Item 1. — Financial Statements
The accompanying notes are an integral part of these condensed financial statements.
The accompanying notes are an integral part of these condensed financial statements
The accompanying notes are an integral part of these condensed financial statements.
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2017
(Unaudited)
1.
Description of Company and Basis of Presentation
CytRx Corporation ("we," "us," "our," CytRx" or the "company") is a biopharmaceutical company specializing in oncology. Our focus is on the discovery, research and clinical development of novel anti-cancer drug candidates that employ linker technologies to enhance the accumulation and release of drug at the tumor. Aldoxorubicin, our lead clinical candidate, has been tested in over 600 patients with various types of cancer.
CytRx's lead product candidate is aldoxorubicin, a conjugate of the commonly prescribed chemotherapeutic agent doxorubicin that binds to circulating albumin in the bloodstream and is believed to concentrate the drug at the site of the tumor. Specifically, it is comprised of (6-maleimidocaproyl) hydrazine, an acid-sensitive molecule that is conjugated to doxorubicin. Our lead indication for aldoxorubicin is for patients with advanced soft tissue sarcomas (STS). We met with the FDA in March 2017 to discuss a regulatory pathway for a New Drug Application (NDA) for aldoxorubicin in STS.
Aldoxorubicin has received Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of STS. ODD provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits, and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan designation for STS which confers ten years of market exclusivity among other benefits.
On July 27, 2017, CytRx entered into an exclusive worldwide license with NantCell, Inc. ("NantCell"), granting them rights to develop, manufacture and commercialize aldoxorubicin in all indications. As part of the license, NantCell made a strategic investment of $13 million in CytRx common stock $1.10 per share, a premium of 92% to the market price on that date. CytRx is entitled to receive up to $343 million in milestones related to regulatory approvals and commercial milestones. CytRx is entitled to receive ascending double-digit royalties for net sales for soft tissue sarcomas and mid to high single digit royalties for other indications. NantCell will take over the development, manufacturing and commercialization responsibility for aldoxorubicin including the cost of filing the NDA.
CytRx has an active drug discovery and research operation at our laboratory facilities in Freiburg, Germany, focusing on the creation of novel drug anti-cancer candidates by combining our proprietary linker technologies with ultra-high potency cytotoxic drugs. We are expanding our pipeline of ultra-high potency oncology candidates through our LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx's expertise in albumin biology and next generation linker technologies for the development of a new class of potential breakthrough anti-cancer therapies.
We have created a "toolbox" of linker technologies that have the ability to significantly increase the therapeutic index of ultra-high potency drugs (10-1,000 times more potent than traditional chemotherapies) by controlling the release of the drug payloads and improving drug-like properties. After infusion, these ultra-high potency drug conjugates bind to circulating albumin for transport of the drug to the tumor. Subsequently, due to specific conditions within the tumor, the linkers are cleaved and release the anti-cancer drug payload.
Our current efforts are focused on two classes of ultra-high potency drug conjugates. Our strategy across these programs is to generate additional pre-clinical data that will allow us to make informed decisions regarding the selection of one or both programs for moving into human clinical trials either independently or on a partnered basis.
The accompanying condensed financial statements at June 30, 2017 and for the three-month and six-month periods ended June 30, 2017 and 2016, respectively, are unaudited, but include all adjustments, consisting of normal recurring entries, that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2016 have been derived from the our audited financial statements as of that date.
The financial statements included herein have been prepared by us pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to such rules and regulations. The financial statements should be read in conjunction with the Company's audited financial statements contained in its Annual Report on Form 10-K for the year ended December 31, 2016.
As a result of the worldwide license of all of our rights to aldoxorubicin to NantCell, NantCell will take over the development, manufacturing and commercialization responsibility for aldoxorubicin, thereby enabling us to eliminate our future research and development activities related to aldoxorubicin. Currently, our only research and development activities are conducted by our Freiburg, Germany, laboratory facility. For this reason and others, our operating expenses are expected to be significantly lower in the near future. Therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.
2.
