Item 7. Management’s Discussion and Analysis
ITEM 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial
statements and related notes appearing elsewhere in this Annual Report. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual
results may differ materially from those anticipated in these forward-looking statements as a result of certain factors. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this Annual
Report, including those set forth under Item 1A. “Risk Factors” and under “Forward-Looking Statements” in this Annual Report.
Introduction to PDS Biotechnology Corporation
We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies based on our Versamune®, Versamune® in combination with our IL-12
fused anti-body drug conjugate (ADC) PDS01ADC (formerly known as PDS0301/M9241/NHS-IL-12). In addition, we are developing the Infectimune® T cell-activator in infectious diseases. We believe our targeted immunotherapies have the potential to
overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. Versamune®, and Versamune® in combination with PDS01ADC are utilized for treatments in oncology and
Infectimune®, for treatments in infectious disease. When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune® and Infectimune® have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD4 helper and CD8 killer T cells, a specific sub-type of T cell that is more effective at killing infected or target cells. Infectimune® is also designed
to promote the induction of disease-specific neutralizing antibodies. PDS01ADC is an investigational tumor targeting IL-12 that we believe may enhance the proliferation, potency and longevity of T cells in the tumor microenvironment. Based on
preclinical studies and recent investigational clinical data, we believe that Versamune® in combination with PDS01ADC may enhance the proliferation, potency and longevity of antigen specific multifunctional CD8 T cells in the tumor
microenvironment and work synergistically to overcome tumor immune suppression.
In December 2022, we executed an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor targeting IL-12 fused antibody drug conjugate, M9241, which joined our
pipeline as PDS01ADC. PDS01ADC is a novel investigational tumor-targeting fusion protein of Interleukin 12 that enhances the proliferation, potency, infiltration and longevity of T cells in the tumor microenvironment and is therefore designed to
overcome the limitations of cytokine therapy which today have resulted in high toxicity and limited therapeutic potential. The proprietary combination of Versamune® and PDS01ADC is designed to overcome tumor immune suppression utilizing a
different mechanism from immune checkpoint inhibitors (ICI). The potential ability of the c ombination of Versamune® and PDS01ADC to overcome immune suppression is patented by us, and we believe our ownership
of both assets will streamline the clinical development, registrational process and their potential therapeutic use. In a Phase 2 National Cancer Institute (NCI)-led clinical trial in ICI-resistant patients, the
combination of Versamune® HPV and PDS01ADC administered with an investigational bi-functional ICI resulted in a median overall survival of approximately 20 months. The historical median survival reported in ICI-resistant HPV-positive cancers
when treated with ICIs is 3-4 months, and best reported median survival to date with systemic therapy is 8.2 months in ICI-resistant head and neck cancer.
In February 2023, we announced the completion of a Type B meeting with the FDA for the triple combination of Versamune® HPV and PDS01ADC with an FDA-approved immune checkpoint
inhibitor for the treatment of recurrent/metastatic, ICI-resistant head and neck cancer that is positive for the HPV type 16. In recent interactions with the FDA, we confirmed the required contents of a clinical protocol for the potential
registrational trial.
In June 2023, an abstract was presented at the 2023 American Society of Clinical Oncology: Abstract number 6012, Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study
of Versamune® HPV and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC). The abstract was also selected as one of the featured posters reviewed by an expert panel in the Head and Neck Cancer discussion session.
In September 2023, data on our investigational universal flu vaccine, PDS0202, was presented at the 9 th European
Scientific Working Group on Influenza (ESWI) conference. This data demonstrated broad neutralization across multiple influenza strains in animals and provided protection against infection after challenging animals not previously exposed to flu
with lethal doses of the pandemic H1N1 flu virus.
In October 2023, data demonstrating Versamune® HPV in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus circulating cell-free
DNA (ctHPV-DNA), a potential predictive biomarker of treatment response. The data from the IMMUNOCERV Phase 2 clinical trial were featured in an oral presentation at the American Society for Radiation Oncology Annual Meeting.
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In October 2023, updated interim data based on an August 2 cut off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune® HPV in combination with Merck’s anti-PD-1
therapy, Keytruda® (pembrolizumab) which is the FDA-approved standard of care for first-line treatment of recurrent/ metastatic head and neck cancer was presented at a Company-sponsored key opinion leader roundtable.
In October 2023, interim safety and immune response data was presented for the first-in-human Phase1/2 clinical trial evaluating PDS01ADC in combination with current SOC chemotherapy, docetaxel,
to treat metastatic castration sensitive and castration resistant prostate cancer. The data was featured in an oral presentation at the 11 th Annual Meeting of the
International Cytokine & Interferon Society.
In October 2023, immune response data from a preliminary analysis of a subset of patients in our VERSATILE-002 Phase 2 clinical trial was presented at the European Society for Medical Oncology
Congress 2023.
In November 2023, we announced updated survival data from our NCI-led Phase 2 trial investigating the triple combination of Versamune® HPV, PDS01ADC and an investigational immune checkpoint
inhibitor (ICI) in two groups of advanced cancer patients with various types of human papillomavirus (HPV) 16-positive cancers.
In November 2023, we announced updated interim survival data from our NCI-led Phase 2 triple combination trial.
In November 2023, preclinical data from our NCI-led trial including Versamune® HPV, PDS01ADC and an HDAC inhibitor in ICI-resistant HPV-16 positive cancer was presented during a poster
presentation at the Society for Immunotherapy of Cancer 38 th Annual Meeting.
In May 2024, at a virtual key opinion leader event, updated interim data was presented based on a November 30, 2023 cut-off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune® HPV
in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer. Data from 53 patients was presented.
In June 2024, we provided a data update from our VERSATILE-002 clinical trial. Interim data was presented based on a May 17, 2024 cut-off.
In August 2024, we provided an update to our clinical strategy following discussions with the FDA. During the August 2024 update, we announced our intent to initiate a registrational trial in first line treatment in
HPV16-positive recurrent/metastatic HNSCC with the double combination of Versamune® HPV + pembrolizumab.
In September 2024, we announced updated data from our VERSATILE-002 Phase 2 clinical trial presented during a poster session at the European Society for Medical Oncology (ESMO) Congress 2024.
In October 2024, we announced updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV with chemoradiation to treat locally advanced cervical cancer presented at the
American Society for Radiation Oncology (ASTRO) Annual Meeting 2024.
