Heat Biologics Provides Second Quarter 2021 Business Update
August 11 2021 - 4:05PM
Heat Biologics, Inc. (“Heat”)
(NASDAQ: HTBX), a clinical-stage
biopharmaceutical company focused on developing first-in-class
therapies to modulate the immune system, today provided financial,
clinical and operational updates for the second quarter ended June
30, 2021.
Jeff Wolf, Chief Executive Officer of Heat,
commented, “This quarter we achieved several meaningful clinical,
research and business milestones. First, we presented favorable
survival data of HS-110 in previously treated non-small cell lung
cancer (NSCLC) patients at the 2021 American Society of Clinical
Oncology (ASCO) Annual Meeting. Based on these results, we believe
HS-110, in combination with a checkpoint inhibitor (CPI), holds
significant potential to improve survival benefit for patients with
non-small cell lung cancer. We are continuing to evaluate possible
Phase 3 registration pathways with the FDA and potential partners.
At the same time, we are exploring a variety of paths forward
related to our infectious disease efforts. We look forward to
providing further near-term updates.”
“This quarter we also announced the
groundbreaking for our biomanufacturing/bioanalytic facility in San
Antonio, TX and the expansion of our current research and
development (R&D) facilities at our corporate headquarters in
Morrisville, NC. This expansion will support enhanced R&D
capabilities including in-house synthesis and production of
antibodies and other drugs/reagents, as well as an expanded
vivarium for onsite pre-clinical studies. We believe that this
expansion will allow us to accelerate R&D timelines and
generate cost savings on research and development by bringing more
of our development activities in-house.”
“Moreover, we have maintained a strong balance
sheet with approximately $122.5 million of cash, cash equivalents
and short-term investments which should allow us to augment our
clinical programs as well as enhance and expand our therapeutic
pipeline.”
Second Quarter 2021 Financial
Results
- Recognized $0.5 million of grant
revenue for qualified expenditures under the CPRIT grant compared
to $0.6 million for the quarter ended June 30, 2020. 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 June 30, 2021, we had a grant receivable
balance of $0.4 million for CPRIT proceeds not yet received but for
which the costs had been incurred or the conditions of the award
had been met. We continue our efforts to secure future non-dilutive
grant funding to subsidize ongoing research and development
costs.
- Research and development expense
was $4.2 million and $2.8 million for the three months ended June
30, 2021 and 2020, respectively.
- General and administrative expense
was $2.9 million and $1.8 million for the three months ended June
30, 2021 and 2020. The increase was primarily due to an increase in
stock-based compensation expense.
- Net loss attributable to Heat
Biologics was approximately $6.5 million, or ($0.26) per basic and
diluted share for the quarter ended June 30, 2021 compared to a net
loss of approximately of $4.5 million, or ($0.35) per basic and
diluted share for the quarter ended June 30, 2020.