Foreign Currency Remeasurement
The U.S. dollar has been determined to be the functional currency for the net assets of our German laboratory facilty. The transactions are recorded in the local currencies and are remeasured at each reporting date using the historical rates for nonmonetary assets and liabilities and current exchange rates for monetary assets and liabilities at the balance sheet date. Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income (loss). The Company recognized a gain of approximately $6,200 and $1,300, respectively, for the three-month and six-month periods ended June 30, 2017 and a gain of approximately $600 and $5,800, respectively, for the three and six-month periods ended June 30, 2016, respectively. The Company does not engage in currency hedging transactions.
3.
Recent Accounting Pronouncements
In January 2017, the FASB issued updated guidance to clarify the definition of a business within the context of business combinations. The updated guidance requires that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. This updated guidance is expected to reduce the number of transactions that need to be further evaluated as business combinations. If further evaluation is necessary, the updated guidance will require that a business set include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output. The updated guidance will remove the evaluation of whether a market participant could replace missing elements. The new guidance is effective for annual and interim periods beginning after December 15, 2017 and is to be applied on a prospective basis. We are currently evaluating the new guidance.
In January 2017, the FASB issued updated guidance which eliminated Step 2 from the goodwill impairment test. Step 2 is the process of measuring a goodwill impairment loss by comparing the implied fair value of a reporting unit's goodwill with the carrying amount of that goodwill. The new guidance requires entities to measure a goodwill impairment loss as the amount by which a reporting unit's carrying value exceeds its fair value, limited to the carrying amount of goodwill. The FASB also eliminated the requirements for entities that have reporting units with zero or negative carrying amounts to perform a qualitiative assessment for the goodwill impairment test. Instead, those entities would be required to disclose the amount of goodwill allocated to each reporting unit with a zero or negative carrying amount. The new guidance is effective for intrerim or annual goodwill impairment tests performed in fiscal years beginning after December 15, 2019, with early adoption permitted. We are currently evaluating the new guidance.
In March 2016, the FASB issued Accounting Standards Update 2016-09,
Compensation—Stock Compensation
("ASU 2016-09"). ASU 2016-09 includes several areas of simplification to stock compensation including simplifications to the accounting for income taxes, classification of excess tax benefits on the Statement of Cash Flows and forfeitures. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016. We adopted this Standard on January 1, 2017. The adoption of this Standard did not have material impact to the Company's financial position or its results of operations.
In February 2016, the FASB issued Accounting Standards Update 2016-02,
Leases
("ASU 2016-02"). ASU 2016-02 allows the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. The classification criteria for distinguishing between finance leases and operating leases are substantially similar to the classification criteria for distinguishing between capital leases and operating leases in the previous leases guidance. The Update 2016-02 is effective for annual reporting periods beginning after December 15, 2018 and early adoption is permitted. We are still evaluating the effect of this update.
In January 2016, the FASB issued Accounting Standards Update 2016-01,
Recognition and Measurement of Financial Assets and Financial Liabilities
("ASU 2016-01"). ASU 2016-01 eliminates the requirement to disclose the methods and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet. The standard also clarifies the need to evaluate a valuation allowance on a deferred tax asset related to available-for-sale securities in combination with our other deferred tax assets. The update 2016-01 is effective for annual reporting periods beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact on our financial statements.
4.
Term Loan
On February 5, 2016, we entered into a loan and security agreement with Hercules Technology Growth Capital, Inc. ("HTGC"), as administrative agent and lender, and Hercules Technology III, L.P., as lender ("Hercules"), pursuant to which the lenders made term loans to us on February 8, 2016 in the aggregate principal amount of $25 million (the "Term Loans").
The Term Loans bear interest at the daily variable rate per annum equal to 6.0% plus the prime rate, or 10.25%, whichever is greater. We are required to make interest-only payments on the Term Loans through February 28, 2017, and beginning on March 1, 2017 blended equal monthly installments of principal amortization and accrued interest until the maturity date of the Term Loans on February 1, 2020. Under the terms of the loan, we are required to maintain a minimum cash balance equal to the greater of (i) $10 million or (ii) forward three months projected cash burn. As security under our obligations, we issued to the lenders warrants to purchase a total of 634,146 shares of our common stock at an exercise price of $2.05. These warrants are classified as equity warrants with a fair value of $633,749. All outstanding principal and accrued interest on the term loans will be due and payable in full on the maturity date of February 1, 2020.
