Celldex Therapeutics(CLDX) - 2019 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - In Q2 2019, the net loss was $11.8 million or $0.84 per share, compared to a net loss of $16.4 million or $1.67 per share in Q2 2018, indicating an improvement in financial performance [26] - For the six months ended June 30, 2019, the net loss was $29 million or $2.21 per share, compared to $134.5 million or $14.01 per share for the same period in 2018, reflecting a significant reduction in losses [26] - Research and development expenses were $21.2 million for the six months ended June 30, 2019, down from $43.3 million in the comparable period in 2018, showing cost management efforts [26] - General and administrative expenses decreased to $8.8 million for the six months ended June 30, 2019, from $11.2 million in the same period in 2018 [26] - As of June 30, 2019, the company reported cash, cash equivalents, and marketable securities of $81.3 million, which are expected to be sufficient to meet working capital requirements through 2020 [27] Business Line Data and Key Metrics Changes - The company has two programs advancing in the clinic, a third expected to enter clinical trials before year-end, and a fourth planned for 2020, indicating a robust pipeline [5] - CDX-1140 is in a Phase I trial with encouraging results, demonstrating strong biological activity associated with CD40 activation [10][11] - CDX-3379 is undergoing a Phase II study in combination with cetuximab for cetuximab-resistant head and neck cancer, showing notable clinical activity in a difficult-to-treat patient population [21][22] Market Data and Key Metrics Changes - The prevalence of chronic idiopathic urticaria (CIU) is estimated to be 0.5% to 1% of the total population in the U.S., indicating a significant market opportunity for CDX-0159 [14] - The company is exploring the potential of CDX-0159 in CIU, which presents a need for more effective therapies [15] Company Strategy and Development Direction - The company is consolidating its Massachusetts laboratory and manufacturing facilities, which is expected to save over $3.5 million annually starting in the second half of 2020 [7] - The focus on advancing the clinical development of its product pipeline is evident, with plans to initiate a Phase I study of CDX-0159 before year-end and to advance bispecific programs [29] - The company aims to validate a biomarker strategy in head and neck cancer through the expansion of the CDX-3379 study, which could change the standard of care for these patients [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of CDX-1140 and CDX-3379 programs, anticipating key clinical insights within the next 6 to 12 months [28] - The company is pleased with the expanding breadth and depth of its pipeline, which is expected to support significant news flow and meaningful inflection points in the coming months [30] Other Important Information - The company made a significant hire by bringing Dr. Diane Young on board as Senior Vice President and Chief Medical Officer, which is expected to strengthen clinical development efforts [6] Q&A Session Summary Question: Safety profile of CDX-1140 and comparison with competitors - Management confirmed that while biological activity associated with CD40 activation has increased with higher doses, they have not reached a level where safety has become limiting [33][34] Question: Population sizes for FAT1 and NOTCH mutations and commercial diagnostics - Management indicated that FAT1 mutations are seen in about a third of head and neck tumors, while NOTCH mutations are present in about a quarter, and they are pursuing next-generation sequencing to confirm these findings [36][37]