UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
Current Report
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| Item 7.01 | Regulation FD Disclosure. |
On November 20, 2023, Plus Therapeutics, Inc. (the “Company”) issued a press release entitled “Plus Therapeutics Reports New ReSPECT-GBM Phase 2 Trial Data at the Society for NeuroOncology Annual Meeting and will Host Key Opinion Leader Webinar.”
The information in this Item 7.01, including Exhibit 99.1 to this Current Report on Form 8-K, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
The Company announced positive data from the ongoing ReSPECT-GBM Phase 2 trial evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma at the Society for NeuroOncology 28th Annual Meeting, which was held November 15-19, 2023 in Vancouver, Canada.
Key findings include:
| • | Median overall survival (mOS) in 15 patients with recurrent glioblastoma (rGBM) from the Phase 2 study is 13 months, which is 63% better than current standard of care (bevacizumab monotherapy) of 8 months; 9 of the 15 patients remain alive |
| • | Median progression free survival (mPFS) is 11 months, compared to SOC at 4 months |
| • | Rhenium (186Re) Obisbemeda continues to demonstrate a favorable safety profile, despite delivering up to 20x the dose of radiation (up to 740 Gy) typically delivered by external beam radiation therapy (EBRT) for rGBM patients (up to 35 Gy) |
| • | Imaging data presented by Andrew Brenner, MD, PhD is consistent with the efficacy signal of Rhenium (186Re) Obisbemeda in rGBM |
| • | Company to Host Virtual KOL Webinar to Discuss Data Today at 10:00 am ET |
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1 | Press Release, dated November 20, 2023 (announcing clinical update) | |
| 104 | The cover pages of this Current Report on Form 8-K, formatted in Inline XBRL | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: November 20, 2023
| PLUS THERAPEUTICS, INC. | ||
| By: | /s/ Marc H. Hedrick, M.D. | |
| Marc H. Hedrick, M.D. President and Chief Executive Officer | ||