HTBX: The Antigen Chaperone: gp96

By John Vandermosten, CFA

NASDAQ:HTBX

READ THE FULL HTBX RESEARCH REPORT

Full Year 2019 Results

Heat Biologics, Inc. HTBX reported first quarter 2020 results in a May 15th release along with the submission of the 10-Q to the SEC. For the first five months of the year, Heat has been busy advancing preclinical work for a coronavirus vaccine, assembling data related to the Phase II HS-110 DURGA trial and raising significant capital to support the pipeline of projects. Heat management has also attended scientific and investor events sharing the company's progress. The company is in the process of preparing a data package to share with the FDA in an End-of-Phase II meeting that we expect will be scheduled in the next few months. The IND for PTX-35 has been submitted and clearance is expected in 2Q:20.

Cash and equivalents as of March 31, 2020 were $26.4 million, compared to $14.8 million at the end of 2019. Heat continues with no debt on the books. Cash burn was ($5.8) million in the first quarter compared with ($4.2) million in 1Q:19. Add-back of stock based compensation and change in fair value of warrants partially offset by recognition of deferred revenue explained the majority of the difference between the ($6.3) million net loss and the ($5.8) million cash used in operations. Net cash provided by financing activities totaled $17.6 million, reflecting cash from the issuance of common stock and warrant exercise. Following the end of the reporting period, Heat raised an additional $2.9 million in capital from an at-the-market (ATM) facility.

Coronavirus

The global threat of coronavirus has changed the landscape for many biotechnology research and development companies. The spread of the virus may delay trial progression and the availability of drug product. But, it also has accelerated programs that many companies, including Heat Biologics, have developed in infectious disease. Heat's wholly-owned subsidiary, Zolovax, has been focused on developing medicines and vaccines for infectious diseases using the gp96 platform for many years.

The vaccine incorporates multiple SARS-CoV-2 antigens using the gp96 platform. The approach is expected to induce long-term immunity and provide protection against future infections. As no viral vector is used, Heat's coronavirus vaccine avoids anti-vector immunity and viral activation while activating T and B cells with high immunogenicity. The activation of T and B cells drives induction of mucosal immunity and long-term memory response. In early March, the company filed multiple provisional patent applications for its technology that treat and prevent infection from the SARS-CoV-2 virus.

HS-110

The HS-110 Phase II Durga trial provided the latest update to its interim data in mid-November 2019. Cohort A enrolled checkpoint-inhibitor naïve patients and Cohort B enrolled patients previously on checkpoint inhibitor therapy that have progressed. Both groups are treated with a combination of HS-110 and nivolumab. Initial results have been promising. There are two additional cohorts, designated C and D, which will examine HS-110 in combination with pembrolizumab, and pembrolizumab and chemotherapy which are intended to evaluate safety with an alternative checkpoint inhibitor. About 20 patients are expected to be enrolled in the C and D cohorts with 122 patients enrolled overall.

HS-110 Trial Design (1)




ASCO 2020 Abstract

Heat is scheduled to present at the 2020 American Society of Clinical Oncology (ASCO) annual meeting to be held virtually. The conference will run from May 29th to June 2nd and will feature the company's poster entitled: "Tumor antigen expression and survival of patients with previously treated advanced non-small cell lung cancer (NSCLC) receiving viagenpumatucel-L (HS-110) plus nivolumab." The abstract highlights Cohort A in the Durga trial, which combines HS-110 with nivolumab in the 47-patient study. Subjects enrolled in this group exhibited an overall survival duration of 28.7 months. The cohort was divided into patients based on whether their tumor-antigens were similar to those in HS-110. (≥8 vs <8 antigens in common). Where HS-110 had a higher similarity to the patients' CTA, patients experienced a longer median overall survial.

gp96 Platform (2)

HS-130 and PTX-35

In an August 12, 2019 release, Heat announced that its IND for HS-130 had been submitted and received clearance from the FDA to begin a Phase I safety trial. On December 16, the first patient was dosed in the dose escalation trial. The combination study, which will pair HS-130 with HS-110, will enroll patients with advanced solid tumors refractory to standard of care. The candidate is in development to treat solid tumors and will employ the ComPACT technology which delivers the gp96 heat shock protein along with a T-cell co-stimulatory fusion protein (OX40L). The associated trial expects to enroll up to 30 patients and have primary endpoints of safety and optimal dose determination for its Phase II trial.

In November 2019 the period of the CPRIT grant was extended to May 30, 2020. Clearance for the PTX-35 IND is expected in 2Q:20, after which we expect the launch of the Phase I trial. CPRIT grant funds are expected to allow Pelican to develop PTX-35 through a 70-patient Phase I clinical program.

Corporate Milestones

‣ Below we list key milestones for Heat Biologics.

‣ Complete HS-110 Phase II NSCLC enrollment – 2Q:19

‣ HS-130 (ComPACT) IND filing and FDA Clearance – August 2019

‣ HS-110 interim data readout – November 2019

‣ HS-110 Phase II interim readout – 4Q:19

‣ PTX-35 IND clearance and first patient dosing – 2Q:20

‣ Various coronavirus vaccine milestones – 2Q:20

‣ ASCO Poster Presentation – May 29, 2020

‣ Discussion with potential partners – Ongoing

‣ Schedule End of Phase II Meeting with FDA – 2H:20

‣ Complete HS-130 Phase I trial – 4Q:20

‣ Develop Phase III / commercial manufacturing capacity for HS-110 – 2020

Pipeline

Heat Biologics Product Pipeline (3)

Sources of Capital

Heat Biologics started 2020 with a solid $15 million in cash on the balance sheet. With multiple programs in the pipeline, management saw the opportunity to accelerate development by raising additional capital. Financing activities provided $17.6 million during the first quarter from a public share offering.

Following the end of the quarter, Heat filed a shelf registration enabling the company to conduct up to $150 million in equity fundraising. Along with this effort, an agreement was signed with B. Riley FBR to serve as Heat's sales agent and offer shares of common stock under an ATM facility. During the second quarter of 2020, $2.9 million was raised through the issuance of 5,352,234 shares under this program.

Summary

Heat Biologics made substantial progress in 2019 with advancements for all four cohorts in its Phase II NSCLC trial. A poster will be presented for HS-110 at ASCO at the end of the month featuring updated data for the Durga trial, after which Heat will schedule an End of Phase II meeting with the FDA to help chart the course forward for the treatment. Year to date, Heat has been opportunistic in raising capital and has established an ATM facility. They have also re-energized their work on infectious disease and have launched programs to develop a coronavirus vaccine using the gp96 platform.

Checkpoint inhibitors have been an exciting new area of immunotherapy; however, they are only successful in a minority of patients. Heat's portfolio seeks to awaken the immune system and increase the effectiveness of checkpoint inhibitors even in patients previously treated with checkpoint inhibitors. Interim data suggest that there may be a synergy between the two approaches.

Progress in being made across the portfolio. In addition to HS-110 progress, HS-130 received clearance to commence a Phase I dose-finding trial and has dosed its first patient. We also anticipate the start of a trial for PTX-35 in the near term. The company has a favorable cash position and should have sufficient funds to support operations into 2021.

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1. Source: Heat Biologics Corporate Presentation. November 5, 2019.

2. Source: Heat Biologics Corporate Presentation. May 2020.

3. Source: Heat Biologics May 2020 Corporate Presentation.