Avata Biosciences Signs Co-Development and Licensing Agreement with Oceanus Bio for Exclusive Rights in Japan and Asia (Excluding China and India) for Novel Adult and Pediatric Oral Cannabidiol Therapies for Development in Epilepsy and Schizophrenia
Oceanus Bio, Inc. is a clinical-stage pharmaceutical company founded by Kazunari Tsunaba and built upon proven leadership experience from Novartis Japan and Aculys Japan. With a mission to accelerate access to breakthrough therapies in Asia, Oceanus brings deep CNS expertise and a track record of successful drug development and commercialization in Japan.
"We are thrilled to enter into this co-development and licensing agreement with Oceanus Bio to advance our patient-friendly, solid dose investigational CBD medicine in Japan and Asia," said Rupert Haynes, Chief Executive Officer of Avata Biosciences. "The epilepsy community has long sought a solid dose CBD medicine. While many have attempted to deliver a solid dose form, achieving the high therapeutic levels needed has proven challenging for developers. The ability to pack more than 200mg of CBD into size 0 capsules represents a significant technological innovation. This agreement and funding will accelerate clinical development, enable build out of our scalable manufacturing in the US, and open a broader opportunity to support many more patients with neurological diseases."
Avata has achieved positive Phase 1 data demonstrating the tolerability and bioavailability of its lead oral asset, AVAT-021, in comparison to Epidiolex®. The trial met all pharmacokinetic objectives, marking a significant milestone in the development of the portfolio. The company is also developing AVAT-022, a water-soluble powder, as an alternative route of administration for children and others who find capsules difficult to swallow.
'We are excited to partner with Avata to advance the development of AVAT-021 and AVAT-022 in Japan and Asian countries. At Oceanus, we are committed to bridging global innovation with regional patient needs by accelerating access to transformative therapies. This collaboration represents a key step in fulfilling our mission to improve outcomes for patients with neurological and psychiatric disorders in Asia,' said Kazunari Tsunaba, CEO of Oceanus Bio.
In the U.S., Avata plans to file an Investigational New Drug application in 2H 2025 and utilize the Food and Drug Administration 505(b)(2) expedited regulatory pathway, with a view to making a solid dose CBD prescription medicine commercially available for U.S. patients in the shortest possible timeframe. Oceanus will lead regulatory engagement and clinical development in Japan and Asian regions in close collaboration with Avata.
About Avata Biosciences
Avata Biosciences Ltd is a privately held biopharmaceutical company with a mission to improve the lives of patients living with neurological disease. The Company's lead asset has successfully completed its first Phase 1 study and is advancing to the next stage of clinical development in 2025. With a leadership team comprised of neuroscience and cannabinoid medicine veterans, Avata is utilizing the experience gained in cannabinoid drug development to bring new prescription medicines to patients suffering from serious diseases. For more information, visit AvataBio.com.
About Oceanus Bio
Oceanus Bio, Inc. is a private, clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics in neurology and psychiatry. With deep experience in CNS drug development and a proven track record in bringing treatments to market in Japan and across Asia, Oceanus aims to accelerate patient access to transformative therapies through global partnerships.
