Core Insights - PDS Biotechnology Corporation reported a net loss of $9.4 million for Q2 2025, an increase from $8.3 million in Q2 2024, primarily due to higher net interest expenses [5][8] - The company is advancing its VERSATILE-003 Phase 3 clinical trial for PDS0101 (Versamune HPV) targeting HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma [3][11] - PDS Biotech presented three abstracts at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, showcasing positive data from the VERSATILE-002 trial [10] Financial Performance - The reported net loss for Q2 2025 was $9.4 million, or $0.21 per share, compared to a loss of $8.3 million, or $0.23 per share, in Q2 2024 [5][16] - Research and development expenses decreased to $4.2 million in Q2 2025 from $4.5 million in Q2 2024, attributed to lower personnel costs [6] - General and administrative expenses also fell to $3.4 million in Q2 2025 from $4.2 million in Q2 2024, mainly due to reduced personnel costs and professional fees [7] Cash Position and Debt - As of June 30, 2025, the company's cash balance was $31.9 million, down from $41.7 million at the end of 2024 [8][15] - Long-term debt increased to $12.9 million as of June 30, 2025, compared to $9.2 million at the end of 2024 [15] Clinical Trials and Developments - The VERSATILE-003 trial is the only registrational stage trial specifically targeting HPV16-positive head and neck cancer patients [3][11] - The colorectal cancer cohort in the Phase 2 clinical trial with PDS01ADC met criteria for expansion to Stage 2 following positive Stage 1 results [10] - The company plans to publish the full data set for the VERSATILE-002 trial later this year [3]

Core Insights - Elicio Therapeutics published follow-up data from the Phase 1 AMPLIFY-201 study in Nature Medicine, demonstrating that over two-thirds of participants with T cell responses exceeding the antitumor efficacy threshold had significantly reduced risks of relapse or death [1][5][11] Group 1: Study Results - At a median follow-up of 19.7 months, median overall survival (OS) increased from 16.33 months to 28.94 months [5][11] - A 77% reduction in the risk of death and an 88% reduction in the risk of relapse were associated with T cell responses above the efficacy threshold [5][11] - Direct ex vivo mKRAS-specific T cell responses were observed in 84% of patients, with both CD4+ and CD8+ T cell responses in 71% of patients [6][11] - Antigen-spreading was observed in 67% of patients, indicating a broader immune response beyond the targeted mKRAS antigens [11] Group 2: Clinical Implications - The updated data supports the potential of the AMP platform to provide durable benefits to pancreatic ductal adenocarcinoma (PDAC) patients in the adjuvant setting [3][5] - The final event-driven disease-free survival (DFS) analysis for the ongoing Phase 2 AMPLIFY-7P study is anticipated in Q4 2025 [5][6] Group 3: Technology and Future Directions - Elicio's AMP platform aims to enhance the education, activation, and amplification of cancer-specific T cells, potentially leading to improved clinical outcomes compared to conventional vaccination strategies [9][14] - ELI-002 targets the most common KRAS mutations, which drive approximately 25% of all solid tumors, and is being studied in patients with mKRAS-positive pancreatic and colorectal cancers [9][12] - Future plans include expanding ELI-002 to other indications, such as mKRAS-positive lung cancer [9][12]

Drug Development & Clinical Trials - Padcev 联合默克公司的重磅免疫疗法 Keytruda 延长了难治性膀胱癌患者的生命 [1]

Company Overview - Evaxion A/S is a clinical-stage TechBio company that specializes in developing AI-Immunology™ powered vaccines [4] - The company utilizes proprietary AI prediction models to decode the human immune system and create novel immunotherapies for cancer, bacterial diseases, and viral infections [4] - Evaxion has a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline targeting infectious diseases with high unmet medical needs [4] Upcoming Events - Evaxion will provide a business update and report its Q2 2025 financial results on August 14, 2025, before the opening of Nasdaq CM [1] - An executive management conference call and webcast will take place on the same day at 14:30 CET/08:30 EST, which is free and open to the public [2] - Participants can register in advance to receive dial-in numbers and a unique PIN code for the conference call [2] Contact Information - Mads Kronborg is the Vice President of Investor Relations & Communication at Evaxion, and can be contacted at +45 53 54 82 96 or via email at mak@evaxion.ai [4]

