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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: February 12, 2025
(Date of earliest event reported)
ANAPTYSBIO, INC.
(Exact Name of Registrant as Specified in Charter)
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Delaware | 001-37985 | 20-3828755 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
10770 Wateridge Circle, Suite 210,
San Diego, CA 92121
(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):
☐Written communication 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 communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communication 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:
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Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock, par value $0.001 per share | 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 (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 7.01. Regulation FD.
On February 12, 2025, AnaptysBio, Inc. (“AnaptysBio” or the “Company”) issued a press release announcing top-line data from rosnilimab’s Phase 2b clinical trial in rheumatoid arthritis (the “Top-Line Data”), a copy of which is attached hereto as Exhibit 99.1.
On February 12, 2025, AnaptysBio presented a slide presentation regarding the Top-Line Data, a copy of which is attached hereto as Exhibit 99.2.
The information in this Item 7.01, including Exhibits 99.1 and 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 8.01. Other Events.
On February 12, 2025, AnaptysBio announced the Top-Line Data from the global 424-patient Phase 2b RENOIR trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis (RA).
The Phase 2b RENOIR trial is evaluating the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of rosnilimab in patients with moderate-to-severe RA on background conventional disease-modifying antirheumatic drugs (cDMARDs) (e.g., methotrexate). The trial enrolled 424 patients with a mean baseline disease activity score -- 28 joints (DAS-28) C-Reactive Protein (CRP) score of 5.64 and mean baseline clinical disease activity index (CDAI) score of 37.7 across the U.S., Canada and Europe, who were either biologic or targeted synthetic DMARD (b/tsDMARD) naïve (n=250; 59%) or experienced (n=174; 41%). Patients classified as b/tsDMARD-experienced reported prior utilization of at least one biologic or targeted synthetic therapy, such as TNFα inhibitors, B cell inhibitors, selective costimulatory modulators or JAK inhibitors.
Patients were randomized to receive either 100mg of subcutaneous rosnilimab every four weeks (Q4W), 400mg Q4W, 600mg every two weeks (Q2W), or placebo. The primary endpoint was assessed at Week 12 and secondary endpoints were assessed at both Week 12 and Week 14. Following completion of the Week 14 visit, rosnilimab-treated patients who achieved CDAI low disease activity (LDA) of ≤ 10, continued their assigned treatment through Week 28 in a blinded, all-active treatment period.
Efficacy Endpoints
The trial achieved its primary endpoint of the mean change from baseline in DAS-28 CRP at Week 12 for all three doses of rosnilimab vs. placebo.
Rosnilimab achieved statistical significance in at least one dose and numerical superiority at all doses, including once monthly administration, on key secondary endpoints of ACR20, ACR50 and CDAI LDA at Week 12, even though higher than typical placebo rates were observed. Also, rosnilimab demonstrated the highest ever reported responses for these key secondary endpoints at Week 14. 69% of rosnilimab-treated patients achieved CDAI LDA at Week 14 and appear to show sustained CDAI LDA and ACR50 responses, as well as potentially deepening ACR70 responses out to Week 28.
Translational blood biomarker data, across all doses, showed similar immunological impact with robust on-target pharmacological activity in rosnilimab-treated patients that was not observed on placebo. Rosnilimab demonstrated rapid and sustained reduction of ~90% PD-1high T cells and ~50% of PD-1+ T cells, and an increase in total Tregs. Together, this resulted in a minimal impact on total T cell counts and favorable T cell composition reflective of healthy immune homeostasis. Additionally, a ~50% reduction in the mean CRP from baseline, an objective measure of inflammation, was observed in rosnilimab-treated patients through the entire trial period that was not observed on placebo.
At Week 14, 69% (71% of b/tsDMARD-naïve and 66% of b/tsDMARD-experienced) or 220 of the 318 rosnilimab-treated patients across all doses achieved CDAI LDA and were eligible to remain on continued active therapy
through Week 28. As of the Dec. 10, 2024 data cutoff, these patients appear to show sustained CDAI LDA and ACR50 responses and potentially deepening ACR70 responses out to Week 28. This portion of the ongoing trial remains blinded, and complete Week 28 data are anticipated in Q2 2025.
Safety Data
Consistent with prior studies, these rosnilimab Phase 2b data demonstrate a favorable safety and tolerability profile. The data through Week 12 show:
•No malignancies
•No MACE
•No elevation of serious infections vs. placebo
•No anaphylaxis or systemic hypersensitivity associated with rosnilimab
•Low incidence of injection site reactions and similar to placebo
As of the Dec. 10, 2024 data cutoff, the safety profile for patients who achieved CDAI LDA through Week 14, and continued active therapy up to Week 28, remains consistent with the reported profile of all rosnilimab-treated patients through Week 12.
Forward-Looking Statements
This Current Report 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 rosnilimab’s Phase 2b clinical trial in rheumatoid arthritis at Week 28 and Phase 2 clinical trial in ulcerative colitis; and whether current trends in partial 28 Week data will be maintained once complete Week 28 data becomes available. 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 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 report, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
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Exhibit Number | Exhibit Title or Description |
| Press release issued by AnaptysBio, Inc. regarding the Top-Line Data, dated February 12, 2025. |
| Presentation regarding Top-Line Data, presented February 12, 2025. |
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.
