Neon Therapeutics, Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2019. For the quarter, the company reported loss from operations of $21,580,000 compared to $16,757,000 a year ago. Net loss was $21,024,000 compared to $16,520,000 a year ago. Net loss per share attributable to common stockholders, basic and diluted was $0.76 compared to $9.47 a year ago.

The company is developing neoantigen-targeting therapies across multiple treatment modalities, including vaccines, adoptive T cell therapies and TCR-based T cell therapies to bring benefit to a broad set of patients across tumor types and stages of disease. This approach requires effectively identifying and selecting the optimal neoantigen targets for the unique mutational fingerprint of each individual patient's tumor. The company is pioneering a proprietary neoantigen platform to identify and harness the most therapeutically relevant neoantigens, including through its RECON bioinformatic neoantigen prediction engine, deep capabilities in peptide chemistry and manufacturing, and NEO-STIM™ T cell biology and immune-monitoring expertise. The company is using two distinct neoantigen therapeutic approaches across this platform: personal therapies that target individualized mutations (NEON /ONE), and off-the-shelf precision therapies (NEON /SELECT) that target shared mutations present in sub-populations of cancer patients. NEON /ONE is the company's personal medicine approach to neoantigen-targeted therapies that are tailored for the individual profile of each patient's tumor. The company's initial clinical strategy has focused on solid tumor indications where checkpoint inhibitors have been approved, either in combination or in refractory settings. The company is evaluating its lead product candidate, a personal neoantigen vaccine, in a variety of treatment settings in Phase 1b development to determine the optimal late-stage clinical trials. The company's ongoing Phase 1b open-label clinical trial is evaluating a combination of NEO-PV-01 with OPDIVO® (nivolumab) in patients with metastatic melanoma, non-small cell lung cancer (NSCLC) or bladder cancer. The company completed enrollment in NT-002, its Phase 1b clinical trial evaluating NEO-PV-01 in combination with the current standard of care, KEYTRUDA® (pembrolizumab) and chemotherapy, in first-line patients with untreated advanced or metastatic NSCLC. This trial is evaluating the safety, tolerability and efficacy of NEO-PV-01 in the metastatic setting. The Phase 1b clinical trial of NEO-PV-01 in metastatic melanoma combinations is currently enrolling. NT-003 will evaluate NEO-PV-01 and OPDIVO in combination with other agents, including Apexigen's CD40 agonist (APX005M) or a CTLA-4 antagonist, to further enhance any NEO-PV-01-induced neoantigen immune response and improve clinical outcomes. This trial will also evaluate alternative NEO-PV-01 dosing schedules. The company is planning to explore NEO-PV-01 in a monotherapy approach in an earlier disease setting in this Phase 1b trial. The company's personal adoptive T cell therapy consists of multiple T cell populations targeting neoantigens that are predicted to be the most therapeutically relevant from each patient's tumor. NEO-PTC-01 uses T cells from the periphery of each patient that are then primed, activated and expanded to generate a therapy that specifically targets that patient's personal neoantigens, with the potential to drive a robust and persistent anti-tumor response. NEON /SELECT is the company's off-the-shelf precision approach to neoantigen-targeted therapies that seek to target prevalent neoantigens that are shared across subsets of patients or tumor types. The company is planning to develop its off-the-shelf neoantigen vaccine for the treatment of a genetically-defined subset of hormone receptor-positive (HR+) breast cancer, potentially across disease stages in combination with hormonal, chemotherapy or targeted therapies. The company continues to advance its precision T cell approach and has assembled libraries of high-quality T-cell receptors (TCRs) against various shared neoantigens. The company is leveraging its proprietary NEO-STIM induction protocol to rapidly generate T cells specific to these targets where multiple TCRs can be sequenced and characterized.