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Applied Molecular Transport Inc. (AMTI) is a clinical-stage biopharmaceutical company focused on the development of innovative oral biological therapeutics. Leveraging its proprietary technology platform, AMTI designs novel biologic product candidates in patient-friendly oral dosage forms. Their core expertise lies in mucosal immunology and microbiome-epithelial interfaces, leading to the creation of first-in-class molecules aimed at treating autoimmune, inflammatory, and other grievous diseases, including cancer, metabolic, and hepatologic disorders.
Recent developments highlight AMTI's pursuit of strategic alternatives, with MTS Health Partners, L.P. advising the company. As of June 30, 2023, cash and cash equivalents stood at $22.5 million. The company has undergone significant restructuring, including workforce reductions and the cessation of all research and development activities, reflected in a decrease in R&D expenses from $22.8 million in Q2 2022 to $2.6 million in Q2 2023.
AMTI's most advanced product candidate, AMT-101, has completed four Phase 2 clinical trials. In a strategic move, AMTI has entered a merger agreement with Cyclo Therapeutics, Inc., expected to finalize by the end of 2023. This merger aims to advance Cyclo Therapeutics' pivotal Phase 3 study of Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1), with the combined company operating under the Cyclo Therapeutics name and trading on Nasdaq as CYTH.
The merger is anticipated to bolster the combined company's cash position, extending the runway into the second half of 2024, crucial for meeting clinical and regulatory milestones. Shawn Cross, CEO of AMTI, will join the Cyclo Therapeutics Board, ensuring continuity and strategic alignment.
Applied Molecular Transport Inc. (Nasdaq: AMTI) announced FDA's Orphan Drug Designation for AMT-101 in patients suffering from pouchitis, a condition with significant unmet medical need. AMT-101 is an investigational oral treatment combining IL-10 with a proprietary carrier, also targeting ulcerative colitis and rheumatoid arthritis. The Phase 2 FILLMORE trial showed promising results with 36.4% of patients achieving stool frequency response. If approved, AMT-101 could be the first U.S. treatment for pouchitis, granting the company potential marketing exclusivity and financial incentives.
Applied Molecular Transport Inc. (Nasdaq: AMTI) will participate in two upcoming investor conferences. The first event is the Guggenheim 4th Annual Immunology and Neurology Day on November 14, 2022, at 9:35 a.m. ET in New York, presented by CEO Tahir Mahmood. The second is the Jefferies London Healthcare Conference on November 16, 2022, at 1:30 p.m. GMT, featuring COO Shawn Cross and CMO Bittoo Kanwar. Live webcasts will be available on their website, with archived replays for 30 days.
AMT focuses on developing novel oral biologic products leveraging its technology platform.
Applied Molecular Transport Inc. (Nasdaq: AMTI) announced its recent end of Phase 2 meeting with the FDA, allowing the advancement of oral AMT-101 monotherapy for chronic pouchitis to Phase 3, an orphan indication without FDA-approved products. The company also reported third-quarter financial results for 2022, with a net loss of $25.2 million and cash reserves of $76.0 million, expected to support operations for at least the next twelve months. Top-line data from ongoing Phase 2 trials for AMT-101 in ulcerative colitis is anticipated by early 2023.
Applied Molecular Transport Inc. (NASDAQ: AMTI) announced the completion of enrollment for its Phase 2 LOMBARD trial of AMT-101, aimed at treating moderate-to-severe ulcerative colitis (UC). The trial enrolled 105 patients globally and is designed to evaluate the drug's safety and efficacy over 12 weeks. Top-line data, including clinical remission rates, is expected to be reported in late 2022 or early 2023. AMT-101, a novel oral fusion of IL-10, aims to target inflammation directly in the gastrointestinal tract while minimizing systemic side effects.
Applied Molecular Transport Inc. (AMTI) announced positive top-line data from its Phase 2 trials for AMT-101, focusing on chronic pouchitis and ulcerative colitis (UC). The company received an end of Phase 2 meeting with the FDA to discuss advancing to Phase 3 for chronic pouchitis. AMT-101 demonstrated favorable clinical activity and safety in both trials, meeting pre-specified efficacy endpoints. The company's net loss for Q2 2022 was $35.9 million, with R&D expenses increasing to $25.9 million. Cash reserves as of June 30, 2022, stood at $95.8 million.
Applied Molecular Transport's Phase 2 MARKET trial results showed similar clinical remission rates at week 8, 31.8% for AMT-101 combined with adalimumab versus 33.3% for adalimumab alone. However, for patients with ulcerative colitis under 5 years, the combination yielded a 43.8% remission rate compared to 15.4% with adalimumab alone. AMT-101 was well-tolerated with mostly mild side effects. The findings indicate potential benefits of early combination therapy in the treatment of ulcerative colitis, suggesting a direction for future clinical development.
Applied Molecular Transport Inc. (AMTI) has announced a live conference call on July 6, 2022, at 8:30 a.m. ET, to share top-line data from its Phase 2 MARKET combination trial of AMT-101, targeting moderate-to-severe ulcerative colitis. This oral biologic product candidate combines IL-10 with anti-TNFα in biologic-naïve patients. Interested investors can join via phone or watch a live webcast on the company’s website, which will also host an archived replay for 30 days.
Applied Molecular Transport Inc. (Nasdaq: AMTI) will participate in two key investor conferences in June 2022. The company will present at the Jefferies Global Healthcare Conference on June 9 at 8:30 a.m. ET, featuring CEO Tahir Mahmood. Additionally, they will present at the JMP Securities 2022 Life Sciences Conference on June 15 at 1:00 p.m. ET, with presentations by COO Shawn Cross and CMO Bittoo Kanwar. Live webcasts and archived replays will be available on the company's website, providing insights into their oral biologic product candidates and innovative technology.
Applied Molecular Transport Inc. (AMTI) announced strategic actions to advance their lead product, AMT-101, into Phase 3 trials for chronic pouchitis while pausing earlier-stage programs. The company anticipates three Phase 2 top-line readouts for AMT-101 in ulcerative colitis and rheumatoid arthritis by the end of 2022. To enhance financial stability, AMTI will reduce its workforce by approximately 40% and implement cost reductions to extend its cash runway into 2024. The firm plans to prepare for end-of-Phase 2 meetings with regulators and looks for partnership opportunities.
Applied Molecular Transport (AMTI) announced positive top-line data from its FILLMORE Phase 2 trial for chronic pouchitis, validating AMT-101's potential. The Independent Data Monitoring Committee has recommended progressing to Phase 3 trials. The company reported a net loss of $42.6 million for Q1 2022, increasing from $20.5 million in Q1 2021, with R&D expenses rising to $31.2 million. As of March 31, 2022, AMTI holds $126.5 million in cash, sufficient for at least 12 months of operations. Upcoming Phase 2 readouts for ulcerative colitis and rheumatoid arthritis are anticipated in 2022.
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