Cryopyrin-Associated Periodic Syndromes

A Phase 2 obesity and cardiometabolic trial of VTX3232 and a Phase 2a trial of VTX3232 in patients with Parkinson’s disease are both expected to initiate in H2 2024 A Phase 2 trial of VTX2735 in recurrent pericarditis is expected to initiate in H2 2024 Mark Forman, MD, PhD will join Ventyx as Chief Medical Officer effective August 12, 2024 Cash, cash equivalents and marketable securities of $279.7 million as of June 30, 2024 are expected to fund planned operations into at least the second half of 2026 SAN DIEGO, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced financial results for the second quarter ended June 30, 2024, and highlighted recent pipeline and business progress. “We are looking forward to advancing our portfolio of NLRP3 inhibitors into three Phase 2 clinical trials in the coming months with clinical updates expected from all three trials in 2025,” said Raju Mohan, Chief Executive Officer. “With indications spanning cardiometabolic, obesity and neurodegenerative diseases, we believe we are poised to exploit the full potential of the NLRP3 inflammasome through transformational therapeutic advancements. I would also like to take this opportunity to welcome Mark Forman to the Ventyx team as our Chief Medical Officer. Mark brings a wealth of experience in translational medicine and drug development and will play a key role in shaping our clinical strategy.” Corporate Updates Ventyx appoints Mark Forman, MD, PhD as Chief Medical Officer effective August 12, 2024. Dr. Forman will join the executive team and assume responsibility for leading all aspects of clinical development. Dr. Forman most recently served as Chief Medical Officer at Passage Bio. He brings nearly two decades of experience in translational medicine and clinical development for neurological diseases, having previously held leadership roles at the Alzheimer’s Drug Discovery Foundation, Acadia Pharmaceuticals, and Merck. Dr. Forman received his PhD from Rockefeller University, MD from Duke University and BS from Yale University.“I am pleased to join the Ventyx team at this important time in the Company’s evolution,” said Mark Forman, MD, PhD. “Ventyx’s portfolio of oral medicines targeting inflammatory pathways implicated in human disease offers the potential to meaningfully change the treatment paradigm for patients in multiple areas of unmet medical need. I am particularly excited about the portfolio of novel NLRP3 inhibitors and look forward to working with my Ventyx colleagues to advance their development for systemic inflammatory and neuroinflammatory conditions.” Pipeline Updates VTX3232 (CNS-penetrant NLRP3 Inhibitor): In the first quarter of 2024, we announced positive topline results from a Phase 1 single- and multiple-ascending dose trial of VTX3232 in adult healthy volunteers. VTX3232 exhibited a dose-dependent and dose-linear pharmacokinetic profile with repeat once-daily doses of VTX3232 exceeding steady-state IL-1β IC90 coverage in both plasma and cerebrospinal fluid (CSF). Robust, dose-dependent pharmacodynamic effects were observed in a whole blood ex vivo IL-1β stimulation assay and potent effects on plasma and CSF biomarkers were demonstrated in both the SAD and MAD parts of the study. VTX3232 was well-tolerated with no dose-limiting toxicities identified. We believe these data support the potential for VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory and cardiometabolic diseases and conditions.We expect to initiate a Phase 2a trial of VTX3232 in participants with early Parkinson’s disease during the second half of 2024, with the primary goal of evaluating safety and key inflammatory biomarkers in the plasma and CSF. We also plan to include an exploratory endpoint of PET-tracer imaging as an assessment of microglial activation.We also expect to initiate a 12-week Phase 2 trial of VTX3232 in participants with obesity and additional cardiovascular and cardiometabolic risk factors during the second half of 2024. This trial will evaluate the effect of VTX3232 on key inflammatory biomarkers as well as on weight change when dosed as a monotherapy and in combination with a GLP-1 receptor agonist. VTX2735 (Peripheral NLRP3 Inhibitor): In the first quarter of 2024, we announced positive topline results from a Phase 2 proof of concept trial of VTX2735 in participants with cryopyrin-associated periodic syndromes (CAPS), a group of rare autoinflammatory conditions caused by gain-of-function mutations in the NLRP3 gene. Treatment with VTX2735 demonstrated clinically meaningful improvements in disease activity and reductions in key inflammatory biomarkers, including high sensitivity C-reactive protein (hsCRP), serum amyloid A (SAA) and interleukin-6 (IL-6).We are