Financials & Organization - The company had approximately $101 million in cash balance as of year-end 2024, which is expected to fund operations into Q2 2026, excluding potential milestones or new business development[6] - The company's organization consists of approximately 70 employees with integrated R&D capabilities[6] Clinical Pipeline (CX-2051) - CX-2051 (EpCAM PROBODY® Topo-1 ADC) is being developed for advanced CRC, with initial Phase 1 data expected in the first half of 2025 and determination of Phase 1b doses[7, 8] - Over 90% of CRC cases are estimated to have high EpCAM expression, making it a relevant target for CX-2051[32, 33] - In preclinical models, CX-2051 demonstrated >100x masking efficiency by ELISA and equivalent preclinical activity to deruxtecan (DXd) in irinotecan-resistant CRC models[22, 25] Clinical Pipeline (CX-801) - CX-801 (PROBODY® IFN-α2b) is being developed for advanced melanoma, with initial Phase 1 translational & biomarker data expected in the second half of 2025, and initiation of Keytruda® combination[7, 8] - Preclinical data suggests CX-801 has synergistic activity with PD-1 inhibitors and enhanced safety compared to unmasked IFNα2b[55] - CX-801 demonstrated 1000X masking efficiency based on preclinical models[54] Strategic Focus - The company is focused on addressing major unmet needs in oncology with its PROBODY® pipeline[4, 71] - The company plans to determine Phase 1b doses for potential CRC expansions and evaluate strategies for CRC combinations and additional tumor types for CX-2051[47, 72]

Business Overview - Mirum Pharmaceuticals projects net product sales of $310-320 million for 2024[9, 17] - The company has three approved rare disease products and three additional indications in late-stage development[8, 13] - Mirum's cash balance is $303 million, positioning it to execute its strategy[14] LIVMARLI (maralixibat) - In Alagille Syndrome (ALGS), 93% of participants experienced at least a 1-point reduction in ItchRO[Obs] in cholestatic pruritus[30, 95] - In ALGS, 83% of patients with a >1-point reduction in ItchRO[Obs] remained transplant-free 6 years after starting LIVMARLI[30, 100, 102] - In Progressive Familial Intrahepatic Cholestasis (PFIC), 62% of patients achieved minimal to no itch after 26 weeks of treatment[34, 35, 104] CHENODAL - CHENODAL addresses Cerebrotendinous Xanthomatosis (CTX), with a US prevalence of approximately 1,000-2,000 patients[13, 49] - RESTORE Phase 3 study showed a 20-fold increase in urine 23S-Pentol (bile alcohol) after placebo withdrawal (p<0.0001)[122] - RESTORE Phase 3 study showed a 50-fold increase in plasma 7αC4 after placebo withdrawal (p<0.0001)[122] Volixibat - Primary Sclerosing Cholangitis (PSC) affects approximately 54,000 patients across the US & EU, with ~65% experiencing active pruritus[13, 59] - In a CAMEO study, patients with PSC experienced a 70% mean reduction in pruritus and a 40% mean reduction in bile acids after 14 weeks of treatment with an IBAT inhibitor[61]

Amezalpat (TPST-1120) in HCC - Amezalpat randomized Phase 2 data in first-line HCC showed superiority to the Standard of Care (SoC) arm[6] - Overall Survival (OS) data revealed a six-month improvement with a stable hazard ratio of 0.65 compared to the control arm[6, 32, 35, 58] - Confirmed Objective Response Rate (ORR) in the ITT population was 30% in the Amezalpat + atezolizumab + bevacizumab arm compared to 13.3% in the atezolizumab + bevacizumab arm[32] - In PD-L1 negative patients, the confirmed ORR was 27% in the Amezalpat arm versus 7% in the SoC arm[32] - In patients with β-catenin mutations, the confirmed ORR in the Amezalpat arm was 43% with 100% Disease Control Rate (DCR)[32] Clinical Development and Regulatory - The FDA and EMA have agreed on a Phase 3 plan for Amezalpat[4, 48] - A pivotal Phase 3 study is designed with over 700 subjects and a 1:1 randomization[49] - The Phase 3 study has a critical hazard ratio of <0.805 for primary efficacy and <0.729 for early efficacy[49] - FDA granted Orphan Drug Designation in December 2024 and Fast Track Designation in January 2025[52] Market Opportunity - First-Line HCC is a large market, with 234,785 treated cases across the US, EU5, and China[54]