Clinical Candidate Pipeline
National Cancer Institute: Versamune® HPV + PDS01ADC + Bintrafusp Alfa
In June 2020, the first patient was dosed under a Versamune® HPV Cooperative Research and Development Agreement (CRADA), in the NCI led Phase 2 investigator-initiated trial evaluating Versamune®
HPV with an IL-12 ADC now PDS01ADC, and M7824 (Bintrafusp alfa), which is owned by EMD Serono (Merck KGaA), in patients with advanced HPV-positive cancers who have failed prior treatment. In February 2021, the NCI’s Phase 2 clinical trial of
Versamune® HPV for the treatment of advanced HPV-positive cancers had achieved its preliminary objective response target in patients naïve to check point inhibitors which allowed for full enrollment of approximately 20 patients in this group. In
addition, based on promising results in the ICI naïve arm, the trial was amended to allow enrollment of a separate cohort of ICI-resistant patients for assessment of safety and activity of the triple combination. The trial has been closed for
enrollment. Preliminary efficacy assessment of the triple combination in this added group of 29 ICI-resistant patients has been completed and evaluation of long-term patient survival is ongoing.
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Preclinical study results arising from this CRADA were published in the Journal for ImmunoTherapy of Cancer, Immunomodulation to enhance the efficacy of an HPV
therapeutic vaccine (Journal for ImmunoTherapy of Cancer2020;8:e000612. Doi:10.1136/ jitc-2020-000612) and indicate that Versamune® HPV generated both HPV-specific T cells and an associated antitumor response when used as a monotherapy. When Versamune® HPV was combined with the two other novel clinical-stage anti-cancer agents,
Bintrafusp Alfa and M9241 (which is now owned by us and referred to as PDS01ADC), the preclinical data suggested that all three therapeutic agents worked synergistically to provide superior
tumor T cell responses and subsequent tumor regression when compared to any of the agents alone or the 2-component combinations. The published preclinical data demonstrating powerful activity of the triple combination appears to be corroborated in the Phase 2 trial, and this triple combination could form the basis of a unique platform providing improved cancer treatments across multiple cancers.
In June 2022, at the 2022 ASCO Annual Meeting, the NCI provided an update to the preliminary data presented at the 2021 meeting (Strauss J et al. J Clin Oncol 40, 2022 [suppl 16; abstr 2518]). This included data from 30 HPV16-positive patients and highlights were as follows:
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Objective response (OR = > 30% tumor reduction) was seen in 88% (7/8) of patients with ICI-naïve disease; 4/7 (57%) patients’ responses are ongoing (median 17 months).
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With ICI-resistant patients: PDS01ADC dosing appears to affect response rates, with 5/8 (63%) patients receiving PDS01ADC at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients who received PDS01ADC at 8
mcg/kg achieving an OR; 4/6 (67%) patients’ responses are ongoing (median 12 months).
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Tumor reduction was seen in 45% (10/22) of patients with ICI-resistant disease, including patients receiving high or low dose PDS01ADC.
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In ICI-resistant patients treated with high or low dose PDS01ADC, survival outcomes were similar (p=0.96 by Kaplan Meier analysis). At a median of 12 months of follow up 17/22 (77%) of patients were alive.
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In ICI-naïve patients, 6/8 (75%) were alive at median 17 months of follow up.
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Similar OR and survival were seen across all types of HPV16-positive cancers.
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Preliminary safety data: 13/30 (43%) of patients experienced Grade 3 treatment-related adverse events (AEs), and 2/30 patients (7%) experienced Grade 4 AEs. There were no grade 5 treatment-related AEs.
We believe the trial results to date strongly suggest, in agreement with the published preclinical studies, that all 3 drugs contribute to the clinical outcomes.
In September 2022, we determined, in agreement with the NCI, to select the ICI-resistant patients as the preferred treatment group in the on-going Versamune® HPV - based triple
combination therapy in advanced HPV-positive cancers and the trial was closed to further enrollment given the ICI-resistant arm had been fully recruited.
In October 2022, we presented additional interim data as follows:
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Survival data: 66% (19/29) of HPV16-positive ICI-resistant patients in the cohort were alive at a median follow up of 16 months.
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Safety profile: 48% (24/50) patients experienced Grade 3 treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 AEs. There were no Grade 5 treatment-related AEs.
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HPV16-positive ICI naïve patients: 75% (6/8) were alive at a median follow up of 25 months and 38% (3/8) of responders had a complete response.
In December 2022, we presented interim data as follows:
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Median OS was 21 months in 29 checkpoint inhibitor resistant patients who received the triple combination. The reported historical median OS in patients with ICI-resistant disease is 3-4 months seen with
checkpoint inhibitors and best reported median survival to date with systemic therapy of 8.2 months in ICI-resistant head and neck cancer.
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In ICI-naïve subjects, 75% remain alive at a median follow-up of 27 months. As a result, median OS had not yet been reached. Historically median OS for similar patients with platinum experienced ICI-naïve
disease is 7-11 months.
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Objective response rate (ORR) in ICI-resistant patients who received the optimal dose of the triple combination is 63% (5/8). In current approaches ORR is reported to be less than 10%.
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ORR in ICI-naïve patients with the triple combination is 88%. In current approaches ORR is reported to be less than 25% with FDA-approved ICIs in HPV-positive cancers.
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Safety data had not changed since October’s update. 48% (24/50) of patients experienced Grade 3 (moderate) treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 (severe) AEs,
compared with approximately 70% of patients receiving the combination of ICIs and chemotherapy reporting Grade 3 and higher treatment-related AEs.
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In February 2023, we announced the successful completion of a Type B meeting with the FDA for the combination therapy of Versamune® HPV, PDS01ADC, and an FDA-approved immune
checkpoint inhibitor for the treatment of recurrent/metastatic HPV-positive ICI-resistant head and neck cancer. We confirmed the required contents of the trial design for a potential registrational trial of the combination.
In November 2023, we released updated interim survival data as follows:
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75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36 months; published median overall survival (OS) in similar patients is 7-11 months
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12-month survival rate in (ICI) resistant patients of 72%
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Median OS in ICI-resistant HPV-positive patients is approximately 20 months; published median OS is 3.4 months
VERSATILE-002: Versamune® HPV + Keytruda®
In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune® HPV in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is the
FDA-approved standard of care for first-line treatment of recurrent/ metastatic head and neck cancer commenced. Enrollment in stage 2 of 2 for the ICI-naïve arm and the ICI-resistant arms are complete. The clinical trial will evaluate the
efficacy and safety of this therapeutic combination as a first and second line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection.