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| AnaptysBio, Inc. |
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Date: February 12, 2025 | By: | /s/ Eric Loumeau |
| | Name: Eric Loumeau |
| | Title: Chief Legal Officer |
Anaptys Announces Rosnilimab Achieved Positive Results in RA Phase 2b Trial and Highest Ever Reported CDAI LDA Response Over 6 Months • Achieved statistical significance on primary endpoint at Week 12 on mean change from baseline DAS- 28 CRP across all rosnilimab doses vs. placebo • Achieved statistical significance on key secondary endpoints at Week 12 on ACR20, ACR50 and CDAI LDA • Demonstrated highest ever reported responses on key secondary endpoints at Week 14 on ACR20, ACR50, ACR70 and CDAI LDA • 69% of rosnilimab-treated patients achieved CDAI LDA at Week 14 and appear to show sustained CDAI LDA and ACR50 responses and potentially deepening ACR70 responses out to Week 28 • Robust pharmacological activity observed in reduction of PD-1high T cells, increase in total Tregs and reduction of CRP across all doses • Rosnilimab was safe and well tolerated with similar adverse event rates vs. placebo • Full Week 28 and additional translational RA data in Q2 2025 • Top-line Week 12 Phase 2 ulcerative colitis data for rosnilimab, now in Q4 2025 • Conference call and webcast to discuss results today at 8:30am ET SAN DIEGO, Feb. 12, 2025 — AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced statistically significant Week 12 data from the global 424-patient Phase 2b RENOIR trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis (RA). Rosnilimab was safe and well tolerated with similar adverse event rates vs. placebo. The Phase 2b RENOIR trial is evaluating the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of rosnilimab in patients with moderate-to-severe RA on background conventional disease- modifying antirheumatic drugs (cDMARDs) (e.g., methotrexate). The trial enrolled 424 patients with a mean baseline disease activity score -- 28 joints (DAS-28) C-Reactive Protein (CRP) score of 5.64 and mean baseline clinical disease activity index (CDAI) score of 37.7 across the U.S., Canada and Europe, who were either biologic or targeted synthetic DMARD (b/tsDMARD) naïve (n=250; 59%) or experienced (n=174; 41%). Patients classified as b/tsDMARD-experienced reported prior utilization of at least one biologic or targeted synthetic therapy, such as TNFα inhibitors, B cell inhibitors, selective costimulatory modulators or JAK inhibitors. Patients were randomized to receive either 100mg of subcutaneous rosnilimab every four weeks (Q4W), 400mg Q4W, 600mg every two weeks (Q2W), or placebo. The primary endpoint was assessed at Week 12 and secondary endpoints were assessed at both Week 12 and Week 14. Following completion of the Week 14 visit, rosnilimab-treated patients who achieved CDAI low disease activity (LDA) of ≤ 10, continued their assigned treatment through Week 28 in a blinded, all-active treatment period. Rosnilimab Achieved Primary and Secondary Efficacy Endpoints
The trial achieved its primary endpoint of the mean change from baseline in DAS-28 CRP at Week 12 for all three doses of rosnilimab vs. placebo. Rosnilimab achieved statistical significance in at least one dose and numerical superiority at all doses, including once monthly administration, on key secondary endpoints of ACR20, ACR50 and CDAI LDA at Week 12, even though higher than typical placebo rates were observed. Also, rosnilimab demonstrated the highest ever reported responses for these key secondary endpoints at Week 14. 69% of rosnilimab-treated patients achieved CDAI LDA at Week 14 and appear to show sustained CDAI LDA and ACR50 responses, as well as potentially deepening ACR70 responses out to Week 28. Translational blood biomarker data, across all doses, showed similar immunological impact with robust on- target pharmacological activity in rosnilimab-treated patients that was not observed on placebo. Rosnilimab demonstrated rapid and sustained reduction of ~90% PD-1high T cells and ~50% of PD-1+ T cells, and an increase in total Tregs. Together, this resulted in a minimal impact on total T cell counts and favorable T cell composition reflective of healthy immune homeostasis. Additionally, a ~50% reduction in the mean CRP from baseline, an objective measure of inflammation, was observed in rosnilimab-treated patients through the entire trial period that was not observed on placebo. “We are excited about these trial results and the impact they could have on patients living with RA. Rosnilimab is safe and well tolerated with the highest ever reported CDAI low disease activity at ~3 months that, to date, is sustained and potentially deepening over 6 months. These findings, further supported by objective translational data, surpass our target product profile in the ~$20 billion U.S. RA market,” said Daniel Faga, president and chief executive officer of Anaptys. “In Q2 2025, we will report full six-month data and additional translational data that we expect will further substantiate rosnilimab’s impact on restoring healthy immune homeostasis in RA and additional diseases, such as ulcerative colitis (UC). We also look forward to reporting top-line Week 12 Phase 2 data for rosnilimab in UC, now in Q4 2025.” Results for trial endpoints at Week 12 and Week 14 were as follows: Efficacy Measures Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W Placebo O ve ra ll po pu la tio n (n =4 24 ) Primary Endpoint n=106 n=107 n=105 n=106 Mean change in DAS28-CRP Week 12 -2.06 0.0092 -2.12 0.0016 -2.06 0.0062 -1.69 Week 14 -2.52 <0.0001 -2.57 <0.0001 -2.65 <0.0001 -1.39 Secondary Endpoints n=106 n=107 n=105 n=106 CDAI ≤ 10 (LDA) Week 12 46% 0.0224 50% 0.0053 38% 0.2982 31% Week 14 69% <0.0001 68% <0.0001 71% <0.0001 23% ACR20 Week 12 69% 0.0149 70% 0.0082 75% 0.0005 53% Week 14 82% <0.0001 79% <0.0001 81% <0.0001 47% ACR50 Week 12 44% 36% 47% 33%
