Malignant melanoma of eye

ATLANTA, March 19, 2024 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, announces that the first patient has been randomized in the DRCR Retina Network’s Protocol AL. The study is titled, “A Randomized Clinical Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss due to Radiation Retinopathy.” The study, chaired by Arun Singh, M.D. (Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio), plans to include 600 participants with primary choroidal melanoma receiving treatment with plaque brachytherapy. It will assess development of macular edema and associated long-term visual acuity effects of consistent and continuous release of corticosteroid or repeated injections of anti-VEGF initiated near the time of radiation therapy compared to observation until macular edema develops in patients at risk for radiation retinopathy. “We are very excited that this study is underway as it has the potential to show ILUVIEN addressing another unmet need affecting the retina,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “We believe ILUVIEN with CONTINUOUS MICRODOSING™ delivery may prevent, delay or reduce the occurrence of the complication of radiation retinopathy and consequent vision loss when used in patients treated with plaque brachytherapy and look forward to the continuing progress of this study.” About Radiation Retinopathy Radiation retinopathy (RR) is a common complication after Iodine-125 plaque brachytherapy for choroidal melanoma. Although the initial radiation insult is immediate, clinical onset of RR is not seen until many months later and RR frequently progresses over time to profound vision loss. The Collaborative Ocular Melanoma Study reported that at three years, 45% of patients have visual acuity 20/200 or worse. A treatment that prevents the development of RR, or dampens its severity, would have important consequences for many of these eyes that may be successfully treated for choroidal melanoma but will likely develop severe RR and loss of vision over time. About the DRCR Retina Network (DRCR.net) The DRCR Retina Network was formed in 2002 and includes clinical sites and physicians throughout the United States and Canada. It is funded by the National Eye Institute (NEI), part of the National Institutes of Health, which is the federal government agency that funds medical research. The DRCR Retina Network is supported in overall operation and leadership by the office of the Network Chairs (Daniel F. Martin, M.D., Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio and Jennifer K. Sun, M.D., M.P.H., Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts) and the Coordinating Center (Executive Director Adam R. Glassman, M.S., Jaeb Center for Health Research, Tampa, FL), and the National Eye Institute (Project Officer, Sangeeta Bhargava, Ph.D.). About ILUVIEN The Company’s primary product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Kuwait, Lebanon and the U.A.E. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands, and Luxembourg. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in late 2019, Belgium in 2021 and Spain and Italy in 2022. Alimera markets YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18mg for treatment of uveitis in the United States. About Alimera Sciences, Inc. Alimera Sciences is a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. For more information, please visit . Forward Looking Statements This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s expectations with respect to ILUVIEN’s potential to address another unmet need affecting the retina. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, ILUVIEN’s ability to prevent or reduce the occurrence of the complication of radiation retinopathy and consequent vision loss when used in patients treated with plaque brachytherapy, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2023 which is on the Securities and Exchange Commission (SEC) and available on the SEC’s website at All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For press inquiries: Cassy Dump for Alimera Sciences 619-971-1887 cassydoespr@gmail.com For investor inquiries: Scott Gordon for Alimera Sciences scottg@coreir.com

