Heat Biologics Provides First Quarter 2021 Business Update; Reports Continued Progress on Oncology and COVID-19 Vaccine Prog...
May 05 2021 - 7:30AM
Heat Biologics, Inc. (“Heat”)
(NASDAQ: HTBX), a clinical-stage
biopharmaceutical company focused on developing first-in-class
therapies to modulate the immune system, including multiple
oncology product candidates and a novel COVID-19 vaccine, today
provided financial, clinical and operational updates for the first
quarter ended March 31, 2021.
Jeff Wolf, Chief Executive Officer of Heat,
commented, “We continue to make tremendous progress on our clinical
programs, including both our oncology program and COVID-19 vaccine
program, which we recently advanced into scale-up manufacturing. We
are currently reviewing a variety of possible Phase 3 registration
settings for HS-110 in combination with checkpoint inhibitors,
following positive interim data from our Phase 2 trial in patients
with advanced non-small cell lung cancer (NSCLC).”
“We recently announced promising new preclinical
data around PTX-35, our potential first-in-class T-cell
co-stimulatory antibody at the AACR Annual Meeting 2021. We are
completing enrollment in our Phase 1 PTX-35 trial in patients with
solid tumors and expect to share interim data later this year.”
“Finally, we have maintained a solid balance
sheet with over $128 million of cash and short-term investments,
which should provide us substantial runway to fund our current
clinical programs and further expand our therapeutic portfolio.
Moreover, we believe that upcoming catalysts and milestones have
the potential to drive significant shareholder value in 2021,”
concluded Mr. Wolf.
First Quarter 2021 Financial
Results
- Recognized $0.5 million of grant
revenue for qualified expenditures under the CPRIT and NIH grant
compared to $0.9 million of grant revenue for the same period last
year. The decrease in grant revenue in the current-year period
primarily reflects the expected timing of completion of deliveries
under the current phase of the contracts. As of March 31, 2021, we
had deferred revenue of $0.09 million for CPRIT proceeds received
but for which the costs had not been incurred or the conditions of
the award had not been met.
- Research and development expenses
was $3.4 million and $2.8 million for the three months ended March
31, 2021 and 2020, respectively.
- General and administrative expense
was $4.8 million and $3.3 million for the three months ended March
31, 2021 and 2020. The increase was primarily due to stock
compensation expense.
- Net loss attributable to Heat
Biologics was approximately $7.5 million, or ($0.31) per basic and
diluted share for the quarter ended March 31, 2021 compared to a
net loss of approximately of $6.3 million, or ($0.77) per basic and
diluted share for the quarter ended March 31, 2020.
- As of March 31, 2021, the Company
had approximately $132 million in cash, cash equivalents and short
investments.
About Heat Biologics, Inc.Heat
Biologics is a biopharmaceutical company focused on developing
first-in-class therapies to modulate the immune system. Heat’s gp96
platform is designed to activate immune responses against cancer or
infectious diseases. The Company has multiple product candidates in
development leveraging the gp96 platform, including HS-110, which
has completed enrollment in its Phase 2 trial, and a COVID-19
vaccine program in preclinical development. In addition, Heat
Biologics is also developing a pipeline of proprietary
immunomodulatory antibodies and cell-based therapies, including
PTX-35 and HS-130 in Phase 1 clinical trials.
For more information, please
visit: www.heatbio.com, and also follow us
on Twitter.
