8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): June 4, 2021

Heat Biologics, Inc.

(Exact name of registrant as specified in charter)

Delaware

(State or other jurisdiction of incorporation)

001-35994	26-2844103
(Commission File Number)	(IRS Employer Identification No.)

627 Davis Drive, Suite 400

Morrisville, North Carolina 27560

(Address of principal executive offices and zip code)

(919) 240-7133

(Registrant’s telephone number including area code)

N/A

(Former Name and Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0002 par value per share	HTBX	The Nasdaq Stock Market (The Nasdaq Capital Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01.   Regulation FD Disclosure.

On June 4, 2021, Heat Biologics, Inc. (the “Company”) issued a press release announcing that Dr. Roger B. Cohen, MD, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, presented a poster of the latest HS-110 data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting which is being held from June 4-8, 2021. At ASCO, Dr. Cohen presented a poster entitled “Interim results of viagenpumatucel-L (HS-110) plus nivolumab in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC) in two treatment settings”.

A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. A copy of the Poster Presentation is attached hereto as Exhibit 99.2 and is incorporated herein by reference. 

The furnishing of the attached Poster Presentation is not an admission as to the materiality of any information therein. The information contained in the Poster Presentation is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the Securities and Exchange Commission and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in this current report on Form 8-K, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures.

The information in this Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

The press release attached as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.

The Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K, although it may do so from time to time if its management believes it is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosures.

Item 8.01.  Other Events.

On June 4, 2021, the Company presented a poster at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting entitled “Interim results of viagenpumatucel-L (HS-110) plus nivolumab in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC) in two treatment settings” (the “Poster”). In a cohort of previously treated, checkpoint inhibitor naïve patients with advanced NSCLC (Cohort A, N = 47), the Company observed median overall survival (mOS) of 24.6 months. In patients who progressed after checkpoint inhibitor treatment (Cohort B, N = 68), the Company observed mOS of 11.9 months. Multiple subset analyses including injection-site reaction (ISR) and tumor PD-L1 expression were performed.

o Significantly longer mOS was observed in patients with ISR compared with those without such a reaction for both Cohorts A and B.

o Extended survival benefit was observed in PD-L1 positive patients in Cohort A.

o A trend of improved overall survival was observed in patients with low blood tumor mutation burden in Cohort B.

A copy of the Poster is attached as Exhibit 99.2 to this Current Report on Form 8-K.

Item 9.01.   Financial Statements and Exhibits.

(d) Exhibits.

The following exhibits are furnished with this Current Report on Form 8-K.

Exhibit Number	Exhibit Description
99.1	Heat Biologics, Inc. Press Release
99.2	Poster Presentation “Interim results of viagenpumatucel-L (HS-110) plus nivolumab in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC) in two treatment settings. ”

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated:  June 4, 2021	HEAT BIOLOGICS, INC.
	By:	/s/ Jeffrey Wolf
	Name:	Jeffrey Wolf
	Title:	Chairman, President and Chief Executive Officer

EX-99.1

Exhibit 99.1

Heat Biologics to Showcase Favorable Survival Data of HS-110 in Previously Treated Non-Small Cell Lung Cancer Patients at 2021 American Society of Clinical Oncology Annual Meeting

Survival benefit observed in two treatment settings of previously treated non-small lung cancer patients

DURHAM, NC – June 4, 2021 – Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that Dr. Roger B. Cohen, MD, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, presented an overview of the latest HS-110 data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting which is being held from June 4-8, 2021. This poster presentation can be viewed on Heat Biologics' website at: https://www.heatbio.com/product-pipeline/scientific-publications. The ASCO Annual Meeting is the world’s largest oncology conference showcasing the latest advancements in cancer research.

HS-110, in combination with a checkpoint inhibitor (CPI), is a potentially transformational agent to improve survival benefit for patients with non-small cell lung cancer (NSCLC). This is a first-in-class, allogeneic, off-the shelf cell-based therapy developed by Heat leveraging its proprietary gp96 platform. At this year’s ASCO meeting, the Company is pleased to report the latest data of HS-110 in combination with OPDIVO^® (nivolumab) in two distinct treatment settings in a total of 115 previously treated patients with NSCLC:

· Median overall survival (mOS) of 24.6 months was observed in previously treated, CPI naïve patients with advanced NSCLC (Cohort A, n=47). This data compares favorably with published data of Checkmate 057, which reported a mOS of 12.2 months in patients who received nivolumab as single agent in a similar treatment setting.