As security for our obligations under the loan and securities agreement, we granted HTGC, as administrative agent, a security interest in substantially all of our existing and after-acquired assets except for our intellectual property and certain other excluded assets. The loan and security agreement contains customary representations, warranties and covenants.
|
|
June 30,
2017
|
|
|
December 31,
2016
|
|
Term Loan Principal – Current
|
|
$
|
7,737,492
|
|
|
$
|
6,214,057
|
|
Issuance Cost/Loan Discount – Current
|
|
|
(1,036,452
|
)
|
|
|
(732,401
|
)
|
Term Loan, Net – Current
|
|
$
|
6,701,040
|
|
|
$
|
5,481,656
|
|
|
|
|
|
|
|
|
|
|
Long Term Loan Principal
|
|
$
|
14,835,146
|
|
|
$
|
18,785,943
|
|
End Fee Payable
|
|
|
1,771,250
|
|
|
|
1,771,250
|
|
Long Term Loan Discount/Issuance Cost
|
|
|
(792,889
|
)
|
|
|
(2,072,683
|
)
|
Long Term Loan, Net
|
|
$
|
15,813,507
|
|
|
$
|
18,484,510
|
|
On July 28, 2017, we entererd into an Amended Loan Services Agreement with the lenders of the Term Loans whereby we agreed to make an immediate payment of $5 million of principal and unpaid interest, a further $5 million payment of principal and unpaid interest by September 30, 2017, and agreed to an updated schedule of monthly payments and a new maturity date of August 1, 2018.
The interest expense on the loan for the three-month and six-month periods ended June 30, 2017 was $848,395 and $2,171,110, respectively, as compared to $741,346 and $1,158,148 for comparative 2016 periods.
5.
Basic and Diluted Net Loss Per Common Share
Basic and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding. Common share equivalents (which consist of options and warrants) are excluded from the computation of diluted net loss per common share where the effect would be anti-dilutive. Common share equivalents that could potentially dilute net loss per share in the future, and which were excluded from the computation of diluted loss per share, totaled 44.8 million shares for each of the three-month and six-month periods ended June 30, 2017, and 22.4 million shares for each of the three-month and six-month periods ended June 30, 2016.
6.
Warrant Liabilities
Liabilities measured at fair value on a recurring basis include warrant liabilities resulting from our equity financings. In accordance with ASC 815-40
, Derivatives and Hedging – Contracts in Entity's Own Equity
("ASC 815-40"), the warrant liabilities are recorded at fair value until they are completely settled. The warrants are valued using the Black-Scholes method, using assumptions consistent with the Company's application of ASC 505-50,
Equity-Based Payments to Non-Employees
("ASC 505-50"). The gain or loss resulting from the change in fair value is shown on the Condensed Statements of Operations as gain (loss) on warrant derivative liability. We recognized a loss of $4.3 million and a gain of $0.9 million for the three-month periods ended June 30, 2017 and 2016, respectively, and a loss of $4.3 million and a gain of $0.7 million for the six-month periods ended June 30, 2017 and 2016, respectively. The following reflects the weighted-average assumptions for each of the six-month periods indicated:
|
|
Six Months Ended June 30,
|
|
|
|
2017
|
|
|
2016
|
|
|
|
|
|
|
|
|
Risk-free interest rate
|
|
|
1.13
|
%
|
|
|
0.20
|
%
|
Expected dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
Expected lives
|
|
|
0.79
|
|
|
|
0.09
|
|
Expected volatility
|
|
|
125.3
|
%
|
|
|
59.3
|
%
|
Warrants classified as liabilities (in shares)
|
|
|
24,110,577
|
|
|
|
6,371,854
|
|
|
|
|
|
|
|
|
|
|
Our computation of expected volatility is based on the historical daily volatility of our publicly traded stock. The dividend yield assumption of zero is based upon the fact that we have never paid cash dividends and presently have no intention to do so. The risk-free interest rate used for each warrant classified as a derivative is equal to the U.S. Treasury rates in effect at June 30 of each year presented. The expected lives are based on the remaining contractual lives of the related warrants at the valuation date.
