ITEM 1.
|
FINANCIAL STATEMENTS
|
RXi PHARMACEUTICALS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and
per share data)
(Unaudited)
|
|
June 30,
2018
|
|
|
December 31,
2017
|
|
ASSETS
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
5,315
|
|
|
$
|
3,581
|
|
Restricted cash
|
|
|
50
|
|
|
|
50
|
|
Prepaid expenses and other current assets
|
|
|
459
|
|
|
|
201
|
|
Total current assets
|
|
|
5,824
|
|
|
|
3,832
|
|
Property and equipment, net
|
|
|
207
|
|
|
|
248
|
|
Other assets
|
|
|
–
|
|
|
|
18
|
|
Total assets
|
|
$
|
6,031
|
|
|
$
|
4,098
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
542
|
|
|
$
|
511
|
|
Accrued expenses
|
|
|
2,217
|
|
|
|
1,754
|
|
Total current liabilities
|
|
|
2,759
|
|
|
|
2,265
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value, 10,000,000 shares authorized; no shares issued or outstanding
|
|
|
–
|
|
|
|
–
|
|
Common stock, $0.0001 par value, 100,000,000 shares authorized; 4,360,566 and 2,429,993 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively
|
|
|
–
|
|
|
|
–
|
|
Additional paid-in capital
|
|
|
85,963
|
|
|
|
80,384
|
|
Accumulated deficit
|
|
|
(82,691
|
)
|
|
|
(78,551
|
)
|
Total stockholders’ equity
|
|
|
3,272
|
|
|
|
1,833
|
|
Total liabilities and stockholders’ equity
|
|
$
|
6,031
|
|
|
$
|
4,098
|
|
The accompanying notes are an integral part
of these condensed consolidated financial statements.
RXi PHARMACEUTICALS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Amounts in thousands, except share and
per share data)
(Unaudited)
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Revenues
|
|
$
|
58
|
|
|
$
|
–
|
|
|
$
|
81
|
|
|
$
|
–
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,183
|
|
|
|
1,329
|
|
|
|
2,544
|
|
|
|
2,676
|
|
Acquired in-process research and development
|
|
|
–
|
|
|
|
85
|
|
|
|
–
|
|
|
|
4,696
|
|
General and administrative
|
|
|
774
|
|
|
|
1,100
|
|
|
|
1,675
|
|
|
|
2,223
|
|
Total operating expenses
|
|
|
1,957
|
|
|
|
2,514
|
|
|
|
4,219
|
|
|
|
9,595
|
|
Operating loss
|
|
|
(1,899
|
)
|
|
|
(2,514
|
)
|
|
|
(4,138
|
)
|
|
|
(9,595
|
)
|
Total other expense, net
|
|
|
(2
|
)
|
|
|
–
|
|
|
|
(2
|
)
|
|
|
–
|
|
Loss before income taxes
|
|
|
(1,901
|
)
|
|
|
(2,514
|
)
|
|
|
(4,140
|
)
|
|
|
(9,595
|
)
|
Income tax benefit
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
1,621
|
|
Net loss
|
|
$
|
(1,901
|
)
|
|
$
|
(2,514
|
)
|
|
$
|
(4,140
|
)
|
|
$
|
(7,974
|
)
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.46
|
)
|
|
$
|
(1.12
|
)
|
|
$
|
(1.25
|
)
|
|
$
|
(3.71
|
)
|
Weighted average shares: basic and diluted
|
|
|
4,102,423
|
|
|
|
2,238,836
|
|
|
|
3,302,885
|
|
|
|
2,148,477
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part
of these condensed consolidated financial statements.
RXi PHARMACEUTICALS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS
(Amounts in thousands)
(Unaudited)
|
|
Six Months Ended
June 30,
|
|
|
|
|
2018
|
|
|
|
2017
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,140
|
)
|
|
$
|
(7,974
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
41
|
|
|
|
27
|
|
Non-cash stock-based compensation
|
|
|
78
|
|
|
|
233
|
|
Acquired in-process research and development
|
|
|
–
|
|
|
|
4,696
|
|
Deferred taxes
|
|
|
–
|
|
|
|
(1,621
|
)
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid expenses and other assets
|
|
|
(240
|
)
|
|
|
(187
|
)
|
Accounts payable
|
|
|
31
|
|
|
|
(378
|
)
|
Accrued expenses
|
|
|
463
|
|
|
|
88
|
|
Net cash used in operating activities
|
|
|
(3,767
|
)
|
|
|
(5,116
|
)
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Cash acquired in MirImmune Inc. acquisition
|
|
|
–
|
|
|
|
100
|
|
Cash paid for purchase of property and equipment
|
|
|
–
|
|
|
|
(188
|
)
|
Net cash used in investing activities
|
|
|
–
|
|
|
|
(88
|
)
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Net proceeds from the issuance of common stock and warrants
|
|
|
5,501
|
|
|
|
–
|
|
Net cash provided by financing activities
|
|
|
5,501
|
|
|
|
–
|
|
Net increase (decrease) in cash, cash equivalents and restricted cash
|
|
|
1,734
|
|
|
|
(5,204
|
)
|
Cash, cash equivalents and restricted cash at the beginning of period
|
|
|
3,631
|
|
|
|
12,956
|
|
Cash, cash equivalents and restricted cash at the end of period
|
|
$
|
5,365
|
|
|
$
|
7,752
|
|
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
|
|
|
|
|
Conversions of Series B convertible preferred stock into common stock
|
|
$
|
–
|
|
|
$
|
3,525
|
|
Conversion of Series C convertible preferred stock into common stock
|
|
$
|
–
|
|
|
$
|
816
|
|
MirImmune Inc. Acquisition:
|
|
|
|
|
|
|
|
|
Cancellation of notes receivable
|
|
$
|
–
|
|
|
$
|
150
|
|
Accounts payable assumed
|
|
$
|
–
|
|
|
$
|
5
|
|
Fair value of securities issued
|
|
$
|
–
|
|
|
$
|
2,824
|
|
The accompanying notes are an integral part
of these condensed consolidated financial statements.
