- Appointed Kate Hermans as Interim Chief
Executive Officer –
Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage
biopharmaceutical company using an expanded genetic code technology
platform to create Engineered Precision Biologics (EPBs), today
provided a corporate update and reported financial results for the
first half of 2022.
"I am very grateful for all that Tian accomplished during his
tenure leading Ambrx, from spearheading the development of the
company’s research and development programs to the transition to a
public company last year," said Kate Hermans, Interim Chief
Executive Officer of Ambrx. “While the Board conducts a search for
a permanent CEO, we will review the company’s pipeline to focus on
Ambrx’s strongest commercial opportunities and further extend our
cash runway. Additionally, I would like to congratulate NovoCodex
for their recent successful Series B financing and am thankful for
the relationship we have built. Our strong partnerships will remain
a priority for us. We remain confident in our platform to deliver
on the promise of precision medicine and I look forward to having
the opportunity to lead Ambrx during this transition.”
1H 2022 and Subsequent Highlights
- Appointed Kate Hermans as Interim Chief Executive
Officer. In August, Ambrx announced the appointment of Kate
Hermans as Interim Chief Executive Officer (CEO), replacing Feng
Tian, Ph.D. Ms. Hermans has more than two decades of commercial and
operational experience in the healthcare industry, previously
serving in executive leadership roles at companies including Radius
Health, Bristol Myers Squibb and Pfizer. Ambrx’s Board has
commenced a search for a permanent CEO. Dr. Tian has agreed to
continue with Ambrx in an advisory capacity.
- Received a “Study May Proceed” letter from the FDA related
to an IND application for ARX305. In February, Ambrx announced
that the FDA accepted the company’s IND and provided a “Study May
Proceed” letter for ARX305 for the treatment of solid and
hematological tumors. ARX305 is the third antibody drug conjugate
(ADC) developed by Ambrx on its proprietary EPB platform to receive
IND clearance. In July, Ambrx’s partner in China, NovoCodex,
announced that it had received drug clinical trial approval notice
for ARX305 and intends to initiate a Phase 1 trial in China in the
second half of 2022.
- Announced Inclusion of ARX788 in a Quantum Leap’s I-SPY 2.2
Phase 2 Clinical Trial. In April, the company announced the
inclusion of ARX788 in Quantum Leap Healthcare Collaborative’s
investigational treatment arm in the I-SPY 2.2 TRIAL for the
treatment of HER2-positive breast cancer in the neoadjuvant
setting. Sponsored by Quantum Leap, I-SPY 2.2 is an adaptive Phase
2 clinical trial that evaluates emerging targeted agents, allowing
those agents to either be combined with less toxic chemotherapeutic
regimens or to replace cytotoxic chemotherapy entirely. The first
patient was dosed with ARX788 in August 2022.
- Appointed Janice Lu, M.D., Ph.D., as Chief Medical
Officer. In May, Janice Lu, M.D., Ph.D., joined Ambrx as its
Chief Medical Officer. Dr. Lu is a distinguished clinical professor
of medicine who has more than 18 years of experience in leading
clinical trials and breast cancer drug development. Dr. Lu, a
board-certified medical oncologist, was on the faculty in
Hematology and Oncology at UCLA, and most recently served as
Clinical Professor of Medicine and Medical Director of the Breast
Oncology Program at the USC Keck School of Medicine.
- Strengthened Board of Directors. In August, Ambrx
announced the appointment of Katrin Rupalla, Ph.D. to Chair of the
Board of Directors. Since the start of 2022, Ambrx has appointed
Paul V. Maier, Janet Loesberg, Pharm. D., Edward Hu and Kate
Hermans to its Board.
Financial Highlights
- Cash and Cash Equivalents and Marketable Securities:
Cash and cash equivalents and marketable securities were $129.7
million as of June 30, 2022, of which $64.1 million are marketable
securities, compared to $170.1 million in cash and cash equivalents
as of December 31, 2021.
- Revenue: Revenue was $2.9 million for the six months
ended June 30, 2022, as compared to $5.1 million for the six months
ended June 30, 2021. The decrease was primarily driven by less
revenue recognized in connection with our R&D and license
agreements, partially offset by increased third party reimbursable
charges.
- Research and development (R&D) expenses: R&D
expenses were $32.8 million for the six months ended June 30, 2022,
as compared to $22.1 million for the six months ended June 30,
2021. The increase was mainly due to increased costs related to our
clinical trial programs, primarily driven by our lead product
candidate ARX788, and related manufacturing costs, partially offset
by lower stock-based compensation expense.