Forward Looking StatementThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 on
our current expectations and projections about future events. In
some cases, forward-looking statements can be identified by
terminology such as "may," "should," "potential," "continue,"
"expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions. These statements are based
upon current beliefs, expectation, and assumptions and include
statements such as sharing interim data later this year from the
Phase 1 PTX-35 trial in patients with solid tumors, cash and
short-term investments providing Heat a substantial runway to fund
Heat’s current clinical programs and further expand Heat’s
therapeutic portfolio, and upcoming catalysts and milestones having
the potential to drive significant shareholder value in 2021. These
statements are subject to a number of risks and uncertainties, many
of which are difficult to predict, including the timing of
providing interim data from the Phase 1 PTX-35 trial in patients
with solid tumors, ability of Heat's vaccine platform to provide
prevention and treatment of cancer and infectious diseases, such as
COVID-19, the ability of Heat's therapies to perform as designed,
to demonstrate safety and efficacy, as well as results that are
consistent with prior results, the ability to enroll patients and
complete the clinical trials on time and achieve desired results
and benefits, especially in light of COVID-19, Heat's ability to
obtain regulatory approvals for commercialization of product
candidates or to comply with ongoing regulatory requirements,
regulatory limitations relating to Heat's ability to promote or
commercialize its product candidates for specific indications,
acceptance of its product candidates in the marketplace and the
successful development, marketing or sale of products, Heat's
ability to maintain its license agreements, the continued
maintenance and growth of its patent estate, its ability to
establish and maintain collaborations, its ability to obtain or
maintain the capital or grants necessary to fund its research and
development activities and its cash and short-term investments
providing significant runway to fund Heat’s current clinical
programs and further expand Heat’s therapeutic portfolio, its
ability to continue to maintain its listing on the Nasdaq Capital
Market and its ability to retain its key scientists or management
personnel, and the other factors described in Heat's annual report
on Form 10-K for the year ended December 31, 2020 filed with the
SEC, and other subsequent filings with the SEC. The information in
this release is provided only as of the date of this release, and
Heat undertakes no obligation to update any forward-looking
statements contained in this release based on new information,
future events, or otherwise, except as required by law.
Media and Investor Relations ContactDavid
Waldman+1 919 289 4017investorrelations@heatbio.com
(tables follow)
HEAT BIOLOGICS, INC.
Consolidated Balance Sheets
|
March 31, |
|
December 31, |
|
2021 |
|
|
2020 |
|
|
|
(unaudited) |
|
|
|
Current
Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
31,156,747 |
|
|
$ |
10,931,890 |
|
Short-term investments |
|
100,899,984 |
|
|
|
100,842,438 |
|
Accounts receivable |
|
103,232 |
|
|
|
177,239 |
|
Prepaid expenses and other current assets |
|
1,718,364 |
|
|
|
1,842,620 |
|
Total Current
Assets |
|
133,878,327 |
|
|
|
113,794,187 |
|
|
|
|
|
|
|
Property and
Equipment, net |
|
967,582 |
|
|
|
676,262 |
|
|
|
|
|
|
|
Other
Assets |
|
|
|
|
|
In-process R&D |
|
5,866,000 |
|
|
|
5,866,000 |
|
Goodwill |
|
1,452,338 |
|
|
|
1,452,338 |
|
Operating lease right-of-use asset |
|
1,947,192 |
|
|
|
2,035,882 |
|
Finance lease right-of-use asset |
|
217,469 |
|
|
|
247,194 |
|
Deposits |
|
141,201 |
|
|
|
122,779 |
|
Total Other
Assets |
|
9,624,200 |
|
|
|
9,724,193 |
|
|
|
|
|
|
|
Total
Assets |
$ |
144,470,109 |
|
|
$ |
124,194,642 |
