8-K
ANAPTYSBIO, INC (ANAB)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, 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 (Date of earliest event reported): March 03, 2026 |
|---|
ANAPTYSBIO, INC.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-37985 | 20-3828755 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission File Number) | (IRS Employer<br>Identification No.) |
| 10770 Wateridge Circle, Suite 210 | ||
| San Diego, California | 92121 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
| Registrant’s Telephone Number, Including Area Code: 858 362-6295 | ||
| --- | ||
| 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:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br>Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, $0.001 par value | ANAB | The Nasdaq Stock Market LLC |
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On March 3, 2026, AnaptysBio, Inc. (“AnaptysBio”) issued a press release announcing its financial results for the three months and year ended December 31, 2025. 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 7.01 Regulation FD.
AnaptysBio is furnishing the Presentation, a full copy is attached hereto as Exhibit 99.2.
The information in this Item 7.01, including Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Exhibit Title or Description |
|---|---|
| 99.1 | Press release issued by AnaptysBio, Inc. regarding its financial results for the three months and year ended December 31, 2025, dated March 3, 2026. |
| 99.2 | Anaptys Corporate Presentation March 2026 |
| 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 hereunto duly authorized.
| AnaptysBio, Inc. | |||
|---|---|---|---|
| Date: | March 3, 2026 | By: | /s/ Dennis Mulroy |
| Name: Dennis Mulroy<br>Title: Chief Financial Officer |
EX-99.1
Anaptys Provides Update on Business Separation and Announces Fourth Quarter and Full Year 2025 Financial Results
- Spin-off of biopharma operations into a public company to be called “First Tracks Biotherapeutics” on track for Q2 2026, potentially as early as late-April
- Phase 1b enrollment ongoing in celiac disease and trial cohort initiated in eosinophilic esophagitis for ANB033, a CD122 antagonist
- GSK announced strong commercial performance for Jemperli, growing >13% quarter-over-quarter to $343 million in Q4 2025, implying a ~$1.4 billion annualized run rate
- Expect to achieve >$390 million in annualized Jemperli royalties payable to Anaptys at GSK’s peak sales guidance of >$2.7 billion as early as 2029
- Year-end 2025 cash and investments of ~$311 million
SAN DIEGO, March 3, 2026 — AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today provided an update on the potential spin-off of its biopharma operations and reported financial results for the fourth quarter and year ended Dec. 31, 2025.
“We are approaching a defining inflection point for Anaptys, as we plan to spin-off in Q2 2026 our wholly owned biopharma portfolio into a public company, to be called First Tracks Biotherapeutics, to unlock and amplify value for investors across two distinct sets of assets,” said Daniel Faga, president and chief executive officer of Anaptys. “In our royalty portfolio, Jemperli exited Q4 2025 on a ~$1.4 billion annualized run rate, reinforcing GSK’s peak sales guidance of far more than $2.7 billion2 in monotherapy indications. At the same time, our biopharma portfolio is advancing multiple attractive, high-potential assets, including ANB033, which has pipeline-in-a-product potential, initially in a Phase 1b trial for both celiac disease and eosinophilic esophagitis.”
INTENT TO SEPARATE BUSINESS
Intention to separate biopharma operations from substantial royalty assets on track for Q2 2026, potentially as early as late-April
Designed to unlock potential value by creating two independent, publicly traded companies with different business objectives and opportunities
The royalty management company will initially retain the name AnaptysBio (Nasdaq: ANAB) and will manage the financial collaborations from Jemperli with GSK and imsidolimab with Vanda, with a focus on protecting and returning their value to shareholders
While specific decisions regarding board composition, leadership and financial operations will be disclosed at a later time, Daniel Faga is anticipated to be the initial CEO
First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX) (formerly referred to as Biopharma Co), will be a public company focused on the development and potential commercialization of innovative immunology therapeutics for autoimmune and inflammatory diseases, including ANB033, rosnilimab and ANB101
Form 10 registration statement has been publicly filed in connection with the planned spin-off
Initial Board of Directors for First Tracks Biotherapeutics is expected to include certain current members of Anaptys’ Board: Daniel Faga, Dennis Fenton, Ph.D., John Orwin (Chairman), John Schmid, Magda Marquet, Ph.D., Rita Jain, M.D., and Tony Ware, M.D.
Initial executive leadership team for First Tracks Biotherapeutics will include Daniel Faga, CEO, Paul Lizzul, CMO and Ben Stone, CBO. Additional executives will be disclosed at a later time.
