Aptorum Group Limited (“Aptorum Group” or the “Company”)
(NASDAQ: APM), a biopharmaceutical company focused on the
development of novel therapeutics to address global unmet medical
needs, today provided a business update and announced financial
results for the six months ended June 30, 2019.
“During the first six months of 2019, Aptorum Group achieved a
number of milestones. Across our pipeline, ALS-4, the drug
candidate for the treatment of infections caused by Staphylococcus
aureus including methicillin-resistant Staphylococcus aureus
(MRSA), has been progressing well and already entered IND-enabling
studies. The first series of GLP toxicology study has been
completed and we plan to target the related IND submission around
the first to second calendar quarter of 2020. After which, hybrid
clinical studies are being designed and are planned to take place
in North America. We are also excited to announce the investigation
and development of two new preclinical drug candidates, CLS-1 and
SACT-1, targeting obesity and neuroblastoma under our recently
announced Claves and Smart-ACTTM platforms respectively. Under both
platforms, Aptorum Group will continue to drive the discovery and
development of new therapeutic candidates focused on unmet needs
related to gastrointestinal microbiome and in the orphan diseases
area,” said Ian Huen, Founder and Chief Executive Officer of
Aptorum Group. “To promote further exciting venture opportunities,
on April 24, 2019, we entered into a Master Collaboration Agreement
with Singapore based A*ccelerate Technologies Pte Ltd, the
enterprise office of the government research institution Agency for
Science, Technology and Research (A*STAR), pursuant to which the
parties may contribute up to an aggregate of $90 million cash and
in-kind contributions to suitable start-ups. Through this
agreement, Aptorum Group and A*ccelerate intend to jointly create a
number of deep tech healthcare and life sciences based ventures in
Singapore over the next five years.”
Recent Business Updates
- Aptorum Group has commenced the investigational new drug
(IND)-enabling studies for ALS-4, the small drug molecule candidate
indicated for the treatment of infections caused by Staphylococcus
aureus including methicillin-resistant Staphylococcus aureus (MRSA,
a “super-bug”) based on a novel anti-virulence approach.
- Claves Life Sciences Limited, a wholly owned subsidiary of
Aptorum Group, established a novel therapeutic platform for the
treatment of various diseases via modulation of the chemical
signaling relating to gut microbiota. Investigation and development
of a new preclinical drug candidate, CLS-1, targeting obesity have
commenced with the view to commence IND enabling studies in
2020.
- Aptorum Group has established a new subsidiary, Smart Pharma,
which operates its novel computational repurposed drug discovery,
modeling and validation platform, i.e. the Smart-ACTTM platform.
Abbreviated for Accelerated Commercialization of Therapeutics,
Smart-ACTTM encompasses state-of-the-art technology to perform
systematic screening and repurposing of approved drug molecules
against thoughtfully selected therapeutic targets. Specifically,
the Smart-ACTTM platform comprises of a network of modules and
processes that simulate the effectiveness of drug molecules against
diseases for outcome prediction and selection. The Smart-ACTTM
platform will initially focus on the screening and repurposing of
drug molecules for orphan diseases and diseases with other rare
unmet medical needs. Under the Smart-ACTTM platform, computational
screening has been completed for 1,615 marketed drugs against 3
therapeutic target proteins which are related to poor prognosis of
neuroblastoma. The selected candidates under the SACT-1 program,
which is looking for a cure for neuroblastoma, are currently being
investigated and undergoing preclinical development.
- Aptorum Group, Aeneas Capital Limited and A*ccelerate
Technologies Pte Ltd, the enterprise office of the Agency for
Science, Technology and Research (A*STAR), signed a contribution
agreement to co-create local deep tech start-ups in the healthcare
and life sciences sector. Through this agreement, Aptorum Group and
A*ccelerate intend to jointly create up to 20 deep tech ventures in
Singapore over the next five years. These enterprises will leverage
technologies co-developed by A*STAR research institutes and Aptorum
Group. The parties agreed to contribute up to an aggregate of $90
million in cash or in-kind contributions to create these
ventures.
Upcoming Milestones
- For ALS-4, Aptorum Group anticipates filing an IND submission
in the first or second calendar quarter of 2020 and a hybrid Phase
1 clinical study is currently planned in North America with both
healthy volunteers and patients to obtain preliminary efficacy
readout.
Financial Results for the Six Months Ended June 30,
2019
Aptorum Group reported a net loss of $9.6 million for the six
months ended June 30, 2019 compared to $5.5 million for the same
period in 2018. The increase in net loss in current period was
driven by increase in research and development expenses, general
and administrative fees and legal and professional fees.
Research and development expenses were $2.7 million for the six
months ended June 30, 2019 compared to $1.3 million for the same
period in 2018. The increase was primarily due to the incurred
expenses for new sponsored research entered into with Universities
in such period, and the full operation of research and development
was started in the second half of 2018 which led to depreciation
and increase in payroll expenses since second half of 2018.
General and administrative fees were $3.2 million for the six
months ended June 30, 2019 compared to $2.2 million for the same
period in 2018. The increase was mainly driven by increased
headcount in the Group to support the business development, and the
higher amounts of insurance expense incurred after the Company
listed its securities on NASDAQ.