In this trial sponsored by us, patients whose cancer has returned following initial treatment or spread will be treated with the combination of Versamune® HPV and Keytruda®
to evaluate if the addition of Versamune® HPV might improve the efficacy reported in published studies of Keytruda® alone. Patients in the trial will receive a total of 5 cycles of combination therapy in the
context of standard of care Keytruda® therapy administered every three weeks until disease progression. The primary endpoint of VERSATILE-002 is the objective response rate, or ORR, at six months following
initiation of treatment. There are two cohorts in the trial. Cohort 1 is for patients who have yet to be treated with an immune checkpoint inhibitor (ICI naïve) and cohort 2 which consists of patients who
have failed immune checkpoint inhibitor therapy (ICI resistant).
In May 2023, we completed enrollment in the ICI naïve arm. We filed our amended IND with the FDA in the third quarter of 2023. In October 2023, we received feedback from the FDA
on the amended IND.
In June 2023, an abstract was presented at the 2023 American Society of Clinical Oncology: Abstract number 6012, Safety and Efficacy of Immune Checkpoint
Inhibitor (ICI) Naïve Cohort from Study of Versamune® HPV and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC). The abstract was also selected as one of the featured posters to be reviewed by an expert panel in the
Head and Neck Cancer discussion session. Data on 34 patients was presented. The data from the abstract is as follows:
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Estimated 12-month overall survival rate was 87.1%. Published results are 36-50% with approved ICIs used alone.
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Median progression-free survival was 10.4 months (95% CI 4.2, 15.3). Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels.
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A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)
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Confirmed and unconfirmed objective response rate is 41.2% (14/34 patients), which is identical to the preliminary response rate data previously reported by us at ASCO 2022 (7/17 patients). To date these responses have been confirmed
in nine of the 34 patients (26.5%), including one complete response.
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15/34 patients (44.1%) had stable disease.
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9/34 patients (26.5%) had progressive disease.
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4/48 (8.3%) of patients had a Grade 3 treatment-related adverse event (TRAE). No Grade 4 or higher TRAEs were observed.
In October 2023, at a key opinion roundtable updated interim data was presented based on an August 2, 2023 cut-off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination of
Versamune® HPV in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/ metastatic head and neck cancer. Data on 52 patients was presented. The data
from the roundtable based on investigator assessment was as follows:
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Highlights from the ICI naïve cohort include:
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24-month overall survival (OS) rate is 74%; published 24-month survival rate of less than 30% for approved ICI.
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12-month OS rate is 80%; published results of 30-50% with approved ICIs.
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Tumor shrinkage seen in 60% (31/52) of patients.
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Confirmed overall response rate ORR is 27% (14/52) to date.
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Median progression-free survival (PFS) is 8.1 months to date; published results of 2-3 months PFS with approved ICIs.
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13% (8/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 0% (0/62) experienced Grade 4 or 5 TRAE; published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy.
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60% (33/55) of patients have CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (22/55) have CPS score >20 (who generally have a higher response to Keytruda®).
Highlights from the ICI refractory cohort include:
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The 12-month OS rate is 56%. The published median 12-month OS rate is 17% with no salvage chemotherapy following tumor progression on ICI (ICI Resistant).
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0% (0/21) confirmed ORR suggests that Versamune® HPV’s impact on survival does not appear to be dependent on tumor shrinkage.
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4% (1/25) of patients experienced Grade 3 TRAE and 0% (0/21) patients experienced Grade 4 and 5 TRAE.
In May 2024, at a virtual key opinion leader event, updated interim data was presented based on a November 30, 2023 cut-off from our VERSATILE-002 Phase 2 clinical trial evaluating the
combination of Versamune® HPV in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer. Data from 53 patients was
presented. The data from the event based on investigator assessment was as follows:
Highlights from the ICI naïve cohort with CPS > 1 included:
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Median overall survival of 30 months; published results for ICIs are 7-18 months.
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Confirmed overall response rate ORR of 34% (18/53) to date; published results for comparable patients receiving treatment with ICIs are less than 20%.
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Confirmed complete responses, partial responses and stable disease according to RECIST v1.1 were seen in 75.5% of patients.
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Median progression-free survival (PFS) of 6.3 months to date; published results of 2-3 months PFS with approved ICIs.
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The combination of Versamune® HPV and Keytruda® appeared to be well tolerated with 11% (7/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 2% (1/62) experienced Grade 4 or 5 TRAE; published results report
13-17% Grade 3-5 TRAE with approved ICI monotherapy.
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60% (32/53) of patients had CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (21/53) have CPS score >20 (who generally have a higher response to Keytruda®).
In June 2024, we provided a data update from our VERSATILE-002 clinical trial. Interim data was presented based on a May 17, 2024 cut-off. The data update was as follows:
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Median Overall Survival of 30 months, consistent with data presented our key opinion leader event in May of 2024, which was based on a data cut as of November 30, 2023.
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27 of the censored patients remained alive and were awaiting their next clinical assessment, 6 censored patients had withdrawn consent for further follow-up, and 2 patients had been lost to follow-up, and 18 patients had died.
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The lower limit of the 95% confidence interval is 19.7 months, and the upper limit is not yet estimable, as the majority of patients continue to be followed for survival.
In August 2024, we provided an update to our clinical strategy following discussions with the FDA. During the August 2024 update, we announced our intent to initiate a registrational trial in
first line treatment in HPV16-positive recurrent/metastatic HNSCC with the double combination of Versamune® HPV + pembrolizumab.
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In September 2024, we announced updated data from our VERSATILE-002 Phase 2 clinical trial presented during a poster session at the European Society for Medical Oncology (ESMO) Congress 2024.
The data presented was based on a May 17, 2024 data cut-off. The main elements of the update were as follows:
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Median Overall Survival (mOS) was 30 months with a lower 95% confidence interval of 19.7 months; Published mOS for pembrolizumab is 12-18 months
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Objective Response Rate (ORR) of 36% (19/53); Published ORR for pembrolizumab is 19-25%
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Disease Control Rate (DCR) is 77% (41/53)
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21% (11/53) of patients had deep tumor responses and shrinkage of 90-100%
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9% (5/53) of patients had a complete response
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Treatment-related adverse events of Grade ≥3 were seen in 9 patients (Grade 3, n=8 and Grade 4, n=1)
MD Anderson Cancer Center (IMMUNOCERV): Versamune® HPV + Chemoradiotherapy
In October 2020, a Versamune® HPV Phase 2 IIT was initiated with The University of Texas MD Anderson Cancer Center and is actively recruiting patients. This clinical trial is
investigating the safety and anti-tumor efficacy of Versamune® HPV in combination with standard-of-care chemo-radiotherapy, or CRT, and their correlation with critical immunological biomarkers in patients with locally advanced cervical cancer. We
believe that Versamune® has strong T cell induction with the potential to enhance efficacy of the current standard of care CRT treatment in this indication with the FDA at this meeting.
