Regulatory News:
Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM)
(“Aptorum Group” or the “Company”), a clinical stage
biopharmaceutical company dedicated to meeting unmet medical needs
in oncology and infectious diseases, today provided a business
update and announced financial results for the six months ended
June 30, 2021.
“During the first half of 2021, we remained focused on advancing
the development of our therapeutic programs. As announced in early
2021, our ALS-4 program (targeting infections caused by
Staphylococcus aureus including MRSA) commenced a Phase 1 clinical
study in Canada. We are pleased that 5 total cohorts, which
represent the essential part of the single ascending dose (“SAD”)
portion of the trial, have been completed without any serious
adverse events being observed. On the basis of ALS-4’s favourable
safety profile, we are commencing the multiple ascending dose
(“MAD”) portion of the trial in Q3, 2021. Our other lead program
SACT-1 (targeting neuroblastoma), has also received clearance from
the US FDA to commence clinical trials in the United States. SACT-1
will be our second therapeutic program entering into the clinical
phase. Our RPIDD program (liquid biopsy based approach to
infectious disease rapid diagnostics) is also progressing well and
we are very pleased to continue its clinical validation currently
in collaboration with A*Star. Finally, we are excited to continue
with our efforts of commercialising our NativusWell® DOI product, a
novel supplement targeting woman’s health including menopausal
symptoms. We are also excited to continue to identify and progress
on certain other potential novel therapeutic candidates, including
our ongoing assessment of a number of novel immunomodulators
developed by Yale University targeting major autoimmune diseases,
as we announced earlier in the year,” said Mr. Ian Huen, Chief
Executive Officer and Executive Director of Aptorum Group
Limited.
Clinical Pipeline Update and Upcoming
Milestones
In September 2021, Aptorum Group received clearance from the US
FDA to open an IND to conduct clinical trials on SACT-1, an orally
administered small molecule repurposed drug for the treatment of
neuroblastoma. The IND-opening study is a bioavailability/Food
Effect study, followed by a Phase 1b/2a trial in neuroblastoma
patients which is subject to further FDA approval.
In May 2021, Aptorum Group announced its ongoing Phase I
clinical trial for one of its lead programs, ALS-4, an orally
administered small molecule drug for the treatment of infections
caused by Staphylococcus aureus including MRSA, under which two
initial cohorts of the SAD portion of the trial in healthy male and
female adult subjects have been completed with no serious adverse
events observed. In July 2021, the Company further announced two
additional cohorts (Cohort C & D) of the SAD portion have been
completed with no serious adverse events observed. In total, up to
6 cohorts for SAD and 3 cohorts for MAD have been planned. The MAD
study is commencing in Q3, 2021.
In May 2021, Aptorum Group entered into an agreement with
Exeltis regarding Aptorum's preclinical asset targeting women’s
health and gynaecological conditions, including endometriosis, in
the European Union and Latin America. Aptorum retained development
rights in the rest of the world.
In April 2021, Aptorum Group entered into a material transfer
and license option agreement with Yale University to evaluate a
group of preclinical stage novel immunomodulators that could
represent first-in-class therapeutics in treating autoimmune and
oncology diseases, among other indications.
Corporate Highlights
In May 2021, Jurchen Investments Limited, purchased an aggregate
of 1,387,925 of the Company’s Class A Ordinary Shares at $2.882 per
share, representing 10% premium to the last closing price.
On March 26, 2021, Aptorum Group entered into a Sales Agreement
with H.C. Wainwright & Co., LLC, acting as the Company’s sales
agent, pursuant to which the Company may offer and sell, from time
to time, through the Sales Agent, Class A Ordinary Shares for an
aggregate offering price of up to $15,000,000.
