DURHAM, NC / ACCESSWIRE / August 7, 2020 / 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 second quarter ended June 30, 2020.
Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, “This quarter we achieved significant milestones in advancing our unique COVID-19 vaccine program, which we are developing in collaboration with researchers at University of Miami. Specifically, our latest pre-clinical studies demonstrated immunogenicity proof-of-concept, validating that the selected vaccine antigen may be appropriate for human testing. Preclinical testing demonstrated expansion of antibody-supporting CD4+, and virus killing CD8+ T-cells in the lungs of the animals, a major site for COVID-19 infection. We believe this platform may play an important role as a standalone vaccine or in combination with other antibody-generating vaccines to provide broad cellular T-cell and humoral protection against COVID-19, particularly for elderly patients and those with underlying health conditions who have an increased risk of complications and death from COVID-19.”
“Additionally, we established a partnership with Waisman Biomanufacturing to manufacture our COVID-19 vaccine for anticipated Phase 1 trials in humans. We believe that the unique capabilities and previous expertise gained working with Waisman on our cancer programs, HS-110 and HS-130 that are based upon the same gp96 platform, will help shorten the development timeline for our COVID-19 vaccine.”
“We recently presented our latest data for HS-110 in combination with Nivolumab in our Phase 2 lung cancer trial at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. Importantly, this data demonstrated a strong survival benefit in a cohort of previously treated checkpoint inhibitor (CPI) naïve patients with advanced non-small cell lung cancer (NSCLC) and further reinforced the potential utility of HS-110 in combination with a checkpoint inhibitor as a frontline treatment for NSCLC.”
“We also continue to accelerate PTX-35, our potential first-in-class T-cell co-stimulatory antibody, through clinical development. Specifically, we announced patient enrollment in our first-in-human clinical trial in multiple solid tumors following FDA clearance of our Investigational New Drug (IND) application. This study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care.”
“We have continued to strengthen our balance sheet, and now have over $100 million in cash and short-term investments as of August 6, 2020, which should provide us with the resources to significantly advance our clinical programs,” concluded Mr. Wolf.
Second Quarter 2020 Financial Results
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. The company’s gp96 platform is designed to activate immune responses against cancer or pathogenic antigens. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, HS-130 in Phase 1, and a COVID-19 vaccine program in preclinical development. In addition, Heat is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35 which is enrolling in a Phase 1 trial.
For more information, please visit: www.heatbio.com, and also follow us on Twitter.
Forward Looking Statement
This 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 the platform playing an important role as a standalone vaccine or in combination with other antibody-generating vaccines to provide broad cellular T-cell and humoral protection against COVID-19, particularly for elderly patients and those with underlying health conditions that have an increased risk of complications and death from COVID-19, the unique capabilities and previous expertise gained working with Waisman on HS-130 helping shorten the clinical timeline for our potentially life-saving COVID-19 vaccine, the potential utility of HS-110 in combination with a checkpoint inhibitor as a frontline treatment for NSCLC ,the continued acceleration of PTX-35, our potential first-in-class T-cell co-stimulatory antibody, through clinical development, the enrollment in the PTX-35 clinical trial of up to 30 patients with advanced solid tumors refractory to standard of care and having sufficient capital to significantly advance our clinical programs. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat’s vaccine platform to provide protection against 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, 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 most recent annual report on Form 10-K 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 Contact
David Waldman
+1 919 289 4017
investorrelations@heatbio.com
HEAT BIOLOGICS, INC.
