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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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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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 November 10, 2022, Atreca, Inc. (the “Company”) issued a press release reporting its financial results for the quarter ended September 30, 2022 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 Third Quarter 2022 Financial Results and Provides Pipeline Update," dated November 10, 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: November 10, 2022 | By: | /s/ Herbert Cross |
| Herbert Cross | ||
| Chief Financial Officer | ||
EXHIBIT 99.1
Atreca Reports Third Quarter 2022 Financial Results and Provides Pipeline Update
SAN CARLOS, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- SAN CARLOS, Calif., November 10, 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 third quarter ended September 30, 2022 and provided an overview of recent developments.
"The third quarter was a productive period, as we continue to enroll patients in the Phase 1b trial of ATRC-101,” said John Orwin, Chief Executive Officer of Atreca. “We remain encouraged by the association we see between clinical activity and target expression, the durability of the clinical activity observed and the tolerability demonstrated in the study. We are making progress toward accelerating enrollment and are now planning to present data in early 2023, once we’ve treated enough participants to provide a meaningful update.”
“An NHP toxicity study to evaluate ATRC-301, an ADC candidate in our anti-EphA2 program, revealed safety signals, including bleeding, and as a result, we are discontinuing the development of ATRC-301; however, we continue to evaluate our anti-EphA2 antibodies in multiple weaponized formats,” said Stephen Gould, Ph.D., Chief Scientific Officer of Atreca. “While this will delay the timing of our next IND in oncology, our preclinical pipeline is otherwise progressing well, and in early 2023 we expect to provide updates on both an ADC targeting a novel tumor glycan and a bispecific T-cell engager targeting another RNA-binding protein.”
“In addition, the Bill & Melinda Gates Medical Research Institute continues to advance MAM01/ATRC-501, an antibody clinical candidate generated by the Atreca platform that is in development for the prevention of malaria, for which they expect to file an IND early next year,” said John Orwin.
Recent Developments and Highlights
Atreca continued enrolling patients in its ongoing Phase 1b study of ATRC-101 based on ATRC-101 target expression in archival or newly obtained biopsies. To-date, 67 participants have been enrolled across the monotherapy and pembrolizumab combination cohorts of the study. The Company has taken steps to accelerate enrollment in the trial, including initiating additional trial sites and streamlining enrollment criteria. Atreca now expects to present updated monotherapy and combination data from the trial in the first quarter of 2023.
An non-human primate (NHP) toxicity study to evaluate ATRC-301, an antibody drug conjugate (ADC) candidate in our anti-EphA2 program, revealed safety signals, including bleeding, and as a result, Atreca is discontinuing the development of ATRC-301. The Company continues to evaluate its anti-EphA2 antibodies in multiple weaponized formats and advance its other lead-stage oncology programs, including APN-497444, an ADC against a novel tumor glycan target, and APN-346958, a CD3 bispecific T-cell engager against an RNA-binding protein target. Atreca is now targeting one additional Investigational New Drug (IND) application per year in oncology beginning in 2024.
A IND for MAM01/ATRC-501, an Atreca-discovered antibody clinical candidate licensed to the Bill & Melinda Gates Medical Research Institute (“Gates MRI”) for the prevention of malaria, is expected to be filed by Gates MRI in the first quarter of 2023, and they expect to commence clinical development by the second half of 2023. Atreca retains commercial rights in the U.S., Europe and parts of Asia, and potential product development opportunities in those regions include prevention of malaria for those traveling to malaria endemic regions.
In October 2022, Atreca announced the presentation of two posters at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, a trial-in-progress update on the Phase 1b clinical study of ATRC-101, and a poster on the discovery and preclinical development of its novel EphA2-targeted antibodies. Poster sessions began today, November 10th, at 9 a.m. ET.
