BCEL Atreca Inc.

5.49
+0.58  (+12%)
Previous Close 4.91
Open 4.9
52 Week Low 4.8
52 Week High 20.29
Market Cap $202,547,006
Shares 36,893,808
Float 22,381,338
Enterprise Value $-9,122,995
Volume 3,663,418
Av. Daily Volume 1,131,641
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Drug Pipeline

Drug Stage Notes
ATRC-101
Solid tumors
Phase 1b
Phase 1b
Phase 1b initial data released July 29, 2021. 20/50 (40%) of patients exhibited stable disease.

Latest News

  1. Completed dose escalation portion of Phase 1b trial; ATRC-101 was well-tolerated with no dose-limiting toxicities observed

    Disease control associated with ATRC-101 target expression; preliminary biomarker data support the proposed mechanism of action (MOA) as elucidated in preclinical studies

    Phase 1b monotherapy dose expansion ongoing; developing diagnostic to select patients based on target expression

    Conference call and webinar scheduled for today at 8:00 a.m. ET

    SAN CARLOS, Calif., July 29, 2021 (GLOBE NEWSWIRE) -- 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…

    Completed dose escalation portion of Phase 1b trial; ATRC-101 was well-tolerated with no dose-limiting toxicities observed

    Disease control associated with ATRC-101 target expression; preliminary biomarker data support the proposed mechanism of action (MOA) as elucidated in preclinical studies

    Phase 1b monotherapy dose expansion ongoing; developing diagnostic to select patients based on target expression

    Conference call and webinar scheduled for today at 8:00 a.m. ET

    SAN CARLOS, Calif., July 29, 2021 (GLOBE NEWSWIRE) -- 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 initial data from the dose escalation portion of its ongoing Phase 1b trial evaluating ATRC-101 in select solid tumor types that displayed greater than 50% target expression in preclinical studies.

    "We are pleased to present initial summary data from our first-in-human study of ATRC-101," said Jonathan Benjamin, M.D., Ph.D., Sr. Vice President, Clinical Research. "We are very encouraged by the results observed thus far in a relatively small set of heavily pre-treated participants. ATRC-101, which targets a novel tumor antigen and acts via a novel MOA in oncology, was well-tolerated at all doses evaluated in the study with no dose-limiting toxicities observed. Furthermore, disease control is associated with ATRC-101 target expression, and the preliminary biomarker analysis is consistent with the proposed MOA for ATRC-101. We anticipate reporting additional data from monotherapy dose expansion cohorts in the Phase 1b trial and from combination cohorts evaluating ATRC-101 with pembrolizumab in 2022, and initiating additional combination cohorts evaluating ATRC-101 with chemotherapy later this year."

    "ATRC-101 represents a new approach in cancer research," said Dr. John Powderly, M.D., Founder and President of the Carolina BioOncology Institute. "While these data are from a limited number of treatment-refractory patients, I was pleased to see that ATRC-101 was well-tolerated and appears to have an informative biomarker. I look forward to continue investigating the potential of ATRC-101 in cancer patients."

    ATRC-101 Phase 1b Study Design

    The Phase 1b trial is a first-in-human, open-label study of ATRC-101 in patients with select solid tumor cancers, utilizing a 3+3 design for the dose escalation portion. Enrollment is limited to patients with tumor types reactive to ATRC-101 in more than 50% of historical patient samples evaluated preclinically, which includes non-small cell lung, breast, ovarian, and colorectal cancer, as well as acral melanoma. The objectives of the study are to characterize safety, determine a maximum tolerated or recommended dose for expansion, measure initial clinical activity, and characterize potential biomarkers of activity in tumors, plasma, and peripheral blood mononuclear cells (PBMC).

