Anaptys Reports Fiscal First Quarter 2027 Financial Results and Provides Business Update

(NASDAQ:ANAB) AnaptysBio, Inc. reported financial results for the fiscal first quarter ended September 30, 2026, and provided a business update. Jemperli achieved global net sales of $1.0 billion through September 30, 2026, with $365 million in global net sales for the three months ended September 30, 2026, representing 20% year-over-year growth. For the nine months ended September 30, 2026, Jemperli global net sales grew 29% year-over-year. Anaptys receives royalties equal to 12% of net sales between $1.0 billion and $1.5 billion in a given calendar year. Anaptys expects to achieve over $390 million in annualized Jemperli royalties as early as 2029 at GSK’s peak monotherapy sales guidance of over $2.7 billion. Anaptys estimates Sagard will have accrued approximately $330 million in royalties and sales milestones through September 30, 2026, and anticipates paydown of the remaining approximately $270 million non-recourse debt monetization in calendar H2 2027. GSK received FDA approval in October 2026 for Jemperli (dostarlimab) in adults with stage II and III MSI-H/dMMR locally advanced rectal cancer, with first results from the AZUR-1 trial presented at ESMO Congress 2026 in Madrid, Spain, on October 25, 2026. Regulatory submission for Jemperli is expected in Japan in calendar H1 2027 and in Europe and China in calendar H2 2027, with a regulatory decision expected in Europe in calendar H2 2027. Data from the AZUR-2 pivotal Phase 3 trial and the JADE pivotal Phase 3 trial are expected in 2028, while the AZUR-4 Phase 2 trial has a primary completion date in Q4 2026. The FDA target action date (PDUFA) for Quimilza (imsidolimab) in generalized pustular psoriasis is December 12, 2026. The post-trial hearing in the GSK and Tesaro litigation was held before the Delaware Chancery Court on October 20, 2026, with Anaptys seeking reversion of Jemperli rights and anticipating a judgment in calendar Q4 2026 or Q1 2027. The separation of AnaptysBio and First Tracks Biotherapeutics was completed on April 20, 2026, and beginning in Q2 2026, AnaptysBio reclassified historical First Tracks Biotherapeutics, Inc. related assets, liabilities, and expenses as discontinued operations. Cash, cash equivalents, and investments totaled $153.0 million as of September 30, 2026, compared to $164.1 million as of June 30, 2026, for a decrease of $11.1 million, due primarily to $15.5 million used for operating activities offset by $4.4 million received from stock option exercises. Collaboration revenue was $30.3 million for the three months ended September 30, 2026, compared to $76.3 million for the same period in 2025, with the decrease primarily due to $50 million in milestone revenue recognized in Q3 2025, offset by Jemperli royalties increasing 11% quarter over quarter. General and administrative expenses from continuing operations were $11.6 million for the three months ended September 30, 2026, compared to $1.1 million for the same period in 2025, with $4.8 million in legal costs for the GSK and Tesaro litigation and $2.2 million in recurring expenses. G&A non-cash, stock-based compensation expense was $3.2 million for the three months ended September 30, 2026, compared to $0.5 million in 2025. Research and development expenses from continuing operations were a negative $1.3 million for the three months ended September 30, 2026, compared to a negative $2.0 million for the same period in 2025. Net income from continuing operations was $3.9 million for the three months ended September 30, 2026, or $0.13 per share, compared to $56.3 million, or $2.02 per share, for the same period in 2025. Total assets as of September 30, 2026, were $307,043,000, and total liabilities and stockholders’ equity matched this amount. The weighted-average number of shares outstanding was 29,847 basic and 35,072 diluted for the three months ended September 30, 2026.

Jemperli (dostarlimab) Approved in the U.S. as First and Only Immunotherapy for Adults with MSI-H/dMMR Locally Advanced Rectal Cancer