- As of June 30, 2021, the Company
had approximately $122.5 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, various infectious
disease programs in preclinical development and 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 regarding the potential of HS-110, in combination with a
checkpoint inhibitor (CPI), to improve survival benefit for
patients with non-small cell lung cancer, providing further
near-term HS-110 updates, the expansion of Heat’s current research
and development (R&D) facilities at its corporate headquarters
in Morrisville, North Carolina allowing Heat to accelerate R&D
timelines and generate cost savings on research and development by
bringing more of our development activities in-house and Heat’s
balance sheet allowing it to augment its clinical programs as well
as enhance and expand its therapeutic pipeline. These statements
are subject to a number of risks and uncertainties, many of which
are difficult to predict, including the ability of HS-110, in
combination with a checkpoint inhibitor (CPI), holds significant
potential to improve survival benefit for patients with non-small
cell lung cancer, the ability of Heat's vaccine platform to provide
prevention and treatment of cancer and infectious diseases, such as
COVID-19, Heat's ability to provide further near-term updates,
Heat's ability to accelerate R&D timelines and generate cost
savings on research and development by bringing more of its
development activities in-house, Heat's ability to augment its
clinical programs and enhance and expand its therapeutic pipeline,
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
|
|
June 31, |
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
|
|
(unaudited) |
|
|
|
Current
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
21,567,287 |
|
|
$ |
10,931,890 |
|
Short-term investments |
|
|
100,964,986 |
|
|
|
100,842,438 |
|
Accounts receivable |
|
|
102,593 |
|
|
|
177,239 |
|
Prepaid expenses and other current assets |
|
|
2,124,419 |
|
|
|
1,842,620 |
|
Total Current
Assets |
|
|
124,759,285 |
|
|
|
113,794,187 |
|
|
|
|
|
|
|
|
Property and
Equipment, net |
|
|
4,146,111 |
|
|
|
676,262 |
|
|
|
|
|
|
|
|
Other
Assets |
|
|
|
|
|
|
In-process R&D |
|
|
5,866,000 |
|
|
|
5,866,000 |
|
Goodwill |
|
|
1,452,338 |
|
|
|
1,452,338 |
|
Grant receivable |
|
|
368,465 |
|
|
|
— |
|
Operating lease right-of-use asset |
|
|
1,857,309 |
|
|
|
2,035,882 |
|
Finance lease right-of-use asset |
|
|
187,744 |
|
|
|
247,194 |
|
Deposits |
|
|
152,267 |
|
|
|
122,779 |
|
Total Other
Assets |
|
|
9,884,123 |
|
|
|
9,724,193 |
|
|
|
|
|
|
|
|
Total
Assets |
|
$ |
138,789,519 |
|
|
$ |
124,194,642 |
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,180,965 |
|
|
$ |
1,051,764 |
|
Deferred revenue, current portion |
|
|
— |
|
|
|
603,717 |
|
Operating lease liability, current portion |
|
|
293,226 |
|
|
|
278,753 |
|
Finance lease liability, current portion |
|
|
111,411 |
|
|
|
108,127 |
|
Accrued expenses and other liabilities |
|
|
1,766,311 |
|
|
|
1,614,534 |
|
Total Current
Liabilities |
|
|
3,351,913 |
|
|
|
3,656,895 |
|
|
|
|
|
|
|
|
Long Term
Liabilities |
|
|
|
|
|
|
Other long-term liabilities |
|
|
48,949 |
|
|
|
36,243 |
|
Derivative warrant liability |
|
|
37,802 |
|
|
|
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 |
|
|
1,151,886 |
|
|
|
1,301,636 |
|
Financing lease liability, net of current portion |
|
|
103,700 |
|
|
|
160,240 |
|
Contingent consideration, net of current portion |
|
|
2,336,626 |
|
|
|
2,250,844 |
|
Contingent consideration, related party - net of current
portion |
|
|
686,889 |
|
|
|
661,671 |
|
Total
Liabilities |
|
|
8,317,176 |
|
|
|
8,700,719 |
|
|
|
|
|
|
|
|
Stockholders'
Equity |
|
|
|
|
|
|
Common stock, $.0002 par value; 250,000,000 and 250,000,000 shares
authorized, 25,137,502 and 22,592,500 shares issued and outstanding
