LOS ANGELES, March 19, 2018 /PRNewswire/ -- CytRx
Corporation (NASDAQ: CYTR), a biopharmaceutical research and
development company specializing in oncology, today announced
financial results for the year ended December 31, 2017, and provided an overview of
recent accomplishments and upcoming milestones for its research and
development programs.
"2017 was a pivotal year for CytRx with the strategic
outlicensing of aldoxorubicin to NantCell, Inc. for future
development and commercialization,"
said Steven A. Kriegsman, CytRx's
Chairman and CEO. "Our partner and aldoxorubicin licensee NantCell
has made progress not just for the indications we developed, but
also initiating clinical trials testing aldoxorubicin in
combination with their immunotherapy protocols in multiple disease
states, including metastatic pancreatic cancer, advanced squamous
cell carcinoma of the head and neck, and advanced squamous
non-small cell lung cancer. We eagerly await upcoming developments
on these studies."
Mr. Kriegsman continued, "Looking ahead to 2018 and the fully
owned pipeline assets of CytRx, we are focused on advancing our
four new LADR™ (Linker Activated Drug Release) drug candidates
which we unveiled last week. Supportive data for these ultra-high
potency candidates have already garnered significant investigator
interest, evidenced by the selection of three out of three
abstracts submitted for presentation at the upcoming American
Association for Cancer Research (AACR) 2018 annual meeting next
month in Chicago. Each of the four LADR candidates are
eligible to be advanced into Investigational New Drug
(IND)-enabling studies."
Fourth Quarter 2017 and Recent Highlights
Selected Four LADR™ Candidates for IND-Enabling Clinical
Studies. In March 2018, CytRx
announced the selection of four LADR™ (Linker Activated Drug
Release) candidates for advancement into IND-enabling studies with
the goal of filing IND applications for one or more candidates
during 2018. These candidates, preliminarily named LADR-7
(AE-Keto-Sulf07), LADR-8 (AE-Ester-Sulf07), LADR-9 (PP072) and
LADR-10 (FN296) were chosen from two distinct classes of drugs,
auristatins and maytansinoids, both with highly potent cytotoxic
agents.
LADR Candidate Data Selected for Presentation at the AACR
2018 Annual Meeting. In February 2018,
CytRx announced that all three submitted abstracts
highlighting significant data relating to the Company's LADR drug
candidates were selected for presentation at the 2018 AACR Annual
Meeting taking place April 14-18,
2018 in Chicago. Posters (abstracts #1657, #2661,
and #3703) highlighting the potential of CytRx's ultra-high potency
conjugates in solid tumors will be presented between Monday,
April 16, 2018 and Tuesday, April 17,
2018.
Initiation of Pharma Partnering Activities for the LADR™
Ultra-High Potency Drug Candidates. In February and
March 2018, CytRx made two
announcements that highlighted efforts to strengthen its strategic
alliance team. First, CytRx announced that it had entered
into an exclusive agreement with Destum Partners, Inc., a leading
strategic advisory firm serving companies in the life sciences
industry, to assist in executing a strategic alliance for CytRx's
LADR™ drug candidates. CytRx also announced that Mr. Eric L. Curtis, MBA, joined its team to provide
strategic counsel to the Chairman and CEO for the Company's ongoing
programs, including its LADR™ discovery platform and the ultra-high
potency drug candidates. Mr. Curtis will assist with introductions
to strategic partners from his extensive network of big
pharma and biotech companies. He brings a wealth of drug
development and commercialization experience to CytRx, and he,
along with Destum Partners, will be making introductions at
AACR.
Partner NantCell Dosed First Patient in Clinical Trial
Investigating Cell-Based Therapy in Combination with Multiple
Anti-Cancer Agents, including Aldoxorubicin, in Patients with
Metastatic Pancreatic Cancer. In January
2018, CytRx announced that aldoxorubicin licensee NantCell,
Inc. (a private subsidiary of NantWorks, LLC) dosed
the first patient in the Phase 1b
portion of a Phase 1b/2 clinical
trial for patients with metastatic pancreatic cancer. The
trial will investigate high-affinity natural killer (haNK) cell
therapy in combination with several anti-cancer agents, including
aldoxorubicin, in patients with metastatic pancreatic cancer whose
cancer has progressed on or following standard-of-care
chemotherapy. This trial is a single-center, open-label, Phase
1b/2 clinical trial designed to
evaluate the safety and efficacy of the various combination
therapies with enrollment expected to be approximately 173
patients. The primary endpoint for the Phase 1b portion of the trial is safety and the primary
endpoint for the Phase 2 portion of the trial is objective response
rate (ORR) by RECIST.