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities |
|
|
|
|
|
Accounts payable |
$ |
792,545 |
|
|
$ |
1,051,764 |
|
Deferred revenue, current portion |
|
93,529 |
|
|
|
603,717 |
|
Operating lease liability, current portion |
|
285,927 |
|
|
|
278,753 |
|
Finance lease liability, current portion |
|
109,757 |
|
|
|
108,127 |
|
Accrued expenses and other liabilities |
|
1,764,385 |
|
|
|
1,614,534 |
|
Total Current
Liabilities |
|
3,046,143 |
|
|
|
3,656,895 |
|
|
|
|
|
|
|
Long Term
Liabilities |
|
|
|
|
|
Other long-term liabilities |
|
43,754 |
|
|
|
36,243 |
|
Derivative warrant liability |
|
42,481 |
|
|
|
33,779 |
|
Deferred tax liability |
|
361,911 |
|
|
|
361,911 |
|
Deferred revenue, net of current portion |
|
237,500 |
|
|
|
237,500 |
|
Operating lease liability, net of current portion |
|
1,227,634 |
|
|
|
1,301,636 |
|
Financing lease liability, net of current portion |
|
132,181 |
|
|
|
160,240 |
|
Contingent consideration, net of current portion |
|
2,255,480 |
|
|
|
2,250,844 |
|
Contingent consideration, related party - net of current
portion |
|
663,035 |
|
|
|
661,671 |
|
Total
Liabilities |
|
8,010,119 |
|
|
|
8,700,719 |
|
|
|
|
|
|
|
Stockholders'
Equity |
|
|
|
|
|
Common stock, $.0002 par value; 250,000,000 and 250,000,000 shares
authorized, 25,137,410 and 22,592,500 shares issued and outstanding
at March 31, 2021 and December 31, 2020,
respectively |
|
5,027 |
|
|
|
4,519 |
|
Additional paid-in capital |
|
275,618,780 |
|
|
|
247,048,349 |
|
Accumulated deficit |
|
(138,179,663 |
) |
|
|
(130,647,485 |
) |
Accumulated other comprehensive loss |
|
(147,788 |
) |
|
|
(166,056 |
) |
Total Stockholders'
Equity - Heat Biologics, Inc. |
|
137,296,356 |
|
|
|
116,239,327 |
|
Non-Controlling
Interest |
|
(836,366 |
) |
|
|
(745,404 |
) |
Total Stockholders'
Equity |
|
136,459,990 |
|
|
|
115,493,923 |
|
|
|
|
|
|
|
Total Liabilities and
Stockholders' Equity |
$ |
144,470,109 |
|
|
$ |
124,194,642 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HEAT
BIOLOGICS INC.Consolidated Statements of
Operations and Comprehensive Loss
(unaudited)
|
Three Months Ended |
|
March 31, |
|
2021 |
|
|
2020 |
|
Revenue: |
|
|
|
|
|
Grant and contract revenue |
$ |
538,645 |
|
|
$ |
901,880 |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
3,406,248 |
|
|
|
2,782,506 |
|
General and administrative |
|
4,767,645 |
|
|
|
3,270,548 |
|
Change in fair value of contingent consideration |
|
6,000 |
|
|
|
(27,000 |
) |
Total operating expenses |
|
8,179,893 |
|
|
|
6,026,054 |
|
|
|
|
|
|
|
Loss from operations |
|
(7,641,248 |
) |
|
|
(5,124,174 |
) |
|
|
|
|
|
|
Change in fair value of warrant liability |
|
(8,702 |
) |
|
|
(977,710 |
) |
Investor relations expense |
|
— |
|
|
|
(66,767 |
) |
Interest income |
|
195,165 |
|
|
|
52,710 |
|
Other expense, net |
|
(168,355 |
) |
|
|
(257,479 |
) |
Total non-operating income (loss) |
|
18,108 |
|
|
|
(1,249,246 |
) |
|
|
|
|
|
|
Net loss before income
taxes |
|
(7,623,140 |
) |
|
|
(6,373,420 |
) |
Income tax expense |
|
— |
|
|
|
— |
|
Net loss |
|
(7,623,140 |
) |
|
|
(6,373,420 |
) |
Net loss - non-controlling
interest |
|
(90,962 |
) |
|
|
(81,314 |
) |
Net loss attributable to Heat
Biologics, Inc. |
$ |
(7,532,178 |
) |
|
$ |
(6,292,106 |
) |
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.31 |
) |
|
$ |
(0.77 |
) |
|
|
|
|
|
|
Weighted-average common shares outstanding, basic and diluted |
|
24,199,916 |
|
|
|
8,183,154 |
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
Net loss |
$ |
(7,623,140 |
) |
|
$ |
(6,373,420 |
) |
Unrealized gain on foreign currency translation |
|
18,268 |
|
|
|
218,804 |
|
Total comprehensive loss |
|
(7,604,872 |
) |
|
|
(6,154,616 |
) |
Comprehensive loss
attributable to non-controlling interest |
|
(90,962 |
) |
|
|
(81,314 |
) |
Comprehensive loss - Heat
Biologics, Inc. |
$ |
(7,513,910 |
) |
|
$ |
(6,073,302 |
) |
|
|
|
|
|
|
|
|
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