Category: 3. Business

A recent announcement by the Saudi Capital Market Authority has lifted the final barriers to direct foreign ownership of Saudi stocks. Although qualified foreign investors have had access since 2015, the process involved registration requirements and certain restrictions. The new rules simplify access, allowing all international investors to participate directly on par with domestic investors. 

The key positive impacts may include enhanced liquidity, improved market valuations, faster integration into global indices, diversification of the investor base, and knowledge transfer. On the other hand, challenges may include increased correlation with global markets, potential short-term volatility driven by external factors, and the need for continuous regulatory evolution to align with global standards. 

Regarding timing, Saudi Arabia presents a unique and increasingly attractive investment opportunity, backed by strong fundamentals such as economic size and reform momentum, high market capitalization, a robust fiscal position, and substantial foreign exchange reserves, all supported by a young and expanding population that fuels domestic consumption. 

The full opening of the Saudi capital market marks a milestone with wide-reaching impacts. It significantly enhances liquidity, valuation prospects, and global integration, strengthening Tadawul’s position as a key G20 market. The market’s attractiveness is evident, supported by solid fundamentals, unique opportunities driven by Vision 2030, and rapidly improving infrastructure and regulation, although cautious investors continue to weigh valuations and geopolitical risks. 

Foreign institutions tend to prioritize markets with strong, independent exchange governance. The new board signals Tadawul’s shift from a state-run entity to a commercially oriented, globally competitive exchange group that focuses on investor needs and aligns with leading international standards. This change directly reduces perceived operational and governance risks, making the market more attractive to global investors. 

The new Tadawul board, led by Mazin Al-Romaih, is well positioned to play an important role. Its focus on governance, international engagement, product innovation, and alignment with national goals directly addresses key requirements for attracting and retaining foreign institutional investment. 

Al-Romaih’s broad experience with global and local financial institutions, along with his expertise from his tenure at the Saudi Capital Market Authority, makes him highly qualified to lead and oversee this important transition. 

Saudi Arabia is not merely opening its market; it is actively transforming it to become a central pillar of its future economy. For foreign investors, it offers a compelling, dynamic, and increasingly sophisticated opportunity. The pace of change has accelerated, and the world is watching as liquidity is expected to flow into one of the world’s most attractive capital markets. 

• Basil M.K. Al-Ghalayini is chairman and CEO of BMG Financial Group.

 

Preliminary 4Q 2025 VYJUVEK net revenue of $106 million to $107 million

Robust clinical pipeline with multibillion dollar opportunities and strong balance sheet for sustained growth

PITTSBURGH, Jan. 11, 2026 (GLOBE NEWSWIRE) — Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced selected preliminary unaudited 2025 financial results, including fourth quarter and full year 2025 VYJUVEK® net product revenue, and outlined the Company’s strategic vision to drive the next stage of growth of its rare disease business. These topics will be discussed during the Company’s presentation at the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco tomorrow, Monday, January 12, 2026, at 10:30 am ET / 7:30 am PT.

“2025 was a standout year for Krystal, with the successful launch of VYJUVEK in Europe and Japan setting the foundation for our broader ambitions to build a true global leader in rare disease,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. “As we execute on the next stage of our growth story, we will be leaning into our strengths – the strengths of our HSV-1 platform and the strengths of our organization – and focusing in on rare disease indications where we can move quickly and launch truly differentiated and impactful redosable genetic medicines. With multiple potential blockbuster launches in the next four years, as well as a strong growth outlook for VYJUVEK, we are well positioned to execute on this vision and deliver transformational outcomes for patients.”

Preliminary and Unaudited Fourth Quarter and Full Year 2025 Financial Updates

Based on preliminary unaudited financial information, the Company expects net product revenue for VYJUVEK to be between $106 million and $107 million for the fourth quarter of 2025. VYJUVEK net revenue for the full year 2025 is expected to be between $388 million and $389 million.

Cash, cash equivalents, and investments were approximately $955 million as of December 31, 2025.

These preliminary unaudited results are based on management’s initial analysis of operations for the year ended December 31, 2025 and subject to adjustment. The Company will report its full financial results for the fourth quarter and full year 2025 in February 2026.

Rare Disease Strategic Vision and 2026 Corporate Objectives

Over 300 million people around the world are living with rare diseases, many of whom lack adequate therapies. With global rare disease drug development and launch infrastructure and a redosable HSV-1 platform with Platform Technology Designation that is well-suited for gene delivery to high turnover tissues in the skin, lung, and eye, the Company is uniquely positioned to help fill this treatment gap.

