SAN DIEGO, May 02, 2025 (GLOBE NEWSWIRE) -- iBio, Inc. (Nasdaq:IBIO), today reported financial results for the third quarter ended March 31, 2025, and provided a corporate update on its progress. “During the third quarter we were able to broaden our access to investors given our move to Nasdaq and subsequently in April, strengthened our financial position with a $6.2 million warrant-inducement equity raise, positioning us for continued growth and keeping us on track for regulatory submission of IBIO-600 in ...

Core Viewpoint - Kura Oncology has submitted its first New Drug Application (NDA) for ziftomenib to the FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation, marking a significant milestone for the company [2][5]. Company Updates - The NDA submission for ziftomenib occurred on March 31, 2025, with a 60-day filing review period expected from the FDA, potentially leading to a six-month review if Priority Review is granted [5]. - Kura Oncology is preparing for two Phase 3 studies in the frontline setting and anticipates multiple clinical data readouts throughout the year [2][4]. - The first patients have been dosed in the Phase 1 trial of ziftomenib in combination with imatinib for gastrointestinal stromal tumors (GIST) [1][6]. Financial Highlights - Collaboration revenue from the partnership with Kyowa Kirin for Q1 2025 was $14.1 million, compared to no revenue in Q1 2024 [9]. - Research and development expenses for Q1 2025 were $56.0 million, up from $36.3 million in Q1 2024, while general and administrative expenses increased to $22.8 million from $18.2 million [9]. - The net loss for Q1 2025 was $57.4 million, compared to a net loss of $49.5 million in Q1 2024, with cash, cash equivalents, and short-term investments totaling $658.2 million as of March 31, 2025 [9][16]. Milestones and Future Plans - Kura expects to present data from the KOMET-001 Phase 1b/2 trial at the ASCO and EHA meetings in the second quarter of 2025 [9]. - The company plans to initiate two independent Phase 3 registration-enabling trials in the second half of 2025 [9][13]. - Kura anticipates receiving up to $375 million in additional milestone payments from Kyowa Kirin, following the $45 million milestone payment triggered by the NDA submission [4][5].

First real-world dataset with integrated clinical and multiomic insights from 25,000 patients treated with GLP-1 therapiesDataset will advance development of GLP-1 therapies in new indications and accelerate discovery of novel drug targets in patients who are unresponsive to therapiesSAN DIEGO, May 1, 2025 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN), and Ovation.io, Inc., an organization dedicated to building best-in-class multiomics datasets, today announced the development of the largest commercially av ...

WILMINGTON, Del., May 01, 2025 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, announced today that the Company will participate in the Citizens Life Sciences Conference taking place in New York on May 7, 2025. On Wednesday, May 7, 2025, at 11:00 a.m. ET, Kris Vaddi, Ph.D., Chief Executive Officer of Prelude, Jane Huang, M.D., President and Chief Medical Officer, and Peggy Scherle, Ph.D., Chief Scientific Officer will participate i ...

Financial Data and Key Metrics Changes - Net revenue for Q1 2025 was $26.6 million, a decrease from $46.5 million in Q1 2024, primarily due to a temporary payment suspension from TRICARE and slowing order growth [20][21] - Gross profit in Q1 2025 was $18.2 million, representing 69% of revenue, compared to $37.2 million or 80% of revenue in Q1 2024 [20][21] - Net loss for Q1 2025 was $10.4 million, or $0.33 per share, compared to a net income of $10,000 in the previous year [21][22] Business Line Data and Key Metrics Changes - Device revenue was $11.9 million, while supplies revenue was $14.7 million in Q1 2025 [20] - Non-NexWave product order percentage increased to 34% in Q1 2025, up from an average of 30% in the previous year [13] Market Data and Key Metrics Changes - The company is experiencing a temporary payment suspension from TRICARE, which has affected revenue recognition [6][12] - The patient monitoring market is identified as a multibillion-dollar opportunity, with the company planning to enter with a superior product [19] Company Strategy and Development Direction - The company is restructuring to operate without TRICARE business in a worst-case scenario and is focusing on new revenue opportunities [9][10] - The company aims to generate revenue exceeding $800 million annually in the long term [25] - The launch of the Nico pulse oximeter is anticipated to significantly impact the patient monitoring market, with a focus on improving health equity [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about growth prospects despite current challenges, emphasizing a commitment to high-quality service and technology [24][25] - The company expects to receive a response from TRICARE regarding the payment suspension within 40 days [24] Other Important Information - The company has reduced overall staff by approximately 15%, primarily in the corporate office, which is expected to result in annual savings of about $35 million [13] - The company maintains a strong balance sheet with $40 million in working capital and approximately $24 million in cash [22] Q&A Session Summary Question: Insights into TRICARE conversations and potential domino effects - Management indicated that the claims from TRICARE were vague and emphasized compliance with guidelines, stating there are no current issues with other payers [28][30][31] Question: Clarification on Q1 revenue miss and future guidance - The revenue miss was attributed to multiple factors, and management is waiting for clarity on TRICARE before providing full-year guidance [32][34][35] Question: Confirmation of TRICARE payments in Q1 and Q2 guidance - Management confirmed that Q1 revenue and guidance for Q2 do not include TRICARE payments, and they expect reimbursement for claims once the suspension is lifted [37][38] Question: Plans if TRICARE outcome is negative - The company plans to refocus its sales force to generate revenue from other areas if TRICARE payments are not restored [40][41] Question: Expected revenue from Nico post-approval - Management expects to launch Nico immediately upon FDA clearance, with revenue anticipated in 2026 [42]

Phase 1a dose-escalation study data update: treatment with NXP900 resulted in exposure levels leading to robust pharmacodynamic responses across a range of tolerated doses; NXP900 has an acceptable safety profile, dose limiting toxicity dose level has not been identified in doses up to 250 mg/day Preclinical posters strengthen the NXP900 clinical development strategy as single agent in biomarker-targeted cancers and in combination with market leading therapies to overcome resistance in NSCLC Fort Lee, NJ ...

