Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage
biopharmaceutical company using an expanded genetic code technology
platform to discover and develop Engineered Precision Biologics
(EPBs), today provided a corporate update and reported financial
results for the first half of 2021.
“I want to thank the entire Ambrx team for their efforts in
making our June IPO such a success. I believe we have created a
strong foundation on which to grow our company. Subsequently, we
provided several clinical updates regarding our ARX788 program in
gastric cancer and our ARX517 program in PSMA expressing tumors.
For ARX788, the first patient was dosed in our co-sponsored
ACE-Gastric-02 Phase 2/3 clinical study and updated positive data
from our co-sponsored ACE-Gastric-01 study was presented at The
Chinese Society of Clinical Oncology (CSCO) annual meeting. We were
also able to dose the first patient in our Phase 1 trial of ARX517
in the United States,” said Feng Tian, Ph.D., Chairman of the
Board, President and CEO of Ambrx. “Additionally, during the
period, Ambrx strengthened its leadership team with the formation
of a Scientific Advisory Board, the appointment of Sonja Nelson as
CFO, and the addition to our Board of Directors of Olivia Ware and
Katrin Rupalla. I am proud of how far Ambrx has come and look
forward to carrying forward the momentum we have built into the end
of the year and beyond.”
1H 2021 and Subsequent Highlights
- Positive Data on ARX788 for the Treatment of HER2+ Gastric
Cancer Presented at CSCO. In October, NovoCodex Pharmaceuticals
Ltd., Ambrx’s partner in China, presented positive interim data
from the ACE-Gastric-01 Phase 1 clinical study of ARX788 for the
treatment of HER2+ metastatic gastric / gastroesophageal junction
(GEJ) cancer at CSCO. The data presented added to and updated
initial trial data presented by both companies at the 2021 American
Society of Clinical Oncology (ASCO) Annual Meeting in June
2021.
- Advanced the Development of ARX788 in Three Trials.
Subsequent to the end of first half of the year, Ambrx dosed the
first patient in a global Phase 2/3 clinical study of ARX788
(ACE-Gastric-02) in patients with HER2+ gastric/GEJ cancer,
initiated a global Phase 2 basket clinical study of ARX788 (ACE-Pan
tumor-02) for HER2-mutated or HER2-amplified/over-expressed solid
tumors, and initiated a Phase 2 clinical study of ARX788
(ACE-Breast-03) in patients with HER2+ metastatic breast
cancer.
- First Patient Dosed in a Phase 1 Trial for ARX517. In
August, Ambrx announced that the first patient had been dosed in a
Phase 1, multicenter, dose-escalation, and dose expansion study to
evaluate the safety, pharmacokinetics, and anti-tumor activity of
ARX517, an ADC being developed to treat subjects with prostate
specific membrane antigen (PSMA) expressing tumors.
- BMS Provided Update on FA Relaxin Program. In August,
BMS provided notice that it closed the FA Relaxin Studies CV019-008
and CV019-010 based on internal considerations and not upon any
observed safety concerns.
- Completed Successful Initial Public Offering. In June,
Ambrx successfully completed its initial public offering raising
$126.0 million in gross proceeds prior to deducting underwriting
discounts, commissions and offering expenses. Ambrx’s American
Depository Shares (ADSs) began trading on the New York Stock
Exchange under the symbol "AMAM" on June 18, 2021. In addition, in
early July, the underwriters partially exercised their greenshoe
option resulting in additional gross proceeds to Ambrx of
approximately $16.1 million prior to deducting underwriting
discounts, commissions and offering expenses.
- Reorganization. During the second quarter of 2021, Ambrx
completed a reorganization of its corporate structure. As a result,
Ambrx Shanghai and Ambrx Hong Kong became wholly owned subsidiaries
of Ambrx Biopharma Inc.
- Formed a Scientific Advisory Board (SAB). In June, Ambrx
announced the formation of a Scientific Advisory Board comprised of
industry leaders in oncology and protein sciences. The board is
chaired by Peter Schultz, Ph.D., President and CEO of Scripps
Research and a professor of chemistry. The other founding members
of the Ambrx SAB include: Stuart Lutzker, M.D., Ph.D., an industry
veteran with decades of oncology drug development experience; Jakob
Dupont, M.D., a renowned expert in oncology, immunology and cell
therapy; Melissa Starovasnik, Ph.D., an accomplished scientific
leader and 28-year Genentech veteran; Luisa Salter-Cid, Ph.D.,
M.Sc., the Chief Scientific Officer at Pioneering Medicines; and
Feng Tian, Ph.D., the Chairman of the Board of Directors, President
and CEO of Ambrx.
- Appointed Sonja Nelson as CFO. In June, Sonja Nelson
joined Ambrx as its Chief Financial Officer. Ms. Nelson is an
experienced financial executive, who joined Ambrx with 10 years of
executive experience within the biotechnology industry. Most
recently, she served as Chief Financial Officer at NantKwest, now
ImmunityBio.
