Apollomics Reports First Half 2023 Financial Results and Provides Corporate Update
2023年9月29日 - 5:17AM
Apollomics Inc. (Nasdaq: APLM) (the “Company”), a late- stage
clinical biopharmaceutical company developing multiple oncology
drug candidates to address difficult-to-treat and
treatment-resistant cancers, today announced its financial results
for the six months ended June 30, 2023, and provided a corporate
update.
“The first half of 2023 was a period of significant
accomplishment, culminating in the completion of our business
combination and listing on Nasdaq, which positions us well to
advance our lead product candidate, vebreltinib, in non-small cell
lung cancer and other solid tumors with MET dysregulation, as well
as other product candidates in development,” said Guo-Liang Yu,
Ph.D., Chairman and Chief Executive Officer of Apollomics. “We
remain on track to generate key clinical data across our pipeline
later this year and into 2024, including for our two late-stage
candidates, vebreltinib and uproleselan.”
Pipeline Update
- Vebreltinib
(APL-101) – a
highly specific
cMet inhibitor
in non-small
cell lung cancer
(NSCLC) and other solid tumors with cMet
dysregulation
- The Company expects results from
SPARTA, its ongoing global Phase 2 multi-cohort clinical trial in
NSCLC and other solid tumors with cMet dysregulations
(NCT03175224), in the second half of 2023. Based on a meeting with
the U.S. Food and Drug Administration in July 2023, the Company
believes data from this trial in combination with data from the
Phase 2 KUNPENG study (NCT04258033) by Beijing Pearl (China
partner) may support its first new drug application (NDA) for the
treatment of NSCLC with MET exon14 skipping mutation with the U.S.
FDA, while generating clinical data on other indications.
- The vebreltinib NDA for treatment of
NSCLC with MET exon14 skipping mutation was submitted by Beijing
Pearl to the China National Medical Products Administration (NMPA)
in September 2022, with an NDA review decision anticipated in
2023.
- The Company has received orphan drug
designation of vebreltinib for the treatment of NSCLC with MET
genomic tumor aberrations from the U.S. FDA.
- Uproleselan
(APL-106) – an
E-selectin inhibitor
as an adjunct
to chemotherapy
in acute myeloid leukemia (AML) treatment
with Breakthrough Therapy designation
- The Company expects to complete patient
recruitment of its Phase 3 bridging clinical study for uproleselan
for the treatment of relapsed/refractory (r/r) AML in China in
2023.
- The U.S. National Cancer Institute is
sponsoring an ongoing Phase 2/3 study for treatment of newly
diagnosed older adults with AML who are fit for
chemotherapy.
- GlycoMimetics, Apollomics’
collaboration partner in the U.S., expects topline results from its
pivotal Phase 3 study of uproleselan in r/r AML by the end of the
second quarter of 2024.
- Product
pipeline
- The Company’s pipeline includes nine
novel oncology drug candidates, six of which are currently in the
clinical stage of development, using targeted therapy, immuno-
oncology agents and other innovative approaches to potentially
address a range of cancers, including lung cancer, brain cancer,
AML and other solid tumors.
Business Highlights
- Debuted as a publicly traded
targeted oncology company: On March 29, 2023, Apollomics
completed its business combination with Maxpro Capital Acquisition
Corp. Apollomics’ Class A ordinary shares and public warrants began
trading on March 30, 2023, on the Nasdaq Capital Market under the
symbols "APLM" and “APLMW”, respectively.
First Half
2023 Financial
Results
- Cash, cash equivalents and
investments as of June 30, 2023 were approximately $52.6 million,
compared with $58.9 million as of December 31, 2022. In March 2023,
the Company raised $23.7 million in a private placement in public
equity (PIPE) financing, before transaction expenses. Based on
current projections, the Company believes its cash position is
sufficient to fund planned operations into the second half of
2024.
- Research and development (R&D)
expenses were $16.5 million, including stock-based compensation of
$2.8 million, in the first six months of 2023, compared to $18.0
million, including stock-based compensation of $1.3 million, in the
same period of 2022. The decrease in R&D expenses was due
primarily to one-time expenses in 2022 associated with drug
substance manufacturing and a license in China.
- General and administrative (G&A)
expenses were $9.7 million, including stock-based compensation of
$2.4 million, in the first six months of 2023, compared to $5.1
million, including stock-based compensation of $0.8 million, in the
same period of 2022. The increase in G&A expenses was due
primarily from directors’ and officers’ insurance as a result of
being a publicly listed company and an increase in employee
stock-based compensation.
- The net loss for the first six months
of 2023 was $(150.7) million, or $(2.55) per diluted share,
compared with a net loss for the first six months of 2022 of $(3.4)
million, or $(0.68) per diluted share. The increase in net loss is
due primarily to a $76.4 million expense to the change in fair
value of the preferred shares in the first six months of 2023,
compared to a $23.7 million benefit to the change in fair value of
the preferred shares in the first six months of 2022, and a charge
of $45.5 million in the six months ended June 30, 2023 for the
excess of fair value of shares exchanged over the fair value of net
tangible assets acquired in the business combination booked to
other expense. The change in the fair value of the preferred shares
during the six months ended 2023 is due to their write-up of fair
value at the date of the conversion into common shares at the time
of the business combination.
