NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(In thousands, except share and per share
amounts)
(Unaudited)
1. Nature of Business, Basis of Presentation and Liquidity
Nature of Business
Leap Therapeutics, Inc. was incorporated
in the state of Delaware on January 3, 2011. During 2015, HealthCare Pharmaceuticals Pty Ltd. (“HCP Australia”)
was formed and is a wholly owned subsidiary of the Company.
The Company is a biopharmaceutical company
acquiring and developing novel therapeutics at the leading edge of cancer biology. The Company’s approach is designed to
target compelling tumor-promoting and immuno-oncology pathways to generate durable clinical benefit and enhanced outcomes for patients.
The Company’s programs are monoclonal antibodies that target key cellular pathways that enable cancer to grow and spread
and specific mechanisms that activate the body’s immune system to identify and attack cancer.
Basis of Presentation
The accompanying condensed consolidated
financial statements as of March 31, 2020 and for the three months ended March 31, 2020 and 2019 have been prepared by the
Company, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for interim
financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance
with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted
pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information
presented not misleading. These condensed consolidated financial statements should be read in conjunction with the Company’s audited
consolidated financial statements and the notes thereto for the year ended December 31, 2019 included in the Company’s Annual
Report on Form 10-K filed with the SEC on March 16, 2020.
The condensed consolidated financial statements
have been prepared on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying
condensed consolidated financial statements contain all adjustments which are necessary for the fair presentation of the Company’s
financial position as of March 31, 2020, statements of operations and statements of comprehensive loss for the three months ended
March 31, 2020 and 2019 and statements of cash flows for the three months ended March 31, 2020 and 2019. Such adjustments
are of a normal and recurring nature. The results of operations for the three months ended March 31, 2020 are not necessarily indicative
of the results of operations that may be expected for the year ending December 31, 2020.
Liquidity
Since inception, the Company has been engaged
in organizational activities, including raising capital, and research and development activities. The Company does not yet have
a product that has been approved by the Food and Drug Administration (the “FDA”), has not generated any product sales
revenues and has not yet achieved profitable operations, nor has it ever generated positive cash flows from operations. There is
no assurance that profitable operations, if achieved, could be sustained on a continuing basis. Further, the Company’s future
operations are dependent on the success of the Company’s efforts to raise additional capital, its research and commercialization
efforts, regulatory approval, and, ultimately, the market acceptance of the Company’s products.
In accordance with Accounting Standards
Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered
in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year
after the date that the condensed consolidated financial statements are issued. As of March 31, 2020, the Company had cash and
cash equivalents of $25,465. Additionally, the Company had an accumulated deficit of $202,702 at March 31, 2020, and during the
three months ended March 31, 2020, the Company incurred a net loss of $7,231. The Company expects to continue to generate operating
losses for the foreseeable future.
The Company believes that its cash and
cash equivalents of $25,465 as of March 31, 2020, will be sufficient to fund its operating expenses for at least the next 12 months
from issuance of these financial statements. In November 2019, the Company suspended enrollment of its TRX518 clinical trials and
deprioritized further development.
In addition, the Company will seek additional
funding through public or private equity financings and will seek funding or development program cost-sharing through collaboration
agreements or licenses with larger pharmaceutical or biotechnology companies, such as the agreement with BeiGene. If the Company
does not obtain additional funding or development program cost-sharing, or exceeds its current spending forecasts or fails to receive
the research and development tax incentive payment, the Company has the ability and would be forced to: delay, reduce or eliminate
certain clinical trials or research and development programs, reduce or eliminate discretionary operating expenses, and/or delay
company and pipeline expansion, any of which would adversely affect its business prospects. The inability to obtain funding, as
and when needed, would have a negative impact on the Company's financial condition and ability to pursue its business strategies.
2. Summary of Significant Accounting Policies
Principles of Consolidation
The accompanying condensed consolidated
financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions
are eliminated upon consolidation.
Use of Estimates
The presentation of condensed consolidated
financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial
statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those
estimates.
Research and development
incentive income and receivable
The Company recognizes other income from
Australian research and development incentives when there is reasonable assurance that the income will be received, the relevant
expenditure has been incurred, and the consideration can be reliably measured. The research and development incentive is one of
the key elements of the Australian Government’s support for Australia’s innovation system and is supported by legislative
law primarily in the form of the Australian Income Tax Assessment Act 1997, as long as eligibility criteria are met.
Management has assessed the Company’s
research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under
the research and development incentive regime described above. At each period end, management estimates the refundable tax offset
available to the Company based on available information at the time. This estimate is also reviewed by external tax advisors on
an annual basis.
Under the program, a percentage of eligible
research and development expenses incurred by the Company through its subsidiary in Australia are reimbursed. The percentage
was 43.5% for the year ended December 31, 2019 and for the three months ended March 31, 2020.
The research and development incentive
receivable represents an amount due in connection with the above program. The Company has recorded a research and development incentive
receivable of $247 and $185 as of March 31, 2020 and December 31, 2019, respectively, in the condensed consolidated balance
sheets and other income from Australian research and development incentives of $85 and $75 for the three months ended March 31,
2020 and 2019, respectively.
The following table shows the change in the research and development
incentive receivable from December 31, 2018 to March 31, 2020 (in thousands):
Balance at December 31, 2018
|
|
$
|
836
|
|
Australian research and development incentive income, net
|
|
|
132
|
|
Cash received for 2018 eligible expenses
|
|
|
(757
|
)
|
Foreign currency translation
|
|
|
(26
|
)
|
Balance at December 31, 2019
|
|
|
185
|
|
Australian research and development incentive income, net
|
|
|
85
|
|
Foreign currency translation
|
|
|
(23
|
)
|
Balance at March 31, 2020
|
|
$
|
247
|
|
Foreign Currency Translation
The financial statements of the Company’s
Australian subsidiary are measured using the local currency as the functional currency. Assets and liabilities of this subsidiary
are translated into U.S. dollars at an exchange rate as of the consolidated balance sheet date. Equity is translated at historical
exchange rates. Revenues and expenses are translated into U.S. dollars at average rates of exchange in effect during the period.
The resulting cumulative translation adjustments have been recorded as a separate component of stockholders’ equity. Realized
foreign currency transaction gains and losses are included in the results of operations.