Third Quarter 2022 Financial Results
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, our pipeline of lead-stage oncology programs, and MAM01/ATRC-501, a clinical candidate licensed to the Bill & Melinda Gates Medical Research Institute for the prevention of malaria. 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
This release contains forward-looking statements regarding our strategy and future plans, including statements regarding enrollment of patients in our Phase 1b clinical trial of ATRC-101, the development of ATRC-101 and our clinical and regulatory plans, and the timing thereof, data read-outs and the timing thereof, including the reporting of updated data from the monotherapy and pembrolizumab combination arms of our Phase 1b clinical trial of ATRC-101, our evaluation of anti-EphA2 antibodies in multiple weaponized formats and advancement of other lead-stage oncology programs, including APN-497444 and APN-346958, the expected timing of INDs, including delays thereof and plans to submit one additional IND per year in oncology beginning in 2024, advancement of MAM01/ATRC-501 by Gates MRI, including plans to commence clinical development by the second half of 2023. 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 “continue,” “progress,” “accelerate,” “will,” “expect,” “advance,” “target,” 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)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 20,903 | $ | 94,746 | ||||
| Investments | 64,822 | 22,287 | ||||||
| Prepaid expenses and other current assets | 7,050 | 5,337 | ||||||
| Total current assets | 92,775 | 122,370 | ||||||
| Property and equipment, net | 39,670 | 43,015 | ||||||
| Operating lease right-of-use assets | 36,481 | - | ||||||
| Long-term investments | - | 31,042 | ||||||
| Deposits and other | 3,149 | 3,630 | ||||||
| Total assets | $ | 172,075 | $ | 200,057 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current Liabilities | ||||||||
| Accounts payable | $ | 1,698 | $ | 3,352 | ||||
| Accrued expenses | 9,399 | 11,555 | ||||||
| Current portion of operating lease liabilities | 3,434 | - | ||||||
| Other current liabilities | 39 | 1,992 | ||||||
| Total current liabilities | 14,570 | 16,899 | ||||||
| Deferred rent | - | 28,229 | ||||||
| Operating lease liabilities, net of current portion | 61,252 | - | ||||||
| Total liabilities | 75,822 | 45,128 | ||||||
| Stockholders’ equity | ||||||||
| Common stock | 4 | 4 | ||||||
| Additional paid-in capital | 532,409 | 514,794 | ||||||
| Accumulated other comprehensive income (loss) | (581 | ) | (102 | ) | ||||
| Accumulated deficit | (435,579 | ) | (359,767 | ) | ||||
| Total stockholders’ equity | 96,253 | 154,929 | ||||||
| Total liabilities and stockholders’ equity | $ | 172,075 | $ | 200,057 | ||||
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 | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Expenses | ||||||||||||||||
| Research and development | $ | 16,045 | $ | 18,721 | $ | 53,062 | $ | 56,145 | ||||||||
| General and administrative | 7,247 | 8,796 | 23,930 | 24,648 | ||||||||||||
| Total expenses | 23,292 | 27,517 | 76,992 | 80,793 | ||||||||||||
| Interest and other income (expense) | ||||||||||||||||
| Other income | - | 158 | 750 | 851 | ||||||||||||
| Interest income | 233 | 36 | 430 | 183 | ||||||||||||
| Interest expense | - | (1 | ) | - | (3 | ) | ||||||||||
| Loss on disposal of property and equipment | - | (34 | ) | - | (45 | ) | ||||||||||
| Loss before Income tax expense | (23,059 | ) | (27,358 | ) | (75,812 | ) | (79,807 | ) | ||||||||
| Income tax expense | - | - | - | (1 | ) | |||||||||||
| Net loss | $ | (23,059 | ) | $ | (27,358 | ) | $ | (75,812 | ) | $ | (79,808 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.60 | ) | $ | (0.74 | ) | $ | (1.97 | ) | $ | (2.16 | ) | ||||
| Weighted-average shares used in computing | ||||||||||||||||
| net loss per share, basic and diluted | 38,720,575 | 36,918,255 | 38,434,327 | 36,884,665 | ||||||||||||
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.
Cover |
Nov. 10, 2022 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Nov. 10, 2022 |
| Entity File Number | 001-38935 |
| Entity Registrant Name | Atreca, Inc. |
| Entity Central Index Key | 0001532346 |
| Entity Tax Identification Number | 27-3723255 |
| Entity Incorporation, State or Country Code | DE |
| Entity Address, Address Line One | 835 Industrial Rd., Suite 400 |
| Entity Address, City or Town | San Carlos |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 94070 |
| City Area Code | 650 |
| Local Phone Number | 595-2595 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Class A Common Stock, $0.0001 par value per share |
| Trading Symbol | BCEL |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | true |
| Elected Not To Use the Extended Transition Period | false |