TORRANCE, Calif., Aug. 14, 2025 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQB: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today reported on its financial condition and results of operations as of and for the three and six months ended June 30, 2025.Highlights"We experienced a 48% decline in net revenue for the three months ended June 30, 2025 as compared to the same period in 2024 due to ongoing competition from generic L-Glutamine, partially ...

Financial Data and Key Metrics Changes - Research and development expenses decreased to $13.4 million in Q1 2025 from $19.8 million in Q1 2024, a reduction of $6.4 million attributed to the discontinuation of the losmapimod program and global development cost sharing reimbursement under the Sanofi collaboration [11] - General and administrative expenses fell to $7 million in Q1 2025 from $10.1 million in Q1 2024, a decrease of $3.1 million primarily due to reduced employee compensation costs following a workforce reduction [12] - Net loss improved to $17.7 million in Q1 2025 compared to a net loss of $26.9 million in Q1 2024 [12] - Cash, cash equivalents, and marketable securities decreased to $226.6 million as of March 31, 2025, from $241 million as of December 31, 2024, a decrease of $14.4 million mainly due to cash used for operating activities [12][13] Business Line Data and Key Metrics Changes - The lead program, coceridere, is currently enrolling in a phase 1b trial called PIONEER for sickle cell disease, with 16 patients enrolled in the 12 mg cohort [5][7] - The data monitoring committee recommended continuing the study and initiating the 20 mg cohort, which is now underway [7] Market Data and Key Metrics Changes - Approximately 100,000 people in the US and 4.4 million people worldwide are afflicted by sickle cell disease, indicating a significant market opportunity for treatments targeting this condition [5] Company Strategy and Development Direction - The company aims to induce fetal hemoglobin as a strategy for treating sickle cell disease, supported by data showing that even modest increases in fetal hemoglobin correlate with reduced disease severity [8] - The company plans to submit an IND for Diamond Blackfan anemia in Q4 2025, indicating a focus on expanding its treatment portfolio for inherited hematological conditions [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in 2025 and looks forward to delivering important data releases from the PIONEER trial [14] - The company believes that the current operating plans will allow existing cash reserves to fund operations into at least 2027 [13] Other Important Information - The company has two abstracts accepted for presentation at the upcoming European Hematology Association meeting, highlighting ongoing research efforts [9] Q&A Session Summary Question: Data expectations from the twelve milligram cohort of PIONEER - Management confirmed that data will include hematological parameters and that all 16 patients will have data from the three-month treatment phase, with a subset having four-week follow-up data [16][17] Question: Adherence data and dosing timing - Management explained that adherence is monitored using an AI tool, with over 90% adherence reported, and that they can track the timing of doses taken by patients [19][20][22] Question: Representativeness of the patient sample - Management acknowledged that while the sample size is small, the baseline fetal hemoglobin levels were higher than expected, and they do not believe baseline levels will determine response to treatment [25][28] Question: Expectations for the twelve-week data - Management indicated that any increase in fetal hemoglobin is beneficial, with clinically meaningful reductions in vaso-occlusive crises expected from the data [34][36] Question: Enrollment dynamics and site selection - Management attributed faster enrollment to having the right sites on board and the loss of other treatment options, which increased patient interest in the trial [42][44] Question: FDA interactions and endpoint selection - Management plans to interact with the FDA at the end of the 20 mg cohort to discuss future study plans and endpoint selection [54][56]