Applied Molecular Transport Inc. - AMTI STOCK NEWS

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) reported strong enrollment in its pivotal Phase 3 global study evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (“NPC1”). The company is also on track to close a merger with Applied Molecular Transport, Inc. before the year ends. Additionally, they have taken steps to strengthen their balance sheet and extend their cash position.

Applied Molecular Transport Inc. (AMTI) entered into a definitive merger agreement with Cyclo Therapeutics, focusing on advancing Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1). The merger is expected to close by year end 2023, with upcoming milestones including completion of enrollment in pivotal Phase 3 clinical trial in NPC1, reporting top line data and preparation for NDA submission. Financially, the company reported a significant decrease in research and development expenses compared to the same period in 2022, leading to a reduced net loss and cash and cash equivalents of $18.1 million as of September 30, 2023.

Cyclo Therapeutics and Applied Molecular Transport have entered into a merger agreement, forming Cyclo Therapeutics, Inc. The combined company will focus on advancing Trappsol Cyclo for the treatment of Niemann-Pick Disease Type C1 (NPC1). The closing of the merger is expected to result in approximately $13.7 million in cash for operations until 2H 2024. Upcoming milestones include completing enrollment in a pivotal Phase 3 clinical trial, reporting top-line data, and preparing for NDA submission.

Applied Molecular Transport Inc. (AMTI) reported financial results for Q2 2023, with a net loss of $17.3 million compared to $35.9 million in Q2 2022. Cash and cash equivalents as of June 30, 2023, were $22.5 million.

Applied Molecular Transport Inc. (Nasdaq: AMTI) announces a significant workforce reduction of approximately 57% and has engaged MTS Health Partners, L.P. to explore strategic alternatives. CEO Tahir Mahmood will step down but remain on the board, while COO Shawn Cross will take over as CEO and chair the board. The restructuring will include pausing research and development, particularly the AMT-101 Castro trial in Rheumatoid Arthritis. The company reported cash reserves of about $47.4 million as of February 28, 2023, and estimates severance costs of approximately $4.8 million due to the layoffs.

Applied Molecular Transport Inc. (Nasdaq: AMTI) released its corporate update and financial results for Q4 and full year 2022. The company is focusing on strategic partnerships to advance AMT-101, which has received FDA Orphan Drug Designation for chronic pouchitis. Notable highlights include presenting positive Phase 2 data at ECCO and anticipation of top-line results from the CASTRO trial in Rheumatoid Arthritis. Financially, R&D expenses rose by $18.4 million, while G&A expenses increased by $8.1 million. The net loss for Q4 2022 was $22.6 million, with an annual net loss of $126.3 million. Cash reserves stood at $61.1 million at year-end.

Applied Molecular Transport Inc. (Nasdaq: AMTI) announced new Phase 2 data for oral AMT-101 targeting chronic pouchitis, presented at ECCO ’23. The trial demonstrated AMT-101's gut-restricted pharmacodynamics, with no systemic exposure, showcasing significant immunomodulatory effects at both 3mg and 10mg doses. Key findings included increased tissue levels of IL-10 and enhanced regulatory T cells. The double-blinded trial randomized 22 patients over 12 weeks, reinforcing AMT-101's safety and efficacy. CEO Tahir Mahmood indicated ongoing efforts to secure a strategic partnership for this promising treatment.

Applied Molecular Transport Inc. (AMT) announced mixed results from the Phase 2 LOMBARD trial for AMT-101, a treatment for moderate-to-severe ulcerative colitis (UC). The clinical remission rate was 17.1% for AMT-101, slightly below the 20% observed with placebo. Despite the disappointing results, AMT-101 was well-tolerated, with mild adverse events. The company is preparing for a Phase 1b trial of AMT-126 and is seeking partnerships to advance AMT-101 into Phase 3. As of Q3 2022, AMT reported a strong cash position of $76M.