- Impairment loss on intangible assets: The loss of $9.7
million for the six months ended June 30, 2022 was driven by the
impairment of intangible assets related to assets that were in
development with a collaboration partner.
- General and administrative (G&A) expenses: G&A
expenses were $9.4 million for the six months ended June 30, 2022,
as compared to $8.4 million for the six months ended June 30, 2021.
The increase was mainly attributable to professional services and
fees in connection with operating as a public company including
directors & officer insurance.
- Other expenses, net: Other expense, net, for the six
months ended June 30, 2022 were $0.9 million, as compared to $3.9
million for the six month ended June 20, 2021. The current period
expense is mainly related to fees and interest incurred related to
a promissory note settlement and capital reduction related to Ambrx
Shanghai.
- Net loss: Net loss for the six months ended June 30,
2022 was $51.5 million, as compared to $29.0 million for the six
months ended June 30, 2021.
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 results of the strategic review of the company’s
pipeline, Ms. Hermans’ anticipated contributions 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
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited; In thousands,
except share and per share data)
For the Six Months Ended June
30,
2022
2021
Revenues
$
2,912
$
5,132
Operating expenses:
Research and development
32,766
22,079
Impairment of intangible assets
9,660
-
General and administrative
9,393
8,355
Total operating expenses
51,819
30,434
Loss from operations
(48,907
)
(25,302
)
Other expense, net:
Investment income, net
223
-
Interest expense, net
(965
)
-
Other expense, net
(124
)
(13
)
Change in fair value of redeemable
noncontrolling interests
-
(3,903
)
Total other expense, net
(866
)
(3,916
)
Loss before provision for income taxes
(49,773
)
(29,218
)
Provision for income taxes
(1,716
)
(1
)
Net loss
(51,489
)
(29,219
)
Less: net loss attributable to the
redeemable noncontrolling interests
-
209
Net loss attributable to Ambrx Biopharma
Inc. shareholders
$
(51,489
)
$
(29,010
)
Net loss per share attributable to Ambrx
Biopharma Inc. ordinary shareholders - basic and diluted
$
(0.19
)
$
(1.63
)
Weighted-average ordinary shares used to
compute net loss per share attributable to ordinary shareholders
basic and diluted
270,142,269
17,748,713
Other comprehensive loss, net of
tax:
Net loss
$
(51,489
)
$
(29,219
)
Foreign currency translation
adjustment
-
(18
)
Comprehensive loss
(51,489
)
(29,237
)
Add: Unrealized loss on marketable debt
securities, available-for-sale
(217
)
-
Less: Comprehensive loss attributable to
the redeemable noncontrolling interests
-
208
Comprehensive loss attributable to Ambrx
Biopharma Inc.
$
(51,706
)
$
(29,029
)
AMBRX BIOPHARMA INC.
Condensed Consolidated Balance
Sheets
(Unaudited; In thousands,
except share data)
June 30,
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
65,642
$
170,064
Restricted cash
831
842
Marketable debt securities,
available-for-sale
45,251
-
Accounts receivable, net
1,466
1,239
Prepaid expenses and other current
assets
7,816
4,661
Total current assets
121,006
176,806
Marketable debt securities,
available-for-sale, net of current portion
18,827
-
Property and equipment, net
3,146
2,984
Right-of-use assets, net
11,860
12,737
Intangible assets, net
25,565
35,962
Other long-term assets
466
530
Total assets
$
180,870
$
229,019
Liabilities and Shareholders'
Equity
Current liabilities:
Accounts payable
$
5,696
$
5,272
Accrued liabilities
15,585
14,125
Operating lease liabilities, current
portion
1,320
915
Deferred revenue, current portion
3,137
4,267
Total current liabilities
25,738
24,579
Operating lease liabilities, net of
current portion
11,251
12,212
Deferred tax liabilities
880
880
Deferred revenue, net of current
portion
1,109
1,381
Total liabilities
38,978
39,052
Shareholders' Equity:
Ordinary Shares, par value $0.0001;
500,000,000 shares authorized at June 30, 2022 and December 31,
2021; 270,328,483 and 270,120,548 shares issued and outstanding at
June 30, 2022 and December 31, 2021, respectively
27
27
Additional paid-in capital
407,993
404,362
Accumulated other comprehensive loss
(1,007
)
(790
)
Accumulated deficit
(265,121
)
(213,632
)
Total shareholders' equity
141,892
189,967
Total liabilities and shareholders'
equity
$
180,870
$
229,019
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220829005608/en/
INVESTORS Laurence Watts Managing Director Gilmartin Group, LLC.
619-916-7620 ir@ambrx.com
MEDIA media@ambrx.com
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