Cellectis SA: What is a Clinical Hold?

Yesterday, small cap clinical-stage biopharmaceutical stock Cellectis SA (NASDAQ: CLLS) reported that they had received notice fromFDA that a clinical hold was placed on both UCART123 ongoing Phase 1 studies -in acute myeloid leukemia (AML) and in blastic plasmacytoid dendritic cell neoplasm (BPDCN). The clinical hold was initiated after Cellectis reported one fatality in the BPDCN clinical trial (ABC study) with the Company now working closelywith the investigators and the FDA in order to resume the trials with an amended protocol including a lowered dosing of UCART123. The FDA has a detailed page about clinical holds which mentions:

When a proposed study is placed on clinical hold, subjects may not be given the investigational drug. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and given the investigational drug; patients already in the study are expected to be taken off therapy involving the investigational drug unless treatment continuation is specifically permitted by FDA in the interest of patient safety

The IND application sponsor is expected to address the cited deficiencies in writing and submit a complete response to the issue(s) identified in the clinical hold letter in a separate submission. Oncethe complete response to all of the clinical hold deficiencies has been received, FDA will review the submission within 30 calendar days and determine whether the applicants response to clinical hold satisfactorily addresses the issues. The investigation may resume after FDA (usually the Division Director or their designee) has notified the applicant that the investigation may proceed.

Paris based Cellectis SA is a clinical-stage biopharmaceutical company that harnesses the immune system to target and eradicate cancers. Unlike autologous CAR-T immunotherapies that require a custom immunotherapy product for each patient, Cellectis uses gene editing to create cost-effective, “off-the-shelf” (allogeneic) products (UCART) from healthy donors that can be immediately available for patients across all geographies. Cellectis SA is listed on the Nasdaq Global Market and on the Alternext market of Euronext (ticker: ALCLS).

Shares had broken out in February and bounced or remained above a key resistance level at the $22 mark:

However, shares are now dropping around $9 or close to30% in premarket trading.

In early August, Cellectis SA reported that during the quarters ended June 30 2016 (second quarter)and 2017, it recorded 18.1 million and 8.2 million, respectively, in revenues and other income. During the three months ended June 30, 2016 and 2017,the Companyrecorded a net loss attributable to shareholders of Cellectis of 6.3 million and net loss attributable to shareholders of Cellectis of 24.1 million, respectively. As of June 30, 2017, Cellectis SA had 237.6 million in total cash, cash equivalents and current financial assets compared to 258.5 million as of March 31, 2017.

Otherwise its worth noting that tomorrow,CEO Andr茅 Choulika will present at the Wells Fargo Conference in Boston from 4:10 to 4:40pm ET meaning shares could move once more before the Thursday open.

Leave a Reply

Your email address will not be published. Required fields are marked *