· mOS of 11.9 months was reported in NSCLC patients who were previously treated with CPI and whose disease had subsequently progressed (Cohort B, n=68). Published data from other studies stated median OS of 6.8 to 9.0 months for NSCLC patients treated with chemotherapies after CPI progression.

· Multiple subset analyses including injection-site reaction (ISR) and tumor PD-L1 expression were performed.

o Significantly longer mOS was observed in patients with ISR compared with those without such a reaction for both Cohorts A and B.

o Extended survival benefit was observed in PD-L1 positive patients in Cohort A.

o A trend of improved overall survival was observed in patients with low blood tumor mutation burden in Cohort B.

Dr. Roger B. Cohen, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, commented, “HS-110 is a promising agent for treatment of incurable NSCLC. The latest data presented support further clinical evaluation in combination with first line regimens that include a CPI as well as addressing high unmet medical needs for CPI progressors.”

Jeff Wolf, Chief Executive Officer of Heat, commented, “This data further reinforces the potential utility of HS-110 in combination with a CPI for multiple treatment settings of NSCLC. The growing body of clinical data demonstrates that HS-110 in combination with a CPI is well tolerated and has the potential to enhance survival benefit when given with a CPI. Our latest results, consistent with previously reported data, provide a strong foundation for the Company to discuss possible Phase 3 registration trial designs with the FDA and potential partners.”

About HS-110

HS-110 is a first-in-class, off-the-shelf, allogeneic cell therapy designed to utilize gp96 for immune activation against multiple tumor testis antigens. Phase 2 trial of HS-110 in combination with Bristol-Myers Squibb's OPDIVO® (nivolumab) has completed enrollment in patients with incurable or metastatic NSCLC. OPDIVO® is a programmed death-1 immune checkpoint inhibitor. HS-110 has broad potential for providing multiple treatment options to NSCLC patients in combination with a PD-1 inhibitor. Positive interim survival data has been demonstrated in two distinct treatment settings in previously treated NSCLC patients who have not been treated with CPI as well as patients who have progressed during or after previous treatment with a CPI. Combination of HS-110 and PD-(L)1 therapies may confer additional survival benefit.

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.

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 HS-110, in combination with a checkpoint inhibitor (CPI), being a potentially transformational agent to improve survival benefit for patients with non-small cell lung cancer (NSCLC), HS-110 being a promising agent for treatment of incurable NSCLC, potential utility of HS-110 in combination with a CPI for multiple treatment settings of NSCLC, HS-110 in combination with a CPI having the potential to enhance survival benefit when given with a CPI and HS-110 being administered in combination with first line regimens that include a CPI as well as addressing high unmet medical needs for CPI progressors These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including 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 of HS-110, in combination with a CPI to be utilized in multiple treatment settings of NSCLC and to improve survival benefit for patients with non-small cell lung cancer (NSCLC), the ability HS-110 to be administered in combination with first line regimens that include a CPI as well as addressing high unmet medical needs for CPI progressors, Heat's vaccine platform to provide protection against COVID-19, 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