NTLA-2002 (Hereditary Angioedema - HAE) - NTLA-2002 aims to be the first to offer lifelong freedom from attacks and prophylaxis after a single dose for HAE, with a BLA submission planned in 2026[8] - Phase 2 study results showed 73% of patients were attack-free and off chronic prophylaxis after a single dose of NTLA-2002 at 16 weeks[37, 41] - The global market for HAE is projected to reach approximately $5 billion by 2028[8, 44] Nex-z (Transthyretin Amyloidosis - ATTR) - Nex-z aims to be the first to stabilize or reverse disease progression with a single dose for ATTR, with a BLA submission planned in 2028 for polyneuropathy[8] - Phase 1 data showed deep, rapid, and durable reductions in serum TTR, with an 89% reduction in ATTR-CM and a 90% reduction in ATTRv-PN at day 28[63] - The global market for ATTR is projected to reach approximately $12 billion by 2028[8, 86] Clinical Development and Milestones - Intellia expects three commercial launches starting in 2027[8] - The company plans to complete enrollment in the Phase 3 HAELO trial for NTLA-2002 in the second half of 2025 and the MAGNITUDE-2 trial for ATTRv-PN in 2026[2] - Intellia plans to enroll at least 550 patients in the Phase 3 MAGNITUDE trial for ATTR-CM in 2025 and complete enrollment in early 2027[2]

Portfolio & Performance - RLJ's urban-centric portfolio is expected to outperform the industry, with urban markets representing over two-thirds of the portfolio[3, 91] - In Q4, RLJ achieved 2.2% RevPAR growth, placing it in the top quartile of its peers[5] - Urban hotels, comprising two-thirds of the portfolio, experienced 3.7% RevPAR growth[8] - January 2025 RevPAR increased 3.2%, and February RevPAR increased 3.9%, primarily driven by ADR growth[11] Growth Initiatives - Phase I and II initiatives are projected to generate $14 million to $18 million of incremental EBITDA[3, 91] - RLJ acquired Hotel Teatro in Denver for $35.5 million in June 2024, with stabilized margins of approximately 32%[3, 38, 41] - Phase 2 conversions are expected to generate +$5 million-$6 million in incremental EBITDA[55] Capital Allocation & Balance Sheet - RLJ has approximately $0.9 billion of liquidity, providing optionality for growth[3, 90, 91] - The company repurchased $12.0 million of shares YTD through February 2025 and increased the dividend by 50% in 2024[3, 8, 90, 91] - RLJ recycled $22 million of non-core disposition proceeds into share repurchases in 2024[90] ESG & Sustainability - RLJ is active in social contribution with over $4 million in donations[105] - 76% of RLJ's properties utilize an environmental management system[101] - 56% of trustees are ethnically diverse, with 33% female[105]