Upon completion of the spin-off, First Tracks Biotherapeutics will launch with adequate capital to fund operations through significant potential product milestones
AnaptysBio (formerly referred to as “Royalty Management Co”)
GSK Jemperli Financial Collaboration
- GSK announced strong commercial performance for Jemperli ($343 million/£261 million in Q4 2025 sales; $1.128 billion/£861 million in YTD 2025 sales) with >13% USD and GBP quarter-over-quarter growth1
- Implies a ~$1.4 billion annualized run rate
- In Dec. 2025, Anaptys received a one-time $75 million commercial sales milestone from GSK when Jemperli achieved $1 billion in worldwide net sales in Nov. 2025
- Anaptys expects to achieve >$390 million in annualized Jemperli royalties payable to Anaptys at GSK’s peak sales guidance of >$2.7 billion2 as early as 2029
- Anaptys estimates Sagard will have accrued ~$250 million in royalties and sales milestones through year-end 2025 and anticipates full paydown of $600 million non-recourse debt monetization by the end of Q2 20273
- Substantial GSK investment in additional monotherapy and potential combination trials for Jemperli, including:
o AZUR-1 – pivotal Phase 2 – dostarlimab monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
- Top-line data expected in 2026; U.S. FDA Breakthrough Therapy Designation
- Received an FDA Commissioner’s National Priority Voucher (CNPV) in Nov. 2025 allowing for only a one to two-month BLA review timeline for US FDA approval
o AZUR-2 – pivotal Phase 3 – dostarlimab versus standard of care in untreated TN40 or stage III dMMR/ MSI-H resectable colon cancer
- Top-line data expected in 2028
o AZUR-4 – Phase 2 – dostarlimab plus chemotherapy versus standard of care (chemotherapy) in untreated stage III MMRp/MSS resectable colon cancer
- Top-line data expected in Q4 2026
o JADE – pivotal Phase 3 – dostarlimab monotherapy versus placebo in locally advanced unresected head and neck squamous cell carcinoma (PD-L1 hiPghD-L1 CPS≥1) post chemoradiation
- Top-line data expected in 2028
Vanda Imsidolimab Financial Collaboration
- FDA accepted the BLA filing for imsidolimab in generalized pustular psoriasis (GPP) in Feb. 2026 with a target action date of Dec. 12, 2026
First Tracks Biotherapeutics (formerly referred to as “Biopharma Co”)
ANB033 (CD122 antagonist)
- Phase 1b trial in celiac disease ongoing
- 60-patient trial assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) across two different cohorts
- Cohort 1 (n=30) is a gluten-challenge study to assess the prevention of mucosal damage
- Patients enrolled have a Vh:Cd ratio of >2.0 are treated with ANB033 or placebo for 4 weeks, and after are administered a daily 6-gram gluten challenge at Week 4 for 14 days, and are assessed at Week 6 via biopsy
- Cohort 2 (n=30) is a study to assess the possibility of mucosal healing in the likely commercial population
- Patients enrolled have a Vh:Cd ratio of <2.0 are treated with ANB033 or placebo for 4 weeks and are assed at Week 12 via biopsy
- Top-line Phase 1b data for both cohorts anticipated in Q4 2026
- Phase 1b trial in eosinophilic esophagitis initiated in Q1 2026
- 50-patient cohort assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1)
- Top-line Phase 1b data anticipated in 2027
Rosnilimab (Pathogenic T Cell Depleter)
- Presented Phase 2b data for rosnilimab, a pathogenic T cell depleter, in rheumatoid arthritis as a late-breaking oral presentation at American College of Rheumatology (ACR) Convergence 2025
- Presentation available on the Anaptys website at https://www.anaptysbio.com/technology/#anb030
- Anticipate providing an update on advancement of rosnilimab in RA, which would be funded by strategic or other outside sources of capital, in Q2 2026
ANB101 (BDCA2 modulator)
- Phase 1a trial in healthy volunteers ongoing
- To date, ANB101’s preclinical and Phase 1a data have suggested it is a more potent antibody with longer half-life resulting in deeper and more durable PD effect of pDC depletion vs. Biogen’s litifilimab, a competing BDCA2 modulator
FINANCIAL UPDATES
Cash Position and Stock Repurchase Program
- Cash and investments of $311.6 million as of Dec. 31, 2025
- Company has repurchased a total of 3,444,079 shares of common stock (11.2% shares outstanding) with $68.6 million as of Dec. 31, 2025, from its $175.0 million Stock Repurchase Program, which expires March 31, 2026
Fourth Quarter and Full Year 2025 Financial Results
- Cash, cash equivalents and investments totaled $311.6 million as of Dec. 31, 2025, compared to $420.8 million as of Dec. 31, 2024, for a decrease of $109.2 million due primarily to $130.6 million used for operating activities and $68.6 million in shares repurchased offset by $75.0 million received from GSK for Jemperli total sales for 2025 exceeding $1.0 billion and $15.0 million received from Vanda Pharmaceuticals for the license of imsidolimab.