Consolidated Balance Sheets
|
|
June 30, | December 31, | ||||||
|
|
2020 | 2019 | ||||||
|
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(unaudited) | |||||||
|
Current Assets
|
||||||||
|
Cash and cash equivalents
|
$ | 20,668,241 | $ | 9,039,887 | ||||
|
Short-term investments
|
26,312,039 | 5,713,922 | ||||||
|
Accounts receivable
|
26,967 | 34,986 | ||||||
|
Prepaid expenses and other current assets
|
593,924 | 420,328 | ||||||
|
Total Current Assets
|
47,601,171 | 15,209,123 | ||||||
|
|
||||||||
|
Property and Equipment, net
|
669,401 | 559,410 | ||||||
|
|
||||||||
|
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
|
2,134,573 | 2,287,500 | ||||||
|
Finance lease right-of-use asset
|
306,643 | 187,573 | ||||||
|
Deposits
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122,905 | 394,637 | ||||||
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Total Other Assets
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9,882,459 | 10,188,048 | ||||||
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|
||||||||
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Total Assets
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$ | 58,153,031 | $ | 25,956,581 | ||||
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||||||||
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Liabilities and Stockholders’ Equity
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||||||||
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||||||||
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Current Liabilities
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||||||||
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Accounts payable
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$ | 779,642 | $ | 1,503,342 | ||||
|
Deferred revenue, current portion
|
1,915,924 | 3,410,319 | ||||||
|
Contingent consideration, current portion
|
1,531,636 | 1,124,970 | ||||||
|
Contingent consideration, related party – current portion
|
454,364 | 454,364 | ||||||
|
Operating lease liability, current portion
|
228,776 | 216,832 | ||||||
|
Finance lease liability, current portion
|
104,828 | 49,104 | ||||||
|
Accrued expenses and other liabilities
|
1,202,705 | 1,676,467 | ||||||
|
Total Current Liabilities
|
6,217,875 | 8,435,398 | ||||||
|
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||||||||
|
Long Term Liabilities
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||||||||
|
Other long-term liabilities
|
22,847 | – | ||||||
|
Derivative warrant liability
|
47,939 | – | ||||||
|
Deferred tax liability
|
361,911 | 361,911 | ||||||
|
Deferred revenue, net of current portion
|
200,000 | 200,000 | ||||||
|
Operating lease liability, net of current portion
|
1,402,962 | 1,519,574 | ||||||
|
Financing lease liability, net of current portion
|
215,112 | 142,667 | ||||||
|
Contingent consideration, net of current portion
|
1,969,538 | 1,653,197 | ||||||
|
Contingent consideration, related party – net of current portion
|
578,977 | 485,984 | ||||||
|
Total Liabilities
|
11,017,161 | 12,798,731 | ||||||
|
|
||||||||
|
Stockholders’ Equity
|
||||||||
|
Common stock, $.0002 par value; 250,000,000 shares authorized, 110,023,783 and 33,785,999 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively
|
22,006 | 6,757 | ||||||
|
Additional paid-in capital
|
163,007,558 | 118,173,843 | ||||||
|
Accumulated deficit
|
(115,344,284 | ) | (104,597,748 | ) | ||||
|
Accumulated other comprehensive income (loss)
|
28,044 | (11,250 | ) | |||||
|
Total Stockholders’ Equity – Heat Biologics, Inc.
|
47,713,324 | 13,571,602 | ||||||
|
Non-Controlling Interest
|
(577,454 | ) | (413,752 | ) | ||||
|
Total Stockholders’ Equity
|
47,135,870 | 13,157,850 | ||||||
|
|
||||||||
|
Total Liabilities and Stockholders’ Equity
|
$ | 58,153,031 | $ | 25,956,581 | ||||
HEAT BIOLOGICS INC.
