Imsidolimab

Enrollment ongoing for global Phase 2b trial to treat atopic dermatitis (AD) with ANB032, our BTLA agonist; reiterating top-line data anticipated by year-end 2024Enrollment ongoing for global Phase 2b trial to treat rheumatoid arthritis (RA) and global Phase 2 trial to treat ulcerative colitis (UC) with rosnilimab, our PD-1 agonist; reiterating top-line data anticipated by mid 2025 and H1 2026, respectivelyIND submissions for ANB033 (anti-CD122 antagonist) and ANB101 (BDCA2 modulator) anticipated Q2 2024 and H2 2024, respectivelyAnnounced positive top-line GEMINI-2 Phase 3 trial results of imsidolimab, our IL-36R mAb, in generalized pustular psoriasisAnnounced a $50 million capped non-recourse royalty monetization from amended agreement with Sagard in exchange for additional Jemperli royalties SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported financial results for the first quarter ended March 31, 2024 and provided a business update. “This quarter, we continued to enroll patients globally across three Phase 2 trials for our two best-in-class checkpoint agonists: ANB032, our BTLA agonist, and rosnilimab, our PD-1 agonist. By year end, we anticipate sharing top-line data from ANB032's Phase 2b trial in atopic dermatitis, as well as moving our two preclinical immune cell modulators, ANB033 and ANB101, into clinical development,” said Daniel Faga, president and chief executive officer of Anaptys. “Additionally, we are excited to further strengthen our balance sheet by adding $50 million through a capped non-recourse monetization of Jemperli royalties as well as share incremental data from the imsidolimab Phase 3 program.” Updates on Wholly Owned Immune Cell Modulator Pipeline ANB032 (BTLA agonist antibody) Enrollment ongoing for global Phase 2b trial in moderate-to-severe AD 160-patient 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 periodReiterating top-line Week 14 data anticipated by year-end 2024 Primary endpoint in Phase 2b trial to be updated from absolute change in EASI score to EASI-75 at Week 14, which is a well-accepted registrational endpoint that enables more relevant comparisons to benchmark therapiesPresented posters on previously reported ANB032 preclinical data supporting the modulation of dendritic cell (DC) maturation and function and preclinical graft vs. host disease (GvHD) data at the 2024 American Academy of Dermatology (AAD) Annual Meeting in March 2024 and American Association of Immunologists (AAI) Annual Meeting in May 2024 Poster presentations are available here Rosnilimab (PD-1 agonist antibody) Enrollment ongoing for global Phase 2b trial in moderate-to-severe RA 420-patient 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 Reiterating top-line Week 12 data anticipated by mid 2025 Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC 130-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 Reiterating top-line Week 12 data anticipated by H1 2026 Presented poster on previously reported rosnilimab Phase 1 data and membrane proximal binding epitope to optimize PD-1 agonist signaling at the 19th Congress of the European Crohn’s and Colitis Organisation (ECCO) in February 2024 Poster presentation is available here ANB033 (anti-CD122 antagonist antibody) Plan to submit an Investigational New Drug (IND) application in Q2 2024 ANB101 (BDCA2 modulator antibody) Plan to submit an IND application in H2 2024 Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing Announced positive top-line results from its global GEMINI-1 and GEMINI-2 Phase 3 trials evaluating the safety and efficacy of investigational imsidolimab (IL-36R mAb) in patients with generalized pustular psoriasis (GPP) See full press release here Plan to submit a comprehensive data abstract for GEMINI-1 and GEMINI-2 to a H2 2024 medical meetingIntend to out-license imsidolimab in 2024 Updates on GSK Immuno-Oncology Financial Collaboration Announced a $50 million capped non-recourse monetization from amended agreement with Sagard in exchange for additional Jemperli (dostarlimab) royalties See full press release here GSK anticipates top-line data in H2 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 cancerGSK anticipates top-line data in 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 First Quarter Financial Results and Cash Runway Excluding the $50 million in proceeds from the capped non-recourse monetization of Jemperli royalties by Sagard, cash, cash equivalents and investments totaled $370.1 million as of March 31, 2024, compared to $417.9 million as of December 31, 2023, for a decrease of $36.9 million relating primarily to cash used for operating activities as well as a one-time non-operating cash payment of $10.9 million during the quarter. Reiterating cash runway through year-end 2026 Collaboration revenue was $7.2 million for the three months ended March 31, 2024, compared to $1.4 million for the three months ended March 31, 2023. The change is due primarily to increased royalties recognized for sales of Jemperli.Research and development expenses were $37.0 million for the three months