In November 2022, data from this trial was included in a poster presentation at the 2022 SITC Annual Meeting which included the following:
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9 of the 17 patients had completed a Day 170 post-treatment positron emission tomography, computed tomography (PET CT) scan to assess the status of the cancer. This included 78% (7/9) of treated patients with
advanced cervical cancer (FIGO stage III or IV).
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100% (9/9) of patients treated with the combination of Versamune® HPV and CRT had an objective response.
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89% (8/9) of patients treated with the combination of Versamune® HPV and CRT demonstrated a complete response (CR) on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of Versamune® HPV
showed signs of residual disease. One patient who had a CR died from an event unrelated to either their underlying disease or treatment.
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1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of Versamune® HPV and CRT.
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As previously reported, data confirm Versamune® HPV treatment activates HPV16-specific CD8 T cells. This increase was not seen in patients who did not receive Versamune® HPV. The increase in HPV16-specific T
cells generated by the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8 T cells are important mediators of antigen-specific immunity.
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The data affirms that Versamune® HPV activates Type 1 interferon pathway in humans, mimicking the mechanism previously demonstrated in preclinical studies in animal models.
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Toxicity of Versamune® HPV remains limited to low-grade local injection site reactions.
In October 2023, data demonstrating Versamune® HPV in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus circulating cell-free
DNA (ctHPV-DNA), a potential predictive biomarker of treatment response. The data from the IMMUNOCERV Phase 2 clinical trial was featured in an oral presentation at the American Society for Radiation Oncology Annual Meeting which included the
following:
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Earlier and greater proportion of ctDNA clearance with Versamune® HPV plus chemoradiation (CRT) vs. SOC CRT alone 81.3% clearance after 3 weeks vs. 30.3% with SOC (p=0.0018), and 91.7% of clearance at 5 weeks vs. 53.1% with SOC
(p=0.0179).
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Baseline ctDNA levels correlated with the International Federation of Gynecology and Obstetrics (FIGO) stage and lymph node involvement; 100% of patients treated with Versamune® HPV had cancer that had spread to the lymph nodes.
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In October 2024, we announced updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV with chemoradiation to treat locally advanced cervical cancer presented at the
American Society for Radiation Oncology (ASTRO) Annual Meeting 2024 which included the following:
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All patients received at least 2 doses of Versamune® HPV.
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Median follow-up was 19 months.
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36-month overall survival (OS) rate was 84.4%, and 100% for the eight patients who received all five doses of Versamune® HPV. Historical published data show 36-month OS rate with chemoradiation in this
population of approximately 64%.
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36-month progression free survival (PFS) rate was 74.9%, among all patients and 100% for the eight patients who received all five doses of Versamune® HPV. Historical published data show 36-month PFS rate with
chemoradiation in this population of approximately 61%.
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Complete metabolic response (CMR) was achieved in 15/17 (88%) patients.
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Versamune® HPV appeared to be safe and well-tolerated. The most common treatment-related toxicities were injection site reactions in twelve patients (71%).
Mayo Clinic: Versamune® HPV Monotherapy and in combination with Keytruda®
In February 2022, we initiated an Investigator-Initiated Trial (ITT), MC200710, for Versamune® HPV alone or in combination with the immune checkpoint inhibitor, Keytruda®, in
patients with HPV-positive oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence. The trial is being led by Drs. David Routman, Katharine Price, Kathryn Van Abel, and Ashish Chintakuntlawar at Mayo Clinic, a nationally and internationally
recognized center of excellence for the treatment of head and neck cancers. We believe that this trial not only broadens our addressable patient population of those affected by the increasing incidence of HPV(+)OPSCC, but also allows us to better
understand the activity of Versamune® HPV alone or in combination with Keytruda® in earlier stages of disease. This trial is currently open for enrollment.
In this trial, treatment will be administered before patients proceed to transoral robotic surgery (TORS) with curative intent. Treatment in this setting is referred to as
neoadjuvant treatment. Versamune® HPV has been shown to induce killer T cells that target and kill HPV-positive cancers, either alone or in combination with ICIs in preclinical studies, and in combination in clinical studies of patients with
advanced recurrent/metastatic HPV-positive cancers. This trial will explore whether Versamune® HPV with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic
regression, and decreases in circulating tumor DNA (ctDNA).
PDS0102
PDS0102 is an investigational immunotherapy utilizing tumor-associated and immunologically active T cell receptor gamma alternate reading framed protein (TARP) from the NCI.
PDS0102 is designed to treat TARP-associated cancers including, acute myeloid leukemia (AML), prostate and breast cancer. In our preclinical work, in the administration of PDS0102, the Versamune®+TARP antigen combination led to the induction of
large numbers of tumor targeted killer T cells. In addition, the TARP tumor antigen alone has already been studied at the NCI in men with prostate cancer and has been shown to be safe, and immunogenic with slowing tumor growth rates
(NCT00972309).
PDS0103
In April 2020, the above-mentioned CRADA between PDS Biotech and the NCI was expanded beyond Versamune® HPV to include clinical and preclinical development of PDS0103. PDS0103 is an
investigational immune therapy owned by us and designed to treat cancers associated with the mucin-1, or MUC1, oncogenic protein. These include cancers such as ovarian, breast, colorectal and lung cancers. PDS0103 combines Versamune® with novel
highly immunogenic agonist epitopes of MUC1 developed by the NCI and licensed by us.
MUC1 is highly expressed in several types of cancer and has been shown to be associated with drug resistance and poor disease prognosis in breast, colorectal, lung and ovarian cancers, for which
PDS0103 is being developed. Expression of MUC1 is often associated with poor disease prognosis, due in part to drug resistance. In preclinical studies, and similarly to Versamune® HPV, PDS0103 demonstrated the ability to generate powerful
MUC1-specific CD8 killer T cells.
In January 2025, we submitted an investigational new drug application to the FDA for a Phase 1 trial with PDS0103 and PDS01ADC in colorectal cancer.