EX-99.2

Exhibit 99.2

Interim results of viagenpumatucel - L (HS - 110) plus nivolumab in previously treated patients with advanced non - small cell lung cancer in two treatment settings BACKGROUND • Viagenpumatucel - L (HS - 110) is an allogeneic, off - the - shelf, cell - based immunotherapy engineered from a human lung adenocarcinoma cell line that expresses a diverse repertoire of cancer testis antigens (CTAs) and a secretory form of heat shock protein gp96 • HS - 110 is designed to utilize gp96 to (1) chaperone multiple CTAs for effective uptake by antigen - presenting cells via CD91; (2) activate antigen presenting cells via stimulation of toll - like receptor (TLR) - 2 and TLR - 4; and (3) activate and expand antigen - specific CD8+ cytotoxic T cells ( Figure 1 ) • Synergistic antitumor activities of HS - 110 in combination with an a nti - programmed cell death 1 (PD - 1) monoclonal antibody have been demonstrated in a B16 melanoma mouse model 1 • HS - 110 is being evaluated in a multi - arm phase 2 trial for the treatment of patients with unresectable or metastatic non - small cell lung cancer (NSCLC) ( NCT02439450 ) in multiple therapeutic settings. This trial has completed enrollment – Here, we present interim findings of HS - 110 in combination with nivolumab (NIVO) in previously treated patients with NSCLC who were checkpoint inhibitor (CPI) therapy naïve and patients who progressed on or after prior CPI therapy (CPI progressors) Abstract No. 9100 Roger B. Cohen 1 , George E. Peoples 2 , Toana Kawashima 2 , Bill Arana 3 , Xiaoxing Cui 3 , Lyudmila Bazhenova 4 , Rachel E. Sanborn 5 , Wael A. Harb 6 , Nathan A. Pennell 7 , Daniel Morgensztern 8 1 Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; 2 Cancer Insight LLC, San Antonio, TX; 3 Heat Biologics, Inc., Morrisville, NC; 4 UC San Diego, Moores Cancer Center, San Diego, CA; 5 Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR; 6 Horizon Oncology Center, Lafayette, IN; 7 Cleveland Clinic, Cleveland, OH; 8 Washington University School of Medicine, St. Louis, MO Figure 1 . MOA of HS - 110 in combination with an anti – PD - 1 inhibitor Study Endpoints • Primary endpoint was objective response rate (ORR) by RECIST 1.1; secondary endpoints included progression - free survival (PFS) by RECIST 1.1, overall survival (OS), safety, and tolerability Statistical Analyses • Safety analyses were conducted using data from all patients who received at least 1 dose of HS - 110 (safety population) • PFS and OS data were analyzed using Kaplan – Meier methodology; ORR data are presented as counts and percentages for each cohort • Retrospective subgroup analyses were conducted by – Injection site reaction (ISR): yes (+) or no ( – ) – Baseline blood tumor mutational burden (bTMB): low (bTMB - L, <10 mutations/megabase [mut/Mb]) or high (bTMB - H, ≥10 mut/Mb) – Baseline tumor PD - L1 expression: negative (<1%) or positive (≥1%) • The data cutoff date for this pre - specified interim analysis was November 2020 Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 4 – 8, 2021; Virtual REFERENCE 1 . Morgensztern D, et al. Treating advanced non - small lung cancer patients after checkpoint inhibitor treatment failure with a novel combination of viagenpumatucel - L (HS - 110) plus nivolumab. Poster presented at: The Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting; November 6 – 10, 2019; National Harbor, MD. Corresponding author: Roger B. Cohen, MD < roger.cohen@pennmedicine.upenn.edu > ACKNOWLEDGMENTS We are grateful for patients and their families, the