Company Overview and Strategy - VolitionRx focuses on advancing low-cost, early detection, and treatment monitoring tests in cancer and sepsis[7] - The company's strategy involves licensing its IP to major players, following a low CapEx/low OpEx model similar to its Nu.Q® Vet business[11, 20] - Volition aims to be cash neutral on a full-year basis in 2025, balancing income with expenditure[87] Veterinary Commercial Progress - The Nu.Q® Vet Cancer test is available in over 20 countries[20] - Approximately 120,000 Nu.Q® Vet Cancer tests and test components were sold in 2024[20, 39] - The company has received $23 million in upfront and milestone payments to date, with an additional $5 million milestone payment anticipated in 2025[20] Expansion into Human Diagnostics - Volition is targeting licensing deals in the human sepsis and cancer space in 2025[10] - The company sees a $4 billion opportunity in lung cancer screening, prognostics, and MRD, and a $1 billion+ opportunity in sepsis testing and monitoring[21] - First revenue was recorded for CE-marked product in Q1 2025[85] Financial Performance - Volition recorded approximately $0.25 million in revenue in Q1 2025, a 44% increase over the first quarter of the prior year[87] - Net cash used in operating activities averaged $1.4 million a month, almost 50% lower than the first quarter of 2024[87]

DNase I Oncology Platform - The company is focused on advancing its proprietary DNase I technology platform to address multiple high-value cancer indications[2, 5] - DNase I targets Neutrophil Extracellular Traps (NETs) to improve immunotherapies and chemotherapies[2, 5] - DNase I digests both double and single-stranded DNA, as well as DNA:RNA hybrids, exposing cancer cells to the immune system and reducing therapy resistance[6] - Systemic administration of DNase I improves the efficacy of PD-1 blockade, resulting in the lowest tumor volume growth compared to either DNase I or anti-PD-1 alone[19] Pipeline and Clinical Development - The company's lead program, XBIO-015, combines systemic DNase I with chemotherapy for pancreatic carcinoma[7] - A Phase 1 study is planned, featuring dose escalation and expansion in subjects with locally advanced or metastatic solid tumors, with pancreatic cancer and other solid tumor indications[2, 40] - The company believes that an ORR greater than 50% or PFS greater than 9 months would be a meaningful improvement to the current standard of care for pancreatic cancer[45] Market Opportunity - The company is initially targeting pancreatic carcinoma, a multi-billion-dollar indication with significant unmet need, with a projected market of $48 billion by 2025[2, 39] - Approximately 62,000 people are diagnosed with pancreatic cancer annually, and approximately 50,000 die from it annually[39] - There were approximately 19 million new solid tumor cases in the U S in 2022, leading to approximately 6 million solid tumor-related deaths[46] Collaboration and Intellectual Property - The company is collaborating with VolitionRX to develop proprietary adoptive cell therapies potentially targeting multiple solid cancer types[2, 58] - VolitionRX is expected to fund the research program, with both parties sharing proceeds from commercialization or licensing of any resulting products[60] - The company has an IP portfolio covering the co-administration of Systemic DNase I with ICIs, radiation, and chemo, as well as DNase I for pancreatic cancer and DNase I-secreting CAR T cells[62, 64]

Entera Bio's N-Tab Platform and Pipeline - Entera Bio's proprietary N-Tab platform transforms peptides into orally bioavailable tablets, potentially unlocking patient acceptance and driving superior health outcomes[7, 19] - The company's lead asset, EB613, is a differentiated Phase 3 asset poised for blockbuster sales as a first-in-class oral PTH(1-34) anabolic tablet treatment for osteoporosis, a condition affecting over 200 million people worldwide[7, 27] - Entera has a rich pipeline with multiple blockbuster opportunities in high-impact therapeutic areas, including EB612 for hypoparathyroidism, OXM for obesity/metabolic disorders, and GLP-2 for GI inflammatory disorders and short bowel syndrome[7, 8] - The company's cash runway extends into H2 2026, with multiple catalysts expected in the next 12 months[8] EB613 for Osteoporosis - EB613 is positioned as the first oral anabolic treatment to support earlier intervention in osteoporosis, addressing a substantial treatment gap[7, 28] - A Phase 2 study of EB613 in post-menopausal women with low bone mass or osteoporosis demonstrated a faster onset of action and higher increases in BMD at the cortical bone (femoral neck and hip region)[23] - EB613's Phase 2 results showed a distinct dual mechanism of increased bone formation (P1NP) and reduced bone resorption (CTX)[44] - Phase 2 data indicated that EB613 increased BMD at all major skeletal sites, with placebo-adjusted BMD change of EB613 2.5mg from Baseline to Month 6 as Compared with Published Forteo® Data[56, 57] GLP-1/Glucagon and GLP-2 Programs - Entera is developing an oral GLP-1/Glucagon (OXM) dual agonist tablet for metabolic disorders and obesity in partnership with OPKO, with an IND filing expected late 2025/early 2026[8, 104, 116] - Pre-clinical data supports the development of once-daily oral GLP-2 analog tablets for short bowel syndrome (SBS), a rare disease affecting approximately 30,000 patients across the US and EU[8, 106, 108]

