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Item 7. Management’s Discussion and Analysis

2024-03-28 compared with 2023-03-28 · 451 added, 339 removed, 206 unchanged (79% of the section changed)

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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.

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 and infectious disease immunotherapies based on our proprietary Versamune®, Versamune plus PDS0301 and Infectimune™ T cell activating technology platforms.

Our Versamune based products have demonstrated the potential to overcome the limitations of current immunotherapies by inducing, in vivo, large quantities of high-quality, potent polyfunctional CD4 helper and CD8 killer T cells.

We have developed multiple therapies, based on combinations of Versamune and disease-specific antigens,

designed to train the immune system to recognize diseased cells and effectively attack and destroy them.

We continue to advance our pipeline of candidates to address a wide range of cancers including HPV-positive cancers (anal, cervical, head and

neck, penile, vaginal, vulvar) and breast, colon, lung prostate and ovarian cancers.

Our Infectimune -based vaccines have demonstrated the potential to induce, not only robust and durable neutralizing antibody response, but also powerful T cell

responses including long-lasting memory T cell responses.

Our infectious disease candidates are of potential interest primarily for use in universal influenza vaccines.

In June 2022, two abstracts were presented at the 2022 American Society of Clinical Oncology Annual Meeting:

Abstract number 6041, PDS0101 a novel type 1 interferon and CD8 T cell activating

immunotherapy in combination with pembrolizumab in subjects with recurrent/metastatic HPV16-positive squamous cell carcinoma (HNSCC) and Abstract number 2518, Phase 2 evaluation of the combination of PDS0101, M9241, now PDS0301, and bintrafusp alfa

with HPV16+malignancies.

Also in May 2022, we announced expansion of our VERSATILE-002 clinical trial into Europe and in June 2022, we announced the U.S.

Food and Drug Administration (the “FDA”) had granted Fast Track designation to our lead

candidate, PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).

The FDA’s Fast Track designation is designed to aid in the development and to expedite the review of drug candidate applications that would potentially

treat serious or life-threatening conditions.

In order to receive Fast Track designation, a product must also demonstrate the potential to address an unmet medical need.

Treatments granted this designation are given the opportunity to have more

frequent meetings with the FDA throughout the entire dug development and review process, with the goal of moving promising new drugs more rapidly through the process.

It also provides the opportunity to submit sections of a New Drug Application

(the “NDA”) on a rolling basis, where the FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission.

In addition, Fast Track designated products are eligible for priority review at the time of NDA or

Biologics License Application submission.

In October 2023, we announced the successful end-of-phase 2 meeting with the FDA including guidance on key elements of the clinical program that will support the

submission of a Biologics License Application (BLA).

We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease 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) and Infectimune® T cell-activating platforms and PDS01ADC tumor targeting immunocytokine.

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

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 July 2022, we announced the presentation of universal flu vaccine preclinical data for PDS0202 at the 41 st American

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Abstract number 3733830, Infectimune®™ enhances antibodies elicited by COBRA hemagglutinin influenza vaccine.

In November 2022, we announced the presentation of data from two Phase 2 clinical trials at the 37 th Annual Meeting

for the Society of Immunotherapy of Cancer (SITC):

Abstract number 674, IMMUNOCERV, an ongoing Phase 2 trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers

and abstract number 695, Immune correlates associated with clinical benefit in patients with checkpoint refractory HPV-associated malignancies treated with triple combination immunotherapy.

In January 2023, we announced the exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor targeting antibody conjugated IL-12, M9241, which joined our pipeline as

PDS0301 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 designed to overcome tumor immune

suppression utilizing a different mechanism from immune checkpoint inhibitors (ICI).

The ownership of these two assets we believe will streamline the registrational process and as use of the combination of Versamune®

and an IgG1 IL-12 is patented by PDS Biotech .

In a Phase 2 National Cancer Institute (NCI)-led clinical trial in ICI refractory patients, the combination of PDS0101 and

PDS0301 administered with an investigational bi-functional ICI resulted in a median overall survival of 21 months, which compares favorably to the historical median survival of 3-4 months seen with checkpoint inhibitors and best reported median

survival to date with systemic therapy of 8.2 months in ICI refractory head and neck cancer.