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IL-12 Oncology Immunocytokine Pipeline
PDS01ADC (formerly known as PDS0301/M9241/NHS-IL-12) is a novel investigational IL-12 fused antibody drug conjugate (IgG1), tumor-targeting interleukin 12 (IL-12)
immune-cytokine that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Together with Versamune® based immunotherapies PDS01ADC works synergistically to overcome tumor immune suppression and to promote a
targeted T cell attack against cancers. As with Versamune®, PDS01ADC is given by a simple subcutaneous injection. Clinical data suggests the addition of PDS01ADC to Versamune® based immunotherapies may demonstrate significant disease control in
advanced cancer patients by shrinking tumors and/or prolonging life.
With the exclusive global license agreement with Merck KGaA, Darmstadt, Germany for PDS01ADC, we believe we have simplified our registrational pathway for the NCI-led triple combination by
owning both Versamune® HPV and PDS01ADC and combining these agents with an FDA approved ICI. PDS01ADC has been designed to overcome the limitations of cytokine therapy as explained above, and based on extensive preclinical studies performed at
the NCI evaluating PDS01ADC as a monotherapy and also in combinations with established standard of care treatments for cancer, we believe that PDS01ADC has significant potential as a cytokine therapy independent of Versamune®. Based on the
informative preclinical studies, a number of ITT Phase 2 trials are currently in progress at the NCI, some of which are outlined below:
●
Phase 2 trial evaluating ICI naïve and resistant patients with HPV-positive malignancies treated with PDS01ADC, Versamune® HPV and bintrafusp alfa
●
A Phase 2 trial evaluating T-cell clonality after stereotactic body radiation therapy alone and in combination with the immunocytokine PDS01ADC in localized high and intermediate risk prostate cancer treated with androgen deprivation
therapy
●
A Phase 1/2 trial of PDS01ADC in combination with docetaxel in adults with metastatic castration sensitive and castration resistant prostate cancer
●
Phase 1/2 of PDS01ADC going forward as a monotherapy in advanced kaposi sarcoma
●
Phase 1/2 of PDS01ADC in combination of with a histone deacetylase (HDAC) inhibitor in ICI-resistant MUC1-positive colon and bladder cancers among others
In October 2023, interim safety and immune response data was presented for the first-in-human Phase1/2 clinical trial evaluating PDS01ADC in combination with current SOC chemotherapy,
docetaxel, to treat metastatic castration sensitive and castration resistant prostate cancer. The data was featured in an oral presentation at the 11 th Annual
Meeting of the International Cytokine & Interferon Society. The data presented included the following:
●
Decrease in PSA levels was seen in all patients at all three tested doses of PDS01ADC and 61% of patients had at least a 60% decrease in PSA levels.
●
All doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia.
●
Administration of the combination was associated with decreases in T reg cells and increases in activated natural killer (NK) cells, memory CD8 T cells, proliferating CD4 and CD8 T cells and cytokines INF-γ and Interleukin 10
(IL-10).
●
The changes in immune responses with the combination were independent of the PDS01ADC dose.
We are working closely with the NCI to determine the best pathway forward for the prioritized PDS01ADC studies, as well as evaluating the use of PDS01ADC in combination with other Versamune®
based clinical candidates. In January 2025, we submitted an investigational new drug application to the FDA for a Phase 1 trial with PDS0103 and PDS01ADC in colorectal cancer.
Infectimune® Development Strategy
We believe that the key differentiating attributes of the Infectimune® platform technology are strong induction of CD8 and CD4 T cells as well as antibodies which can be leveraged to improve
treatment and preventive options in several infectious disease indications. In January 2022, we presented preclinical data on our universal flu program sponsored by the National Institute of Allergy and Infectious Disease (NIAID) demonstrating
the potential of the Infectimune® technology with computationally designed influenza proteins developed by the laboratory of Dr. Ted Ross at the University of Georgia to generate broadly protective anti-influenza immune responses across multiple
strains of influenza. This data has provided a unique opportunity to highlight Infectimune®’s potentially transformative utility in the development of more broadly effective and longer lasting protective vaccines. Current preventive and
prophylactic vaccine approaches and technologies predominantly focus on creating strong induction of antibody responses. However, the induction of T cell responses, in addition to antibody responses, provides more durable and broad protection
against infectious diseases.
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Based on the preclinical data with the universal seasonal flu vaccine and the current focus of the NIAID in developing more effective flu vaccines, we have decided to focus our near-term
infectious disease activities to align with the interests of the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) program. This may involve development of a universal seasonal flu vaccine and the potential development of a
universal pandemic influenza vaccine based on similar computationally designed antigens as have shown promise with Infectimune®.
The preclinical results for Infectimune® based vaccines were published in two separate articles in the peer reviewed journal Viruses in
February 2023: 1. preclinical studies demonstrating complete protection against sickness after lethal challenge with live SARS-CoV-2 or influenza viruses (Gandhapudi SK et al. Viruses 2023, 15 , 432) and 2. Dramatically enhanced CD4 T cell responses to recombinant influenza proteins compared to leading commercial vaccine adjuvants (Henson TR et al. Viruses
2023, 15 , 538).
In September 2023, preclinical data on our investigational universal flu vaccine, PDS0202, was presented at the 9 th
European Scientific Working Group on Influenza (ESWI) conference. This data demonstrated active neutralization across multiple influenza viruses in animals and provided protection against infection and weight loss after challenging with high
doses of H1N1 viruses when they were not previously exposed to flu.
Our current clinical pipeline of Versamune® and PDS01ADC based therapies is as follows:
We have never been profitable and have incurred net losses in each year since inception. Our net losses were $37.6 million, and $42.9 million for the years ended December 31, 2024
and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $182.1 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and
administrative costs associated with these operations.
As of December 31, 2024, we had $41.7 million in cash and cash equivalents.
Our future funding requirements will depend on many factors, including the following:
●
the timing and costs of our planned clinical trials;
●
the timing and costs of our planned preclinical studies of our Versamune® platform;
●
the outcome, timing and costs of seeking regulatory approvals;
●
the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;
●
the amount and timing of any payments we may be required to make in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other
intellectual property rights; and
●
the extent to which we license or acquire other products and technologies.
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Selected Financial Operations Overview
Revenue
We have not generated any revenues from commercial product sales and do not expect to generate any such revenue in the near future. We may, but there are no assurances that we
will generate revenue in the future from a combination of research and development payments, product royalties, license fees and other upfront payments or milestone payments.
