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Lisata Therapeutics(LSTA) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Financial Data and Key Metrics Changes - For Q2 2025, revenue totaled $70,000 from a research license agreement with Catalent, compared to no revenue in Q2 2024 [9] - Operating expenses decreased to $4,900,000 in Q2 2025 from $5,500,000 in Q2 2024, a reduction of 10.6% [10] - Net losses were $4,700,000 for Q2 2025, down from $5,000,000 in Q2 2024, indicating progress in capital management [11] Business Line Data and Key Metrics Changes - Research and development expenses were approximately $2,300,000 in Q2 2025, down from $2,600,000 in Q2 2024, a decrease of 13.4% [10] - General and administrative expenses were approximately $2,700,000 in Q2 2025, compared to $2,900,000 in Q2 2024, a decrease of 8.1% [10] Market Data and Key Metrics Changes - The company anticipates a data-rich period in the next twelve months with several key milestones on the horizon [6] Company Strategy and Development Direction - The company is focused on developing its proprietary cyclic internalizing RGD peptide product candidate, certepatide, for advanced solid tumors and other difficult-to-treat diseases [12] - Recent collaborations include a research agreement with Catalent and a strategic alliance with GATC Health to enhance drug discovery [24][25] - The company has secured multiple special designations from both the FDA and EMA for certepatide [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of certepatide based on positive preliminary results from ongoing clinical trials [6][28] - The company is preparing for a Phase III trial based on FDA agreement on the protocol, with an expected enrollment of 650 to 900 patients [30] Other Important Information - The company has extended its patent protection for certepatide until March 2040, enhancing its intellectual property portfolio [25] - The company believes available funds will support current operations into 2026 [11] Q&A Session Summary Question: Insights on the ASCEND trial Phase III protocol - Management confirmed a tacit agreement with the FDA on the structure of an open-label Phase III trial, potentially including 650 to 900 patients [30] Question: Expectations on spending and runway extension - Management indicated that spending may see a modest decrease over time, depending on the initiation of the Phase III trial and results from ongoing trials [33] Question: Inclusion of future license revenues in projections - Management clarified that current projections only include a small contribution from the New Jersey sale of NOLs, with no anticipated capital raises included [36] Question: Changes in patent coverage - Management explained that the latest patent recognized specific intellectual property around the composition of matter of certepatide, securing the intellectual property portfolio [38] Question: Comparison of regulatory environments in the US and China - Management stated that it is difficult to compare the two regulatory environments due to the unique relationships Chinese companies have with their authorities [40]
INmune Bio Inc. Announces Second Quarter 2025 Results, Provides Business Update and Announces Management Changes
Globenewswire· 2025-08-07 20:05
Core Insights - INmune Bio Inc. reported its financial results for Q2 2025, highlighting a net loss of approximately $24.5 million, a significant increase from a net loss of about $9.7 million in Q2 2024 [12][30] - The company is focused on developing treatments that utilize the innate immune system, with three main product platforms: XPro™, CORDStrom™, and INKmune® [21] Financial Performance - The net loss attributable to common stockholders for Q2 2025 was approximately $24.5 million, compared to approximately $9.7 million in Q2 2024 [12][30] - Research and development expenses for Q2 2025 totaled approximately $5.8 million, down from approximately $7.1 million in Q2 2024 [12][30] - General and administrative expenses were approximately $2.3 million for Q2 2025, compared to approximately $2.8 million in Q2 2024 [12][30] - As of June 30, 2025, the company had cash and cash equivalents of approximately $33.4 million, an increase from $20.9 million at the end of 2024 [12][25] Product Development Highlights - XPro™ showed favorable trends in the MINDFuL phase 2 trial, particularly in a subset of patients with two or more biomarkers of inflammation [5][4] - CORDStrom™ is in the process of establishing large-scale manufacturing, with plans for MAA and BLA submissions by mid-2026 [10][15] - INKmune® is currently in an open-label Phase I/II trial for metastatic castration-resistant prostate cancer [20][21] Corporate Updates - Dr. RJ Tesi has retired as CEO, with David Moss appointed as the new President & CEO [10] - The company closed a $19 million registered direct offering to support its operations [10] Upcoming Milestones - The company anticipates an end-of-phase 2 meeting regarding the MINDFuL trial with the FDA in Q4 2025 [15] - Additional data from the ongoing phase 2 trial of INKmune® in metastatic castration-resistant prostate cancer is expected to be released [15]