Deferred Costs
The
Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process
equity financings as deferred costs until such financings are consummated. After consummation of the equity financing, these costs
are recorded in stockholders' equity (deficiency) as a reduction of additional paid-in capital generated as a result of
the offering.
The Company also capitalizes certain contract
acquisition costs. During the three months ended March 31, 2020, the Company incurred contract acquisition costs which were capitalized
under ASC 340-40 as incremental costs of obtaining the contract with BeiGene. This cost is amortized on a straight-line basis over
the performance period of the research and development services.
As of March 31, 2020 and December 31, 2019
there was $623 and $831, respectively, of deferred costs.
Deposits
As of March 31, 2020 and December 31,
2019, $1,074 and $1,099, respectively, of deposits made by the Company with certain service providers that are to be applied to
future payments due under the service agreements or returned to the Company if not utilized, were recorded in the condensed consolidated
balance sheets.
Warrants
On January 1, 2019, the Company adopted
ASU No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), and
Derivatives and Hedging (Topic 815) (“ASU 2017-11”), which changes the classification analysis of certain
equity-linked financial instruments (or embedded features) with down round features. The amendments require entities that present
earnings per share (“EPS”) in accordance with Topic 260 to recognize the effect of the down round feature when
triggered with the effect treated as a dividend and as a reduction of income available to common stockholders in basic EPS.
The Company concluded that the common stock
warrants (the “2017 Warrants”) issued in connection with the private placement of common stock completed in November 2017
(the “November 2017 Private Placement”), qualify for equity classification. The adoption guidance of ASU 2017-11
provides for a modified retrospective adoption. The Company applied the guidance retrospectively to the 2017 Warrants by
means of a cumulative-effect adjustment to its statement of financial position as of the beginning of the interim and annual period
beginning January 1, 2019. The Company performed a final remeasurement of the warrant liability as of January 1,
2019 and reclassified $3,448 from warrant liability to equity.
The Company will recognize on a prospective
basis the value of the effect of the down round feature in the 2017 Warrants when it is triggered (i.e., when the exercise price
is adjusted downward). This value is measured as the difference between (1) the financial instrument’s fair value (without
the down round feature) using the pre-trigger exercise price and (2) the financial instrument’s fair value (with the
down round feature) using the reduced exercise price. The value of the effect of the down round feature will be treated as a dividend
and a reduction to income available to common stockholders in the basic EPS calculation. In connection with the public offering,
completed in February 2019 (the “2019 Public Offering”), when the 2017 Warrants were repriced from $6.085 to $1.75
as a result of a down round, the Company recorded a dividend of $359 during the three months ended March 31, 2019. In connection
with the January 2020 Private Placement, when the 2017 Warrants were repriced from $1.75 to $1.055 as a result of a down round,
the Company recorded a dividend of $303 during the three months ended March 31, 2020.
Fair Value of Financial Instruments
Certain assets and liabilities are carried
at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a
liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between
market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable
inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified
and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable
and the last is considered unobservable:
|
·
|
Level 1—Quoted prices in active markets for
identical assets or liabilities.
|
|
·
|
Level 2—Observable inputs (other than Level 1
quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not
active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable
market data.
|
|
·
|
Level 3—Unobservable inputs that are supported
by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including
pricing models, discounted cash flow methodologies and similar techniques.
|
During the periods presented, the Company
has not changed the manner in which it values assets and liabilities that are measured at fair value using Level 3 inputs.
There were no transfers within the hierarchy during the three months ended March 31, 2020 or the year ended December 31, 2019.
A summary of the assets and liabilities
carried at fair value in accordance with the hierarchy defined above is as follows (in thousands):
|
|
Total
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
March 31, 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents
|
|
$
|
25,465
|
|
|
$
|
25,465
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Total assets
|
|
$
|
25,465
|
|
|
$
|
25,465
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents
|
|
$
|
3,891
|
|
|
$
|
3,891
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Total assets
|
|
$
|
3,891
|
|
|
$
|
3,891
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Cash equivalents of $25,465 and $3,891
as of March 31, 2020 and December 31, 2019, respectively, consisted of overnight investments and money market funds and are
classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets.
The carrying value of the research and
development incentive receivable, accounts payable and accrued liabilities approximate their fair value due to the short-term nature
of these assets and liabilities.
Leases
In February 2016, the Financial Accounting
Standards Board, or FASB, issued ASU 2016-02, Leases, or ASU 2016-02, to enhance the transparency and comparability of financial
reporting related to leasing arrangements. The Company adopted ASU 2016-02 on January 1, 2019, or the effective date, and
used the effective date as its date of initial application.
At the inception of an arrangement, the
Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Most leases
with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable,
long-term lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less.
Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments
over the expected remaining lease term. The Company has determined that the rate implicit in the lease is not determinable and
the Company does not have borrowings with similar terms and collateral. Therefore, the Company considered a variety of factors,
including observable debt yields from comparable companies and the volatility in the debt market for securities with similar terms,
in determining that 8% was reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities.
In accordance with the guidance in ASU
2016-02, components of a lease should be split into three categories: lease components (e.g. land, building, etc.), non-lease
components (e.g. common area maintenance, maintenance, consumables, etc.), and non-components (e.g. property taxes, insurance, etc.).
Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based
on fair values to the lease components and non-lease components.
Although separation of lease and
non-lease components is required, certain practical expedients are available. Entities may elect the practical expedient to
not separate lease and non-lease components. Rather, they would account for each lease component and the related non-lease
component together as a single component. The Company has elected to account for the lease and non-lease components of each
of its operating leases as a single lease component and allocate all of the contract consideration to the lease component
only. The lease component results in an operating right-of-use asset being recorded on the consolidated balance sheets and
amortized such that lease expense is recorded on a straight line basis over the term of the lease.
Revenue Recognition
The Company records revenue in accordance
with Accounting Standards Codification, or ASC, Topic 606, Revenue
From
Contracts with Customers. This standard applies to all contracts with customers, except for contracts that are within
the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606,
an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration
that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that
an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s)
with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate
the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies
a performance obligation. The Company only applies the five step model to contracts when it is probable that the entity will collect
the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception,
once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within
each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct.
The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation
when (or as) the performance obligation is satisfied.
