Current Report Filing (8-k)
January 12 2022 - 08:06AM
Edgar (US Regulatory)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act
of 1934
Date of Report (date of earliest event reported):
January 12, 2022
Heat Biologics, Inc.
(Exact name of registrant as specified in charter)
Delaware
(State or other jurisdiction of incorporation)
001-35994 |
26-2844103 |
(Commission File
Number) |
(IRS Employer Identification
No.) |
627 Davis Drive,
Suite 400
Morrisville,
North Carolina
27560
(Address of principal executive offices and zip code)
(919)
240-7133
(Registrant’s telephone number including area code)
N/A
(Former Name and Former Address)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of registrant under
any of the following provisions:
|
¨ |
Written communications pursuant to Rule 425
under the Securities Act (17 CFR 230.425) |
|
¨ |
Soliciting material pursuant to Rule
14a-12(b) under the Exchange Act (17 CFR 240.14a-12) |
|
¨ |
Pre-commencement communications pursuant to
Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
¨ |
Pre-commencement communications pursuant to
Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which
registered |
Common Stock, $0.0002 par value per share |
HTBX |
The Nasdaq Stock Market
(The Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨ |
|
If an emerging growth company, indicate by checkmark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act. ¨
Item 7.01. Regulation FD Disclosure.
On January
12, 2022, Heat Biologics, Inc. (the “Company”) issued a press
release announcing that promising new preclinical data regarding
PTX-35 has been accepted for publication in the American Journal of
Transplantation. The Company’s subsidiary, Pelican Therapeutics,
Inc. “Pelican Therapeutics”), is developing PTX-35, a novel,
potential first-in-class antibody immunomodulator of TNFRSF25
(death receptor 3), a receptor that is preferentially expressed by
antigen-experienced T cells and can be manipulated to expand
regulatory T-cell subsets. PTX-35 is the Company’s first
antibody-based product, currently in a Phase 1 clinical trial for
the treatment of patients with solid
tumors. The following are the
PTX-35 key findings:
-
A single dose of the preclinical version of PTX-35 (mPTX-35), was
able to expand regulatory T cells (Tregs) and significantly improve
disease and graft survival outcomes.
-
Chemically induced pancreatic failure (a model for type-1 diabetes)
could be partially reversed when mice were transplanted with
beta-cell islet allografts and treated with mPTX-35.
-
Disease protection in preclinical models was correlated with a
significant expansion of Tregs and protection of the allograft,
resulting in euglycemia and a graft survival benefit.
-
Long-term surviving grafts showed a marked increase in Treg
infiltration which directly correlated with mPTX-35 agonist
activity.
The
Company also announced that it expected to file for an End of Phase
2 meeting with the FDA this quarter with the goal of discussing
potential Phase 3 registration pathways for HS-110.
A copy of the press release is furnished as Exhibit 99.1 to this
Current Report on Form 8-K.
The information in this Item 7.01 and in the press release
attached as Exhibit 99.1 to this Current Report on Form 8-K 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. The information contained
in this Item 7.01 and in the press release attached as Exhibit 99.1
to this Current Report on Form 8-K shall not be incorporated by
reference into any filing with the U.S. Securities and Exchange
Commission made by the Company, whether made before or after the
date hereof, regardless of any general incorporation language in
such filing.
The press release attached as Exhibit 99.1 to this Current Report
on Form 8-K includes “safe harbor” language pursuant to the Private
Securities Litigation Reform Act of 1995, as amended, indicating
that certain statements contained therein are “forward-looking”
rather than historical.
The Company undertakes no duty or obligation to update or revise
the information contained in this Current Report on Form 8-K,
although it may do so from time to time if its management believes
it is appropriate. Any such updating may be made through the filing
of other reports or documents with the Securities and Exchange
Commission, through press releases or through other public
disclosures.
Item 8.01. Other Events.
On January 12, 2022, the Company issued a press release announcing
that promising new preclinical data regarding PTX-35 has been
accepted for publication in the American Journal of
Transplantation. Pelican Therapeutics is developing PTX-35, a
novel, potential first-in-class antibody immunomodulator of
TNFRSF25 (death receptor 3), a receptor that is preferentially
expressed by antigen-experienced T cells and can be manipulated to
expand regulatory T-cell subsets. PTX-35 is the Company’s first
antibody-based product, currently in a Phase 1 clinical trial for
the treatment of patients with solid tumors. The following are the
PTX-35 key findings:
-
A single dose of the preclinical version of PTX-35 (mPTX-35), was
able to expand regulatory T cells (Tregs) and significantly improve
disease and graft survival outcomes.
-
Chemically induced pancreatic failure (a model for type-1 diabetes)
could be partially reversed when mice were transplanted with
beta-cell islet allografts and treated with mPTX-35.
-
Disease protection in preclinical models was correlated with a
significant expansion of Tregs and protection of the allograft,
resulting in euglycemia and a graft survival benefit.
-
Long-term surviving grafts showed a marked increase in Treg
infiltration which directly correlated with mPTX-35 agonist
activity.
The
Company also announced that it expected to file for an End of Phase
2 meeting with the FDA this quarter with the goal of discussing
potential Phase 3 registration pathways for HS-110.
Item 9.01. Financial Statements and
Exhibits.
(d)
Exhibits.
The following Exhibit 99.1 is
furnished with this Current Report on Form 8-K:
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.
Dated: January 12, 2022 |
HEAT BIOLOGICS, INC. |
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By: |
/s/ Jeffrey Wolf |
|
Name: |
Jeffrey Wolf |
|
Title: |
Chairman, President and
Chief Executive Officer |
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