To that end, the Company is accelerating and expanding clinical development efforts for its rare disease pipeline of programs:

• KB803 for ocular complications of dystrophic epidermolysis bullosa (DEB)
• KB801 for neurotrophic keratitis (NK)
• KB407 for cystic fibrosis (CF)
• KB111 for Hailey-Hailey disease (HHD)

In support of potential expedited development of KB801 for the treatment of NK, the Company has increased the enrollment target of its ongoing registrational double-masked, randomized, placebo-controlled study from 27 to 60 patients. The Company will provide a detailed update on the registrational study design when it reports its 2025 financial results in February 2026. Top line data from the study is expected before the end of 2026.

The Company’s strategic vision is to have at least four marketed rare disease medicines, inclusive of VYJUVEK, by the end of 2030, treating over 10,000 patients worldwide.

The Company expects to achieve these goals while remaining profitable throughout the period and continuing to invest strategically across its broader preclinical and clinical pipeline, including programs targeting larger indications such as KB408 for alpha-1 antitrypsin deficiency and KB707 for non-small cell lung cancer.

To achieve the Company’s broader ambitions in rare disease, the Company’s corporate objectives for 2026 include:

• Launch VYJUVEK in at least one more major European market and expand specialty distributor network to cover over 40 countries
• Report top-line results from its registrational Phase 3 study evaluating KB803 for the treatment of ocular complications of DEB
• Report top-line results from its registrational double-masked, randomized, placebo-controlled study evaluating KB801 for the treatment of NK
• Initiate and complete enrollment in a registrational repeat dose study evaluating KB407 for the treatment of CF
• Dose first patient in registrational double-blind, intra-patient randomized, placebo-controlled study evaluating KB111 in HHD patients

The Company also expects to report updates for both KB408 and KB707 before the end of the year.

Non-GAAP Research & Development (R&D) and Selling, General & Administrative (SG&A) Expense Guidance for 2026

Based on its current operating plans, the Company expects its combined non-GAAP R&D and SG&A expense in 2026 to be between $175 million and $195 million. Non-GAAP R&D and SG&A expense does not include stock-based compensation.

44^th Annual J.P. Morgan Healthcare Conference Presentation and Webcast

Krish S. Krishnan, Chairman and Chief Executive Officer, and Suma M. Krishnan, President of Research and Development, will highlight these updates and Krystal’s strategic vision in a presentation at the 44^th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 10:30 am ET / 7:30 am PT.

A webcast of the presentation will be available here beginning at 10:30 am ET / 7:30 am PT on Monday, January 12, 2026 and will be posted on the Investors section of the Company’s website.

About Krystal Biotech, Inc.

Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. For more information, please visit http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn and X (formerly Twitter).

Forward-Looking Statements

Statements in this press release about future expectations, plans, and prospects, as well as statements that are not historical facts, including statements about, among other topics, our selected preliminary and unaudited financial results for 2025; our strategic vision and our 2026 corporate goals; our combined R&D and SG&A expense guidance; and our expectations for our product pipeline, including clinical trial plans, enrollment in clinical trials, and the timing of initiating clinical trials, dosing patients, data read-outs, and regulatory submissions may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Undue reliance should not be placed on the forward-looking statements in this press release. These statements are not guaranties of future performance and actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the availability or commercial potential of VYJUVEK or our product candidates; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. The Company is providing the information in this press release as of the date hereof and undertakes no duty to update this information unless required by law.

Non-GAAP Financial Measure

This press release includes forward-looking combined R&D and SG&A expense guidance that is not required by, or presented in accordance with, U.S. GAAP. The Company believes this non-GAAP financial measure is useful to investors as a supplemental measure to evaluate operating performance. The Company has not provided a quantitative reconciliation of forecasted non-GAAP combined R&D and SG&A expense to forecasted GAAP combined R&D and SG&A expense because the Company is unable, without making unreasonable efforts, to calculate the reconciling item, stock-based compensation expenses, with confidence. This item, which could materially affect the computation of forward-looking GAAP combined R&D and SG&A expense, is inherently uncertain and depends on various factors, some of which are outside of the Company’s control.

CONTACT
Investors and Media:Stéphane PaquetteKrystal Biotech
spaquette@krystalbio.com

Source: Krystal Biotech, Inc.