License
revenue. The Company’s performance obligations under its license agreements may include providing
intellectual property licenses, performing technology transfer, performing research and development consulting services and
notifying the customer of any enhancements to licensed technology or new technology that it discovers, among others. The
Company determined that its performance obligations under its license agreements as evaluated at contract inception were not
distinct and represented a single performance obligation. For these agreements, revenue is recognized using a proportional
performance model, representing the transfer of goods or services as activities are performed over the term of the agreement.
Upfront payments are also amortized to revenue on a straight-line basis over the performance period. Upfront payment contract
liabilities resulting from the Company’s license agreements do not represent a financing component as the payment is
not financing the transfer of goods or services, and the technology underlying the licenses granted reflects research and
development expenses already incurred by the Company. When no performance obligations are required of the Company, or
following the completion of the performance obligation period, such amounts are recognized upon transfer of control of the
goods or services to the customer. Generally, all amounts received or due other than sales-based milestones and royalties are
classified as license revenues. Sales-based milestones and royalties under the Company’s license agreements will be
recognized as royalty revenue in the period the related sale occurred. The Company generally invoices its licensees upon the
completion of the effort or achievement of a milestone, based on the terms of each agreement. Deferred revenue arises from
amounts received in advance of the culmination of the earnings process and is recognized as revenue in future periods as
performance obligations are satisfied. Deferred revenue expected to be recognized within the next twelve months is classified
as a current liability.
Research
and Development Services. The promises under the Company’s license agreements may include research and development
services to be performed by the Company on behalf of the customer. Payments or reimbursements resulting from the Company’s
research and development efforts are recognized as the services are performed and presented on a gross basis because the Company
is the principal for such efforts. Reimbursements from and payments to the customer that are the result of a collaborative relationship
with a partner, instead of a customer relationship, such as co-development activities, are recorded as a reduction to research
and development expense.
Customer
Options. If an arrangement is determined to contain customer options that allow the customer to acquire additional goods
or services, the goods and services underlying the customer options that are not determined to be material rights are not considered
to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. The Company evaluates
the customer options for material rights, or options to acquire additional goods or services for free or at a discount. If the
customer options are determined to represent a material right, the material right is recognized as a separate performance obligation
at the outset of the arrangement. The Company allocates the transaction price to material rights based on the relative standalone
selling price, which is determined based on the identified discount and the probability that the customer will exercise the option.
Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised.
Milestone
Payments. At the inception of each arrangement that includes research or development milestone payments, the Company
evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction
price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated
milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the
licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company
evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the
particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that
a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability
of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price.
Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.
Royalties.
For arrangements that include sales-based royalties, including milestone payments upon first commercial sales and milestone payments
based on a level of sales, which are the result of a customer-vendor relationship and for which the license is deemed to be the
predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur,
or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially
satisfied. To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements.
Collaborative Arrangements
The Company analyzes its collaboration arrangements
to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in
the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and therefore
within the scope of ASC Topic 808, Collaborative Arrangements (ASC 808). This assessment is performed throughout the life of the
arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the
scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to
be within the scope of ASC 808 and which elements of the collaboration are more reflective of a vendor-customer relationship and
therefore within the scope of ASC 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an
appropriate recognition method is determined and applied consistently, generally by analogy to ASC 606. Amounts that are owed to
collaboration partners are recognized as an offset to collaboration revenues as such amounts are incurred by the collaboration
partner. Where amounts owed to a collaboration partner exceed the Company’s collaboration revenues in each quarterly period,
such amounts are classified as research and development expense. For those elements of the arrangement that are accounted for pursuant
to ASC 606, the Company applies the five-step model described above under ASC 606.
See footnote 3 for a complete discussion of the revenue
recognition for the Company’s license agreement.
Net Loss per Share
Basic net loss per share is computed using
the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted
average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares
of common stock, including the assumed exercise of stock options and warrants.
Warrant Liability
In connection with entering into the November
2017 Private Placement, the Company issued the 2017 Warrants with each share of common stock sold in the November 2017 Private
Placement. The Company classified the 2017 Warrants as a liability on its consolidated balance sheet prior to January 1, 2019,
because each warrant represented a freestanding financial instrument that is not indexed to the Company’s own shares. The
warrant liability was initially recorded at fair value upon entering into the November 2017 Private Placement agreement and was
subsequently remeasured to fair value at each reporting date. Changes in the fair value of the warrant liability were recognized
as gains (losses) in the condensed consolidated statements of operations through the year ended December 31, 2018.
Subsequent Events
The Company considers events or transactions
that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence for
certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated as required.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements
are issued by the FASB, and are early adopted by the Company or adopted as of the specified effective date.
In November 2018, the FASB issued “ASU
2018-18, Clarifying the Interaction between Topic 808 and Topic 606.” The objective of the standard is to clarify the interaction
between ASC Topic 808--Collaborative Arrangements and ASC Topic 606--Revenue from Contracts with Customers. Currently, ASC Topic
808 does not provide comprehensive recognition or measurement guidance for collaborative arrangements, and the accounting for those
arrangements is often based on an analogy to other accounting literature or an accounting policy election. Similarly, aspects of
ASC Topic 606 have resulted in uncertainty in practice about the effect of the revenue standard on the accounting for collaborative
arrangements. The standard became effective for us beginning on January 1, 2020 and the adoption of this ASU did not have a material
impact on our financial condition, results of operations, cash flows, and financial statement disclosures.
3. BeiGene Exclusive Option and License Agreement
Terms of Agreement
On January 3, 2020, the Company entered
into an exclusive option and license agreement (the “BeiGene Agreement”) with BeiGene, Ltd. (“BeiGene”)
for the clinical development and commercialization of DKN-01, in Asia (excluding Japan), Australia, and New Zealand. The Company
retains exclusive rights for the development, manufacturing, and commercialization of DKN-01 for the rest of the world.
Pursuant to the BeiGene Agreement, the Company
received an upfront cash payment of $3,000 from BeiGene in exchange for granting BeiGene an option to an exclusive license to develop
and commercialize DKN-01 in Asia (excluding Japan), Australia, and New Zealand. The Company is eligible to receive up to $132,000
in future option exercise and milestone payments, based upon the achievement of certain development, regulatory, and sales milestones,
as well as tiered royalties on any product sales of DKN-01 in the licensed territory.