Company Overview - Barinthus Bio is developing immunotherapies for autoimmunity and inflammatory diseases, focusing on restoring immune tolerance using the SNAP-TI platform[5] - The company has a strong financial position with $100.6 million in cash as of March 31, 2025, and an estimated cash runway into 2027[5, 92] - Barinthus Bio has 40.4 million outstanding ordinary shares and no debt or outstanding warrants[5] SNAP-TI Platform & VTP-1000 - The SNAP-TI platform is designed for antigen-specific immune tolerance, aiming to reduce inflammation and restore immune non-responsiveness to healthy tissue[5] - VTP-1000, the lead candidate for Celiac disease, is in an ongoing Phase 1 clinical trial with data readout expected in Q3 2025[5, 24, 92] - Approximately 1% of people worldwide have Celiac disease, equating to about 80 million people[27] - Around 60% of Celiac patients, or about 48 million people, cannot adhere to a strict Gluten-Free Diet[27] - Roughly 20% of Celiac patients are Non-Responsive, meaning about 16 million people's symptoms continue despite avoiding gluten[27] Viral Vector Platform Programs - VTP-300, a viral vector-based program for Chronic Hepatitis B, is pursuing partnership opportunities for advancement[56] - Approximately 254 million people are chronically infected with HBV, and there are 1.2 million new HBV infections per year[60] - In the HBV003 Phase 2b trial, 31.8% in Group 1 and 34.8% in Group 2 achieved >1 log HBsAg decline at Day 169, while only 4.2% in Group 3 achieved the same[77] - In the IM-PROVE II trial, 25% (2/8) of participants with starting baseline HBsAg levels less than 1000 IU/mL who received IDR+VTP-300+LDN reached Functional Cure[89]

TriKE® Technology and Pipeline - GT Biopharma's TriKE® platform utilizes camelid nanobodies to target NK cells to tumor cells, activating them via CD16A and IL-15 [5, 13] - The company has 6+ pipeline assets in preclinical development, targeting both solid tumors and hematological malignancies [5] - GTB-3650, a 2nd generation TriKE® targeting CD33, has an IND accepted in June 2024, with the first patient dosed on January 21, 2025 [5, 7] - GTB-7550 TriKE® is in development for the treatment of lupus and other autoimmune disorders [5, 37] - GTB-3550, the first generation TriKE® targeting CD33, showed proof of concept in Phase 1 in AML patients, reducing CD33+ bone marrow blast levels by 333%-636% in some patients [5, 26] Financial Status - As of March 31, 2025, GT Biopharma had $25 million in cash and short-term investments, with a debt-free balance sheet [5] - An additional $54 million in cash was raised on May 12, 2025 [5]

Akari Therapeutics Overview - Akari Therapeutics focuses on innovating antibody-drug conjugates (ADCs) as immuno-oncology therapies [3] - The company's lead payload, PH1, is a spliceosome inhibitor that causes cell death and activates the immune system [10] - Akari is developing novel target ADCs with the PH1 payload applicable to colon, lung, breast, and prostate cancers [12] PH1 Payload Mechanism and Advantages - PH1's mechanism of action generates mis-spliced transcripts leading to immunogenic neoantigens, 9 times greater than DM4 [23, 25] - PH1 overcomes resistance mechanisms and has reduced off-target toxicity due to its linker being engineered for intracellular release [17] - Preclinical data shows synergy between PH1 payload ADCs and checkpoint inhibitors [16] ADC Pipeline and Development - Akari's proprietary PH1 payload can build an entire ADC pipeline, with the ability to design several uniquely targeted ADCs in parallel [33] - AKTX-101 (Trop2 target) is ready for GMP manufacturing/GLP tox studies [36] - AKTX-102 is being developed against a novel target with potential in lung, colon, and breast cancers [36] Market Opportunity and Deal Flow - There is a strong need for ADCs with new payload mechanisms beyond current ADC therapies, especially in lung cancer [13] - Early-stage ADC deal flow shows continued momentum, with deals ranging from $20 million to $400 million upfront and total deal highlights reaching up to $1.34 billion [8] - One licensing deal for EO-1022 (HER3) reached $368 million in upfront and clinical, regulatory, and commercial milestone payments [8]