On July 19, 2017, 6,340,148 warrants expired.
7
.
Stock Based Compensation
We have a 2000 Long-Term Incentive Plan, which expired on August 6, 2010. As of June 30, 2017, there were approximately 0.4 million shares subject to outstanding stock options under this plan. No further shares are available for future grant under this plan.
We also have a 2008 Stock Incentive Plan. As of June 30, 2017, there were 16.4 million shares subject to outstanding stock options and 2.5 million shares outstanding related to restricted stock grants options and 10.4 million shares available for future grant under this plan.
We follow ASC 718,
Compensation-Stock Compensation,
which requires the measurement and recognition of compensation expense for all stock-based awards made to employees.
For stock options and stock warrants paid in consideration of services rendered by non-employees, we recognize compensation expense in accordance with the requirements of ASC 505-50.
Non-employee option grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period, the value of these options, as calculated using the Black-Scholes option-pricing model, is determined, and compensation expense recognized or recovered during the period is adjusted accordingly. As a result, the amount of the future compensation expense is subject to adjustment until the common stock options are fully vested.
The following table sets forth the total stock-based compensation expense resulting from stock options and warrants included in our Condensed Statements of Operations:
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Research and development — employee
|
|
$
|
278,533
|
|
|
$
|
507,195
|
|
|
$
|
631,616
|
|
|
$
|
988,006
|
|
General and administrative — employee
|
|
|
401,820
|
|
|
|
2,499,368
|
|
|
|
869,485
|
|
|
|
3,156,418
|
|
Total employee stock-based compensation
|
|
$
|
680,353
|
|
|
$
|
3,006,563
|
|
|
$
|
1,501,101
|
|
|
$
|
4,144,424
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development — non-employee
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
General and administrative — non-employee
|
|
|
36,578
|
|
|
|
32,506
|
|
|
|
65,237
|
|
|
|
220,462
|
|
Total non-employee stock-based compensation
|
|
$
|
36,578
|
|
|
$
|
32,506
|
|
|
$
|
65,237
|
|
|
$
|
220,462
|
|
During the six-month period ended June 30, 2017, we granted stock options to purchase 10,000 shares of our common stock at an average weighted exercise price of $0.41. During the six-month period ended June 30, 2016, we granted stock options to purchase 425,000 shares of our common stock and warrants to purchase 500,000 shares of our common stock at a weighted average exercise price of $1.74. In the three-month period ended June 30, 2016, we amended the terms of stock options of a former executive in respect of a Retirement Agreement, resulting in a one-time expense of approximately $1.9 million. The fair value of the stock options was estimated using the Black-Scholes option-pricing model, based on the following assumptions:
|
|
Six Months Ended
June 30, 2017
|
|
|
Six Months Ended
June 30, 2016
|
|
Risk-free interest rate
|
|
|
2.04
|
%
|
|
|
1.47
|
%
|
Expected volatility
|
|
|
85.5
|
%
|
|
|
76.3
|
%
|
Expected lives (years)
|
|
|
6
|
|
|
|
5 - 10
|
|
Expected dividend yield
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
Our computation of expected volatility is based on the historical daily volatility of our publicly traded stock. We use historical information to compute expected lives. In the six-month period ended June 30, 2017, the contractual term of the options granted was ten years. The dividend yield assumption of zero is based upon the fact we have never paid cash dividends and presently have no intention to do so. The risk-free interest rate used for each grant and issuance is equal to the U.S. Treasury rates in effect at the time of the grant and issuance for instruments with a similar expected life. Based on historical experience, for the six-month period ended June 30, 2016, we estimated annualized forfeiture rates of 10% for options granted to our employees, 2% for options granted to senior management and 0% for options granted to directors and non-employees and for warrants issued to non-employees Compensation costs will be adjusted for future changes in estimated forfeitures. We will record additional expense if the actual forfeitures are lower than estimated and will record a recovery of prior expense if the actual forfeiture rates are higher than estimated. On January 1, 2017, we adopted ASU 2016-09 and made a policy election to recognize forfeitures as they occur. The adoption of ASU 2016-09 did not have a material impact to the Company's financial condition or results of operations. No amounts relating to stock-based compensation have been capitalized.