at June 30, 2021 and December 31, 2020, respectively |
|
|
5,027 |
|
|
|
4,519 |
|
Additional paid-in capital |
|
|
276,225,048 |
|
|
|
247,048,349 |
|
Accumulated deficit |
|
|
(144,722,860 |
) |
|
|
(130,647,485 |
) |
Accumulated other comprehensive loss |
|
|
(121,127 |
) |
|
|
(166,056 |
) |
Total Stockholders'
Equity - Heat Biologics, Inc. |
|
|
131,386,088 |
|
|
|
116,239,327 |
|
Non-Controlling
Interest |
|
|
(913,745 |
) |
|
|
(745,404 |
) |
Total Stockholders'
Equity |
|
|
130,472,343 |
|
|
|
115,493,923 |
|
|
|
|
|
|
|
|
Total Liabilities and
Stockholders' Equity |
|
$ |
138,789,519 |
|
|
$ |
124,194,642 |
|
|
|
|
|
|
|
|
|
|
HEAT
BIOLOGICS INC.Consolidated Statements of
Operations and Comprehensive Loss
(unaudited)
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2019 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Grant and licensing revenue |
|
$ |
459,494 |
|
|
$ |
593,165 |
|
|
$ |
998,139 |
|
|
$ |
1,495,045 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,216,294 |
|
|
|
2,790,797 |
|
|
|
7,622,542 |
|
|
|
5,573,303 |
|
General and administrative |
|
|
2,853,265 |
|
|
|
1,801,674 |
|
|
|
7,620,910 |
|
|
|
5,072,222 |
|
Change in fair value of contingent consideration |
|
|
105,000 |
|
|
|
843,000 |
|
|
|
111,000 |
|
|
|
816,000 |
|
Total operating expenses |
|
|
7,174,559 |
|
|
|
5,435,471 |
|
|
|
15,354,452 |
|
|
|
11,461,525 |
|
Loss from operations |
|
|
(6,715,065 |
) |
|
|
(4,842,306 |
) |
|
|
(14,356,313 |
) |
|
|
(9,966,480 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of warrant liability |
|
|
4,679 |
|
|
|
(24,363 |
) |
|
|
(4,023 |
) |
|
|
(1,002,073 |
) |
Investor relations expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(66,767 |
) |
Interest income |
|
|
176,798 |
|
|
|
56,080 |
|
|
|
371,963 |
|
|
|
108,790 |
|
Other income (expense), net |
|
|
(86,988 |
) |
|
|
273,771 |
|
|
|
(255,343 |
) |
|
|
16,292 |
|
Total non-operating income (loss) |
|
|
94,489 |
|
|
|
305,488 |
|
|
|
112,597 |
|
|
|
(943,758 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income
taxes |
|
|
(6,620,576 |
) |
|
|
(4,536,818 |
) |
|
|
(14,243,716 |
) |
|
|
(10,910,238 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
|
(6,620,576 |
) |
|
|
(4,536,818 |
) |
|
|
(14,243,716 |
) |
|
|
(10,910,238 |
) |
Net loss - non-controlling
interest |
|
|
(77,379 |
) |
|
|
(82,388 |
) |
|
|
(168,341 |
) |
|
|
(163,702 |
) |
Net loss attributable to Heat
Biologics, Inc. |
|
$ |
(6,543,197 |
) |
|
$ |
(4,454,430 |
) |
|
$ |
(14,075,375 |
) |
|
$ |
(10,746,536 |
) |
Net loss per share
attributable to Heat Biologics, Inc.- |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to Heat Biologics, Inc.-basic and diluted |
|
$ |
(0.26 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.57 |
) |
|
$ |
(1.04 |
) |
Weighted-average number of
common shares used in net loss per share attributable to common
stockholders- |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of
common shares used in net loss per share attributable to Heat
Biologics, Inc.—basic and diluted |
|
|
25,137,466 |
|
|
|
12,561,549 |
|
|
|
24,671,281 |
|
|
|
10,372,352 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,620,576 |
) |
|
$ |
(4,536,818 |
) |
|
$ |
(14,243,716 |
) |
|
$ |
(10,910,238 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on foreign currency translation |
|
|
26,661 |
|
|
|
(179,510 |
) |
|
|
44,929 |
|
|
|
39,294 |
|
Total comprehensive loss |
|
|
(6,593,915 |
) |
|
|
(4,716,328 |
) |
|
|
(14,198,787 |
) |
|
|
(10,870,944 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
attributable to non-controlling interest |
|
|
(77,379 |
) |
|
|
(82,388 |
) |
|
|
(168,341 |
) |
|
|
(163,702 |
) |
Comprehensive loss - Heat
Biologics, Inc. |
|
$ |
(6,516,536 |
) |
|
$ |
(4,633,940 |
) |
|
$ |
(14,030,446 |
) |
|
$ |
(10,707,242 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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