RXi PHARMACEUTICALS CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(Unaudited)
1. Nature of Operations
RXi
Pharmaceuticals Corporation (“
RXi
,” “
we
,” “
our
” or the “
Company
”)
is a biotechnology company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (“
sd-rxRNA
®
”)
therapeutic platform. The Company’s sd-rxRNA compounds do not require a delivery vehicle to penetrate the cell
and are designed to “silence,” or down-regulate, the expression of a specific gene that may be over-expressed in a
disease condition. We believe that this provides RXi with a distinct advantage in adoptive cell transfer therapy, the Company’s
initial focus and approach to immuno-oncology.
Prior
to RXi’s acquisition of MirImmune Inc. in January 2017, the Company’s principal activities consisted of the
preclinical and clinical development of the Company’s sd-rxRNA compounds and topical immunotherapy agent in
the areas of dermatology and ophthalmology. In January 2018, after a thorough review of its business operations, development
programs and financial resources, the Company made a strategic decision to focus solely on immuno-oncology to accelerate
growth and support a potential return on investment for its stockholders. The Company’s business strategy focuses on
the development of immuno-oncology therapeutics utilizing our proprietary sd-rxRNA technology. The Company intends
to seek a partner and/or out-licensee for each of its dermatology and ophthalmology franchises, including RXI-109
and Samcyprone™, to continue their development. The goal of any such transaction would be to allow the Company to
monetize these preclinical and clinical assets to further fund ongoing and future development work in our immuno-oncology
programs and extend our financial runway.
On January 3, 2018, the Board
of Directors of the Company approved a 1-for-10 reverse stock split of the Company’s outstanding common stock, which was
effected on January 8, 2018. All share and per share amounts in the financial statements have been retroactively adjusted
for all periods presented to give effect to the reverse stock split, including reclassifying an amount equal to the reduction in
par value to additional paid-in capital.
2. Liquidity and Going Concern
The Company has limited cash resources
and has expended substantial funds on the research and development of the Company’s product candidates and funding general
operations. As a result, the Company has reported recurring losses from operations since inception and expects that the Company
will continue to have negative cash flows from its operations for the foreseeable future. Historically, the Company’s primary
source of financing has been the sale of its securities. The Company’s ability to continue to fund its operations is dependent
on the amount of cash on hand and its ability to raise additional capital through, but not limited to, equity or debt offerings
or strategic opportunities. This is dependent on a number of factors, including the market demand or liquidity of the Company’s
common stock. There can be no assurance that the Company will be successful in accomplishing these plans.
The funds available under
the Company’s purchase agreement with Lincoln Park Capital Fund, LLC (“
LPC
”) should provide the
Company with sufficient cash to fund operations for at least the next twelve months. However, certain ownership
limitations under the terms of the purchase agreement preclude the Company from relying on the full available funds for going
concern purposes. As a result, the Company has concluded that there is substantial doubt regarding its ability to continue as
a going concern for at least the next twelve months. If the Company fails to obtain additional funding when needed, the
Company would be forced to scale back or terminate its operations or to seek to merge with or to be acquired by another
company. These financial statements do not include any adjustments to, or classification of, recorded asset amounts and
classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
3. Significant Accounting Policies
Basis of Presentation
The
accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with accounting principles
generally accepted in the United States of America (“
GAAP
”). Certain information and footnote disclosures included
in the Company’s annual financial statements have been condensed or omitted. The year-end condensed balance sheet
data was derived from audited financial statements, but does not include all disclosures required by GAAP. In the opinion of management,
all adjustments (including normal recurring accruals) considered necessary for a fair presentation of the condensed consolidated
financial statements have been included. Interim results are not necessarily indicative of results for a full year.
Principles of Consolidation
The consolidated financial statements include
the accounts of RXi Pharmaceuticals Corporation and its wholly-owned subsidiary, MirImmune, LLC. All material intercompany accounts
have been eliminated in consolidation.
Uses of Estimates in Preparation of Financial Statements
The preparation of financial statements in
accordance 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 financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could differ materially from these estimates.
Cash Equivalents and Restricted Cash
The Company considers all highly liquid instruments
with an original maturity of three months or less to be cash equivalents. Cash equivalents consist primarily of amounts invested
in certificates of deposit.
Restricted cash consists of certificates
of deposit held by financial institutions as collateral for the Company’s corporate credit cards.
Fair Value of Financial Instruments
The carrying amounts reported in the balance
sheet for cash equivalents, restricted cash, accounts payable and accrued expenses approximate their fair values due to their short-term
nature.
Research and Development Expenses
Research
and development costs relate to salaries, employee benefits, facility-related expenses, supplies, stock-based compensation related
to employees and non-employees involved in the Company’s research and development, external services, other operating
costs and overhead related to its research and development departments, costs to acquire technology licenses and expenses associated
with preclinical activities and its clinical trials. Research and development expenses are charged to expense as incurred. Payments
made by the Company in advance for research and development services not yet provided and/or for materials not yet received are
recorded as prepaid expenses and expensed when the service has been performed or when the goods have been received. Accrued liabilities
are recorded related to those expenses for which vendors have not yet billed the Company with respect to services provided and/or
materials that it has received.
