Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage
biotechnology company focused on developing novel therapeutics
generated through a unique discovery platform based on
interrogation of the active human immune response, today announced
financial results for the fourth quarter and full-year ended
December 31, 2021, and provided updated clinical data from the
ongoing Phase 1b trial of ATRC-101 in select solid tumors.
"Last year was a highly productive year for Atreca with regard
to both clinical development of ATRC-101 and the generation and
advancement of other pipeline assets,” said John Orwin, Chief
Executive Officer. “We are pleased to report additional results
from the ATRC-101 program today. The data continue to show a
significant association between activity and target expression, and
we’ve now observed a partial response in monotherapy along with a
complete response in the pembrolizumab combination cohort. Given
the relationship between activity and target expression, we are
preparing to integrate a diagnostic for participant selection. We
believe these data demonstrate that ATRC-101 has clinical activity,
validating our platform and our approach to identifying potentially
valuable therapeutic antibodies against novel targets in oncology.
On the preclinical side, we look forward to presenting more
information on our EphA2 program and other pipeline assets at an
R&D day in April.”
ATRC-101 Update
- The Phase 1b trial
is a first-in-human, open-label study of ATRC-101 in patients with
select solid tumor cancers. The trial began with a dose escalation
portion of five dose levels from 0.3 mg/kg to 30 mg/kg, which was
completed last year with no dose-limiting toxicities observed.
Patient enrollment is ongoing in a once-every-three-week (Q3W)
monotherapy dose cohort, a once-every-two-week (Q2W) monotherapy
dose cohort and combination dose cohort with pembrolizumab.
Enrollment in the monotherapy cohorts is limited to patients with
tumor types displaying greater than 50% immunoreactivity to
ATRC-101 in preclinical studies, and greater than 30% in the
combination cohort. The objectives of the study are to characterize
safety, determine a maximum tolerated or recommended dose for
future studies, measure initial anti-cancer activity, and
characterize potential biomarkers of activity in tumors, plasma,
and peripheral blood mononuclear cells (PBMC).
- As of the data
cut-off date of February 15, 2022, a total of 47 participants have
been dosed in the trial and evaluated for safety, including 36
participants treated in the Q3W arm, 8 in the Q2W arm, and 3 in the
combination arm. Thirty-eight of 47 participants were treated with
doses of 3 mg/kg, 10 mg/kg or 30 mg/kg, which we believe are
pharmacologically relevant. Participants enrolled in the study had
received a median of five prior lines of treatment, and
participants in the combination arm are required to have had prior
anti-PD-1 or anti-PD-L1 therapy.
- ATRC-101 has been
generally well-tolerated, with no dose-limiting toxicities in the
monotherapy or combination dose-escalation cohorts. Among the 47
participants enrolled, 16 (34%) had at least one grade ≥ 3 adverse
event (AE). Only two grade 3 AEs were considered potentially
treatment-related, which were headache and a small intestinal
obstruction. The most common treatment-related AEs were fatigue
(n=15, 32%) and nausea (n=12, 26%).
- Target expression
in tumor biopsies obtained at screening was significantly
associated with anti-tumor activity in the 3,10 and 30 mg/kg
cohorts. Among participants treated at the higher dose levels who
were evaluable for target expression and response, stable disease
(SD) (n=6), PR (n=1) or CR (n=1) was observed in 8 of 12 (66%) with
a screening H-score ≥ 50 (high). By comparison, in such
participants with a screening H-score < 50 (low), SD was
observed in 2 of 12 (17%), and none achieved PR or better.
- A confirmed CR was
observed in a melanoma participant (H-score high) in the
pembrolizumab combination cohort who had progressed on prior
anti-PD-1 and combined BRAF/MEK inhibitor therapy. In the
monotherapy cohorts, a participant with non-small cell lung cancer
(H-score high) achieved PR with 48% reduction in tumor burden, and
a participant with colorectal cancer (H-score unknown) experienced
a 29% reduction. All three participants remain on study.
- Enrollment is
ongoing in the Q3W and Q2W monotherapy cohorts and in the
pembrolizumab combination cohort. Atreca has now completed
validation of the target diagnostic and is planning to begin
participant selection based on target expression in 2Q22. Atreca
expects to report additional monotherapy and combination data in
2H22.
“We are very encouraged by the safety profile and evidence of
the anti-tumor activity of ATRC-101, both as a single agent and in
combination with a checkpoint inhibitor,” said Jonathan Benjamin,
M.D., Ph.D., Senior Vice President, Clinical Research. “We are
pleased to see stable disease with tumor burden reduction in
several trial participants and are especially gratified that two
participants achieved objective responses, including a 78-year-old
participant with melanoma who had progressed on a prior anti-PD1
agent yet achieved a complete response with the combination of
ATRC-101 and pembrolizumab. ATRC-101 recognizes a previously
unknown ribonucleoprotein complex that is expressed selectively in
tumor tissue of many different cancer types. Among participants
with evaluable baseline tumor biopsies, tumor burden reduction was
achieved exclusively in those with high ATRC-101 target expression.