Targeting two independent Phase 2 clinical efficacy updates for darovasertib in neoadjuvant uveal melanoma (UM) in mid-2024, including from the Phase 2 IST and Phase 2 company-sponsored study Targeting FDA regulatory guidance on darovasertib in neoadjuvant UM indication in 2024 Ongoing enrollment of IDE397 and AMG 193 Phase 1 combo in MTAP solid tumors and targeting development of joint Amgen / IDEAYA publication strategy in 2024 Established clinical study collaboration with Gilead Sciences to evaluate IDE397 and Trodelvy® combo in MTAP bladder cancer with FPI targeted for mid-year 2024 Targeting IDE161 clinical program update(s) and enabling of clinical combination(s) in 2024 Targeting Werner IND-filing in 2024 ($7.0 million milestone upon IND clearance) in collaboration with GSK Targeting multiple wholly-owned next generation development candidate nominations in 2024, including in MTAP, representing 7 or more potential first-in-class programs $632.6 million cash balance as of December 31, 2023, supplemented by net proceeds of $342.3 million from January 2024 ATM offerings, expected to fund operations into 2028 SOUTH SAN FRANCISCO, Calif., Feb. 20, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, provided a business update and announced financial results for the quarter and full-year ended December 31, 2023. "We believe the ongoing clinical advancement of darovasertib in neoadjuvant Uveal Melanoma, IDE397 and AMG 193 clinical combination in MTAP solid tumors, and IDE161 and GSK101 both in HRD solid tumors, represent important clinical initiatives for IDEAYA in 2024 as potential first-in-class opportunities that address high unmet medical needs. Next, we are targeting this year the Werner IND-filing and multiple development candidate nominations, including in MTAP, representing 7 or more potential first-in-class programs and further advancing our vision to build a leading precision medicine oncology company," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. "We have seen compelling results from our Phase 2 darovasertib and crizotinib program in patients with MUM and are targeting two clinical efficacy updates from our Phase 2 company sponsored neoadjuvant UM study and Phase 2 IST in mid-year 2024. Our IDE397 program trials remain on track, and we established a new clinical trial collaboration with Gilead Sciences to evaluate IDE397 in combination with Trodelvy® in patients with bladder cancer, with trial initiation activities now underway. Additionally, IND-enabling studies of the Werner helicase inhibitor for microsatellite instability (MSI)-high cancers are progressing well, further expanding our pipeline of first-in-class precision medicine candidates." added Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences. Recent Key Developments Reported top-line results of darovasertib and crizotinib combination demonstrating evidence of superior clinical efficacy in any-line and first-line MUM patients compared to standard of care as a Proffered Paper oral presentation at the 2023 European Society for Medical Oncology's Congress (ESMO). Expanded Phase 2 trial evaluating the darovasertib and crizotinib combination in GNAQ/11 metastatic cutaneous melanoma based on preliminary clinical efficacy observed. Selected Werner helicase inhibitor development candidate and progressing IND-enabling GLP studies in collaboration with GSK; received $3.0 million milestone and eligible to receive $17.0 million aggregate milestones payments through early Phase 1 clinical studies, including $7.0 million upon investigational new drug (IND) clearance. IDEAYA is also eligible to receive future aggregate development milestones of up to $465.0 million and commercial milestones of up to $475.0 million and 50% of U.S. net profits. Established clinical study collaboration with Gilead Sciences to evaluate IDE397 and Trodelvy® combination in MTAP-deletion bladder cancer. Significantly expanded balance sheet Raised gross proceeds of approximately $352.0 million in January 2024 through at-the-market offerings. Raised gross proceeds of approximately $143.7 million in October 2023 through a follow-on public offering. Hosted an R&D Investor Day in December 2023 showcasing the synthetic lethality pipeline, including IDE397 in Phase 2, IDE161 in Phase 1, GSK101/IDE705 in Phase 1, and the Werner Helicase program, as well as its next generation initiatives for MTAP-deletion. Clinical Programs Update and Upcoming Milestones Darovasertib Program in Tumors with GNAQ or GNA11 Mutations Darovasertib is a potent and selective protein kinase C (PKC) inhibitor for which the Company owns the worldwide commercial rights, subject to certain economic obligations pursuant to its exclusive, worldwide license with Novartis. IDEAYA is developing darovasertib to broadly address primary and metastatic UM. Darovasertib is currently being evaluated in four ongoing clinical trials, three of which are in collaboration with Pfizer. The darovasertib + crizotinib combination