    Initial Study Results

    A total of 26 participants had been dosed in the trial as of the data cut-off date of July 16th, including 24 participants treated at five once-every-21-day (q21d) dose levels, 0.3 mg/kg (n = 3), 1 mg/kg (n = 3), 3 mg/kg (n = 9), 10 mg/kg (n = 6), and 30 mg/kg (n = 3), and two participants treated at one once-every-14-day (q14d) dose level, 1 mg/kg (n = 2). Tumor types enrolled in the q21d cohorts were colorectal (n = 13), ovarian (n = 5), breast (n = 3), non-small cell lung (n = 2) and acral melanoma (n = 1). Participants enrolled in the study had received a median of five prior lines of treatment. Of the 26 participants dosed, 24 participants treated with any dose of ATRC-101 were evaluable for safety, 19 for PK, 20 for clinical response, and 18 participants for target expression.

    Pharmacokinetics (PK)

    The peak concentration of ATRC-101 was dose proportional and minimal accumulation was observed following multiple doses. ATRC-101's half-life was 10.5 days and was relatively consistent across all dose levels.

    Safety

    ATRC-101 was generally well-tolerated, with no dose-limiting toxicities at doses ≤30 mg/kg. Thirty-three percent of participants (n = 8) had at least one grade ≥ 3 adverse event (AE). Respiratory failure (n = 2) and sepsis (n = 2) were the only grade ≥ 3 AEs observed in more than one participant, and the one grade 4 treatment-emergent AE observed was a case of acute respiratory failure. The most common treatment-related AEs were fatigue (n = 5, 21%), nausea (n = 4, 17%), and tumor pain (n = 4, 17%).

    Disease Efficacy Observations

    Eight of the 20 participants (40%) evaluable prior to the data cut-off in this analysis experienced stable disease (SD) as their best RECIST response, including four with tumor reduction observed. The remaining 12 participants had progressive disease as their best RECIST response. Disease control observed in the study was associated with target expression, as 3 of 6 (50%) of participants with evaluable response assessments and baseline tumor H-scores ≥50 achieved SD, compared with 1 of 9 (11%) evaluable participants with an H-score <50.

    Biomarkers

    Preliminary biomarker evaluation supports the proposed MOA of ATRC-101 initially proposed from preclinical studies. Expansion of peripheral blood CD8+ T cells was observed at day 8 following dosing with ATRC-101 among participants with evaluable baseline tumor biopsies and tumor H-scores ≥50. Preliminary observations of serum cytokines appeared consistent with the proposed MOA of innate immune system activation leading to an adaptive immune response against tumor.

    Next Steps

    Phase 1b monotherapy dose expansion is ongoing at 30 mg/kg, a combination study evaluating ATRC-101 with pembrolizumab is active and another combination study with pegylated liposomal doxorubicin is expected to begin enrolling patients in 4Q21. Atreca expects to report additional monotherapy data by mid-2022, pembrolizumab combination data in mid-2022 and chemotherapy combination data in late 2022. Supported by data from the dose escalation portion of the trial, Atreca is developing a diagnostic to select patients based on target expression.

    "We are very pleased with the results of the Phase 1b study presented today and look forward to the continued clinical development of ATRC-101 as both a monotherapy and in combination studies," said John Orwin, Chief Executive Officer of Atreca. "ATRC-101 is the first anti-cancer agent discovered via Atreca's platform to be tested in humans, and we believe that the activity observed in the trial provides a strong rationale for further investigation. Furthermore, we believe that these data provide validation for the ability of our discovery platform to identify novel, druggable tumor targets shared across groups of patients. We would like to thank all of the patients who enrolled, their families, and their caregivers for participating in this study."

    ATRC-101 Conference Call and Webcast Information

    Atreca will host a conference call/webcast today at 8:00 a.m. ET. The live webcast, including slides, can be accessed through the Events & Presentations section of the Company's website at https://ir.atreca.com/news-and-events/event-calendar. To access the conference call, please dial (800) 373-6606 (United States) or (409) 937-8918 (international) and reference the conference ID 2386207. An archived replay of the webcast will be available on the Company's website for 90 days following the live event.

    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 tumor cancers in early 2020. Clinical trials to evaluate ATRC-101 in combination with a PD-1 inhibitor and in combination with chemotherapy are planned for 2021, as well as in monotherapy dose expansion cohorts in the ongoing Phase 1b trial.