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Business Wire
20 minutes ago
- Business Wire
Lantern Pharma Reports Second Quarter 2025 Financial Results and Business Updates
DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging its proprietary RADR® artificial intelligence (AI) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced operational highlights and financial results for the second quarter 2025 ended June 30, 2025, and provided an update on its portfolio of AI-driven drug candidates and AI platform, RADR®. ' This quarter we observed complete responses in patients across two of our clinical trials, delivering meaningful patient benefit and providing further validation of both the mechanisms and therapeutic potential of our drug candidates, ' said Panna Sharma, CEO & President of Lantern Pharma. Simultaneously, our team is transforming our AI platform into functional, accessible modules for the broader oncology community. These parallel advances mark a pivotal inflection point in our clinical and technological evolution, reinforcing our fiscally disciplined, AI-driven approach to addressing critical unmet patient needs with a clear pathway to commercialization and value creation. ' Clinical Pipeline Developments LP-184: Successful Completion of Enrollment for Phase 1a & Advancing Toward Phase 1b/2 Studies Lantern successfully completed enrollment of its LP-184 Phase 1a first-in-human trial with 65 patients across multiple solid tumor indications. The trial established both the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), positioning LP-184 for advancement of planned Phase 1b/2 studies in indications with large multi-billion dollar annual market potential, including recurrent TNBC and recurrent bladder cancer. LP-184 has received Fast Track Designations from the FDA for both glioblastoma multiforme (GBM) and triple negative breast cancer (TNBC), along with four Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, malignant rhabdoid tumors, and atypical teratoid rhabdoid tumors (ATRT). Through its wholly-owned subsidiary Starlight Therapeutics, Lantern is developing LP-184 as STAR-001 for central nervous system cancers. During the quarter, Lantern announced findings from independent research conducted at Johns Hopkins validating Lantern's data used to secure the FDA Rare Pediatric Disease Designation for LP-184 in ATRT and support planned pediatric clinical trials. The data demonstrated that LP-184, a next-generation acylfulvene clinical-stage drug candidate, significantly extended survival in mouse models of ATRT. In the CHLA06 model, median survival increased from 20 days in the control group to 89 days in the LP-184 treatment group, representing a 345% improvement (p<0.0001). In the BT37 model, median survival increased from 68 days to 98 days (p=0.0422). LP-184 is a next-generation acylfulvene drug candidate, a synthetic small molecule belonging to a class of naturally-derived anti-cancer agents. LP-184 works by preferentially damaging DNA in cancer cells that overexpress specific biomarkers or that harbor mutations in DNA damage repair pathways. LP-184 is the product of years of research, including insights from RADR ®, Lantern's proprietary AI platform that leverages over 200 billion oncology-focused data points. LP-184 is a prodrug that is converted to its bioactive form inside the cancer cell by PTGR1 (prostaglandin reductase 1), an enzyme that is overexpressed in certain cancers. Once activated, LP-184 creates cytotoxic metabolites that form adducts with DNA, leading to irreparable DNA damage and ultimately tumor cell death. LP-300 HARMONIC™ Trial: Complete Response Observed Demonstrating Clinical Activity & Successful Completion of Enrollment in Japan The Phase 2 HARMONIC™ trial continues to advance with enrollment across the United States and expansion sites in Asia. A remarkable complete response was observed in a 70-year-old never-smoker patient with advanced NSCLC who had exhausted three prior treatment regimens. This outcome builds on previously reported data showing an 86% clinical benefit rate and 43% objective response rate in the initial safety lead-in cohort. Additionally the Phase 2 HARMONIC™ trial made advancements in Asia with completion of the Japanese cohort of 10 patients. Multiple centers in Japan participated in the clinical trial including The National Cancer Center Tokyo. The study is strategically positioned in regions with high prevalence of never-smoker lung cancer patients, with active sites in Taiwan where over 40% of new lung cancer diagnoses occur in never-smokers. Additional clinical data and findings are anticipated in September 2025, including initial safety and response evaluations from the Asian expansion cohort. The treatment of never-smokers with NSCLC represents a