study investigators and staff for their strong support. Medical writing support was provided by Russell Craddock, PhD of Parexel and funded by Heat Biologics, Inc. RESULTS (cont’d) CONCLUSIONS 1. In previously treated patients with unresectable or mNSCLC, HS - 110 in combination with NIVO was well tolerated and demonstrated potential signs of efficacy: • In cohort A (CPI naïve patients) – OS was significantly longer in PD - L1 ≥1% versus PD - L1 <1% patients – Data support evaluating HS - 110 in combination with CPI - containing frontline regimens • In cohort B (CPI progressor patients) – Survival was independent of tumor PD - L1 status – A trend of improved OS was observed in bTMB - L versus bTMB - H patients 2. ISR could potentially be utilized to identify patients who may derive a therapeutic benefit from HS - 110 • Significantly longer OS was observed in ISR+ versus ISR – patients in both cohorts A and B 3. Taken together, these results support future clinical evaluation of HS - 110 in combination with a PD - 1 inhibitor mAb, monoclonal antibody; MHC, major histocompatibility complex; MOA, mechanism of action; PD - L1, programmed death ligand 1; TLR, toll - like receptor. RESULTS • In total, 115 patients were enrolled: 47 patients to cohort A and 68 to cohort B Table 1. Baseline characteristics Baseline characteristics Cohort A n = 47 Cohort B n = 68 Age (years), median (range) 65 (37 – 87) 67 (46 – 84) Sex, female, n (%) 26 (55.3) 37 (54.4) Race, n (%) Asian 1 (2.1) 1 (1.5) Black 4 (8.5) 11 (16.2) White 42 (89.4) 54 (79.4) Other 0 1 (1.5) Unknown 0 1 (1.5) ECOG PS, n (%) 0 16 (34.0) 25 (36.8) 1 31 (66.0) 43 (63.2) Histology, n (%) Adenocarcinoma 44 (93.6) 55 (80.9) Adenosquamous 0 1 (1.5) Squamous cell carcinoma 3 (6.4) 12 (17.6) Smoking status, n (%) Current/former 39 (83.0) 57 (83.8) Never 8 (17.0) 11 (16.2) Tumor driver mutations, n (%) EGFR positive 6 (12.8) 3 (4.4) ALK positive 0 1 (1.5) KRAS positive 7 (14.9) 16 (23.5) Prior line(s) of treatment, n (%) 1 33 (70.2) 26 (38.2) 2 6 (12.8) 21 (30.9) ≥3 8 (17.0) 21 (30.8) PD - L1 status, n (%) <1% 22 (46.8) 29 (42.6) ≥1% 9 (19.1) 23 (33.8) Not evaluable 16 (34.0) 16 (23.5) TMB status, n (%) Low (<10 mut/mb) 2 (4.3) 32 (47.1) High (≥10 mut/mb) 2 (4.3) 11 (16.2) Unknown 43 (91.5) 25 (36.8) ALK, anaplastic lymphoma kinase; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; KRAS, Kirsten rat sarcoma viral oncogene homolog. Table 2. Summary of TEAEs and SAEs Events, n (%) Cohort A n = 47 Cohort B n = 68 Any TEAEs 47 (100) 66 (97.1) Any TEAE grade ≥3 16 (34.0) 17 (25.0) Most common TEAEs (≥15%) Fatigue 13 (27.7) 23 (33.8) Nausea 7 (14.9) 12 (17.6) Dyspnea 5 (10.6) 12 (17.6) Diarrhea 7 (14.9) 11 (16.2) Decreased appetite 6 (12.8) 11 (16.2) Pruritus 5 (10.6) 11 (16.2) Any treatment - emergent SAE 13 (27.7) 16 (23.5) TEAEs leading to discontinuation of HS - 110 5 (10.6) 3 (4.4) TEAEs leading to discontinuation of NIVO 4 (8.5) 3 (4.4) TEAEs leading to death 2 (4.3) 0 HS - 110 – related TEAEs 21 (44.7) 18 (26.5) HS - 110 – related TEAE grade 3 a 2 (4.3) 0 HS - 110 – related TEAE leading to death 0 0 Most common HS - 110 – related TEAEs (≥5%) Fatigue 2 (4.3) 6 (8.8) Pruritus 2 (4.3) 4 (5.9) Diarrhea 3 (6.4) 2 (2.9) Maculopapular rash 3 (6.4) 0 a No grade 4 or grade 5 HS - 110 - related TEAEs had been reported as of November 2020 data cutoff. Table 3. Summary of outcomes for Cohort A including retrospective subgroup analyses All ISR+ ISR – Adj. HR or OR a ; P PD - L1 ≥1% PD - L1 <1% Adj. HR or OR a ; P n 47 28 19 – 9 22 – ORR, % 21.3 28.6 10.5 3.91 b ; 0.12 