in MUM has U.S. Food & Drug Administration (FDA) Fast Track designation. IDE196-002: Phase 2/3 Potential Registration-Enabling Clinical Trial of Darovasertib + Crizotinib combination in First-Line HLA-A2*02:01(-) MUM This study (NCT05987332) has an accelerated approval trial design and international site activation, and double-digit patient enrollment has been achieved to date. The company has several clinical sites open and is targeting to open an aggregate of over 50 clinical sites across U.S., Canada, Europe and Australia to support this registrational study. Clinical program update(s) are anticipated in 2024. IDE196-001: Phase 1/2 Clinical Trial Evaluating Darovasertib + Crizotinib Combination in MUM A clinical update of preliminary data from 20 evaluable first-line and 63 evaluable any-line patients from the study (NCT03947385) at the expansion dose of 300 mg twice-a-day darovasertib and 200 mg twice-a-day crizotinib was presented at ESMO 2023. Darovasertib and crizotinib combination treatment demonstrated evidence of superior clinical efficacy in any-line and first-line compared to standard of care. The detailed results can be found here. Phase 2 Clinical Trial Evaluating Darovasertib Combination in Cutaneous Melanoma Based on the Cancer Genome Atlas, about 5% of patients with cutaneous melanoma harbor the GNAQ/11 mutation. Therefore, the annual incidence is estimated to be 5,000 patients in the U.S. and 8,000 patients in the EU-28, and the estimated total prevalence of GNAQ/11 cutaneous melanoma is approximately 70,000 patients in the U.S. and 110,000 patients in the EU-28. There are currently no FDA approved therapies in this genetically-defined GNAQ/11 cutaneous melanoma patient population. Hence, GNAQ/11 metastatic cutaneous melanoma presents a potentially significant expansion opportunity for darovasertib, reflecting approximately double or more of the annual addressable metastatic patient population of metastatic uveal melanoma alone, especially given that GNAQ/11 is available on multiple next-generation sequencing and liquid biopsy platforms, enabling patient identification. Along with other available data and IDEAYA's strategic priority to broaden its darovasertib program to the multiple solid tumor setting, in October 2023, the Company expanded its Phase 2 expansion of the darovasertib and crizotinib combination in metastatic cutaneous melanoma. The expansion was based on preliminary clinical activity observed in three cohorts of patients treated with darovasertib, either as monotherapy or in combination with either binimetinib or crizotinib. The detailed results were reported in October 2023 and can be found here. Phase 1 and 2 Trials Darovasertib as Neoadjuvant / Adjuvant Therapy in Primary UM Darovasertib is being evaluated as monotherapy in two clinical trials as neoadjuvant / adjuvant therapy: IDE196-009: a company-sponsored Phase 2 trial (NCT05907954) evaluating darovasertib as neoadjuvant treatment of UM prior to primary interventional treatment of enucleation or radiation therapy, and as adjuvant therapy following the primary treatment. Phase 1 Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma, or NADOM: an investigator-sponsored trial (IST) Phase 1 study (NCT05187884). The study is being led by Anthony Joshua, MBBS, PhD, FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent's Hospital in Sydney with additional participating sites in Melbourne, Australia. The clinical objectives of neoadjuvant therapy are to save the eye by avoiding enucleation and/or to reduce the tumor thickness in the eye, enabling treatment with less radiation to preserve vision. As an adjuvant therapy, a clinical goal is to potentially extend relapse free survival. Preliminary clinical data of darovasertib as neoadjuvant treatment showed evidence of anti-tumor activity and supported further clinical evaluation of darovasertib to determine its potential as a neoadjuvant therapy or an adjuvant therapy. As of February 1, 2024, double digit patients have been dosed with several sites open and actively recruiting additional patients into the company-sponsored Phase 2 clinical trial. Two independent clinical efficacy updates for darovasertib in neoadjuvant UM are anticipated in mid-2024, including from the Phase 2 IST study and IDEAYA's Phase 2 company-sponsored study. A regulatory guidance update is planned in 2024. In preliminary results from the Phase 1 NADOM trial darovasertib demonstrated eye preservation in 3 of 6 (50%) evaluable patients treated with darovasertib as neoadjuvant therapy for primary UM. The detailed results can