The
Company is responsible for conducing development activities prior to the exercise of the option. After the option is exercised,
BeiGene is solely responsible for development and commercialization activities of DKN-01 in the territory. The BeiGene Agreement
continues in effect until the earlier of: (i) 120 days after the end of the option period, if BeiGene has not exercised the option
by such date; and (ii) on a country-by country and Licensed Product-by-Licensed Product (as defined in the BeiGene Agreement) basis,
the expiration of the Royalty Term (as defined in the BeiGene Agreement) applicable to such licensed product in such country. At
any time, BeiGene may terminate the agreement by providing at least 60 days written notice of termination to the Company. Upon
termination of the License Agreement, all rights granted by the Company to BeiGene terminate.
Revenue Recognition
The Company evaluated the BeiGene
Agreement to determine whether it is a collaborative arrangement for purposes of ASC 808. The Company concluded that because
both parties were active participants and were exposed to the risks and rewards of the BeiGene Agreement, that such
activities are under the scope of ASC 808. The Company concluded that BeiGene was a customer with regard to the combined
license and research & development activities and as such the contract should be evaluated under ASC 606.
In determining the appropriate amount of
revenue to be recognized under ASC 606 as the Company fulfills its obligations under the Agreement, the Company performed the following
steps: (i) identified the promised goods or services in the contract; (ii) determined whether the promised goods or services are
performance obligations including whether they are distinct in the context of the contract; (iii) measured the transaction price,
including any constraints on variable consideration; (iv) allocated the transaction price to the performance obligations; and (v)
recognizes revenue when (or as) the Company satisfies each performance obligation.
The Company identified the following material
promises under the BeiGene Agreement: (1) option to an exclusive license to develop and commercialize DKN-01 in Asia (excluding
Japan), Australia, and New Zealand, (2) participation in a joint development committee, (3) technology transfer services and (4)
pre-option research and development services. The Company determined that the option to an exclusive license in the territory did
not represent a material right. Additionally, the Company determined that the participation in the joint development committee,
research and development services and technology transfer services were not distinct from each other, as each has limited value
without the other. As such, for the purposes of ASC 606, the Company determined that these four material promises, described above,
should be combined into a single performance obligation.
The Company determined the transaction
price is equal to the up-front fee of $3,000. The transaction price was fully allocated to the single performance obligation and
is recognized as revenue on a straight-line basis over the performance period of the research and development services. During
the three months ended March 31, 2020, the Company recognized $375 of license revenue related to the up-front fee received from
BeiGene. The Company did not have any such license revenue during the three months ended March 31, 2019.
Cost of contract acquisition
The Company incurred contract acquisition
costs of $270 which were capitalized under ASC 340-40 as incremental costs of obtaining the contract with BeiGene. This cost is
amortized on a straight-line basis over the performance period of the research and development services. The total amount of amortization
expense in the period is $34 and the closing balance recorded in deferred costs as of March 31, 2020 was $236.
Royalties
As the license is deemed to be the predominant
item to which sales-based royalties relate, the Company will recognize revenue when the related sales occur. No royalty revenue
was recognized during the three months ended March 31, 2020.
The following table presents a summary of
the activity in the Company's contract liabilities, related to the upfront cash payment received of $3,000, during the three months
ended March 31, 2020 (in thousands):
|
|
Balance at
|
|
|
|
|
|
|
|
|
Balance at
|
|
|
|
January 1, 2020
|
|
|
Additions
|
|
|
Deductions
|
|
|
March 31, 2020
|
|
Contract liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue - current
|
|
$
|
-
|
|
|
$
|
1,875
|
|
|
$
|
(375
|
)
|
|
$
|
1,500
|
|
Deferred revenue - non current
|
|
|
-
|
|
|
|
1,125
|
|
|
|
-
|
|
|
|
1,125
|
|
Total contract liabilities
|
|
$
|
-
|
|
|
$
|
3,000
|
|
|
$
|
(375
|
)
|
|
$
|
2,625
|
|
4. Accrued Expenses
Accrued expenses consist of the following:
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Clinical trials
|
|
$
|
1,421
|
|
|
$
|
1,828
|
|
Professional fees
|
|
|
270
|
|
|
|
609
|
|
Payroll and related expenses
|
|
|
696
|
|
|
|
1,004
|
|
Accrued expenses
|
|
$
|
2,387
|
|
|
$
|
3,441
|
|
5. Leases
In February 2016, the FASB issued
ASU 2016-02, Leases, or ASU 2016-02. ASU 2016-02 requires a lessee to recognize on its balance sheet (for both finance and operating
leases) a liability to make lease payments and a right-of-use asset representing its right to use the underlying asset for the
lease term. The Company adopted ASU 2016-02 on January 1, 2019, on the effective date, and used the effective date as its
date of initial application. As such, the Company did not adjust prior period amounts. The Company also elected to adopt the practical
expedients upon transition, which permit companies to not reassess lease identification, classification, and initial direct costs
under ASU 2016-02 for leases that commenced prior to the effective date.
The Company has operating leases for real
estate in the United States and does not have any finance leases. The Company’s leases may contain options to renew
and extend lease terms and options to terminate leases early. Reflected in the right-of-use asset and lease liability on the Company’s
consolidated balance sheets are the periods provided by renewal and extension options that the Company is reasonably certain to
exercise, as well as the periods provided by termination options that the Company is reasonably certain to not exercise.
The Company has existing leases that include
variable lease and non-lease components that are not included in the right-of-use asset and lease liability and are reflected as
an expense in the period incurred. Such payments primarily include common area maintenance charges and increases in rent payments
that are driven by factors such as future changes in an index (e.g., the Consumer Price Index).
In calculating the present value of future
lease payments, the Company utilized its incremental borrowing rate based on the remaining lease term at the date of adoption.