Preclinical
and clinical trial expenses relate to estimates of costs incurred and fees connected with clinical trial sites, third-party clinical
research organizations and other preclinical and clinical related activities and include such items as subject-related fees, laboratory
work, investigator fees and analysis costs. Costs associated with these expenses are generally payable on the passage of time or
when certain milestones are achieved. Expense is recorded during the period incurred or in the period in which a milestone is achieved.
In order to ensure that the Company has adequately provided for preclinical and clinical expenses during the proper period, the
Company maintains an accrual to cover these expenses. These accruals are assessed on a quarterly basis and are based on such assumptions
as expected total cost, the length of the study, timing of certain milestones and other information available to us. Actual results
may differ from these estimates and could have a material impact on the Company’s reported results. The Company’s historical
accrual estimates have not been materially different from its actual costs.
Stock-based Compensation
The Company follows the provisions of
the Financial Accounting Standards Board (“
FASB
”) Accounting Standards Codification
(“
ASC
”) Topic 718, “
Compensation — Stock Compensation
” (“
ASC
718
”), which requires the measurement and recognition of compensation expense for all stock-based payment awards
made to employees, officers, non-employee directors, and non-employees, including stock options. Stock compensation expense
based on the grant date fair value estimated in accordance with the provisions of ASC 718 is recognized as an expense over
the requisite service period.
Income Taxes
The
Company recognizes assets or liabilities for the deferred tax consequences of temporary differences between the tax basis of assets
or liabilities and their reported amounts in the financial statements in accordance with the FASB ASC Topic 740,
“Accounting
for Income Taxes”.
On December 22, 2017, the President of the United States signed into law the Tax Cuts and
Jobs Act tax reform legislation. This legislation makes significant changes in U.S. tax law including a reduction in the corporate
tax rates, changes to net operating loss carryforwards and carrybacks, and a repeal of the corporate alternative minimum tax. There
has been no impact to the Company’s income tax expense as a result of the Tax Cuts and Jobs Act. The Company is still assessing
the impact of the Tax Cuts and Jobs Act and does not expect the other provisions to have a material impact on the Company’s
financial statements.
Comprehensive Loss
The Company’s comprehensive loss is
equal to its net loss for all periods presented.
Net Loss per Share
The
Company accounts for and discloses net loss per share in accordance with the FASB ASC Topic 260, “
Earnings per
Share”.
Basic and diluted net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding. Diluted earnings per share is computed by dividing the
Company’s net earnings by the weighted average number of common shares outstanding and the impact of all dilutive
potential common shares.
4. Recent Accounting Pronouncements
In
May 2014, the FASB issued Accounting Standards Update (“
ASU
”) 2014-09, “
Revenue from Contracts
with Customers (Topic 606)
”. ASU 2014-09 states that an entity should recognize revenue to depict the transfer
of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled
in exchange for those goods or services. On July 9, 2015, the FASB voted to delay the effective date of the new revenue standard
by one year but to permit entities to choose to adopt the standard as of the original effective date. In March 2016, the FASB issued
ASU 2016-08, “
Revenue from Contracts with Customers (Topic 606) – Principal Versus Agent Considerations,”
which
improves the operability and understandability of the implementation guidance on principal versus agent considerations. In April
2016, the FASB issued ASU 2016-10, “
Revenue from Contracts with Customers (Topic 606) – Identifying Performance
Obligations and Licensing
,” which clarifies two aspects of the guidance on accounting for revenue contracts with customers:
identifying performance obligations and the licensing implementation guidance. In May 2016, the FASB issued ASU 2016-12, “
Revenue
from Contracts with Customers (Topic 606) – Narrow Scope Improvements and Practical Expedient
s,” which addresses
collectability assessment, presentation of sales taxes, noncash consideration and completed contracts and contract modifications
at transition. The amendments in these ASUs do not change the core principles for those areas. This standard became effective for
annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Early
adoption is not permitted. The Company adopted this ASU in the first quarter of 2018. Since the Company has no significant revenue,
this ASU had no immediate impact on its consolidated financial statements.
In
February 2016, the FASB issued ASU 2016-02, “
Leases (Topic 842)
,” which requires companies that
are lessees to recognize a right-of-use asset and lease liability for most leases that do not meet the definition
of a short-term lease. For income statement purposes, leases will continue to be classified as either operating or financing.
Classification will be based on criteria that are largely similar to those applied in current lease accounting. This standard
will result in extensive qualitative and quantitative disclosure changes. This standard will be effective for annual
reporting periods beginning after December 15, 2018, including interim periods within that reporting period. The Company is
currently evaluating the impact of this ASU on its consolidated financial statements.
In June 2018, the FASB issued ASU 2018-07,
“
Compensation – Stock Compensation (Topic 718) – Improvements to Nonemployee Share-Based Payment Accounting
,”
which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees.
The amendment specifies that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services
to be used or consumed in a grantor’s own operations by issuing share-based payment awards. This standard will be effective
for annual reporting periods beginning after December 15, 2018, including interim periods within that reporting period. Early adoption
is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company early adopted this ASU in the second
quarter of 2018. The ASU had no material impact on the Company’s consolidated financial statements.
5. Stockholders’ Equity
Lincoln Park Capital Fund, LLC –
On August 8, 2017, the Company entered into a purchase agreement (the “
LPC Purchase Agreement
”) and a registration
rights agreement with LPC, pursuant to which the Company has the right to sell to LPC shares of the Company’s common stock,
subject to certain limitations and conditions set forth in the LPC Purchase Agreement.
During the three months ended June 30, 2018,
the Company sold 150,000 shares of common stock to LPC for net proceeds of approximately $359,000. During the six months ended
June 30, 2018, the Company sold 420,000 shares of common stock to LPC for net proceeds of approximately $1,291,000.