evaluating VTX2735 for future development in cardiovascular diseases with high unmet medical need, beginning with recurrent pericarditis, a debilitating autoinflammatory disease associated with activation of the NLRP3 inflammasome. We expect to initiate a Phase 2 trial of VTX2735 in participants with recurrent pericarditis during the second half of 2024 with the goal of evaluating safety and the effect of VTX2735 on disease-relevant biomarkers and pain scores. We believe that, by treating and preventing disease recurrence, VTX2735 has the potential to be the first approved oral therapy for recurrent pericarditis. VTX002 (S1P1R Modulator): In the fourth quarter of 2023, we announced positive results from a Phase 2 trial of VTX002 in participants with moderately to severely active ulcerative colitis (UC). We believe these results establish VTX002 as a potential best-in-disease oral agent in UC based on its differentiated efficacy profile, including a high rate of complete endoscopic remission, and its potential best-in-class safety profile.We recently completed the long-term extension (LTE) portion of the Phase 2 trial, and we expect to present the results of the LTE at a future medical meeting. We intend to identify a partner or other source of non-dilutive financing to support the pivotal Phase 3 trial of VTX002 in UC. Business development efforts are ongoing, and we plan to provide an update during the second half of this year. VTX958 (TYK2 Inhibitor): We recently announced the results of the Phase 2 trial of VTX958 in participants with moderately to severely active Crohn’s disease. While the trial did not meet its primary endpoint of change in mean CDAI score from baseline to Week 12, a dose-dependent treatment effect was observed on the key secondary endpoint of endoscopic response. VTX958 also showed a greater magnitude of decrease compared to placebo in two key biomarkers of inflammation, C-reactive protein and fecal calprotectin. Based on these results, the Company intends to conduct further analyses to better understand the discordance between symptomatic and endoscopic response data. At this time, Ventyx does not anticipate conducting additional clinical trials of VTX958 with internal resources. Second Quarter 2024 Financial Results: Cash Position: Cash, cash equivalents and marketable securities were $279.7 million as of June 30, 2024. We believe our current cash, cash equivalents and marketable securities are sufficient to fund our planned operations into at least the second half of 2026.Research and Development (R&D) expenses: R&D expenses were $27.8 million for the second quarter of 2024, compared to $48.6 million for the second quarter of 2023.General and Administrative (G&A) expenses: G&A expenses were $7.9 million for the second quarter of 2024, compared to $8.6 million for the second quarter of 2023.Net loss: Net loss was $32.0 million for the second quarter of 2024, compared to $53.3 million for the second quarter of 2023. About Ventyx Biosciences Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical need with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. Ventyx is headquartered in San Diego, California. For more information about Ventyx, please visit www.ventyxbio.com. Forward-Looking Statements Ventyx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Ventyx’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential of Ventyx’s product candidates, including the potential of VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory and cardiometabolic diseases and conditions, the potential of VTX002 as a best-in-disease oral agent in UC and best-in-class safety profile, the potential of VTX3232 and VTX2735 to change treatment paradigms for patients, and the potential of VTX2735 to be the first approved oral therapy for recurrent pericarditis; the design of clinical studies to be conducted by the Company, including that the Phase 2a study of VTX3232 in Parkinson’s will include an exploratory endpoint of PET-tracer imaging; the anticipated continued progression of the development pipeline for Ventyx’s product candidates, including the anticipated timing for the initiation of Phase 2a trials of VTX3232 in Parkinson’s disease and obesity and cardiometabolic diseases or conditions in H2 2024, and the initiation of a Phase 2 trial of VTX2735 in recurrent pericarditis in H2 2024; the timing of clinical updates for all three studies, including the publication of any clinical data from these studies in 2025; the ability to deliver shareholder value; the presentation of the LTE data from the Phase 2 study of VTX002 in UC; management’s plans with respect to a potential pivotal Phase 3 trial for VTX002 in UC, supported by a partner or other source of non-dilutive financing; the