Belrestotug

- Multiple clinical milestones across portfolio anticipated in second half of 2024, including two Phase 2 trials assessing belrestotug + dostarlimab in 1L NSCLC and 1L HNSCC- Pro forma cash and investment balance of $714.4 million as of June 30, 2024 expected to provide runway through 2027 across a number of impactful portfolio milestones WATERTOWN, Mass. and GOSSELIES, Belgium, Aug. 08, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today reported financial results for the second quarter ended June 30, 2024 and provided a business update. “Our achievements and pipeline progress this year, specifically the positive interim assessment data from the Phase 2 GALAXIES Lung-201 study which supported the launch of the Phase 3 GALAXIES Lung-301 study, demonstrate significant momentum for iTeos. Our conviction in the potential of the belrestotug and dostarlimab doublet only continues to grow,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos. “Furthermore, we are very excited to be approaching data readouts for both adenosine programs – inupadenant and EOS-984. As we continue to build on this impressive foundation, we are enthusiastic about our growing pipeline and the opportunities that lie ahead in the catalyst-rich second half of the year.” Program Highlights Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody targeting first-line non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) in collaboration with GSK GALAXIES Lung-301: Enrollment ongoing in randomized, double-blind Phase 3 registrational study assessing belrestotug + dostarlimab versus placebo + pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC. GALAXIES Lung-201: Interim data from Phase 2 platform study assessing belrestotug + dostarlimab doublet in first-line advanced / metastatic PD-L1 high NSCLC anticipated in second half of 2024. GALAXIES H&N-202: Enrollment ongoing in randomized Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody, nelistotug, in first-line patients with PD-L1 positive recurrent / metastatic HNSCC. TIG-006 HNSCC: Topline data from the first portion of TIG-006 study in cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced / metastatic HNSCC anticipated in second half 2024. TIG-006 mNSCLC: Enrollment completed in Phase 1b expansion trial assessing belrestotug, dostarlimab, and chemotherapy triplet in first-line advanced or metastatic NSCLC. Continued advancement of Phase 1b trials exploring two novel triplets in advanced solid tumors: belrestotug + dostarlimab and GSK’s nelistotug (anti-CD96 antibody), and belrestotug + dostarlimab and GSK’s investigational anti-PVRIG antibody (GSK’562). Adenosine Pathway Inupadenant (EOS-850): insurmountable small molecule antagonist targeting adenosine A2A receptor in second-line NSCLC A2A-005: Data from the dose escalation portion of the Phase 2 trial with inupadenant and platinum-doublet chemotherapy in post-IO metastatic non-squamous NSCLC anticipated in late 2024. EOS-984: potential first-in-class small molecule inhibiting ENT1, a dominant transporter of adenosine on lymphocytes involved in T cell metabolism, expansion, effector function, and survival Topline data from the Phase 1 trial anticipated in the second half of 2024. Second Quarter 2024 Financial Results Cash and Investment Position: The Company’s cash, cash equivalents, and investments position was $679.4 million as of June 30, 2024, as compared to $677.5 million as of June 30, 2023. Pro forma cash, cash equivalents, and investments position were $714.4 million as of June 30, 2024, inclusive of a $35.0 million unbilled milestone receivable relating to the dosing of the first patient in the GALAXIES Lung-301 clinical trial. The Company expects its cash balance to provide runway through 2027, which includes the potential initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet. The Company expects its cash balance to provide runway through 2027, which includes the potential initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet. Research and Development (R&D) Expenses: R&D expenses were $36.7 million and $71.2 million for the quarter and six months ended June 30, 2024, respectively, as compared to $29.2 million and $54.9 million for the same quarter and same six months of 2023, respectively. The increase compared to the comparative period was primarily due to increases in activities related to the belrestotug, inupadenant, and EOS-984 programs, and included the addition of new R&D employees hired to help advance these programs. General and Administrative (G&A) Expenses: G&A expenses were $12.5 million and $25.2 million for the quarter and six months ended June 30, 2024, respectively, as compared to $13.4 million and $25.4 million for the same quarter and same six months of 2023, respectively. The decrease was primarily due to decreases in professional fees and expenses, commercial-related expenses, and various other general and administrative expenses. These were partially offset by an increase in compensation expenses for G&A employees. Net Income/Loss: Net loss was $7.1 million, or net loss of $0.18 per basic and diluted share for the quarter ended June 30, 2024, as compared to a net loss of $34.3 million, or a net loss of $0.96 per basic and diluted share for the quarter ended June 30, 2023. Net