market opportunity estimated at over $4 billion annually. There are no approved therapies specifically targeted at the treatment of never-smokers with NSCLC currently. Lantern is actively exploring collaboration and partnering opportunities to maximize LP-300's commercial potential in multiple geographies. LP-284: Phase 1a Clinical Trial in Refractory Lymphoma Observed a Complete Response LP-284 exhibited remarkable clinical activity in a heavily pretreated 41-year-old patient with aggressive Grade 3 diffuse large B-cell lymphoma (DLBCL). Following failure of standard R-CHOP/Pola-R-CHP chemotherapy, CAR-T cell therapy (liso-cel), and CD3xCD20 bispecific antibody therapy (glofitamab), the patient achieved complete metabolic response with non-avid lesions after completing just two doses of LP-284. This represents the first complete response observed with LP-284. The complete response provides support to the mechanistic rationale and the potential for further future clinical activity in one of the most therapeutically challenging hematological malignancies. Lantern believes that this supports LP-284's synthetic lethal mechanism and potential paradigm-shifting role in treating refractory aggressive lymphomas. The complete metabolic response achievement positions LP-284 to seek a future role within a global blood cancer market focused on B-cell cancer that is estimated at $4 billion annually, with DLBCL representing the largest aggressive lymphoma subtype affecting approximately 200,000 patients globally each year. The critical unmet need in refractory/relapsed settings represents a substantial commercial opportunity for innovative therapeutic approaches that can deliver meaningful clinical benefit to therapeutically exhausted patient populations. Intellectual Property Advancements Lantern significantly strengthened its global intellectual property portfolio during the second quarter with two major patent developments: European Patent Allowance for LP-284: The European Patent Office (EPO) issued a notice of allowance for a composition of matter patent covering LP-284, expected to be granted with exclusivity through early 2039. This EU patent complements existing composition of matter patents granted in the U.S. (April 2023) and Japan (June 2024), with additional patent allowances in India and Mexico, and applications pending in China, Australia, Canada, and Korea. This expanding international IP portfolio positions LP-284 for global commercialization and strategic partnerships. Blood-Brain Barrier Prediction Patent Application: Lantern announced the publication of its PCT patent application (PCT/US2024/019851) covering a novel machine learning solution for predicting blood-brain barrier (BBB) permeability, which received a favorable PCT search report indicating no significant prior art. The technology powering predictBBB™ demonstrates exceptional performance, processing up to 100,000 molecules per hour with industry-leading accuracy. Lantern's AI algorithms currently hold five of the top eleven positions on the Therapeutic Data Commons Leaderboard. The PCT application, if granted, will enable multi-country patent protection for 20 years from the filing date. RADR ® AI Platform Enhancements Lantern continues to expand the capabilities of its RADR ® platform, which now leverages over 200 billion oncology-focused data points and a library of 200+ advanced machine learning algorithms. Key enhancements this quarter include: Module Public Launch: The public release of an AI module for predicting blood-brain barrier permeability with 94% prediction accuracy, 95% sensitivity and 89% specificity. This addresses a critical pharmaceutical development challenge where only 2-6% of small-molecule drugs can successfully cross the blood-brain barrier. Drug Combination Prediction Module: An innovative AI-powered module to improve prediction of synergistic cancer drug combinations, with framework and analytics based on peer-reviewed research. The module focuses initially on DNA damaging agents and DNA repair inhibitors, aimed at a market opportunity where approximately $50 billion is spent annually on the development of combination therapies for cancer. The AI module, trained on 221 clinical trials, will be incorporated as part of Lantern's AI platform, RADR®, and will initially focus on tailored combinations of DNA damaging agents and DNA repair inhibitors. The framework and foundational data for the module was published in a peer-reviewed study published in Frontiers in Oncology, ' Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review '. The company plans to make select RADR ® modules available to the broader scientific and research community, fostering collaborative, open-source innovation in oncology drug development while creating potential new revenue