anticipated role of Mark Forman as Chief Medical Officer in shaping Ventyx’s clinical strategy; the conduct of analyses on the results of the Phase 2 trial of VTX958 in Crohn’s disease to understand the discordance between symptomatic and endoscopic response data; and the expected timeframe for funding Ventyx’s operating plan with current cash, cash equivalents and marketable securities. The inclusion of forward-looking statements should not be regarded as a representation by Ventyx that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Ventyx’s business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; Ventyx’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; disruptions in the supply chain, including raw materials needed for manufacturing and animals used in research, delays in site activations and enrollment of clinical trials; the results of preclinical studies and clinical trials; early clinical trials not necessarily being predictive of future results; interim results not necessarily being predictive of final results; the potential of one or more outcomes to materially change as a trial continues and more patient data become available and following more comprehensive audit and verification procedures; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of Ventyx’s product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Ventyx’s ability to obtain and maintain intellectual property protection for its product candidates; the use of capital resources by Ventyx sooner than expected; and other risks described in Ventyx’s prior press releases and Ventyx’s filings with the Securities and Exchange Commission (SEC), including in Part II, Item 1A (Risk Factors) of Ventyx’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed on May 9, 2024, and Ventyx’s subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Ventyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor Relations ContactPatti BankManaging DirectorICR Westwicke(415) 513-1284IR@ventyxbio.com Ventyx Biosciences, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(unaudited) Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Operating expenses: Research and development $27,805 $48,560 $61,552 $83,997 General and administrative 7,907 8,585 15,928 15,700 Total operating expenses 35,712 57,145 77,480 99,697 Loss from operations (35,712) (57,145) (77,480) (99,697)Other (income) expense: Interest income (3,783) (3,899) (7,010) (7,521)Other expense 21 5 52 6 Total other (income) expense (3,762) (3,894) (6,958) (7,515)Net loss $(31,950) $(53,251) $(70,522) $(92,182)Unrealized gain (loss) on marketable securities (119) (187) (181) 352 Foreign currency translation (8) 38 (17) 61 Comprehensive loss $(32,077) $(53,400) $(70,720) $(91,769)Net loss per share, basic and diluted $(0.45) $(0.91) $(1.07) $(1.59)Weighted average common shares outstanding, basic and diluted 70,554,718 58,556,529 66,192,348 58,100,261 Ventyx Biosciences, Inc.Selected Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) June 30, December 31, 2024 2023 Cash, cash equivalents and marketable securities $279,699 $252,220 Working capital 238,827 242,080 Total assets 309,193 277,693 Total liabilities 28,398 33,770 Accumulated deficit (489,709) (419,187)Total stockholders' equity 280,795 243,923

– ARCALYST® (rilonacept) Q2 2024 net product revenue of $103.4 million, representing 90% year-over-year growth –– ARCALYST 2024 expected net product revenue increased to $405 - $415 million –– Abiprubart clinical development fully funded; Phase 2b clinical trial in Sjögren’s Disease enrolling patients –– Kiniksa expects to remain cash flow positive on an annual basis –– Conference call and webcast scheduled for 8:30 am ET today – LONDON, July 23, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today reported second quarter 2024 financial results and recent portfolio execution. “Kiniksa’s work to establish ARCALYST as the standard of care in recurrent pericarditis continues to drive the company’s commercial performance. As of the end of the second quarter, ~11% of the 14,000 multiple-recurrence target population were actively on ARCALYST treatment, and total average duration of therapy increased to approximately 26 months. We now expect 2024 ARCALYST net sales to increase to between $405 and $415 million from our previous guidance of between $370 and $390 million,” said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “Within our pipeline, commencing enrollment in the abiprubart Phase 2b trial in Sjögren’s Disease, a debilitating, chronic autoimmune disease, which currently has no FDA-approved therapies, represents an exciting growth opportunity for the company. Clinical development of abiprubart in Sjögren’s Disease is fully funded in our current operating