- Collaboration revenue was $108.2 million and $234.6 million for the three and twelve months ended Dec. 31, 2025, compared to $43.1 million and $91.3 million for the three and twelve months ended Dec. 31, 2024. The increase was due primarily to Jemperli total sales for 2025 exceeding $1.0 billion which earned one-time $50 million and $75 million commercial sales milestones under our license agreement with GSK, Jemperli royalties increased 89% from $17.3 million to $32.7 million and 103% from $47.4 million to $96.0 million for the three and twelve months ended Dec. 31, 2025, and $9.7 million in revenue recognized for the Vanda license agreement.
- Research and development expenses were $25.6 million and $136.0 million for the three and twelve months ended Dec. 31, 2025, compared to $42.6 million and $163.8 million for the three and twelve months ended Dec. 31, 2024. The decrease for the three and twelve months ended Dec. 31, 2025, was primarily due to decreased development costs for ANB032, rosnilimab, and imsidolimab, offset by increased costs relating to the Phase 1 trials for ANB033 and ANB101. The R&D non-cash, stock-based compensation expense was $3.8 million and $17.1 million for the three and twelve months ended Dec. 31, 2025, as compared to $3.9 million and $14.8 million in the same period in 2024.
- General and administrative expenses were $15.8 million and $50.7 million for the three and twelve months ended Dec. 31, 2025, compared to $10.2 million and $42.4 million for the three and twelve months ended Dec. 31, 2024. The increase was due primarily to legal costs including the separation of the company and transaction costs associated with the Vanda Pharmaceuticals license agreement. The G&A non-cash, stock-based compensation expense was $4.7 million and $18.9 million for the three and twelve months ended Dec. 31, 2025, as compared to $4.3 million and $19.2 million in the same period in 2024.
- Net income was $49.6 million for the three months ended Dec. 31, 2025, or a net income per share of $1.79 and a net loss of $13.2 million for the twelve months ended Dec. 31, 2025, or a net loss per share of $0.46, compared to a net loss of $21.8 million and $145.2 million for the three and twelve months ended Dec. 31, 2024, or a net loss per share of $0.72 and $5.12.
About Anaptys
Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. The company’s pipeline includes rosnilimab, a pathogenic T cell depleter, which has completed a Phase 2b trial for rheumatoid arthritis; ANB033, a CD122 antagonist, in a Phase 1b trial for celiac disease and eosinophilic esophagitis; and ANB101, a BDCA2 modulator, in a Phase 1a trial. Anaptys has also discovered and out-licensed in financial collaborations multiple therapeutic antibodies, including a PD-1 antagonist (Jemperli (dostarlimab-gxly)) to GSK and an IL-36R antagonist (imsidolimab) to Vanda Pharmaceuticals. To learn more, visit www.AnaptysBio.com or follow us on LinkedIn.
Anaptys recently announced the intent to separate its biopharma operations from its substantial royalty assets by year-end 2026, enabling investors to align their investment philosophies and portfolio allocation with the strategic opportunities and financial objectives of each company. Learn more at https://ir.anaptysbio.com/news-releases/news-release-details/anaptys-announces-intent-separate-biopharma-operations.
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 initial data from ANB033's Phase 1b clinical trial in celiac disease and initial data from ANB033's Phase 1b clinical trial in eosinophilic esophagitis; expectations regarding the structure, infrastructure, timing and taxation of the proposed separation of companies; timing of paydown of financial obligations to Sagard; whether any partnership with rosnilimab will take place; the potential to receive any royalties or milestone payments from the Vanda Pharmaceuticals license agreement; the potential to receive any additional milestones or royalties from the GSK collaboration and timing therefor; and the projected cash runway for First Tracks Biotherapeutics. Statements including words such as “plan,” “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, the ability to effect the separation of companies as described herein 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 Executive Director, Investor Relations
858.732.0178 investors@anaptysbio.com
_______________________________________
- GSK Q4 2025 earnings call, 2/4/2026
- CEO Emma Walmsley, 2025 JP Morgan CEO Series fireside chat, 9/11/2025, “there's no change to our peak year sales overall ambition for Jemperli, that's for sure, which is far more than £2 billion.”; Converted from GBP to USD using Q3 2025 average exchange rate (1.35x)
- ~$250 million accrued to Sagard accruals by YE 2025 and assumes a ~10% quarter-over-quarter growth rate for Jemperli from Q4’25 through Q2’27 and milestone payments associated with filing ($5mm) and approval ($10mm) of dMMR rectal approval in the EU
AnaptysBio, Inc.