Financial Performance & Growth - Innodata reported Q1 2025 revenue of $58.3 million, a 120% year-over-year increase[44] - The company's adjusted gross margin was 43% in Q1 2025[44] - Adjusted EBITDA as a percentage of revenue rose from 14% in Q1 2024 to 22% in Q1 2025[53] - Innodata has a strong cash position, with $56.6 million in cash on the balance sheet[44] - The company anticipates FY25 revenue growth of 40% or more, projecting revenue of $238.6 million compared to $170.5 million in 2024[55, 56] Market Positioning & Strategy - Innodata is positioned as a "picks and shovels" beneficiary of the AI and GenAI race, with contracts with five of the "Magnificent Seven" technology companies[12] - The company estimates a total addressable market (TAM) opportunity for generative AI IT services of $200 billion by 2029[14] - Innodata's revenue is primarily driven by services, accounting for approximately 91% of the total, while SaaS contributes about 9%[44] AI & Data Engineering Focus - Innodata is focused on providing end-to-end AI lifecycle solutions, including generative AI and traditional AI services[11, 12] - The company has developed a proprietary Goldengate foundational AI platform[19, 25] - Innodata supports both AI builders and AI adopters with scaled data solutions, including data curation, transformation, and annotation for LLMs[21]

Financial Status and Strategy - Editas Medicine has a strong cash position with operational runway into Q2 2027[9] - The company secured $57 million through non-dilutive financing with DRI Healthcare Trust[42] - Editas aims to leverage its foundational IP estate for access to non-dilutive capital[41] Technology and Therapeutic Approach - Editas utilizes a functional upregulation treatment strategy, validated by reni-cel[9] - The company employs proprietary, targeted LNPs (tLNPs) for tissue targeting, including HSCs and liver[9] - Preclinical data shows up to ~47% HBG1/2 editing observed in HSCs at 3 months after a single dose of LNP2 in non-human primates[24] - In vivo targeting to three extrahepatic cell types at ≥80% efficiency with our plug 'n play platform in humanized mice[40] Pipeline and Milestones - Editas plans to declare two in vivo development candidates by mid-2025, one for hemoglobinopathies (sickle cell disease and beta thalassemia) and another for an undisclosed liver indication[48, 51] - The company aims to submit at least one IND/CTA by mid-2026 and begin at least one human clinical trial by 2H 2026[53] - Editas anticipates achieving human proof-of-concept for at least one indication by year-end 2026[53]

FILSPARI (sparsentan) for IgAN - FILSPARI is positioned as a foundational treatment for IgAN, targeting kidney injury by blocking ET-1 and ANG-II, with >70,000 addressable patients in the U S [9, 10, 22, 32, 64] - Clinical trials showed FILSPARI resulted in ~40% reduction in proteinuria after 110 weeks compared to irbesartan [43] - SPARTAN study showed ~70% reduction in proteinuria from baseline at week 24 in newly diagnosed patients [56] - U S commercial launch of FILSPARI outperformed benchmark launches, with ~$132 million in net sales in FY24, a ~78% growth over 2023 [61, 110] Sparsentan for FSGS - Travere plans to submit an sNDA for sparsentan in FSGS around the end of 1Q25 [11, 14] - DUPLEX study showed sparsentan resulted in a ~50% reduction in proteinuria [79] - DUPLEX study showed ~2 5x greater complete remission with sparsentan compared to irbesartan [84] - There are 15,000-30,000 potential addressable patients with FSGS in the U S [10, 70] Pegtibatinase for HCU - Pegtibatinase is a potential disease-modifying therapy for classical HCU, targeting the underlying genetic cause [14, 88, 95] - Phase 1/2 COMPOSE study showed a ~67% mean relative reduction in total homocysteine (tHcy) from baseline in the highest dose cohort [99, 106] - The company is on track to restart enrollment in the Phase 3 HARMONY Study in 2026 [14, 108]