(NASDAQ:ANAB) AnaptysBio, Inc. announced that GSK has received U.S. Food and Drug Administration (FDA) approval for Jemperli (dostarlimab) as the first and only immunotherapy for adults with stage II and III microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) locally advanced rectal cancer. Jemperli received FDA Fast Track and Breakthrough Therapy designations for this indication. The application was granted Priority Review and received the National Priority Voucher, resulting in accelerated approval ahead of the February 2027 PDUFA date. This approval is supported by data from the AZUR-1 trial, which met its primary objective by showing a significant proportion of participants achieved sustained clinical complete responses at 12 months (cCR12), with data continuing to mature. Investigator-assessed data showed 68% of evaluable patients (98/144; 95% CI: 60%, 76%) achieved cCR12. In an exploratory analysis, 76% (110/144; 95% CI: 69%, 83%) of evaluable patients had no evidence of cancer one year or more after treatment. This includes 68% (98/144) (95% CI: 60%, 76%) of patients who reached cCR12 without surgery, plus 12 participants who had their complete response confirmed through tissue analysis after surgery (pathological complete response, or pCR). No disease recurrences have been reported among responders to date, after a median follow up of more than two years. Data on the primary objective, cCR12 assessed by independent central review, continue to mature, with 47% (54/116) (95% CI: 37%, 56%) of evaluable patients achieving cCR12. An additional 38 participants who are still progressing through to 12 month follow up have already achieved a clinical complete response. The safety profile of Jemperli was generally consistent with its established profile across solid tumors. Serious adverse reactions occurred in 20% of patients receiving Jemperli. The most common adverse reactions were fatigue (32%), rash (22%), diarrhea (18%), and pruritus (17%). Jemperli was permanently discontinued due to adverse reactions in 3% of patients. GSK plans to present full data from the AZUR-1 interim analysis as a late-breaking abstract at ESMO Congress 2026 in Madrid, Spain on October 25, 2026. The current standard of treatment for locally advanced rectal cancer includes chemotherapy, radiation, and surgery, which can have lasting consequences. For patients with MSI-H/dMMR tumors, a biomarker found in around 5-10% of rectal cancers, Jemperli monotherapy could help avoid these interventions. The AZUR-1 sBLA is being reviewed under Project Orbis, an FDA Oncology Center of Excellence initiative that enables concurrent review by international health authorities, and regulatory reviews are ongoing in participating countries. 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 United States, Jemperli is currently approved for endometrial cancer, rectal cancer, and dMMR solid tumors, and is being studied as monotherapy in colon cancer and head and neck squamous cell carcinoma. Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. Under this agreement, GSK is conducting ongoing research, development, commercialization, and manufacturing of Jemperli. AnaptysBio manages the financial collaborations for Jemperli with GSK and Quimilza with Vanda, focusing on protecting and returning the value of its royalties to shareholders.

Anaptys Announces First Quarter 2026 Financial Results and Provides Business Update

AnaptysBio, Inc. (NASDAQ:ANAB) reported financial results for the first quarter ended March 31, 2026, following the completed spin-off of First Tracks Biotherapeutics, Inc. The company now exclusively manages financial collaborations for Jemperli with GSK and imsidolimab with Vanda, operating with limited FTEs and an EBIT margin greater than 95%. For Q1 2026, cash, cash equivalents and investments totaled $286.5 million, with collaboration revenue of $25.6 million and a net loss of $52.9 million, or $1.84 per share. AnaptysBio announced a $100.0 million Stock Repurchase Plan and several leadership appointments, including Chris Murphy as CFO.

Anaptys to Participate at the H.C. Wainwright 2nd Annual Royalty Company Virtual Conference

AnaptysBio, Inc. (NASDAQ:ANAB) announced that Daniel Faga, president and chief executive officer, will participate in a fireside chat at the H.C. Wainwright 2nd Annual Royalty Company Virtual Conference on May 6, 2026, at 1:30pm ET. The company focuses on managing financial collaborations for Jemperli with GSK and imsidolimab with Vanda. Anaptys emphasizes protecting and returning the value of its royalties to shareholders. Investors can register for the conference online.

Delaware Chancery Court Rules in Favor of Anaptys by Dismissing Tesaro’s Anticipatory Breach Claim

AnaptysBio, Inc. (NASDAQ:ANAB) announced that the Delaware Chancery Court has dismissed Tesaro’s anticipatory breach of contract claim against Anaptys, preserving the current contracted royalty rates and rejecting Tesaro’s request for any royalty reduction. The trial to adjudicate Anaptys’ contract claims and right to seek reversion of Jemperli against Tesaro/GSK is scheduled for July 14-17, 2026. Under the Collaboration Agreement, Anaptys is eligible to receive royalties on Jemperli sales at rates ranging from 8% to 25% depending on net sales thresholds. The royalty term extends through patent expirations in 2035 in the U.S., 2036 in the EU, and 2037 in Japan, with potential extensions into 2038. This ruling is significant for investors as it validates Anaptys’ contractual rights to the Jemperli royalty stream.