    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 participants. For more information on Atreca, please visit www.atreca.com.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and typically are identified by use of terms such as "continued," "anticipate," "potential," "expect," "believe," "planned," and similar words, although some forward-looking statements are expressed differently. These statements include those related to our strategy and future plans, including statements regarding the development of ATRC-101 and our preclinical, clinical and regulatory plans and the timing thereof, the availability and timing of data from monotherapy dose expansion cohorts in the Phase 1b trial and from combination cohorts evaluating ATRC-101 with pembrolizumab and with pegylated liposomal doxorubicin, initiating additional combination cohorts evaluating ATRC-101 with chemotherapy, trends consistent with the proposed MOA of innate immune system activation, and our development of a diagnostic to select patients based on target expression. 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 filings with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov, including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contacts

    Atreca, Inc.

    Herb Cross

    Chief Financial Officer





    Investors:

    Alex Gray, 650-779-9251

    Media:

    Sheryl Seapy, 213-262-9390

    Source: Atreca, Inc.

     



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  2. SAN CARLOS, Calif., July 26, 2021 (GLOBE NEWSWIRE) -- 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 it will host a webinar to present initial data from the dose escalation portion of its ongoing Phase 1b trial evaluating ATRC-101 in select solid tumor types on Thursday, July 29, 2021, at 8:00 a.m. ET.

    Conference Call and Webcast Information

    The live webcast, including slides, can be accessed through the Events & Presentations section of the Company's website at https://ir.atreca.com/news-and-events/event-calendar. To access the conference call, please…

    SAN CARLOS, Calif., July 26, 2021 (GLOBE NEWSWIRE) -- 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 it will host a webinar to present initial data from the dose escalation portion of its ongoing Phase 1b trial evaluating ATRC-101 in select solid tumor types on Thursday, July 29, 2021, at 8:00 a.m. ET.

    Conference Call and Webcast Information

    The live webcast, including slides, can be accessed through the Events & Presentations section of the Company's website at https://ir.atreca.com/news-and-events/event-calendar. To access the conference call, please dial (800) 373-6606 (United States) or (409) 937-8918 (international) and reference the conference ID 2386207. An archived replay of the webcast will be available on the Company's website following the live event.

    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 patients with select solid tumor cancers in early 2020. Clinical trials to evaluate ATRC-101 in combination with a PD-1 inhibitor and in combination with chemotherapy are planned for 2021, as well as in monotherapy dose expansion cohorts in the ongoing Phase 1b trial.

    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

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and typically are identified by use of terms such as "continued," "anticipate," "potential," "expect," "believe," "planned," and similar words, although some forward-looking statements are expressed differently. These statements include those related to our strategy and future plans, including statements regarding the development of ATRC-101 and our preclinical, clinical and regulatory plans and the timing thereof, the availability and timing of data from monotherapy dose expansion cohorts in the Phase 1b trial and from combination cohorts evaluating ATRC-101 with a PD-1 inhibitor and with chemotherapy. 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 filings with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov, including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contacts

    Atreca, Inc.

    Herb Cross

    Chief Financial Officer





    Investors:

    Alex Gray, 650-779-9251

    Media:

    Sheryl Seapy, 213-262-9390

    Source: Atreca, Inc.

     



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  3. SAN CARLOS Calif., July 19, 2021 (GLOBE NEWSWIRE) -- 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 the appointment of Dr. Stacey Ma, Executive Vice President and Head of Technical Operations at Sana Biotechnology, and Stephen R. Brady, Chief Executive Officer of Tempest Therapeutics, to its Board of Directors.

    "We are pleased to be expanding our Board of Directors with the addition of two experienced and accomplished biopharmaceutical executives" said John Orwin, Chief Executive Officer. "Together, Stacey and Steve bring over 40 years of industry experience…

    SAN CARLOS Calif., July 19, 2021 (GLOBE NEWSWIRE) -- 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 the appointment of Dr. Stacey Ma, Executive Vice President and Head of Technical Operations at Sana Biotechnology, and Stephen R. Brady, Chief Executive Officer of Tempest Therapeutics, to its Board of Directors.

