SAN DIEGO, March 1, 2022 /PRNewswire/ -- BioAtla, Inc.
(Nasdaq: BCAB), a global clinical-stage biotechnology company
focused on the development of Conditionally Active Biologic (CAB)
antibody therapeutics, today announces its financial results for
the fourth quarter and full year December
31, 2021, and provides an update on product pipeline
developments.
![BioAtla Logo BioAtla Logo](https://mma.prnewswire.com/media/445856/bioatla_Logo.jpg)
"BioAtla made significant progress in 2021 by advancing the
potentially registration-enabling Phase 2 clinical trials for our
two lead CAB product candidates as well as our other preclinical
and pipeline programs. Our cash resources at year end by themselves
are sufficient to provide the funding for all of our clinical,
pre-clinical and development stage product candidates and corporate
operations into the first half of 2024, without including upside
opportunities to further extend our cash runway through regional
licensing and partnering deals for select candidates," stated
Jay M. Short, Ph.D., Chairman, Chief
Executive Officer and co-founder of BioAtla, Inc. "We expect to
provide interim updates on our Phase 2 clinical programs by
mid-year for both mecbotamab vedotin and ozuriftamab vedotin.
We have aggressive development plans for these clinical assets, and
have initiated a Phase 1/2 trial for CAB-CTLA-4. In addition, we
have several CAB bispecific and CAB next generation ADC product
candidates in our near term IND strategy," stated Scott Smith, President of BioAtla.
Mecbotamab Vedotin (BA3011)
We are developing
mecbotamab vedotin (BA3011), CAB-AXL-ADC, a conditionally and
reversibly active antibody drug conjugate targeting the receptor
tyrosine kinase AXL, as a potential therapeutic for multiple solid
tumor types, including soft tissue and bone sarcoma, non-small cell
lung cancer (NSCLC) and ovarian cancer, with other potential
indications in the future. The Office of Orphan Drug Products
(OODP) at FDA granted Orphan Drug Designation to mecbotamab vedotin
for the treatment of soft tissue sarcoma. In the Phase 1 clinical
study in sarcoma patients mecbotamab vedotin was generally
well-tolerated, few patients discontinued due to an adverse event,
and no clinically meaningful on-target toxicity to normal
AXL-expressing tissue was observed. Of the seven sarcoma patients
who had an AXL tumor membrane percent score (TmPS) of greater than
or equal to 70, four of these obtained a confirmed partial
response, including patients with leiomyosarcoma, undifferentiated
pleiomorphic sarcoma (UPS), and Ewing sarcoma. The several subtypes
of sarcoma present a significant unmet medical need. For
example, UPS is one of the most aggressive sarcoma subtypes with
the highest recurrence rate and has approximately 4,000 new cases
annually in the U.S. There is no FDA approved treatment for UPS and
current first and second line therapy are typically limited to
doxorubicin, gemcitabine and docetaxel. In the overall Phase 2
sarcoma trial, over 70 patients are currently enrolled, and we plan
to provide an interim update in the second quarter of 2022. We also
are conducting a Phase 2 study (BA3011-002) in AXL-expressing NSCLC
patients who previously progressed on PD-1/L1, EGFR, or ALK
inhibitor therapy. An interim clinical update of this trial is
projected in the first half of 2022. In addition, a
multi-center investigator-initiated Phase 2 clinical trial of
mecbotamab vedotin in combination with a PD-1 inhibitor in patients
with platinum-resistant ovarian cancer has been initiated.
Ozuriftamab Vedotin (BA3021)
Ozuriftamab
vedotin, CAB-ROR2-ADC, is a conditionally and reversibly active
antibody drug conjugate directed against ROR2, a receptor tyrosine
kinase that is overexpressed across many different solid tumors
including lung, head and neck, melanoma and breast. We are
developing ozuriftamab vedotin as a potential therapeutic for
multiple solid tumor types, including NSCLC, melanoma, squamous
cell cancer of the head and neck (SCCHN) and ovarian cancer. Based
on encouraging Phase 1 data we believe ozuriftamab vedotin has
broad potential as a cancer therapy for patients with advanced
solid tumors that have previously progressed on a PD-1 inhibitor.
We are enrolling a Phase 2 trial of ozuriftamab vedotin monotherapy
or in combination with a PD-1 inhibitor in ROR2-expressing melanoma
patients who had previously progressed on PD-1/L1 inhibitor
and in ROR2-expressing NSCLC patients who had progressed on
previous PD-1/L1, EGFR or ALK inhibitor therapy. A Phase 2 study in
ROR2-expressing SCCHN patients has been initiated. In addition, a
multi-center investigator-initiated Phase 2 clinical trial of
ozuriftamab vedotin in combination with a PD-1 inhibitor in
patients with platinum-resistant ovarian cancer has been
initiated.