In February 2023, we announced a successful completion of a Type B meeting with the FDA for the triple combination of PDS0101 and PDS0301 with an FDA-approved immune checkpoint

inhibitor for the treatment of recurrent/metastatic, ICI refractory head and neck cancer that is positive for the human papilloma virus (HPV) type 16.

In recent interactions with the FDA, we confirmed the required contents of a clinical protocol

for the potential registrational trial.

VERSATILE-002:

PDS0101 + KEYTRUDA®

In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 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 and is actively recruiting patients.

The clinical trial will evaluate the efficacy and safety of this therapeutic combination as a first-line

treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection.

In this PDS Biotech-sponsored trial patients whose cancer has returned or spread following initial treatment will be treated with the combination of

PDS0101 and KEYTRUDA® to evaluate if the addition of PDS0101 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 a immune checkpoint inhibitor (ICI naïve) and cohort 2 which consists of patients who have failed immune checkpoint inhibitor therapy (ICI refractory).

In February 2022, we announced we had achieved the preliminary efficacy milestone of at least four or more objective responses of the first 17 patients in the ICI naïve arm that allowed that arm to

proceed to full enrollment.

We also announced detailed preliminary safety data which showed that the combination is well tolerated without evidence of enhanced or significant toxicity in the first 18 patients in the ICI naïve arm.

We have completed enrollment in Stage 1 of the ICI refractory arm and are waiting for sufficient follow up to conduct the futility analysis .

In June 2022, we announced additional preliminary efficacy and safety data from this trial at the ASCO Annual Meeting (Weiss J et al.

J Clin Oncol 40, 2022

abstr 6041) .

The abstract provided preliminary data on 19 patients (safety) with available imaging data for 17 of the 19 patients (efficacy).

Highlights from the abstract were as follows:

Response rates thus far (tumor shrinkage greater than 30%) seen in 7/17 (41.2%) patients in comparison to the published results of approximately 19% for approved ICIs, used as monotherapy for recurrent or metastatic head and neck cancer,

with 2 of the 7 having complete responses (CR)

Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30%

Clinical efficacy (ORR + SD) was seen in 13/17 (76.5%) patients

Progressive/ongoing disease was reported in 4/17 (23.5%) patients

Patients had received a median of 4/5 doses of PDS0101 (range 1-5) and 9/35 doses of KEYTRUDA® (range 1-18)

There were no treatment-related adverse events greater than or equal to Grade 3 (N=19)

No patients required dose interruption or reduction on the combination treatment

No patients discontinued the combination treatment

At 9 months of follow up (median not yet achieved):

Progression free survival (PFS) rate was 55.2%

Overall survival (OS) rate was 87.2%

no control or comparative studies have been conducted between ICIs and PDS0101

In May 2022, we announced the expansion of this trial into Europe and in June 2022, as described above, we received Fast Track designation for PDS0101 in combination with pembrolizumab.

In August 2022, we announced our independent Data Monitoring Committee (DMC) met and evaluated data from 43 patients and noted there were no Grade 3 or greater treatment-related adverse events

attributed to the combination.

The DMC recommended continuing the trial with no modifications.

In October 2022, we announced an end-of-phase 2 meeting with the FDA for PDS0101 in combination with KEYTRUDA®.

We are currently evaluating the guidance on the key elements of the clinical

program that will support the submission of a Biologics License Application for PDS0101.

In December 2022, we announced completion of the first stage of enrollment in the ICI refractory arm.

Cohort follow-up is in progress that will permit a futility analysis to

determine progression to stage 2 enrollment.

In November 2022, we announced the presentation of data from two Phase 2 clinical trials at the 37 th Annual

Meeting for the Society of Immunotherapy of Cancer (SITC):

Abstract number 674, IMMUNOCERV, an ongoing Phase 2 trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced

cervical cancers and abstract number 695, Immune correlates associated with clinical benefit in patients with checkpoint refractory HPV-associated malignancies treated with triple combination immunotherapy.