Financial Results for the Six Months
Ended June 30, 2021
Aptorum Group reported a net loss of $17.1 million for the six
months ended June 30, 2021 compared to $7.0 million for the same
period in 2020. The increase in net loss in the current period was
driven by loss on investments in marketable securities, net of $7.6
million, and there was a gain on non-marketable investment of $1.6
million in the same period in 2020 while there was no such gain in
current period.
Research and development expenses were $5.5 million for the six
months ended June 30, 2021 compared to $4.3 million for the same
period in 2020. The increase in research and development expenses
was mainly due to the increase in services provided by contracted
research organizations as a result of our projects’
development.
General and administrative fees were $2.6 million for the six
months ended June 30, 2021 compared to $2.1 million for the same
period in 2020. The increase in general and administration fees was
mainly due to a one-off reversal of over-provision in relations to
bonus payables to our directors, employees, external consultants
and advisors in the last period. It was partly offset by the
decrease in travelling expenses due to the outspread of COVID-19
and the decrease in amortization and depreciation due to the
disposal of fixed assets in the second half of 2020.
Legal and professional fees were $1.2 million for the six months
ended June 30, 2021 compared to $1.5 million for the same period in
2020. The decrease in legal and professional fees was mainly due to
the decrease in consultancy services during current period.
As of June 30, 2021, cash and restricted cash totalled
approximately $20.1 million and total equity was approximately
$26.5 million.
Aptorum Group expects that its existing cash and restricted cash
together with undrawn line of credit facility from related parties,
will enable it to fund its operating and capital expenditure
requirements for at least the next 12 months.
APTORUM GROUP LIMITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Stated in U.S. Dollars)
June 30, 2021
December 31, 2020
(Unaudited)
ASSETS
Current assets:
Cash
$
19,935,888
$
3,495,231
Restricted cash
130,125
130,125
Digital currencies
-
1,539
Accounts receivable
47,093
62,221
Inventories
32,785
39,133
Marketable securities, at fair value
702,937
28,384,944
Investments in derivatives
-
4,289
Amounts due from related parties
113,858
-
Due from brokers
160,341
160,337
Other receivables and prepayments
795,087
1,378,996
Total current assets
21,918,114
33,656,815
Property, plant and equipment, net
4,148,449
4,686,323
Operating lease right-of-use assets
355,202
547,389
Non-marketable investments
4,079,707
4,079,707
Intangible assets, net
917,170
964,857
Long-term deposits
296,225
296,225
Total Assets
$
31,714,867
$
44,231,316
LIABILITIES AND EQUITY
LIABILITIES
Current liabilities:
Amounts due to related parties
$
133,761
$
145,926
Accounts payable and accrued expenses
3,537,237
3,240,772
Finance lease liabilities, current
50,881
49,396
Operating lease liabilities, current
339,040
432,600
Total current liabilities
4,060,919
3,868,694
Finance lease liabilities, non-current
22,106
47,923
Operating lease liabilities,
non-current
63,008
155,121
Loan payables to related parties
1,098,492
2,007,285
Total Liabilities
$
5,244,525
$
6,079,023
Commitments and contingencies
-
-
EQUITY
Class A Ordinary Shares ($1.00 par value;
60,000,000 shares authorized,
13,170,374 and 11,584,324
shares issued and outstanding as of June 30, 2021
and December 31, 2020,
respectively)
$
13,170,374
$
11,584,324
Class B Ordinary Shares ($1.00 par value;
40,000,000 shares authorized,
22,437,754 shares issued and
outstanding as of June 30, 2021 and
December 31, 2020)
22,437,754
22,437,754
Additional paid-in capital
42,441,471
38,247,903
Accumulated other comprehensive income
28,267
53,296
Accumulated deficit
(46,570,550
)
(30,489,126
)
Total equity attributable to the
shareholders of Aptorum Group Limited
31,507,316
41,834,151
Non-controlling interests
(5,036,974
)
(3,681,858
)
Total equity
26,470,342
38,152,293
