Regulatory News:
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM)
(“Aptorum Group” or “We”), a clinical stage biopharmaceutical
company dedicated to meeting unmet medical needs in oncology,
autoimmune diseases and infectious diseases, today announced
financial results for the fiscal year ended December 31, 2022, and
provided an update on clinical and corporate developments.
Mr. Darren Lui, Chief Executive Officer and
Executive Director of Aptorum Group, commented “Aptorum’s
operational plans remain on track. In particular, our lead
projects, ALS-4 (targeting infections caused by Staphylococcus
aureus including Methicillin-resistant Staphylococcus aureus
(MRSA)) and SACT-1 (targeting neuroblastoma), have completed their
Pre-IND discussion and End of Phase 1 meeting, respectively, with
US FDA. We are working towards completion of regulatory clearance
regarding next stage of clinical trials for these 2 lead projects
in the United States and further explore ALS-4 in non-human
applications. PathsDx is continuing its validations and we are
targeting to generate further data to support the planned
commercialization efforts of PathsDx and facilitate external
strategic collaborations. NativusWell® has also commenced
commercialization in China through JD.com, one of the largest
e-commerce platforms in China.”
Clinical Pipeline Update and Upcoming
Milestones
In 2023, we announced a number of updates for our lead and other
projects:
- Our ALS-4 (a first in-class anti-virulence based small
molecule drug targeting infections caused by Staphylococcus aureus,
including, but not limited to Methicillin Resistant Staphylococcus
Aureus (“MRSA”)) Pre-IND discussion with the US Food and Drug
Administration (“US FDA”) is completed. Upon the completion of
ALS-4’s respective Phase I clinical trials in Canada, ALS-4 has
been targeting to obtain the necessary IND clearance for Phase II
clinical trials in the United States. The Pre-IND discussions with
US FDA focused on overall development plan in preparation for the
IND application of ALS-4 targeting Acute Bacterial Skin and Skin
Structure Infections (ABSSSI) initially. With the positive feedback
on the overall development strategy from the US FDA, Aptorum is now
proceeding towards obtaining IND clearance of ALS-4.
- Our SACT-1 (a repurposed small molecule drug targeting
Neuroblastoma and potentially other cancer types) End of Phase 1
(“EOP1”) meeting with USFDA is completed. The EOP1 meeting was
focused on gaining alignment with the US FDA regarding the clinical
and regulatory pathway for SACT-1 for the treatment of
neuroblastoma in pediatric patients aged 2-18. At the EOP1, the FDA
generally agreed with the chemistry-manufacturing-control (CMC)
strategy and our proposed clinical development plan for Phase 1/2
trials.
- Our NativusWell® (a new dietary supplement supporting women’s
health throughout the Menopausal cycles) has commenced
collaboration with one of the largest e-commerce platforms in
China, JD.com, and NativusWell® is now distributable in China via
JD (also known as Jingdong).
- Our PathsDx (a liquid biopsy NGS based technology for the
diagnosis of infectious diseases) continues its validation to
generate further supporting data prior to its eventual
commercialization.
Corporate Highlights
On January 23, 2023, the Company effectuated a ten-for-one share
consolidation of its authorized share capital, such that every 10
Class A Ordinary Shares, par value of US$1.00 per share, in the
authorized share capital of the Company (including issued and
unissued share capital) be consolidated into 1 Class A Ordinary
Share, par value of US$10.00 per share, and that every 10 Class B
Ordinary Shares, par value of US$1.00 per share in the authorized
share capital of the Company (including issued and unissued share
capital) be consolidated into 1 Class B Ordinary Share, par value
of US$10.00 per share.
On February 21, 2023, the shareholders of the Company approved a
merger of the Company with Aptorum Group Cayman Limited, a newly
established wholly owned subsidiary of the Company, whereby the
Company was the surviving company, on the terms of the plan of
merger that includes the change in par value in the authorized
shares of the Company from $10 to $0.00001. In addition, among
other things, the shareholders approved to increase the voting
rights of the Class B Ordinary Shares from 10 votes per share to
100 votes per share, and to increase the number of Class A Ordinary
Shares authorized to 9,999,996,000,000 shares, par value $0.00001
each. These corporate actions were effective as of February 21,
2023.