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 combination 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

PDS0101 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 a successful completion of a Type B meeting with the FDA for the triple combination of PDS0101 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 PDS0101 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 PDS0101 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.

In October 2023, updated interim data based on an August 2 nd cut off from our VERSATILE-002 Phase 2 clinical trial

evaluating the combination of PDS0101 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 PDS0101, 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 PDS0101, 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.

Clinical Candidate Pipeline

National Cancer Institute:

PDS0101+ M9241 (now PDS0301) +Bintrafusp Alfa

In June 2020, the first patient was dosed under a PDS0101 Cooperative Research and Development Agreement (CRADA), in the NCI led Phase 2 investigator initiated trial evaluating PDS0101 with an IgG1

IL-12 (M9241), now PDS0301, and M7824 (Bintrafusp alfa), which is owned by EMD Serono (Merck KGaA) in patients with advanced/refractory HPV-positive cancers who have failed prior treatment.

In February 2021, we announced that the NCI’s Phase 2

clinical trial of PDS0101 for the treatment of advanced/refractory 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-refractory patients for assessment of safety and activity of the triple combination.

Preliminary efficacy assessment of the triple combination in this added group of 20 ICI refractory patients is ongoing.

PDS0101+ M9241 (now PDS01ADC) +Bintrafusp Alfa

In June 2020, the first patient was dosed under a PDS0101 Cooperative Research and Development Agreement (CRADA), in the NCI led Phase 2 investigator-initiated trial evaluating PDS0101 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 PDS0101 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 IC -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.

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) , indicating that PDS0101 generated both HPV-specific T cells and an associated antitumor response when used as a monotherapy.

When PDS0101 was combined with two other novel clinical-stage anti-cancer agents, Bintrafusp Alfa and M9241, now

PDS0301, 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.

If the published preclinical data demonstrating powerful activity of the triple combination is successfully confirmed in the

ongoing Phase 2 trial, this triple combination could form the basis of a unique platform providing improved cancer treatments across multiple cancers.

In June 2021, at the American Society of Clinical Oncology (ASCO) conference the NCI announced interim data in this trial which included, data in both ICI naïve and refractory patients.

naïve group 83% (5/6) of patients had an objective response, and 1 subject had achieved a complete response with no evidence of disease.

100% of the ICI naïve patients were alive at a median duration of 8 months.

In the ICI refractory group 42%

(5/12) of patients had an objective response, and 1 subject had achieved a complete response with no evidence of disease.

10/12 (83%) of ICI refractory patients were alive at a median duration of 8 months.

An update provided in January 2022 showed

as of December 31, 2021, that >40 subjects had been recruited into the trial and 30 HPV16-positive patients had been evaluated.

The median survival of all patients (3:1 ICI refractor to naïve) was 12 months and progressing.

The historical

survival of ICI naïve and ICI refractory advanced HPV-positive cancers when treated with ICI are 7-11 months and 3-4 months, respectively, and best reported median survival to date with systemic therapy of 8.2

months in ICI refractory head and neck cancer .

Doi:10.1136/ jitc-2020-000612) , and indicate that PDS0101 generated both HPV-specific T cells and an associated antitumor response when used as a monotherapy.

When PDS0101 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.

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abstr 2518]).

This included data from 30 patients and highlights were as follows:

This included data from 30 HPV16-positive patients and highlights were as follows:

Objective response (OR = > 30% tumor reduction) was seen in 88% (7/8) of patients with ICI naive disease;

4/7 (57%) patients’ responses are ongoing (median 17 months).

With ICI refractory patients:

PDS0301 dosing appears to affect response rates, with 5/8 (63%) patients receiving PDS0301 at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients who received PDS0301 at 8 mcg/kg achieving an OR;

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).

Tumor reduction was seen in 45% (10/22) of patients with ICI-refractory disease, including patients receiving high or low dose PDS0301.

In ICI refractory patients treated with high or low dose PDS0301, survival outcomes were similar (p=0.96 by Kaplan Meier analysis).

Tumor reduction was seen in 45% (10/22) of patients with ICI resistant disease, including patients receiving high or low dose PDS01ADC.