The Company has elected to account for each lease component and its associated non-lease components as a single lease component
and has allocated all of the contract consideration across lease components only. This will potentially result in the initial and
subsequent measurement of the balances of the right-of-use asset and lease liability for leases being greater than if the policy
election was not applied. The Company has existing net leases in which the non-lease components (e.g. common area maintenance,
maintenance, consumables, etc.) are paid separately from rent based on actual costs incurred and therefore are not included
in the right-of-use asset and lease liability and are reflected as an expense in the period incurred. On January 1, 2019,
the Company recorded a right-of-use asset of $1,755 and a lease liability of $1,720 on its consolidated balance sheets and reclassified
a rent liability against the right-of-use asset of $35. As of March 31, 2020, a right-of-use asset of $835 and lease liability
of $833 are reflected on the consolidated balance sheets. The Company recorded rent expense of $198 and $209, respectively, during
the three months ended March 31, 2020 and 2019.
Future lease payments under non-cancelable
operating leases as of March 31, 2020 are detailed as follows:
Future Operating Lease Payments
|
2020
|
|
$
|
321
|
|
2021
|
|
|
434
|
|
2022
|
|
|
146
|
|
Total Lease Payments
|
|
|
901
|
|
Less: imputed interest
|
|
|
(68
|
)
|
Total operating lease liabilities
|
|
$
|
833
|
|
6. Warrants
As of March 31, 2020, outstanding warrants
to purchase common stock, all of which are classified as equity warrants, consisted of the following:
March 31, 2020
|
Date Exercisable
|
|
Number of Shares
Issuable
|
|
|
Exercise Price
|
|
|
Classification
|
1/23/2017
|
|
|
54,516
|
|
|
$
|
0.01
|
|
|
Equity
|
11/14/2017
|
|
|
2,758,094
|
|
|
$
|
1.055
|
|
|
Equity
|
2/5/2019
|
|
|
7,491,442
|
|
|
$
|
1.95
|
|
|
Equity
|
3/5/2020
|
|
|
14,413,902
|
|
|
$
|
0.001
|
|
|
Equity
|
3/5/2020
|
|
|
25,945,035
|
|
|
$
|
2.11
|
|
|
Equity
|
|
|
|
50,662,989
|
|
|
|
|
|
|
|
2017 Warrants
The 2017 Warrants contain full ratchet
anti-dilution protection provisions. Prior to January 1, 2019, the Company classified the 2017 Warrants as a liability on
its consolidated balance sheet because each warrant represented a freestanding financial instrument that, due to the potential
variable nature of the exercise price, is not considered to be indexed to the Company’s own shares. The warrant liability
was initially recorded at fair value upon entering into the November 2017 Private Placement and has been subsequently remeasured
to fair value at each reporting date. Changes in the fair value of the warrant liability were recognized as gains (losses) in the
Company’s consolidated statement of operations.
On January 1, 2019, the Company adopted
ASU 2017-11 and concluded that the 2017 Warrants now qualify for equity classification. The Company applied the guidance
retrospectively to the 2017 Warrants by means of a cumulative-effect adjustment to its statement of financial position as of the
beginning of the interim and annual period beginning January 1, 2019. The Company performed a final remeasurement of
the warrant liability as of January 1, 2019 and reclassified $3,448 to additional paid in capital.
The Company will recognize on a prospective
basis the value of the effect of the down round feature in the warrant when it is triggered (i.e., when the exercise price is adjusted
downward). This value is measured as the difference between (1) the financial instrument’s fair value (without the down
round feature) using the pre-trigger exercise price and (2) the financial instrument’s fair value (with the down round
feature) using the reduced exercise price. The value of the effect of the down round feature will be treated as a dividend and
a reduction to income available to common stockholders in the basic EPS calculation. In connection with the 2019 Public Offering,
when the 2017 Warrants were repriced from $6.085 to $1.75, the Company recorded a dividend of $359 during the three months ended
March 31, 2019. In connection with the January 2020 Private Placement, when the 2017 Warrants were repriced from $1.75 to $1.055,
the Company recorded a dividend of $303 during the three months ended March 31, 2020.
2019 Warrants
On February 5, 2019, in connection
with the 2019 Public Offering, the Company issued immediately exercisable warrants (the “2019 Warrants”) to purchase
7,557,142 shares of common stock to investors. The 2019 Warrants have an exercise price of $1.95 per share and expire on February 5,
2026. The 2019 Warrants qualify for equity classification.
During the three months ended March 31,
2020, 65,700 warrants were exercised for cash resulting in gross proceeds to the Company of $128.
2020 Warrants
On January 3, 2020, the Company entered
into a Securities Purchase Agreement with investors, providing for a private placement transaction exempt from the Securities Act
of 1933, as amended, pursuant to which the Company issued and sold 1,421,801 shares of its Series A Preferred Stock, at a purchase
price of $10.54 per share, and 1,137,442 shares of its Series B Preferred Stock at a purchase price of $10.55 per share, and one
(1) share of the Company's Special Voting Stock entitling the purchaser of Series A Preferred Stock to elect one member of the
Company's board of directors.
On March 5, 2020, the Company's stockholders
approved the conversion of the Series A Preferred Stock into a pre-funded warrant to purchase 14,413,902 shares of common stock
at an exercise price of $0.001 (the “2020 Pre-funded Warrants”) and the conversion of the Series B Preferred Stock
into 11,531,133 shares of common stock. Each investor also received a warrant to purchase an equal number of shares of common stock
at an exercise price of $2.11 per share (the “Coverage Warrants”). The 2020 Pre-funded Warrants and the Coverage Warrants
expire on March 5, 2027 and qualify for equity classification.
7. Common Stock
Each share of common stock entitles the
holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to
receive dividends, as may be declared by the board of directors, if any, subject to the preferential dividend rights of the preferred
stockholders. Through March 31, 2020, no dividends have been declared.
Public Offering of Common Stock — February 2019
On February 5, 2019, the Company completed
the 2019 Public Offering whereby the Company issued 7,557,142 shares of its common stock at a price of $1.75 per share, which included
985,714 shares issued pursuant to the underwriters’ exercise of their option to purchase additional shares of common stock,
each share issued with a warrant to purchase one share of common stock. Each warrant has an exercise price of $1.95 per share with
an exercise period expiring seven years from the date of issuance. The aggregate net proceeds received by the Company from the
2019 Public Offering were approximately $12,122, net of underwriting discounts and commissions and estimated offering expenses
payable by the Company.
