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8/15/2022
and welcome to the Califera Biosciences Second Quarter 2022 Earnings Conference Hall. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. As a reminder, this call may be recorded. I would like to turn the call over to Stephanie Wong, CFO. You may begin.
Thank you, Operator. Good afternoon, everyone, and welcome to our Second Quarter 2022 Conference Hall. Joining me today are Susan Molyneux, Founder, President, and CEO of and Emil Curiaco, Chief Medical Officer. Earlier this afternoon, we issued a press release, which included an overview of the second quarter 2022 financial and operational results, which can be accessed through our website at Caledonia.com. Before we begin, I would like to remind you that today's discussion will include statements about our future expectations, plans, and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the private security litigation reform act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the respective sections of the periodic filing for the FCC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. Please note that this call is being recorded, and with that, I'll turn the call over to Susan.
Thanks, Stephanie. Good afternoon, everyone, and thank you for joining us for today's conference call. When we spoke last quarter, I noted that Calicera was off to an exciting start in 2022, and I'm pleased to say that this momentum has continued in recent months as we work to advance our pipeline of investigational small molecule oncology compounds to address the needs of biomarker-defined patient populations. The most notable developments, of course, were the initiations and enrollment of the first patients in our Phase II clinical trials of mivivotinib in relapsed refractory non-GCV diffuse large B-cell lymphoma, or DLBCL, in June, and sepanacertib in relapsed refractory Nrf2-mutated squamous non-small cell lung cancer in the first week of July. We remain on track to report data from both of these monotherapy studies by the first quarter of 2023 and look forward to sharing additional details along the way. Further, updates on both programs were shared at the Pan-Pacific Lymphoma Conference and the World Conference for Lung Cancer. At the Pan-Pacific Conference last month, Dr. Reem Karmali of Northwestern University presented a poster detailing the design of the Phase II Mivovotinib study. And just last week at World Lung, Dr. Jonathan Reese of UC Davis Comprehensive Cancer Center presented during a mini oral session the findings from an investigator-initiated multicenter phase 1, 2 dose escalation study of cipanacertib in combination with teloglanostat in advanced non-small cell lung cancer patients. Preclinical studies had shown that combining teloglanostat and cipanacertib demonstrated synergistic anti-tumor activity. As you recall, we are not developing teloglenostat at this time. However, we are interested in this combination and look forward to the results of this investigator-initiated study. Emma will provide more details on these presentations in his remarks. We continue to believe that by focusing on well-characterized genetic vulnerabilities with molecules that have already shown single agent activity, we will be able to generate phase two data with targeted efficient study designs, such as those we are currently enrolling. We believe that these studies have the potential to lead us to efficient paths to approval in biomarker defined patient populations. Turning to our preclinical programs, we have continued to advance our pipeline of synthetically sality targets, most notably VPS4A and VPS4B. And as you heard on last quarter's earning call, We shared the first data from this program at AACR in April. We are continuing to advance multiple compound series through lead optimization and look forward to updating you on our progress as we advance towards first in human clinical studies. We expect to provide further updates on our preclinical efforts by year end. And with that said, I will pass the call over to Emil to provide additional details on our program.
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