April 2018 Registered Direct
Offering and Private Placement
– On April 11, 2018, the Company closed a registered direct offering of 1,510,604
shares of the Company’s common stock at a purchase price of $3.15 per share (the “
Offering
”)
pursuant to the Securities Purchase Agreement dated as of April 9, 2018, by and among the Company and each purchaser
identified on the signature pages thereto. In a concurrent private placement, the Company sold warrants
(the “
Warrants
”) to purchase a total of 1,132,953 shares of common stock at a purchase price of $0.125
per underlying warrant share and with an exercise price of $3.15 per share (the “
Private Placement
”).
In connection with the Offering and Private Placement, the Company issued warrants to purchase a total of 75,530 shares
of common stock with an exercise price of $4.0546 per share to the placement agent, H.C. Wainwright & Co., LLC
(the “
Placement Agent Warrants
”). Assuming the Warrants and Placement Agent Warrants are not exercised,
net proceeds to the Company from the Offering and Private Placement were $4,210,000 after deducting placement agent fees
and offering expenses paid by the Company.
The
Company assessed the Warrants and Placement Agent Warrants under the FASB ASC Topic 480, “
Distinguishing Liabilities from
Equity
” (“
ASC 480
”) and determined that the Warrants and Placement Agent Warrants were outside the
scope of ASC 480. The Company next assessed the Warrants and Placement Agent Warrants under the FASB ASC Topic 815, “
Derivatives
and Hedging
” (“
ASC 815
”). Under the related guidance, a reporting entity shall not consider a contract
to be a derivative instrument if the contract is both (1) indexed to the entity’s own stock and (2) classified
in stockholders’ equity. The Company determined that the Warrants and Placement Agent Warrants were indexed to the Company’s
stock, as the agreements do not contain any exercise contingencies and the settlement amount equals the difference between the
fair value of the Company’s common stock price and the strike price. The Company also assessed the classification in stockholders’
equity and determined the Warrants and Placement Agent Warrants met all of the criteria for classification as equity under ASC
815. Based on this analysis, the Company determined that the Warrants and Placement Agent Warrants would be classified in stockholders’
equity.
Warrants —
The following table
summarizes the Company’s outstanding equity-classified warrants at June 30, 2018:
|
|
|
|
|
|
|
|
Exercise price
|
|
|
Number of Shares
Underlying Warrants
|
|
|
Expiration
|
|
$
|
52.00
|
|
|
|
130,007
|
|
|
|
June 2, 2020
|
|
$
|
9.00
|
|
|
|
1,277,793
|
|
|
|
December 21, 2021
|
|
$
|
3.15
|
|
|
|
1,132,953
|
|
|
|
May 31, 2023
|
|
$
|
4.0546
|
|
|
|
75,530
|
|
|
|
April 9, 2023
|
|
|
Total warrants outstanding
|
|
|
|
2,616,283
|
|
|
|
|
|
6. Net Loss per Share
The following table sets forth the potential
common shares excluded from the calculation of net loss per share because their inclusion would be anti-dilutive:
|
|
June 30,
|
|
|
|
2018
|
|
|
2017
|
|
Options to purchase common stock
|
|
|
53,180
|
|
|
|
67,745
|
|
Warrants to purchase common stock
|
|
|
2,616,283
|
|
|
|
1,407,800
|
|
Total
|
|
|
2,669,463
|
|
|
|
1,475,545
|
|
7. Stock-based Compensation
The Company uses the Black-Scholes option-pricing
model to determine the fair value of all its option grants. For valuing options granted during the three and six months ended June
30, 2018 and 2017, the following assumptions were used:
|
|
For
the Three Months Ended
June
30,
|
|
|
For
the Six Months Ended
June
30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Risk-free interest rate
|
|
|
2.93
|
%
|
|
|
1.73 – 2.25
|
%
|
|
|
2.70 – 2.93
|
%
|
|
|
1.73 – 2.49
|
%
|
Expected volatility
|
|
|
95.77
|
%
|
|
|
82.99 – 115.18
|
%
|
|
|
91.28 – 95.77
|
%
|
|
|
82.99 – 123.01
|
%
|
Weighted average expected volatility
|
|
|
95.77
|
%
|
|
|
85.51
|
%
|
|
|
92.84
|
%
|
|
|
84.63
|
%
|
Expected lives (in years)
|
|
|
5.50
|
|
|
|
5.20 – 10.00
|
|
|
|
5.50 – 10.00
|
|
|
|
5.20 – 10.0
|
0
|
Expected dividend yield
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
The weighted average fair value of
options granted during the three months ended June 30, 2018 and 2017 was $1.72 and $4.70, respectively. The weighted average fair
value of options granted during the six months ended June 30, 2018 and 2017 was $2.80 and $4.90, respectively.
The risk-free interest rate used for each
grant is based upon the yield on zero-coupon U.S. Treasury securities with a term similar to the expected life of the related option.
The Company’s expected stock price volatility assumption is based upon the Company’s own implied volatility. The expected
life assumption for option grants is based upon the simplified method provided for under ASC 718. The dividend yield assumption
is based upon the fact that the Company has never paid cash dividends and presently has no intention of paying cash dividends.
