UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
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CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
On March 3, 2022, Atreca, Inc. (the “Company”) issued a press release reporting its financial results for the quarter and year ended December 31, 2021 and recent corporate developments. A copy of such press release is furnished hereto as Exhibit 99.1.
The information contained in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, nor shall it be deemed incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, except as expressly set forth by reference in such a filing.
(d) Exhibits
Exhibit Number | Exhibit Description | |
99.1 | Press Release titled “Atreca Reports Fourth Quarter and Full-Year 2021 Financial Results and ATRC-101 Data Update,” dated March 1, 2022, furnished herewith | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Atreca, Inc. | ||
Date: March 3, 2022 | By: | /s/ Herbert Cross |
Herbert Cross | ||
Chief Financial Officer | ||
EXHIBIT 99.1
Atreca Reports Fourth Quarter and Full-Year 2021 Financial Results and ATRC-101 Data Update
Partial response (PR) observed in ATRC-101 monotherapy cohort as well as a confirmed complete response (CR) observed in pembrolizumab combination cohort in Phase 1b clinical trial
Clinical activity observed in multiple tumor types and significantly associated with ATRC-101 target expression; target diagnostic validated and planning for participant selection based on target expression
ATRC-101 has been well-tolerated with no dose-limiting toxicities observed
Conference call and webcast with accompanying slides scheduled for today at 4:30 p.m. EST
SAN CARLOS, Calif., March 03, 2022 (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 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
“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
Fourth Quarter and Year End 2021 Financial Results
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 Cross
Chief Financial Officer
info@atreca.com
Investors:
Alex Gray, 650-779-9251
agray@atreca.com
Media:
Julia Fuller, 858-692-2001
julia@fordhutmanmedia.com
Source: Atreca, Inc.