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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There were no grade 5 treatment-related AEs.

The study 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 announced, in agreement with the NCI, that the ICI refractory patients had been selected as the preferred treatment group in the on-going PDS0101 based triple combination

therapy in advanced HPV-positive cancers and the trial was closed to further enrollment given the ICI refractory arm has been fully recruited.

In October 2022, we announced expanded interim data as follows:

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 PDS0101-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:

Survival data:

66% (19/29) of HPV16-positive ICI refractory patients in the cohort were alive at a median follow up of 16 months

66% (19/29) of HPV16-positive ICI resistant patients in the cohort were alive at a median follow up of 16 months.

Safety profile:

3 unchanged sentences

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 announced expanded interim data as follows:

Median OS is 21 months in 29 checkpoint inhibitor refractory patients who received the triple combination.

The reported historical median OS in patients with ICI refractory 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 refractory head and neck cancer .

In December 2022, we presented interim data as follows:

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.

In ICI naïve subjects, 75% remain alive at a median follow-up of 27 months.

As a result, median OS has not yet been reached.

Historically median OS for similar patients with platinum experienced ICI naïve disease is 7-11 months.

Objective response rate (ORR) in ICI refractory patients who received the optimal dose of the triple combination is 63% (5/8).

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.

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%.

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-associated cancers.

Safety data have 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

In February 2023, we announced the successful completion of a Type B meeting with the FDA for the combination therapy of PDS0101, PDS0301, and an FDA-approved immune

checkpoint inhibitor for the treatment of recurrent/metastatic HPV-positive ICI-refractory head and neck cancer.

We confirmed the required contents of the study design for a potential registration of the combination.

In current approaches ORR is reported to be less than 25% with FDA-approved ICIs in HPV-positive cancers.

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..

In February 2023, we announced the successful completion of a Type B meeting with the FDA for the combination therapy of PDS0101, 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:

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

12-month survival rate in (ICI) resistant patients of 72%

Median OS in ICI resistant HPV-positive patients is approximately 20 months;

published median OS is 3.4 months

VERSATILE-002:

PDS0101 + Keytruda®

In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 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 PDS Biotech, patients whose cancer has returned following initial treatment or spread will be treated with the combination of PDS0101 and Keytruda® to evaluate if the addition of PDS0101 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 February 2022, we achieved the preliminary efficacy milestone of at least four or more objective responses of the first 17 patients in the ICI naïve arm that allowed that arm to proceed to

full enrollment.

We have completed enrollment in Stage 1 of the ICI resistant arm and we are waiting for sufficient follow up to conduct the futility analysis .

In June 2022, we presented additional preliminary efficacy and safety data from this trial at the ASCO Annual Meeting (Weiss J et al.

J Clin Oncol 40, 2022

abstr 6041)) .

The abstract provided preliminary data on 19 patients (safety) with available imaging data for 17 of the 19 patients (efficacy).

Data on 17 patients was presented.

Highlights from the abstract were as follows:

Confirmed and unconfirmed response rates thus far (tumor shrinkage greater than 30%) seen in 7/17 (41.2%) patients in comparison to the published results of approximately 19% for approved ICIs, used as monotherapy for recurrent or

metastatic head and neck cancer, with 2 of the 7 having complete responses (CR)

Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30%

Clinical efficacy (ORR + SD) was seen in 13/17 (76.5%) patients

Progressive/ongoing disease was reported in 4/17 (23.5%) patients

Patients had received a median of 4/5 doses of PDS0101 (range 1-5) and 9/35 doses of Keytruda® (range 1-18)

There were no treatment-related adverse events greater than or equal to Grade 3 (N=19)

No patients required dose interruption or reduction on the combination treatment

No patients discontinued the combination treatment

At 9 months of follow up (median not yet achieved):

Progression free survival (PFS) rate was 55.2%

Overall survival (OS) rate was 87.2%

no control or comparative studies have been conducted between ICIs and PDS0101

In May 2022, we expanded this trial into Europe and in June 2022, as described above, we received Fast Track designation from the U.S.

FDA for PDS0101 in combination with Keytruda®.