The following table summarizes the activity
of Company’s stock option plan for the six months ended June 30, 2018:
|
|
|
Total Number
of Shares
|
|
|
Weighted-
Average
Exercise
Price
Per Share
|
|
|
Aggregate
Intrinsic
Value
|
|
|
Balance at December 31, 2017
|
|
|
|
50,180
|
|
|
$
|
192.30
|
|
|
|
|
|
|
Granted
|
|
|
|
3,000
|
|
|
|
3.32
|
|
|
|
|
|
|
Exercised
|
|
|
|
–
|
|
|
|
–
|
|
|
|
|
|
|
Cancelled
|
|
|
|
–
|
|
|
|
–
|
|
|
|
|
|
|
Balance at June 30, 2018
|
|
|
|
53,180
|
|
|
$
|
181.63
|
|
|
$
|
–
|
|
|
Exercisable at June 30, 2018
|
|
|
|
37,881
|
|
|
$
|
250.86
|
|
|
$
|
–
|
|
The Company recorded stock-based compensation
expense in the condensed consolidated statement of operations for the three and six months ended June 30, 2018 and 2017 as follows,
in thousands:
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Research and development
|
|
$
|
11
|
|
|
$
|
40
|
|
|
$
|
20
|
|
|
$
|
73
|
|
General and administrative
|
|
|
26
|
|
|
|
79
|
|
|
|
58
|
|
|
|
160
|
|
Total stock-based compensation
|
|
$
|
37
|
|
|
$
|
119
|
|
|
$
|
78
|
|
|
$
|
233
|
|
ITEM 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
|
In this document, “we,” “our,” “ours,”
“us,” “RXi” and the “Company” refers to RXi Pharmaceuticals Corporation and our subsidiary,
MirImmune, LLC and the ongoing business operations of RXi Pharmaceuticals Corporation and MirImmune, LLC, whether conducted through
RXi Pharmaceuticals Corporation or MirImmune, LLC.
This management’s discussion and analysis of financial
condition as of June 30, 2018 and results of operations for the three and six months ended June 30, 2018 and 2017 should be read
in conjunction with the financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2017, which was filed with the Securities and Exchange Commission on March 26, 2018.
This report contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as
“intends,” “believes,” “anticipates,” “indicates,” “plans,” “expects,”
“suggests,” “may,” “should,” “potential,” “designed to,” “will”
and similar references, although not all forward-looking statements contain these words. Forward-looking statements are neither
historical facts nor assurances of future performance. These statements are based only on our current beliefs, expectations and
assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the
economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties,
risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results
and financial condition may differ materially from those indicated in the forward-looking statements as a result of a number of
important factors, including those identified in our Annual Report on Form 10-K for the year ended December 31, 2017 under the
heading “Risk Factors” and in other filings the Company periodically makes with the Securities and Exchange Commission.
Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements contained in this Quarterly
Report on Form 10-Q speak as of the date hereof and the Company does not undertake to update any of these forward-looking statements
to reflect a change in its views or events or circumstances that occur after the date of this report.
Overview
RXi
Pharmaceuticals Corporation is a biotechnology company developing the next generation of immuno-oncology therapeutics based on
its self-delivering RNAi (“
sd-rxRNA
®
”) therapeutic platform. Our sd-rxRNA compounds
do not require a delivery vehicle to penetrate the cell and are designed to “silence,” or down-regulate, the expression
of a specific gene that may be over-expressed in a disease condition. We believe that this provides the Company with a distinct
advantage in adoptive cell transfer (“
ACT
”) therapy, the Company’s initial focus and approach to immuno-oncology.
Prior
to the Company’s acquisition of MirImmune Inc. (“
MirImmune
”) in January 2017, the Company’s principal
activities consisted of the preclinical and clinical development of our sd-rxRNA compounds and topical immunotherapy
agent in the areas of dermatology and ophthalmology. In January 2018, after a thorough review of our business operations, development
programs and financial resources, the Company made a strategic decision to focus solely on immuno-oncology to accelerate growth
and support a potential return on investment for its stockholders. The Company’s business strategy focuses on the development
of immuno-oncology therapeutics utilizing our proprietary sd-rxRNA technology. The Company intends to seek a partner
and/or out-licensee for both its dermatology and ophthalmology franchises, including RXI-109 and Samcyprone™, to
continue their development. The goal of any such transaction would be to allow the Company to monetize these preclinical and clinical
assets to further fund ongoing and future development work in our immuno-oncology programs and extend our financial runway.
In
ACT, immune cells are isolated from specific patients or retrieved from allogeneic immune cell banks, which are banks of
cells donated from healthy volunteers. The immune cells are then expanded and modified before being returned and used to
treat the same patient. We believe our sd-rxRNA compounds are ideally suited to be used in combination with ACT, in
order to make these immune cells more effective. Our approach involves the treatment of the immune cells with our
sd-rxRNA compounds during the expansion and modification phase.
Because our sd-rxRNA compounds do not require a delivery vehicle to penetrate into the cells, we are able
to enhance these cells (for example by inhibiting the expression of immune checkpoint genes) by merely adding
our sd-rxRNA compounds during the expansion process. After enhancing these cells
ex-vivo
, they are
returned to the patient for treatment. In various types of immune cells tested to
date, the sd-rxRNA treatment results in potent silencing while maintaining close to 100% transfection
efficiency and nearly full cell viability.
We believe that
our sd-rxRNA therapeutics are uniquely positioned in the immuno-oncology field for the following reasons:
|
·
|
|
Our
sd-rxRNA compounds do not need facilitated delivery (mechanical or formulation);
|
|
·
|
|
Can target multiple genes (i.e. multiple immunosuppression pathways) in a single therapeutic entity;
|
|
·
|
|
Demonstrated
efficient uptake of sd-rxRNA to immune cells;
|
|
·
|
|
Silencing by
sd-rxRNA has been shown to have a sustained (long-term) effect
in vivo
;
|
|
·
|
|
Favorable clinical
safety profile of sd-rxRNA with local administration; and
|
|
·
|
|
Can be readily manufactured under current good manufacturing practices.
|
We currently
have discovery and preclinical programs to develop our sd-rxRNA targeting PD-1, TIGIT and other
undisclosed checkpoints in ACT for the treatment of solid tumors. We are also developing sd-rxRNA against multiple
undisclosed targets that influence cell differentiation and metabolism for use in ACT to treat hematologic cancers and solid
tumors.