As of June 30, 2017, there remained approximately $2.4 million of unrecognized compensation expense related to unvested stock options granted to current and former employees, directors, to be recognized as expense over a weighted-average period of 1.01 years. Presented below is our stock option activity:
|
|
Six Months Ended June 30, 2017
|
|
|
|
Number of Options
(Employees)
|
|
|
Number of Options
(Non-Employees)
|
|
|
Total Number of
Options
|
|
|
Weighted-Average
Exercise Price
|
|
Outstanding at January 1, 2017
|
|
|
16,879,770
|
|
|
|
600,000
|
|
|
|
17,479,770
|
|
|
$
|
2.37
|
|
Granted
|
|
|
10,000
|
|
|
|
—
|
|
|
|
10,000
|
|
|
$
|
0.41
|
|
Exercised, Forfeited or Expired
|
|
|
(646,847
|
)
|
|
|
—
|
|
|
|
(
646,847
|
)
|
|
$
|
3.16
|
|
Outstanding at June 30, 2017
|
|
|
16,242,923
|
|
|
|
600,000
|
|
|
|
16,842,932
|
|
|
$
|
2.34
|
|
Options exercisable at June 30, 2017
|
|
|
11,655,168
|
|
|
|
600,000
|
|
|
|
12,255,168
|
|
|
$
|
2.75
|
|
The following table summarizes significant ranges of outstanding stock options under our plans at June 30, 2017:
Range of Exercise
Prices
|
|
|
Total Number
of Options
|
|
|
Weighted-Average Remaining Contractual Life
(years)
|
|
|
Weighted-Average
Exercise Price
|
|
|
Total Number of Options
Exercisable
|
|
|
Weighted-Average Remaining Contractual Life
(years)
|
|
|
Weighted-Average
Exercise Price
|
|
$
|
0.41 - $1.50
|
|
|
|
4,317,533
|
|
|
|
9.45
|
|
|
$
|
0.44
|
|
|
|
1,586,461
|
|
|
|
9.46
|
|
|
$
|
0.44
|
|
$
|
1.51 – $2.50
|
|
|
|
8,669,296
|
|
|
|
7.32
|
|
|
$
|
2.26
|
|
|
|
6,835,946
|
|
|
|
7.07
|
|
|
$
|
2.22
|
|
$
|
2.51 – $4.00
|
|
|
|
960,670
|
|
|
|
6.64
|
|
|
$
|
2.88
|
|
|
|
937,337
|
|
|
|
6.61
|
|
|
$
|
2.87
|
|
$
|
4.01 – $32.55
|
|
|
|
2,895,424
|
|
|
|
5.69
|
|
|
$
|
5.24
|
|
|
|
2,895,424
|
|
|
|
5.69
|
|
|
$
|
5.24
|
|
|
|
|
|
|
16,842,923
|
|
|
|
7.55
|
|
|
$
|
2.34
|
|
|
|
12,255,168
|
|
|
|
7.02
|
|
|
$
|
2.75
|
|
The aggregate intrinsic value of all outstanding options and vested options as of June 30, 2017 was $0.8 million and $0.3 million, respectively, representing options with exercise prices of less than the closing fair market value of our common stock on June 30, 2017 of $0.63 per share.
There were 27,989,723 and 32,502,790 warrants outstanding at June 30, 2017 and December 31, 2016, respectively both at a weighted-average exercise price of $0.68.
Restricted Stock
In December 2016, the Company granted to our Chairman and Chief Executive Officer, 2,325,581 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years. The fair value of the restricted stock is based on the market price of the Company's shares on the grant date less the par value received as consideration. The fair value of the restricted stock on the grant date was $1,000,000. The Company recorded an employee stock-based compensation expense for restricted stock of approximately $83,029 and $165,146 respectively, for the three and six-month periods ended June 30, 2017 as compared to zero for the comparative 2016 periods.