In August 2022, our independent Data Monitoring Committee (DMC) met and evaluated data from 43 patients and noted there were no Grade 3 or greater treatment-related adverse events attributed to

the combination.

The DMC recommended continuing the trial with no modifications.

In October 2022, we announced the results of an end-of-phase 2 meeting with the FDA for PDS0101 in combination with Keytruda®.

We have completed the plan for a potential Phase 3 clinical

program that will support the submission of a BLA for PDS0101 and have submitted our plan to the FDA.

In 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 PDS0101 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:

Estimated 12-month overall survival rate was 87.1%.

Published results are 36-50% with approved ICIs used alone.

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.

A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)

Confirmed and unconfirmed objective response rate is 41.2% (14/34 patients), which is identical to the preliminary response rate data PDS Biotech previously reported 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.

15/34 patients (44.1%) had stable disease.

9/34 patients (26.5%) had progressive disease.

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 PDS0101 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:

Highlights from the ICI naïve cohort include:

24-month overall survival (OS) rate is 74%;

published 24-month survival rate of less than 30% for approved ICI.

12-month OS rate is 80%;

published results of 30-50% with approved ICIs.

Tumor shrinkage seen in 60% (31/52) of patients.

Confirmed overall response rate ORR is 27% (14/52) to date.

Median progression-free survival (PFS) is 8.1 months to date;

published results of 2-3 months PFS with approved ICIs.

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.

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:

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).

0% (0/21) confirmed ORR suggests that PDS0101’s impact on survival does not appear to be dependent on tumor shrinkage.

4% (1/25) of patients experienced Grade 3 TRAE and 0% (0/21) patients experienced Grade 4 and 5 TRAE.

MD Anderson Cancer Center (IMMUNOCERV):

PDS0101+ Chemoradiotherapy

In October 2020, another PDS0101 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 PDS0101 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 Versamune has

strong T cell induction has the potential to meaningfully enhance efficacy of the current standard of care CRT treatment in this indication.

Enrollment in this trial is on-going.

In November 2022, we announced data from this trial was included in a poster presentation at the 2022 SITC Annual Meeting which included the following:

In October 2020, a PDS0101 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 PDS0101 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:

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).

This included 78% (7/9) of treated patients

with advanced cervical cancer (FIGO stage III or IV).

100% (9/9) of patients treated with the combination of PDS0101 and CRT had an objective response.

89% (8/9) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT.

One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease.

patient who had a CR died from an event unrelated to either their underlying disease or treatment.

One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs

of residual disease.

One patient who had a CR died from an event unrelated to either their underlying disease or treatment.

1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of PDS0101 and CRT.

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generated by the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8 T cells are important mediators of antigen-specific immunity.

The data affirm that PDS0101 activates Type 1 interferon pathway in humans, mimicking the mechanism previously demonstrated in preclinical studies in animal models

The data affirms that PDS0101 activates Type 1 interferon pathway in humans, mimicking the mechanism previously demonstrated in preclinical studies in animal models.

Toxicity of PDS0101 remains limited to low-grade local injection site reactions.

In October 2023, data demonstrating PDS0101 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

Earlier and greater proportion of ctDNA clearance with PDS0101 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).

Baseline ctDNA levels correlated with the International Federation of Gynecology and Obstetrics (FIGO) stage and lymph node involvement;

100% of patients treated with PDS0101 had cancer that had spread to the lymph nodes.

PDS0101 Monotherapy and in combination with Keytruda®

In February 2022 we announced the initiation of another ITT, MC200710, for PDS0101 alone or in combination with the check point inhibitor, KEYTRUDA®, in patients with HPV-positive oropharyngeal

cancer(HPV(+)OPSCC) at high risk of recurrence.

In February 2022, we initiated an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 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 PDS0101 alone

or in combination with KEYTRUDA® in earlier stages of disease.

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 PDS0101 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.

PDS0101 has been shown to induce CD8 killer T cells that target and kill HPV-positive cancers, either alone or in combination with checkpoint inhibitors in preclinical studies, and in combination in clinical studies of patients with advanced

Treatment in this setting is referred to as

neoadjuvant treatment.

