11/5/2020

speaker
Rahul
President & CEO

enrollment response, and it's an increase of HBF of 3% or greater from baseline to week 24 versus placebo. And the trial is powered for statistical significance for this endpoint. Patients will continue on treatment through 52 weeks to provide data for planned secondary and additional endpoints, including the evaluation of IMR687 versus placebo on VOCs, HPF-associated biomarkers, indices of red cell hemolysis. white blood cell adhesion, quality of life measures, and NT-PRO-BNP. The 4-T trial is designed to analyze the line of placebo-cold patients with beta-alcemia. The trial will evaluate the safety and tolerability of IMR-687 in approximately 60 transfusion-dependent patients and approximately 60 non-transfusion-dependent patients. Additionally, for transfusion-dependent patients, we plan to evaluate the effect of IMR67 versus placebo on transition burden and the change in iron load as a result of transfusion during the trial and in comparison recorded rates in the 12 weeks prior to initiation. The FORTE trial will also examine additional exploratory efficacy endpoints as well as safety and PK endpoints. Like our ARDENT study, We plan to continue utilizing weight-based dosing with potential doses as high as 400 mg. Safety and tolerability will be assessed after 24 weeks of dosing. As a reminder, we plan to report formal interim analysis for phase 2B trials when 33 and 30 patients respectively have completed 24 weeks of treatment. Due to COVID-19 enrollment delays, we are adjusting our expected time to report interim data on these trials from our previously estimated timeline of the first half of 2021 to the second half of 2021. I can assure you that our team has worked diligently internally as well as with our CRO and clinical site to minimize delays as much as possible. For example, we continue to increase the global reach of the ARDENT and FORTESH studies with 16 active clinical centers across multiple countries. For the ardent sickle cell disease study, we have seven active clinical centers in three countries and have received approval . In the Forte beta thalassemia trial, we have nine active clinical centers in five countries, with regulatory approval in 14 of 15 planned countries, with final approval expected later this month. We are continuing to activate multiple clinical centers for each of these studies across multiple countries, despite COVID-19. I will touch briefly on our pediatric development program in sickle cell disease next. Most to accelerate our originally planned timeline to initiate this clinical program, primarily due to advancements in our oral solution formulation of IMR687, which includes promising preclinical stability data and progress in scaling up third-party manufacturing. Oral solutions are generally preferred in younger patients and enable dosing to be more customized based on weight, age, and other parameters. We currently anticipate initiating the clinical program in the first half of 2021, approximately six months ahead of our previous expectations. We plan to conduct a single ascending dose trial and expand the program to a multiple dose extension study in adolescents and younger children. In summary, we believe the third quarter marked another productive period for Amara, and we look forward to seeing progress. Thank you, and I will now turn the call back to Mike to review our third quarter financial results.

speaker
Mike
Chief Financial Officer

Okay, thanks, Rahul. Our third quarter results can be found in the press release we issued this morning, which I'll summarize now. More details are also included within the 10Q that we filed with the SEC earlier this morning. R&D expenses were $9.5 million for the third quarter of 2020, as compared to $5.1 million for the third quarter of 2019. The increase of $4.4 million was primarily related to the conduct of our clinical trials and manufacturing of clinical materials related to the development of IMR 687, as well as increased personnel related and other R&D operating costs. General administrative expenses were $3 million for the third quarter of 2020, as compared to $1.7 million for the third quarter of 2019. The increase was primarily due to increased personnel related and other G&A costs as a result of operating as a public company. Net loss attributable to common stockholders was $12.4 million or 72 cents per share for the third quarter of 2020 as compared to a net loss of $6.6 million or $9.43 per share for the third quarter of 2019. We ended the third quarter with cash, cash equivalents, and investments of $96.1 million, and we expect that this will be sufficient to fund our planned operations into mid-2022. That concludes our prepared remarks. Operator, if you could open the line for questions. Thank you.

speaker
Operator
Operator

If you would like to ask a question, please press star, then a number 1 on your telephone keypad. Again, press star, then a number 1 on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. You have a question from Matthew Harrison with Morgan Stanley.

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