Barinthus Bio Reports Second Quarter 2025 Financial Results and Updates on Corporate Developments
Globenewswire· 2025-08-07 12:00
Core Insights - Barinthus Biotherapeutics plc reported its financial results for Q2 2025, focusing on advancements in its immunotherapy programs, particularly VTP-1000 for celiac disease [1][5][12]. Clinical Developments - The company is advancing its VTP-1000 immunotherapy, currently in the Phase 1 AVALON trial, with the last cohort of the single ascending dose (SAD) portion being screened and the multiple ascending dose (MAD) portion initiated [2][6][7]. - The SAD data readout is expected early in Q4 2025, while MAD data is anticipated in mid-2026 [6][7]. - The Phase 1 trial of VTP-850 for prostate cancer is complete, showing encouraging signs of immunogenicity [7]. Financial Highlights - As of June 30, 2025, the company had cash and cash equivalents of $87.8 million, down from $100.6 million as of March 31, 2025, primarily due to operating activities [8]. - Research and development expenses for Q2 2025 were $8.0 million, a slight decrease from $8.3 million in Q1 2025, attributed to reduced preclinical activity and workforce [8][9]. - General and administrative expenses increased to $15.4 million in Q2 2025 from $12.6 million in Q1 2025, mainly due to unrealized foreign exchange losses [13]. Net Loss - The net loss for Q2 2025 was $21.1 million, or $(0.52) per share, compared to a net loss of $19.7 million, or $(0.49) per share in Q1 2025 [13][19]. Corporate Updates - Barinthus Bio is actively seeking partners for its VTP-300 program in chronic hepatitis B and other viral vector-based assets [4].
Compugen(CGEN) - 2025 Q2 - Earnings Call Transcript
2025-08-06 13:30
Financial Data and Key Metrics Changes - As of June 30, 2025, the company had approximately $93.9 million in cash, cash equivalents, short-term bank deposits, and investments in marketable securities [14] - Revenues for 2025 were approximately $1.3 million, a significant decrease from approximately $6.7 million in the comparable period in 2024 [15] - The net loss for 2025 was approximately $7.3 million, or $0.08 per basic and diluted share, compared to a net loss of approximately $2.1 million, or $0.02 per basic and diluted share in 2024 [16] Business Line Data and Key Metrics Changes - The company is advancing its immuno-oncology clinical and early-stage pipeline programs, including the potential first-in-class anti-PVRIG antibody COM701 [7] - The first patient was dosed in the ovarian maintenance immunotherapy trial, with plans to share interim analysis in 2026 [7] - Research and Development (R&D) expenses for 2025 were approximately $5.6 million, down from approximately $6.2 million in 2024 [16] Market Data and Key Metrics Changes - The company is observing increased competition in the platinum-sensitive ovarian cancer space, with a focus on improving treatment options for patients [8] - The initial opportunity in the platinum-sensitive maintenance setting is estimated to involve approximately 8,000 to 12,000 patients based on available epidemiology data [30] Company Strategy and Development Direction - The company aims to leverage its UniGen platform to identify novel mechanisms to activate the immune system against cancer [5] - The leadership transition is expected to provide a strong foundation for the company's next phase of growth, with a focus on corporate strategy and strategic collaborations [4] - The company is committed to advancing its extensive and differentiated early-stage pipeline focused on potential first-in-class drugs [13] Management's Comments on Operating Environment and Future Outlook - Management believes that the differentiated approach in immunotherapy can create significant value, addressing unmet medical needs in cancer treatment [5] - The company is well-positioned to capitalize on potential growth opportunities ahead, supported by a solid balance sheet and expected cash runway into 2027 [6] Other Important Information - The company has partnerships with AstraZeneca and Gilead, with potential milestone payments exceeding $1 billion [6] - The company has received milestone payments of $30.5 million and remains eligible for up to $170 million in future regulatory and commercial milestone payments [12] Q&A Session Summary Question: Can you provide an update on patient enrollment for the ovarian cancer trial? - The company has not disclosed the number of sites but has open sites in the US and Israel, actively enrolling with high investigator enthusiasm [22] Question: What should investors focus on regarding the upcoming presentation? - The focus will be on understanding the patients who had responses in prior studies, with more information on efficacy and safety to be presented [23] Question: What are the expectations from Merck's successful Phase III in ovarian cancer? - The Merck study provides insights into potential activity in earlier lines of treatment but does not change the company's current approach as it focuses on platinum-sensitive patients [36] Question: Can you provide more details on the interim analysis planned for 2026? - The interim analysis is to evaluate for futility and characterize the magnitude of effect size for COM701, with expectations that the study will be fully enrolled [41]