The Bluescope (ASX: BSL) board has unanimously rejected a takeover proposal of $30 per share from an Australian and US consortium comprising Seven Group Holdings and Steel Dynamics.

Why it matters: We are not surprised by the rejection. Bluescope rebuffed prior approaches, and the board has made it clear it thinks the offer undervalues the company, including its land bank and future returns on current organizational and capital projects.

• The bid was Steel Dynamics’ fourth offer in 18 months, but the first with SGH. The two have entered a 12-month exclusivity agreement and invested resources, informing our confidence that a further offer is possible. We think the market agrees, with shares trading close to the failed bid price.

The bottom line: We’ve taken a closer look at our tariff assumptions and Bluescope’s land bank, raising our fair value estimate for no-moat Bluescope by 8% to $27 from $25 previously, and our stand-alone fair value estimate by 21% to $24.00 from $19.80 previously.

• We now ascribe a 25% chance that US tariffs persist for longer. So, we lift our midcycle EBIT assumption for North Star by 10% to $745 million, from $680 million, to reflect this probability.
• Likewise, we consider the possibility of tariffs being implemented in Australia and apply a 25% probability weighting to our spreads from fiscal 2029. We assume tariffs land at 25% and lift our midcycle EBIT assumption for Australia by 4% to $595 million (from $570 million).

Between the lines: Bluescope has a large excess land portfolio. We think management’s valuation of up to $2.8 billion may be optimistic, as it assumes all land is residentially zoned and sells at the same price per hectare as its most recent sale in Dapto, near its Port Kembla plant.

• We assume a present value for the land of $1.1 billion, or $2.50 per share. About one-fifth of it is zoned residential, but we are not certain if or when the remaining 1,000 hectares will be zoned residential.

Raising our Bluescope valuation on tariff outlook and property portfolio

Over the past decade, BlueScope Steel has transitioned away from the highly contested global markets, where returns are generally poor. The company’s strategy is to run a cost-competitive steel business that underpins the profitability of its premium branded products. Serving the residential, nonresidential, and construction markets, key branded products include Colorbond, Truecore, Zincalume, and Lysaght.

In Australia and New Zealand, where BlueScope has been operating for almost 60 years, about half of sales volumes are value-added products. However, in Asia these products are nascent, and in the US they are emerging. The group is targeting sales growth in the US via a bolt-on acquisition of a coil coating company, the second largest of its kind in North America. While we commend the strategy, which has served the company well in its antipodean locations, we think it is likely to take time for value-added products to become a meaningful contributor in the US. Our midcycle segment forecast includes only a small operating margin and revenue uplift from value-added sales.

The group’s Ohio-based North Star operations are the crown jewel. North Star specializes in the production of flat steel products for US customers in the automotive, nonresidential, and manufacturing sectors. The business operates efficient electric arc furnace-based capacity, which produces steel at a relatively low cost per unit. North Star demonstrates industry-leading operating margins and operates at a nearly full utilization rate.

BlueScope has gradually expanded production capacity at North Star to capture a greater share of demand and to reduce unit costs to maximize returns. We estimate production ramping up to 3.4 million metric tons by fiscal 2028 from 2.7 million in fiscal 2024 as the company completes a series of small debottlenecking projects. The firm’s strategy is to direct most additional volumes to its higher-margin coil coating business.

Bulls say

• North Star is expected to sell additional volumes following its recent capacity expansion and should continue to operate with high utilization and high efficiency.
• Increased market adoption of BlueScope’s branded products helps increase the share of branded products in total sales and supports margins in Australian steel products.
• Capital investment and a strategic focus in coating capacity in the US should increase sales of higher-margin products in the region.

Bears say

• The addition of competing electric arc furnace-based steel capacity leads to a flattening in the North American steel cost curve, reducing North Star margins.
• Automotive, nonresidential, and manufacturing activity could soften, thereby reducing demand for BlueScope’s products and services in the US.
• BlueScope is exposed to cyclicality, and demand is sensitive to construction activity.

Get Morningstar insights in your inbox

Terms used in this article

Star Rating: Our one- to five-star ratings are guideposts to a broad audience and individuals must consider their own specific investment goals, risk tolerance, and several other factors. A five-star rating means our analysts think the current market price likely represents an excessively pessimistic outlook and that beyond fair risk-adjusted returns are likely over a long timeframe. A one-star rating means our analysts think the market is pricing in an excessively optimistic outlook, limiting upside potential and leaving the investor exposed to capital loss.