At Week 14, 69% (71% of b/tsDMARD-naïve and 66% of b/tsDMARD-experienced) or 220 of the 318 rosnilimab-treated patients across all doses achieved CDAI LDA and were eligible to remain on continued active therapy through Week 28. As of the Dec. 10, 2024 data cutoff, these patients appear to show sustained CDAI LDA and ACR50 responses and potentially deepening ACR70 responses out to Week 28. This portion of the ongoing trial remains blinded, and complete Week 28 data are anticipated in Q2 2025. “In RA, there is an urgent need for innovative therapies such as rosnilimab, which have the potential of reducing the debilitating effects of this disease for a longer period of time for a broader range of patients,” said Jonathan Graf, M.D., professor of Medicine, Division of Rheumatology at the University of California, San Francisco and RENOIR investigator. “RA patients have an abnormal population of PD-1high expressing T cells circulating in their bloodstream and joints. I am strongly encouraged by these Phase 2 data, which support the hypothesis that by depleting these PD-1high expressing T cells and agonizing the remaining PD-1+ T cells, rosnilimab offers a fundamentally different approach to treating RA by resetting the immune system, potentially offering more durable relief of symptoms and disease modification.” Rosnilimab Safe and Well Tolerated with AEs Similar Across Treatment Groups and Placebo Consistent with prior studies, these rosnilimab Phase 2b data demonstrate a favorable safety and tolerability profile. The data through Week 12 show: • No malignancies • No MACE 0.0887 0.5961 0.0432 Week 14 59% <0.0001 59% <0.0001 67% <0.0001 26% ACR70 Week 12 22% 0.4903 22% 0.5090 22% 0.4734 18% Week 14 42% <0.0001 41% <0.0001 48% <0.0001 10% b/ ts D M A R D -n aï ve (n =2 50 ) Secondary Endpoints n=62 n=62 n=64 n=62 CDAI ≤ 10 (LDA) Week 14 74% <0.0001 65% <0.0001 75% <0.0001 23% ACR20 Week 14 81% <0.0001 81% <0.0001 88% <0.0001 48% ACR50 Week 14 65% <0.0001 61% <0.0001 73% <0.0001 27% ACR70 Week 14 50% <0.0001 45% <0.0001 53% <0.0001 13% b/ ts D M A R D - ex pe ri en ce d (n =1 74 ) Secondary Endpoints n=44 n=45 n=41 n=44 CDAI ≤ 10 (LDA) Week 14 61% <0.0001 73% <0.0001 63% <0.0001 23% ACR20 Week 14 84% <0.0001 76% <0.0023 71% <0.0145 46% ACR50 Week 14 52% <0.0026 56% <0.0007 56% <0.0008 23% ACR70 Week 14 30% <0.0038 36% <0.0004 39% <0.0002 7%
• No elevation of serious infections vs. placebo • No anaphylaxis or systemic hypersensitivity associated with rosnilimab • Low incidence of injection site reactions and similar to placebo The table below shows safety data for all patients through Week 12: Adverse Events, n Rosnilimab 100mg Q4W (n=105) Rosnilimab 400mg Q4W (n=107) Rosnilimab 600mg Q2W (n=105) Placebo (n=106) Patients with any AE, n (%) 51 (48%) 48 (45%) 38 (36%) 36 (34%) Any SAE1 1 (1%) 1 (1%) 3 (3%) 1 (1%) Any Drug-Related SAE 0 0 0 1 (1%) Severe AE2 1 (1%) 0 4 (4%) 2 (2%) Drug-Related AE 13 (12%) 18 (17%) 17 (16%) 18 (17%) Infections 24 (23%) 21 (20%) 12 (11%) 14 (13%) AE Leading to Treatment Discontinuation 1 (1%) 2 (2%) 2 (2%) 1 (1%) Patients with any AE ≥ 5%, n Headache 7 (7%) 6 (6%) 4 (4%) 4 (4%) Upper respiratory tract infection 7 (7%) 2 (2%) 3 (3%) 1 (1%) 1. SAEs (severe unless otherwise noted): pneumonia – mild (100 mg Q4W); meniscus tear – moderate (400 mg Q4W); anaphylaxis from wasp sting, ureter stone, and cholecystitis/pericardial effusion (600mg Q2W); cellulitis/diarrhea (placebo) 2. Severe AE (excluding SAEs): flu (100mg Q4W); RA flare (600mg Q2W); macular degeneration/retinal hemorrhage (placebo) As of the Dec. 10, 2024 data cutoff, the safety profile for patients who achieved CDAI LDA through Week 14, and continued active therapy up to Week 28, remains consistent with the reported profile of all rosnilimab- treated patients through Week 12. "Despite multiple advances in the treatment of patients with RA, a large number remain difficult to treat. Unfortunately, no new drug classes have been approved for RA in the last decade. As we continue to advance our understanding of RA and look to reduce long-term damage to the body’s joints and organs caused by this disease, it is imperative that we develop treatment options with different modes of action, that are not only effective but also safe for long-term use,” said Paul Emery, M.D., Versus Arthritis professor of rheumatology at the University of Leeds and Leeds Biomedical Research Centre, UK. “Rosnilimab’s efficacy data paired with a favorable safety and tolerability profile present a promising new option for people living with RA." "Today’s data offer new hope for patients living with RA and I am particularly encouraged by the combined efficacy and safety profile in both b/tsDMARD-naïve and -experienced patients. This advance in our understanding of RA would not have been possible without the patients and clinicians who participated in this important trial, and we are sincerely grateful,” added Paul Lizzul, M.D., Ph.D., chief medical officer of Anaptys. “Importantly, these positive clinical and translational data validate our scientific approach to target the PD-1 co-inhibitory receptor on activated immune cells in RA, as well as other heterogeneous, systemic autoimmune and inflammatory diseases, including UC, that would benefit from this novel approach targeting a central node of inflammation.”