plan, and we expect to remain cash flow positive on an annual basis.” Portfolio ExecutionARCALYST (IL-1α and IL-1β cytokine trap) ARCALYST net product revenue was $103.4 million for the second quarter of 2024.Since launch in April 2021, more than 2,300 prescribers have written ARCALYST prescriptions for recurrent pericarditis.As of the end of the second quarter of 2024, the average total duration of ARCALYST therapy in recurrent pericarditis increased to approximately 26 months, compared to ~23 months as of the end of the first quarter of 2024.As of the end of the second quarter of 2024, approximately 11% of the target 14,000 multiple-recurrence patients were actively on ARCALYST treatment, compared to ~9% as of the end of 2023.In June 2024, Kiniksa announced its sponsorship of the American Heart Association’s Addressing Recurrent Pericarditis initiative, a multi-faceted effort aimed at improving access to expert care and quality of care for patients with recurrent pericarditis.In June 2024, Kiniksa announced a partnership with National Hockey League Hall-of-Famer, Henrik Lundqvist, to raise awareness in support of patients suffering from recurrent pericarditis. Abiprubart (anti-CD40 monoclonal antibody inhibitor of CD40-CD154 interaction) Kiniksa is enrolling patients in a Phase 2b clinical trial designed to evaluate the efficacy and safety of biweekly and monthly abiprubart administered subcutaneously in patients with Sjögren’s Disease. Financial Results Total revenue for the second quarter of 2024 was $108.6 million, compared to $71.5 million for the second quarter of 2023. Total revenue for the second quarter of 2024 included $5.2 million in license and collaboration revenue, compared to $17.0 million for the second quarter of 2023. Total operating expenses for the second quarter of 2024 were $108.7 million, compared to $74.6 million for the second quarter of 2023. Total operating expenses for the second quarter of 2024 included $30.0 million in collaboration expenses, which are driven by ARCALYST collaboration profitability, compared to $14.0 million for the second quarter of 2023.Total operating expenses for the second quarter of 2024 included $7.4 million in non-cash, share-based compensation expense, compared to $6.5 million for the second quarter of 2023. Net loss for the second quarter of 2024 was $3.9 million, compared to a net income of $15.0 million for the second quarter of 2023.As of June 30, 2024, Kiniksa had $218.8 million of cash, cash equivalents, and short-term investments and no debt. Financial Guidance Kiniksa expects 2024 ARCALYST net product revenue of between $405 million and $415 million, compared to prior guidance of between $370 million and $390 million.Kiniksa expects to remain cash flow positive on an annual basis. Conference Call Information Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, July 23, 2024, to discuss second quarter 2024 financial results and recent portfolio execution.Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event. About KiniksaKiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s immune-modulating assets, ARCALYST, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation. For more information, please visit www.kiniksa.com. About ARCALYSTARCALYST is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. ARCALYST was discovered by Regeneron Pharmaceuticals, Inc. (Regeneron) and is approved by the U.S. Food and Drug Administration (FDA) for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and deficiency of IL-1 receptor antagonist (DIRA). The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug exclusivity to ARCALYST in 2021 for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and pediatric patients 12 years and older. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021. IMPORTANT SAFETY INFORMATION ABOUT ARCALYST ARCALYST may affect your immune system and can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in patients taking ARCALYST. If you have any signs of an infection, call your doctor right away. Treatment with ARCALYST should be stopped if you get a serious infection. You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection).While taking ARCALYST, do not take other medicines that block interleukin-1, such as Kineret® (anakinra), or medicines that block tumor necrosis factor, such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), as this may increase your risk of getting a serious infection.Talk with your doctor about your vaccine history. Ask your doctor whether you should receive any vaccines before you begin treatment with ARCALYST.Medicines that affect the immune system may increase the risk of getting cancer.Stop taking ARCALYST and call your doctor or get emergency care right away if you have any