Item 8.01. Other Events.
On January 3, 2019, the Company announced new interim data from five patients in its Phase 2 trial of SEL-212 receiving five monthly combination doses of SEL-212, consisting of up to 0.15 mg/kg of ImmTOR in combination with 0.2 or 0.4 mg/kg of pegadricase. In these cohorts, approximately 66% of the evaluable patients maintained serum uric acid level control below 6 mg/dL throughout five months of therapy. Furthermore, reduced total urate burden and lowered flare rates and severity were observed in the Phase 2 clinical trial, and SEL-212 continued to be generally well tolerated.
In addition, the Company announced plans to initiate a head-to-head superiority trial of SEL-212, utilizing revised stopping rules, compared to
the current FDA-approved uricase therapy, Krystexxa
, in the first quarter of 2019. An interim six-month
data readout is projected for the fourth quarter of 2019 with a full statistical superiority data analysis expected in the first quarter of 2020. The Company plans to initiate a Phase 3 clinical trial of SEL-212 in the fourth quarter of 2019.
In September 2018, the Company announced a collaboration with the European consortium, CureCN, for an ImmTOR+AAV gene therapy combination product candidate in CN. The Company expects CureCN to initiate preclinical toxicology studies in the first half of 2019 and for the combination product candidate to enter the clinic in the second half of 2019.
In March 2018, the Company initiated a Phase 1 trial of SEL-403 in patients with malignant pleural or peritoneal mesothelioma who have undergone at least one regimen of chemotherapy under a Cooperative Research and Development Agreement at the National Cancer Institute, part of the National Institutes of Health. On January 3, 2019, the Company announced that it plans to deprioritize the SEL-403 Phase 1 oncology development program, which was placed on clinical hold by the FDA.
Forward-Looking Statements Disclaimer
This Current Report on Form 8-K (the “Current Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our business strategy and operations, the size, timing and impact of the Workforce Reduction and related activities, the expected size and sufficiency of our workforce following such reduction, the estimated charges and costs expected to be incurred in connection with such reduction, and the amount of such charges expected to result in cash expenditures, the anticipated timing of the head-to-head trial comparing SEL-212 and Krystexxa and related data readouts, expectations surrounding the initiation of a Phase 3 clinical trial of SEL-212 and timing thereof, the potential of ImmTOR to enable re-dosing of AAV gene therapy and the anticipated timing of preclinical toxicology studies and initiation of a clinical trial related thereto, and plans to deprioritize the SEL-403 program. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our strategy may change, and we may not be able to effectively implement our current strategic plan; the size of our workforce following the reduction in force may not be sufficient, and we may not be able to effectively attract or retain new employees; risks associated with our reduction in workforce, such as employee claims and the risk that the actual financial and other impacts of the reduction could vary materially from the outcomes anticipated; the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes;
the unproven approach of our ImmTOR technology; undesirable side effects of our product candidates; our reliance on third parties to manufacture our product candidates and to conduct our clinical trials; our inability to maintain our existing or future collaborations or licenses; our inability to protect our proprietary technology and intellectual property; potential delays in regulatory approvals; our dependence on our ability to retain key executives and to attract, retain and motivate qualified personnel; and availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 8, 2018, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this Current Report. Any such forward-looking
statements represent management’s estimates as of the date of this Current Report. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this Current Report.