Research and Development Expenses
Research and development expenses include employee-related expenses, costs to acquire license rights to use certain technology in our research and development projects, costs of
acquiring, developing and manufacturing clinical trial materials, as well as fees paid to consultants and various entities that perform certain research and testing on our behalf. Costs for certain development activities, such as clinical trials,
are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided by vendors on their actual costs incurred. Payments for these
activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued expenses. Costs incurred in connection with
research and development activities are expensed as incurred.
We expect that our research and development expenses will increase significantly over the next several years as we advance our Versamune® and PDS01ADC product candidates into
and through clinical trials, pursue regulatory approval of our Versamune® product candidates and prepare for a possible commercial launch, all of which will also require a significant investment in contract research services, manufacturing
process validation and inventory related costs.
The process of conducting human clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for our
clinical product candidates. The probability of successful commercialization of our product candidates may be affected by numerous factors, including clinical data obtained in future trials, competition, manufacturing capability and commercial
viability. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product
candidates.
The following table summarizes our research and development expenses incurred for the periods indicated (in thousands):
Year Ended December 31,
2024
2023
PDS Biotech projects
$
14,148
$
17,610
Clinical consulting
144
176
Salaries and other costs
8,273
9,977
Total
$
22,566
$
27,763
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, related to our executive, finance, legal, business
development and support functions. Other general and administrative expenses include travel expenses, professional fees for auditing, tax and legal services and facility-related costs.
Interest Income (Expense), net
Interest income (expense), net consists of interest income earned from bank deposits and interest expense consists of interest paid on outstanding debt plus amortization of the
debt discount and interest from capital leases. These amounts will fluctuate based on changes to the interest rate environment.
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Critical Accounting Policies
Our accounting policies are more fully described in Note 2 to the consolidated financial statements included in this Annual Report on Form 10-K. As described in Note 2, the
preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements,
as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various market specific and other relevant assumptions that we believe are reasonable
under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Estimates are assessed each period and updated to reflect
current information. Actual results may differ from these estimates. We believe that the following discussion addresses our most critical accounting policies, which are those that are most important to the portrayal of our financial condition
and results of operations and require management’s most difficult, subjective and complex judgments.
Income Taxes
We file U.S. federal income tax returns and New Jersey state tax returns. Our deferred tax assets are primarily comprised of federal and state tax net operating losses and tax
credit carryforwards and are recorded using enacted tax rates expected to be in effect in the years in which these temporary differences are expected to be utilized. At December 31, 2024, we had federal net operating loss, or NOLs,
carryforwards of approximately $157.7 million, $29.9 million of which expire at various dates between 2028 and 2037, losses generated in 2018 or later of $127.8 million will carry forward indefinitely. At December 31, 2024, we had federal
research and development credit carryforwards of approximately $6.1 million. We may be subject to the net operating loss utilization provisions of Section 382 of the Internal Revenue Code. The effect of an ownership change would be the
imposition of an annual limitation on the use of NOL carryforwards attributable to periods before the change. The amount of the annual limitation depends upon our value immediately before the ownership change, changes to our capital during a
specified period prior to the change, and the federal published interest rate. Although we have not completed an analysis under Section 382 of the Code, it is likely that the utilization of the NOLs will be limited.
Accrued Clinical Expenses
When preparing our financial statements, we are required to estimate our accrued clinical expenses. This process involves reviewing open contracts and communicating with our
personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost. If we
underestimate or overestimate the cost associated with a trial or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued clinical expenses have
approximated actual expense incurred.
Stock-based Compensation
We estimate the fair value of our stock-based compensation awards to employees, directors and non-employees using the Black-Scholes option-pricing model, which requires the
following assumptions: (1) the expected volatility assumption was changed on January 1, 2023 from using volatilities of a peer group of similar companies in the biotechnology industry whose share prices were publicly available to using the
volatility of the Company’s historical share price performance over the contractual term of the options, (2) the expected term of the award is based on the simplified method, which is the midpoint between the requisite service period and the
contractual term of the option, as we have a limited history of being a public company to develop reasonable expectations about future exercise patterns and employment duration for our options, (3) the risk-free interest rate based on U.S.
Treasury notes with a term approximating the expected life of the option and (4) expected dividend yield of 0, since we have never paid cash dividends and have no present intention to pay cash dividends.
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Index
Results of Operations
Comparison of the Years Ended December 31, 2024 and 2023
Year Ended December 31,
Increase (Decrease)
2024
2023
$
%
(in thousands)
Operating expenses:
Research and development expenses
$
22,565
$
27,763
$
(5,198
)
(19
)%
General and administrative expenses
13,756
15,282
(1,526
)
(10
)%
Total operating expenses
36,321
43,045
(6,724
)
(16
)%
Loss from operations
(36,321
)
(43,045
)
6,724
(16
)%
Interest income (expense), net
(2,158
)
(1,303
)
(855
)
66
%
Benefit from income taxes
869
1,406
(537
)
(38
)%
Net loss and comprehensive loss
$
(37,610
)
$
(42,942
)
$
5,332
(12
)%
Research and Development Expenses
For the year ended December 31, 2024, research and development expenses decreased to approximately $22.6 million compared to approximately $27.8 million for the year ended
December 31, 2023. The decrease of $5.2 million was primarily attributable to decreases in clinical costs of $4.1 million, personnel costs of $1.0 million and professional fees of $0.1 million.
General and Administrative Expenses
For the year ended December 31, 2024, general and administrative expenses decreased to approximately $13.8 million compared to approximately $15.3 million for the year ended
December 31, 2023. The $1.5 million decrease was primarily attributable to decreases in professional fees of $1.3 million, and facilities costs of $0.2 million.
Interest Income (Expense), net
For the year ended December 31, 2024, interest expense was $4.7 million compared to $4.2 million for the year ended December 31, 2023. The $0.5 million increase in interest
expense was due to the Loan and Security Agreement.
For the year ended December 31, 2024, interest income was $2.5 million compared to $2.9 million for the year ended December 31, 2023. The decrease of $0.4 million in interest
income was due to lower cash balances.
Benefit from Income Taxes
Income tax benefit was $0.9 million for the year ended December 31, 2024 as compared to $1.4 million for the prior year ended December 31, 2023. The decrease of $0.5 million was
due to decreased proceeds from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL)
program.