be found here. IDE397 Program in Solid Tumors and Bladder Cancer with MTAP Deletion IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. MTAP deletion is found in 15% of solid tumors and is estimated to have annual incidence of greater than 50,000 patients in the US, EU5 and Japan across priority solid tumor types of non-small cell lung cancer (NSCLC), bladder, gastric, and esophageal cancers. The Company is focused on evaluating IDE397 in select monotherapy indications and in high conviction clinical combinations with AMG 193, Amgen's investigational MTA-cooperative PRMT5 inhibitor, and in combination with Gilead's Trop-2 directed antibody-drug conjugate (ADC) Trodelvy (Sacituzumab-govitecan-hziy). IDEAYA owns all rights, title, and interest in and to the IDE397 and MAT2A program, including all worldwide commercial rights thereto. IDE397-001: Phase 2 IDE397 Monotherapy Expansion in MTAP-Deletion NSCLC and Bladder Cancer The Company-sponsored IDE397 monotherapy Phase 2 expansion trial (NCT04794699) is continuing to enroll patients with MTAP-deletion squamous NSCLC and bladder cancers. Preliminary clinical data demonstrated responses in multiple MTAP-deletion high-priority tumor types based on experience across several patients in the early phase of the monotherapy dose expansion: RECIST 1.1 compete response in a bladder cancer patient and a 33% tumor reduction in squamous NSCLC patient as measured by CT-PET. Multiple ctDNA molecular responses were observed in NSCLC and bladder cancer patients. Low rates of discontinuations and serious adverse events (SAEs) were observed. As of October 13, 2023: 8 patients have been dosed in the IDE397 monotherapy expansion in the priority tumor types, and 2 patients have not yet had a first tumor scan assessment. Phase 1/2 trial of IDE397 + AMG 193 in MTAP-Deletion NSCLC Enrollment is ongoing in the dose escalation portion of the Amgen-sponsored Phase 1/2 trial (NCT05975073) evaluating IDE397 and AMG 193 (PRMT5MTA)) combination in patients with MTAP-deletion solid tumors. Additionally, in 2024, the Company will develop a joint publication strategy with Amgen. Phase 1 trial of IDE397 + Trodelvy in MTAP-Deletion Bladder Cancer The Company-sponsored Phase 1 (NCT04794699) in patients with MTAP-deletion bladder cancer will evaluate IDE397 in combination with Trodelvy, a Trop-2 directed ADC which is currently approved in the U.S. for the treatment of HR+/HER2- metastatic breast cancer, metastatic triple-negative breast cancer and metastatic urothelial cancer. Trial initiation activities are under way and the first-patient-in is anticipated in mid-2024. IDE161 Program in Tumors with Homologous Recombination Deficiency IDE161 is a potential first-in-class inhibitor of poly(ADP-ribose) glycohydrolase (PARG), a novel, mechanistically distinct target in the same clinically validated biological pathway as poly(ADP-ribose) polymerase (PARP). IDEAYA owns or controls all commercial rights to IDE161 and its PARG program, subject to certain economic obligations pursuant to its exclusive, worldwide license with Cancer Research UK and University of Manchester. IDE161 received two FDA Fast Track designations in platinum-resistant advanced or metastatic ovarian cancer patients having tumors with BRCA1/2 mutations, and pretreated advanced or metastatic HR+, Her2-, BRACA1/2 mutant breast cancer. IDE161-001: Phase 1/2 of IDE161 Monotherapy Dose Escalation and Expansion in HRD Solid Tumors The Phase 1 trial (NCT05787587) is evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 in patients having tumors with homologous recombination deficiency (HRD). Early clinical data from the dose escalation cohorts showed: Multiple partial responses (PRs) by RECIST 1.1 and tumor shrinkage observed in multiple HRD solid tumor patients, including: An endometrial cancer subject with a first imaging assessment of a PR, which was subsequently confirmed by RECIST 1.1 at the second scan and an 87% reduction of the CA-125 marker. A colorectal cancer subject with a second imaging assessment of a PR, which was subsequently confirmed by RECIST 1.1 Over 50% reduction in prostate-specific antigen (PSA) in prostate cancer patient with non-measurable disease No drug related discontinuations or SAEs at the IDE161 expansion dose observed. Phase 1 dose optimization is ongoing to confirm move forward Phase 2 expansion dose. The Phase 1 expansion trial continues to enroll in HRD solid tumor types, including ER+ HER-breast, colorectal, endometrial, and prostate cancers. Clinical program update(s) are expected in 2024. IDEAYA is also validating IDE161 