Item 7.01 Regulation FD Disclosure.
On
The information in Item 7.01 of this Current Report on Form 8-K, including the slides incorporated herein by reference, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Item 7.01 of this Current Report on Form 8-K.
Item 8.01 Other Events.
On
In the ECBF+A cohort (n=7) receiving zotatifin, fulvestrant and abemaciclib, two patients experienced confirmed partial responses ("PRs"), and a third patient had stable disease continuing beyond 24 weeks, for an objective response rate ("ORR") of 29% (2/7) and a clinical benefit rate ("CBR") of 43% (3/7). Zotatifin was generally safe and well-tolerated in this triplet combination. ORR and CBR data for the remaining 11 patients is anticipated to be available in the first half of 2023.
In addition, in the ECBF cohort (n=18) receiving zotatifin and fulvestrant, one patient experienced a confirmed PR continuing beyond Week 52 and one patient had stable disease continuing beyond 24 weeks. Zotatifin was generally safe and well-tolerated in this doublet combination. Dose-dependent target engagement was observed by two independent methods, without obvious signs of target saturation. Therefore, the Company has resumed dose escalation with topline data anticipated in the second half of 2023.
The Company is deferring initiation of the Cyclin D1 amplification cohort in ER+ BC and pausing enrollment in the KRAS G12C lung cancer cohort until completion of dose escalation.
The Company has also completed enrollment in the third and final cohort in its Phase 1b study with zotatifin in COVID-19, and anticipates providing topline data from this trial in the first half of 2023.
With respect to the tomivosertib program, the Company has experienced enrollment challenges across both cohorts resulting from staffing issues across clinical sites and competition from other trials. The Company is focusing its efforts on completing enrollment in the front-line PD-L1 >50% cohort and now anticipates topline data from this cohort in the second half of 2023. The Company is discontinuing further enrollment of the PD-L1 >1% maintenance cohort.
Based on its updated development plans, the Company believes its existing cash resources will be sufficient to fund operations into the first quarter of 2024.
Cautionary Note Regarding Forward-Looking Statements
The Company cautions you that statements contained in this report regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the future clinical development of our product candidates, including expectations on enrollment and the timing of reporting data from ongoing clinical trials; the planned expanded
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development of zotatifin and the timing thereof; the potential therapeutic
benefits of our product candidates; the potential market opportunity for our
product candidates; and our expected cash runway and the sufficiency of our
capital resources to allow clinical trial data readouts and the expansion of our
clinical development programs. Actual results may differ from those set forth in
this report due to the risks and uncertainties inherent in our business,
including, without limitation: the risk that interim results of a clinical trial
are not necessarily indicative of final results and one or more of the clinical
outcomes may materially change as patient enrollment continues, following more
comprehensive reviews of the data and more patient data become available;
potential delays in the commencement, enrollment and completion of clinical
trials; additional disruptions to our operations from the COVID-19 pandemic,
including clinical trial and manufacturing delays; our dependence on third
parties in connection with product manufacturing, research and preclinical and
clinical testing; the results of preclinical studies and early clinical trials
are not necessarily predictive of future results; the success of our clinical
trials and preclinical studies for our product candidates is uncertain; we may
use our capital resources sooner than expected and they may be insufficient to
allow clinical trial readouts; regulatory developments in
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Slide Presentation 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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