streams. Financial Results for Second Quarter 2025 Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $15.9 million as of June 30, 2025, compared to approximately $24.0 million as of December 31, 2024. The company believes that its existing cash, cash equivalents, and marketable securities as of June 30, 2025 and anticipated expenditures will enable funding of operating expenses and capital expenditure requirements at least into June 2026. Research and Development Expenses: R&D expenses were approximately $3.1 million for the quarter ended June 30, 2025, compared to approximately $3.9 million for the quarter ended June 30, 2024, reflecting continued disciplined cost management while advancing multiple clinical programs. General and Administrative Expenses: G&A expenses were approximately $1.6 million for the quarter ended June 30, 2025, compared to approximately $1.5 million for the quarter ended June 30, 2024. Net Loss: Net loss was approximately $4.33 million (or $0.40 per share) for the quarter ended June 30, 2025, compared to a net loss of approximately $4.96 million (or $0.46 per share) for the quarter ended June 30, 2024. Capitalization: As of June 30, 2025, the Company had 10,784,725 shares of common stock outstanding, and options to purchase 1,239,766 shares of common stock at a weighted average exercise price of $5.72 per share were outstanding. There were no outstanding warrants as of June 30, 2025. Quarterly Earnings Calls: Lantern has determined not to host a quarterly earnings call at the present time given the concentration of resources required for a live video based webinar style call. In addition to quarterly press releases with earnings information, and more frequent updates regarding the progress of our portfolio and platform, we plan to focus our resources on other distribution channels that we believe will be more effective in conveying information to stockholders, including webinars, digital media resources and broader social media channels. June 30, 2025 December 31, 2024 (Unaudited) CURRENT ASSETS Cash and cash equivalents $ 6,061,408 $ 7,511,079 Marketable securities 9,840,366 16,501,984 Prepaid expenses & other current assets 1,299,016 1,234,566 Total current assets 17,200,790 25,247,629 Property and equipment, net 39,524 47,440 Operating lease right-of-use assets 143,240 239,985 Other assets 36,738 36,738 TOTAL ASSETS $ 17,420,292 $ 25,571,792 CURRENT LIABILITIES Accounts payable and accrued expenses $ 4,752,848 $ 4,140,361 Operating lease liabilities, current 131,515 190,814 Total current liabilities 4,884,363 4,331,175 Operating lease liabilities, net of current portion 13,524 52,843 TOTAL LIABILITIES 4,897,887 4,384,018 COMMITMENTS AND CONTINGENCIES (NOTE 4) STOCKHOLDERS' EQUITY Preferred Stock (1,000,000 authorized at June 30, 2025 and December 31, 2024; $.0001 par value) (Zero shares issued and outstanding at June 30, 2025 and December 31, 2024) - - Common Stock (25,000,000 authorized at June 30, 2025 and December 31, 2024; $.0001 par value) (10,784,725 shares issued and outstanding at June 30, 2025 and December 31, 2024) 1,078 1,078 Additional paid-in capital 97,366,699 97,058,323 Accumulated other comprehensive income 48,043 153,990 Accumulated deficit (84,893,415 ) (76,025,617 ) Total stockholders' equity 12,522,405 21,187,774 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ $ 25,571,792 Expand About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 200 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of drug candidates that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0 - 2.5 million per program. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR ® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR ® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that our research and the research of our collaborators may not be successful, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR ® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025. You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at or on the SEC's website at Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. Lantern Pharma Disclosure Channels to Disseminate Information: Lantern Pharma's investors and others should note that we announce material information to the public about our company and its technologies, clinical developments, licensing matters and other matters through a variety of means, including Lantern Pharma's website, press releases, SEC filings, digital newsletters, and social media, in order to achieve broad, non-exclusionary distribution of information to the public. We encourage our investors and others to review the information we make public in the locations above as such information could be deemed to be material information. Please note that this list may be updated from time to time.