Fair Value: Morningstar’s Fair Value estimate results from a detailed projection of a company’s future cash flows, resulting from our analysts’ independent primary research. Price To Fair Value measures the current market price against estimated Fair Value. If a company’s stock trades at $100 and our analysts believe it is worth $200, the price to fair value ratio would be 0.5. A Price to Fair Value over 1 suggests the share is overvalued.

Moat Rating: An economic moat is a structural feature that allows a firm to sustain excess profits over a long period. Companies with a narrow moat are those we believe are more likely than not to sustain excess returns for at least a decade. For wide-moat companies, we have high confidence that excess returns will persist for 10 years and are likely to persist at least 20 years. To learn about finding different sources of moat, read this article by Mark LaMonica.

A section of the M6 has reopened earlier than expected after a new bridge was installed.

The Clifton railway bridge near Penrith has been replaced by Network Rail and Skanska as part of a £60m investment into the West Coast Main Line.

A road closure was put in place between junctions 39 and 40 for the duration of the weekend and the road, which was due to open at 05:00 GMT on Monday, re-opened at 16:00.

Christian Irwin, Network Rail North West and Central director, said it took “hard work” from hundreds of people to install the new structure so quickly.

PLEASANTON, Calif., Jan. 11, 2026 /PRNewswire/ — 10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, today announced preliminary, unaudited select results for the fourth quarter and full year ended December 31, 2025.

Preliminary, Unaudited Select Fourth Quarter 2025 Financial Results

• Revenue of approximately $166.0 million for the three months ended December 31, 2025, representing 11% growth sequentially and 1% growth compared to the corresponding prior year period.
• Instruments revenue of approximately $15.5 million, representing 29% growth sequentially and a 36% decrease as compared to the corresponding prior year period. Instruments revenue consists of approximately $6.1 million of Single Cell instruments revenue, representing 24% growth sequentially and a 44% decrease year-over-year, and $9.4 million of Spatial instruments revenue, representing 32% growth sequentially and a 30% decrease year-over-year.
• Consumables revenue of approximately $141.7 million, representing 11% growth sequentially and a 6% increase as compared to the corresponding prior year period. Consumables revenue consists of approximately $100.8 million of Single Cell consumables revenue, representing 9% growth sequentially and 3% growth year-over-year, and $41.0 million of Spatial consumables revenue, representing 16% growth sequentially and 14% growth year-over-year.
• Services and License and Royalty revenue of approximately $8.8 million, representing a 3% decrease sequentially and 23% growth year-over-year.

Preliminary, Unaudited Select Full Year 2025 Financial Results

• Revenue of approximately $642.8 million for the year ended December 31, 2025. Excluding $44.1 million related to patent litigation settlements in the first and second quarters, full year 2025 revenue was approximately $598.7 million, representing a 2% decrease from the prior year.
• Instruments revenue of approximately $56.8 million, representing a 39% decrease from the prior year. Instruments revenue consists of approximately $22.7 million of Single Cell instruments revenue, representing a 36% decrease year-over-year and $34.1 million of Spatial instruments revenue, representing a 41% decrease year-over-year.
• Consumables revenue of approximately $507.2 million, representing 3% growth over the prior year. Consumables revenue consists of approximately $363.2 million of Single Cell consumables revenue, representing a 2% decrease year-over-year and $144.0 million of Spatial consumables revenue, representing 19% growth year-over-year.
• Services and License and Royalty revenue of approximately $34.8 million, excluding $44.1 million of upfront payments related to patent litigation settlements in the first and second quarters, representing 41% growth year-over-year.
• Increased cumulative Chromium instruments sold to more than 6,400 instruments and cumulative Spatial instruments sold to more than 1,500 as of the end of 2025.
• Single Cell consumables reactions sold increased by more than 20% compared to the prior year period.
• Cash, cash equivalents and marketable securities of approximately $520 million as of December 31, 2025.

“I am incredibly proud of the tenacity and ingenuity our team displayed throughout 2025,” said Serge Saxonov, Co-founder and CEO of 10x Genomics. “While the macro environment was challenging, the team forged even stronger partnerships with customers, made important progress across our product roadmap and maintained tight operational discipline, leading to a significant strengthening of our balance sheet. I am confident that our greatest impact lies ahead and 10x is well positioned for the future.”