- The weighted average diluted common shares outstanding for the
first six months of 2023 was approximately 59,000,000, compared to
approximately 46,364,000 in the same period of 2022.
First Half 2023 Financial Results Conference
Call
Apollomics’ management team will host a conference call and
webcast Monday, October 2, 2023 at 8:30 a.m. ET to discuss the
financial results and provide a corporate update.
A live webcast will be available at
https://ir.apollomicsinc.com/news-events/events.
Participants may also pre-register any time before the call
here. Once registration is completed, participants
will be provided a dial-in number with a personalized conference
code to access the call. Please dial in 15 minutes prior to the
start time.
About Apollomics
Inc.
Apollomics Inc. is an innovative clinical-stage
biopharmaceutical company focused on the discovery and development
of oncology therapies with the potential to be combined with other
treatment options to harness the immune system and target specific
molecular pathways to inhibit cancer. Apollomics currently has a
pipeline of nine drug candidates across multiple programs, six of
which are currently in the clinical stage of development.
Apollomics’ lead programs include investigating its core product,
vebreltinib (APL-101), a potent, selective c-Met inhibitor for the
treatment of non-small cell lung cancer and other advanced tumors
with c-Met alterations, which is currently in a Phase 2 multicohort
clinical trial in the United States, and developing an anti-cancer
enhancer drug candidate, uproleselan (APL- 106), a specific
E-Selectin antagonist that has the potential to be used
adjunctively with standard chemotherapy to treat acute myeloid
leukemia (AML) and other hematologic cancers, which is currently in
a Phase 3 bridging clinical trial in China. Outside of China,
enrollment is complete utilizing uproleselan in combination with
standard chemotherapy in a Phase 3 trial sponsored by GlycoMimetics
in relapsed or refractory AML and a Phase 2/3 trial sponsored by
the U.S. National Cancer Institute in first-line AML.
Cautionary Statement
Regarding Forward-Looking
Statements
This press release includes statements that constitute
“forward-looking statements” within the meaning of the federal
securities laws, including Section 27A of the Securities Act of
1933, as amended (the “Securities Act”), and Section 21E of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”).
All statements, other than statements of present or historical fact
included in this press release, regarding the Company’s future
financial performance, as well as the Company’s strategy, future
operations, revenue guidance, projected costs, prospects, plans and
objectives of management are forward-looking statements. When used
in this press release, the words “could,” “should,” “will,” “may,”
“believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,”
the negative of such terms and other similar expressions are
intended to identify forward-looking statements, although not all
forward- looking statements contain such identifying words. These
forward-looking statements are based on management’s current
expectations and assumptions about future events and are based on
currently available information as to the outcome and timing of
future events. Apollomics cautions you that these forward-looking
statements are subject to numerous risks and uncertainties, most of
which are difficult to predict and many of which are beyond the
control of Apollomics. In addition, Apollomics cautions you that
the forward-looking statements contained in this press release are
subject to unknown risks, uncertainties and other factors,
including: (i) the impact of any current or new government
regulations in the United States and China affecting Apollomics’
operations and the continued listing of Apollomics’ securities;
(ii) the inability to achieve successful clinical results or to
obtain licensing of third-party intellectual property rights for
future discovery and development of Apollomics’ oncology projects;
(iii) the failure to commercialize product candidates and achieve
market acceptance of such product candidates; (iv) the failure to
protect Apollomics’ intellectual property; (v) breaches in data
security; (vi) risks related to the ongoing COVID-19 pandemic and
response; (vii) the risk that Apollomics may not be able to develop
and maintain effective internal controls; (viii) unfavorable
changes to the regulatory environment; and those risks and
uncertainties discussed in the Annual Report on Form 20-F and
Registration Statement on Form F-1 (as amended or supplemented from
time to time) filed by Apollomics, Inc. with the U.S. Securities
and Exchange Commission (“SEC”) under the heading “Risk Factors”
and the other documents filed, or to be filed, by the Company with
the SEC. Other unknown or unpredictable factors also could have
material adverse effects on the Company’s future results and/or
could cause our actual results and financial condition to differ
materially from those indicated in the forward-looking statements.
Should one or more of the risks or uncertainties described in this
press release materialize or should underlying assumptions prove
incorrect, actual results and plans could differ materially from
those expressed in any forward-looking statements. New risk factors
that may affect actual results or outcomes emerge from time to time
and it is not possible to predict all such risk factors, nor can
Apollomics assess the impact of all such risk factors on its
business, or the extent to which any factor or combination of
factors may cause actual results to differ materially from those
contained in any forward-looking statements. Forward-looking
statements are not guarantees of performance. You should not put
undue reliance on these statements, which speak only as of the date
hereof. Additional information concerning these and other factors
that may impact the operations and projections discussed herein can
be found in the reports that Apollomics has filed and will file
from time to time with the SEC. These SEC filings are available
publicly on the SEC’s website at www.sec.gov.