Selection of trial participants based on target expression will be
important in further evaluation of ATRC-101 and is expected to
begin by mid-year.”
Other Recent Developments and Highlights
- Atreca presented
two posters on ATRC-101 at the 2021 Society for Immunotherapy of
Cancer (SITC) Annual Meeting.
- Atreca disclosed
data on its anti-SARS-CoV-2 antibody discoveries, originally
planned for presentation at the Keystone Symposia Conference:
Antibodies as Drugs, which was postponed. By applying its
proprietary IRC® technology, the company discovered antibodies from
the immune responses of patients infected with the original
SARS-CoV-2 virus, two of which were determined to be
pan-neutralizing against a panel of SARS-CoV-2 variants, including
Delta and more recently, Omicron.
- Atreca will be hosting a pipeline-focused virtual R&D Day
on April 5th, 2022. Topics to be covered include our EphA2 program,
as well as other previously undisclosed antibodies against new
targets in ADC, T cell engager and other weaponized formats, in
addition to our non-oncology programs.
Fourth Quarter and Year End 2021 Financial
Results
- As of December 31, 2021, cash and cash equivalents and
investments totaled $148.1 million.
- Research and
development expenses for the year ended December 31, 2021, were
$78.3 million, including non-cash share-based compensation expense
of $8.6 million. Research and development expenses for the three
months ended December 31, 2021, were $22.2 million, including
non-cash share-based compensation expense of $2.5 million.
- General and
administrative expenses for the year ended December 31, 2021, were
$32.0 million, including non-cash share-based compensation expense
of $8.3 million. General and administrative expenses for the three
months ended December 31, 2021, were $7.3 million, including
non-cash share-based compensation expense of $2.2 million.
- Atreca reported a
net loss of $109.3 million, or basic and diluted net loss per share
attributable to common stockholders of $2.95, for the year ended
December 31, 2021. The Company reported a net loss of $29.5
million, or basic and diluted net loss per share attributable to
common stockholders of $0.79, for the three months ended December
31, 2021.
Conference Call and Webcast Details
Atreca will host a live conference call and webcast today at
4:30 p.m. EST. To access the conference call by telephone, please
dial (800) 373-6606 (Domestic) or 409-937-8918 (International). The
conference ID number is 5089907.
The live audio webcast and accompanying slide presentation can
be accessed via the Events section of the Company’s investor
relations website at
https://ir.atreca.com/news-and-events/event-calendar. An archived
replay of the webcast will be available on the Company's website
for 90 days following the live event.
About Atreca, Inc.
Atreca is a biopharmaceutical company developing novel
antibody-based immunotherapeutics generated by its differentiated
discovery platform. Atreca's platform allows access to an
unexplored landscape in oncology through the identification of
unique antibody-target pairs generated by the human immune system
during an active immune response against tumors. These antibodies
provide the basis for first-in-class therapeutic candidates, such
as our lead product candidate ATRC-101. A Phase 1b study evaluating
ATRC-101 in multiple solid tumor cancers is currently enrolling
patients. For more information on Atreca, please visit
www.atreca.com.
About ATRC-101
ATRC-101 is a monoclonal antibody derived from an antibody
identified using Atreca’s discovery platform. ATRC-101 is believed
to function through Driver Antigen Engagement, a novel mechanism of
action in oncology. This mechanism involves systemic delivery of an
antibody that, in preclinical models, engages the innate immune
system to cause remodeling of the tumor microenvironment and drive
T cell-mediated destruction of tumor cells. Atreca has identified
the target of ATRC-101 as a tumor-specific ribonucleoprotein (RNP)
complex. ATRC-101 has demonstrated robust anti-tumor activity as a
single agent in multiple preclinical syngeneic tumor models,
including one model in which PD-1 checkpoint inhibitors typically
display limited activity. Further, ATRC-101 has been shown to react
in vitro with a majority of human ovarian, non-small cell lung,
colorectal, breast cancers and acral melanoma samples from multiple
patients. Atreca initiated a Phase 1b first-in-human study of
ATRC-101 in participants with select solid tumors in 2020, and
initiated the combination arm with pembrolizumab in 2021.
Forward-Looking Statements
This release contains forward-looking statements regarding our
strategy and future plans, including statements regarding the
development of ATRC-101 and our preclinical and clinical plans,
specifically, plans to begin participant selection based on target
expression, the ability of our discovery platform to identify
potentially valuable therapeutic antibodies, plans to present new
information on our EphA2 program and other pipeline assets, the
results of our clinical trials and studies and other developing
data, plans regarding the evaluation of clinical data, reports of
monotherapy data and combination data and other data read-outs,
enrollment objectives, our ability to obtain sufficient clinical
enrollment, reports of clinical enrollment updates, plans to file
an Investigational New Drug application, and the timing thereof,
the safety or potential efficacy of ATRC-101 or our anti-SARS-CoV-2
antibody discoveries, and our ability to fund current operations
and develop and commercialize our current or potential future
product candidates. These forward-looking statements include, but
are not limited to, statements about our plans, objectives,
representations and contentions and are not historical facts and
typically are identified by use of terms such as "preparing,"
"potential," "expect," "believe," “presenting,” "planned," “will,”
“continue” and similar words, although some forward-looking
statements are expressed differently. Our actual results may differ
materially from those indicated in these forward-looking statements
due to risks and uncertainties related to the initiation, timing,
progress and results of our research and development programs,
preclinical studies, clinical trials, regulatory submissions, and
other matters that are described in our most recent Annual Report
on Form 10-K and Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) and available on the SEC's
website at www.sec.gov, including the risk factors set forth
therein. Investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
of this release, and we undertake no obligation to update any
forward-looking statement in this press release, except as required
by law.