ended March 31, 2024, compared to $35.0 million for the three months ended March 31, 2023. The increase was due primarily to development costs for rosnilimab, ANB032 and ANB033 offset by a decrease in development costs for imsidolimab. The R&D non-cash, stock-based compensation expense was $3.5 million for the three months ended March 31, 2024 as compared to $2.8 million in the same period in 2023.General and administrative expenses were $12.3 million for the three months ended March 31, 2024, compared to $10.8 million for the three months ended March 31, 2023. The G&A non-cash, stock-based compensation expense was $6.7 million for the three months ended March 31, 2024 as compared to $6.1 million in the same period in 2023.Net loss was $43.9 million for the three months ended March 31, 2024, or a net loss per share of $1.64, compared to a net loss of $44.3 million for the three months ended March 31, 2023, or a net loss per share of $1.58. About Anaptys Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. It is developing immune cell modulators, including two checkpoint agonists for autoimmune and inflammatory disease: 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. Its preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody, and ANB101, a BDCA2 modulator antibody, for the treatment of autoimmune and inflammatory diseases. 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 antibody (Jemperli (dostarlimab-gxly)) and an anti-TIM-3 antagonist antibody (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 IND filings for ANB033 and ANB101; the timing of a presentation of Phase 3 clinical data at a medical conference; 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 MontemaranoSenior Director, Investor Relations and Strategic Communications 858.732.0178investors@anaptysbio.com AnaptysBio, Inc.Consolidated Balance Sheets (in thousands, except par value data)(unaudited) March 31, 2024 December 31, 2023 ASSETSCurrent assets: Cash and cash equivalents$53,695 $35,965 Receivables from collaborative partners 7,089 6,851 Short-term investments 300,970 354,939 Prepaid expenses and other current assets 10,666 9,080 Total current assets 372,420 406,835 Property and equipment, net 1,954 2,098 Operating lease right-of-use assets 15,732 16,174 Long-term investments 15,473 27,026 Other long-term assets 256 256 Total assets$405,835 $452,389 LIABILITIES AND STOCKHOLDERS’ EQUITYCurrent liabilities: Accounts payable$4,582 $4,698 Accrued expenses 25,903 30,967 Current portion of operating lease liability 1,813 1,777 Total current liabilities 32,298 37,442 Liability related to sale of future royalties 310,184 310,807 Operating lease liability, net of current portion 15,575 16,037 Stockholders’ equity: Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at March 31, 2024 and December 31, 2023, respectively — — Common stock, $0.001 par value, 500,000 shares authorized, 27,317 shares and 26,597 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively 27 27 Additional paid in capital 706,407 702,969 Accumulated other comprehensive loss (624) (797)Accumulated deficit (658,032) (614,096)Total stockholders’ equity 47,778 88,103 Total liabilities and stockholders’ equity$405,835 $452,389 AnaptysBio, Inc. Consolidated Statements of Operations and Comprehensive Loss(in thousands, except per share data) (unaudited) Three Months EndedMarch 31, 2024 2023 Collaboration revenue$7,179 $1,374 Operating expenses: Research and development 37,042 34,957 General and administrative 12,338 10,818 Total operating expenses 49,380 45,775 Loss from operations (42,201) (44,401)Other (expense) income, net: Interest income 4,584 4,486 Non-cash interest expense for the sale of future royalties (6,317) (4,336)Other expense, net (2) (4)Total other (expense) income, net (1,735) 146 Net loss (43,936) (44,255)Unrealized gain on available for sale securities 173 1,979 Comprehensive loss$(43,763) $(42,276)Net loss per common share: Basic and diluted$(1.64) $(1.58)Weighted-average number of shares outstanding: Basic and diluted 26,801 27,953

Anaptys to receive $50 million upfront cash payment from Sagard HealthcarePrior agreement amended to now expire once Sagard receives a capped payoff of either $600 million if received by March 31, 2031 or $675 million if received thereafter SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced the execution of an amended agreement with Sagard Healthcare for additional Anaptys Jemperli (dostarlimab) royalties. Anaptys intends to utilize the proceeds of the transaction to continue the broad development of its immune cell modulators (ICMs), including its best-in-class checkpoint agonists, in heterogeneous, systemic autoimmune and inflammatory diseases. “We believe this amended agreement with Sagard further validates the commercial potential of Anaptys-discovered Jemperli and brings significant non-dilutive funding to Anaptys, further strengthening our balance sheet,” said Daniel Faga, president and chief executive officer of Anaptys. “This additional capital will further enable investment across our industry leading