Partner NantCell Dosed First Patient in Clinical Trial
Evaluating Aldoxorubicin in Combination with Immuno-Oncology Agents
and Cell-Based Therapies in Patients with Advanced Squamous Cell
Carcinoma. In February 2018,
CytRx announced that NantCell dosed the first patient in the Phase
1b portion of a Phase 1b/2 clinical trial for patients with advanced
squamous cell carcinoma (SCC) of either the head and neck or
non-small cell lung cancer, the second trial conducted by NantCell
to investigate haNK cell therapy in combination with several
anti-cancer agents, including aldoxorubicin, in certain high unmet
need cancer indications. This single-center, open-label,
Phase 1b/2 clinical trial is designed
to evaluate the safety and efficacy of the various combination
therapies, including combinations with aldoxorubicin, in subjects
with SCC who have progressed on or after platinum-based
chemotherapy and anti-PD1/PD-L1 therapy. Approximately 65 patients
are expected to be enrolled. The primary endpoint for the Phase
1b portion of the trial is safety and
the primary endpoint for the Phase 2 portion of the trial is
objective response rate (ORR) by RECIST.
Filed Key Provisional Patent Applications for Ultra-High
Potency LADR™ Drug Candidates. In December 2017, the Company filed provisional
patent applications covering two series of drug candidates from its
LADR™ Technology Platform. The newly filed applications cover
compounds, pharmaceutical compositions and methods of use thereof.
When granted, these new patents will
expand CytRx's intellectual property estate and the
Company will own worldwide rights for each.
Regained Nasdaq Listing Compliance. On November 16, 2017, CytRx received written
notification from the NASDAQ Listing Qualifications
Department that it has regained compliance with the minimum
bid price requirement set forth in NASDAQ Listing Rule Section
5550(a)(2) for continued listing of its common stock on
The NASDAQ Capital Market.
Completed Reverse Stock Split. On November 1, 2017, CytRx completed a 1-for-6
reverse stock split of its issued and outstanding common stock. The
split-adjusted shares of CytRx's common stock will continue trading
on the Nasdaq Capital Market under the Company's existing symbol
"CYTR," provided that the Company continues to comply with the
Nasdaq listing requirements. The reverse stock split reduced
the number of common shares outstanding to approximately 27.6
million as of the effective date. Authorized shares were also
proportionally reduced to approximately 41.7 million, and the
Company's preferred stock was reduced to approximately 800,000
shares. The reverse stock split was approved by the Company's
stockholders at a Special Meeting held on October 27, 2017.
Completed Strategic Licensing Transaction with NantCell for
Development of Aldoxorubicin. In July 2017, CytRx and NantCell executed a
strategic licensing agreement for the global rights to
aldoxorubicin. NantCell, led by Dr. Patrick Soon-Shiong, who developed and
commercialized Abraxane®, an albumin-mediated cytotoxic agent,
received exclusive rights to develop and commercialize
aldoxorubicin for all indications. Under the terms of the
agreement, NantCell purchased $13
million of CytRx common stock at a per share price of
$6.60 (split-adjusted), representing
approximately a 92% premium to the market price at the time of the
transaction. CytRx is eligible to receive up to an additional
$343 million in regulatory and
commercial milestones, plus increasing double-digit royalties on
sales for aldoxorubicin's lead indication of soft tissue sarcomas,
and mid to high single-digit royalties for any additional
indications. CytRx also issued NantCell a warrant to purchase
on a split-adjusted basis up to 500,000 shares of common stock at
$6.60 over the next 18 months. As a
result of this transaction, NantCell is responsible for
development, manufacturing and commercialization activities
relating to aldoxorubicin.
Patterson Derivative Action in Delaware. On March 13, 2018, the Vice-Chancellor of the
Delaware Court of Chancery ruled
that CytRx's motion to dismiss was granted, with prejudice.