Apollomics undertakes no obligation to update publicly any of
these forward-looking statements to reflect actual results, new
information or future events, changes in assumptions or changes in
other factors affecting forward-looking statements, except to the
extent required by applicable laws. If Apollomics updates one or
more forward-looking statements, no inference should be drawn that
Apollomics will make additional updates with respect to those or
other forward-looking statements.
CONTACTSInvestor
RelationsPeter Vozzo ICR
WestwickePeter.Vozzo@westwicke.com+1-443-213-0505
Media RelationsSean Leous ICR
WestwickeSean.Leous@westwicke.com+1-646-866-4012
APOLLOMICSINC.CONDENSEDCONSOLIDATEDINTERIMSTATEMENTSOFLOSSANDCOMPREHENSIVE
LOSS (UNAUDITED)(All amounts in thousands of US$, except
for per share data) |
|
|
SixMonthsEndedJune30, |
|
2023 |
|
2022 |
|
|
US$ |
|
US$ |
|
Other income |
401 |
|
756 |
|
Foreign exchange gains and
(losses) |
(2,104) |
|
(725) |
|
Fair value change of financial
assets at FVTPL |
460 |
|
32 |
|
Fair value change of financial
liabilities at FVTPL |
676 |
|
— |
|
Fair value change of convertible
preferred shares |
(76,430) |
|
23,669 |
|
Research and development
expenses |
(16,518) |
|
(17,999) |
|
Administrative expenses |
(9,652) |
|
(5,097) |
|
Finance costs |
(60) |
|
(44) |
|
Other expense |
(47,457) |
|
(4,008) |
|
Loss before taxation |
(150,684) |
|
(3,416) |
|
Income tax expenses |
(10) |
|
(1) |
|
Loss and total comprehensive loss
for the period, net of taxation, attributable to owners of the
Company |
(150,694) |
|
(3,417) |
|
Loss per share |
|
|
Basic loss per common share
(US$) |
(2.55) |
|
(0.12) |
|
Diluted loss per common share
(US$) |
(2.55) |
|
(0.68) |
|
Weighted average number of common
shares outstanding - Basic ('000) |
59,000 |
|
27,982 |
|
Weighted average number of common
shares outstanding - Diluted ('000) |
59,000 |
|
46,364 |
|
APOLLOMICS INC.CONDENSED
CONSOLIDATED INTERIM
STATEMENTS OF
FINANCIAL POSITION(All
amounts in thousands of US$) |
|
|
As of
June 30, 2023 |
|
As of
December 31, 2022 |
|
|
(Unaudited) |
|
|
|
|
US$ |
|
US$ |
|
Non-current assets |
|
|
Plant and equipment, net |
439 |
|
485 |
|
Right-of-use assets |
678 |
|
991 |
|
Intangible assets |
14,767 |
|
14,778 |
|
Rental deposits |
119 |
|
124 |
|
Time deposits with maturity
greater than twelve months |
— |
|
4,307 |
|
Total
non-current assets |
16,003 |
|
20,685 |
|
|
|
|
Current assets |
|
|
Deposits, prepayments and
deferred expenses |
2,759 |
|
1,176 |
|
Financial assets at fair value
through profit and loss ("FVTPL") |
20,400 |
|
19,067 |
|
Time deposits with maturity less
than twelve months |
6,920 |
|
2,872 |
|
Cash and cash equivalents |
25,296 |
|
32,675 |
|
Total current assets |
55,375 |
|
55,790 |
|
|
|
|
Total assets |
71,378 |
|
76,475 |
|
|
|
|
Current liabilities |
|
|
Other payables and accruals |
12,804 |
|
11,675 |
|
Accounts payable and accrued
offering costs |
947 |
|
— |
|
Financial liabilities arising
from unvested restricted shares |
— |
|
68 |
|
Lease liabilities |
385 |
|
614 |
|
Totalcurrentliabilities |
14,136 |
|
12,357 |
|
|
|
|
Net current assets |
41,239 |
|
43,433 |
|
|
|
|
Totalassetslesscurrentliabilities |
57,242 |
|
64,118 |
|
|
|
|
Non-current liabilities |
|
|
Lease liabilities |
294 |
|
377 |
|
Warrant liabilities |
1,251 |
|
— |
|
Convertible preferred shares |
— |
|
511,861 |
|
Total
non-currentliabilities |
1,545 |
|
512,238 |
|
|
|
|
Netassets(liabilities) |
55,697 |
|
(448,120) |
|
|
|
|
Equity |
|
|
Share capital |
— |
|
3 |
|
Apollomics class A ordinary
shares |
1 |
|
— |
|
Apollomics class B ordinary
shares |
8 |
|
— |
|
Treasury shares |
— |
|
(68) |
|
Share premium |
661,472 |
|
12,317 |
|
Reserves |
19,312 |
|
14,228 |
|
Accumulated losses |
(625,096) |
|
(474,600) |
|
Total
equity (deficit) |
55,697 |
|
(448,120) |
|
Apollomics (NASDAQ:APLM)
過去 株価チャート
から 12 2024 まで 1 2025
Apollomics (NASDAQ:APLM)
過去 株価チャート
から 1 2024 まで 1 2025