IBRX Sales Soar 2,540%
The Motley Fool· 2025-08-06 03:55
Core Insights - ImmunityBio reported a significant increase in revenue for Q2 2025, reaching $26.4 million, surpassing analyst expectations of $23.15 million, driven by strong sales of its immunotherapy product ANKTIVA [1][2] - The company narrowed its net loss per share to ($0.10), an improvement from the projected ($0.11) and a substantial reduction from ($0.20) a year prior, indicating better financial performance [1][2] Financial Performance - Revenue for Q2 2025 increased by 2,540% year-over-year from $1.0 million in Q2 2024 [2] - The GAAP revenue saw a 60% increase compared to Q1 2025, primarily due to rising sales of ANKTIVA for bladder cancer [5] - ANKTIVA unit sales surged 246% in the first half of 2025 compared to the second half of 2024, following the assignment of a J-code for easier reimbursement [5] - Research and Development expenses were reported at $52.4 million, reflecting the company's commitment to pipeline development [2] Business Focus and Strategy - ImmunityBio is focused on ramping up commercial sales of ANKTIVA for bladder cancer and expanding into global markets while investing in a diverse pipeline [4] - The company is pursuing regulatory approvals and maintaining robust sales growth for ANKTIVA, alongside advancing other product candidates into late-stage trials [4] - Recent regulatory developments include approval from the UK MHRA for ANKTIVA in BCG-unresponsive non-muscle invasive bladder cancer, while facing challenges from the FDA regarding a supplemental application [6] Pipeline Development - ImmunityBio launched a pivotal randomized trial for non-small cell lung cancer (NSCLC) combining its proprietary N-803 with BeOne Medicines' tislelizumab [7] - The company is expanding clinical trials into Europe and Asia and has received FDA support for its lymphopenia program [7] - Strategic collaborations with BeOne Medicines and the Serum Institute of India are enhancing manufacturing capabilities for bladder cancer therapies [8] Future Outlook - Management did not provide explicit guidance for the next quarter or fiscal 2025 but emphasized priorities around expanding ANKTIVA's market reach and advancing regulatory filings [9] - The company raised $80 million in equity in July 2025, which may extend its cash runway amid ongoing cash burn and fundraising needs [9][10]
Sensei Biotherapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-08-05 11:30
Core Viewpoint - Sensei Biotherapeutics is transitioning from early response-focused readouts to longer-term efficacy signals in its Phase 1/2 study of solnerstotug, which shows a favorable safety profile and potential for better patient adherence and outcomes [2][3] Clinical Program Highlights - Full data for the Phase 1/2 dose expansion cohort is expected by year-end 2025, with enrollment complete at 64 patients [6] - The ongoing trial evaluates solnerstotug as a monotherapy and in combination with cemiplimab in patients with advanced solid tumors [3] - Preliminary clinical data indicates favorable activity in PD-(L)1 resistant "hot" tumors, with solnerstotug well tolerated and no dose-limiting toxicities reported [6] Corporate Updates - Sensei's cash position was $28.6 million as of June 30, 2025, down from $41.3 million at the end of 2024, with expectations to fund operations into Q2 2026 [8] - Research and Development expenses decreased to $2.5 million in Q2 2025 from $4.6 million in Q2 2024, attributed to lower personnel and facility costs [9] - General and Administrative expenses also decreased to $2.7 million in Q2 2025 from $3.2 million in Q2 2024, primarily due to lower personnel costs [10] Financial Results - The net loss for Q2 2025 was $4.9 million, an improvement from a net loss of $7.1 million in Q2 2024 [10] - Total operating expenses for Q2 2025 were $5.2 million, down from $7.8 million in Q2 2024 [13]
Elicio Therapeutics Announces Positive Recommendation by IDMC to Continue ELI-002 7P Randomized Phase 2 Study in Pancreatic Cancer Without Modifications to Final Analysis
Globenewswire· 2025-08-05 11:00