combination opportunities preclinically and is targeting identification of potential combination(s) in 2024. GSK-Partnered Programs GSK101 (IDE705) Program in Tumors with Homologous Recombination Mutations or HRD GSK101 (IDE705) is a potential first-in-class small molecule inhibitor of Pol Theta Helicase being developed as a combination treatment with niraparib for advanced solid tumors with HRD. IND clearance was obtained from the U.S. FDA to enable the GSK-sponsored Phase 1/2 clinical trial to evaluate GSK101 in combination with niraparib, the GSK small molecule inhibitor of PARP, for patients having solid tumors with BRCA or other HR mutations, or with HRD. IDEAYA earned a $7.0 million milestone payment for IND clearance and will receive an additional $10.0 million upon initiation of Phase 1 clinical dose expansion, as well as potential further aggregate later-stage development and regulatory milestones of up to $465.0 million. GSK is the sponsor of the Phase 1/2 clinical trial and will lead clinical development for the Pol Theta program pursuant to its global, exclusive license from IDEAYA. GSK is responsible for all research and development costs for the program. Werner Helicase Inhibitor in Tumors with High Microsatellite Instability IDEAYA, in collaboration with GSK, selected a Werner Helicase inhibitor for further development and IDEAYA earned a $3.0 million milestone from GSK in connection with IND-enabling studies. IDEAYA has the potential to earn up to an additional $17.0 million aggregate milestones through early Phase 1, including $7.0 million upon IND effectiveness. IDEAYA is entitled to receive up to $465.0 million in additional later-stage development and regulatory milestones. The companies are targeting IND submission in 2024. Subject to IND submission and clearance, GSK will lead clinical development for the Werner Helicase program pursuant to its global, exclusive license to develop and commercialize the Werner Helicase Inhibitor DC. GSK is responsible for 80% of global research and development costs and IDEAYA is responsible for 20% of such costs. Next-Generation Precision Medicine Pipeline Programs IDEAYA has initiated early preclinical research programs focused on pharmacological inhibition of several new targets for patients with solid tumors characterized by defined biomarkers based on genetic mutations and/or molecular signatures. These research programs have the potential for discovery and development of first-in-class or best-in-class therapeutics with multiple wholly owned development candidate nominations targeted in 2024, including to treat MTAP-deletion solid tumors. Select Fourth Quarter and Full-Year 2023 Financial Results As of December 31, 2023, IDEAYA had cash, cash equivalents and marketable securities of $632.6 million, compared to $373.1 million as of December 31, 2022. The increase was primarily driven by total net proceeds of $323.3 million from underwritten public follow-on offerings completed in April and October 2023 partially offset by cash used in operations. Subsequent to the reporting period for the quarter ended December 31, 2023, the Company generated gross proceeds of approximately $352.0 million from the sale of shares of its common stock through at-the-market (ATM) offerings in January 2024. IDEAYA believes that its cash, cash equivalents and marketable securities of $632.6 million as of December 31, 2023, supplemented by estimated net proceeds of $342.3 million, after deducting underwriting discounts and commissions and other offering expenses, from the January 2024 ATM sales of common stock, will be sufficient to fund its planned operations into 2028. These funds will support the Company's efforts through potential achievement of multiple preclinical and clinical milestones across multiple programs. Collaboration revenue for the three months ended December 31, 2023, totaled $3.9 million compared to $4.0 million for the three months ended December 31, 2022. Collaboration revenue was recognized for the performance obligations satisfied through December 31, 2023, under the GSK Collaboration Agreement, and the Werner Helicase program's GLP toxicology study initiation milestone achievement. As of December 31, 2023, IDEAYA has fully recognized the contract liability related to the upfront payment research and development performance obligations under the GSK Collaboration Agreement. Research and development (R&D) expenses for the three months ended December 31, 2023, totaled $38.8 million compared to $24.7 million for the three months ended December 31, 2022. The increase was