Our most
advanced immuno-oncology programs are RXI-762 and RXI-804, sd-rxRNA compounds that are designed to suppress the expression of
immune checkpoint proteins PD-1 and TIGIT, respectively, which, when used in ACT, are expected to result in an improved
efficacy to the targeted tumors. In August 2017, the Company announced the selection of these two sd-rxRNA compounds for
preclinical development in ACT for solid tumors. We expect to enter clinical development with RXI-762 as part of an
ACT therapy for solid tumors within the next 12 – 18 months.
We are advancing these compounds and our
other discovery and preclinical ACT compounds towards clinical development, both independently and with our strategic collaborations.
We plan to focus our internal resources on therapeutic areas where research and development is appropriate for the size and financial
resources of the Company and to seek partners in therapeutic areas with the requisite expertise and resources to advance our product
and research candidates through clinical development. To that end, we have established research collaborations with the Center
for Cancer Immune Therapy at Herlev Hospital (a leading European cancer center); Gustave Roussy (a leading comprehensive cancer
center in Europe); Medigene AG (a German biotechnology company); PCI Biotech (a private biotechnology firm); the University of
Minnesota (a highly ranked public research university) and Iovance Biotherapeutics, Inc. (a biotechnology company developing novel
cancer immunotherapies).
One
aspect of our ongoing strategy is to build upon these current collaborations to add additional partnerships to our immuno-oncology
pipeline. If results from these collaborations and others are positive, the synergies between the Company’s technology and
its partner’s technology and expertise may provide multiple avenues for human clinical testing of the Company’s sd-rxRNA compounds
in ACT within the next 12 – 18 months.
While
the Company announced in January 2018 that its current business strategy is to focus solely on its immuno-oncology pipeline
development, the Company has completed its clinical trials in dermatology and ophthalmology with RXI-109, our
first sd-rxRNA clinical candidate, and Samcyprone™. In parallel, the Company intends to partner and/or
out-license each of its dermatology and ophthalmology franchises, including RXI-109 and Samcyprone™, to continue their
development. The status of the Company’s clinical trials with RXI-109 and Samcyprone™ is as
follows:
|
·
|
In December 2017, the Company announced positive
results with RXI-109 in a Phase 2 open-label, multi-center, prospective, within-subject controlled study evaluating the effectiveness
and safety of RXI-109 on the outcome of scar revision surgery for hypertrophic scars in healthy adults. The primary effectiveness
objective was met as shown by a statistically significant improved visual appearance of revised scars after scar revision surgery
and treatment with RXI-109 versus control, as assessed by the investigator. The full study results showed that the product was
safe and well tolerated for all dosage groups. Exploratory endpoint analysis furthermore showed that the cosmetic outcomes of RXI-109
treated scars were highly preferred over the untreated revised scars, by both investigators and patients.
|
|
·
|
In
May 2018, the Company announced results from our Phase 2 clinical trial with Samcyprone™ in cutaneous warts. The primary
effectiveness objectives were met as shown by high levels of immunotherapeutic response and therapeutic response. The immunotherapeutic
response rate – a prerequisite for therapeutic response – was 97.7% across all 88 subjects enrolled in the study.
From a therapeutic response viewpoint, with once weekly dosing for up to 10 weeks, more than 70% of all warts showed a positive
wart response rate, i.e. reduction of wart size of more than 50%. Complete wart clearance throughout the study was 54% for all
warts, and up to 71.4% for certain wart types (non-plantar warts). The study results show furthermore that Samcyprone™ was
safe and well tolerated.
|
|
·
|
In August 2018, the Company announced positive results from
our Phase 1/2 clinical trial to evaluate the safety and clinical activity of RXI-109 in
reducing the
progression of retinal scarring. The trial was a multi-dose, dose escalation study conducted in subjects with wet
age-related macular degeneration with evidence of subretinal fibrosis. Each subject in the study received four doses of
RXI-109 by intraocular injection at one-month intervals for a total dosing period of three months. The primary objective was
met as shown by the absence of dose-limiting and serious toxicities, and only mild to moderate procedure related adverse
events. None of the adverse events were drug related. In addition, comprehensive ocular examinations showed no indications of
inflammation nor any other tolerability issues related to the treatment. The secondary objective of the study was also met
with improved or stable disease in the study eyes of several subjects.
|
On
January 3, 2018, the Board of Directors of the Company approved a 1-for-10 reverse stock split of the
Company’s outstanding common stock, which was effected on January 8, 2018. All share and per share amounts have been
retroactively adjusted for all periods presented to give effect to the reverse stock split, including reclassifying an amount
equal to the reduction in par value to additional paid-in capital in the financial statements.
On April 11, 2018,
the Company closed a registered direct offering of 1,510,604 shares of the Company’s common stock at a purchase price of
$3.15 per share (the “
Offering
”) pursuant to the Securities Purchase Agreement dated as of April 9, 2018, by
and among the Company and each purchaser identified on the signature pages thereto. In a concurrent private placement, the Company
sold warrants (the “
Warrants
”) to purchase a total of 1,132,953 shares of common stock at a purchase price
of $0.125 per underlying warrant share and with an exercise price of $3.15 per share (the “
Private Placement
”).