Legal and professional fees were $2.0 million for the six months
ended June 30, 2019 compared to $1.1 million for the same period in
2018. The increase in legal and professional fees was mainly due to
the increasing need for consultancy services on various
projects.
As of June 30, 2019, cash and marketable securities totaled
approximately $6.1 million and total equity was in excess of $24.0
million.
On August 13, 2019, Aptorum Group entered into financing
arrangements allowing the Company to access up to a total $15.0
million in line of credit debt financing. As of the date of this
release, the Company has not yet drawn down from this line of
credit.
Aptorum Group expects that its existing cash and marketable
securities, together with expected and committed cash from existing
collaborations, will enable it to fund its operating and capital
expenditure requirements to the end of 2020.
About Aptorum Group
Aptorum Group is a pharmaceutical company currently in the
preclinical stage, dedicated to developing and commercializing
therapeutic technologies to tackle unmet medical needs. The company
is pursuing therapeutic projects in infectious diseases,
gastroenterology, orphan diseases and other disease areas.
For more information about the Company, please visit
www.aptorumgroup.com.
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 BALANCE SHEETS
(Stated in U.S. Dollars)
As of June 30, 2019
As of December 31,
2018
(unaudited)
ASSETS
Current assets:
Cash
$
4,466,741
$
12,006,624
Restricted cash
-
14,100,614
Digital currencies
117,482
-
Accounts receivable
8,367
2,827
Inventories
33,911
30,642
Marketable securities, at fair value
1,669,096
1,014,338
Investments in derivatives
425,916
115,721
Amounts due from related parties
-
169,051
Due from brokers
109,134
818,968
Other receivables and prepayments
911,997
464,156
Total current assets
7,742,644
28,722,941
Property, plant and equipment, net
5,777,657
4,260,602
Non-marketable investments
7,112,180
7,094,712
Intangible assets, net
1,347,594
1,409,540
Amounts due from related parties
50,000
50,000
Long-term prepayments
2,048,570
3,417,178
Loan receivable
571,975
-
Other non-current asset
89,750
119,667
Total Assets
$
24,740,370
$
45,074,640
LIABILITIES AND EQUITY
LIABILITIES
Current liabilities:
Amounts due to related parties
$
3,512
$
33,417
Accounts payable and accrued expenses
548,433
1,247,147
Finance lease payable, current portion
45,196
43,877
Warrant liabilities
-
753,118
Convertible debts
-
10,107,306
Total current liabilities
597,141
12,184,865
Finance lease payable, non-current
portion
120,941
143,873
Total Liabilities
$
718,082
$
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 as at June 30, 2019 and 6,537,269 shares issued and
outstanding as 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 June 30, 2019 and December 31, 2018)
22,437,754
22,437,754
Additional paid-in capital
23,857,814
23,003,285
Accumulated other comprehensive gain
(loss)
7,345
(1,484,688)
Accumulated deficit
(27,957,689)
(17,379,185)
Total equity attributable to the
shareholders of Aptorum Group Limited
24,942,586
33,114,435
Non-controlling interests
(920,298)
(368,533)
Total equity
24,022,288
32,745,902
Total Liabilities and Equity
$
24,740,370
$
45,074,640
APTORUM GROUP LIMITED
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE INCOME (LOSS)
(Stated in U.S. Dollars)
For the six months ended June
30,
2019
2018
(unaudited)
(unaudited)
Revenue
Healthcare services income
$
239,792
$
26,662
Operating expenses
Costs of healthcare services
(371,218)
(22,749)
Research and development expenses
(2,714,217)
(1,342,179)
General and administrative fees
(3,232,916)
(2,238,025)
Legal and professional fees
(2,008,774)
(1,063,032)
Other operating expenses
(120,788)
(235,413)
Total operating expenses
(8,447,913)
(4,901,398)
Other loss
Gain on investments in marketable
securities, net
315,977
-
Gain on non-marketable investment
1,147,199
-
Gain (loss) on investments in derivatives,
net
310,195
(359,844)
Realized gain on sale of digital
currencies
12,334
-
Changes in fair value of warrant
liabilities
(866,300)
-
Gain on extinguishment of convertible
debts
1,198,490
-
Interest expense, net
(3,678,566)
(301,362)
Sundry income
128,444
-
Total other loss, net
(1,432,227)
(661,206)
Net loss
$
(9,640,348)
$
(5,535,942)
Less: net loss attributable to
non-controlling interests
(551,877)
(47,570)
Net loss attributable to Aptorum Group
Limited
$
(9,088,471)
$
(5,488,372)
Net loss per share – basic and diluted
$
(0.31)
$
(0.20)
Weighted-average shares outstanding –
basic and diluted
28,978,151
27,864,135
Net loss
$
(9,640,348)
$
(5,535,942)
Other Comprehensive income
(loss)
Unrealized loss on investments in
available-for-sale securities
-
(178,027)
Exchange differences on translation of
foreign operations
2,000
167
Other Comprehensive income (loss)
2,000
(177,860)
Comprehensive loss
(9,638,348)
(5,713,802)
Less: comprehensive loss attributable to
non-controlling interests
(551,877)
(47,570)
Comprehensive loss attributable to the
shareholders of Aptorum Group Limited
(9,086,471)
(5,666,232)
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Email: info@aptorumgroup.com
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