Core Viewpoint - Edesa Biotech, Inc. is advancing its drug candidate EB06 for treating moderate-to-severe nonsegmental vitiligo and has reported financial results for the three and nine months ended June 30, 2025, indicating a strategic focus on this development program [1][2][3]. Financial Performance - For the three months ended June 30, 2025, total operating expenses were $1.9 million, consistent with the same period in 2024 [5]. - The net loss for the quarter was $1.7 million, or $0.25 per common share, compared to a net loss of $1.7 million, or $0.52 per common share, for the same period in 2024 [6]. - For the nine months ended June 30, 2025, total operating expenses decreased by $0.6 million to $5.4 million compared to $6.0 million for the same period in 2024 [7]. - The net loss for the nine months was $5.0 million, or $0.95 per common share, compared to a net loss of $5.2 million, or $1.64 per common share, for the same period in 2024 [10]. Research and Development Focus - Research and development expenses for the nine months ended June 30, 2025, decreased by $0.4 million to $2.4 million, primarily due to reduced external research expenses related to EB05, offset by increased expenses for EB06 [7]. - The company is channeling operational efforts into regulatory preparation and drug manufacturing for EB06, aiming for rapid progression into clinical testing [4]. Cash Position and Working Capital - As of June 30, 2025, Edesa had cash and cash equivalents of $12.4 million and working capital of $12.1 million [11]. Upcoming Events - Edesa management is scheduled to participate in the Canaccord Genuity 45th Annual Growth Conference on August 12-13, 2025, and the H.C. Wainwright 27th Annual Global Investment Conference on September 8-10, 2025 [12].

Core Opinion - Oncolytics Biotech is advancing its clinical-stage immunotherapy pelareorep, focusing on regulatory clarity and pivotal studies for pancreatic cancer treatment [2][6][7] Company Developments - New management team members, including CEO Jared Kelly and CBO Andrew Aromando, bring extensive biotech experience to enhance pelareorep's development [3] - The company is committed to limiting dilution by terminating its At-the-Market and Equity Line of Credit facilities, indicating confidence in its current capital to reach key milestones [8] Clinical Data and Research - Recent presentations at the American Society of Clinical Oncology Annual Meeting highlighted pelareorep's mechanism of action and its potential to improve survival rates in metastatic pancreatic ductal adenocarcinoma (mPDAC) [2][4] - In a review of landmark studies, pelareorep demonstrated a two-year survival rate of 21.9% in mPDAC patients, significantly higher than the historical benchmark of 9.2% for chemotherapy regimens [4] Strategic Initiatives - The company is pursuing a registration-enabling pivotal study for pelareorep in first-line mPDAC, with discussions ongoing with regulators to finalize the approval pathway [6][7] - Pelareorep has received Fast Track and Orphan Drug designations from the FDA, underscoring its potential in addressing high unmet medical needs in pancreatic cancer [7] Financial Performance - As of June 30, 2025, Oncolytics reported cash and cash equivalents of CAD 14.6 million, projecting a cash runway through key milestones into Q1 2026 [12] - The net loss for Q2 2025 was CAD 6.2 million, an improvement from CAD 7.3 million in Q2 2024, with R&D expenses decreasing to CAD 2.8 million from CAD 4.6 million year-over-year [12][15] Future Milestones - The company plans to initiate start-up activities for the pivotal study in Q4 2025, with updated clinical data expected by the end of 2025 [10][12]

Core Viewpoint - Oncolytics Biotech Inc. will voluntarily delist its common shares from the Toronto Stock Exchange (TSX) effective August 22, 2025, while maintaining its listing on the Nasdaq [1][2]. Group 1: Delisting Details - The delisting from TSX is deemed beneficial for the company and its shareholders, allowing shares to continue trading on Nasdaq under the symbol "ONCY" [2]. - Canadian shareholders can trade their shares on Nasdaq through U.S.-registered broker-dealer affiliates [2]. - Oncolytics will remain a reporting issuer in Canada, and shareholder approval for the delisting is not required under TSX regulations [2]. Group 2: Company Overview - Oncolytics is a clinical-stage biotechnology company focused on developing pelareorep, an immunotherapeutic agent that has shown promising results in treating various cancers, including pancreatic and breast cancers [3][4]. - Pelareorep works by converting "cold" tumors into "hot" tumors, thereby activating immune responses against cancer [3]. Group 3: Strategic Focus - The company is advancing pelareorep in combination with chemotherapy and checkpoint inhibitors for metastatic pancreatic and breast cancers, both of which have received Fast Track designation from the FDA [4]. - Oncolytics is actively seeking strategic partnerships to enhance development and commercial impact [4]. Group 4: Future Considerations - Oncolytics will cease to be treated as a Foreign Private Issuer under U.S. federal securities laws effective January 1, 2026, and is contemplating re-domiciling to the U.S. [6]. - The company believes that the costs associated with maintaining a secondary listing on TSX do not justify the benefits, given its focus on the U.S. market and shareholder base [6].

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]

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]

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].