primarily due to higher personal-related expenses, consulting expenses and clinical trial expenses to support the portfolio growth. General and administrative (G&A) expenses for the three months ended December 31, 2023, totaled $7.1 million compared to $5.8 million for the three months ended December 31, 2022. The increase was primarily due to higher personnel-related expenses, higher legal and audit fees. The net loss for the three months ended December 31, 2023, was $34.0 million compared to the net loss of $24.2 million for the three months ended December 31, 2022. Total stock compensation expense for the three months ended December 31, 2023, was $4.8 million compared to $3.0 million for the same period in 2022. The net loss for the year ended December 31, 2023, was $113.0 million compared to $58.7 million for the same period in 2022. Total stock compensation expense for the year ended December 31, 2023, was $18.5 million compared to $11.6 million for the same period in 2022. About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets. IDEAYA's updated corporate presentation is available on its website, at its Investor Relations page: . Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing, content and venue of clinical program updates, (ii) the timing of FDA regulatory guidance, (iii) the timing for the development of a joint Amgen/IDEAYA publication strategy, (iv) the timing of a first-patient-in in the IDE397 and Trodelvy combination study, (v) additional clinical combinations, (vi) the timing of IND submission for the Werner Helicase inhibitor DC, (vii) the timing of designation of next generation development candidates, (viii) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations, (ix) the potential therapeutic benefits of IDEAYA therapeutics, (x) the translation of preliminary clinical trial results into future clinical trial results, (xi) the estimate of patient populations, and (xii) the receipt of development and regulatory milestones. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, the effects on IDEAYA's business of the worldwide COVID-19 pandemic, the ongoing military conflict between Russia and Ukraine, banking sector volatility, and other matters that could affect the sufficiency of existing cash to fund operations. 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 Annual Report on Form 10-K dated February 20, 2024 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. Investor and Media Contact IDEAYA Biosciences Andres Ruiz Briseno SVP, Head of Finance and Investor Relations [email protected] SOURCE IDEAYA Biosciences, Inc.

NEW YORK, Jan. 31, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced that the Centers for Medicare & Medicaid Services ("CMS") has established a permanent and product-specific J-code (J9248) for HEPZATO. The J-code will become effective on April 1, 2024. J-codes are a form of Healthcare Common Procedure Coding System Level II identifiers used by payors to streamline the billing of Medicare Part B drugs. In its summary of Delcath's application for the J-code, CMS stated that "[e]xistng melphalan hydrochloride is FDA approved at 0.25 mg/kg via intravenous infusion for patients with multiple myeloma and is not substitutable for the melphalan hydrochloride in the HEPZATO KIT which is approved at 3.0 mg/kg via intraarterial delivery for patients with metastatic ocular melanoma." The HEPZATO KIT is a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. "We believe that the establishment of the permanent J-code for HEPZATO will facilitate patient access to this important treatment," said Gerard Michel, Delcath's Chief Executive Officer. "This is a significant step towards accurate and efficient reimbursement of the HEPZATO KIT, facilitating access for patients." About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP) are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to surgically isolate the liver while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Forward Looking Statements The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company's commercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company's successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company's successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company's ability to obtain reimbursement for the HEPZATO KIT; and the Company's ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company's filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made. Contact: Investor Relations Contact: Ben Shamsian Lytham Partners 646-829-9701 [email protected] SOURCE Delcath Systems, Inc.