Total Liabilities and Equity
$
31,714,867
$
44,231,316
APTORUM GROUP LIMITED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE INCOME (LOSS) (Stated in U.S. Dollars)
For the six months ended June
30,
2021
2020
(Unaudited)
(Unaudited)
Revenue
Healthcare services income
$
637,784
$
327,273
Operating expenses
Costs of healthcare services
(629,987
)
(436,171
)
Research and development expenses
(5,508,356
)
(4,315,033
)
General and administrative fees
(2,564,117
)
(2,076,634
)
Legal and professional fees
(1,240,512
)
(1,540,304
)
Other operating expenses
(189,125
)
(641,457
)
Total operating expenses
(10,132,097
)
(9,009,599
)
Other (loss) income
(Loss) gain on investments in marketable
securities, net
(7,565,273
)
192,134
Gain on non-marketable investment
-
1,635,939
Loss on investments in derivatives,
net
(4,289
)
(101,233
)
Gain on use of digital currencies
4,918
-
Interest expense, net
(126,102
)
(144,226
)
Sundry income
82,652
111,398
Total other (loss) income, net
(7,608,094
)
1,694,012
Net loss
$
(17,102,407
)
$
(6,988,314
)
Less: net loss attributable to
non-controlling interests
(1,020,983
)
(783,749
)
Net loss attributable to Aptorum Group
Limited
$
(16,081,424
)
$
(6,204,565
)
Net loss per share – basic and diluted
$
(0.47
)
$
(0.21
)
Weighted-average shares outstanding –
basic and diluted
34,280,137
29,956,393
Net loss
$
(17,102,407
)
$
(6,988,314
)
Other Comprehensive (loss)
income
Exchange differences on translation of
foreign operations
(25,029
)
31,170
Other Comprehensive (loss) income
(25,029
)
31,170
Comprehensive loss
(17,127,436
)
(6,957,144
)
Less: comprehensive loss attributable to
non-controlling interests
(1,020,983
)
(783,751
)
Comprehensive loss attributable to the
shareholders of Aptorum Group
Limited
(16,106,453
)
(6,173,393
)
About Aptorum Group
Limited
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a
clinical stage biopharmaceutical company dedicated to the
discovery, development and commercialization of therapeutic assets
to treat diseases with unmet medical needs, particularly in
oncology (including orphan oncology indications) and infectious
diseases. The pipeline of Aptorum is also enriched through (i) the
establishment of drug discovery platforms that enable the discovery
of new therapeutics assets through, e.g. systematic screening of
existing approved drug molecules, and microbiome-based research
platform for treatments of metabolic diseases; and (ii) the
co-development of a novel molecular-based rapid pathogen
identification and detection diagnostics technology with Accelerate
Technologies Pte Ltd, commercialization arm of the Singapore’s
Agency for Science, Technology and Research.
For more information about Aptorum Group, please visit
www.aptorumgroup.com.
Disclaimer and Forward-Looking
Statements
This press release does not constitute an offer to sell or a
solicitation of offers to buy any securities of Aptorum Group.
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
US 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 well as the prospectus that received
the French Autorité des Marchés Financiers visa n°20-352 on 16 July
2020. As a result, the projections included in such forward-looking
statements are subject to change and actual results may differ
materially from those described herein.
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.
This announcement is not a prospectus within the meaning of the
Regulation (EU) n°2017/1129 of 14 June 2017 as amended by
Regulations Delegated (EU) n°2019/980 of 14 March 2019 and
n°2019/979 of 14 March 2019.
This press release is provided “as is” without any
representation or warranty of any kind.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210915005596/en/
Aptorum Group Limited Investor Relations Department
investor.relations@aptorumgroup.com +44 20 80929299
Redchip – Financial Communications United States Investor
relations Dave Gentry dave@redchip.com +1 407 491 4498
Actifin – Financial Communications Europe Investor relations
Ghislaine Gasparetto ggasparetto@actifin.fr +33 1 56 88 11 22
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