Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage
biopharmaceutical company using an expanded genetic code technology
platform to create Engineered Precision Biologics, today provided a
corporate update and reported financial results for the full year
ended December 31, 2021.
“We have made great progress in advancing our engineered
precision biologics and clinical pipeline in recent months. We
continue to transition preclinical candidates into the clinic and
anticipate submitting another IND to the U.S. FDA in 2022. Ambrx
has several potential key milestones coming up in the mid-year and
into the second half of this year including initiating two clinical
trials of ARX788 for Her2+ breast cancer in the neoadjuvant
setting, a single agent and a combination trial with an anti-PD-1
agent, and a clinical trial of ARX305 in renal cell carcinoma (RCC)
and other cancers,” commented Feng Tian, Ph.D., Chairman of the
Board, President and CEO of Ambrx. “Ambrx has truly positioned
itself as a leader in the antibody drug conjugate and precision
biologics space, working together with our partners, demonstrating
promising data from its ongoing trials. I look forward to
furthering our clinical development throughout 2022, bringing value
to stakeholders and patients alike.”
2H 2021 and Subsequent Clinical Highlights
- ARX788 Included in Quantum Leap’s I-SPY 2.2 Phase 2 Clinical
Trial in Breast Cancer. In April 2022, Ambrx announced the
inclusion of ARX788 in Quantum Leap Healthcare Collaborative’s
I-SPY 2.2 Phase 2 clinical trials in patients with HER2-positive
breast cancer. ARX788 will be evaluated as a monotherapy and in
combination with cemiplimab, in HER2-positive early-stage breast
cancer in the neoadjuvant setting.
- Acceptance of an Investigational New Drug Application (IND)
for ARX305 to the U.S. Food and Drug Administration (FDA). In
February 2022, Ambrx announced that the FDA had accepted the
company’s IND for ARX305 for the treatment of solid and
hematological tumors and provided a “Study May Proceed” letter. The
acceptance allows Ambrx to prepare a first in human, Phase 1
clinical trial of ARX305.
- Positive Data on ARX788 for the Treatment of HER2+
Metastatic Breast Cancer Presented at SABCS. In December 2021,
Ambrx presented positive data from the ACE-Breast-01 Phase 1
clinical trial of ARX788 for the treatment of HER+ positive
metastatic breast cancer in patients whose disease is
resistant/refractory to HER2 targeted agents including trastuzumab,
ADCs, TKIs (tyrosine kinase inhibitors) and bispecific antibodies.
At 1.5 mg/kg every three weeks, ARX788 demonstrated robust
treatment effect with a disease control rate of 100% in 29
evaluable patients.
- First Patient Dosed in Phase 2 ACE-Breast-03 Clinical Trial
of ARX788. In November 2021, the company announced that the
first patient had been dosed in its global ACE-Breast-03 Phase 2
clinical trial of ARX788 in patients with HER2+ metastatic breast
cancer. The Phase 2 trial will measure the objective response rate
in patients whose HER2+ metastatic breast cancer is resistant or
refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing
regiments.
- Positive Data on ARX788 for the Treatment of HER2+ Gastric
Cancer Presented at CSCO. In October 2021, NovoCodex
Pharmaceuticals Ltd., Ambrx’s partner in China, presented positive
interim data from the ACE-Gastric-01 Phase 1 clinical trial of
ARX788 for the treatment of HER2+ metastatic gastric /
gastroesophageal junction (GEJ) cancer.
- First Patient Dosed in a Phase 1 Trial for ARX517. In
August 2021, Ambrx announced that the first patient had been dosed
in a Phase 1, multicenter, dose-escalation, and dose expansion
trial 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.
2H 2021 and Subsequent Corporate Highlights
- Strengthened Board of Directors. In February 2022, Ambrx
appointed Paul Maier to its Board of Directors and as Chair of the
Audit Committee. Mr. Maier joins Ambrx’s Board with more than 25
years in senior operational, international and financial management
experience in rapid growth biotechnology companies.
Anticipated Near-Term Milestones
- Topline Phase 3 data in ACE-Breast-02 by the end of 2022
- Additional Phase 1 data in ACE-Pan Tumor-01 in 2H 2022
- Interim Phase 1 safety data in ARX517 for PSMA in 2H 2022
- Initiate Phase 1 trial in ARX305 for RCC and other cancers in
2H 2022
- Submit IND to FDA for ARX102 in 2H 2022
Financial Highlights
- Cash and Cash Equivalents: Cash and cash equivalents
were $170.1 million as of December 31, 2021, compared to $167.2
million for the first half ended June 30, 2021.
- Revenue: Revenue was $2.4 million and $7.5 million for
the six months and full year ended December 31, 2021, respectively,
as compared to $7.2 million and $13.7 million for the six months
and full year ended December 31, 2020, respectively. The decrease
was primarily driven by less revenue recognized in connection with
our R&D and license agreements including a cumulative catch-up
adjustment, partially offset by increased third party reimbursable
charges.
- Research and development (R&D) expenses: R&D
expenses were $32.7 million and $54.8 million for the six months
and full year ended December 31, 2021, respectively, as compared to
$10.5 million and $20.4 million for the six months and full year
ended December 31, 2020, respectively. The increase year over year
of $34.4 million was mainly due to increased costs related to
clinical trial program spend primarily driven by our ARX788
clinical trials and related manufacturing and outside services
costs as well as personnel related costs including stock-based
compensation expense.