Issuance of Common Stock under Distribution Agreement
On September 7, 2018, the Company
filed a Prospectus Supplement to register the offer and sale of shares of common stock having an aggregate offering price of up
to $30,000 pursuant to the terms of a distribution agreement, or the Distribution Agreement, with Raymond James & Associates, Inc.
During the year ended December 31, 2019, the Company issued 1,033,147 shares under the Distribution Agreement, for net proceeds
of $1,923. During the three months ended March 31, 2020, the Company did not issue any shares under the Distribution Agreement.
Lincoln Park Purchase Agreements
On July 10, 2019, the Company entered
into a Commitment Purchase Agreement and a Registration Rights Agreement with Lincoln Park, pursuant to which the Company has the
right to sell to Lincoln Park up to $20,000 in shares of its common stock, subject to certain limitations and conditions set forth
in the Commitment Purchase Agreement. As consideration for Lincoln Park’s commitment to purchase shares of common stock pursuant
to the Commitment Purchase Agreement, the Company issued to Lincoln Park 330,000 shares of common stock. The Company did not receive
any cash proceeds from the issuance of such shares. During the three months ended March 31, 2020, the Company did not issue any
shares under the Commitment Purchase Agreement Agreement.
On July 11, 2019, the Company entered
into a Registered Offering Purchase Agreement and together with the Commitment Purchase Agreement, under which the Company agreed
to sell to Lincoln Park, and Lincoln Park agreed to purchase 571,429 shares of common stock, at a price of $1.75 per share for
an aggregate purchase price of $1,000, pursuant to the Company’s effective shelf Registration Statement on Form S-3,
including the prospectus supplement thereto dated July 11, 2019.
January 2020 Private Placement
On January 3, 2020,
the Company issued and sold 1,421,801 shares of its Series A Preferred Stock at a purchase price of $10.54 per share, and 1,137,442
shares of its Series B Preferred Stock at a purchase price of $10.55 per share, and one (1) share of its Special Voting Stock,
entitling the purchaser of Series A Preferred Stock to elect one member of the Company’s board of directors, for aggregate
net proceeds to the Company of approximately $25,322.
On March 5, 2020, the
Company’s stockholders approved the conversion of the Series A Preferred Stock into a pre-funded warrant to purchase 14,413,902
shares of common stock at an exercise price of $0.001 per share and the conversion of the Series B Preferred Stock into 11,531,133
shares of its common stock, par value $0.001 per share. Each investor also received the Coverage Warrants to purchase an equal
number of shares at an exercise price of $2.11 per share.
In
connection with the January 2020 Private Placement, Series A Preferred Stock holders and Series B Preferred Stock holders were
entitled to cash dividends at fixed cumulative percentage of 8% per annum plus any dividends declared on outstanding common stock
on an as-converted basis, effective on the issuance date of the Series A Preferred Stock and Series B Preferred Stock. The cash
dividends were converted to shares of common stock upon the conversion of the Series A Preferred Stock to pre-funded warrants and
Series B Preferred Stock to common stock. During the three months ended March 31, 2020, the Company recorded $372 of Series A Preferred
Stock and Series B Preferred Stock dividends, which qualify as cumulative dividends, and in the calculation of EPS are subtracted
from net income in arriving at income attributable to common stockholders.
The
Company determined that the embedded conversion features of the Series A Preferred Stock and Series B Preferred Stock to receive
the Coverage Warrants both met the definition a beneficial conversion feature and should be accounted for separately as a derivative.
The recognition of the beneficial conversion feature occurred upon the conversion of the Series A Preferred Stock into pre-funded
warrants and Series B Preferred Stock into common stock and the issuance of the Coverage Warrants. The Company measured
the beneficial conversion features’ intrinsic values on January 3, 2020 and determined that the beneficial conversion features
were valued at $5,226 for Series A and $4,173 for Series B, respectively. Upon conversion, the discount originated by the beneficial
conversion option, at its intrinsic value for Series A Preferred Stock and Series B Preferred Stock, was immediately recognized
as a dividend. The dividend is reflected as an adjustment to basic and diluted net loss per share attributable to common stockholders.
8. Equity Incentive Plans
Equity Incentive Plans
In September 2012, the Company adopted
the 2012 Equity Incentive Plan, as amended (the “Plan”), which provides designated employees of the Company and its
affiliates, certain consultants and advisors who perform services for the Company and its affiliates, and nonemployee members of
the board of directors of the Company and its affiliates with the opportunity to receive grants of incentive stock options, nonqualified
stock options and stock awards.
On January 20, 2017, the Company’s
stockholders approved the 2016 Equity Incentive Plan (the “2016 Plan”). Beginning on January 1, 2018, the
number of shares of common stock authorized for issuance pursuant to the 2016 Plan was increased each January 1 by an amount
equal to four percent (4%) of the Company’s outstanding common stock as of the end of the immediately preceding calendar
year or such other amount as determined by the compensation committee of the Company’s board of directors. In 2019, the board
of directors and the stockholders approved and authorized an additional 3,000,000 shares of Common Stock to be added to the shares
authorized for issuance under the 2016 Plan.
As of March 31, 2020, there were 1,760,288
shares available for grant under the Company’s equity incentive plans.
A summary of stock option activity under
the Equity Plans is as follows:
|
|
|
|
|
Weighted
Average
Exercise Price
|
|
|
Weighted
Average Remaining
|
|
|
Aggregate
Intrinsic
|
|
|
|
Options
|
|
|
Per Share
|
|
|
Life in Years
|
|
|
Value
|
|
Outstanding at December 31, 2019
|
|
|
4,024,566
|
|
|
$
|
7.48
|
|
|
|
7.98
|
|
|
$
|
2
|
|
Granted
|
|
|
1,265,000
|
|
|
$
|
2.34
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(7,778
|
)
|
|
$
|
1.39
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(190,579
|
)
|
|
$
|
6.87
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2020
|
|
|
5,091,209
|
|
|
$
|
6.23
|
|
|
|
8.16
|
|
|
$
|
299
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at March 31, 2020
|
|
|
2,567,661
|
|
|
$
|
9.79
|
|
|
|
6.98
|
|
|
$
|
61
|
|
Options vested and expected to vest at March 31, 2020
|
|
|
5,091,209
|
|
|
$
|
6.23
|
|
|
|
8.16
|
|
|
$
|
299
|
|
The grant date fair value of the options
granted during the year ended December 31, 2019 and the three months ended March 31, 2020, was estimated at the date of grant
using the Black-Scholes option valuation model. The expected life was estimated using the “simplified” method as defined
by the SEC’s Staff Accounting Bulletin 107, Share-Based Payment. The expected volatility was based on the historical volatility
of comparable public companies from a representative peer group selected based on industry and market capitalization data. The
risk-free interest rate was based on the continuous rates provided by the U.S. Treasury with a term approximating the expected
life of the option. The expected dividend yield was 0% because the Company does not expect to pay any dividends for the foreseeable
future. The Company elected the straight-line attribution method in recognizing the grant date fair value of options issued over
the requisite service periods of the awards, which are generally the vesting periods.