Pipeline and Approvals - Ultragenyx expects Phase 3 data readout for UX143 for Osteogenesis Imperfecta (OI) in 2025[21, 32] - Ultragenyx anticipates completing Phase 3 enrollment for GTX-102 for Angelman Syndrome (AS) in the second half of 2025[46, 49] - The company has a PDUFA date of August 18, 2025, for UX111 for Sanfilippo syndrome (MPS IIIA), with a potential commercial launch in the second half of 2025[63, 67] - Ultragenyx expects to submit a BLA for DTX401 for Glycogen Storage Disease Type Ia (GSDIa) in mid-2025, with a potential launch in 2026[78, 80] Financial Performance and Projections - Ultragenyx projects total revenue to grow by 14-20% in 2025, reaching $640-670 million[93, 95] - The company anticipates Crysvita revenue to be $460-480 million in 2025, representing a 12-17% increase[95] - Dojolvi revenue is projected to be $90-100 million in 2025, a 2-13% increase[95] - Ultragenyx aims to achieve full-year GAAP profitability in 2027, driven by revenue growth, new product launches, and expense management[2, 96, 99] Clinical Trial Results - Phase 2 data for UX143 in OI showed a 67% reduction in annualized fracture rate (AFR) [33] - Phase 3 data for DTX401 in GSDIa demonstrated a statistically significant 41% reduction in daily cornstarch intake at Week 48 (p < 0.0001)[83] - UX111 for MPS IIIA showed >80% of participants reduced CSF HS by 50% in efficacy set[71]

PRAME Franchise & Market Opportunity - Immatics is developing three clinical product candidates (IMA402, IMA203, IMA203CD8) precisely targeting PRAME, an intracellular protein presented on tumor cell surfaces[10, 12] - PRAME expression is prevalent in over 50 cancers[8], with prevalence ranging from 20% in Hepatocellular Carcinoma and Bladder Carcinoma to 95% in Cutaneous Melanoma, Uterine Carcinoma, and Synovial Sarcoma[9] - The addressable PRAME+/HLA-A*02:01+ patient population in the US & EU5 is estimated to be approximately 230,000 per year[20, 24] IMA203 PRAME Cell Therapy (Wave 1) - In a Phase 1 study, IMA203 demonstrated a confirmed objective response rate (cORR) of 56% (18/32) in heavily pretreated patients with metastatic melanoma[34, 45] - The median duration of response (mDOR) was 121 months, with ongoing responses for up to 25+ years[34] - The median progression-free survival (mPFS) was 61 months, and the median overall survival (mOS) was 159 months in all melanoma patients[34, 51] - The SUPRAME Phase 3 trial is actively enrolling patients with unresectable or metastatic melanoma post-ICI, with a planned launch in Q3 2027[35, 59] - Approximately 9,000 PRAME+/HLA-A*02:01+ patients in the US/EU5 with cutaneous and uveal melanoma are addressable[34] IMA203CD8 PRAME Cell Therapy (GEN2) (Wave 2) - IMA203CD8 is a next-generation PRAME cell therapy leveraging CD8 and CD4 T cells, with enhanced pharmacology[24] - In a Phase 1a dose escalation study, IMA203CD8 achieved a cORR of 41% (14/34) at presumably suboptimal doses, with 84% (32/38) of patients experiencing tumor shrinkage[73, 85] - The median duration of response (mDOR) was 92 months, with 3 confirmed responses ongoing at 1+ year[73, 85] - The addressable PRAME+/HLA-A*02:01+ patient opportunity for IMA203CD8 is approximately 75,000 per year, including indications with both high and medium-level PRAME expression[20, 68] IMA402 PRAME Bispecific (Wave 3) - IMA402 is a next-generation half-life extended bispecific primarily targeting first-line settings in combination with ICI and targeted agents[22] - Early signs of clinical activity have been observed, with a melanoma patient achieving a confirmed partial response ongoing at 3 months at DL7[115] - The addressable PRAME+/HLA-A*02:01+ patient population for IMA402 in 1L solid tumors is approximately 145,000 in the US & EU5[20, 100] Beyond PRAME: IMA401 MAGEA4/8 Bispecific - IMA401 is a bispecific targeting MAGEA4/8, with a Phase 1a study demonstrating a 29% (5/17) ORR and 25% (4/16) cORR in patients with MAGEA4/8high expression at relevant doses[132, 149] - The addressable MAGEA4/8+ and HLA-A*02:01+ patient population in the US & EU5 is approximately 62,000 per year[128, 130]