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SAN DIEGO, Nov. 05, 2024 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported financial results for the third quarter ended Sept. 30, 2024 and provided a business update.
"We remain confident in the potential best-in-class profiles of our programs targeting BTLA and PD-1 co-inhibitory receptors to drive differentiated results as we approach multiple clinical catalysts and value drivers for Anaptys, including top-line Phase 2b data in AD for ANB032, our BTLA agonist, in December. We’ve also completed enrollment for the Phase 2b trial of rosnilimab, our PD-1 agonist, in RA and are narrowing our guidance for top-line data to February 2025," said Daniel Faga, president and chief executive officer of Anaptys. "Additionally, enrollment in healthy volunteers has commenced for the Phase 1 trial for ANB033, our anti-CD122 antagonist, and we look forward to disclosing the Phase 1b indication in 2025. Looking to the end of the year, we are on track to have four programs in clinical development."
Updates on Wholly Owned ICM Pipeline
ANB032 (BTLA agonist antibody)
Rosnilimab (PD-1 agonist antibody)
ANB033 (anti-CD122 antagonist antibody)
ANB101 (BDCA2 modulator antibody)
Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing
GSK Immuno-Oncology Financial Collaboration
Cash Runway
Third Quarter Financial Results
About Anaptys
Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. Its pipeline includes two programs targeting co-inhibitory receptors: ANB032, its BTLA agonist, in a Phase 2b trial for the treatment of atopic dermatitis and rosnilimab, its PD-1 agonist, in a Phase 2b trial for the treatment of rheumatoid arthritis and in a Phase 2 trial for the treatment of ulcerative colitis. It also has other antibodies in its portfolio, including ANB033, an anti-CD122 antagonist, in a Phase 1 trial and ANB101, a BDCA2 modulator, soon to enter clinical development. In addition, Anaptys has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, that has completed Phase 3 trials for the treatment of generalized pustular psoriasis, and etokimab, an anti-IL-33 antagonist that is Phase 2/3 ready. Anaptys has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immuno-oncology, including an anti-PD-1 antagonist ( Jemperli (dostarlimab-gxly)) and an anti-TIM-3 antagonist (cobolimab, GSK4069889). To learn more, visit www.AnaptysBio.com or follow us on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from the Company’s clinical trials, including ANB032’s Phase 2b clinical trial in atopic dermatitis, and rosnilimab’s Phase 2b clinical trial in rheumatoid arthritis and Phase 2 clinical trial in ulcerative colitis; the timing of initiation of ANB101’s Phase 1 clinical trial; the timing of disclosure of the Phase 1b indication for ANB033; the potential to receive any additional royalties from the GSK collaboration; the Company’s ability to find a licensing partner for imsidolimab or etokimab and the timing of any such transaction; and the Company’s projected cash runway. Statements including words such as “plan,” “intend,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Contact:
Nick Montemarano
Senior Director, Investor Relations and Strategic Communications
858.732.0178
investors@anaptysbio.com
| AnaptysBio, Inc. Consolidated Balance Sheets (in thousands, except par value data) (unaudited) | |||||||
| September 30, 2024 | December 31, 2023 | ||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 191,581 | $ | 35,965 | |||
| Receivables from collaborative partners | 12,195 | 6,851 | |||||
| Short-term investments | 238,536 | 354,939 | |||||
| Prepaid expenses and other current assets | 6,369 | 9,080 | |||||
| Total current assets | 448,681 | 406,835 | |||||
| Property and equipment, net | 1,728 | 2,098 | |||||
| Operating lease right-of-use assets | 14,839 | 16,174 | |||||
| Long-term investments | 27,914 | 27,026 | |||||
| Other long-term assets | 256 | 256 | |||||
| Total assets | $ | 493,418 | $ | 452,389 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 3,592 | $ | 4,698 | |||
| Accrued expenses | 38,401 | 30,967 | |||||
| Current portion of operating lease liability | 1,887 | 1,777 | |||||
| Total current liabilities | 43,880 | 37,442 | |||||
| Liability related to sale of future royalties | 350,564 | 310,807 | |||||
| Operating lease liability, net of current portion | 14,607 | 16,037 | |||||
| Stockholders’ equity: | |||||||
| Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at September 30, 2024 and December 31, 2023, respectively | — | — | |||||
| Common stock, $0.001 par value, 500,000 shares authorized, 30,429 shares and 26,597 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively | 30 | 27 | |||||
| Additional paid in capital | 821,121 | 702,969 | |||||
| Accumulated other comprehensive gain (loss) | 759 | (797 | ) | ||||
| Accumulated deficit | (737,543 | ) | (614,096 | ) | |||
| Total stockholders’ equity | 84,367 | 88,103 | |||||
| Total liabilities and stockholders’ equity | $ | 493,418 | $ | 452,389 | |||
| AnaptysBio, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share data) (unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Collaboration revenue | $ | 30,017 | $ | 3,318 | $ | 48,167 | $ | 8,152 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 42,212 | 30,878 | 121,251 | 98,758 | |||||||||||
| General and administrative | 10,562 | 10,172 | 32,195 | 31,670 | |||||||||||
| Total operating expenses | 52,774 | 41,050 | 153,446 | 130,428 | |||||||||||
| Loss from operations | (22,757 | ) | (37,732 | ) | (105,279 | ) | (122,276 | ) | |||||||
| Other (expense) income, net: | |||||||||||||||
| Interest income | 5,324 | 4,854 | 14,531 | 13,993 | |||||||||||
| Non-cash interest expense for the sale of future royalties | (15,413 | ) | (4,431 | ) | (32,683 | ) | (13,125 | ) | |||||||
| Other (expense) income, net | (5 | ) | 1 | (7 | ) | — | |||||||||
| Total other (expense) income, net | (10,094 | ) | 424 | (18,159 | ) | 868 | |||||||||
| Loss before income taxes | (32,851 | ) | (37,308 | ) | (123,438 | ) | (121,408 | ) | |||||||
| Provision for income taxes | — | — | (9 | ) | — | ||||||||||
| Net loss | (32,851 | ) | (37,308 | ) | (123,447 | ) | (121,408 | ) | |||||||
| Unrealized gain on available for sale securities | 1,174 | 1,261 | 1,556 | 2,896 | |||||||||||
| Comprehensive loss | $ | (31,677 | ) | $ | (36,047 | ) | $ | (121,891 | ) | $ | (118,512 | ) | |||
| Net loss per common share: | |||||||||||||||
| Basic and diluted | $ | (1.14 | ) | $ | (1.41 | ) | $ | (4.46 | ) | $ | (4.49 | ) | |||
| Weighted-average number of shares outstanding: | |||||||||||||||
| Basic and diluted | 28,893 | 26,546 | 27,688 | 27,038 | |||||||||||