Further details are available on: Trial Details | ClinicalTrials.gov About the Primary and Secondary Endpoints The primary endpoint of mean change in DAS28-CRP at Week 12 is calculated based on differential weighting of individual measures, including the patient’s general health, CRP and a count of 28 swollen and tender joints, with a score ranging from 0 to 9.4. Secondary endpoints include the CDAI score, a composite assessment used to measure the severity of RA based on the sum of four assessment tools; the number of swollen and tender joints, the patient’s global disease activity index, and the physician’s global disease activity index. The score ranges from 0 to 76, with a score ≤ 10 is the threshold for LDA. Additionally, secondary endpoint ACR20/50/70 responses are used to measure change in RA disease activity. For example, an ACR50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. ACR20 and ACR70 responses require 20% and 70% reductions, respectively, across the measures listed above. About Rosnilimab Rosnilimab is a novel therapeutic antibody that directly targets PD-1, a co-inhibitory receptor preferentially expressed on the surface of activated T cells, which broadly impacts the pathogenic drivers of inflammatory diseases such as RA and UC. Rosnilimab is a targeted therapy designed to deplete PD-1high T cells and agonize the remaining PD-1+ T cells to restore the immune system back to a state of homeostasis. This is anticipated to result in specific immunological outcomes in both inflamed tissue and the periphery, such as reduction in T cell proliferation, migration and cytokine secretion, and reduction of plasma cell generation and autoantibody levels. Rosnilimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. Efficacy and safety data from this trial, including translational data, will be presented at future medical meetings. Anaptys Investor Call Anaptys management will host an investor call and live webcast, with an accompanying slide presentation, to review results of the data from the Phase 2b RA trial, today, Feb. 12, 2025, at 8:30am ET / 5:30am PT. A live webcast of the call will be available on the Anaptys website at: https://ir.anaptysbio.com/events. A replay of the webcast will be available for at least 30 days following the event. About Anaptys
Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. Its lead program, rosnilimab, a depleter and agonist targeting PD- 1+ T cells, is in a Phase 2b trial for the treatment of rheumatoid arthritis and in a Phase 2 trial for the treatment of ulcerative colitis. Other antibodies in its portfolio include ANB033, an anti-CD122 antagonist, in a Phase 1 trial and ANB101, a BDCA2 modulator, entering a Phase 1 trial. 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. 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 rosnilimab’s Phase 2b clinical trial in rheumatoid arthritis at Week 28 and Phase 2 clinical trial in ulcerative colitis; and whether current trends in partial 28 Week data will be maintained once complete Week 28 data becomes available. 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 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
Feb. 12, 2025 Rosnilimab: Phase 2b Top-line Data in RA
This presentation and any accompanying oral presentation 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 rosnilimab’s Phase 2b clinical trial in rheumatoid arthritis at Week 28 and Phase 2 clinical trial in ulcerative colitis; whether current trends in rosnilimab's partial 28 Week data in the rheumatoid arthritis Phase 2b clinical trial will be maintained once complete Week 28 data becomes available; timing of initiation of ANB101's Phase 1 clinical trial; the potential to receive any additional milestones and royalties from the GSK collaboration; and the Company's projected cash runway. 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 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 presentation, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Certain information contained in this presentation may be derived from information provided by industry sources. The Company believes such information is accurate and that the sources from which it has been obtained are reliable. However, the Company cannot guarantee the accuracy of, and has not independently verified, such information. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products. 2 Safe harbor statement
TOPIC SPEAKER Introduction and Summary Dan Faga Chief Executive Officer Phase 2b Top-line Data Readout Paul Lizzul, M.D., Ph.D. Chief Medical Officer Moving Forward Dan Faga Q&A Dan Faga Paul Lizzul Martin Dahl, Ph.D. SVP, Research Agenda 3