The assumptions that the Company used to
determine the grant-date fair value of stock options granted to employees and directors during the year ended December 31,
2019 and the three months ended March 31, 2020 were as follows, presented on a weighted average basis:
|
|
Three Months
|
|
|
Year Ended
|
|
|
|
Ended March 31,
|
|
|
December 31,
|
|
|
|
2019
|
|
|
2018
|
|
Expected volatility
|
|
|
66.94
|
%
|
|
|
66.94
|
%
|
Weighted average risk-free interest rate
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
Expected dividend yield
|
|
|
0.89
|
%
|
|
|
2.07
|
%
|
Expected term (in years)
|
|
|
6.81
|
|
|
|
6.77
|
|
Stock options generally vest over a three
or four year period, as determined by the compensation committee of the board of directors at the time of grant. The options expire
ten years from the grant date. As of March 31, 2020, there was approximately $4,090 of unrecognized compensation cost related to
non-vested stock options, which is expected to be recognized over a remaining weighted-average period of approximately 2.33 years.
The Company recognized stock-based compensation
expense related to the issuance of stock option awards to employees and non-employees in the condensed consolidated statements
of operations and comprehensive loss as follows:
|
|
Three Months Ended March 31,
|
|
|
|
2020
|
|
|
2019
|
|
Research and development
|
|
$
|
189
|
|
|
$
|
176
|
|
General and administrative
|
|
|
368
|
|
|
|
771
|
|
Total
|
|
$
|
557
|
|
|
$
|
947
|
|
Restricted Stock Units
During the year ended December 31, 2019,
the Company issued 181,000 restricted stock units (“RSUs”) to employees under the 2016 Plan. Upon vesting of the RSUs,
the Company has the option to settle the award by either issuing shares of the Company's common stock or paying an amount of cash
equal to the fair value of the Company's common stock on the settlement date. In October 2019 and January 2020, the Company cash
settled 90,500 and 90,500 RSUs, respectively.
During the three months ended March 31,
2020, the Company granted 660,606 RSUs to an executive officer that will cliff vest and will be settled after three years of continuous
service, or upon a change of control of the Company, whichever is earlier, pursuant to the 2016 Plan. During the three months ended
March 31, 2020, the Company recognized $13 of stock based compensation expense related to RSUs. The Company did not recognize any
stock based compensation expense related to RSUs during the three months ended March 31, 2019.
The following table presents a summary
of outstanding RSUs under the 2016 Plan as of March 31, 2020:
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
|
Number of
|
|
|
Grant Date
|
|
|
|
Shares
|
|
|
Fair Value
|
|
Outstanding at December 31, 2019
|
|
|
90,500
|
|
|
$
|
1.74
|
|
Awarded
|
|
|
660,606
|
|
|
$
|
1.42
|
|
Settled in cash
|
|
|
(90,500
|
)
|
|
$
|
1.74
|
|
Outstanding at March 31, 2020
|
|
|
660,606
|
|
|
$
|
1.42
|
|
As of March 31, 2020, there were 660,606
shares outstanding covered by RSUs that are expected to vest. The weighted average grant date fair value of these shares of restricted
stock was $1.42 per share and the aggregate grant date fair value of these shares of restricted stock was approximately $932. As
of March 31, 2020, there was approximately $919 of unrecognized compensation costs, net of estimated forfeitures, related to RSUs
granted to employees, which are expected to be recognized as expense over a remaining weighted average period of 2.96 years.
9. Net Loss Per Share
Basic and diluted net loss per share for
the three months ended March 31, 2020 and 2019 was calculated as follows (in thousands except share and per share amounts):
|
|
Three Months Ended March 31,
|
|
|
|
2020
|
|
|
2019
|
|
Numerator:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(7,231
|
)
|
|
$
|
(8,603
|
)
|
Dividend attributable to down round feature of warrants
|
|
|
(303
|
)
|
|
|
(359
|
)
|
Dividend attributable to Series A & B convertible preferred stock
|
|
|
(372
|
)
|
|
|
-
|
|
Series A & B convertible preferred stock - beneficial conversion feature
|
|
|
(9,399
|
)
|
|
|
-
|
|
Net loss attributable to common stockholders for basic and diluted loss per share
|
|
$
|
(17,305
|
)
|
|
$
|
(8,962
|
)
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding - basic and diluted
|
|
|
31,632,213
|
|
|
|
19,237,444
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common stockholders - basic and diluted
|
|
$
|
(0.55
|
)
|
|
$
|
(0.47
|
)
|
Included
within weighted average common shares outstanding are common shares issuable upon the exercise of the pre-funded warrants as the
warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose
of calculating basic and diluted net loss per share attributable to common stockholders.
The Company’s potentially dilutive
securities include RSUs, stock options and warrants. These securities were excluded from the computations of diluted net loss per
share for the three months ended March 31, 2020 and 2019, as the effect would be to reduce the net loss per share. The following
table includes the potential shares of common stock, presented based on amounts outstanding at each period end, that were excluded
from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including
them would have had an anti-dilutive effect:
|
|
Three Months Ended March 31,
|
|
|
|
2020
|
|
|
2019
|
|
Restricted stock units to purchase common stock
|
|
|
660,606
|
|
|
|
-
|
|
Options to purchase common stock
|
|
|
5,091,209
|
|
|
|
2,905,334
|
|
Warrants to purchase common stock
|
|
|
36,249,087
|
|
|
|
10,369,752
|
|
|
|
|
42,000,902
|
|
|
|
13,275,086
|
|
10. Commitments and Contingencies
Manufacturing
Agreements—The Company is party to manufacturing agreements with vendors to manufacture DKN-01, its lead product
candidate, for use in clinical trials. As of March 31, 2020, there were no noncancelable commitments under these agreements.