Pipeline and Milestones - Aprea Therapeutics' WEE1 inhibitor (APR-1051) ACESOT-1051 Phase 1 study expects safety/efficacy data in H2 2025 and complete dose escalation in H1 2026 [7, 43] - Aprea Therapeutics' ATR inhibitor (ATRN-119) ABOYA-119 Phase 1/2a study expects safety/efficacy data in H2 2025 and Recommended Phase 2 Dose (RP2D) in H1 2026 [8, 68] - Six patients in the ATRN-119 dose escalation cohorts achieved stable disease, with three patients (50%) in the 550mg BID cohort demonstrating measurable tumor shrinkage of 7%, 14%, and 21% [53] APR-1051 (WEE1 Inhibitor) - APR-1051 is a potent WEE1 inhibitor with high selectivity, showing >150-fold, >50-fold, and >600-fold difference in IC50 compared to PLK1, PLK2, and PLK3 inhibition, respectively [31] - Clinical data cutoff on March 4, 2025, for APR-1051 (N=9) showed treatment-related adverse events, including alanine aminotransferase increased (2 patients), aspartate aminotransferase increased (2 patients), and lymphocyte count decreased (1 patient) [26] ATRN-119 (ATR Inhibitor) - ATRN-119 exhibits near-dose proportional exposure following oral administration, with AUC 0-24hr ranging from 180 ng*h/mL at 50mg to 6899 ng*h/mL at 550mg [55] - Clinical data cutoff on May 1, 2025, for ATRN-119 (N=32) showed treatment-related adverse events, including nausea (13 patients), diarrhea (12 patients), and fatigue (10 patients) [57] - ATRN-119 is the first and only macrocyclic ATR inhibitor, potentially offering increased selectivity and improved tolerability compared to first-generation acyclic structures [59, 66] Financials and Capitalization - As of March 31, 2025, Aprea Therapeutics had approximately $19.3 million in cash and equivalents [73] - Aprea Therapeutics has 5,531,373 common stock, 2,701,864 warrants, 782,243 options, and 30,607 restricted stock units outstanding as of May 14, 2025, resulting in 9,061,683 fully diluted equivalents [73]

Market Opportunity & Solution - The robotic and drone delivery market is estimated to reach $450 billion by 2030 [12] - Serve robots are expected to achieve an average last-mile delivery cost of $1.00 with increased autonomy and adoption [14] - Serve robots aim to reduce reliance on cars, which caused approximately 10% of global energy-related CO2 emissions in 2022 [8, 10] Growth & Operations - Serve has signed a contract for 2,000 robots with Uber Eats, with full deployment expected by the end of 2025 [27] - The company has experienced over 40% quarter-over-quarter growth in deliveries on average since Q1 2022 [24] - Serve's delivery completion rate is up to 99.8% [24] Technology & Innovation - The Gen3 robot achieves a 65% cost reduction compared to previous generations [34, 35] - The Gen3 robot has 5x more brain power with Nvidia Jetson Orin and Ouster REV7 Lidar [34] - The Gen3 robot has 67% more battery capacity and 15% more cargo space [34] Financials - Serve has completed $259 million in financing since January 2024, including $91.5 million in Q1 2025 [60] - The company anticipates $20 million in cash savings over the next 2 years related to the 2,000 robot build [60] - Total Q2 2025 revenue is expected to be in the range of $600k - $700k, representing approximately 35-60% QoQ growth [60]

RLYB116 - C5 Inhibitor - RLYB116 is being developed as a potential first- and best-in-class treatment for severe, refractory hematologic diseases[4, 12] - The estimated peak commercial opportunity for RLYB116 in immune PTR (Platelet Transfusion Refractoriness) is over $1.1 billion annually, targeting approximately 20,000 patients[13, 50, 51] - The estimated peak commercial opportunity for RLYB116 in refractory APS (Antiphospholipid Syndrome) is over $4.0 billion, also targeting approximately 20,000 patients[13, 50, 51] - A Phase 2 trial for immune PTR is expected to begin in the middle of 2026, and a Phase 2 trial for refractory APS is expected to begin in the second half of 2026[13] - Clinical PK/PD study data for RLYB116 is expected in the second half of 2025, with Cohort 1 data in Q3 2025 and Cohort 2 data in Q4 2025[4, 18, 66] REV102 - ENPP1 Inhibitor - REV102 is a potential first- and best-in-class ENPP1 inhibitor for patients with hypophosphatasia (HPP)[4, 54] - Phase 1 study on track to initiate 2H 2026[55] - Preclinical data for REV102 in a later-onset HPP model is expected in the second half of 2025[4, 66] Financial Position - Rallybio's cash position as of March 31, 2025, was $54.5 million, which is expected to support operations into the first half of 2027[5]

Cylembio (IO102-IO103) Development and Clinical Trials - Cylembio, in combination with pembrolizumab, has Breakthrough Therapy Designation for advanced melanoma[11, 12] - Phase 3 pivotal trial in advanced melanoma with PFS as the primary endpoint, readout expected in Q3 2025[12, 23, 27] - Phase 1/2 trial (MM1636) showed 80% ORR, 50% CRR, and 255 months mPFS in melanoma[13, 55] - Completed enrollment of 407 patients in the Phase 3 trial in December 2023[27, 55] - A Phase 2 neoadjuvant/adjuvant basket study is fully enrolled[57] Pipeline and Platform - T-win platform delivers investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccines[11, 35, 66] - The company has 3 pipeline programs, including IO170 targeting Melanoma, SCCHN, NSCLC, and other cancers[11, 35] - IO112, targeting Arginase 1, is a next pipeline candidate expected to enter clinical development, with an IND filing planned in 2025[35, 63, 64] Market and Financial Outlook - The global melanoma market is expected to reach >$13 billion by 2030[15] - The US melanoma market was approximately $45 billion in 2023, growing at 9%[32] - The global NSCLC market is expected to reach approximately $60 billion by 2030[36, 37] - The global SCCHN market is expected to reach approximately $5 billion by 2030[40]