• Statistically significant on primary endpoint (DAS28-CRP) at Week 12 as well as on key secondary endpoints at both Week 12 and Week 14 • Absolute Week 12 and Week 14 data surpass our benchmarked Phase 2 target product profile • CDAI LDA responders3 appear to show sustained CDAI LDA and ACR50 and potentially deepening ACR70 responses out to Week 28 • Rosnilimab was safe and well tolerated 4 61% 52% 30% 73% 56% 36% 63% 56% 39% 58% 59% 37% 52% 50% 27% 43% 43% 23% 20% 30% 40% 50% 60% 70% 80% % o f P a ti e n ts Rosnilimab - 100mg Q4W Rosnilimab - 400mg Q4W Rosnilimab - 600mg Q2W Rinvoq Orencia Kevzara Bio-Experienced Patients: Absolute Rosnilimab Week 14 vs. Competitors H2H Week 24 Week 14 Week 24 Week 14 Week 24 Week 14 Week 24 CDAI LDA ACR50 ACR70 Legend 1 1 2 1. SELECT-CHOICE Phase 3 study; NRI data 2. ContRAst-3 Phase 3 study; Missing data in ContRAst-3 handled with multiple imputation method 3. Only Week 14 CDAI LDA responders initially randomized to rosnilimab were eligible to stay on treatment from Week 14 to Week 28; As of Dec. 10, 2024 CDAI = Clinical Diseases Activity Index; LDA = Low Disease Activity. Rosnilimab Week 14 efficacy is highest ever reported, surpassing all-active H2H comparator studies at Week 24
5 Screening Period (up to 35 days) Blinded Placebo-Controlled Treatment Period (12 weeks) Follow-Up Period (10 weeks) Blinded All-Active Treatment Period (16 weeks) Week -5 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 34 38 Visit V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 V13 V14 V15 V16 FUV1 FUV2 FUV3 Dosing EOT EOS Rosnilimab SC 100mg Q4W Rosnilimab SC 400mg Q4W Rosnilimab SC 600mg Q2W Placebo SC Rosnilimab SC 100mg Q4W Rosnilimab SC 400mg Q4W Rosnilimab SC 600mg Q2W N = 424 Randomized 1:1:1:1 Final Statistical Analysis Top-line Data 1Blinded study drug treatment will continue for active treatment group subjects that achieve Clinical Disease Activity Index (CDAI) low disease activity (CDAI ≤10) Active Eligibility Visit1 Primary Statistical Analysis Note: All patients in trial (rosnilimab and placebo arms) are required to be on background cDMARD ClinicalTrials.gov: NCT06041269 Rosnilimab RENOIR Phase 2b in moderate-to-severe RA
6 Participant disposition through Week 12 *ITT – Intent-to-Treat (all randomized participants) ITT* (n=424) Placebo, n=106 Naïve – n=62 (59%) Experienced – n=44 (42%) Discontinued treatment, n=9 (8%) Primary reason: Adverse events, n=1 Disease progression, n=0 Withdrawal of consent, n=7 Other, n=1 Completed – n=97 Rosnilimab 100mg Q4W, n=106 Naïve – n=62 (59%) Experienced – n=44 (42%) Discontinued treatment, n=5 (5%) Primary reason: Adverse events, n=1 Disease progression, n=1 Withdrawal of consent, n=3 Other, n=0 Completed – n=101 Rosnilimab 400mg Q4W, n=107 Naïve – n=62 (58%) Experienced – n=45 (42%) Discontinued treatment, n=6 (6%) Primary reason: Adverse events, n=2 Disease progression, n=2 Withdrawal of consent, n=1 Other, n=1 Completed – n=101 Rosnilimab 600mg Q2W, n=105 Naïve – n=64 (61%) Experienced – n=41 (39%) Discontinued treatment, n=8 (8%) Primary reason: Adverse events, n=2 Disease progression, n=2 Withdrawal of consent, n=2 Other, n=2 Completed – n=97
7 Baseline Characteristic Placebo (n=106) 100mg Q4W (n=106) 400mg Q4W (n=107) 600mg Q2W (n=105) Overall (N=424) Age, years, mean (SD) 58 (11) 57 (10) 57 (12) 56 (11) 57 (11) Female, n (%) 83 (78%) 79 (75%) 79 (74%) 80 (76%) 321 (76%) Weight (kg), mean (SD) 78 (17) 78 (19) 81 (19) 77 (16) 78 (18) Geographic region, n (%) US Ex-US 35 (33%) 71 (67%) 34 (32%) 72 (68%) 35 (33%) 72 (67%) 26 (25%) 79 (75%) 130 (31%) 294 (69%) Race, n (%) White Black or African American Asian Other 102 (96%) 3 (3%) 0 (0%) 1 (1%) 102 (96%) 1 (<1%) 0 (0%) 3 (4%) 103 (96%) 4 (4%) 0 (0%) 0 (0%) 101 (96%) 4 (4%) 0 (0%) 0 (0%) 408 (96%) 12 (3%) 0 (0%) 4 (1%) Duration of disease, years, mean (SD) 11 (9) 11 (10) 9 (8) 10 (9) 10 (9) DAS28-CRP, mean (SD) 5.7 (0.8) 5.6 (0.8) 5.7 (0.9) 5.7 (0.8) 5.6 (0.8) CDAI, mean (SD) CDAI >22, n (%) 37.9 (10.2) 101 (95%) 37.2 (10.6) 101 (95%) 37.1 (10.6) 102 (95%) 38.6 (11) 100 (95%) 37.7 (10.6) 404 (95%) TJC68, mean (SD) 23 (13) 22 (12) 22 (12) 23 (13) 22 (12) SJC66, mean (SD) 14 (7) 15 (7) 14 (7) 16 (9) 15 (8) CRP, mean (SD) 16 (22) 17 (20) 21 (26) 19 (28) 18 (24) Baseline disease characteristics and demographics DAS28-CRP – Disease Activity Score 28-C-reactive protein; CDAI – Clinical Disease Activity Index; TJC68 – tender joint count, 68 joints; SJC66 – swollen joint count, 66 joints; CRP – high-sensitivity C-reactive protein