Eater
an hour ago
- Eater
Rangoon Bistro Opens a Burmese Tavern in Portland
is the regional editor for Eater's Northern California/Pacific Northwest sites, writing about restaurant and bar trends, upcoming openings, and pop-ups for the San Francisco Bay Area, Portland, Seattle, and Denver. This is a list of Portland's most notable restaurant and bar openings, with new updates published twice a month. Did we miss something great? Please drop us a line. What it is: This Asian supermarket touches down in Portland, finally, bringing 35,000-square-feet of Asian groceries, produce, vegetables, live seafood, and more. When it opens: Saturday, August 16 Where it is: 10544 SE Washington Street Learn more: Popular Asian grocery sets Portland store's opening date What it is: A popular cafe chain in Vietnam opened its first Oregon location, serving ice milk coffee sets, its signature Thien Coffee drink, and kopi luwak — yes, the coffee made with beans digested by civet cats (although that is factory-made, these days). When it opened: Saturday, August 2 Where it is: 8435 SE Powell Boulevard Learn more: A Titanic Vietnamese Cafe Opens After Much Hype in Portland What it is: Longtime favorite Ringside Steakhouse was forced to close after a kitchen fire in April of this year, but now the restaurant has returned after a renovation. When it opened: Monday, August 4 Where it is: 2165 W Burnside Street Learn more: Portland's Ringside Steakhouse returns after fire, complete renovation What it is: Seattle's Sea Wolf Bakers opened an outpost of its shop — dubbed Woodblock Bakery — inside the Woodblock Chocolate facility. Sea Wolf co-founder Jess Schumann is behind the micro-bakery, his first without co-founder (and brother) Kit Schumann, and their third shop overall. When it opened: Wednesday, August 6 Where it is: 1715 NE 17th Avenue Learn more: Seattle's great Sea Wolf Bakers will open a 'tiny' new bakery at Portland's Woodblock Chocolate What it is: Kim Dam and chef Richard Le of Mémoire Cà Phê and Mikey Nguyen of consignment store Index, have joined forces for this vinyl bar with an all-day menu from Matta, plus a dinner menu and cocktails. When it opened: Thursday, August 7 Where it is: 2226 NE Broadway Learn more: Hennessy and Anti-Smash Burgers Reign Supreme at After Ours What it is: Bollywood Theater chef-owner Troy MacLartty closed the SE Division location of his business, reopening as Maglia Rosa, a seasonal Italian restaurant and market. When it opened: Friday, August 8 Where it is: 3010 SE Division Street Learn more: What We Know About Maglia Rosa in Portland What it is: The Aimsir Distilling room is reborn as Kachka Fabrika, a seafood-driven cocktail bar that showcases vodka distilled in-house. This new spot is an offshoot of the popular restaurant Kachka from Bonnie Frumkin Morales and Israel Morales. When it opened: Friday, July 11 Where it is: 2117 NE Oregon Street Learn more: Scallops and Vodka Flights Are On Board at Kachka's Stunning New Bar What it is: Bone Sine is the sister business to Portland favorite Rangoon Bistro, opening next door and serving classic cocktails with Burmese ingredients and dishes like lahpet htamin. When it opened: Thursday, July 17 Where it is: 3753 N Mississippi Avenue Learn more:One of Portland's Buzziest Restaurants Is Opening a Powerful Burmese Tavern Eater Portland All your essential food and restaurant intel delivered to you Email (required) Sign Up By submitting your email, you agree to our Terms and Privacy Notice . This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Business Wire
an hour ago
- Business Wire
Kezar Life Sciences Reports Second Quarter 2025 Financial Results and Provides Business Update
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. 'We are on track with our clinical development and regulatory submission plan for zetomipzomib in autoimmune hepatitis,' said Chris Kirk, PhD, CEO and co-founder of Kezar. 'We are committed to working closely with the FDA to align on our next trial design, which we have proposed as a registration-enabling study. The Type C meeting will be an important milestone as we continue to believe that zetomipzomib has the potential to positively transform the lives of patients living with autoimmune hepatitis.' Zetomipzomib: Selective Immunoproteasome Inhibitor In March, Kezar reported topline results from the PORTOLA Phase 2a clinical trial evaluating zetomipzomib in patients with autoimmune hepatitis (AIH). In relapsed or refractory AIH patients who entered screening on steroid-based therapy, 36% (5 of 14) of zetomipzomib-treated patients achieved a complete biochemical response (CR) and clinically significant steroid taper to 5 mg/day or less by 6 months, compared to 0 of 7 placebo patients. The median duration of response in zetomipzomib patients achieving a CR was 27.6 weeks (including the