BA3071
BA3071, is a
CAB anti-CTLA-4 antibody that is being developed as an
immuno-oncology agent with the goal of delivering efficacy
comparable to the approved anti-CTLA-4 antibody,
ipilimumab, but with lower toxicities due to the CAB's tumor
microenvironment-restricted activity. Like mecbotamab
vedotin, ozuriftimab vedotin and our other CAB candidates, BA3071
is designed to be conditionally and reversibly active in the tumor
microenvironment via the Protein-associated Chemical
SwitchTM or PaCSTM mechanism discovered by
BioAtla scientists. This proprietary system is expected to enable
reduction of systemic toxicity and potentially enable safer
combination therapies, such as with anti-PD-1
antibody checkpoint inhibitors in the case of
BA3071. BA3071 is being developed as a potential therapeutic
for multiple solid tumor indications, including renal cell
carcinoma, NSCLC, small cell lung cancer, hepatocellular carcinoma,
melanoma, bladder cancer, gastric cancer and cervical cancer. We
have initiated a Phase 1/2 clinical trial for BA3071 and plan to
commence patient enrollment in the first half of 2022.
Advancing several pre-clinical CAB bispecific and next
generation CAB ADC candidates
We have also leveraged our CAB
technology to develop bispecific antibodies, which bind both a
tumor-specific antigen and a T cell receptor (CD3) using CAB
antigen-binding domains. With this design, bispecific antibodies
can induce potent T cell responses against tumors expressing the
tumor target antigen. We have shown in preclinical experiments that
our CAB bispecific molecules meet or exceed the activity of
conventional bispecifics and reduce systemic activation of
potentially severe immune responses. We are conducting
IND-enabling studies for two CAB bispecific antibody product
candidates. We are on track to file an IND for CAB EpCAM x
CAB CD3 in 2022, and an IND for CAB B7-H3 x CAB CD3 is targeted in
the first half of 2023. Nectin-4 and B7-H4 CAB next generation ADC
candidates are progressing along with the CAB EGFR x CD3 bispecific
candidate for a total of up to three IND filings in 2023. In
addition, we have several CAB bispecific and CAB ADC in earlier
development stages.
Fourth quarter and full year 2021 financial
results
Cash and cash equivalents as of December 31, 2021 were $245.0 million. We expect current cash and cash
equivalents will be sufficient to fund planned operations into the
first half of 2024.
Research and development (R&D) expenses were $16.4 million for the quarter ended December 31, 2021 compared to $10.5 million for the same quarter in 2020.
R&D expenses were $58.3
million for the full year 2021 as compared to $19.9 million in 2020. We expect our
R&D expenses to continue to increase for the foreseeable future
as we continue to invest in R&D activities to advance our
product candidates and our clinical programs, and expand our
product candidate pipeline.
General and administrative (G&A) expenses were $7.0 million for the quarter ended December 31, 2021 compared to $6.0 million for the same quarter in 2020.
G&A expenses were $38.4
million for the full year 2021 as compared to $10.6 million in 2020. We expect our
G&A expenses to increase to support development of our
product candidates, expand our intellectual property portfolio and
meet all requirements as a public company.
Net loss for the fourth quarter ended December 31, 2021 was $23.4 million compared to a net loss of
$16.4 million for the same quarter in
2020. Net loss for the full year 2021 was $95.4 million as compared to a net loss of
$35.9 million in 2020.
Net cash used in operating activities for the twelve months
ended December 31, 2021 was
$62.2 million compared to net cash
used in operating activities of $36.3
million for the same period in 2020.
About BioAtla, Inc.
BioAtla is a global clinical-stage
biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual
relationship with BioDuro-Sundia, a provider of preclinical
development services. Utilizing its proprietary Conditionally
Active Biologics (CAB) technology, BioAtla develops novel,
reversibly active monoclonal antibody and other protein therapeutic
product candidates. CAB product candidates are designed to have
more selective targeting, greater efficacy with lower toxicity, and
more cost-efficient and predictable manufacturing than traditional
antibodies. BioAtla has extensive and worldwide patent coverage for
its CAB technology and products with more than 500 patents, more
than 250 of which are issued. Broad patent coverage in all major
markets include methods of making, screening and manufacturing CAB
product candidates in a wide range of formats and composition of
matter coverage for specific products. BioAtla has two
first-in-class CAB programs currently in Phase 2 clinical testing
in the United States, mecbotamab
vedotin, BA3011, a novel conditionally active AXL-targeted
antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin,
BA3021, a novel conditionally active ROR2-targeted antibody-drug
conjugate (CAB-ROR2-ADC). The investigational CAB-CTLA-4 antibody,
BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic
toxicity and potentially enable safer combination therapies with
checkpoint inhibitors such as anti-PD-1 antibody. To learn
more about BioAtla, Inc. visit www.bioatla.com.