Black box warnings for increasing SAE incidence of commercial products have not impeded blockbuster sales Black box warning ~30% infection rate vs. 28% placebo5 ~0.7% MACE rate vs. 0.4% placebo5 ~54% infection rate vs. 48% placebo5 ~0.2% MACE rate vs. 0.5% placebo5 Black box warning ~20% infection rate vs. 18% placebo5 ~3.4% MACE rate vs. 2.5% placebo5 ~4.2% malignancy rate vs. 2.9% placebo5 Black box warning ~39% infection rate vs. 34% placebo5 ~1.7% MACE rate vs. 1.3% placebo5 8 Increased co-morbidity rate in RA patients vs. general population 2-3x DVT, PE, and MACE Risk1,2 2x Infection Rate1 2x Malignancy Rate3 $4.5B RA sales4 $3.6B RA sales4 $2.3B RA sales4 ~$1B RA sales 1. Avina-Zubieta et al., A&R, 2008, 2. Fazal et al., BMC Rheumatology, 2024, 3. Smitten et al., ART, 2008, 4. Evaluate Pharma 2023 WW RA sales, 5. Phase 3 registrational data from product labels RA patients have significant co-morbidities which are further exacerbated with treatment
9 Adverse Events through Week 12, n (%) Placebo (n=106) 100mg Q4W (n=106) 400mg Q4W (n=107) 600mg Q2W (n=105) Participants with any AE, n (%) 36 (34%) 51 (48%) 48 (45%) 38 (36%) Any SAE1 1 (1%) 1 (1%) 1 (1%) 3 (3%) Any Drug-Related SAE 1 (1%) 0 (0%) 0 (0%) 0 (0%) Severe AE2 2 (2%) 1 (1%) 0 (0%) 4 (4%) Drug-Related AE 18 (17%) 13 (12%) 18 (17%) 17 (16%) Infections 14 (13%) 24 (23%) 21 (20%) 12 (11%) AE Leading to Treatment Discontinuation 1 (1%) 1 (1%) 2 (2%) 2 (2%) Participants with any AEs >5%, n Headache 4 (4%) 7 (7%) 6 (6%) 4 (4%) Upper respiratory tract infection 1 (1%) 7 (7%) 2 (2%) 3 (3%) • No malignancies • No MACE • No elevation of serious infections vs. placebo • No anaphylaxis or systemic hypersensitivity associated with rosnilimab • Low incidence of injection site reactions and similar to placebo Safety profile up to Week 28 remains consistent with reported profile through Week 12 1. SAEs (severe unless otherwise noted): pneumonia – mild (100 mg Q4W); meniscus tear – moderate (400 mg Q4W); anaphylaxis from wasp sting, ureter stone, and cholecystitis/pericardial effusion (600mg Q2W) and cellulitis/diarrhea (placebo) 2. Severe AE (excluding SAEs): flu (100mg Q4W); RA flare (600mg Q2W); macular degeneration/retinal hemorrhage (placebo) Rosnilimab was safe and well tolerated with similar adverse event rates vs. placebo
10 -100% -80% -60% -40% -20% 0% 20% 40% 60% C el l C o u n t (% C h a n g e fr o m B a se li n e) PD-1high T Cells PD-1+ T Cells Total Treg Total T Cell Representative Rosnilimab T Cell Impact Overall Population – 400mg Q4W1 Wk0 Wk6 Wk12 10-wk off-drug follow-up Translational biomarker data in the periphery show clear on-target pharmacological activity Placebo T Cell Impact Overall Population – Placebo Rosnilimab demonstrated – • Rapid and sustained reduction of ~90% PD- 1high T cells including Tph cells regardless of baseline cell count • Few PD-1+ Tregs were present and were reduced proportionally to PD-1+ T cells overall • Minimal impact on total T cells with an increase in total Tregs Supports favorable T cell composition reflective of immune homeostasis 0 20 40 60 C el l C o u n t p er μ L in B lo o d Tph Impact Overall Population2 Wk0 Wk12 Wk0 Wk12 -100% -80% -60% -40% -20% 0% 20% 40% 60% C el l C o u n t (% C h a n g e fr o m B a se li n e) PD-1high T Cells PD-1+ T Cells Total Treg Total T Cell Wk28 Wk0 Wk6 Wk12 10-wk off-drug follow-up Tph – T peripheral helper cell defined as CD3+ CD4+ CD45RA- PD-1high CXCR5-, ***p<0.001 1. Rosnilimab 400mg Q4W dose is representative of all other doses 2. Pooled rosnilimab data Placebo Rosnilimab No reduction of PD-1+ T cells in placebo *** T ra n sl a ti o n a l
11 -1.0 -9.7 -10.1 -7.6 -2.3 -9.6 -10.0 -9.7 -12.0 -10.0 -8.0 -6.0 -4.0 -2.0 0.0 Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W M e a n C h a n g e f ro m B a se li n e • Clear and consistent on target reduction at all rosnilimab doses • No immunological change on placebo at both Week 12 or Week 14 • Decrease of CRP demonstrates objective reduction of inflammation beyond directly targeting T cells CRP – high-sensitivity C-reactive protein, ****p<0.0001, ***p<0.001, **p<0.01, *p<0.05 Week 12 Week 14 Week 12 p<0.0001 Week 14 p<0.0001 Week 12 p=0.0002 Week 14 p=0.0013 Week 12 p=0.0030 Week 14 p=0.0005 **** **** *** ** ** *** Rosnilimab significantly decreased CRP demonstrating an objective reduction of inflammation Mean Change in CRP Overall Population (n=424) S e co n d a ry E n d p o in t