On March 27, 2023, the Company entered into a non-binding Letter
of Intent and Term Sheet to acquire (“Transaction”) 100% of URF
Holding Group Limited and its underlying businesses (collectively
“U Group”). Currently, it is contemplated that the Transaction will
occur via a reverse takeover of the Company, which would result in
the continued listing of the combined entity on Nasdaq. The
Transaction is subject to, among other things, the execution of a
mutually agreeable definitive agreement, completion of due
diligence, fairness opinions, stockholder approvals, if necessary,
delivery of relevant financial statements, board of directors and
special committee approvals and satisfaction of all regulatory and
Nasdaq approvals, where relevant. There can be no assurance that a
definitive agreement will be entered into or that the proposed
transaction will be consummated on the terms set forth herein or at
all. Therefore, it is possible that the Transaction may never
occur.
Fiscal Year End Financial
Results
Aptorum Group reported a net loss of $11.5 million in 2022, as
compared to $27.1 million in 2021. The decrease in net loss were
mainly driven by the gain on long-term investments of $5.6 million,
and decrease in loss on investments in marketable securities, net
of $7.9 million.
Research and development expenses were $9.2 million in 2022 as
compared to $10.9 million in 2021. The decrease in research and
development expenses in 2022 was mainly due to the decrease in
contracted research organizations services as we are in a planning
process for Phase 2 of our lead projects which does not require
many services from contracted research organizations.
General and administrative fees were $5.2 million in 2022 as
compared to $5.4 million in 2021. The decrease in general and
administration fees was mainly due to decrease in payroll expenses
due to decrease in number of staff.
Legal and professional fees were $2.9 million in 2022 as
compared to $2.6 million in 2021. The increase in legal and
professional fees was mainly due to more consulting services
engaged during 2022.
Aptorum Group reported $5.0 million of cash and restricted cash
as of December 31, 2022 compared to $8.3 million as of December 31,
2021. The decrease in cash and restricted cash was mainly the cash
used in operating activities of $11.5 million, partly offset by the
repayment of loan from related parties of $3.0 million, loan from a
bank of $3.0 million, and proceeds from issuance of convertible
notes of $3.0 million in 2022.
About Aptorum Group
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), autoimmune and
infectious diseases. Aptorum has completed two phase I clinical
trials for its ALS-4 (MRSA) and orphan drug designated SACT-1
(Neuroblastoma) small molecule drugs and commercializing its NLS-2
NativusWell® nutraceutical (menopause). 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 and ongoing
clinical validation of its novel molecular-based rapid pathogen
identification and detection diagnostics technology with
Singapore’s Agency for Science, Technology and Research.
For more information about the Company, 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.
APTORUM GROUP LIMITED
CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
For Years Ended December 31,
2022 and 2021
(Stated in U.S.