Consolidated Statements of Operations and Comprehensive Loss (unaudited)
|
|
Three Months Ended | Six Months Ended | ||||||||||||||
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June 30, | June 30, | ||||||||||||||
|
|
2020 | 2019 | 2020 | 2019 | ||||||||||||
|
Revenue:
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||||||||||||||||
|
Grant and licensing revenue
|
$ | 593,165 | $ | 342,487 | $ | 1,495,045 | $ | 1,043,549 | ||||||||
|
|
||||||||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development
|
2,790,797 | 3,424,141 | 5,573,303 | 6,596,388 | ||||||||||||
|
General and administrative
|
1,801,674 | 1,860,459 | 5,072,222 | 5,208,060 | ||||||||||||
|
Change in fair value of contingent consideration
|
843,000 | 112,000 | 816,000 | 226,290 | ||||||||||||
|
Total operating expenses
|
5,435,471 | 5,396,600 | 11,461,525 | 12,030,738 | ||||||||||||
|
|
||||||||||||||||
|
Loss from operations
|
(4,842,306 | ) | (5,054,113 | ) | (9,966,480 | ) | (10,987,189 | ) | ||||||||
|
|
||||||||||||||||
|
Change in fair value of warrant liability
|
(24,363 | ) | – | (1,002,073 | ) | – | ||||||||||
|
Investor relations expense
|
– | – | (66,767 | ) | – | |||||||||||
|
Interest income
|
56,080 | 124,793 | 108,790 | 275,645 | ||||||||||||
|
Other income (expense), net
|
273,771 | (15,585 | ) | 16,292 | (7,264 | ) | ||||||||||
|
Total non-operating income (loss)
|
305,488 | 109,208 | (943,758 | ) | 268,381 | |||||||||||
|
|
||||||||||||||||
|
Net loss before income taxes
|
(4,536,818 | ) | (4,944,905 | ) | (10,910,238 | ) | (10,718,808 | ) | ||||||||
|
Income tax expense
|
– | – | – | (45,178 | ) | |||||||||||
|
Net loss
|
(4,536,818 | ) | (4,944,905 | ) | (10,910,238 | ) | (10,763,986 | ) | ||||||||
|
Net loss – non-controlling interest
|
(82,388 | ) | (174,035 | ) | (163,702 | ) | (277,640 | ) | ||||||||
|
Net loss attributable to Heat Biologics, Inc.
|
$ | (4,454,430 | ) | $ | (4,770,870 | ) | $ | (10,746,536 | ) | $ | (10,486,346 | ) | ||||
|
|
||||||||||||||||
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Net loss per share attributable to Heat Biologics, Inc.-
|
||||||||||||||||
|
Net loss per share attributable to Heat Biologics, Inc.-basic and diluted
|
$ | (0.05 | ) | $ | (0.14 | ) | $ | (0.15 | ) | $ | (0.32 | ) | ||||
|
|
||||||||||||||||
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Weighted-average number of common shares used in net loss per share attributable to common stockholders-
|
||||||||||||||||
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Weighted-average number of common shares used in net loss per share attributable to Heat Biologics, Inc.-basic and diluted
|
87,930,846 | 33,255,724 | 72,606,461 | 33,240,529 | ||||||||||||
|
|
||||||||||||||||
|
Comprehensive loss:
|
||||||||||||||||
|
Net loss
|
$ | (4,536,818 | ) | $ | (4,944,905 | ) | $ | (10,910,238 | ) | $ | (10,763,986 | ) | ||||
|
Unrealized (loss) gain on foreign currency translation
|
(179,510 | ) | 16,612 | 39,294 | 8,423 | |||||||||||
|
Total comprehensive loss
|
(4,716,328 | ) | (4,928,293 | ) | (10,870,944 | ) | (10,755,563 | ) | ||||||||
|
Comprehensive loss attributable to non-controlling interest
|
(82,388 | ) | (174,035 | ) | (163,702 | ) | (277,640 | ) | ||||||||
|
Comprehensive loss – Heat Biologics, Inc.
|
$ | (4,633,940 | ) | $ | (4,754,258 | ) | $ | (10,707,242 | ) | $ | (10,477,923 | ) | ||||
SOURCE: Heat Biologics, Inc.
View source version on accesswire.com:
https://www.accesswire.com/600677/Heat-Biologics-Provides-Second-Quarter-2020-Business-Update
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