Celldex Therapeutics, Inc. Q2 FY2020 earnings call

• Anthony Marucci discussed recent events like CDX-0159 data at EAACI and $150M public offering, prioritized certain programs and halted CDX-3379.
• Diane Young detailed CDX-0159 Phase 1a results, plans for Phase 1b urticaria studies, CDX-1140 Phase 1 study progress, CDX-527 entering clinic, and reasons for discontinuing CDX-3379.
• Sam Martin reviewed financials for the period.

For the second quarter of 2020, net loss was $11 million or $0.50 per share, compared to a net loss of $11.8 million or $0.84 per share for the second quarter of 2019. Net loss for the six months ended June 30, 2020 was $23.7 million or $1.20 per share, compared to $29 million or $2.21 per share for the comparable period in 2019. Research and development expenses were $21.4 million for the six months ended June 30, 2020, compared to $21.2 million for the comparable period in 2019. General and administrative expenses were $7.2 million for the six months ended June 30, 2020, compared to $8.8 million for the comparable period in 2019. As of June 30, 2020, cash, cash equivalents and marketable securities were $206.9 million.

• Plan to initiate two Phase 1b studies of CDX-0159 in fall 2020.
• Initiate Phase 1 study of CDX-527 and CDX-1140 expansion cohort later in 2020.
• Plan to initiate third study of CDX-0159 in an additional mast cell indication in summer 2021.
• Anticipate data updates for CDX-1140 later in 2020 and data from various programs in 2021.

• Impact of COVID-19 and hurricanes on call quality.
• General risks from forward-looking statements, including factors set forth in SEC filings that could cause actual results to differ from forward-looking statements.

Q: For the CDX-0159 program, given some patients may have comorbidities, if they are worth evaluating in Phase 1b and Phase 2 studies A: Diane Young noted they intend to capture comorbidities and assess response in early studies Q: Regarding choosing the third mast cell driven indication and results from CIndU trial in Q1 2021, will CIndU results help determine the third indication A: Diane Young stated they will definitely take data from the CIndU study to inform next steps Q: Patients in Phase 1b trials are refractory to antihistamines, if majority have been prescribed up to 4 times dosage and if CSU trial patients could have failed Xolair A: Margo Heath-Chiozzi said 4 times dosage is common but not required, and for CSU trial, prior Xolair use is allowed but with washout Q: For CDX-1140, color on patient numbers or specific endpoints from cohorts with data in second half of 2020 A: Margo Heath-Chiozzi said the study is ongoing, with data from dose escalation cohort with CDX-301 and interim data from expansion cohorts Q: How to think about spending trends with new trials and discontinuation of CDX-3379 A: Sam Martin said they've factored it in as per guidance through 2023 and will consider extension as plans are built out