In connection with the Offering and Private Placement, the Company issued warrants to purchase a total of 75,530 shares of common
stock with an exercise price of $4.0546 per share to the placement agent, H.C. Wainwright & Co., LLC (the “
Placement
Agent Warrants
”). Assuming the Warrants and Placement Agent Warrants are not exercised, net proceeds to the Company
from the Offering and Private Placement were $4,210,000 after deducting placement agent fees and offering expenses paid by the
Company.
Critical Accounting Policies and Estimates
There
have been no significant changes to our critical accounting policies since the beginning of this fiscal year. Our critical
accounting policies are described in the “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” section of our Annual Report on Form 10-K for the year ended December 31, 2017, which we filed
with the SEC on March 26, 2018.
Results of Operations
The following data summarizes the results
of our operations for the periods indicated, in thousands:
|
|
Three Months Ended June 30,
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
Description
|
|
2018
|
|
|
2017
|
|
|
Dollar
Change
|
|
|
2018
|
|
|
2017
|
|
|
Dollar Change
|
|
Revenues
|
|
$
|
58
|
|
|
$
|
–
|
|
|
$
|
58
|
|
|
$
|
81
|
|
|
$
|
–
|
|
|
$
|
81
|
|
Operating expenses
|
|
|
(1,957
|
)
|
|
|
(2,514
|
)
|
|
|
557
|
|
|
|
(4,219
|
)
|
|
|
(9,595
|
)
|
|
|
5,376
|
|
Operating loss
|
|
|
(1,899
|
)
|
|
|
(2,514
|
)
|
|
|
615
|
|
|
|
(4,138
|
)
|
|
|
(9,595
|
)
|
|
|
5,457
|
|
Income tax benefit
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
1,621
|
|
|
|
(1,621
|
)
|
Net loss
|
|
|
(1,901
|
)
|
|
|
(2,514
|
)
|
|
|
613
|
|
|
|
(4,140
|
)
|
|
|
(7,974
|
)
|
|
|
3,834
|
|
Comparison of the Three and Six Months Ended June 30, 2018
and 2017
Revenues
The following table summarizes our total
revenues, for the periods indicated, in thousands:
|
|
|
Three Months Ended June 30,
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
Description
|
|
|
2018
|
|
|
2017
|
|
|
Dollar
Change
|
|
|
2018
|
|
|
2017
|
|
|
Dollar Change
|
|
|
Revenues
|
|
|
$
|
58
|
|
|
$
|
–
|
|
|
$
|
58
|
|
|
$
|
81
|
|
|
$
|
–
|
|
|
$
|
81
|
|
Revenues for the three and six months ended
June 30, 2018 related to the work performed by the Company as a sub-awardee under the government grant issued to our collaborator
BioAxone Biosciences, Inc. from the National Institute of Neurological Disorders and Stroke. The grant provides funding for the
development of a novel sd-rxRNA compound, BA-434, that targets PTEN for the treatment of spinal cord injury. There were no revenues
for the three and six months ended June 30, 2017.
Operating Expenses
The following table summarizes our total
operating expenses, for the periods indicated, in thousands:
|
|
Three Months Ended June 30,
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
Description
|
|
2018
|
|
|
2017
|
|
|
Dollar
Change
|
|
|
2018
|
|
|
2017
|
|
|
Dollar
Change
|
|
Research and development
|
|
$
|
1,183
|
|
|
$
|
1,329
|
|
|
$
|
(146
|
)
|
|
$
|
2,544
|
|
|
$
|
2,676
|
|
|
$
|
(132
|
)
|
Acquired in-process research and development
|
|
|
–
|
|
|
|
85
|
|
|
|
(85
|
)
|
|
|
–
|
|
|
|
4,696
|
|
|
|
(4,696
|
)
|
General and administrative
|
|
|
774
|
|
|
|
1,100
|
|
|
|
(326
|
)
|
|
|
1,675
|
|
|
|
2,223
|
|
|
|
(548
|
)
|
Total operating expenses
|
|
$
|
1,957
|
|
|
$
|
2,514
|
|
|
$
|
(557
|
)
|
|
$
|
4,219
|
|
|
$
|
9,595
|
|
|
$
|
(5,376
|
)
|
Research and Development Expenses
Research
and development expenses relate to salaries, employee benefits, facility-related expenses, supplies, stock-based compensation related
to employees and non-employees involved in the Company’s research and development, external services, other operating
costs and overhead related to our research and development departments, costs to acquire technology licenses and expenses associated
with preclinical activities and our clinical trials.
Research and development expenses for the
three months ended June 30, 2018 decreased 11% compared with the three months ended June 30, 2017, primarily due to a decrease
in clinical-trial related expenses as subject participation is now complete for all of the Company’s clinical trials.
Research and development expenses for the
six months ended June 30, 2018 decreased 5% compared with the six months ended June 30, 2017, primarily due to decreases in clinical-trial
and manufacturing related expenses for RXI-109 and Samcyprone™, offset by increases in lab supplies and manufacturing fees
for the Company’s immuno-oncology program.
Acquired In-process Research and Development
Expense
In
January 2017, the Company acquired all of the issued and outstanding capital stock of MirImmune, a privately-held biotechnology
company that was engaged in the development of cancer immunotherapies, in exchange for securities of the Company. The Company determined
that the acquired assets did not constitute a business and that the transaction would be accounted for as an asset acquisition.
As the assets and development programs acquired from MirImmune were at an early stage of development and determining the future
economic benefit of the acquired assets at the date of acquisition was highly uncertain, the fair value of the assets was fully
expensed as in-process research and development expense.
There was no acquired in-process research
and development expense during the three and six months ended June 30, 2018. During the three and six months ended June 30, 2017,
the Company recorded acquired in-process research and development expense related to the fair value of consideration given, which
included transaction costs, liabilities assumed and cancellation of notes receivable, and the deferred tax impact of the acquisition
of MirImmune.