Liquidity and Capital Resources
In August 2022, we filed a shelf registration statement, or the 2022 Shelf Registration Statement, with the SEC for the issuance of common stock, preferred stock, warrants,
rights, debt securities, and units, which the Company refers to collectively as the Shelf Securities, up to an aggregate amount of $150 million, $50 million of which covers the offer, issuance and sale by the Company of its common stock under
the Sales Agreement (as discussed below). The 2022 Shelf Registration Statement was declared effective on September 2, 2022.
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Index
In August 2022, we entered into an At Market Issuance Sales Agreement, or the Sales Agreement, with B. Riley Securities, Inc. and BTIG, LLC, each an Agent and collectively the
Agents, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price of up to $50.0 million, or the Placement
Shares, through or to the Agents, as sales agents or principals. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agents may sell the Placement Shares by any method permitted by law deemed
to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Capital Market or on any other existing trading market for our common stock. The
Agents will use commercially reasonable efforts to sell the Placement Shares from time to time, based upon our instructions (including any price, time or size limits or other customary parameters or conditions we may impose). We will pay the
Agents a commission equal to three percent (3%) of the gross sales proceeds of any Placement Shares sold through the Agents under the Sales Agreement, and we have also provided the Agents with customary indemnification and contribution rights.
We are not obligated to make any sales of our common stock under the Sales Agreement. The offering of Placement Shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Placement Shares subject to the Sales
Agreement or (ii) termination of the Sales Agreement in accordance with its terms. In August 2024, the Company entered into an Amended and Restated At Market Issuance Sales Agreement, or the New Sales Agreement, with B. Riley Securities, Inc.
and H.C. Wainwright & Co., LLC, with terms that are substantially consistent with those included in the original Sales Agreement. The New Sales Agreement superseded and replaced the Sales Agreement. During the year ended December 31, 2024,
we sold 3,428,681 shares of common stock for a net value of $19.5 million pursuant to the Sales Agreement and 1,108,105 shares of common stock for a net value of $3.2 million pursuant to the New Sales Agreement. For the year ended December 31,
2023, we sold 2,642,269 shares of our common stock for a net value of $16.1 million pursuant to the Sales Agreement. As of the date of this Annual Report, in the first quarter 2025, we sold 205,350 shares of our common stock for a net value of
$0.30 million pursuant to the New Sales Agreement.
In August 2022, we entered into a venture loan and security agreement, or the Loan and Security Agreement, with Horizon Technology Finance Corporation, as lender and collateral
agent for itself and the other lenders. The Loan and Security Agreement provides for the following 6 separate and independent term loans: (a) a term loan in the amount of $7,500,000, or Loan A, (b) a term loan in the amount of $10,000,000, or
Loan B, (c) a term loan in the amount of $3,750,000, or Loan C, (d) a term loan in the amount of $3,750,000, or Loan D, (e) a term loan in the amount of $5,000,000, or Loan E, and (f) a term loan in the amount of $5,000,000, or Loan F, (with
each of Loan A, Loan B, Loan C, Loan D, Loan E, and Loan F, individually a Loan and, collectively, the Loans). Loan A, Loan B, Loan C, and Loan D were delivered to us on August 24, 2022. In total, we received $24.6 million in net proceeds.
Loan E and Loan F were uncommitted Loans that could have been advanced by the lenders upon the parties agreement prior to July 31, 2023 upon the satisfaction of certain conditions. At this time the option to advance Loan E and Loan F has
expired and Loan E and Loan F are no longer available to the Company under the Loan and Security Agreement. We may only use the proceeds of the Loans for working capital or general corporate purposes. Each Loan matures on the 48-month
anniversary following the applicable funding date unless accelerated pursuant to agreed upon events of default. Payments on the principal balance began on October 1, 2024 and are paid monthly in the succeeding 24 months. The principal balance
of each Loan bears a floating interest. The interest rate is calculated initially and, thereafter, each calendar month as the sum of (a) the per annum rate of interest from time to time published in The Wall Street Journal as contemplated by
the Loan and Security Agreement, or any successor publication thereto, as the “prime rate” then in effect, plus (b) 5.75%; provided that, in the event such rate of interest is less than 4.00%, such rate shall be deemed to be 4.00% for purposes
of calculating the interest rate.
Interest is payable on a monthly basis based on each Loan principal amount outstanding the preceding month. We, at our option upon at least ten (10) business days’ written
notice to the lenders, may prepay all (and not less than all) of the outstanding Loan by simultaneously paying to each lender an amount equal to (i) any accrued and unpaid interest on the outstanding principal balance of the Loans; plus (ii) an
amount equal to (A) if such Loan is prepaid on or before the Loan Amortization Date (as defined in the Loan and Security Agreement) applicable to such Loan, 3% of the then outstanding principal balance of such Loan, (B) if such Loan is prepaid
after the Loan Amortization Date applicable to such Loan, but on or before the date that is 12 months after such Loan Amortization Date, 2% of the then outstanding principal balance of such Loan, or (C) if such Loan is prepaid more than 12
months after the Loan Amortization Date but prior to the stated maturity date applicable to such Loan, 1% of the then outstanding principal balance of such Loan; plus (iii) the outstanding principal
balance of such Loan; plus (iv) all other sums, if any, that shall have become due and payable thereunder. No prepayment premium will be applied to any outstanding balance of any Loan paid on the
stated maturity date.
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Index
In connection with the Loan and Security Agreement, we issued Horizon Technology Finance Corporation and Powerscourt Investments XXV, LP warrants to purchase an aggregate total
of 381,625 shares of the Company’s common stock at an initial exercise price of $3.6685 per share. Each warrant is classified as equity and is exercisable at any time for a period beginning on the date of grant and ending on the earlier of (A)
10 years from the date of grant, and (B) the closing of (A) (i) the sale, lease, exchange, conveyance or other disposition of all or substantially all of the our property or business, or (ii) its merger into or consolidation with any other
corporation (other than a wholly-owned subsidiary of the Company), or any transaction (including a merger or other reorganization) or series of related transactions, in which more than 50% of the voting power of the Company is disposed of, in
each case, for cash or for marketable securities meeting certain requirements as described in the applicable warrants. The key assumptions used in Black-Scholes option pricing model were (i) expected term of 10 years, (ii) a risk-free rate of
3.11%, (iii) expected volatility of 93.8%, (iv) and no estimated dividend yield.
In April 2023, we received approximately $1.4 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant our participation in the New
Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2021.
In April 2024, we received approximately $0.9 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant our participation in the New
Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2022.