44.4 9.1 8.10 b ; 0.04 mPFS, mo 1.8 5.4 1.5 0.43 c ; 0.01 4.8 1.8 0.46 c ; 0.11 mOS, mo 24.6 36.0 4.5 0.23 c ; <0.001 40.5 20.7 0.25 c ; 0.02 a HR adjusted for smoking status and number of prior lines of therapy; OR adjusted for sex. b Adjusted OR. c Adjusted HR. Adj., adjusted; HR, hazard ratio; mPFS, median PFS; mOS, median OS; OR, odds ratio. Table 4. Summary of outcomes for Cohort B including retrospective subgroup analyses All ISR+ ISR – Adj. HR or OR a ; P bTMB - L bTMB - H Adj. HR or OR a ; P PD - L1 ≥1% PD - L1 <1% Adj. HR or OR a ; P n 68 52 16 – 32 11 – 23 29 – ORR, % 10.3 11.5 6.3 1.99 b ; 0.60 15.6 9.1 2.25 b ; 0.50 13.0 10.3 1.27 b ; 0.80 mPFS, mo 2.8 3.0 1.7 0.63 c ; 0.14 3.7 2.7 0.94 c ; 0.90 3.2 2.9 1.11 c ; 0.80 mOS, mo 11.9 12.1 6.8 0.48 c ; 0.03 18.2 12.2 0.58 c ; 0.20 12.0 12.2 0.99 c ; >0.90 a HR adjusted for smoking status and number of prior lines of therapy; OR adjusted for sex. b Adjusted OR. c Adjusted HR. Safety and T olerability • Combination of HS - 110 and NIVO was well tolerated • No safety concerns were identified based on a review of immune - related adverse events • TEAEs related to HS - 110 were reported in 21 (44.7%) patients in cohort A and 18 (26.5%) patients in cohort B ( Table 2 ) – TEAEs occurring with a prevalence of >5% of patients included fatigue, maculopapular rash, nausea, diarrhea, and pruritus • Few TEAEs related to HS - 110 led to discontinuation of treatment – Cohort A, 5 patients (10.6%); cohort B, 3 patients (4.4%) • No SAEs or deaths were considered to be related to HS - 110 METHODS Figure 2 . Study design a All patients had received 1 – 3 lines of prior therapy for unresectable or metastatic NSCLC and had documented disease progression before study entry; for cohort A, patients had not received prior CPI therapy (CPI naïve patients); for cohort B, patients must have recei ved 1 prior line of CPI therapy for at least 4 months before progression (CPI progressor patients). b Patients with mixed histology other than adeno - squamous were not eligible. c HS - 110 was administered weekly for 18 weeks via 5 simultaneous 0.1 - ml intradermal injections in an extremity. d NIVO was administered every two weeks until disease progression or unacceptable toxicity. e Measured using the FoundationACT assay (Foundation Medicine). bTMB, baseline blood tumor mutational burden; CT, computed tomography; ID, intradermal; ISR, injection - site reaction; IV, intrav enous; mut/Mb, mutations per megabase; (m)NSCLC, (metastatic) non - small cell lung cancer; ORR, objective response rate; OS, overall sur vival; PFS, progression - free survival; QW, weekly; Q2W, every 2 weeks; RECIST 1.1, Response Evaluation Criteria in Solid Tumors v.1.1. Retrospective subgroup analyses: ISR (yes vs no) Baseline bTMB (<10 vs ≥10 mut/Mb) e Baseline PD - L1 expression (<1% vs ≥1%) HS - 110 (1 î 10 7 cells ID, QW) c NIVO (240 mg IV, Q2W) d CT Baseline Week 9 Week 18 Week 10 CT ( Q8W ) Progression Death Biopsy (or recent archival tissue) at baseline Survival follow - up Q12W CT CT Patients • Previously treated a adult patients with unresectable or with adenocarcinoma or squamous NSCLC b • ≥1 lesion measurable by RECIST 1.1 • ECOG PS 0 or 1 Cohort A: CPI naïve patients (n = 47) Cohort B: CPI progressor patients (n = 68) Primary outcome: ORR (per RECIST 1.1) METHODS (cont’d) Efficacy Cohort A: Previously treated, CPI naïve patients with unresectable or mNSCLC • Median OS was 24.6 months for all patients in cohort A at a median follow - up time of 19.4 months ( Table 3, Figure 3 ) – Significantly