measurements Topic defines fair value, establishes a framework for measuring fair value in accordance
with US GAAP, and expands disclosure about fair value measurements. This Topic enables the reader of the financial statements to assess
the inputs used to develop those measurements by establishing a hierarchy for ranking the quality and reliability of the information used
to determine fair values. The Topic requires that financial assets and liabilities carried at fair value be classified and disclosed in
one of the following three categories:
Level 1: Quoted market prices in active markets
for identical assets or liabilities.
Level 2: Observable market-based inputs or unobservable
inputs that are corroborated by market data.
Level 3: Unobservable inputs that are not corroborated
by market data.
Quoted Price in Active
Market for Identical
Instruments
Significant Other Observable Inputs
Significant
Unobservable Inputs
Level 1
Level 2
Level 3
Total
2021
2020
2021
2020
2021
2020
2021
2020
Assets
Cash and cash equivalents
$
668 (1)
$
678 (1)
$
26,083
$
29,666
$
-
$
-
$
26,751
$
30,344
Processa common shares
-
-
182 (2)
-
-
182
-
(1)
The Company held approximately, $668 in cash as of March 31, 2021, of which approximately, $34 was in Canadian funds (translated into U.S. dollars). As of December 31, 2020, the Company held approximately $347 of which approximately $45 was in Canadian funds (translated into U.S. dollars).
(2) The
Company received 41,250 restricted common shares of Processa (PSCA). The share restriction will expire in three tranches: 50%, 25% and
25% at the 6, 9 and 12 month intervals, respectively from October 30, 2020. At October 30, 2020 Processa shares were trading
at $4.11 per share. The Company originally applied a 20%, 30% and 40% liquidity discount to the shares and will mark to market at each
balance sheet date.
13
Fennec Pharmaceuticals Inc.
Notes to the Unaudited Interim Condensed Consolidated
Financial Statements
(U.S. dollars and shares in thousands, except
per share information)
6.
Commitments and Contingencies
Oregon Health & Science University Agreement
On February 20, 2013, Fennec entered into a new
exclusive license agreement with Oregon Health & Science University (“OHSU”) for exclusive worldwide license rights to
intellectual property directed to thiol-based compounds, including PEDMARK TM , and their use in oncology (the "OHSU Agreement"). OHSU
will receive certain milestone payments, royalty on net sales for licensed products and a royalty on any consideration received from sublicensing
of the licensed technology.
On May 18, 2015, Fennec negotiated an amendment
("Amendment 1") to the OHSU Agreement, which expands Fennec’s exclusive license to include the use of N-acetylcysteine
as a standalone therapy and/or in combination with sodium thiosulfate for the prevention of ototoxicity induced by chemotherapeutic agents
to treat cancers. Further, Amendment 1 adjusts select milestone payments entered in the OHSU Agreement including but not limited to the
royalty rate on net sales for licensed products, royalty rate from sublicensing of the licensed technology and the fee payable upon the
regulatory approval of a licensed product.
The term of the OHSU Agreement as amended by Amendment
1 expires on the date of the last to expire claim(s) covered in the patents licensed to Fennec or 8 years, whichever is later. In the
event a licensed product obtains regulatory approval and is covered by the Orphan Drug Designation, the parties will in good faith amend
the term of the agreement. Sodium thiosulfate is currently protected by methods of use patents that the Company exclusively licensed from
OHSU that expire in Europe in 2021 and that expire in the United States in 2038. The OHSU Agreement is terminable by either Fennec or
OHSU in the event of a material breach of the agreement by either party after 45 days prior written notice. Fennec also has the right
to terminate the OHSU Agreement at any time upon 60 days prior written notice and payment of all fees due to OHSU under the OHSU Agreement.
Securities Class Action Suit
Following the FDA’s CRL regarding our NDA
for PEDMARK TM as described in Note 1, a putative lawsuit was filed against us purportedly on behalf of purchasers of the Company’s
securities between December 20, 2018 and August 10, 2020. The lawsuit seeks to recover damages for Fennec investors under federal
securities laws. While we believe that the lawsuit is without merit and intend to vigorously defend against it, the lawsuit is in its
early stages and no assessment can be made as to its likely outcome or whether the outcome will be material to us. This litigation, and
any other securities class actions that may be brought against us, could result in substantial costs and a diversion of our management’s
attention and resources.
Executive Severance
In the event of his termination with us other
than for cause, we will be obligated to pay Mr. Raykov a one-time severance payment equal to twelve months of salary ($442,900 as of March
31, 2021). In the event of his termination with us other than for cause, we will be obligated to pay Mr. Andrade a one-time severance
payment equal to six months of salary ($160,423 as of March 31, 2021). In the event of her termination with us other than for cause, we
will be obligated to pay Ms. Goel a one-time severance payment equal to three months of salary ($92,700 as of March 31, 2021).
Leases
We have an operating lease in Research Triangle
Park, North Carolina utilizing small space within a commercial building. The operating lease has payments of $400 per month with no scheduled
increases. This operating lease is terminable with 30 days’ notice and has no penalties or contingent payments due.
On January 23, 2020, the Company entered into an
Office Service Agreement (the “Office Service Agreement”) with Regus to lease office space at in Hoboken, New Jersey.
Per the terms of the Office Service Agreement, the monthly rent payments are $1,441. The Company was required to pay a security deposit
of $2,300, which is the equivalent to two months of rent. The Office Service Agreement commenced on January 27, 2020 and
terminates on July 31, 2020, thereafter the lease may continue on a month-to-month basis with either party being able to terminate
the agreement by providing one months' advance written notice of termination.
14
Fennec Pharmaceuticals Inc.
Notes to the Unaudited Interim Condensed Consolidated
Financial Statements
(U.S. dollars and shares in thousands, except
per share information)
COVID-19
Our operations may be affected by the ongoing
COVID-19 pandemic. The ultimate disruption which may be caused by the outbreak is uncertain; however, it may result in a material adverse
impact on our financial position, operations and cash flows. Possible effects may include, but are not limited to, disruption to our product
launch which includes the ability of sales reps to communicate with oncologists, absenteeism in our labor workforce, unavailability of
products and supplies used in operations, and a decline in value of our assets, including inventories, property and equipment, and marketable
securities. COVID-19 has not had a material effect on our operations to date as we have historically had a workforce which works remotely,
preparations for product launch have been under the assumption of a virtual launch, and product supplies have not been impacted.
7.
Subsequent Events
Management has evaluated subsequent events through
the date of this filing and concluded there are no events of significance which require disclosure.
15
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.