Consolidated Balance Sheets
(in thousands, except par value data)
| December 31, 2024 | |||||
|---|---|---|---|---|---|
| ASSETS | |||||
| Current assets: | |||||
| Cash and cash equivalents | 238,196 | $ | 123,080 | ||
| Receivables from collaborative partners | 33,850 | 40,765 | |||
| Short-term investments | 73,442 | 262,293 | |||
| Prepaid expenses and other current assets | 4,762 | 5,738 | |||
| Total current assets | 350,250 | 431,876 | |||
| Property and equipment, net | 1,370 | 1,849 | |||
| Operating lease right-of-use assets | 12,519 | 14,383 | |||
| Long-term investments | — | 35,470 | |||
| Other long-term assets | 256 | 256 | |||
| Total assets | 364,395 | $ | 483,834 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable | 3,871 | $ | 4,002 | ||
| Accrued expenses | 32,674 | 39,501 | |||
| Current portion of operating lease liability | 2,080 | 1,925 | |||
| Total current liabilities | 38,625 | 45,428 | |||
| Liability related to sale of future royalties | 276,528 | 353,426 | |||
| Operating lease liability, net of current portion | 12,032 | 14,112 | |||
| Stockholders’ equity: | |||||
| Preferred stock, 0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at December 31, 2025 and December 31, 2024, respectively | — | — | |||
| Common stock, 0.001 par value, 500,000 shares authorized, 28,019 shares and 30,473 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | 28 | 30 | |||
| Additional paid in capital | 809,765 | 829,860 | |||
| Accumulated other comprehensive (loss) gain | (24 | ) | 305 | ||
| Accumulated deficit | (772,559 | ) | (759,327 | ) | |
| Total stockholders’ equity | 37,210 | 70,868 | |||
| Total liabilities and stockholders’ equity | 364,395 | $ | 483,834 |
All values are in US Dollars.
AnaptysBio, Inc.
Consolidated Statements of Operations and Comprehensive Income (Loss)
(in thousands, except per share data)
| Three Months Ended<br>December 31, | Year Ended<br>December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |||||||||
| Collaboration revenue | $ | 108,249 | $ | 43,113 | $ | 234,603 | $ | 91,280 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 25,559 | 42,589 | 135,970 | 163,840 | ||||||||
| General and administrative | 15,789 | 10,194 | 50,737 | 42,389 | ||||||||
| Total operating expenses | 41,348 | 52,783 | 186,707 | 206,229 | ||||||||
| Income (loss) from operations | 66,901 | (9,670 | ) | 47,896 | (114,949 | ) | ||||||
| Other (expense) income, net: | ||||||||||||
| Interest income | 2,508 | 5,263 | 13,499 | 19,794 | ||||||||
| Non-cash interest expense for the sale of future royalties | (19,711 | ) | (17,404 | ) | (79,893 | ) | (50,087 | ) | ||||
| Other (expense) income, net | (3 | ) | 21 | 5,430 | 14 | |||||||
| Total other (expense) income, net | (17,206 | ) | (12,120 | ) | (60,964 | ) | (30,279 | ) | ||||
| Gain (loss) before income taxes | 49,695 | (21,790 | ) | (13,068 | ) | (145,228 | ) | |||||
| (Provision) benefit for income taxes | (81 | ) | 6 | (164 | ) | (3 | ) | |||||
| Net income (loss) | 49,614 | (21,784 | ) | (13,232 | ) | (145,231 | ) | |||||
| Other comprehensive income (loss): | ||||||||||||
| Unrealized (loss) gain on available for sale securities | (71 | ) | (454 | ) | (329 | ) | 1,102 | |||||
| Comprehensive income (loss) | $ | 49,543 | $ | (22,238 | ) | $ | (13,561 | ) | $ | (144,129 | ) | |
| Net income (loss) per common share: | ||||||||||||
| Basic | $ | 1.79 | $ | (0.72 | ) | $ | (0.46 | ) | $ | (5.12 | ) | |
| Diluted | $ | 1.58 | $ | (0.72 | ) | $ | (0.46 | ) | $ | (5.12 | ) | |
| Weighted-average number of shares outstanding: | ||||||||||||
| Basic | 27,789 | 30,448 | 28,758 | 28,382 | ||||||||
| Diluted | 31,343 | 30,448 | 28,758 | 28,382 |
EX-99.2