    "We are pleased to be expanding our Board of Directors with the addition of two experienced and accomplished biopharmaceutical executives" said John Orwin, Chief Executive Officer. "Together, Stacey and Steve bring over 40 years of industry experience across a variety of corporate functions, including research, technical operations, manufacturing, corporate development and finance. Their expertise will be invaluable to Atreca as we continue to advance ATRC-101 and build our preclinical pipeline."

    Dr. Stacey Ma

    Dr. Ma is currently the Executive Vice President and Head of Technical Operations at Sana Biotechnology, a publicly listed biotechnology company, where she has served since March 2019. From 1996 to 2019, she served various roles at Genentech/Roche, a biotechnology company, including as their Global Head of Innovation, Manufacturing Science and Technology from March 2018 to March 2019, and as Vice President, Global Head of Investigational Medicinal Products (IMP) Quality from May 2015 to February 2018. From July 1996 to May 2015, she held various other roles related to analytical development, pharmaceutical development, quality, technical product management and supply chain.

    Stephen R. Brady

    Mr. Brady is currently the Chief Executive Officer of Tempest Therapeutics, a publicly listed biotechnology company. Previously, he served as the President and Chief Operating Officer at Tempest from September 2019 to June 2021. Prior to joining Tempest, he served in various leadership roles at Immune Design Corp., including as Executive Vice President, Strategy & Finance from May 2015 until its sale to Merck in 2019, and as Chief Business Officer from September 2013 to May 2015. Prior to Immune Design, Mr. Brady served in various leadership roles at 3-V Biosciences, Inc. (now known as Sagimet Biosciences Inc.), including as Chief Business Officer from February 2011 to August 2013, and as Vice President, Corporate Development, Strategy and Operations from February 2010 to February 2011. From April 2007 to March 2010, Mr. Brady held various roles at Proteolix, Inc., most recently serving as Vice President of Corporate Development.

    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.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and typically are identified by use of terms such as "continued," "anticipate," "potential," "expect," "believe," "planned," and similar words, although some forward-looking statements are expressed differently.  The statements include those related to our strategy and future plans, including statements regarding the development of ATRC-101 and our preclinical, clinical and regulatory plans and the timing thereof, and the availability and timing of data from the Phase 1b trial of ATRC-101.  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, and regulatory submissions, and the implementation of our strategic plans for our business, technologies, and current and potential future product candidates. More information on these risks and potential factors that could affect our business and financial results is included in our filings with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov, including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q. 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.

    Contacts

    Atreca, Inc.

    Herb Cross

    Chief Financial Officer





    Investors:

    Alex Gray, 650-779-9251

    Media:

    Sheryl Seapy, 213-262-9390

    Source: Atreca, Inc.



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  4. SAN CARLOS, Calif., May 14, 2021 (GLOBE NEWSWIRE) -- Atreca, Inc. (Atreca) (NASDAQ:BCEL), a biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced that it will present at the following upcoming virtual investor conferences:

    Cowen 2nd Annual Virtual Oncology Innovation Summit
    Friday, May 21, 2021
    Fireside chat time: 10:40 a.m. EDT

    Jefferies Virtual Healthcare Conference
    Wednesday, June 2, 2021
    Fireside chat time: 3:30 p.m. EDT

    A live audio webcast of each presentation can be accessed through the Events & Presentations section of the Company's website at ir.atreca.com. Archived replays will be available on the Company's…

    SAN CARLOS, Calif., May 14, 2021 (GLOBE NEWSWIRE) -- Atreca, Inc. (Atreca) (NASDAQ:BCEL), a biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced that it will present at the following upcoming virtual investor conferences:

    Cowen 2nd Annual Virtual Oncology Innovation Summit

    Friday, May 21, 2021

    Fireside chat time: 10:40 a.m. EDT

    Jefferies Virtual Healthcare Conference

    Wednesday, June 2, 2021

    Fireside chat time: 3:30 p.m. EDT

    A live audio webcast of each presentation can be accessed through the Events & Presentations section of the Company's website at ir.atreca.com. Archived replays will be available on the Company's website for 90 days following the live presentations.

    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.