Core Points - iBio, Inc. has entered into an agreement with existing institutional investors to exercise warrants for 5,626,685 shares at a reduced price of $1.11 per share, generating approximately $6.2 million in gross proceeds [1][2] - In exchange for exercising the existing warrants, investors will receive new warrants to purchase up to 11,253,370 shares at an exercise price of $0.86, expiring in five years [2] - The transaction is expected to close around April 30, 2025, pending customary closing conditions [2][3] Financial Details - The gross proceeds from the warrant exercise will be approximately $6.2 million before deducting advisory fees and other expenses [1] - The new warrants allow for the purchase of shares at a significantly lower price compared to the existing warrants [2] Company Overview - iBio, Inc. is a biotech company focused on developing precision antibody therapies using AI and advanced computational biology for various diseases [6] - The company aims to transform drug discovery and accelerate development timelines to address unmet medical needs [6]

CAMBRIDGE, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, will report first quarter 2025 financial results and corporate highlights after the U.S. financial markets close on Monday, May 5, 2025. About Relay Therapeutics Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicine company transforming the dru ...

Core Viewpoint - Tempus AI, Inc. is set to report its first-quarter fiscal 2025 results, with expectations of a revenue of $248.08 million and a loss of 27 cents per share, reflecting a steady consensus estimate over the past 90 days [2][3]. Financial Performance - In the last reported quarter, Tempus AI had an adjusted loss of 18 cents, which was wider than the Zacks Consensus Estimate of a loss of 15 cents per share, with an average negative earnings surprise of 6.46% over the trailing three quarters [1]. - The company experienced a 43% gain in stock price during the first quarter of 2025, outperforming the broader industry gain of 2.1% and the S&P 500 decline of 4.9% [4][5]. Growth Drivers - The Genomics unit is expected to report strong growth, building on over 30% growth in the previous quarter, while Data and Services revenues are anticipated to have accelerated by 44.6% year over year [10]. - Strategic acquisitions, including Ambry Genetics for $600 million and Deep 6 AI, are expected to enhance Tempus's capabilities in diagnostics and data analytics, contributing positively to financial performance [11][18]. EBITDA and Cash Flow - Tempus AI reported an adjusted EBITDA of -$7.8 million in the fourth quarter of 2025, marking a $27.3 million year-over-year improvement, with expectations of positive adjusted EBITDA of $5 million for the full year 2025 [12]. - The cumulative operating cash outflow improved to $189 million at the end of the fourth quarter of 2024, down from $214.3 million a year ago, indicating a trend towards positive cash flow [13]. Long-term Prospects - The company is advancing precision medicine through AI applications, with a focus on creating Intelligent Diagnostics to enhance personalized care and accelerate therapeutic development [14]. - The launch of the AI-enabled personal health concierge app, olivia, positions Tempus to benefit from the shift towards patient-centric healthcare [15]. - The FDA approval of the xT CDx test strengthens Tempus's oncology portfolio, likely increasing demand for its diagnostic services [16]. Market Position and Valuation - Tempus AI's stock is currently trading at a forward price-to-sales ratio of 6.81, which is higher than the industry average of 5.15, indicating an expensive valuation compared to peers [20]. - Despite the high valuation, the AI market's projected exponential growth positions Tempus AI to capitalize on expanding opportunities in the healthcare sector [21].

Core Insights - Kura Oncology has initiated the KOMET-015 Phase 1 clinical trial to evaluate ziftomenib in combination with imatinib for patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure [1][3] - The combination of ziftomenib and imatinib has shown robust and durable antitumor activity in both imatinib-sensitive and imatinib-resistant GIST preclinical models [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being a key investigational menin inhibitor [8] - The company has received Breakthrough Therapy Designation from the FDA for ziftomenib in treating relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) [7][8] Clinical Trial Details - The KOMET-015 trial is designed to assess the safety, tolerability, and preliminary antitumor activity of ziftomenib combined with imatinib in adults with GIST who have shown disease progression on imatinib [3][4] - The trial will evaluate primary objectives including safety and tolerability, and secondary endpoints such as overall response rate (ORR) and progression-free survival (PFS) [3] Market Context - Approximately 4,000 to 6,000 new cases of GIST are diagnosed annually in the U.S., with limited treatment options available for advanced cases [2][5] - Most patients develop resistance to imatinib within two years, highlighting the need for new therapeutic options [2][6] Preclinical Findings - Preclinical studies indicate that the combination of ziftomenib and imatinib exerts antitumor activity through a synthetic lethal mechanism, targeting vulnerabilities in GIST tumors [2][3] - The combination has the potential to delay or overcome resistance to imatinib in patients [2]