Aptorum Group Limited (NASDAQ:APM), a biopharmaceutical company
focused on the development of novel therapeutics to address global
unmet medical needs, today announced financial results for the
fiscal year ended December 31, 2019, and provided a business
update.
Aptorum Group’s operational plans remain on
track. In particular, the recently announced updates on SACT-1
(targeting neuroblastoma) and ALS-4 (targeting Staphylococcus
aureus) remain on track for its pre-IND preparation work. The
Company will continue to target IND submission in the second half
of 2020, subject to regulatory review of the IND application. With
the additional capital raised in February 2020, the Company is also
on track to expand strategic initiatives including the discovery
and development pipeline such as the recently announced initiative
SACT-COV19 (targeting COVID-19 disease) and additional Smart-Act
platform projects being SACT-2 and SACT-3, which will be announced
in due course. The Company, together with the distributor, is also
focused on the distribution of the recently announced non-hormonal
based Dioscorea opposita bioactive nutraceutical supplement
targeting woman’s health during the menopausal or post-menopausal
cycles. In light of the global coronavirus situation, the Company
would like to report that its day-to-day operations continue as
normal.
Clinical Pipeline
Update and Upcoming Milestones
In March 2020, Aptorum Group initiated an
additional R&D program targeting the coronavirus group. The
Company has completed initial screening under our existing
Smart-ACT™ platform, a repurposed and new drug discovery platform,
to select at least three potential candidates for further
preclinical investigation against the new coronavirus disease,
COVID-19, out of a library of more than 2,600 small drug molecules
that were previously approved for other indications.
Announced further positive data from the
current investigational new drug (IND)-enabling studies for ALS-4,
a small drug molecule candidate for the treatment of infections
caused by Staphylococcus aureus. Subject to positive completion of
the current studies, Aptorum Group targets to submit IND for ALS-4
in the second half of 2020 and commence Phase 1 trials in North
America.
Announced positive data and development in
relation to our first repurposed drug candidate, SACT-1, for the
treatment of neuroblastoma, a rare form of cancer that develops in
infants and young children. Subject to completion of current
validation studies, Aptorum Group targets to leverage the US FDA
505(b)(2) regulatory process pathway and make the IND submission
for SACT-1 in the second half of 2020 and commence clinical trials
in North America.
Corporate
Highlights
In 2019, Aptorum Group entered into two
separate promissory notes and line of credit agreements and
obtained a $15 million line of credit facility.
Full year 2019 research and development
expenses of $6.9 million, an increase of $3.8 million over the full
year 2018.
In January 2020, Aptorum Group entered into a
regional distribution agreement with Hong Kong-based Multipak
Limited for the commercialization of our NLS-2 dietary supplement
for women undergoing menopause and suffering from related symptoms.
The Dioscorea opposita bioactive nutraceutical tablets have
commenced production in Canada and will shortly be marketed under
the brand name NativusWell™.
In February 2020, Aptorum Group completed a
capital raise of approximately USD10 million by a registered direct
offering of 1,351,350 Class A ordinary shares and warrants to
purchase 1,351,350 of its Class A ordinary shares.
Fiscal Year End Financial
Results
Aptorum Group reported a net loss of $20.1 million in 2019, as
compared to $15.1 million in 2018. The increase in net loss in 2019
was driven by the increase in research and development expenses due
to the increase in consultation services for research and
development projects.
Research and development expenses were $6.9 million in 2019 as
compared to $3.1 million in 2018. The increase in research and
development expenses in 2019 was primarily due to the increase in
consultation services for R&D projects.
General and administrative fees were $7.4 million in 2019 as
compared to $4.9 million in 2018. The increase in general and
administrative expenses 2019 was mainly driven by the issuance of
share options to our directors, employees, external consultants and
advisors in 2019 as compensation of their services.
Legal and professional fees were $3.4 million in 2019 as
compared to $1.8 million in 2018. The increase in legal and
professional fees was mainly due to the increased business
consultant services engaged in 2019 and the increased in token
related expenses.
Aptorum Group ended 2019 with $5.3 million in cash and
restricted cash as compared to $26.1 million as of December 31,
2018. The decrease in cash and restricted cash was mainly the
result of the repayment of $13.6 million of convertible bonds and a
net loss of $20.1 million during the year, partly offset by the
loan from related parties of $6.3 million and adjustment of net
non-cash expenses of $5.5 million.
About Aptorum Group
Aptorum Group Limited (Nasdaq:APM) is a pharmaceutical company
dedicated to developing and commercializing novel therapeutics to
tackle unmet medical needs. Aptorum Group’s current drug pipeline
includes indications in orphan diseases, infectious diseases and
metabolic diseases and a number of which are targeted to enter
clinical trial phases in 2020. Aptorum Group also operates a
women’s health supplement business whose Dioscorea opposita
Bioactive Nutraceutical Tablets are currently being
commercialized.
For more information about the Company, please visit
www.aptorumgroup.com.
Disclaimer and Forward-Looking
Statements
This press release includes statements concerning Aptorum Group
Limited and its future expectations, plans and prospects that
constitute "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. For this purpose,
any statements contained herein that are not statements of
historical fact may be deemed to be forward-looking statements. In
some cases, you can identify forward-looking statements by terms
such as "may," "should," "expects," "plans," "anticipates,"
"could," "intends," "target," "projects," "contemplates,"
"believes," "estimates," "predicts," "potential," or "continue," or
the negative of these terms or other similar expressions. Aptorum
Group has based these forward-looking statements, which include
statements regarding projected timelines for application
submissions and trials, largely on its current expectations and
projections about future events and trends that it believes may
affect its business, financial condition and results of operations.