12 -3.0 -2.5 -2.0 -1.5 -1.0 -0.5 0.0 Week 0 Week 2 Week 4 Week 6 Week 8 Week 10 Week 12 Week 14 M e a n C h a n g e f ro m B a se li n e • All rosnilimab doses statistically significant at Week 12 • All rosnilimab doses continue to improve into Week 14 with no evidence of flattening • Following Week 14 visit, placebo patients proceeded to post treatment follow-up Placebo Rosnilimab - 100mg Q4W Rosnilimab - 400mg Q4W Rosnilimab - 600mg Q2W DAS28-CRP based on differential weighting of individual measures, including patient’s general health, CRP and a count of 28 swollen and tender joints, with a score ranging from 0 to 9.4. ****p<0.0001, ***p<0.001, **p<0.01, *p<0.05 P ri m a ry E n d p o in t ** Week 12 statistical significance • 600mg Q2W: p=0.0062 • 400mg Q4W: p=0.0016 • 100mg Q4W: p=0.0092 ** ** * * **** **** **** Mean Change in DAS28-CRP Over Time Overall Population (n=424) Rosnilimab met primary endpoint of mean change from baseline in DAS28-CRP at Week 12 for all active doses
13 31% 46% 50% 38% 0% 10% 20% 30% 40% 50% 60% Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W % o f P a ti e n ts • Physicians minimally seek to achieve LDA by 6-months • Approximately half of rosnilimab-treated patients achieved LDA by Week 12 CDAI, a compositive assessment, is used to measure the severity of RA based on the sum of four assessment tools: the number of swollen and tender joints, the patient’s global disease activity index, and the physician’s global disease activity index. The score ranges from 0 to 76, with a score ≤ 10 is the threshold for LDA. ****p<0.0001, ***p<0.001, **p<0.01, *p<0.05 Statistically significant clinically meaningful benefit was observed within 3-months for majority of rosnilimab patients 53% 69% 70% 75% 0% 10% 20% 30% 40% 50% 60% 70% 80% Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W % o f P a ti e n ts n=33/106 n=49/106 p=0.0224 n=53/107 p=0.0053 n=40/105 p=0.2982 n=56/106 n=73/106 p=0.0149 n=75/107 p=0.0082 n=79/105 p=0.0005 *** ** * ** * S e co n d a ry E n d p o in t CDAI LDA of ≤ 10 at Week 12 Overall Population (n=424) ACR20 at Week 12 Overall Population (n=424)
14 33% 44% 36% 47% 0% 10% 20% 30% 40% 50% 60% 70% 80% Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W % o f P a ti e n ts 27% 65% 61% 73% 0% 10% 20% 30% 40% 50% 60% 70% 80% Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W % o f P a ti e n ts 23% 52% 56% 56% 0% 10% 20% 30% 40% 50% 60% 70% 80% Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W % o f P a ti e n ts ACR50 at Week 12 ACR50 at Week 14 ACR50 at Week 14 18% 22% 22% 22% 0% 10% 20% 30% 40% 50% 60% Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W % o f P a ti e n ts 13% 50% 45% 53% 0% 10% 20% 30% 40% 50% 60% Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W % o f P a ti e n ts 7% 30% 36% 39% 0% 10% 20% 30% 40% 50% 60% Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W % o f P a ti e n ts ACR50/70 - requires a patient to have a 50%/70% reduction in the number of swollen and tender joints, and a reduction of 50%/70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. ****p<0.0001, ***p<0.001, **p<0.01, *p<0.05 ACR70 at Week 12 ACR70 at Week 14 ACR70 at Week 14 Overall Population Naïve Population Experienced Population Consistent with DAS28 trends, ACR50/70 responses continue to materially deepen beyond Week 12 regardless of prior therapy n=35/106 n=47/106 p=0.0887 n=39/107 p=0.5961 n=49/105 p=0.0432 n=17/62 n=40/62 p<0.0001 n=38/62 p<0.0001 n=47/64 p<0.0001 n=10/44 n=23/44 p=0.0026 n=25/45 p=0.0007 n=23/41 p=0.0008 n=19/106 n=23/106 p=0.4903 n=23/107 p=0.5090 n=23/105 p=0.4734 n=8/62 n=31/62 p<0.0001 n=28/62 p<0.0001 n=34/64 p<0.0001 n=3/44 n=13/44 p=0.0038 n=16/45 p=0.0004 n=16/41 p=0.0002 **** **** **** **** **** **** *** *** *** *** ** ** *
0% 20% 40% 60% 80% 100% A C R 5 0 Wk0 Wk2 Wk4 Wk6 Wk8 Wk10 Wk12 Wk14 Wk16 W18 Wk20 Wk22 Wk24 Wk26 Wk28 100mg Q4W n=73 n=34 400mg Q4W n=75 n=34 600mg Q4W n=74 n=33 0% 20% 40% 60% 80% 100% A C R 7 0 Wk0 Wk2 Wk4 Wk6 Wk8 Wk10 Wk12 Wk14 Wk16 W18 Wk20 Wk22 Wk24 Wk26 Wk28 Completers as of Dec. 10th 100mg Q4W n=73 n=34 400mg Q4W n=75 n=34 600mg Q4W n=74 n=33 Trial still ongoing ACR50 Responses Over Time Overall Population, CDAI LDA Responders at Week 14 (n=220) ACR70 Responses Over Time Overall Population, CDAI LDA Responders at Week 14 (n=220) Trendline S e co n d a ry E n d p o in t Trendline As of the Dec. 10, 2024 data cutoff, this portion of the trial remains blinded and ongoing, and complete Week 28 data are anticipated in Q2 2025 Trial still ongoing Completers as of Dec. 10th 69% of patients achieved CDAI LDA at Week 14 and appear to show sustained ACR50 and potentially deepening ACR70 responses 15
-3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 M e a n C h a n g e f ro m B a se li n e f o r D A S 2 8 -C R P Wk0 Wk2 Wk4 Wk6 Wk8 Wk10 Wk12 Wk14 Wk16 W18 Wk20 Wk22 Wk24 Wk26 Wk28 100mg Q4W n=73 n=34 400mg Q4W n=75 n=34 600mg Q4W n=74 n=33 Mean Change in DAS28-CRP Over Time Overall Population, CDAI LDA Responders at Week 14 (n=220) P ri m a ry E n d p o in t As of the Dec. 10, 2024 data cutoff, this portion of the trial remains blinded and ongoing, and complete Week 28 data are anticipated in Q2 2025 Trial still ongoing Completers as of Dec. 10th 69% of patients achieved CDAI LDA at Week 14 and appear to show sustained DAS28-CRP responses 16