License
and Service Agreement—On January 3, 2011, the Company entered into a license agreement with Eli Lilly and
Company (“Lilly”) to grant a license to the Company for certain intellectual property rights relating to pharmaceutically
active compounds that may be useful in the treatment of bone healing, cancer and, potentially, other medical conditions. The Company
previously issued 9,000,000 shares of Series A Preferred Stock to Lilly in consideration for the grant of the license. As
defined in the license agreement, the Company would be required to pay royalties to Lilly based upon a percentage in the low single
digits of net sales of developed products, if and when achieved. However, there can be no assurance that clinical or commercialization
success of developed products will occur, and no royalties have been paid or accrued through March 31, 2020.
License
Agreement—On May 28, 2015, the Company entered into a license agreement with Lonza Sales AG (“Lonza”),
pursuant to which Lonza granted the Company a world-wide, non-exclusive license for certain intellectual property relating to a
gene expression system for manufacturing DKN-01. As defined in the license agreement, the Company would be required to pay royalties
to Lonza based on a percentage in the low single digits of net sales of DKN-01, if and when achieved. However, there can be no
assurance that clinical or commercialization success will occur, and no royalties have been paid or accrued through March 31, 2020.
Legal
Proceedings—At each reporting date, the Company evaluates whether or not a potential loss amount or a potential
range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting
for contingencies. The Company expenses as incurred the costs related to its legal proceedings.
A patent covering the TRX518 antibody and
its uses in methods of inducing or enhancing an immune response in a subject was granted in 2013 to the Company by the European
Patent Office (EPO). Three notices of opposition to this patent were filed: two by major pharmaceutical companies and a third by
an individual, possibly on behalf of a major pharmaceutical company. At the conclusion of the opposition proceedings before the
Opposition Division of the EPO, the Opposition Division issued a decision indicating that the Company’s patent was maintained
with modified claims that differ from the claims as originally granted. These narrowed claims cover the TRX518 antibody and uses
of the TRX518 antibody in methods of inducing or enhancing an immune response in a subject. The Company has filed an appeal of
the decision of the Opposition Division seeking to obtain broader claims that more closely reflect the claims as granted in the
patent. The EPO Board of Appeal has scheduled a date for the appeal hearing in September 2020.
In 2016, a patent covering the use of
the TRX518 antibody in combination with a chemotherapeutic agent for treating cancer was granted to the Company by the EPO.
In March 2017, notices of opposition to this patent were filed at the EPO by ten different entities, including several
major pharmaceutical companies. Oral proceedings at the EPO took place on December 4 and 5, 2018. At the conclusion of
the oral proceedings, the Opposition Division decided that the patent should be revoked in its entirety on the ground that
the claims as granted contained added matter. Subsequently, the Opposition Division issued an interlocutory decision
restating its conclusion that the claims as granted contained added matter and revoking the patent. The Company has filed an
appeal of the decision of the Opposition Division seeking to obtain a reversal of the Opposition Division’s decision on
added matter. The EPO Board of Appeal has not yet scheduled the appeal hearing.
Indemnification
Agreements—In the ordinary course of business, the Company may provide indemnification of varying scope and terms
to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses
arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition,
the Company has entered into indemnification agreements with members of its board of directors that will require the Company, among
other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or
officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements
is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The
Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations
in its condensed consolidated financial statements as of March 31, 2020 or December 31, 2019.
11. Related Party Transactions
The Company has a license agreement with
a stockholder (See Note 10).
On February 5, 2019, the Company completed
the 2019 Public Offering pursuant to which the Company issued 7,557,142 shares of its common stock at a price of $1.75 per share,
which included 985,714 shares issued pursuant to the underwriters’ exercise of their option to purchase additional shares
of common stock, each share issued with a warrant to purchase one share of common stock. Each warrant has an exercise price of
$1.95 per share with an exercise period expiring seven years from the date of issuance. The aggregate net proceeds received by
the Company from the offering were approximately $12,122, net of underwriting discounts and commissions and estimated offering
expenses payable by the Company. HealthCare Ventures IX, L.P. purchased common stock and warrants in the 2019 Public
Offering on the same terms and conditions as the other Purchasers. Three of the Company’s directors and executive officers
are affiliated with HealthCare Ventures IX, L.P. and its affiliates.
January 2020 - Private Placement
In January 2020, the
Company issued and sold 1,421,801 shares of its Series A Preferred Stock, at a purchase price of $10.54 per share, and 1,137,442
shares of its Series B Preferred Stock, at a purchase price of $10.55 per share, and one (1) share of its Special Voting Stock
entitling the purchaser of Series A Preferred Stock to elect one member of its board of directors for aggregate net proceeds to
the Company of approximately $25,322.
On March 5, 2020, the
Company’s stockholders approved the conversion of the Series A Preferred Stock into a pre-funded warrant to purchase 14,413,902
shares of common stock and the conversion of the Series B Preferred Stock into 11,531,133 shares of its common stock. Each investor
also received the Coverage Warrants to purchase an equal number of shares at an exercise price of $2.11 per share. In the January
2020 Private Placement, (i) BeiGene received 4,804,637 shares of common stock and a warrant to purchase an equal number of shares
of common stock and (ii) Perceptive Life Sciences Master Fund, Ltd. and its affiliates (“Perceptive”) received 6,726,496
shares of common stock and a warrant to purchase an equal number of shares of common stock. As a result of the January 2020 Private
Placement, each of BeiGene and Perceptive became a greater than 5% holder of the Company, and, as a result, a “related party”
as contemplated by Item 404 of Regulation S-K.
In connection with
the January 2020 Private Placement, the Company entered into a registration rights agreement with each of BeiGene and Perceptive
pursuant to which the Company agreed, following demand by either BeiGene or Perceptive, to file with the SEC a Registration Statement
on Form S-3 covering the resale of the shares of common stock issued or issuable upon exercise of the above-referenced Coverage
Warrants by BeiGene or Perceptive as promptly as reasonably practicable following such demand, and in any event within sixty days
after such demand.