- General and administrative (G&A) expenses: G&A
expenses were $8.7 million and $17.1 million for the six months and
full year ended December 31, 2021, respectively, as compared to
$3.8 million and $6.4 million for the six months and full year
ended December 31, 2020, respectively. The increase year over year
of $10.7 million was mainly attributable to professional services
and fees in connection with preparing for Ambrx’s IPO and operating
as a public company, 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
and full year ended December 31, 2021 was zero and $3.9 million,
respectively, as compared to $4.7 million for the six months and
full year ended December 31, 2020.
- Net loss: Net loss for the six months and full year
ended December 31, 2021 was $39.1 million and $68.1 million,
respectively, as compared to $11.1 million and $16.5 million for
the six months and full year ended December 31, 2020,
respectively.
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, and the timing of program updates and milestones related to
its product candidates. 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
continuing impact of the COVID-19 pandemic and other public
health-related risks and events 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 trials 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 Annual Report on Form 20-F filed with the United States
Securities and Exchange Commission (SEC) on April 26, 2022, and
elsewhere in Ambrx’s filings and reports with the SEC.
Forward-looking statements contained in this press release 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
Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share
and per share data)
For the Year Ended December
31,
2021
2020
2019
Revenues
$
7,455
$
13,671
$
10,311
Operating expenses:
Research and development
54,808
20,433
26,383
General and administrative
17,071
6,353
6,400
Total operating expenses
71,879
26,786
32,783
Loss from operations
(64,424
)
(13,115
)
(22,472
)
Other (expense) income, net:
Interest income
-
27
195
Other income (expense), net
40
(4,750
)
(38
)
Change in fair value of redeemable
noncontrolling interests
(3,903
)
—
—
Total other (expense) income, net
(3,863
)
(4,723
)
157
Loss before (provision for) benefit from
income taxes
(68,287
)
(17,838
)
(22,315
)
(Provision for) benefit from income
taxes
(1
)
(1
)
2
Net loss
(68,288
)
(17,839
)
(22,313
)
Less: net loss attributable to the
redeemable noncontrolling interests
209
1,296
2,251
Net loss attributable to Ambrx Biopharma
Inc. shareholders
$
(68,079
)
$
(16,543
)
$
(20,062
)
Net loss per share attributable to Ambrx
Biopharma Inc. ordinary shareholders - basic
and diluted
$
(0.48
)
$
(0.14
)
$
(0.15
)
Weighted-average ordinary shares used to
compute net loss per share attributable to
ordinary shareholders basic and
diluted
143,175,224
115,677,467
136,103,550
Other comprehensive loss, net of
tax:
Net loss
$
(68,288
)
$
(17,839
)
$
(22,313
)
Foreign currency translation
adjustment
(18
)
177
(41
)
Comprehensive loss
(68,306
)
(17,662
)
(22,354
)
Less: comprehensive loss attributable to
the redeemable noncontrolling interests
208
1,276
2,257
Comprehensive loss attributable to Ambrx
Biopharma Inc.
$
(68,098
)
$
(16,386
)
$
(20,097
)
AMBRX BIOPHARMA INC.
Consolidated Balance
Sheets
(In thousands, except share
and per share data)
December 31,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
170,064
$
90,462
Restricted cash
842
816
Accounts receivable, net
1,239
428
Prepaid expenses and other current
assets
4,661
1,371
Total current assets
176,806
93,077
Property and equipment, net
2,984
850
Right-of-use assets, net
12,737
2,641
Intangible assets, net
35,962
36,829
Other long-term assets
530
624
Total assets
$
229,019
$
134,021
Liabilities, Redeemable Noncontrolling
Interests, Convertible Preferred
Shares and Shareholders' Equity
(Deficit)
Current liabilities:
Accounts payable
$
5,272
$
2,820
Accrued liabilities
14,125
2,375
Operating lease liabilities, current
portion
915
1,595
Deferred revenue, current portion
4,267
6,470
Total current liabilities
24,579
13,260
Operating lease liabilities, net of
current portion
12,212
1,598
Accrued liabilities, net of current
portion
—
138
Deferred tax liabilities
880
880
Deferred revenue, net of current
portion
1,381
3,261
Total liabilities
39,052
19,137
Redeemable noncontrolling interests
—
1,287
Convertible preferred shares, $0.0001 par
value; no share authorized at December 31, 2021;
217,575,009 shares authorized at December
31, 2020
Series A convertible preferred shares, no
shares designated at December 31, 2021; 160,000,000
shares designated at December 31, 2020; no
shares and 135,936,550 shares outstanding at
December 31, 2021 and December 31, 2020,
respectively. $0 and $176,396 liquidation preference
at December 31, 2021 and December 31,
2020, respectively
—
157,689
Series B convertible preferred shares, no
shares designated at December 31, 2021; 57,575,009
shares designated at December 31, 2020; no
shares and 57,575,008 shares outstanding at
December 31, 2021 and December 31, 2020,
respectively. $0 and $100,000 liquidation preference
at December 31, 2021 and December 31,
2020, respectively
—
95,342
Shareholders' Equity (Deficit):
Ordinary Shares, par value $0.0001
500,000,000 and 282,424,991 shares authorized at December 31,
2021 and December 31, 2020, respectively;
270,120,548 and 170,000 shares issued and outstanding
at December 31, 2021 and December 31,
2020, respectively
27
—
Additional paid-in capital
404,362
6,805
Accumulated other comprehensive loss
(790
)
(686
)
Accumulated deficit
(213,632
)
(145,553
)
Total shareholders' equity (deficit)
189,967
(139,434
)
Total liabilities, redeemable
noncontrolling interests, convertible preferred
shares and shareholders' equity
(deficit)
$
229,019
$
134,021
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220426006131/en/
INVESTORS Laurence Watts Managing Director Gilmartin Group, LLC.
619-916-7620 ir@ambrx.com
MEDIA media@ambrx.com
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