ICM portfolio where we expect to end 2024 with four programs in clinical development to potentially bring transformational medicines to patients.” “We are thrilled to amend our partnership with Anaptys on this royalty transaction which reflects our growing confidence in Jemperli plus chemotherapy as a treatment for patients with certain types of endometrial cancer, as well as the potential of Jemperli as a monotherapy and in combination with other therapeutics to treat a broad range of solid tumor cancers. Sagard’s investment is aligned with our goal of accelerating biopharmaceutical innovation by providing our partners with flexible sources of financing,” said Ali Alagheband, partner at Sagard. Upon closing of this transaction, which is anticipated by the end of next week, Sagard will pay Anaptys $50 million upfront in exchange for royalties payable to Anaptys under its GSK collaboration on all annual global net sales of Jemperli. The amended agreement now includes the royalty tiers of 12% to 25% for annual global net sales above $1 billion. Unchanged from the prior agreement, Sagard receives royalties of 8% for annual global net sales below $1 billion and may also receive up to a total of $105 million in potential cash milestones, of which $15 million are subject to certain future Jemperli regulatory filing and approval milestones and up to $90 million are subject to certain commercial sales milestones due prior to Jemperli achieving the $1 billion in annual global net sales threshold. A $75 million milestone due upon Jemperli achieving the $1 billion in annual global net sales threshold remains not subject to this agreement. Also, royalties and milestones due to Anaptys upon further development and commercialization of the Anaptys-discovered anti-TIM-3 antagonist (cobolimab, (GSK4069889)) antibody under the GSK collaboration remain not subject to this agreement. The capped aggregate Jemperli royalties and milestones to be received by Sagard under this amended agreement have been revised. Now, once Sagard receives an aggregate of either $600 million if received by March 31, 2031, or $675 million if received at any time thereafter, the agreement will expire, resulting in Anaptys regaining all subsequent Jemperli royalties and milestones under the GSK collaboration. Goodwin Procter LLP is acting as counsel to Anaptys, and Foley Hoag LLP is acting as counsel to Sagard, in this monetization transaction. About Jemperli Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2. In the U.S., Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is dMMR, as determined by a U.S. Food and Drug Administration (FDA)-approved test, or MSI-H, and as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by a U.S. FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. The sBLA supporting this indication in combination with carboplatin and paclitaxel for dMMR/MSI-H primary advanced or recurrent endometrial cancer received Breakthrough Therapy designation and Priority Review from the U.S. FDA. Jemperli is also indicated in the U.S. for patients with dMMR recurrent or advanced solid tumors, as determined by a U.S. FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the U.S. under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication in solid tumors may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Jemperli was discovered by Anaptys and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialization and manufacturing of Jemperli and cobolimab. About Anaptys Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. It is developing immune cell modulators, including two checkpoint agonists for autoimmune and inflammatory disease: 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. Its preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody, and ANB101, a BDCA2 modulator antibody, for the treatment of autoimmune and inflammatory diseases. 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 for the treatment of respiratory disorders 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 antibody (Jemperli (dostarlimab-gxly)) and an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889). To learn more, visit www.AnaptysBio.com or follow us on LinkedIn and X. About Sagard Sagard is a multi-strategy alternative asset management firm with over US$25B under management, 150 portfolio companies, and 300 professionals. We invest in venture capital, private equity, private credit, and real estate. We deliver flexible capital, an entrepreneurial culture, and a global network of investors, commercial partners, advisors, and value-creation experts. Our firm has offices in Canada, the United States, Europe and the Middle East. 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 potential to receive any additional royalties from the GSK collaboration; and the Company’s ability to find a licensing partner for imsidolimab or etokimab and the timing of any such transaction. 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 MontemaranoSenior Director, Investor Relations and Strategic Communications 858.732.0178investors@anaptysbio.com