    Forward-Looking Statements

    Certain statements in this press release regarding our strategy and future plans, including statements regarding the development of ATRC-101 and our clinical and regulatory plans and the timing thereof, constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts. 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, and regulatory submissions, the activity of ATRC-101 or potential future candidates once administered in human subjects, and the implementation of our strategic plans for our business, technologies, and current or potential future product candidates. More information on these risks and potential factors that could affect our business and financial results is included in our filings with the U.S. Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov, including in our most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and subsequent filings. 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.

    Contacts

    Atreca, Inc.

    Herb Cross

    Chief Financial Officer





    Investors:

    Alex Gray, 650-779-9251, ext. 251

    Media:

    Sheryl Seapy, 213-262-9390

    Source: Atreca, Inc.



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  5. SAN CARLOS Calif., May 13, 2021 (GLOBE NEWSWIRE) -- 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 first quarter ended March 31, 2021, and provided an overview of recent developments.

    "The first few months of 2021 have been a productive period at Atreca, and we look forward to reporting initial summary data from our Phase 1b trial of ATRC-101 in July of this year," said John Orwin, Chief Executive Officer. "We are making good progress enrolling the monotherapy cohorts, and are moving quickly to commence the combination cohorts…

    SAN CARLOS Calif., May 13, 2021 (GLOBE NEWSWIRE) -- 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 first quarter ended March 31, 2021, and provided an overview of recent developments.

    "The first few months of 2021 have been a productive period at Atreca, and we look forward to reporting initial summary data from our Phase 1b trial of ATRC-101 in July of this year," said John Orwin, Chief Executive Officer. "We are making good progress enrolling the monotherapy cohorts, and are moving quickly to commence the combination cohorts evaluating ATRC-101 with both checkpoint inhibitors targeting the PD-1/PD-L1 axis and with chemotherapy. We also continue to advance our pre-clinical pipeline and are excited to announce our next program, targeting EphA2."

    Recent Developments and Highlights

    ATRC-101 Clinical Update        

    To date, 20 patients have been enrolled and treated in the first-in-human trial evaluating ATRC-101 in multiple solid tumor cancers. Atreca has completed enrollment in the fourth cohort (10 mg/kg) of the dose escalation portion of the trial, and all patients treated at that dose have now completed the 21 day dose-limiting toxicity (DLT) assessment period. No DLTs have been observed in the trial. Atreca and its investigators decided, out of an abundance of caution, to enroll three additional patients in the fourth dose cohort (10 mg/kg), after the first two patients enrolled experienced rapid deterioration associated with disease progression, assessed as unrelated to ATRC-101, relatively soon after completion of the DLT assesment period. Atreca anticipates commencing enrollment in the fifth and final cohort (30 mg/kg) shortly, pending review by the Dose Review Committee, and expects to announce initial summary data from the study in July 2021.

    Enrollment includes additional patients treated at 3 mg/kg through backfill of the third dose escalation cohort and the initiation of a monotherapy dose expansion cohort, as previously disclosed. Atreca expects to enroll additional cohorts evaluating ATRC-101 in combination with a PD-1 inhibitor and in combination with a chemotherapeutic agent in 2Q 2021 and 2H 2021, respectively.

    Pipeline Update        

    Atreca has designated a second program, with APN-122597, an antibody derived from the active immune response of a cancer patient, as the program lead. APN-122597 binds to a membrane proximal extracellular epitope of EphA2, a receptor tyrosine kinase (RTK) validated as a known tumor target that is overexpressed in multiple cancers, but with no approved therapies targeting it. A human normal tissue cross-reactivity study showed no reactivity of toxicological significance, and APN-122597 is active in vitro in multiple formats. Atreca expects to provide additional information on APN-122597 and other pipeline assets, including timelines for development, at an R&D Day in 4Q 2021.

    "APN-122597 is another example of the power of our discovery approach," said Dr. Tito Serafini, Atreca founder and Chief Strategy Officer. "While EphA2 is validated as a known and potentially high value target, there are only a limited number of development-stage programs currently targeting EphA2, and no therapies on the market. We believe our antibody is differentiated by its apparent lack of both EphA2 activation and interference with ligand-induced activation, its unique patterns of reactivity with tumor tissue and cells, and its structural features. Furthermore, lead optimization has already yielded improved molecules with an anticipated low level of sequence-based CMC risk."