General and Administrative Expenses
General
and administrative expenses relate to salaries, employee benefits, facility-related expenses, stock-based compensation expense
related to employees dedicated to general and administrative activities. Other general and administrative expenses include professional
fees for legal, audit, tax and consulting services, as well as other general corporate expenses.
General and administrative expenses
for the three and six months ended June 30, 2018 compared with the three and six months ended June 30, 2017 decreased 30%
and 25%, respectively, primarily due to decreases in professional fees for legal-related services and payroll-related expenses as a
result of a decrease in headcount.
Income Tax
The following table summarizes the Company’s
income tax for the periods indicated, in thousands:
|
|
Three Months Ended June 30,
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
Description
|
|
2018
|
|
|
2017
|
|
|
Dollar
Change
|
|
|
2018
|
|
|
2017
|
|
|
Dollar Change
|
|
Income tax benefit
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
1,621
|
|
|
$
|
(1,621
|
)
|
There was no income tax for the three months
ended June 30, 2018 or 2017 or for the six months ended June 30, 2018. For the six months ended June 30, 2017, we recognized an
income tax benefit for the tax-related impact of the Company’s acquisition of MirImmune in January 2017.
Liquidity and Capital Resources
On August 8, 2017, the Company entered
into a purchase agreement (the “
LPC Purchase Agreement
”) and a registration rights agreement with Lincoln Park
Capital Fund, LLC (“
LPC
”), pursuant to which the Company has the right to sell to LPC up to $15,000,000 in shares
of the Company’s common stock, subject to certain limitations and conditions set forth therein, over the 30-month term of
the LPC Purchase Agreement. During the six months ended June 30, 2018, the Company sold 420,000 shares of common stock to LPC for
net proceeds of approximately $1,291,000. In total, the Company has sold 480,000 shares of common stock to LPC for net proceeds
of approximately $1,581,000.
On April 11, 2018, the Company
closed on the Offering and Private Placement of its common stock and the Warrants. Assuming the Warrants and Placement Agent
Warrants are not exercised, net proceeds to the Company from the Offering and Private Placement were $4,210,000 after
deducting placement agent fees and offering expenses paid by the Company.
We had cash and cash equivalents of
$5,315,000 as of June 30, 2018, compared with $3,581,000 as of December 31, 2017. We have reported recurring losses from
operations since inception and expect that we will continue to have negative cash flows from our operations for the
foreseeable future. Historically, the Company’s primary source of funding has been the sale of its securities.
In
the future, we will be dependent on obtaining funding from third parties, such as proceeds from the issuance of debt, sale of
equity, or strategic opportunities, in order to maintain our operations. There is no guarantee that debt, additional equity
or other funding will be available to us on acceptable terms, or at all. The LPC Purchase Agreement should provide us with
sufficient funding for our operations for at least the next twelve months. However, certain ownership limitations under the
LPC Purchase Agreement preclude us from relying on the full available funds for going concern purposes. As a result of this
ownership limitation and based on the Company’s cash, operational spending rate and other available financial
resources, the Company has concluded that there is substantial doubt regarding its ability to fund operations for at least
the next twelve months. If we fail to obtain additional funding when needed, we would be forced to scale back or terminate
our operations or to seek to merge with or to be acquired by another company.
The following table summarizes our cash flows
for the periods indicated, in thousands:
|
|
Six Months Ended
June 30,
|
|
|
|
2018
|
|
|
2017
|
|
Net cash used in operating activities
|
|
$
|
(3,767
|
)
|
|
$
|
(5,116
|
)
|
Net cash used in investing activities
|
|
|
–
|
|
|
|
(88
|
)
|
Net cash provided by financing activities
|
|
|
5,501
|
|
|
|
–
|
|
Net increase (decrease) in cash, cash equivalents and restricted cash
|
|
$
|
1,734
|
|
|
$
|
(5,204
|
)
|
Net Cash Flow from Operating Activities
Net cash used in operating activities was
$3,767,000 for the six months ended June 30, 2018 compared with $5,116,000 for the six months ended June 30, 2017. The decrease
in cash used in operating activities of $1,349,000 was primarily attributable to changes in working capital of $731,000 due to
payments made for financing-related expenses and the Company’s acquisition of MirImmune in the first quarter of the prior
year.
Net Cash Flow from Investing Activities
There were no net cash flows related to investing
activities for the six months ended June 30, 2018. Net cash used in investing activities was $88,000 for the six months ended June
30, 2017. The decrease in net cash flow from investing activities was primarily related to the purchase of laboratory equipment
in the prior year.
Net Cash Flow from Financing Activities
Net cash provided by financing activities
was $5,501,000 for the six months ended June 30, 2018 and was due to proceeds received by the Company from the Offering, Private
Placement and the issuance of common stock to LPC. There were no cash flows related to financing activities for the six months
ended June 30, 2017.
Off-Balance Sheet Arrangements
In
connection with certain license agreements, we are required to indemnify the licensor for certain damages arising
in connection with the intellectual property rights licensed under the agreement. In addition, we are a party to a number
of agreements entered into in the ordinary course of business that contain typical provisions that obligate us to indemnify
the other parties to such agreements upon the occurrence of certain events. These indemnification obligations
are considered off-balance sheet arrangements in accordance with Accounting Standards Codification Topic
460, “
Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees
of Indebtedness of Others
”. To date, we have not encountered material costs as a result of such obligations and
have not accrued any liabilities related to such obligations in our financial statements. See Note 7 to our consolidated
financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2017, which was
filed with the Securities and Exchange Commission on March 26, 2018, for further discussion of these indemnification
agreements.