ongoing open-label extension at the time of the data cutoff), and no disease flares were reported in any zetomipzomib-treated patient achieving CR during study. A favorable safety profile was observed during the 6-month blinded treatment period. In July, Kezar announced that the Division of Hepatology and Nutrition of the U.S. Food and Drug Administration (FDA) removed the partial clinical hold on the completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with AIH. Kezar submitted a Type C meeting request to the FDA to meet during the fourth quarter of 2025 to discuss the AIH development plan for zetomipzomib. Kezar submitted a complete response to the FDA Division of Rheumatology and Transplant Medicine with a request to remove the clinical hold on zetomipzomib in lupus nephritis. Medical Conferences An abstract featuring PORTOLA Phase 2a data has been selected for an oral presentation at The Liver Meeting® 2025, taking place November 7-11, in Washington, DC. An abstract featuring PORTOLA biomarker data has been selected for poster presentation at The Liver Meeting® 2025. Business Updates In June, Zung To was promoted to Chief Development Officer. Mr. To joined Kezar in 2023 as Senior Vice President & Head of Clinical Development and brings 35 years of industry experience, with more than 20 years in senior leadership roles in early-and late-stage clinical development. He has been instrumental in leading Kezar's development strategy and has played a pivotal role in progressing the Company's clinical trials with speed and precision. Financial Results Cash, cash equivalents and marketable securities totaled $100.8 million as of June 30, 2025, compared to $132.2 million as of December 31, 2024. The decrease was primarily attributable to cash used in operations. Research and development (R&D) expenses for the second quarter of 2025 decreased by $6.7 million to $9.6 million, compared to $16.3 million in the second quarter of 2024. This decrease was primarily due to the decreased clinical activities resulting from the completion and closeout of clinical trials, a decrease in personnel costs including non-cash stock-based compensation and a decrease in facility related expenses. General and administrative (G&A) expenses for the second quarter of 2025 decreased by $0.6 million to $5.0 million compared to $5.6 million in the second quarter of 2024. The decrease was primarily due to a decrease in non-cash stock-based compensation and personnel-related expenses. Restructuring and impairment charges for the second quarter of 2025 decreased by $1.5 million, compared to the second quarter of 2024. The decrease was primarily attributed to the impairment charge in 2024 related to the right-of-use asset for the vacated floor in the company's leased office facility. Net loss for the second quarter of 2025 was $13.7 million, or $1.87 per basic and diluted common share, compared to a net loss of $21.5 million, or $2.96 per basic and diluted common share, for the second quarter of 2024. Total shares of common stock outstanding were 7.3 million shares as of June 30, 2025. About Kezar Life Sciences Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. For more information, visit and follow us on LinkedIn, Facebook, X and Instagram. Cautionary Note on Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'may,' 'will,' 'can,' 'should,' 'expect,' 'believe,' 'potential,' 'anticipate' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the initiation of a registration-enabling trial of zetomipzomib, the clinical development of and regulatory submission plan for zetomipzomib in AIH, and the likelihood of obtaining regulatory approval of zetomipzomib. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during clinical studies, difficulties enrolling and conducting our clinical trials, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar's filings with the U.S. Securities and Exchange Commission, including the 'Risk Factors' contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Summary of Operations Data (In thousands except share and per share data) Three Months Ended Six Months Ended June 30 June 30 2025 2024 2025 2024 (unaudited) (unaudited) Operating expenses: Research and development $ 9,583 $ 16,298 $ 21,763 $ 33,470 General and administrative 5,016 5,603 10,465 12,142 Restructuring and impairment charges - 1,482 - 1,482 Total operating expenses 14,599 23,383 32,228 47,094 Loss from operations (14,599 ) (23,383 ) (32,228 ) (47,094 ) Interest income 1,197 2,237 2,617 4,690 Interest expense (302 ) (401 ) (649 ) (801 ) Net loss $ (13,704 ) $ (21,547 ) $ (30,260 ) $ (43,205 ) Net loss per common share, basic and diluted $ (1.87 ) $ (2.96 ) $ (4.14 ) $ (5.93 ) Weighted-average shares used to compute net loss per common share, basic and diluted 7,311,032 7,284,587 7,308,360 7,282,289 Expand