    IP Update        

    In April 2021, the United States Patent and Trademark Office issued a Notice of Allowance for U.S. patent application serial no. 13/261,763 (exclusively licensed to Atreca), covering fundamental aspects of Atreca's Immune Repertoire Capture® technology (IRC®), which forms a core part of the company's discovery platform. This patent, once issued, further bolsters our global patent coverage for compositions of matter that are a key output of Atreca's IRC® technology.

    First Quarter 2021 Financial Results

    • As of March 31, 2021, cash and cash equivalents and short-term investments totaled $211.7 million.



    • Research and development expenses for the three months ended March 31, 2021 were $18.4 million, including non-cash share-based compensation expense of $2.2 million.



    • General and administrative expenses for the three months ended March 31, 2021 were $7.8 million, including non-cash share-based compensation expense of $2.2 million.



    • Atreca reported a net loss of $25.8 million, or basic and diluted net loss per share attributable to common stockholders of $0.70, for the three months ended March 31, 2021.

    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.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and typically are identified by use of terms such as "continued," "anticipate," "potential," "expect," "believe," "planned," and similar words, although some forward-looking statements are expressed differently. The statements include those related to our strategy and future plans, including statements regarding the development of ATRC-101 and our preclinical, clinical and regulatory plans and the timing thereof, the availability and timing of data from the Phase 1b trial of ATRC-101, our plans and timing to commence combination cohorts evaluating ATRC-101 with checkpoint inhibitors and chemotherapy, and our pre-clinical plans for our next program targeting EphA2 and the differentiation of our antibody in this program. 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, and regulatory submissions, and the implementation of our strategic plans for our business, technologies, and current and potential future product candidates. More information on these risks and potential factors that could affect our business and financial results is included in our filings with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov, including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q. 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) 
          
      March 31, December 31, 
          2021   2020     
          
    ASSETS     
          
    Current Assets
    Cash and cash equivalents $89,712  $60,789  
    Investments  121,958   179,296  
    Prepaid expenses and other current assets  13,109   9,037  
    Total current assets  224,779   249,122  
    Property and equipment, net  33,948   19,831  
    Deposits and other  3,076   3,111  
    Total assets $261,803  $272,064  
          
    LIABILITIES AND STOCKHOLDERS' EQUITY
          
    Current Liabilities
    Accounts payable $7,525  $5,216  
    Accrued expenses  9,133   10,302  
    Other current liabilities  2,097   1,900  
    Total current liabilities  18,755   17,418  
    Capital lease obligations, net of current portion  -   4  
    Deferred rent  21,649   12,585  
    Total liabilities  40,404   30,007  
          
          
    Stockholders' equity
    Common stock  4   4  
    Additional paid-in capital  497,561   492,436  
    Accumulated other comprehensive income  50   58  
    Accumulated deficit  (276,216)  (250,441) 
    Total stockholders' equity  221,399   242,057  
    Total liabilities and stockholders' equity $261,803  $272,064  
          

     

    Atreca, Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share data)

    (unaudited)



    ($ amounts in 000's, except per share amounts)    
           
       Three Months Ended 
       March 31, 
        2021   2020  
       (unaudited) 
    Expenses     
     Research and development $18,388  $14,210  
     General and administrative  7,821   7,123  
     Total expenses  26,209   21,333  
    Interest and other income (expense)     
     Other income  344   231  
     Interest income  91   685  
     Interest expense  (1)  (1) 
    Loss before Income tax expense  (25,775)  (20,418) 
    Income tax expense  -   -  
    Net loss $(25,775) $(20,418) 
    Net loss per share, basic and diluted $(0.70) $(0.73) 
    Weighted-average shares used in computing     
    net loss per share, basic and diluted  36,841,065   28,020,408  
           

     

    Contacts

    Atreca, Inc.

    Herb Cross

    Chief Financial Officer





    Investors:

    Alex Gray, 650-779-9251

    Media:

    Sheryl Seapy, 213-262-9390

    Source: Atreca, Inc.



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