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Applied Molecular Transport price target lowered to $50 from $86 at JMP Securities » 06:2905/1905/19/22
JMP Securities analyst…
JMP Securities analyst Jason Butler lowered the firm's price target on Applied Molecular Transport to $50 from $86 but keeps an Outperform rating on the shares. The analyst cites the company's announcement to narrow its focus to trials underway for lead AMT-101 and adjusts his model, removing the value he assumed for AMT-126. Butler adds however that his confidence in the potential for success in Applied Molecular's upcoming Phase 2 readouts remains unchanged.
Applied Molecular Transport sees cash runway into 2024 » 08:1805/1805/18/22
The company expects to…
The company expects to record a one-time charge, primarily related to severance, in the second quarter of 2022; strategic prioritization extends estimated cash runway into 2024
Applied Molecular Transport reducing workforce by 40% » 08:1805/1805/18/22
Reducing workforce by…
Reducing workforce by approximately 40%, to 81 full-time employees, and focusing on execution of late-stage clinical trials and related CMC activities
Applied Molecular Transport appoints Shawn Cross as president, COO » 08:1705/1805/18/22
Aligning senior management to support the late-stage focus of the company: Shawn Cross named president and chief operating officer; Brandon Hants assumes role of chief financial officer; Randy Mrsny, Ph.D., stepping down as chief scientific officer.
Applied Molecular Transport pauses earlier-stage research programs 08:1705/1805/18/22
Applied Molecular Transport evaluating next steps for AMT-126 » 08:1605/1805/18/22
Evaluating next steps for…
Evaluating next steps for AMT-126, which recently demonstrated safety and tolerability in a Phase 1a trial in healthy volunteers
Applied Molecular Transport to prioritize advancement of AMT-101 » 08:1605/1805/18/22
Preparing for end of…
Preparing for end of Phase 2 meetings with FDA and other regulators to advance AMT-101 to Phase 3 in chronic pouchitis, an orphan indication with no FDA-approved products; Completing the remaining three AMT-101 Phase 2 trials with top-line data readouts in 2022, consistent with previous guidance
Applied Molecular Transport provides strategy update » 08:1305/1805/18/22
Applied Molecular Transport announced strategic actions to focus resources on its lead clinical programs. Strategic Actions Summary: Prioritizing the advancement of AMT-101 into late-stage clinical development, Preparing for end of Phase 2 meetings with FDA and other regulators to advance AMT-101 to Phase 3 in chronic pouchitis, an orphan indication with no FDA-approved products, Completing the remaining three AMT-101 Phase 2 trials with top-line data readouts in 2022, consistent with previous guidance. Evaluating next steps for AMT-126, which recently demonstrated safety and tolerability in a Phase 1a trial in healthy volunteers. Pausing earlier-stage research programs and activities. Aligning senior management to support the late-stage focus of the company: Shawn Cross named president and chief operating officer; Brandon Hants assumes role of chief financial officer; Randy Mrsny, Ph.D., stepping down as chief scientific officer. Reducing workforce by approximately 40%, to 81 full-time employees, and focusing on execution of late-stage clinical trials and related CMC activities. The company expects to record a one-time charge, primarily related to severance, in the second quarter of 2022; strategic prioritization extends estimated cash runway into 2024. "Given the recent positive AMT-101 Phase 2 results in chronic pouchitis, and its broad potential in additional indications, we have taken these strategic actions to prioritize our cash resources to support late-stage clinical advancement, including an anticipated Phase 3 trial in chronic pouchitis, as well as the ongoing Phase 2 trials in UC and RA," said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. "We also continue to explore partnership opportunities for our earlier stage programs and technology platform." Dr. Mahmood continued, "I also want to acknowledge the foundational contributions of AMT's co-founder Randy Mrsny to the technology platform that underpins our product candidates. It has been my great pleasure and honor to work alongside Randy to build AMT in order to create and advance novel oral biologic therapeutics. Parting with the employees who have brought AMT to such an advanced stage is a difficult decision. We thank our AMT colleagues for their contributions to our progress thus far," concluded Dr. Mahmood.
Applied Molecular Transport reports Q1 EPS ($1.10), consensus (75c) » 16:1105/0905/09/22
As of March 31 cash and…
As of March 31 cash and cash equivalents were $126.5 million. The Company believes its cash and cash equivalents will be sufficient to allow the Company to fund its current operating plan for at least twelve months. "We were pleased to recently announce positive top-line data from our FILLMORE trial in chronic pouchitis patients, the first of four important AMT-101 Phase 2 readouts," said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. "These results further substantiate the broad therapeutic potential of AMT-101 and may have positive implications for UC and Crohn's disease, given the meaningful responses achieved in stool frequency and histologic healing."
Applied Molecular Transport announces Phase 2 results from FILLMORE trial » 08:3604/2504/25/22
Applied Molecular Transport announced positive top-line Phase 2 results from the FILLMORE monotherapy trial for AMT-101 in patients with chronic pouchitis, an orphan indication with significant unmet medical need and no current FDA-approved therapies. FILLMORE Results: The objectives of the FILLMORE trial were to assess the safety and efficacy of AMT-101 in severe chronic pouchitis patients and to select a dose for Phase 3. On the first measure, results from the trial demonstrated that 36.4% of patients achieved stool frequency response, defined as a reduction of greater than or equal to 3 stools and greater than or equal to 30% from baseline, OR less than or equal to post-colectomy normal. Rapid onset of stool frequency response was demonstrated as early as week 2 in both dosage groups and was maintained through the duration of treatment. Top-line interim data demonstrated additional symptomatic improvements in fecal urgency, incontinence and abdominal cramps. The proportion of patients achieving the symptomatic stool frequency response in both dosage groups exceeded the criteria for determining advancement into Phase 3. On the second measure, 22.7% of patients met the pre-specified histologic healing response of Geboes score less than or equal to 3.1, an objective assessment of disease improvement. FILLMORE patients had a median baseline Geboes score of 5.1, representing severe pouchitis with ulceration and tissue destruction. Both dosage groups demonstrated histologic healing response. AMT-101 appeared safe and well-tolerated. Treatment emergent adverse events were mostly mild to moderate, with only one serious adverse event observed, cytomegalovirus infection, which was determined to be unrelated to study drug.