J.P. Morgan Healthcare Conference
10x Genomics, Inc. is providing these updates in advance of its participation in the 44th Annual J.P. Morgan Healthcare Conference, which begins tomorrow. A live webcast of the company’s presentation and question and answer session, which begins at 8:15 a.m. Pacific Time on Monday, January 12, 2026, will be available on the “Investors” section of the company’s website at: https://investors.10xgenomics.com/. The webcast will be archived and available for replay for at least 30 days after the event.

Preliminary Select Results Subject to Adjustment
10x Genomics, Inc. has not completed preparation of its consolidated financial statements for the fourth quarter or fiscal year of 2025. The select results presented in this news release for the fourth quarter and year ended December 31, 2025 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete preparation of our consolidated financial statements for the year ended December 31, 2025. 10x Genomics, Inc. is in the process of completing its customary year-end close and review procedures as of and for the fourth quarter and year ended December 31, 2025, and there can be no assurance that final results for these periods will not differ from these estimates. During the course of the preparation of 10x Genomics, Inc.’s consolidated financial statements and related notes as of and for the year ended December 31, 2025, we or our independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary unaudited financial estimates presented herein.

About 10x Genomics
10x Genomics is a life science technology company building products to accelerate the mastery of biology and advance human health. Our integrated research solutions include instruments, consumables and software for single cell and spatial biology, which help academic and translational researchers and biopharmaceutical companies understand biological systems at a resolution and scale that matches the complexity of biology. Our products are behind breakthroughs in oncology, immunology, neuroscience and more, fueling powerful discoveries that are transforming the world’s understanding of health and disease. To learn more, visit 10xgenomics.com or connect with us on LinkedIn, X, Facebook, Bluesky or YouTube.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements included in this press release, other than statements of historical facts, may be forward-looking statements. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “see,” “estimate,” “predict,” “potential,” “would,” “likely,” “seek” or “continue” or the negatives of these terms or variations of them or similar terminology, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include statements regarding 10x Genomics, Inc.’s expected financial results for the fourth quarter and year ended December 31, 2025 and our future opportunities and performance. These statements are based on management’s current expectations, forecasts, beliefs, assumptions and information available to management as of the date hereof. Actual outcomes and results could differ materially from these statements due to a number of factors and such statements should not be relied upon as representing 10x Genomics, Inc.’s views as of any date subsequent to the date of this press release. 10x Genomics, Inc. disclaims any obligation to update any forward-looking statements provided to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based, except as required by law. Although 10x Genomics believes that the expectations reflected in the forward-looking statements are reasonable, it cannot provide any assurance that these expectations will prove to be correct nor can it guarantee that the future results reflected in the forward-looking statements will be achieved or will occur. The material risks and uncertainties that could affect 10x Genomics, Inc.’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the company’s most recently-filed 10-K, 10-Q and elsewhere in the documents 10x Genomics, Inc. files with the Securities and Exchange Commission from time to time. 10x Genomics’ products are for research use only (RUO) and are not for use in diagnostic procedures. “10x Genomics”, “Chromium” and “Xenium” are trademarks of 10x. 10x trademarks are the sole property of 10x, and are subject to legal protection in the United States and/or certain other countries.

Disclosure Information
10x Genomics uses filings with the Securities and Exchange Commission, its website (www.10xgenomics.com), press releases, public conference calls, public webcasts and its social media accounts as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Contacts
Investors: [email protected]
Media: [email protected]

SOURCE 10x Genomics, Inc.

SOUTH SAN FRANCISCO, Calif., Jan. 11, 2026 /PRNewswire/ — IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, provided a business update including an overview of key corporate objectives for 2026. The company will review these updates during its presentation at the 44^th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 3:45pm PST.

“2025 was a year of execution, marked by broad pipeline advancement, commercial readiness activities for darovasertib, and the filing of four INDs resulting in nine clinical programs. Our deep pipeline and cash runway into 2030 enable IDEAYA to advance key combinations and to address multiple indications with high unmet need, including uveal melanoma, small cell lung cancer, neuroendocrine cancer, breast cancer, and MTAP-deleted lung, pancreatic, and urothelial cancers. In 2026, we plan to advance four registrational trials, including for IDE849, our Phase 1 DLL3 TOP1 ADC, as a monotherapy agent in neuroendocrine cancer, and darovasertib in both pre-metastatic and metastatic settings of uveal melanoma. These trials for darovasertib are central to our strategy to save eyes, preserve vision, and extend lives for patients with uveal melanoma – one of the poorest prognosis indications in oncology where the majority of patients have no available FDA approved therapies,” said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

