UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: November 5, 2024
(Date of earliest event reported)
(Exact Name of Registrant as Specified in Charter)
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
(Address of Principal Executive Offices, and Zip Code)
(858 ) 362-6295
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former name or former address, if changed since last report.)
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 (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §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. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 5, 2024, AnaptysBio, Inc. (“AnaptysBio”) issued a press release announcing its financial results for the three and nine months ended September 30, 2024. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02, including Exhibit 99.1 to this Current Report on Form 8-K, shall not be deemed to be “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. The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document filed by AnaptysBio with the Securities and Exchange Commission, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in such filing (or any reference to this Current Report on Form 8-K generally), except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
| Exhibit Number | Exhibit Title or Description | ||||
Press release issued by AnaptysBio, Inc. regarding its financial results for the three and nine months ended September 30, 2024, dated November 5, 2024. | |||||
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document). | ||||
SIGNATURES
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 thereunto duly authorized.
| AnaptysBio, Inc. | |||||||||||
Date: November 5, 2024 | By: | /s/Dennis Mulroy | |||||||||
Name: Dennis Mulroy | |||||||||||
Title: Chief Financial Officer | |||||||||||
Anaptys Announces Third Quarter 2024 Financial Results and
Provides Business Update
•Top-line Phase 2b data anticipated for ANB032, our BTLA agonist, in atopic dermatitis (AD) in December 2024
•Top-line Phase 2b data anticipated for rosnilimab, our PD-1 agonist, in rheumatoid arthritis (RA) in February 2025
•Phase 1 trial initiated in healthy volunteers for ANB033, our anti-CD122 antagonist
•Reiterating cash runway through year-end 2026
SAN DIEGO, Nov. 5, 2024 — 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)
•Top-line Week 14 data for global Phase 2b trial in moderate-to-severe AD anticipated in December 2024
◦Enrolled approximately 200 patients in a placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI-75 and IGA 0/1
▪Enrollment included approximately 15% of patients with Dupixent/anti-IL-13 treatment experience
•Presented analyses that characterize a BTLA transcriptomic signature in AD at the European Academy of Dermatology and Venerology (EADV) Congress in September 2024
◦Poster presentation is available at https://www.anaptysbio.com/technology/#anb032
Rosnilimab (PD-1 agonist antibody)
•Top-line Week 12 data for global Phase 2b trial in moderate-to-severe RA anticipated in February 2025
◦Completed enrollment of approximately 420 patients in a placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70
▪At Week 14, rosnilimab-treated patients who achieve low disease activity, defined as CDAI<=10, are eligible to be dosed for an additional 16-week all-active treatment period and then followed for a three-month off-drug follow-up period
•Enrollment ongoing for global Phase 2 trial in moderate-to-severe ulcerative colitis (UC)
◦132-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission
▪Rosnilimab and placebo-treated patients who achieved clinical response on mMS are eligible to continue on their assigned treatment for an additional 12 weeks, while patients on placebo who are non-responders will be crossed over to the high-dose rosnilimab treatment arm, in an all-active treatment period and then followed for a three-month off-drug follow-up period
▪In October 2024, an optional 26-week, blinded treatment extension period (TEP) was implemented for patients who remain in clinical response at Week 24 in the U.S.; EU implementation anticipated in early 2025
◦Top-line Week 12 data anticipated in Q1 2026
•Presented data evaluating the PD-1 depletion and agonism mechanisms of rosnilimab in vitro with UC patient-derived PBMCs and a mouse model of colitis at the 2024 United European Gastroenterology Week (UEGW) in October 2024
◦Poster presentation is available at https://www.anaptysbio.com/technology/#anb030
ANB033 (anti-CD122 antagonist antibody)
•Phase 1 trial initiated in healthy volunteers in October 2024
◦Phase 1b indication to be disclosed in 2025
ANB101 (BDCA2 modulator antibody)
•Submitted investigational new drug (IND) application and plan to initiate enrollment for Phase 1 trial in healthy volunteers in Q1 2025
Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing
•Presented full data from the Phase 3 GEMINI-1 and GEMINI-2 trials of imsidolimab (IL-36R) in generalized pustular psoriasis (GPP) at the EADV Congress in September 2024
◦Poster presentation is available at https://www.anaptysbio.com/technology/#imsidolimab
•Intend to out-license imsidolimab in 2024
GSK Immuno-Oncology Financial Collaboration
•GSK anticipates top-line data in H1 2025 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
•GSK anticipates top-line data in Q4 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer
Cash Runway
•Cash and investments of $458.0 million as of September 30, 2024 and reiterating cash runway through year-end 2026
Third Quarter Financial Results
•Cash, cash equivalents and investments totaled $458.0 million as of September 30, 2024, compared to $417.9 million as of December 31, 2023, for an increase of $40.1 million due primarily to the $100.0 million underwritten registered direct offering completed in Q3 and $50.0 million received from the Sagard royalty monetization in Q2 offset by operating activities.
•Collaboration revenue was $30.0 million and $48.2 million for the three and nine months ended September 30, 2024, compared to $3.3 million and $8.2 million for the three and nine months ended September 30, 2023. The increase in non-cash revenue is due to a $15.0 million commercial milestone earned for annual Jemperli sales exceeding $250.0 million and increased royalties recognized for sales of Jemperli.
•Research and development expenses were $42.2 million and $121.3 million for the three and nine months ended September 30, 2024, compared to $30.9 million and $98.8 million for the three and nine months ended September 30, 2023. The increase was due primarily to development costs for rosnilimab, ANB032, ANB033 and ANB101 offset by a decrease in development costs for imsidolimab. The R&D non-cash, stock-based compensation expense was $4.0 million and $10.9 million for the three and nine months ended September 30, 2024, as compared to $2.2 million and $7.7 million in the same period in 2023.
•General and administrative expenses were $10.6 million and $32.2 million for the three and nine months ended September 30, 2024, compared to $10.2 million and $31.7 million for the three and nine months ended September 30, 2023. The G&A non-cash, stock-based compensation expense was $4.2 million and $14.9 million for the three and nine months ended September 30, 2024, as compared to $5.6 million and $17.4 million in the same period in 2023.
•Net loss was $32.9 million and $123.4 million for the three and nine months ended September 30, 2024, or a net loss per share of $1.14 and $4.46, compared to a net loss of $37.3 million and $121.4 million for the three and nine months ended September 30, 2023, or a net loss per share of $1.41 and $4.49.
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 | |||||||||||||||||||