Atreca, Inc.Condensed
Consolidated Balance Sheets(in thousands, except share and
per share data)
|
|
|
|
|
December 31, |
|
December 31, |
|
2021 |
|
2020 |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Current Assets |
Cash and cash equivalents |
$ |
94,746 |
|
|
$ |
60,789 |
|
Investments |
|
22,287 |
|
|
|
179,296 |
|
Prepaid expenses and other current assets |
|
5,337 |
|
|
|
9,037 |
|
Total current assets |
|
122,370 |
|
|
|
249,122 |
|
Property and equipment, net |
|
43,015 |
|
|
|
19,831 |
|
Long-term investments |
|
31,042 |
|
|
|
- |
|
Deposits and other |
|
3,630 |
|
|
|
3,111 |
|
Total assets |
$ |
200,057 |
|
|
$ |
272,064 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current Liabilities |
Accounts payable |
$ |
3,352 |
|
|
$ |
5,216 |
|
Accrued expenses |
|
11,555 |
|
|
|
10,302 |
|
Other current liabilities |
|
1,992 |
|
|
|
1,900 |
|
Total current liabilities |
|
16,899 |
|
|
|
17,418 |
|
Capital lease obligations, net of current portion |
|
- |
|
|
|
4 |
|
Deferred rent |
|
28,229 |
|
|
|
12,585 |
|
Total liabilities |
|
45,128 |
|
|
|
30,007 |
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
Common stock |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
514,794 |
|
|
|
492,436 |
|
Accumulated other comprehensive income (loss) |
|
(102 |
) |
|
|
58 |
|
Accumulated deficit |
|
(359,767 |
) |
|
|
(250,441 |
) |
Total stockholders’ equity |
|
154,929 |
|
|
|
242,057 |
|
Total liabilities and stockholders’ equity |
$ |
200,057 |
|
|
$ |
272,064 |
|
|
|
|
|
Atreca, Inc.Condensed
Consolidated Statements of Operations(in thousands, except
share and per share data)(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
Expenses |
|
|
|
|
|
|
|
|
Research and development |
$ |
22,204 |
|
|
$ |
16,847 |
|
|
$ |
78,349 |
|
|
$ |
62,045 |
|
|
General and administrative |
|
7,306 |
|
|
|
6,639 |
|
|
|
31,954 |
|
|
|
26,834 |
|
|
Total expenses |
|
29,510 |
|
|
|
23,486 |
|
|
|
110,303 |
|
|
|
88,879 |
|
Interest and other income (expense) |
|
|
|
|
|
|
|
|
Other income |
|
- |
|
|
|
366 |
|
|
|
851 |
|
|
|
1,353 |
|
|
Interest income |
|
24 |
|
|
|
136 |
|
|
|
207 |
|
|
|
1,218 |
|
|
Interest expense |
|
- |
|
|
|
(1 |
) |
|
|
(3 |
) |
|
|
(4 |
) |
|
Loss on disposal of property and equipment |
|
(32 |
) |
|
|
(22 |
) |
|
|
(77 |
) |
|
|
(22 |
) |
Loss before Income tax expense |
|
(29,518 |
) |
|
|
(23,007 |
) |
|
|
(109,325 |
) |
|
|
(86,334 |
) |
Income tax expense |
|
- |
|
|
|
- |
|
|
|
(1 |
) |
|
|
(1 |
) |
Net loss |
$ |
(29,518 |
) |
|
$ |
(23,007 |
) |
|
$ |
(109,326 |
) |
|
$ |
(86,335 |
) |
Net loss per share, basic and diluted |
$ |
(0.79 |
) |
|
$ |
(0.63 |
) |
|
$ |
(2.95 |
) |
|
$ |
(2.70 |
) |
Weighted-average shares used in computing |
|
|
|
|
|
|
|
net loss per share, basic and diluted |
|
37,493,779 |
|
|
|
36,726,441 |
|
|
|
37,038,195 |
|
|
|
31,924,473 |
|
|
|
|
|
|
|
|
|
|
Contacts
Atreca, Inc.Herb CrossChief Financial
Officerinfo@atreca.comInvestors:Alex Gray,
650-779-9251agray@atreca.com
Media:Julia Fuller, 858-692-2001julia@fordhutmanmedia.com
Source: Atreca, Inc.
Atreca (NASDAQ:BCEL)
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