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Heat Biologics Commences Manufacturing Process for ZVX-60

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DURHAM, NC / ACCESSWIRE / January 19, 2021 / 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 announces it has transferred its gp96-based COVID-19 vaccine cell line ("ZVX-60") to Waisman Biomanufacturing to initiate the manufacturing process for ZVX-60, which is being developed for use as either a standalone vaccine, or in combination with other vaccines, to enhance prophylactic protection against COVID-19.

Jeff Wolf, Heat's CEO, commented, "Initiation of our manufacturing process is an important milestone as we progress ZVX-60 into human clinical trials. As previously announced, recent data generated with our collaborators at the University of Miami Miller School of Medicine confirmed ZVX-60 expression of gp96, OX40L and the COVID-19 Spike protein. We believe ZVX-60 holds promise to enhance protection as a stand-alone vaccine or in combination with other vaccine approaches, and look forward to working with Waisman to manufacture ZVX-60 for our first-in-human clinical trial."

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 ZVX-60 holding promise to enhance protection as a stand-alone vaccine or in combination with other vaccine approachesand the gp96 platform activating immune responses against cancer or pathogenic antigens. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of ZVX-60 to enhance protection as a stand-alone vaccine or in combination with other vaccine approaches, 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

September 30,

December 31,

2020

2019

(unaudited)

Current Assets

Cash and cash equivalents

$

24,808,083

$

9,039,887

Short-term investments

92,501,019

5,713,922

Accounts receivable

212,141

34,986

Prepaid expenses and other current assets

1,620,504

420,328

Total Current Assets

119,141,747

15,209,123

Property and Equipment, net

720,396

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

2,123,414

2,287,500

Finance lease right-of-use asset

276,918

187,573

Deposits

129,505

394,637

Total Other Assets

9,848,175

10,188,048

Total Assets

$

129,710,318

$

25,956,581

Liabilities and Stockholders' Equity

Current Liabilities

Accounts payable

$

753,872

$

1,503,342

Deferred revenue, current portion

1,166,481

3,410,319

Contingent consideration, current portion

-

1,124,970

Contingent consideration, related party - current portion

-

454,364

Operating lease liability, current portion

271,703

216,832

Finance lease liability, current portion

106,409

49,104

Accrued expenses and other liabilities

1,503,899

1,676,467

Total Current Liabilities

3,802,364

8,435,398

Long Term Liabilities

Other long-term liabilities

26,331

-

Derivative warrant liability

60,915

-

Deferred tax liability

361,911

361,911

Deferred revenue, net of current portion

240,000

200,000

Operating lease liability, net of current portion

1,374,141

1,519,574

Financing lease liability, net of current portion

187,881

142,667

Contingent consideration, net of current portion

2,131,830

1,653,197

Contingent consideration, related party - net of current portion

626,685

485,984

Total Liabilities

8,812,058

12,798,731

Commitments and Contingencies (Note 13)

Stockholders' Equity

Common stock, $.0002 par value; 250,000,000 shares authorized, 157,021,194 and 33,785,999 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively

31,402

6,757

Additional paid-in capital

245,740,939

118,173,843

Accumulated deficit

(124,195,893

)

(104,597,748

)

Accumulated other comprehensive loss

(35,910

)

(11,250

)

Total Stockholders' Equity - Heat Biologics, Inc.

121,540,538

13,571,602

Non-Controlling Interest

(642,278

)

(413,752

)

Total Stockholders' Equity

120,898,260

13,157,850

Total Liabilities and Stockholders' Equity

$

129,710,318

$

25,956,581

HEAT BIOLOGICS INC.
Consolidated Statements of Operations and Comprehensive Loss (unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2020

2019

2020

2019

Revenue:

Grant and contract revenue

$

849,732

$

6,439

$

2,344,777

$

1,049,988

Operating expenses:

Research and development

3,172,663

3,129,356

8,745,966

9,725,744

General and administrative

6,579,193

1,993,136

11,651,415

7,201,196

Goodwill impairment loss

-

737,000

-

737,000

Change in fair value of contingent consideration

229,000

502,000

1,045,000

728,290

Total operating expenses

9,980,856

6,361,492

21,442,381

18,392,230

Loss from operations

(9,131,124

)

(6,355,053

)

(19,097,604

)

(17,342,242

)

Change in fair value of warrant liability

(37,230

)

-

(1,039,303

)

-

Investor relations expense

-

-

(66,767

)

-

Interest income

140,614

97,415

249,404

373,060

Other income (expense), net

111,307

(73,275

)

127,599

(80,539

)

Total non-operating income (loss)

214,691

24,140

(729,067

)

292,521

Net loss before income taxes

(8,916,433

)

(6,330,913

)

(19,826,671

)

(17,049,721

)

Income tax expense

-

-

-

(45,178

)

Net loss

(8,916,433

)

(6,330,913

)

(19,826,671

)

(17,094,899

)

Net loss - non-controlling interest

(64,824

)

(136,315

)

(228,526

)

(413,955

)

Net loss attributable to Heat Biologics, Inc.

$

(8,851,609

)

$

(6,194,598

)

$

(19,598,145

)

$

(16,680,944

)

Net loss per share attributable to Heat Biologics, Inc.-

Net loss per share attributable to Heat Biologics, Inc.-basic and diluted

$

(0.06

)

$

(0.18

)

$

(0.20

)

$

(0.50

)

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

143,728,870

33,650,829

96,481,271

33,255,535

Comprehensive loss:

Net loss

$

(8,916,433

)

$

(6,330,913

)

$

(19,826,671

)

$

(17,094,899

)

Unrealized (loss) gain on foreign currency translation

(63,954

)

63,711

(24,660

)

72,134

Total comprehensive loss

(8,980,387

)

(6,267,202

)

(19,851,331

)

(17,022,765

)

Comprehensive loss attributable to non-controlling interest

(64,824

)

(136,315

)

(228,526

)

(413,955

)

Comprehensive loss - Heat Biologics, Inc.

$

(8,915,563

)

$

(6,130,887

)

$

(19,622,805

)

$

(16,608,810

)

SOURCE: Heat Biologics, Inc.



View source version on accesswire.com:
https://www.accesswire.com/624776/Heat-Biologics-Commences-Manufacturing-Process-for-ZVX-60