As of December 31, 2024, we had $41.7 million of cash and cash equivalents. Our primary uses of cash are to fund operating expenses, primarily research and development
expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
In February 2025, we entered into a Securities Purchase Agreement with certain purchasers, pursuant to which we agreed to sell an aggregate of 6,396,787 shares of common stock,
pre-funded warrants to purchase up to an aggregate of 933,334 shares of common stock, and common stock warrants to purchase up to an aggregate of 7,330,121 shares of common stock at a combined purchase price of $1.50 per share and warrant, the
February 2025 Offering. Two of our directors participated in the February 2025 Offering and purchased 30,121 shares of common stock in the aggregate at an offering price per share of $1.66 and common stock warrants to purchase 30,121 shares of
common stock. The common stock warrants issued to our directors have an exercise price per share of $1.53, but are otherwise identical to the common stock warrants issued to all other participants in the February 2025 Offering. Aggregate
gross proceeds from the February 2025 Offering were approximately $11 million. Net proceeds to us from the February 2025 Offering, after deducting the placement agent fees and other estimated offering expenses payable by the Company, were
approximately $10.05 million. The February 2025 Offering closed on February 28, 2025.
We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one
year beyond the filing of this Annual Report on Form 10-K. Our budgeted cash requirements in 2025 and beyond include expenses related to continuing development and clinical studies as well as payments on our debt.
We plan to continue to fund our operations and capital funding needs through existing cash and additional equity and/or debt financing. However, we cannot be certain that
additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or our existing stockholders. We may also enter into government funding programs and consider selectively partnering for
clinical development and commercialization. The sale of additional equity would result in additional dilution to our stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt could
provide for operating and financing covenants that would restrict our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product
development or future commercialization efforts or grant rights to develop and market immunotherapies that we would otherwise prefer to develop and market ourselves. In addition, the Loan and Security Agreement allows for the lenders to call the
outstanding balance of the term loans if the minimum cash balances outlined in the Loans and Security Agreement are not maintained. Any of these actions could harm our business, results of operations and prospects.
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Index
Cash flows
The following table shows a summary of our cash flows for each of the years indicated (in thousands):
Year Ended December 31,
2024
2023
Net cash used in operating activities
$
(35,030
)
$
(33,636
)
Net cash used in investing activities
(29
)
-
Net cash provided by financing activities
20,188
16,376
Net decrease in cash and cash equivalents
$
(14,871
)
$
(17,260
)
Net Cash Used in Operating Activities
Net cash used in operating activities was $35.0 million and $33.6 million for the years ended December 31, 2024 and 2023, respectively. The increase in net cash used in
operating activities of $1.4 million was primarily due to changes in the timing of working capital requirements, including changes in accrued expenses and accounts payable, offset by a decrease in net loss of $5.3 million, a decrease in
non-cash stock-based compensation expense of $0.8 million, and a decrease in the value of shares issued from our consulting agreement of $0.8 million.
Net Cash Used in Investing Activities
Net cash used in investing activities for the year ended December 31, 2024 was due to the purchase of equipment for our Princeton lab.
Net Cash Provided by Financing Activities
Net cash provided by financing activities for the year ended December 31, 2024 was primarily due to the receipt of net proceeds from the issuance of common stock of $22.6 million
and the exercise of stock options of $0.8 million, offset by the principal repayment of $3.1 million on the Loan and Security Agreement.
Net cash provided by financing activities for the year ended December 31, 2023 was primarily due to the receipt of net proceeds from the issuance of common stock of $16.1 million
and the exercise of stock options of $0.3 million.
Operating Capital Requirements
To date, we have not generated any product revenue. We are unable to predict when, or if, we will generate any product revenue and we do not expect to generate significant
product revenue unless and until we obtain regulatory approval and commercialize one of our current or future product candidates. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to
increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any approved products. We are subject to all of the risks incident to the development of new products, and may
encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We expect to incur additional costs associated with operating as a public company and anticipate that we will need
substantial additional funding in connection with our continuing operations.
We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern
within one year after the filing of this Annual Report. Our budgeted cash requirements in 2025 and beyond include expenses related to continuing development and clinical studies as well as payments on our debt . Until we can generate significant cash from our operations, we expect to continue to fund our operations with available financial resources. These financial resources may not be adequate to sustain our operations. While we intend to
finance our cash needs principally through collaborations, strategic alliances, or license agreements with third parties and/or debt or equity financings, there is no assurance that new financing will be available to us on commercially
acceptable terms or in the amounts required, if at all. In addition, the Loan and Security Agreement allows for the lenders to call the outstanding balance of the term loans if the minimum cash balances outlined in the Loans and Security
Agreement are not maintained. We have concluded that substantial doubt exists about our ability to continue as a going concern for a period of at least 12 months from the date of the issuance of these audited consolidated financial statements.
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Index
We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we
expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding
requirements will depend on many factors, including, but not limited to:
●
the initiation, progress, timing, costs and results of our planned clinical trials;
●
the effects of health epidemics, pandemics, or outbreaks of infectious diseases, on our business operations, financial condition, results of operations and cash flows ;
●
the outcome, timing and cost of meeting regulatory requirements established by the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, and other comparable foreign regulatory authorities;
●
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
●
the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us now or in the future;
●
the effect of competing technological and market developments;
●
the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize our vaccines on our own; and
●
the initiation, progress, timing and results of our commercialization of our vaccine candidates, if approved, for commercial sale.
Please see the section titled “Risk Factors” elsewhere in this Annual Report on Form 10-K for additional risks associated with our operations.
Purchase Commitments
We have no material non-cancelable purchase commitments with service providers as we have generally contracted on a cancelable, purchase order basis.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have any off-balance sheet arrangements, as defined under U.S. GAAP or under the rules and regulations of the
SEC.
Smaller Reporting Company
We are a “smaller reporting company,” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended. We will cease to be a smaller reporting company if we have
a non-affiliate public float in excess of $250 million and annual revenues in excess of $100 million, or a non-affiliate public float in excess of $700 million, determined on an annual basis. As a smaller reporting company, we are permitted and
intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not smaller reporting companies. These exemptions include:
●
being permitted to provide only two years of audited consolidated financial statements in this Annual Report on Form 10-K, with correspondingly reduced “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” disclosure;
●
reduced disclosure obligations regarding exe cutive compensation;
●
not being required to furnish a contractual obligations table in “Management’s Discussion and Analysis of Financial Condition and Results of Operations”; and
●
not being required to furnish a stock performance graph i n our annual report.
We expect to continue to take advantage of some or all of the available exemptions.
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Index
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.