8.
Fair Value Measurements
Assets and liabilities recorded at fair value on the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure the fair value. Level inputs are as follows:
Level 1 – quoted prices in active markets for identical assets or liabilities.
Level 2 – other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.
Level 3 – significant unobservable inputs that reflect management's best estimate of what market participants would use to price the assets or liabilities at the measurement date.
The
following
table summarizes fair value measurements by level at June 30, 2017 for assets and liabilities measured at fair value on a recurring basis:
(In thousands)
|
|
Level I
|
|
|
Level II
|
|
|
Level III
|
|
|
Total
|
|
Cash equivalents
|
|
$
|
53,485
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
53,485
|
|
Warrant liabilities
|
|
|
—
|
|
|
|
—
|
|
|
|
(6,567
|
)
|
|
|
(6,567
|
)
|
The following table summarizes fair value measurements by level at December 31, 2016 for assets and liabilities measured at fair value on a recurring basis:
(In thousands)
|
|
Level I
|
|
|
Level II
|
|
|
Level III
|
|
|
Total
|
|
Cash equivalents
|
|
$
|
56,276
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
56,276
|
|
Warrant liabilities
|
|
|
—
|
|
|
|
—
|
|
|
|
(3,789
|
)
|
|
|
(3,789
|
)
|
Liabilities measured at market value on a recurring basis include warrant liabilities resulting from recent debt and equity financings. In accordance with ASC 815-40, the warrant liabilities are marked to market each quarter-end until they are completely settled. The warrants are valued using the Black-Scholes method, using assumptions consistent with our application of ASC 505-50. The $2.8 million increase in fair value of the warrant liabilities is due to the significant excess of the exercise price over the Company's stock price as of June 30, 2017 and the close proximity to the expiration date of the warrants (see Note 6).
We consider carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments.
Our non-financial assets are measured at fair value when there is an indicator of impairment and recorded at fair value only when an impairment charge is recognized. Our non-financial assets were not material at
June 30, 2017
or
2016
.
9
.
Liquidity and Capital Resources
At June 30, 2017, we had cash and cash equivalents of approximately $55.0 million. On July 27, 2017, we entered into a global strategic licensing agreement with NantCell Inc ("NantCell") for the exclusive rights to develop, manufacture and commercialize aldoxorbuicin for all indications. Under the terms of this Agreement, NantCell made a strategic investment into our Company by purchasing $13 million of our common stock. Concurrently, we announced the signing of an amendment to the Loan Services Agreement with Hercules whereby we made an immediate principal repayment of $5 million, a further $5 million repayment by September 30, 2017, and an updated schedule of monthly instalments with a new Term Loan maturity date of August 1, 2018. Under the NantCell license, NantCell agreed to assume all future costs of developing and commercializing aldoxorubicin. Management believes that our
current cash and cash equivalents, along with the net proceeds of the common stock purchase (Se
e Note 13),
will be sufficient to fund our operations for the foreseeable future.
The estimate is based, in part, upon our currently projected expenditures for the remainder of 2017 and the first seven months of 2018 of approximately $35.6 million
,
which
includes approximately $4.7 million for our clinical programs for aldoxorubicin, approximately $3.7 million for the research and clinical development of novel anti-cancer drug candidates at our Freiburg operations, approximately $1.1 million for general operation of our clinical programs, approximately $9.4 million for other general and administrative expenses, and approximately $16.6 million for interest and payments on the term loan. These projected expenditures are also based upon numerous other assumptions and subject to many uncertainties, and our actual expenditures may be significantly different from these projections.
If our licensing partner obtains marketing approval and successfully commercializes aldoxorubicin, we anticipate it could take several
years, for it to generate significant recurring revenue. We will be dependent on future financing and possible other strategic partnerships until such time, if ever, as it can generate significant recurring revenue. We have no commitments from third parties to provide any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. If we fail to obtain sufficient funding when needed, we may be forced to delay, scale back or eliminate all or a portion of our development programs, seek to license to other companies our product candidates or technologies that we would prefer to develop and commercialize ourself, or seek to sell some or all of our assets or merge with or be acquired by another company.