Screening Period (up to 35 days) Blinded Placebo-Controlled Treatment Period (12 weeks) Follow-Up Period (10 weeks) Blinded All-Active Treatment Period (16 weeks) Week -5 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 34 38 Rosnilimab SC 100mg Q4W Rosnilimab SC 400mg Q4W Rosnilimab SC 600mg Q2W Placebo SC Rosnilimab SC 100mg Q4W Rosnilimab SC 400mg Q4W Rosnilimab SC 600mg Q2W N = 424 Randomized 1:1:1:1 Final Statistical Analysis Next steps for rosnilimab in RA Primary Statistical Analysis Active Eligibility Visit1 1Blinded study drug treatment will continue for active treatment group subjects that achieve Clinical Disease Activity Index (CDAI) low disease activity (CDAI ≤10) At Week 14, 69% (71% of bio-naive and 66% of bio- experienced) or 220 of the 318 rosnilimab patients, across all doses, were CDAI LDA responders CDAI LDA responders appear to show sustained CDAI LDA and ACR50 and potentially deepening ACR70 responses out to Week 28 17Note: All patients in trial (rosnilimab and placebo arms) are required to be on background cDMARD Blinded all-active treatment period ongoing Later in 2025, report out • Phase 2b Week 28 data Q2 2025 • Additional translational data Q2 2025 • Present at a medical conference
1. Expected by 2028 (Evaluate 29 Nov 2022); 2. Market research conducted by Ambit in 2022; 3. Expected by 2028 (Evaluate 21 Aug 2023); 4. Phase 3 registrational data from product labels. RA and UC are large commercial markets with high unmet need Potential first new differentiated class in RA in over a decade RA trial increases confidence in UC trial outcome • Differentiated efficacy and safety data • Translational data • Depletion of PD-1high Tph cells • Decrease of CRP demonstrates objective reduction of inflammation beyond directly targeting T cells Rosnilimab has potential to treat wide range of systemic inflammatory diseases 18 Ulcerative colitis: • ~100,000 U.S. patients >$6.5bn U.S. sales, excluding TNF, market3 • 1/3 to 1/2 relapse within 1 year following remission on induction therapy4 Rheumatoid arthritis: • ~500,000 U.S. patients >$10bn U.S. sales in “bio-experienced” market1 • 20-25% cycle through all treatment classes and do not achieve low disease activity2
Actuals $31 $57 $73 $101 $137 $170 $190 $0 $50 $100 $150 $200 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Q4 2024 S al es ( in U S D m ill io ns ) Jemperli Quarterly Performance1 1. GSK earnings presentation, US dollar conversion 2. GSK analyst consensus as of 1/27/2025 converted to USD (1.25 conversion rate), GSK website - https://www.gsk.com/en-gb/investors/analyst-consensus/ 3. GSK June 2024 Oncology Management IR event converted to USD (1.25x conversion rate) $28 $176 $598 $839 $1,002 $1,121 $1,203 $1,265 $1,320 $1,320 $0 $550 $1,100 $1,650 $2,200 $2,750 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 S al es ( in U S D m ill io ns ) Jemperli Wall Street Consensus1,2 Potential GSK growth drivers • 1L “all-comers” endometrial: Approved in US mid-’24; in EU Jan. ‘25 • 2L+ NSCLC: Phase 3 COSTAR (Jemperli + cobolimab) OS data in H1 20251 • Locally advanced dMMR/MSI-H rectal cancer: granted FDA Breakthrough Therapy Designation • Substantial investment in additional Jemperli indications and combinations ongoing GSK Peak Revenue Guidance >$2.5 billion3 Anaptys strong capital position • $420MM YE 2024 cash • Cash runway: YE 2027 • Excludes GSK royalty and milestone potential for Jemperli and cobolimab • Excludes GSK $75MM milestone anticipated in 2025/2026 for Jemperli $1B annual WW sales Strong capital position with ~$420MM YE 2024 cash and significant GSK royalty upside potential 19
Antibody Program Therapeutic Indication Development Stage and Anticipated Milestones IND Enabling Phase 1 Phase 2 Phase 3 Rosnilimab (PD-1 depleter and agonist) Rheumatoid Arthritis Ulcerative Colitis ANB033 (CD122 antagonist) Inflammatory Diseases ANB101 (BDCA2 modulator) Inflammatory Diseases 20 Week 28 and translational data Q2 2025 Top-line P2 data Q4 2025 P1 initiated R&D event in 2025 Im m u n e C el l M od u la to rs P1 initiation Q1 2025 Leading pipeline of immune cell modulating antibodies with multiple 2025 catalysts
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Feb. 12, 2025 |
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ANAPTYSBIO, INC
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