symptoms of an allergic reaction.Your doctor will do blood tests to check for changes in your blood cholesterol and triglycerides.Common side effects include injection-site reactions (which may include pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site), upper respiratory tract infections, joint and muscle aches, rash, ear infection, sore throat, and runny nose. For more information about ARCALYST, talk to your doctor and see the Product Information. About Abiprubart Abiprubart is an investigational humanized monoclonal antibody that binds to CD40 and is designed to inhibit the CD40-CD154 (CD40 ligand) interaction, a key T-cell co-stimulatory signal critical for B-cell maturation and immunoglobulin class switching and Type 1 immune responses. Kiniksa believes disrupting the CD40-CD154 co-stimulatory interaction is an attractive approach to addressing multiple autoimmune disease pathologies. Forward-Looking StatementsThis press release contains forward-looking statements. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our expectation that ARCALYST 2024 net product revenue will be between $405 million and $415 million; our expectation that clinical development of abiprubart in Sjögren’s Disease is fully funded in our current operating plan; our expectation to remain cash flow positive on an annual basis; our beliefs about the mechanisms of our product candidates and potential impact of their approach, including that using abiprubart to disrupt the CD40-CD154 co-stimulatory interaction is an attractive approach to address multiple autoimmune disease pathologies; and our belief that all of our product candidates offer the potential for differentiation. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; raw material, important ancillary product and drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; changes in our operating plan, business development strategy or funding requirements; and existing or new competition. These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Every Second Counts! ® Kiniksa Investor and Media ContactRachel Frank(339) 970-9437rfrank@kiniksa.com KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC(FORMERLY KNOWN AS KINIKSA PHARMACEUTICALS, LTD.)SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)(In thousands)(Unaudited) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Revenue: Product revenue, net $103,394 $54,495 $182,279 $97,154 License and collaboration revenue 5,237 16,978 6,210 22,664 Total revenue 108,631 71,473 188,489 119,818 Costs and operating expenses: Cost of goods sold 12,322 7,699 22,905 14,735 Collaboration expenses 30,014 13,986 50,815 22,274 Research and development 24,017 23,767 50,351 38,939 Selling, general and administrative 42,395 29,175 81,077 58,220 Total operating expenses 108,748 74,627 205,148 134,168 Loss from operations (117) (3,154) (16,659) (14,350)Other income 2,421 1,915 4,687 3,747 Income (loss) before income taxes 2,304 (1,239) (11,972) (10,603)Benefit (provision) for income taxes (6,212) 16,211 (9,640) 13,305 Net income (loss) $(3,908) $14,972 $(21,612) $2,702 Net income (loss) per share attributable to ordinary shareholders—basic $(0.06) $0.21 $(0.31) $0.04 Net income (loss) per share attributable to ordinary shareholders—diluted $(0.06) $0.21 $(0.31) $0.04 Weighted average ordinary shares outstanding—basic 71,004,640 69,918,287 70,818,831 69,835,452 Weighted average ordinary shares outstanding—diluted 71,004,640 71,634,729 70,818,831 71,420,026 KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC(FORMERLY KNOWN AS KINIKSA PHARMACEUTICALS, LTD.)SELECTED CONSOLIDATED BALANCE SHEET DATA(In thousands)(Unaudited) As of June 30, December 31, 2024 2023 Cash, cash equivalents, and short-term investments $218,758 $206,371 Working capital 216,730 212,631 Total assets 542,428 526,322 Accumulated deficit (499,562) (477,950)Total shareholders' equity 435,095 438,839

Phase 2a trials of CNS-Penetrant NLRP3 Inhibitor VTX3232 to initiate in H2 2024 in patients with early Parkinson’s disease and in participants with obesity with certain additional cardiovascular risk factors Cash, cash equivalents and marketable securities of $302.6 million as of March 31, 2024 are expected to fund planned operations into at least the second half of 2026 Ventyx to host conference call and webcast today at 4:30PM ET SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced financial results for the first quarter ended March 31, 2024, and highlighted recent pipeline and business progress. “We are very excited to advance our portfolio of potential best-in-class oral NLRP3 inhibitors into Phase 2 trials in high value indications with substantial unmet medical need,” said Raju Mohan, Chief Executive Officer. “Meanwhile, we remain enthusiastic