10.
Equity Transactions
In the first quarter of 2017, there were 3,108 shares of our outstanding Series B Convertible Preferred converted by the holders into 7.4 million shares of our common stock.
In the second quarter of 2017, there were 4,404,494 shares of our common stock issued from the exercise of warrants.
On May 2, 2017, we issued 30.0 million shares of our common stock in a public offering.
As of June 30, 2017, we have reserved approximately 10.4 million of our authorized but unissued shares of common stock for future issuance pursuant to our employee stock option plans issued to employees and consultants.
11.
Income Taxes
At December 31, 2016, we had federal and state net operating loss carryforwards as of $339.0 million and $224.0 million, respectively, available to offset against future taxable income, which expire in 2017 through 2036, of which $152.0 million and $145.0 million, respectively, are not subject to limitation under Section 382 of the Internal Revenue Code.
12.
Commitments and contingencies
Commitments
We
have an agreement with KTB Tumorforschungs GmbH, or KTB, for the Company's exclusive license of patent rights held by KTB for the worldwide development and commercialization of aldoxorubicin. Under the agreement, we must make payments to KTB in the aggregate of $6.0 million upon meeting clinical and regulatory milestones up to and including the product's second final marketing approval. We also have agreed to pay:
·
|
commercially reasonable royalties based on a percentage of net sales (as defined in the agreement);
|
·
|
a percentage of non-royalty sub-licensing income (as defined in the agreement); and
|
·
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milestones of $1 million for each additional final marketing approval that we obtain.
|
In the event that we must pay a third party in order to exercise our right to the intellectual property under the agreement, we will deduct a percentage of those payments from the royalties due KTB, up to an agreed upon cap. As a result of the NantCell license and the sale of $13 million of our shares to NantCell, we will incur an obligation to pay KTB approximately $0.6 million.
Contingencies
We applied
the disclosure provisions of ASC 460,
Guarantees
("ASC 460") to our agreements that contain guarantees or indemnities by us. We provide (i) indemnifications of varying scope and size to certain investors and other parties for certain losses suffered or incurred by the indemnified party in connection with various types of third-party claims; and (ii) indemnifications of varying scope and size to officers and directors against third party claims arising from the services they provide to us.
Shareholder Derivative Actions in Delaware
. There are two competing derivative complaints pending in the Delaware Court of Chancery alleging claims related to our alleged retention of DreamTeamGroup and MissionIR. On December 14, 2015, a shareholder derivative complaint, captioned
Niedermeyer et al. v. Kriegsman et al.
, C.A. No. 11800, was filed against certain of our officers and directors, for which a second amended complaint was filed on October 12, 2016. On September 6, 2016, one of the plaintiffs in the California litigation (discussed above) effectively refiled his complaint in the Delaware Court of Chancery, with the case captioned
Taylor v. Kriegsman
, C.A. No. 12720. Following competing motions for appointment of a lead plaintiff and lead counsel, On February 22, 2017, the Court of Chancery appointed
Niedermeyer et al.
as lead plaintiffs in the complaint. On May 3, 2017, the parties entered into negotiations with a mediator and on June 2, 2017, the parties entered into a Memorandum of Understanding ("MOU") to settle the entire action. On June 15, 2017, the MOU was submitted to the Court.
Class Action in California.
On July 25 and 29, 2016, nearly identical class action complaints were filed in the U.S. District Court for the Central District of California, titled
Crihfield v. CytRx Corp., et al.
, Case No. 2:16-cv-05519 and
Dorce v. CytRx Corp.