- Strengthened Board of Directors with Two New
Appointments. In April, Ambrx appointed Olivia C. Ware, an
accomplished biotech and pharmaceutical executive, and Katrin
Rupalla, Ph.D., Senior Vice President of Regulatory Affairs,
R&D Quality and Medical Information at Lundbeck, to its Board
of Directors.
Anticipated Near-Term Milestones
- Additional data from the Phase 1 clinical study of ARX788
(ACE-Breast-01) in patients with HER2+ metastatic breast cancer in
2H 2021.
- Submit an Investigational New Drug (IND) application for ARX305
in patients with cancer (renal cell carcinoma (RCC) and other
cancers) in 1H 2022.
Financial Highlights
- Cash and Cash Equivalents: Cash and cash equivalents
were $167.2 million as of June 30, 2021. In July, the underwriters
partially exercised the greenshoe option resulting in net proceeds
of $14.9 million to Ambrx.
- Revenue: Revenue was $5.1 million for the six months
ended June 30, 2021, as compared to $6.5 million for the six months
ended June 30, 2020. The decrease was primarily driven by revenue
recognized associated with upfront payments related to our R&D
agreements, partially offset by increased 3rd party reimbursable
charges.
- Research and development (R&D) expenses: R&D
expenses were $22.1 million for the six months ended June 30, 2021,
as compared to $9.9 million for the six months ended June 30, 2020.
The increase of $12.2 million was mainly due to increased costs
related to new clinical trial programs and related manufacturing
costs as well as personnel related costs including stock-based
compensation expense.
- General and administrative (G&A) expenses: G&A
expenses were $8.4 million for the six months ended June 30, 2021,
as compared to $2.6 million for the six months ended June 30, 2020.
The increase of $5.8 million was mainly attributable to
professional services and fees in connection with preparing for
Ambrx’s IPO, expenses associated with the corporate structure
reorganization, and personnel related costs including stock-based
compensation expense.
- Other expenses: Other expense, net, for the six months
ended June 30, 2021 was $3.9 million, which is primarily due to a
change in fair value of Ambrx’s redeemable noncontrolling interest
liability in connection with the purchase of shares held by
minority shareholders in Ambrx Shanghai which was part of Ambrx’s
reorganization of its corporate structure, completed during the
second quarter of 2021.
- Net loss: Net loss for the six months ended June 30,
2021 was $29.0 million, as compared to $5.4 million for the six
months ended June 30, 2020.
About Ambrx Biopharma Inc. (Ambrx)
Ambrx is a clinical stage biopharmaceutical company using an
expanded genetic code technology platform to discover and develop
Engineered Precision Biologics. These include next generation
antibody drug conjugates (ADCs), bispecifics, targeted
immuno-oncology therapies, novel cytokines to modulate the immune
system, and long-acting therapeutic peptides for metabolic and
cardiovascular disease. Ambrx is advancing a robust portfolio of
clinical and preclinical programs designed to optimize efficacy,
safety and ease of use, in multiple therapeutic areas, including
its lead product candidate ARX788. In addition, Ambrx has clinical
collaborations with multiple partners, for drug candidates
generated using Ambrx technology. For more information, please
visit www.ambrx.com.
Forward-Looking Statements
This press release includes certain “forward-looking statements”
intended to qualify for the “safe harbor” from liability
established by the Private Securities Litigation Reform Act of
1995, as amended. Forward-looking statements may be identified by
the words “anticipate,” “believe,” “estimate,” “expect,” “intend,”
“plan,” “project,” “may,” “will,” “could,” “should,” “seek,”
“potential” and similar expressions, and include, without
limitation, express or implied statements regarding Ambrx’s beliefs
and expectations regarding the advancement and potential benefits
of its product candidates, clinical development and strategic
plans, the timing of future events, and anticipated upcoming
milestones. Forward-looking statements are based on Ambrx’s current
expectations and are subject to inherent uncertainties, risks and
assumptions that are difficult to predict. Factors that could cause
actual results to differ include, but are not limited to, those
risks and uncertainties associated with: the impact of the COVID-19
pandemic on Ambrx’s business, operations, strategy, goals and
anticipated milestones; Ambrx’s ability to execute on its strategy
including with respect to the timing of its R&D efforts,
initiation of clinical studies and other anticipated milestones;
risks associated with development of novel therapeutics, including
potential delays in clinical trials and regulatory submissions and
the fact that future clinical trial results may not be consistent
with preliminary results or results from prior preclinical studies
or clinical trials; Ambrx’s ability to fund operations as
anticipated; and the additional risks and uncertainties set forth
more fully under the caption “Risk Factors” in Ambrx’s registration
statement on Form F-1 filed with the United States Securities and
Exchange Commission (SEC) on June 14, 2021, and elsewhere in
Ambrx’s filings and reports with the SEC. Forward-looking
statements contained in this announcement are made as of this date,
and Ambrx undertakes no duty to publicly update or revise any
forward looking statements, whether as a result of new information,
future events or otherwise, except as may be required under
applicable law.