about our IBD assets and look forward to reporting topline Phase 2 data for our TYK2 inhibitor VTX958 in Crohn’s disease early in the second half of this year. We continue to believe that data from our Phase 2 study with our S1P1R modulator VTX002 in ulcerative colitis support a best-in-disease profile. We have initiated partnering efforts for VTX002 to support a pivotal Phase 3 trial.” Pipeline Updates VTX3232 (CNS-penetrant NLRP3 Inhibitor): In March, we announced positive topline results from a Phase 1 single- and multiple-ascending dose trial of VTX3232 in adult healthy volunteers. VTX3232 exhibited a dose-dependent and dose-linear pharmacokinetic profile with repeat once-daily doses of VTX3232 exceeding steady-state IL-1β IC90 coverage in both plasma and CSF over 24 hours. Robust, dose-dependent pharmacodynamic effects were observed in a whole blood ex vivo IL-1β stimulation assay and potent effects on both plasma and CSF biomarkers were demonstrated in both the SAD and MAD parts of the study. VTX3232 was well-tolerated with no dose-limiting toxicities identified. We believe these data support the potential for VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases.We expect to initiate a Phase 2a trial of VTX3232 in patients with early Parkinson’s disease during the second half of 2024 with biomarkers and imaging as key readouts. We also expect to initiate a Phase 2a trial of VTX3232 in the second half of 2024 in subjects with obesity and additional cardiovascular disease risk factors. Furthermore, we continue to evaluate VTX3232 in preclinical rodent models of diet-induced obesity and we look forward to providing an update on these studies later in the second quarter of this year. VTX2735 (Peripheral NLRP3 Inhibitor): In March, we announced positive topline results from a Phase 2 proof of concept trial of VTX2735 in patients with cryopyrin-associated periodic syndromes (CAPS), a group of rare autoinflammatory conditions caused by gain-of-function mutations in the NLRP3 gene. Treatment with VTX2735 demonstrated clinically meaningful improvements in disease activity, including an 85% mean reduction in the Key Symptom Score during Treatment Period 1. Reductions in inflammatory biomarkers were also observed, consistent with improvements in disease activity. VTX2735 was well-tolerated and all drug-related adverse events were graded mild. We are evaluating VTX2735 for future development in cardiovascular diseases with an initial focus on the secondary prevention of major adverse cardiovascular events (MACE) and recurrent pericarditis. We expect to provide further updates on this plan in the coming months.VTX002 (S1P1R Modulator): In October 2023 we announced positive results from the Phase 2 trial of VTX002 in patients with moderately to severely active ulcerative colitis (UC). We believe these results establish VTX002 as a potential best-in-disease oral agent in UC based on its differentiated efficacy profile, including a high rate of complete endoscopic remission, and its potential best-in-class safety profile. We recently completed a productive End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and we expect to conduct a Scientific Advice meeting with the European Medicines Agency (EMA) during the second quarter of this year. We intend to identify a partner or other source of non-dilutive financing to support the pivotal Phase 3 trial of VTX002 in UC.VTX958 (TYK2 Inhibitor): We are evaluating VTX958 in a Phase 2 trial in patients with moderately to severely active Crohn’s disease. In the first quarter of 2024, we implemented a protocol amendment for the ongoing Phase 2 trial to streamline trial design and accelerate the detection of an efficacy signal. As a result of the protocol amendment, target enrollment in the trial was revised from approximately 132 patients to approximately 93 patients. The trial’s sole primary endpoint is now the change from baseline in the mean Crohn’s disease activity index (CDAI) score at Week 12. We have completed enrollment in the trial, and we expect to report topline results early in the second half of 2024. Conference Call Information Ventyx will host a conference call today at 4:30 p.m. ET to discuss its first quarter 2024 financial results and provide a corporate update. To participate in the conference call, please dial (800) 343-4849 (U.S.) or (203) 518-9848 (international) and reference passcode VTYXQ124. A live audio webcast will be available in the Investors section of the company’s website at www.ventyxbio.com. A recording of the webcast will be available for thirty days following the call. First Quarter 2024 Financial Results: Cash Position: Cash, cash equivalents and marketable securities were $302.6 million as of March 31, 2024. We