Forward-looking statements
Statements in this press
release contain "forward-looking statements" that are subject to
substantial risks and uncertainties. Forward-looking statements
contained in this press release may be identified by the use of
words such as "anticipate," "expect," "believe," "will," "may,"
"should," "estimate," "project," "outlook," "forecast" or other
similar words. Examples of forward-looking statements include,
among others, statements we make regarding our business plans and
prospects, expectations about the sufficiency of our cash and cash
equivalents, expected R&D and G&A expenses, the timing and
expections with respect to enrollment in our clinical trials, the
timing and success of our clinical trials and related data, and
plans to advance development of several bispecific CAB candidates,
including the timing of potential IND
submissions. Forward-looking statements are based on BioAtla's
current expectations and are subject to inherent uncertainties,
risks and assumptions, many of which are beyond our control,
difficult to predict and could cause actual results to differ
materially from what we expect. Further, certain forward-looking
statements are based on assumptions as to future events that may
not prove to be accurate. Factors that could cause actual results
to differ include, among others: potential delays in clinical and
pre-clinical trials due to the global COVID-19 pandemic; other
potential adverse impacts due to the global COVID-19 pandemic such
as delays in regulatory review, manufacturing and supply chain
interruptions, adverse effects on healthcare systems and disruption
of the global economy; our dependence on the success of our CAB
technology platform; our ability to enroll patients in our ongoing
and future clinical trials; the success of our current and future
collaborations with third parties; our reliance on third parties
for the manufacture and supply our product candidates for clinical
trials; our reliance on third parties to conduct our clinical
trials and some aspects of our research and preclinical testing;
and those other risks and uncertainties described in the section
titled "Risk Factors" in our Annual Report on Form 10-K filed with
the Securities and Exchange Commission (SEC) on February 28, 2022 and in our other reports as
filed with the SEC. Forward-looking statements contained in this
press release are made as of this date, and BioAtla undertakes no
duty to update such information except as required under applicable
law.
Contact:
Richard Waldron
Chief Financial Officer
BioAtla, Inc.
rwaldron@bioatla.com
858.356.8945
BioAtla,
Inc.
|
Unaudited
Condensed Consolidated Statements of Operations and Comprehensive
Loss
|
(in
thousands)
|
|
|
Three Months
Ended
December 31,
|
|
|
Years Ended
December 31,
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Collaboration and
other revenue
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
250
|
|
|
$
|
429
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expense
|
|
16,448
|
|
|
|
10,485
|
|
|
|
58,274
|
|
|
|
19,933
|
|
General and
administrative expense
|
|
7,040
|
|
|
|
5,970
|
|
|
|
38,416
|
|
|
|
10,595
|
|
Total operating
expenses
|
|
23,488
|
|
|
|
16,455
|
|
|
|
96,690
|
|
|
|
30,528
|
|
Loss from
operations
|
|
(23,488)
|
|
|
|
(16,455)
|
|
|
|
(96,440)
|
|
|
|
(30,099)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
96
|
|
|
|
63
|
|
|
|
350
|
|
|
|
100
|
|
Interest
expense
|
|
—
|
|
|
|
(2)
|
|
|
|
(3)
|
|
|
|
(1,389)
|
|
Change in fair value
of derivative liability
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(1,581)
|
|
Gain (loss) on
extinguishment of long-term debt
|
|
—
|
|
|
|
—
|
|
|
|
690
|
|
|
|
(2,883)
|
|
Other income
(expense)
|
|
2
|
|
|
|
(1)
|
|
|
|
1
|
|
|
|
(1)
|
|
Total other income
(expense)
|
|
98
|
|
|
|
60
|
|
|
|
1,038
|
|
|
|
(5,754)
|
|
Consolidated net loss
and comprehensive loss
|
$
|
(23,390)
|
|
|
$
|
(16,395)
|
|
|
$
|
(95,402)
|
|
|
$
|
(35,853)
|
|
BioAtla,
Inc.
|
Condensed
Consolidated Balance Sheets Data
|
(in
thousands)
|
|
|
|
December 31,
2021
|
|
|
December 31,
2020
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
244,979
|
|
|
$
|
238,605
|
Total
assets
|
|
|
254,422
|
|
|
|
244,937
|
Total
current liabilities
|
|
19,813
|
|
|
32,261
|
Total
liabilities
|
|
|
43,601
|
|
|
|
34,963
|
Total stockholders'
equity
|
|
|
210,821
|
|
|
|
209,974
|
Total liabilities and
stockholders' equity
|
|
|
254,422
|
|
|
|
244,937
|
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SOURCE BioAtla, Inc.