, Case No. 2:16-cv-05666 alleging that we and certain of our officers violated the Securities Exchange Act of 1934 by allegedly making materially false and/or misleading statements, and/or failing to disclose material adverse facts to the effect that the clinical hold placed on the Phase 3 trial of aldoxorubicin for STS would prevent sufficient follow-up for patients involved in the study, thus requiring further analysis, which could cause the trial's results and/or FDA approval to be materially adversely affected or delayed. The plaintiffs allege that such wrongful acts and omissions caused significant losses and damages to a class of persons and entities that acquired our securities between November 18, 2014 and July 11, 2016, and seek an award of compensatory damages, costs and expenses, including counsel and expert fees, and such other and further relief as the Court may deem just and proper. On October 26, 2016, the Court entered an Order consolidating the actions titled
In re: CytRx Corporation Securities Litigation
, Master File No. 16-cv-05519-SJO and appointing a Lead Plaintiff and Lead Counsel. Following the filing of a first amended complaint on January 13, 2017, on March 14, 2017 the Company and the individual defendants filed a Motion to Dismiss. Plaintiff filed an Opposition thereto on April 28, 2017. The Company and the individual defendants filed a Reply on May 30, 2017 and the matter was heard by the Court on June 12, 2017. On June 14, 2017, the Court issued an Order granting the Motion to Dismiss with leave to amend. Plaintiff filed a Second Amended Complaint and the Individual Defendants filed a renewed Motion to Dismiss. Plaintiff filed an Opposition thereto on July 24, 2017. The Company and the Individual Defendants filed a Reply on July 31, 2017 and the matter is set to be heard by the Court on August 14, 2017.
The Company intends to vigorously defend against the foregoing complaints. CytRx has directors' and officers' liability insurance, which will be utilized in the defense of these matters. The liability insurance may not cover all of the future liabilities the Company may incur in connection with the foregoing matters.
These claims are subject to inherent uncertainties, and management's view of these matters may change in the future.
11
The Company evaluates developments in legal proceedings and other matters on a quarterly basis.
The Company records accruals for loss contingencies to the extent that the Company concludes that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. The Company has accrued $0.7 million of litigation settlement related to Shareholder Derivative actions.
We evaluate developments in legal proceedings and other matters on a quarterly basis. If an unfavorable outcome becomes probable and reasonably estimable, we could incur charges that could have a material adverse impact on our financial condition and results of operations for the period in which the outcome becomes probable and reasonably estimable.
13. Subsequent Events
On July 27, 2017, we entered into a global strategic license agreement (the "License Agreement") with NantCell, Inc. ("NantCell"), for providing NantCell the exclusive rights to develop and commercialize aldoxorubicin for all indications. Under the terms of the License Agreement, CytRx is entitled to receive up to $343 million in milestone payments related to regulatory approvals and commercial milestones for aldoxorubicin. In addition, CytRx will receive certain specified royalties for all other indications (our receipt of which would obligate us to make certain payments to KTB). NantCell will be responsible for all future development, manufacturing and commercialization expenses, other than royalties and milestones that may be owed by CytRx under its existing license agreements.
In connection with the License Agreement, on July 27, 2017, CytRx (i) entered into a stock purchase agreement with NantCell in which NantCell purchased $13 million of CytRx common stock at $1.10 per share, a 92% premium to market on that date, and (ii) issued to NantCell a warrant to purchase up to 3 million shares of common stock at $1.10, expiring on January 27, 2019.
On July 27, 2017, we entered into a First Amendment to Loan and Security Agreement with Hercules to amend our existing long-term loan facility (the "Loan Agreement") originally entered into on February 5, 2016. The amendment provides for our payment, on July 28, 2017, of $5.0 million in outstanding principal and unpaid interest due under the Loan Agreement, plus a $100,000 prepayment charge, and for our repayment, on or prior to September 30, 2017, of an additional $5.0 million outstanding principal and unpaid interest due under the Loan Agreement, plus an additional prepayment charge. We made the first $5 million payment on July 28, 2017. In connection with the Loan Agreement, in February 2016 we issued the lenders warrants to purchase an aggregate of up to approximately 630,000 shares of our common stock at an exercise price of $2.05 per share. Pursuant to the amendment, a portion of the warrants (representing 80% of the total number of shares issuable upon exercise of the warrants) was amended to change the exercise price of that portion of the warrants from $2.05 per share to a reduced amount, to be calculated based upon the 30-day volume-weighted average price of our common stock over the 30-day period beginning 15 days before the July 28, 2017 announcement of the NantCell license transaction.