longer PFS and OS were observed in ISR+ patients ( P = 0.01 and P < 0.001, respectively) – Patients with tumor PD - L1 expression ≥1% had significantly improved ORR and OS ( P = 0.04 and P = 0.02, respectively) Cohort B: CPI progressor patients with unresectable or mNSCLC • Median OS was 11.9 months for all patients in cohort B at a median follow - up time of 11.9 months ( Table 3, Figure 4 ) – Significantly longer OS was observed in ISR+ patients ( P = 0.03) – A trend toward longer OS was observed in bTMB - L patients ( P = 0.20) – Survival was independent of tumor PD - L1 expression Key secondary outcomes: PFS (per RECIST 1.1) OS Safety and tolerability HR adjusted for smoking status and number of prior lines of therapy; OR adjusted for sex. HR adjusted for smoking status and number of prior lines of therapy; OR adjusted for sex. CI, confidence interval; NE, not ev alu able. 0 25 50 75 100 0 6 12 18 24 30 36 42 48 54 60 Months Overall Survival (%) 0 25 50 75 100 0 6 12 18 24 30 36 42 48 54 60 Months Overall Survival (%) 0 25 50 75 100 0 6 12 18 24 30 36 42 48 54 60 Months Overall Survival (%) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | PD - L1 <1% a. All patients c. Stratified by tumor PD - L1 expression b. Stratified by ISR ISR – ISR+ 0 25 50 75 100 0 3 6 9 12 15 18 21 24 27 30 Months Overall Survival (%) PD - L1 <1% 0 25 50 75 100 0 6 9 15 21 27 3 12 18 24 30 Months Overall Survival (%) | | | | | | | | | | | | | | | | | | | | | | | | | | | | a. All patients c. Stratified by tumor PD - L1 expression d. Stratified by TMB status b. Stratified by ISR 47 36 29 24 23 17 12 9 4 2 0 No. at risk 28 27 24 20 19 15 11 8 4 2 0 19 9 5 4 4 2 1 1 0 0 0 No. at risk ISR+ ISR – 9 7 6 6 6 5 4 3 1 0 0 22 16 14 11 10 6 3 2 1 1 0 No. at risk PD - L1 ≥1% PD - L1 <1% PD - L1 ≥1% 68 62 54 45 32 25 20 10 7 5 0 No. at risk 49 48 44 39 28 21 16 7 5 4 0 13 13 9 5 4 3 2 1 1 0 0 0 25 50 75 100 0 3 6 9 12 15 18 21 24 27 30 Months Overall Survival (%) ISR — ISR+ | | | | | | | | | | | | | | | No. at risk ISR+ ISR – PD - L1 ≥1% PD - L1 ≥1% PD - L1 <1% 20 20 18 16 11 7 5 3 1 1 0 27 27 25 20 16 12 10 4 4 3 0 32 30 27 26 21 18 15 7 4 3 0 11 10 9 8 6 3 3 1 1 1 0 bTMB - L bTMB - H 0 25 50 75 100 0 6 9 15 21 27 3 12 18 24 30 Months Overall Survival (%) bTMB - L bTMB - H | | | | | | | | | | | | | | No. at risk No. at risk Cohort A ISR+ (n = 28) ISR – (n = 19) mOS, mo 36.0 4.5 (95% CI) (28.7 – NE) (1.6 – 24.6) Adj. HR (95% CI) 0.23 (0.11 – 0.49), P < 0.001 Figure 3 . OS in Cohort A in (a) all patients, and for retrospective subgroup analyses by (b) ISR status and (c) baseline tumor PD - L1 expression Figure 4. OS in Cohort B in (a) all patients, and for subgroups by (b) ISR status, (c) baseline tumor PD - L1 expression, and (d) baseline bTMB status Cohort A PD - L1 ≥1% (n = 9) PD - L1 <1% (n = 22) mOS, mo 40.5 20.7 (95% CI) (8.0 – NE) (10.2 – 36.0) Adj. HR (95% CI) 0.25 (0.08 – 0.82), P = 0.02 Cohort B ISR+ (n = 52) ISR – (n = 16) mOS, mo 12.1 6.8 (95% CI) (11.1 – 20.8) (4.9 – 19.7) Adj. HR (95% CI) 0.48 (0.25 – 0.92), P = 0.03 Cohort B PD - L1 ≥1% (n = 23) PD - L1 <1% (n = 29) mOS, mo 12.0 12.2 (95% CI) (9.4 – NE) (11.5 – NE) Adj. HR (95% CI) 0. 99 (0.47 – 2.09), P = 0.90 Cohort B bTMB - L (n = 32) bTMB - H (n = 11) mOS, mo 18.2 12.2 (95% CI) (12.9 – NE) (9.7 – NE) Adj. HR (95% CI) 0. 58 (0.23 – 1.42), P = 0.20 Cohort A ( n = 47) mOS, mo 24.6 (95% CI) (11.7 – 36.0) 1 - year OS, % 61.7 (95% CI) (49.3 – 77.3) Cohort B ( n = 68) mOS, mo 11.9 (95% CI) (9.7 – 16.3) 1 - year OS, % 47.1 (95% CI) (36.6 – 60.6) HS - 110 A llogeneic Cell Therapy