Full Year 2017 Financial Results
CytRx reported cash, and cash equivalents of $37.6 million as of December 31, 2017. During the third quarter,
CytRx entered into a global strategic licensing agreement for
aldoxorubicin with NantCell and received a strategic
investment of $13.0 million at
$6.60 per share (split-adjusted).
Concurrent with the closing of the aldoxorubicin license agreement,
CytRx amended its existing long-term loan and made additional
payments of $10 million during the
third quarter to the lender.Net loss for the year ended
December 31, 2017, was $35.0 million, or $(1.46) per share, compared with a net loss of
$50.8 million, or $(3.78) per share, for the year ended
December 31, 2016, a reduction of
$15.8 million. In 2017, the Company
recognized a non-cash gain of $1.4
million on the fair value adjustment of warrant derivative
liabilities related to warrants issued in 2016, compared to a
non-cash gain of $3.8 million during
2016 related to now expired warrants.
Research and development (R&D) expenses were $19.8 million for 2017, including approximately
$11.7 million for aldoxorubicin,
$3.2 million for pre-clinical
development of new LADR albumin-binding, ultra-high potency drug
candidates (Freiburg lab), and approximately $4.9 million for non-cash expenses, licensing
fees and general operations of our clinical programs. This is
a reduction of approximately 45 percent compared to R&D
expenses of $35.9 million for
2016.
General and administrative (G&A) expenses were $12.5 million for 2017, compared with
$16.0 million for 2016, including
non-cash stock-compensation expense of $2.8
million for 2017 and $4.9
million for 2016. G&A expenses decreased by
approximately 22 percent primarily due to a decrease in non-cash
expenses of $2.1 million and a
decrease in salaries of $1.0
million.
Conference Call and Webcast
CytRx will be hosting a conference call and webcast today
beginning at 11:00 am ET (8:00 am
PT). To access the conference call, dial 844-358-6753 (U.S.
and Canada) or 216-562-0397
(international callers) and enter the conference ID number:
8178698. A live and archived webcast will be available in the
investor relations section of the company's website, www.cytrx.com.
A replay of the call and webcast will begin approximately two hours
after the live call has ended. To access the replay, dial
855-859-2056 (U.S. and Canada) or
404-537-3406 (international callers) and enter the conference ID
number: 8178698.
About the LADR™ Technology Platform
CytRx's innovative LADR™ (Linker Activated Drug Release)
technology employs a broad portfolio of novel linker molecules that
selectively bind to circulating albumin and can be linked to a wide
variety of anti-cancer payloads. The Company's research efforts
currently center on creating new molecules from the combination of
ultra-high potency cytotoxic payloads with tunable linkers. The
molecules that CytRx is currently evaluating concentrate at the
tumor site providing targeted delivery of the cell killing
payloads.
About CytRx Corporation
CytRx Corporation (NASDAQ: CYTR) is a biopharmaceutical company
specializing in 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. CytRx is
also rapidly expanding its pipeline of ultra-high potency oncology
candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated
Drug Release) technology platform, a discovery engine designed to
leverage CytRx's expertise in albumin biology and linker technology
for the development of a new class of potential breakthrough
anti-cancer therapies. Aldoxorubicin, CytRx's most advanced drug
conjugate, is an improved version of the widely used anti-cancer
drug doxorubicin and has been out-licensed to NantCell, Inc.
Forward-Looking Statements
This press release contains forward-looking statements. Such
statements involve risks and uncertainties that could cause actual
events or results to differ materially from the events or results
described in the forward-looking statements, including risks and
uncertainties relating to the ability of NantCell, Inc., to obtain
regulatory approval for its products that use aldoxorubicin; the
ability of NantCell, Inc., to manufacture and commercialize
products or therapies that use aldoxorubicin; the amount, if any,
of future milestone and royalty payments that we may receive from
NantCell, Inc.; our ability to develop new ultra-high potency drug
candidates based on our LADRTM technology platform; and
other risks and uncertainties described in the most recent annual
and quarterly reports filed by CytRx with the Securities and
Exchange Commission and current reports filed since the date of
CytRx's most recent annual report. All forward-looking statements
are based upon information available to CytRx on the date the
statements are first published. CytRx undertakes no obligation to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events or otherwise.