These forward-looking statements speak only as of the date of this
press release and are subject to a number of risks, uncertainties
and assumptions including, without limitation, risks related to its
announced management and organizational changes, the continued
service and availability of key personnel, its ability to expand
its product assortments by offering additional products for
additional consumer segments, development results, the company’s
anticipated growth strategies, anticipated trends and challenges in
its business, and its expectations regarding, and the stability of,
its supply chain, and the risks more fully described in Aptorum
Group’s Form 20-F and other filings that Aptorum Group may make
with the SEC in the future. As a result, the projections included
in such forward-looking statements are subject to change. Aptorum
Group assumes no obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
APTORUM GROUP LIMITED
CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
For Years Ended December 31,
2019 and 2018
(Stated in U.S.
Dollars)
Year Ended December 31,
2019
Year Ended December 31,
2018
Revenue
Healthcare service income
$
535,166
$
383,450
Operating expenses
Cost of healthcare service
(794,545
)
(318,011
)
Research and development expenses
(6,939,051
)
(3,101,432
)
General and administrative fees
(7,373,425
)
(4,919,626
)
Legal and professional fees
(3,405,705
)
(1,811,770
)
Other operating expenses
(220,891
)
(560,709
)
Total expenses
(18,733,617
)
(10,711,548
)
Other (loss) income
(Loss) gain on investments in marketable
securities, net
(81,839
)
501,522
Gain on non-marketable investments
1,147,190
-
Gain (loss) on investments in derivatives,
net
87,599
(974,444
)
Realized gain on use of digital
currencies
46,717
-
Gain on extinguishment of convertible
debts
1,198,490
-
Changes in fair value of warrant
liabilities
(866,300
)
124,726
Interest expense, net
(3,699,672
)
(4,458,191
)
Rental income
16,868
-
Sundry income
232,460
-
Total other loss, net
(1,918,487
)
(4,806,387
)
Net loss
(20,116,938
)
(15,134,485
)
Less: net loss attributable to
non-controlling interests
(1,430,176
)
(302,762
)
Net loss attributable to Aptorum Group
Limited
$
(18,686,762
)
$
(14,831,723
)
Net loss per share – basic and diluted
$
(0.64
)
$
(0.53
)
Weighted-average shares outstanding –
basic and diluted
29,008,445
27,909,788
Net loss
$
(20,116,938
)
$
(15,134,485
)
Other Comprehensive loss
Unrealized loss on investments in
available-for-sale securities
-
(1,122,251
)
Exchange differences on translation of
foreign operations
(10,897
)
5,345
Other Comprehensive loss
(10,897
)
(1,116,906
)
Comprehensive loss
(20,127,835
)
(16,251,391
)
Less: comprehensive loss attributable to
non-controlling interests
(1,430,176
)
(302,762
)
Comprehensive loss attributable to the
shareholders of Aptorum Group Limited
(18,697,659
)
(15,948,629
)
APTORUM GROUP LIMITED
CONSOLIDATED BALANCE
SHEETS
December 31, 2019 and
2018
(Stated in U.S.
Dollars)
December 31,
2019
December 31,
2018
ASSETS
Current assets:
Cash
$
5,189,003
$
12,006,624
Restricted cash
104,170
14,100,614
Digital currencies
1,539
-
Accounts receivable
40,543
2,827
Inventories
34,185
30,642
Marketable securities, at fair value
1,063,111
1,014,338
Investments in derivatives
203,320
115,721
Amounts due from related parties
962
169,051
Due from brokers
317,005
818,968
Other receivables and prepayments
1,079,043
464,156
Total current assets
8,032,881
28,722,941
Property, plant and equipment, net
7,093,035
4,260,602
Non-marketable investments
7,112,180
7,094,712
Intangible assets, net
1,311,683
1,409,540
Amounts due from related parties
50,000
50,000
Long-term deposits
294,606
3,417,178
Other non-current asset
59,833
119,667
Total Assets
$
23,954,218
$
45,074,640
LIABILITIES AND EQUITY
LIABILITIES
Current liabilities:
Amounts due to related parties
$
41,593
$
33,417
Accounts payable and accrued expenses
2,586,527
1,247,147
Finance lease payable, current portion
46,555
43,877
Warrant liabilities
-
753,118
Convertible debts
-
10,107,306
Total current liabilities
2,674,675
12,184,865
Finance lease payable, non-current
portion
97,319
143,873
Loan payables to related parties
6,330,472
-
Total Liabilities
$
9,102,466
$
12,328,738
Commitments and contingencies
-
-
EQUITY
Class A Ordinary Shares ($1.00 par value;
60,000,000 shares authorized, 6,597,362 shares issued and
outstanding at December 31, 2019 and 6,537,269 shares issued and
outstanding at December 31, 2018, respectively)
$
6,597,362
$
6,537,269
Class B Ordinary Shares ($1.00 par value;
40,000,000 shares authorized, 22,437,754 shares issued and
outstanding as at December 31, 2019 and 2018)
22,437,754
22,437,754
Additional paid-in capital
24,887,624
23,003,285
Accumulated other comprehensive loss
(5,552
)
(1,484,688
)
Accumulated deficit
(37,555,980
)
(17,379,185
)
Total equity attributable to the
shareholders of Aptorum Group Limited
16,361,208
33,114,435
Non-controlling interests
(1,509,456
)
(368,533
)
Total equity
14,851,752
32,745,902
Total Liabilities and Equity
$
23,954,218
$
45,074,640
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version on businesswire.com: https://www.businesswire.com/news/home/20200429005361/en/
Investor Relations investor.relations@aptorumgroup.com +852 2117
6611
U.S. Investor Relations RedChip Companies, Inc. Dave Gentry
407-491-4498
Media info@aptorumgroup.com + 852 2117 6611
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