PDS0101 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 PDS0101 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).

Other Versamune ® -Based Products in Development :

This trial will explore whether PDS0101 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 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-positive cancers including, acute myeloid leukemia (AML), prostate and breast cancer.

In our preclinical work, the administration of PDS0102, the Versamuine+TARP antigen combination led to the induction of large numbers of

polyfunctional 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 been shown to be safe, immunogenic with slowing tumor growth rates (NCT00972309).

evaluating the next steps in the clinical development of PDS0102 and are seeking nondilutive funding to progress to human trials.

In April 2020, the above mentioned, PDS Biotech-NCI CRADA was expanded beyond PDS0101 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.

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).

In April 2020, the above mentioned CRADA between PDS Biotech and the NCI was expanded beyond PDS0101 to include clinical and preclinical development of PDS0103.

PDS0103 is an investigational

immune therapy owned by PDS Biotech 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 PDS.

PDS0103 is currently in late preclinical development.

PDS0103 combines Versamune® with novel highly

immunogenic agonist epitopes of MUC1 developed by the NCI and licensed by PDS Biotech.

PDS0103 is currently in the tech transfer, clinical scale up and manufacturing stage.

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

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CD8 killer T cells.

In the first quarter of 2022, we held a pre-IND meeting with the FDA on PDS0103 and prepared to submit our IND package in the first half of 2023.

However, the actual submission date may potentially be impacted by the outcome of

our meetings with the FDA on the timing of a pivotal trial for PDS0101.

Our primary goal is commercialization of PDS0101, and allocation of resources to implement an earlier than planned start of a registrational trial may delay PDS0103 initiation.

In the first quarter of 2022, we held a pre-IND meeting with the FDA on PDS0103 and we are prepared to submit our IND package by the end of 2024.

However, the actual submission date may

potentially be impacted by the allocation of resources to initiate a pivotal trial for PDS0101 in combination with PDS01ADC.

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 PDS0101 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 II Study Evaluating ICI Naïve and Resistant Patients with HPV-positive malignancies treated with PDS01ADC, PDS0101 and bintrafusp alfa.

A Phase II Study 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 I/II Study of PDS01ADC in Combination with Docetaxel in Adults with Metastatic Castration Sensitive and Castration Resistant Prostate Cancer

Phase I/II of PDS01ADC going forward as a Monotherapy in Advanced Kaposi Sarcoma

Phase I/II 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

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.

Infectimune® Development Strategy

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treatment and preventive options in several infectious disease indications.

In January 2022 we announced 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.

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

Based on the promising data recently announced with the universal seasonal flu vaccine and the current focus of the NIAID in developing more effective flu vaccines, we have decided to

opportunistically focus our near-term infectious disease activities to align with the interests of the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) program.

This will 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.

In July 2022, we announced the presentation of universal flu vaccine preclinical data for PDS0202 at the 41 st American

Society of Virology meeting:

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.

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 will 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®.

In July 2022, universal flu vaccine preclinical data for PDS0202 at the 41 st American Society of Virology meeting:

Abstract number 3733830, Infectimune® enhances antibodies elicited by COBRA hemagglutinin influenza vaccine.

We are evaluating the next steps in the clinical development and funding for PDS0202.

The results for Infectimune based PDS0202 and PDS0203 were published in the peer reviewed journal Viruses in February 2023:

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 dramatically enhanced CD4 T cell responses to recombinant influenza proteins compared to leading commercial vaccine adjuvants (Henson TR et al.

Viruses 2023, 15 ,

Our current pipeline of Versamune and Infectimune based therapies is as follows:

We have never been profitable and have incurred net

losses in each year since inception.

Our net losses were $40.9 million, and $16.9 million for the years ended December 31, 2022 and 2021, respectively.

The preclinical results for Infectimune® based vaccines were published in two separate articles in the peer reviewed journal Viruses in

February 2023:

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.

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®, PDS01ADC and Infectimune® based therapies is as follows:

We have never been profitable and have incurred net losses in each year since inception.

Our net losses were $42.9 million, and $40.9 million for the years ended December 31,

2023 and 2022, respectively.