loss was $45.3 million, or net loss of $1.20 per basic and diluted share for the six months ended June 30, 2024, as compared to a net loss of $49.9 million, or a net loss of $1.39 per basic and diluted share for the six months ended June 30, 2023. About iTeos Therapeutics, Inc.iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients. iTeos Therapeutics leverages its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates with the potential to restore the immune response against cancer. The Company’s innovative pipeline includes three clinical-stage programs targeting novel, validated immunosuppressive pathways designed with optimized pharmacologic properties for improved clinical outcomes, including the TIGIT/CD226 axis and the adenosine pathway. iTeos Therapeutics is headquartered in Watertown, MA with a research center in Gosselies, Belgium. About Belrestotug (EOS-448/ GSK4428859A) Belrestotug is an Fc active human immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT), an important inhibitory receptor which contributes to the suppression of innate immune responses against cancer. As an optimized high-affinity, potent anti-TIGIT mAb, belrestotug is designed to enhance the antitumor response through a multifaceted immune modulatory mechanism by engaging with TIGIT and FcγR, a key regulator of immune responses which induces cytokine release and antibody dependent cellular cytotoxicity (ADCC). The therapeutic candidate is progressing in multiple indications in collaboration with GSK. About Inupadenant (EOS-850) Inupadenant is a next-generation small molecule antagonist targeting adenosine A2A receptor (A2AR), the primary receptor on immune cells whose activation by adenosine suppresses innate and adaptive immune cell responses leading to inhibition of antitumor responses. Optimized for potency, high selectivity of A2AR, and activity at high adenosine concentrations in solid tumors, inupadenant is uniquely designed with its insurmountable profile to inhibit the ATP-adenosine pathway and has the potential for enhanced antitumor activity as compared to other A2AR antagonists in clinical development. The therapeutic candidate is in Phase 2 development. About EOS-984EOS-984 is a potential first-in-class small molecule targeting equilibrative nucleoside transporter 1 (ENT1) designed to inhibit the immunosuppressive activity of adenosine and restore immune cell proliferation. The therapeutic candidate has the potential to fully reverse the profound immunosuppressive action of adenosine on T and B cells and is in Phase 1 development. Internet Posting of InformationiTeos routinely posts information that may be important to investors in the 'Investors' section of its website at www.iteostherapeutics.com. The Company encourages investors and potential investors to consult our website regularly for important information about iTeos. Forward-Looking Statements This press release contains forward-looking statements. Any statements that are not solely statements of historical fact are forward-looking statements. Words such as “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to the potential benefits of belrestotug, inupadenant, and EOS-984 and the potential of the belrestotug and dostarlimab doublet; our plans and expected milestones, including having interim data in GALAXIES lung-201, topline data from TIG-006 HNSCC, and topline data from the Phase 1 trial in EOS-984 in the second half of 2024, , and having data from the dose escalation portion of A2A-005 in late 2024; intentions around trial enrollment and recruitment; and our expectation that our cash balance will provide runway through 2027 across a number of impactful portfolio milestones. These forward-looking statements involve risks and uncertainties, many of which are beyond iTeos’ control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: the expected benefits and opportunities related to the agreement between iTeos and GSK may not be realized or may take longer to realize due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement, challenges and uncertainties inherent in product research and development and manufacturing limitations; success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and early results from a clinical trial do not necessarily predict final results; interim and early data may change as more patient data become available and are subject to audit and verification procedures; the data for our product candidates may not be sufficient for obtaining regulatory approval to move into later stage trials or to commercialize products; iTeos may encounter unanticipated costs or may expend cash more rapidly or more slowly than currently anticipated due to challenges and uncertainties inherent in product research and development and biologics manufacturing; iTeos may not be able to execute on its business plans, including meeting its expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing its product candidates to market, for various reasons, some of which may be outside of iTeos’ control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, negative developments in the field of immuno-oncology, such as adverse events or disappointing results, including in connection with competitor therapies, and regulatory, court or agency decisions such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading “Risk Factors” in iTeos’ Annual Report on Form 10-Q for the period ended June 30, 2024 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review. Statements regarding the Company’s cash runway do not indicate when or if the Company may access the capital markets. Any of the foregoing risks could materially and adversely affect iTeos’ business, results of operations and the trading price of iTeos’ common stock. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. iTeos does not undertake any obligation to publicly update its forward-looking statements other than as required by law. For further information, please contact: Investor Contact:Carl MauchiTeos Therapeutics, Inc.carl.mauch@iteostherapeutics.com Media Contact:media@iteostherapeutics.com

Top-line data expected in December 2024 after having completed enrollment for Phase 2b trial to treat atopic dermatitis (AD) with ANB032, our BTLA agonistTop-line data accelerated and now anticipated in Q1 2025 for Phase 2b trial to treat rheumatoid arthritis (RA) with rosnilimab, our PD-1 agonistTop-line data now anticipated in Q1 2026 for Phase 2 trial to treat ulcerative colitis (UC) with rosnilimabIND accepted by FDA for ANB033, our anti-CD122 antagonist; Phase 1 trial initiation anticipated in Q4 2024 SAN DIEGO, Aug. 05, 2024 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported financial results for the second quarter ended June 30, 2024 and provided a business update. “We’ve had an exceptional quarter as we approach multiple important value drivers for Anaptys including our first patient data for ANB032, our BTLA agonist. First, enrollment has completed in the Phase 2b trial of ANB032 in AD with strong demand leading to enrollment totaling approximately 200 patients. Importantly, we plan to share top-line Week 14 data in December of 2024,” said Daniel Faga, president and chief executive officer of Anaptys. “Second, strong demand in enrollment for the Phase 2b trial of rosnilimab in RA has accelerated anticipated top-line data from mid-2025 to Q1 2025. And finally, our IND for ANB033 was accepted by FDA in July and we look forward to initiating a Phase 1 trial in healthy volunteers soon. Looking to the end of the year, we still plan to have four immune cell modulators (ICMs) in clinical development.” Updates on Wholly Owned ICM Pipeline ANB032 (BTLA agonist antibody) Completed enrollment for global Phase 2b trial in moderate-to-severe AD Enrolled approximately 200 patients in a placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI-75 and IGA 0/1 Enrollment included approximately 15% of patients with Dupixent/anti-IL-13 treatment experience Top-line Week 14 data expected in December 2024 Presented previously reported ANB032 preclinical graft vs. host disease (GvHD) data at the 2024 American Association of Immunology (AAI) Annual Meeting and Society of Investigative Dermatology (SID) Annual Meeting in May 2024 and ANB032 preclinical data supporting the modulation of dendritic cell (DC) maturation and function at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting in June 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 Top-line Week 12 data anticipated in Q1 2025 Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC 132-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission Rosnilimab and placebo-treated patients who achieved clinical response on mMS are eligible to continue on their assigned treatment for an additional 12 weeks, while patients on placebo who are non-responders will be crossed over to the high-dose rosnilimab treatment arm, in an all-active treatment period and then followed for a three-month off-drug follow-up period Top-line Week 12 data anticipated in Q1 2026 Presented previously reported rosnilimab Phase 1 data and membrane proximal binding epitope to optimize PD-1 agonist signaling data at the 2024 Digestive Disease Week (DDW) Annual Meeting in May 2024 and at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting in June 2024 Poster presentations are available here ANB033 (anti-CD122 antagonist antibody) IND application accepted by FDA in July 2024Phase 1 trial initiation in healthy volunteers anticipated in Q4 2024 ANB101 (BDCA2 modulator antibody) Plan to submit IND application in Q4 2024 Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing Comprehensive data from the Phase 3 GEMINI-1 and GEMINI-2 trials to be presented at a medical meeting in H2 2024Intend to out-license imsidolimab in 2024 GSK Immuno-Oncology Financial Collaboration GSK anticipates top-line data in H1 2025 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapyGSK and iTEOS announced in June 2024 the initiation of the GALAXIES Lung-301 Phase 3 study, assessing belrestotug and dostarlimab in previously untreated, unresectable locally advanced/metastatic PD-L1 selected NSCLCGSK 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 cancer Cash Runway Cash and investments of $393.5 million as of June 30, 2024 and reiterating cash runway through year-end 2026 Second Quarter Financial Results Cash, cash equivalents and investments totaled $393.5 million as of June 30, 2024, compared to $417.9 million as of December 31, 2023, for a decrease of $24.4 million due primarily to cash used for operating activities