Dollars)
Year Ended December 31,
2022
Year Ended December 31,
2021
Revenue
Healthcare services income
$
1,295,889
$
1,541,778
Operating expenses
Cost of healthcare services
(1,215,824
)
(1,459,924
)
Research and development expenses
(9,219,595
)
(10,869,642
)
General and administrative fees
(5,220,405
)
(5,409,302
)
Legal and professional fees
(2,888,140
)
(2,617,834
)
Other operating expenses
(261,038
)
(392,511
)
Total operating expenses
(18,805,002
)
(20,749,213
)
Other income (loss), net
Loss on investments in marketable
securities, net
(134,134
)
(8,031,595
)
Gain on long-term investments
5,588,051
-
Loss on investments in derivatives,
net
-
(4,289
)
Gain on use of digital currencies
-
4,918
Gain on derecognition of non-financial
assets
-
75,000
Interest income (expense), net
146,588
(93,601
)
Loss on disposal of subsidiaries
-
(3,638
)
Sundry income
383,506
146,347
Total other income (loss), net
5,984,011
(7,906,858
)
Net loss
(11,525,102
)
(27,114,293
)
Net loss attributable to non-controlling
interests
1,725,542
2,065,904
Net loss attributable to Aptorum Group
Limited
$
(9,799,560
)
$
(25,048,389
)
Net loss per share attributable to Aptorum
Group Limited
- Basic(1)
$
(2.75
)
$
(7.15
)
- Diluted(1)
$
(2.75
)
$
(7.15
)
Weighted-average shares outstanding
- Basic(1)
3,569,484
3,503,396
- Diluted(1)
3,569,484
3,503,396
Net loss
$
(11,525,102
)
$
(27,114,293
)
Other comprehensive income
(loss)
Exchange differences on translation of
foreign operations
35,826
(55,315
)
Other comprehensive income (loss)
35,826
(55,315
)
Comprehensive loss
(11,489,276
)
(27,169,608
)
Comprehensive loss attributable to
non-controlling interests
1,725,542
2,065,904
Comprehensive loss attributable to the
shareholders of Aptorum Group Limited
(9,763,734
)
(25,103,704
)
(1)
All per share amounts and shares
outstanding for all periods have been retroactively restated to
reflect APTORUM GROUP LIMITED’s 1 for 10 reverse stock split, which
was effective on January 23, 2023.
APTORUM GROUP LIMITED
CONSOLIDATED BALANCE
SHEETS
December 31, 2022 and
2021
(Stated in U.S.
Dollars)
December 31,
2022
December 31,
2021
ASSETS
Current assets:
Cash
$
1,882,545
$
8,131,217
Restricted cash
3,130,335
130,270
Accounts receivable
174,426
78,722
Inventories
27,722
35,775
Marketable securities, at fair value
102,481
236,615
Amounts due from related parties
129,677
47,754
Due from brokers
652
76,380
Loan receivable from related parties
875,956
3,358,089
Other receivables and prepayments
744,008
593,478
Total current assets
7,067,802
12,688,300
Property, plant and equipment, net
2,825,059
3,731,116
Operating lease right-of-use assets
347,000
154,439
Long-term investments
9,744,958
4,156,907
Intangible assets, net
752,705
880,256
Long-term deposits
129,847
296,225
Total Assets
$
20,867,371
$
21,907,243
LIABILITIES AND EQUITY
LIABILITIES
Current liabilities:
Amounts due to related parties
$
12,693
$
11,389
Accounts payable and accrued expenses
6,166,807
4,172,565
Finance lease liabilities current
-
47,923
Operating lease liabilities, current
310,548
145,391
Bank loan
3,000,000
-
Convertible notes
3,013,234
-
Total current liabilities
12,503,282
4,377,268
Operating lease liabilities,
non-current
30,784
23,853
Loan payables to related parties
500,000
-
Total Liabilities
$
13,034,066
$
4,401,121
Commitments and contingencies
-
-
EQUITY
Class A Ordinary Shares ($10.00 par value;
6,000,000 shares authorized, 1,326,953 and 1,320,241 shares issued
and outstanding as of December 31, 2022 and 2021,
respectively(1))
$
13,269,528
$
13,202,408
Class B Ordinary Shares ($10.00 par value;
4,000,000 shares authorized, 2,243,776 shares issued and
outstanding as of December 31, 2022 and 2021(1))
22,437,754
22,437,754
Additional paid-in capital
45,308,080
43,506,717
Accumulated other comprehensive income
(loss)
33,807
(2,019
)
Accumulated deficit
(65,337,075
)
(55,537,515
)
Total equity attributable to the
shareholders of Aptorum Group Limited
15,712,094
23,607,345
Non-controlling interests
(7,878,789
)
(6,101,223
)
Total equity
7,833,305
17,506,122
Total Liabilities and Equity
$
20,867,371
$
21,907,243
(1)
All per share amounts and shares
outstanding for all periods have been retroactively restated to
reflect APTORUM GROUP LIMITED’s 1 for 10 reverse stock split, which
was effective on January 23, 2023.
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Aptorum Group Limited Investor Relations
investor.relations@aptorumgroup.com +44 20 80929299
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