Investor Relations Contact:
Argot Partners
Michelle Carroll/Sean
Augustine-Obi
(212) 600-1902
michelle@argotpartners.com
sean@argotpartners.com
BALANCE
SHEETS
|
|
|
|
December
31,
|
|
2017
|
2016
|
ASSETS
|
|
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$
37,643,404
|
$
56,959,485
|
Receivables
|
7,529,032
|
183,703
|
Prepaid expenses and
other current assets
|
1,914,077
|
3,434,238
|
Total current
assets
|
47,086,513
|
60,577,426
|
Equipment and
furnishings, net
|
1,042,892
|
1,959,667
|
Goodwill
|
183,780
|
183,780
|
Other assets
|
34,334
|
48,911
|
Total
assets
|
$
48,347,519
|
$
62,769,784
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
Current
liabilities:
|
|
|
Accounts
payable
|
$
4,122,017
|
$
6,406,445
|
Accrued expenses and
other current liabilities
|
8,029,274
|
3,830,498
|
Deferred
revenue
|
6,924,353
|
—
|
Term loan, net -
current
|
10,599,795
|
5,481,656
|
Warrant
liabilities
|
527,025
|
3,789,391
|
Total current
liabilities
|
30,202,464
|
19,507,990
|
|
|
|
Long term loan,
net
|
—
|
18,484,510
|
Total
liabilities
|
30,202,464
|
37,992,500
|
Commitment and
contingencies
|
|
|
Stockholders' equity
(2016 restated to reflect a 1-6 reverse stock split, see Note
1):
|
|
|
Preferred Stock,
$0.01 par value, 833,334 shares authorized, including 4,167 shares
of Series
A Junior Participating Preferred Stock; no shares issued and
outstanding
|
—
|
—
|
Preferred Stock,
$0.01 par value, stated value $1,000, 650 shares authorized of
Series B Convertible Preferred Shares at $2.52 per share, 550
issued, 0 outstanding at December 31, 2017, 518 outstanding at
December 31, 2016.
|
—
|
518,000
|
Common stock, $0.001
par value, 41,666,667 shares authorized; 28,037,501 and 18,553,817
shares issued and outstanding at December 31, 2017 and 2016,
respectively
|
28,037
|
18,553
|
Additional paid-in
capital
|
468,969,445
|
440,106,726
|
Accumulated
deficit
|
(450,852,427)
|
(415,865,995)
|
Total stockholders'
equity
|
18,145,055
|
24,777,284
|
Total liabilities and
stockholders' equity
|
$
48,347,519
|
$
62,769,784
|
STATEMENTS OF
OPERATIONS
|
|
|
|
Years Ended
December 31,
|
|
2017
|
2016
|
2015
|
Revenue:
|
|
|
|
Licensing
revenue
|
$
100,000
|
$
200,000
|
$
100,000
|
|
|
|
|
Expenses:
|
|
|
|
Research and
development
|
19,840,106
|
35,930,212
|
43,395,574
|
General and
administrative
|
12,502,042
|
15,990,789
|
19,664,904
|
Depreciation and
amortization
|
629,312
|
536,631
|
317,649
|
|
32,971,460
|
52,457,632
|
63,378,127
|
Loss before other
income (expense)
|
(32,871,460)
|
(52,257,632)
|
(63,278,127)
|
Other income
(expense):
|
|
|
|
Interest
income
|
365,584
|
255,123
|
233,958
|
Interest
expense
|
(3,831,211)
|
(2,754,677)
|
—
|
Other income
(expense), net
|
(16,322)
|
159,148
|
20,151
|
Gain on warrant
liabilities
|
1,367,777
|
3,827,617
|
4,437,628
|
|
|
|
|
Loss before provision
for income taxes
|
(34,985,632)
|
(50,770,421)
|
(58,586,390)
|
Provision for income
taxes
|
(800)
|
(800)
|
(800)
|
Net loss
|
$
(34,986,432)
|
$
(50,771,221)
|
$
(58,587,190)
|
Basic and diluted loss
per share
|
$
(1.46)
|
$
(3.78)
|
$
(5.82)
|
Basic and diluted
weighted average shares outstanding
|
24,042,293
|
13,510,629
|
10,080,526
|
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SOURCE CytRx Corporation