Core Insights - Elicio Therapeutics announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 2 AMPLIFY-7P trial for ELI-002 7P without modifications, indicating preliminary efficacy signals [1][5] - The final disease-free survival (DFS) analysis is expected in Q4 2025, and the company plans to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the Phase 3 study [2][5] - ELI-002 7P is an investigational immunotherapy targeting seven KRAS mutations, which are prevalent in 88% of PDAC patients and 25% of all solid tumors [3][8] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers [4] - The company utilizes its proprietary Amphiphile (AMP) technology to enhance the immune response against cancer, aiming for durable cancer immunosurveillance [4][9] - ELI-002 is designed as an off-the-shelf vaccine candidate targeting common KRAS mutations, with potential benefits including low cost and rapid availability for patients [4][6] Clinical Trial Details - The AMPLIFY-7P trial is a 2:1 randomized, open-label study involving 144 patients across 24 U.S. sites, comparing ELI-002 7P monotherapy to standard of care [2][5] - ELI-002 7P treatment consists of six doses followed by an eight-week observation period and four booster doses [2] - The trial aims to improve DFS in patients with PDAC who have undergone local therapy, surgery, and chemotherapy [2] Future Plans - Elicio plans to expand ELI-002 to other indications, including mKRAS-positive lung cancer and additional mKRAS-positive cancers [6] - The company is also developing other off-the-shelf therapeutic cancer vaccine candidates, such as ELI-007 and ELI-008, targeting BRAF-driven cancers and p53 hotspot mutations [6]
Sonnet BioTherapeutics Expands Clinical Evaluation of SON-1010 Dose Escalation with Atezolizumab in Ovarian Cancer
GlobeNewswire News Room· 2025-08-04 12:40
Core Insights - Sonnet BioTherapeutics is expanding its clinical study of SON-1010 in combination with atezolizumab for patients with advanced platinum-resistant ovarian cancer, showing promising early results with a 66% tumor response rate at the highest dose [1][2] - The company is also exploring a higher maintenance dose of SON-1010 to assess its safety and efficacy before moving to a randomized Phase 2a trial [1][2] - SON-1010 is designed to enhance immune response in tumors by delivering IL-12 directly to the tumor microenvironment, potentially improving treatment outcomes for various cancers [3][4] Company Overview - Sonnet BioTherapeutics focuses on developing targeted biologic drugs using its Fully Human Albumin-Binding (FHAB) platform, which aims to optimize the safety and efficacy of immune-modulating therapies [6][7] - The company is currently evaluating SON-1210, another candidate using the FHAB platform, for the treatment of pancreatic cancer in collaboration with the Sarcoma Oncology Center [7] Clinical Trial Details - The SB221 trial is a Phase 1b/2a multicenter study assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SON-1010, both alone and in combination with atezolizumab [5] - The trial aims to establish the maximum tolerated dose (MTD) and evaluate the potential for improved efficacy in patients with platinum-resistant ovarian cancer [5]
Corvus Pharmaceuticals to Provide Business Update and Second Quarter 2025 Financial Results on August 7, 2025
Globenewswire· 2025-07-31 20:01
Core Viewpoint - Corvus Pharmaceuticals will host a conference call and webcast on August 7, 2025, to provide a business update and report its second quarter 2025 financial results [1]. Group 1: Conference Call Details - The conference call is scheduled for 4:30 pm ET (1:30 pm PT) [1]. - Access to the conference call can be made via a toll-free domestic number (1-800-717-1738) or an international number (1-646-307-1865) [2]. - A live webcast will be available on the investor relations section of the Corvus website, with a replay accessible for 90 days [2]. Group 2: Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition as a novel immunotherapy approach for various cancers and immune diseases [3]. - The lead product candidate is soquelitinib, an investigational oral small molecule drug that selectively inhibits ITK [3]. - The company is developing other clinical-stage candidates targeting a variety of cancer indications [3].
BriaCell Adds UCLA Health as Key Site in Pivotal Phase 3 Breast Cancer Study
Globenewswire· 2025-07-31 11:30
Core Insights - BriaCell Therapeutics Corp. has added UCLA Health Jonsson Comprehensive Cancer Center to its pivotal Phase 3 clinical study evaluating Bria-IMT™ in combination with a checkpoint inhibitor for advanced metastatic breast cancer [1][2] - The Phase 3 study aims to improve survival outcomes in patients with metastatic breast cancer, with overall survival as the primary endpoint [2] - The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential to address significant unmet medical needs [2] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies to transform cancer care [4] - The company is currently conducting a pivotal Phase 3 study (Bria-ABC, NCT06072612) to evaluate the effectiveness of its treatment in a multi-center clinical setting [1][3] Clinical Study Details - The Phase 3 study will conduct an interim analysis after 144 patient events (deaths) have occurred [2] - The study design builds on positive survival data from a previous Phase 2 study, which was presented at ASCO 2025 [2] - The inclusion of UCLA Health is part of BriaCell's strategy to partner with top-tier institutions to enhance trial enrollment and execution [2]