offset by $50.0 million received from the Sagard royalty monetization completed in May.Collaboration revenue was $11.0 million and $18.2 million for the three and six months ended June 30, 2024, compared to $3.5 million and $4.8 million for the three and six months ended June 30, 2023. The change is due primarily to increased royalties recognized for sales of Jemperli.Research and development expenses were $42.0 million and $79.0 million for the three and six months ended June 30, 2024, compared to $32.9 million and $67.9 million for the three and six months ended June 30, 2023. The increase was due primarily to development costs for rosnilimab, ANB032, ANB033 and ANB101 offset by a decrease in development costs for imsidolimab. The R&D non-cash, stock-based compensation expense was $3.5 million and $7.0 million for the three and six months ended June 30, 2024, compared to $2.7 million and $5.5 million in the same period in 2023.General and administrative expenses were $9.3 million and $21.6 million for the three and six months ended June 30, 2024, compared to $10.7 million and $21.5 million for the three and six months ended June 30, 2023. The G&A non-cash, stock-based compensation expense was $4.0 million and $10.7 million for the three and six months ended June 30, 2024, compared to $5.7 million and $11.8 million in the same period in 2023.Net loss was $46.7 million and $90.6 million for the three and six months ended June 30, 2024, or a net loss per share of $1.71 and $3.35, compared to a net loss of $39.8 million and $84.1 million for the three and six months ended June 30, 2023, or a net loss per share of $1.50 and $3.08. About AnaptysAnaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. It is developing immune cell modulators for autoimmune and inflammatory diseases, including two checkpoint agonists: ANB032, its BTLA agonist, in a Phase 2b trial for the treatment of atopic dermatitis and rosnilimab, its PD-1 agonist, in a Phase 2b trial for the treatment of rheumatoid arthritis and in a Phase 2 trial for the treatment of ulcerative colitis. It also has other immune cell modulator candidates in its portfolio, including ANB033, an anti-CD122 antagonist antibody, entering a Phase 1 trial and ANB101, a BDCA2 modulator antibody, in preclinical development. In addition, Anaptys has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, that has completed Phase 3 trials for the treatment of generalized pustular psoriasis, and etokimab, an anti-IL-33 antagonist that is Phase 2/3 ready. Anaptys has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immuno-oncology, including an anti-PD-1 antagonist 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 filing for ANB101; the timing of initiation of ANB033’s Phase 1 clinical trial; 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) June 30, 2024 December 31, 2023 ASSETSCurrent assets: Cash and cash equivalents$71,821 $35,965 Receivables from collaborative partners 9,007 6,851 Short-term investments 278,983 354,939 Prepaid expenses and other current assets 7,539 9,080 Total current assets 367,350 406,835 Property and equipment, net 1,833 2,098 Operating lease right-of-use assets 15,291 16,174 Long-term investments 42,646 27,026 Other long-term assets 256 256 Total assets$427,376 $452,389 LIABILITIES AND STOCKHOLDERS’ EQUITYCurrent liabilities: Accounts payable$4,890 $4,698 Accrued expenses 33,680 30,967 Current portion of operating lease liability 1,850 1,777 Total current liabilities 40,420 37,442 Liability related to sale of future royalties 361,981 310,807 Operating lease liability, net of current portion 15,096 16,037 Stockholders’ equity: Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at June 30, 2024 and December 31, 2023, respectively — — Common stock, $0.001 par value, 500,000 shares authorized, 27,434 shares and 26,597 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively 27 27 Additional paid in capital 714,959 702,969 Accumulated other comprehensive loss (415) (797)Accumulated deficit (704,692) (614,096)Total stockholders’ equity 9,879 88,103 Total liabilities and stockholders’ equity$427,376 $452,389 AnaptysBio, Inc. Consolidated Statements of Operations and Comprehensive Loss(in thousands, except per share data) (unaudited) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Collaboration revenue$10,971 $3,460 $18,150 $4,834 Operating expenses: Research and development 41,997 32,923 79,039 67,880 General and administrative 9,295 10,680 21,633 21,498 Total operating expenses 51,292 43,603 100,672 89,378 Loss from operations (40,321) (40,143) (82,522) (84,544)Other (expense) income, net: Interest income 4,623 4,653 9,207 9,139 Non-cash interest expense for the sale of future royalties (10,953) (4,358) (17,270) (8,694)Other (expense) income, net — 3 (2) (1)Total other (expense) income, net (6,330) 298 (8,065) 444 Loss before income taxes (46,651) (39,845) (90,587) (84,100)Provision for income taxes (9) — (9) — Net loss (46,660) (39,845) (90,596) (84,100)Unrealized gain (loss) on available for sale securities 209 (344) 382 1,635 Comprehensive loss$(46,451) $(40,189) $(90,214) $(82,465)Net loss per common share: Basic and diluted$(1.71) $(1.50) $(3.35) $(3.08)Weighted-average number of shares outstanding: Basic and diluted 27,356 26,629 27,079 27,288