2026 Corporate Objectives

Darovasertib in uveal melanoma (UM)

• Topline results, including progression free survival (PFS) data, from ongoing registrational Phase 2/3 OptimUM-02 trial of the darovasertib and crizotinib combination in first line (1L) patients with HLA*A2-negative metastatic UM (mUM) are expected in Q1 ’26
  • Randomized PFS analysis is based on the first 130 PFS events from the intent-to-treat population (ITT) enrolled in the Phase 2b/3 portion of the trial, which comprises approximately 313 patients randomized 2:1 to the treatment versus control arm. The topline PFS results, if positive, are anticipated to enable a potential accelerated approval filing in the United States
• Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 ’26
  • OptimUM-02 (mUM): full enrollment of 437 patients complete; overall survival (OS) data expected to support a filing for full approval in 1L HLA*A2-negative mUM
  • OptimUM-10 (neoadjuvant): complete full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts by H1 ’27
  • OptimUM-11 (adjuvant): initiate trial in collaboration with Servier in Q2 ’26
• Complete enrollment of approximately 80 HLA*A2-positive mUM patients in ongoing single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib by Q2 ’26; data to support a potential real world evidence (RWE) submission to the U.S. Food and Drug Administration (FDA) and/or NCCN/compendia listing in this patient subset

Antibody-drug Conjugate (ADC) + DNA damage response (DDR) combinations

• IDE849 (DLL3 TOP1 ADC): target to initiate a monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) by the end of 2026
• IDE034 (B7H3/PTK7 bispecific TOP1 ADC): initiate Phase 1 dose escalation trial in Q1 ’26
• IDE161 (PARG): initiate clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 ’26

MTAP Pathway

• IDE397 (MAT2A): provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026
• IDE892 (PRMT5): initiate a Phase 1 monotherapy dose escalation trial in Q1 ’26 to enable a combination trial with IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) in Q2 ’26
• Submit an investigational new drug (IND) application for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, by the end of 2026. With the CDKN2A candidate, IDEAYA plans to enable wholly owned combinations with IDE892 and IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and with IDE574, IDEAYA’s dual KAT6/7 inhibitor

Next Generation Therapies

• IDE574 (KAT6/7): obtained clearance of an IND application with the U.S. FDA in January 2026; target to initiate Phase 1 dose escalation trial in Q1 ’26

Corporate

• ~$1.1 billion in cash, cash equivalents and marketable securities as of 9/30/25; expected to fund current operating plan into 2030
• Darovasertib commercial readiness activities advancing in the United States and globally with their partner, Servier

IDEAYA’s updated corporate presentation reflecting its 2026 corporate guidance is available on its website under the Investor Relations section: https://ir.ideayabio.com/.

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to: i) the potential therapeutic benefits of IDEAYA therapeutics; (ii) the timing and content of clinical program updates, regulatory updates and clinical trial data readouts, including those at medical conferences; (iii) the potential and timing for an accelerated approval filing for darovasertib; (iv) the timing of darovasertib in three Phase 3 registrational trials across all stages of UM; (v) the utilization of OS data to support a potential full approval filing for darovasertib; (vi) the timing of initiating registrational studies and other clinical trials for IDEAYA therapeutics; (vii) the timing of patient enrollments in clinical trials; (viii) the timing of IND submissions for IDEAYA therapeutics; and (iv) the extent to which IDEAYA’s existing cash, cash equivalents, and marketable securities will fund its current operating plan. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA’s current and future filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K filed on February 18, 2025.

Investor and Media Contact

IDEAYA Biosciences

Joshua Bleharski, Ph.D.

Chief Financial Officer

[email protected]

SOURCE IDEAYA Biosciences, Inc.

According to the Local Democracy Reporting Service, 22 objections have been made by people living nearby and from Headingley and Hyde Park councillor Tim Goodall.

Goodall said: “Allowing the Golden Beam to open later is likely to lead to increased consumption of alcohol, which is then likely to lead to an even higher rate of drunk and disorderly crime.”

When considering the extended hours, councillors will have the option of granting or refusing the application, or allowing it with additional conditions.

The Golden Beam, which opened in 2021, was allowed to serve Otley Runners across five consecutive Saturdays in September and October using a Temporary Event Notice (TEN).

The Otley Run, a 19-stop bar crawl through Headingley, attracts thousands of participants every year but has drawn complaints of anti-social behaviour including violence, littering and public urination.