Heat Biologics, Inc. (NASDAQ:HTBX) Files An 8-K Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
On May 29, 2020, Heat Biologics, Inc. (the “Company’) announced the presentation at the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO) of a poster (the “Poster”) with topline data for cohort A from its ongoing Phase 2 study of HS-110 in combination with nivolumab for the treatment of advanced non-small lung cancer in multiple treatment settings. A copy of the Poster is attached hereto as Exhibit 99.1 and is incorporated herein by reference. In addition, a transcript of the virtual presentation of the Poster provided at ASCO is attached hereto as Exhibit 99.2.
The furnishing of the attached Poster is not an admission as to the materiality of any information therein. The information contained in the Poster is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the SEC and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures.
The information in the transcript shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended.
Item 8.01 Other Information
On May 29, 2020, the Company issued a press release announcing the presentation of a poster (the “Poster”) at the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO). The data presented in the Poster was obtained from cohort A from the Company’s ongoing Phase 2 trial in combination with Bristol-Myers Squibb’s (BMS) Opdivo® (nivolumab) for multiple treatment settings in advanced NSCLC. A copy of the press release is furnished as Exhibit 99.3 to this Current Report on Form 8-K and is incorporated herein by reference.
The data demonstrated that significant survival benefit was observed in a cohort of previously treated, checkpoint inhibitor (CPI) naïve patients with advanced NSCLC; with a median overall survival (mOS) of 28.7 months for the intent-to-treat (ITT) patients (N = 47). This data compares favorably with published data of Checkmate-057, which reported a mOS of 12.2 months in patients who received nivolumab as single agent in a similar treatment setting. Notably, a statistically significant survival benefit with mOS of 42.1 months was observed in patients with injection site reaction (p = 0.0001). Exploratory biomarker analyses showed that overlapping CTA expression in patients’ tumors at baseline with HS-110, as well as the expression of a specific CTA were both associated with statistically significant improved overall survival (p = 0.028 and 0.008, respectively).
The Company also updated its corporate presentation, to among other things, include the updated data from the Company’s ongoing Phase 2 trial in combination with Bristol-Myers Squibb’s (BMS) Opdivo® (nivolumab) for in advanced NSCLC that was presented at ASCO. A copy of the corporate presentation is attached hereto as Exhibit 99.4 and is incorporated herein by reference.
The information in the press release shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended.
Item 9.01 Financial Statements and Exhibits.
The following exhibits are filed with this Current Report on Form 8-K.
HEAT BIOLOGICS, INC. Exhibit
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About Heat Biologics, Inc. (NASDAQ:HTBX)
Heat Biologics, Inc. is a development-stage company focused on developing allogeneic, off-the-shelf cellular therapeutic vaccines to combat a range of cancers. The Company is an immuno-oncology company, which focuses on T cell-stimulating platform technologies, such as Immune Pan-Antigen Cytotoxic Therapy (ImPACT) and Combination Pan-Antigen Cytotoxic Therapy (ComPACT). Using its ImPACT platform technology, the Company has developed HS-410 (vesigenurtacel-L) as a product candidate to treat non-muscle invasive bladder cancer (NMIBC), and HS-110 (viagenpumatucel-L), which is intended for use in combination with an anti-PD-1 checkpoint inhibitor, as a potential treatment for patients with non-small cell lung cancer (NSCLC). Using its ComPACT platform technology, it has developed HS-120 as a potential treatment for NSCLC. It is conducting a Phase II trial of HS-410 in patients with NMIBC, and a Phase Ib trial of HS-110, in combination with nivolumab (Opdivo) to treat patients with NSCLC.