AMBRX BIOPHARMA INC
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited; In thousands,
except share and per share data)
For the Six Months Ended June
30
2021
2020
Revenues
$
5,132
$
6,480
Operating expenses:
Research and development
22,079
9,937
General and administrative
8,355
2,588
Total operating expenses
30,434
12,525
Loss from operations
(25,302
)
(6,045
)
Other (expense) income, net:
Interest income
-
33
Other expense, net
(13
)
(26
)
Change in fair value of redeemable
noncontrolling interests
(3,903
)
-
Total other (expense) income, net
(3,916
)
7
Loss before provision for income taxes
(29,218
)
(6,038
)
Provision for income taxes
(1
)
(1
)
Net loss
(29,219
)
(6,039
)
Less: net loss attributable to the
redeemable noncontrolling interests
209
604
Net loss attributable to Ambrx Biopharma
Inc. shareholders
$
(29,010
)
$
(5,435
)
Net loss per share attributable to Ambrx
Biopharma Inc. ordinary shareholders -
basic and diluted
$
(1.63
)
$
(0.04
)
Weighted-average ordinary shares used to
compute net loss per share attributable
to shareholders basic and diluted
17,748,713
136,103,616
Other comprehensive loss, net of
tax:
Net loss
$
(29,219
)
$
(6,039
)
Foreign currency translation
adjustment
(18
)
(43
)
Comprehensive loss
(29,237
)
(6,082
)
Less: comprehensive loss attributable to
the redeemable noncontrolling
interests
208
609
Comprehensive loss attributable to Ambrx
Biopharma Inc.
$
(29,029
)
$
(5,473
)
AMBRX BIOPHARMA INC.
Condensed Consolidated Balance
Sheets
(Unaudited; In thousands,
except share data)
June 30,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
167,201
$
90,462
Restricted cash
831
816
Accounts receivable, net
746
428
Prepaid expenses and other current
assets
4,251
1,371
Total current assets
173,029
93,077
Property and equipment, net
968
850
Right-of-use assets
1,989
2,641
Intangible assets, net
37,337
36,829
Other long-term assets
402
624
Total assets
$
213,725
$
134,021
Liabilities, Redeemable Noncontrolling
Interests, Convertible Preferred
Shares and Shareholders’ Equity
(Deficit)
Current liabilities:
Accounts payable
$
3,768
$
2,820
Accrued liabilities
7,732
2,375
Operating lease liabilities, current
portion
1,670
1,595
Deferred revenue, current portion
4,314
6,470
Total current liabilities
17,484
13,260
Operating lease liabilities, net of
current portion
740
1,598
Accrued liabilities, net of current
portion
67
138
Deferred tax liabilities
880
880
Deferred revenue, net of current
portion
1,757
3,261
Total liabilities
20,928
19,137
Redeemable noncontrolling interests
-
1,287
Convertible preferred shares, $0.0001 par
value; no share authorized at June 30,
2021; 217,575,009 shares authorized at
December 31, 2020
Series A convertible preferred shares, no
shares designated at June 30, 2021;
160,000,000 shares designated at December
31, 2020; no shares and
135,936,550 shares outstanding at June 30,
2021 and December 31,
2020, respectively. $0 and $176,396
liquidation preference at June 30,
2021 and December 31, 2020,
respectively
-
157,689
Series B convertible preferred shares, no
shares designated at June 30, 2021;
57,575,009 shares designated at December
31, 2020; no shares and
57,575,008 shares outstanding at June 30,
2021 and December 31, 2020,
respectively. $0 and $100,000 liquidation
preference at June 30, 2021 and
December 31, 2020, respectively
-
95,342
Shareholders’ Equity (Deficit)
Ordinary shares, par value $0.0001
500,000,000 and 200,000,000 shares
authorized at June 30, 2021 and December
31, 2020 respectively;
244,686,437 and 170,000 shares issued and
outstanding at June 30,2021 and
December 31, 2020, respectively
24
-
Additional paid-in capital
368,126
6,805
Accumulated other comprehensive loss
(790
)
(686
)
Accumulated deficit
(174,563
)
(145,553
)
Total shareholders’ equity (deficit)
192,797
(139,434
)
Total liabilities, redeemable
noncontrolling interests, convertible preferred
shares and shareholders’ equity
(deficit)
$
213,725
$
134,021
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version on businesswire.com: https://www.businesswire.com/news/home/20211028006047/en/
INVESTORS Laurence Watts Managing Director Gilmartin Group, LLC.
619-916-7620 ir@ambrx.com
MEDIA Ian Stone Managing Director Canale Communications (619)
849-5388 media@ambrx.com
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