UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
_________________
CURRENT REPORT
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of the Securities Exchange Act of 1934
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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 2, 2021, Atreca, Inc. (the “Company”) issued a press release reporting its financial results for the quarter ended September 30, 2021 and its 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 under the Securities Act of 1933, as amended, or 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 2021 Financial Results and Recent Corporate Developments,” dated November 2, 2021, 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 2, 2021 | By: | /s/ Herbert Cross |
| Herbert Cross | ||
| Chief Financial Officer | ||
EXHIBIT 99.1
Atreca Reports Third Quarter 2021 Financial Results and Recent Corporate Developments
SAN CARLOS, Calif., Nov. 02, 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 third quarter ended September 30, 2021, and provided an overview of recent developments.
"In the third quarter, we continued to advance our lead program, ATRC-101, following the release of initial summary data from the dose escalation portion of the Phase 1b trial, which supports the further evaluation of ATRC-101 in multiple solid tumor types,” said John Orwin, Chief Executive Officer. “We plan to share additional monotherapy data and initial combination data with pembrolizumab in 2022, and are in a strong position to advance our pipeline with cash runway through mid-2023.”
“Our earlier-stage programs are progressing well, highlighted by our recently announced licensing agreement with the Bill & Melinda Gates Medical Research Institute for the development and commercialization of MAM01/ATRC-501, a novel monoclonal antibody entering preclinical development for the prevention of malaria,” said Tito Serafini, Ph.D., Chief Strategy Officer. “We look forward to sharing more information on our EphA2 program and other pipeline assets at an R&D day early next year.”
Recent Developments and Highlights
- Atreca announced a licensing agreement with the Bill & Melinda Gates Medical Research Institute (“Gates MRI”) for development and commercialization of MAM01/ATRC-501, a monoclonal antibody for malaria prophylaxis. Under the agreement, Gates MRI will lead the development of MAM01/ATRC-501 and receive commercial rights in GAVI-eligible countries located in malaria-endemic regions of the world, while Atreca will retain commercial rights in the U.S., Europe and parts of Asia. Potential product development opportunities for Atreca include developing MAM01/ATRC-501 for prevention of malaria for those traveling to regions where the infection may be circulating.
- Enrollment in the monotherapy portion of the Phase 1b trial of ATRC-101 is ongoing at 30 mg/kg and Atreca plans to report additional monotherapy data in mid-2022.
- Enrollment has commenced in a Phase 1b combination cohort evaluating ATRC-101 with pembrolizumab. Another combination cohort with pegylated liposomal doxorubicin (“PLD”) is expected to begin enrolling patients following completion of ongoing monotherapy cohorts, including those following a Q2W dosing schedule which better aligns with the standard PLD regimen. Atreca plans to report additional monotherapy data in mid-2022 and pembrolizumab combination data in 3Q22.
Third Quarter 2021 Financial Results
- As of September 30, 2021, cash and cash equivalents and short-term investments totaled $152.9 million.
- Research and development expenses for the three months ended September 30, 2021 were $18.7 million, including non-cash share-based compensation expense of $1.9 million.
- General and administrative expenses for the three months ended September 30, 2021 were $8.8 million, including non-cash share-based compensation expense of $1.9 million.
- Atreca reported a net loss of $27.4 million, or basic and diluted net loss per share attributable to common stockholders of $0.74, for the three months ended September 30, 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 “will,” “expect,” “potential,” “plan,” “continue,” 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 ATRC-101 monotherapy and initial combination data with pembrolizumab and enrollment in, and timing of, a combination cohort with pegylated liposomal doxorubicin, our cash runway and the timing thereof, the development of MAM01/ATRC-501, its potential for prevention of malaria, our potential product development opportunities to develop MAM01/ATRC-501 for prevention of malaria for those traveling to regions where the infection may be circulating, and the status of our earlier-stage programs and our plan to share information regarding our EphA2 program and other pipeline assets and the timing thereof. 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.
Atreca, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 113,189 | $ | 60,789 | ||||
| Investments | 39,697 | 179,296 | ||||||
| Prepaid expenses and other current assets | 9,180 | 9,037 | ||||||
| Total current assets | 162,066 | 249,122 | ||||||
| Property and equipment, net | 44,291 | 19,831 | ||||||
| Long-term investments | 10,824 | - | ||||||
| Deposits and other | 3,080 | 3,111 | ||||||
| Total assets | $ | 220,261 | $ | 272,064 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current Liabilities | ||||||||
| Accounts payable | $ | 5,238 | $ | 5,216 | ||||
| Accrued expenses | 9,286 | 10,302 | ||||||
| Other current liabilities | 1,631 | 1,900 | ||||||
| Total current liabilities | 16,155 | 17,418 | ||||||
| Capital lease obligations, net of current portion | - | 4 | ||||||
| Deferred rent | 28,677 | 12,585 | ||||||
| Total liabilities | 44,832 | 30,007 | ||||||
| Stockholders’ equity | ||||||||
| Common stock | 4 | 4 | ||||||
| Additional paid-in capital | 505,680 | 492,436 | ||||||
| Accumulated other comprehensive income (loss) | (6 | ) | 58 | |||||
| Accumulated deficit | (330,249 | ) | (250,441 | ) | ||||
| Total stockholders’ equity | 175,429 | 242,057 | ||||||
| Total liabilities and stockholders’ equity | $ | 220,261 | $ | 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 | Nine Months Ended | ||||||||||||||||
| September 30, | September 30, | ||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||
| Expenses | |||||||||||||||||
| Research and development | $ | 18,721 | $ | 16,808 | $ | 56,145 | $ | 45,198 | |||||||||
| General and administrative | 8,796 | 6,614 | 24,648 | 20,195 | |||||||||||||
| Total expenses | 27,517 | 23,422 | 80,793 | 65,393 | |||||||||||||
| Interest and other income (expense) | |||||||||||||||||
| Other income | 158 | 353 | 851 | 987 | |||||||||||||
| Interest income | 36 | 142 | 183 | 1,082 | |||||||||||||
| Interest expense | (1 | ) | (1 | ) | (3 | ) | (3 | ) | |||||||||
| Loss on disposal of property and equipment | (34 | ) | - | (45 | ) | - | |||||||||||
| Loss before Income tax expense | (27,358 | ) | (22,928 | ) | (79,807 | ) | (63,327 | ) | |||||||||
| Income tax expense | - | (1 | ) | (1 | ) | (1 | ) | ||||||||||
| Net loss | $ | (27,358 | ) | $ | (22,929 | ) | $ | (79,808 | ) | $ | (63,328 | ) | |||||
| Net loss per share, basic and diluted | $ | (0.74 | ) | $ | (0.66 | ) | $ | (2.16 | ) | $ | (2.09 | ) | |||||
| Weighted-average shares used in computing | |||||||||||||||||
| net loss per share, basic and diluted | 36,918,255 | 34,723,888 | 36,884,665 | 30,313,047 | |||||||||||||
Contacts
Atreca, Inc.
Herb Cross
Chief Financial Officer
info@atreca.com
Investors:
Alex Gray, 650-779-9251
agray@atreca.com
Media:
Rachel Ford Hutman, 301-801-5540
Rachel@fordhutmanmedia.com
Source: Atreca, Inc.