believe our current cash, cash equivalents and marketable securities are sufficient to fund our planned operations into at least the second half of 2026.Research and Development (R&D) expenses: R&D expenses were $33.7 million for the first quarter of 2024, compared to $35.4 million for the first quarter of 2023.General and Administrative (G&A) expenses: G&A expenses were $8.0 million for the first quarter of 2024, compared to $7.1 million for the first quarter of 2023.Net loss: Net loss was $38.6 million for the first quarter of 2024, compared to $38.9 million for the first quarter of 2023. About Ventyx Biosciences Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical need with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. Ventyx is headquartered in San Diego, California. For more information about Ventyx, please visit www.ventyxbio.com. Forward-Looking Statements Ventyx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Ventyx’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential of Ventyx’s product candidates, including the potential of VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases, and the potential of VTX002 as a best-in-disease oral agent in UC; the potentially differentiated profile of VTX002 in UC; the anticipated continued progression of the development pipeline for Ventyx’s product candidates, including the anticipated timing for the initiation of Phase 2a trials of VTX3232 in Parkinson’s disease and obesity in H2 2024, the plan to evaluate VTX3232 in preclinical rodent models of diet-induced obesity; and the plan to evaluate VTX2735 in cardiovascular diseases; management’s plans with respect to a potential pivotal Phase 3 trial for VTX002 in UC, supported by a partner or other source of non-dilutive financing; the expectation to meet with EMA for a Scientific Advice meeting regarding VTX002; the anticipated timing of announcing the results of the VTX958 Phase 2 trial in Crohn’s disease; and the expected timeframe for funding Ventyx’s operating plan with current cash, cash equivalents and marketable securities. The inclusion of forward-looking statements should not be regarded as a representation by Ventyx that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Ventyx’s business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; Ventyx’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; disruptions in the supply chain, including raw materials needed for manufacturing and animals used in research, delays in site activations and enrollment of clinical trials; the results of preclinical studies and clinical trials; early clinical trials not necessarily being predictive of future results; interim results not necessarily being predictive of final results; the potential of one or more outcomes to materially change as a trial continues and more patient data become available and following more comprehensive audit and verification procedures; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of Ventyx’s product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Ventyx’s ability to obtain and maintain intellectual property protection for its product candidates; the use of capital resources by Ventyx sooner than expected; and other risks described in Ventyx’s prior press releases and Ventyx’s filings with the Securities and Exchange Commission (SEC), including in Part II, Item 1A (Risk Factors) of Ventyx’s Quarterly Report on Form 10-K for the quarter ended March 31, 2024, filed on or about May 9, 2024, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Ventyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor Relations ContactPatti BankManaging DirectorICR Westwicke(415) 513-1284IR@ventyxbio.com Ventyx Biosciences, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(unaudited) Three months ended March 31, 2024 2023 Operating expenses: Research and development $33,747 $35,437 General and administrative 8,021 7,115 Total operating expenses 41,768 42,552 Loss from operations (41,768) (42,552)Other (income) expense: Interest income (3,227) (3,622)Other expense 31 1 Total other (income) expense (3,196) (3,621)Net loss $(38,572) $(38,931)Unrealized gain (loss) on marketable securities (62) 539 Foreign currency translation (9) 23 Comprehensive loss $(38,643) $(38,369)Net loss per share, basic and diluted $(0.62) $(0.68)Weighted average common shares outstanding, basic and diluted 61,829,976 57,638,923 Ventyx Biosciences, Inc.Selected Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) March 31, December 31, 2024 2023 Cash, cash equivalents and marketable securities $302,582 $252,220 Working capital 305,225 242,080 Total assets 332,078 277,693 Total liabilities 25,082 33,770 Accumulated deficit (457,759) (419,187)Total stockholders' equity 306,996 243,923