As of December 31, 2023, we had an accumulated deficit of $144.5 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.

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, 2023, we had $56.6 million in cash and cash equivalents.

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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, license fees and other

upfront payments or milestone payments.

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

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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 based immuno-oncology, or I-O,

candidates into and through clinical trials, pursues regulatory approval of our injectable Versamune candidates and prepare for a possible commercial launch, all of which will also require a significant investment in contract and internal

manufacturing and inventory related costs.

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

injectable I-O candidates.

The probability of successful commercialization of our I-O candidates may be affected by numerous factors, including clinical data obtained in future trials, competition, manufacturing capability and commercial

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.

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.

product candidates.

The following table summarizes our research and development expenses incurred for the periods indicated (in thousands):

Year Ended December 31,

PDS Biotech projects

Clinical consulting

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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.

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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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

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.

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.

federal income tax returns and New Jersey state tax returns.

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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, 2022, we had federal net operating losses, or NOLs,

At December 31, 2023, we had federal net operating loss, or NOLs,

carryforwards of approximately $136.2 million, $30.0 million of which expire at various dates between 2028 and 2037, losses generated in 2018 or later of $106.2 million will carry forward indefinitely.

At December 31, 2022, we had federal research

and development credits carryforwards of approximately $1.7 million.

At December 31, 2023, we had federal

research and development credit carryforwards of approximately $4.7 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.

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.

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Stock-based Compensation

We estimate the fair value of our stock-based option awards to employees, directors and non-employees using the Black-Scholes option-pricing model, which requires the following

(1) the expected volatility of our stock is based on volatilities of a peer group of similar companies in the biotechnology industry whose share prices are publicly available, (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.

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.

Results of Operations

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Research and Development Expenses

For the year ended December 31, 2022, research and development expenses increased to approximately $29.4 million compared to approximately $11.3 million for the year ended

For the year ended December 31, 2023, research and development expenses decreased to approximately $27.8 million compared to approximately $29.4 million for the year ended

December 31, 2022.

The increase of $18.2 million was primarily attributable to an increase in personnel costs of $2.3 million, clinical costs of $2.3 million, quality and manufacturing costs of $3.6 million and $10 million for the rights to

PDS0301 from Merck KGaA, Darmstadt Germany.

Of the $10 million, $5 million was in cash and the balance in shares of the Company’s common stock.

The decrease of $1.7 million was primarily attributable to a decrease in quality and manufacturing costs of $10.2 million, mainly driven by the $10.0 million purchase in 2022 of the rights to PDS01ADC from Merck KGaA,

Darmstadt Germany, offset by an increase in personnel costs of $2.1 million, clinical costs of $6.1 million, facilities costs of $0.2 million, and professional fees of $0.1 million.

General and Administrative Expenses

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Interest Income (Expense), net

For the year ended December 31, 2022, interest expense, net was $0.4 million compared to an immaterial amount of interest income for the year ended December 31, 2021.

in interest expense for the year ended December 31, 2022 was $1.3 million of interest expense primarily related to the note payable partially offset by $0.9 million of interest income from interest earned on bank balances during the year.

For the year ended December 31, 2023, interest expense was $4.2 million compared to $1.3 million for the year ended December 31, 2022.

The $2.9 million increase in interest

expense was due to the Horizon Financing Loan, which was entered into in August 2022.

For the year ended December 31, 2023, interest income was $2.9 million compared to $0.9 million for the year ended December 31, 2022.

The increase of $2.0 million in interest

income is due to the higher cash balance resulting from the Horizon Financing Loan.

Benefit from Income Taxes

Income tax benefit was $1.4 million for the year ended December 31, 2023 as compared to $1.2 million for the prior year ended December 31, 2022.

A decrease of $3.3 million was due

to a smaller portion of the accumulated Net Operating Losses ( NOL) through 2021 available for sale through our NJ tax benefits pursuant to the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss program.

The increase of $0.2 million was

due to increased 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)

Liquidity and Capital Resources

In May 2021, we received approximately $4.5 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 Net Operating Loss (NOL) program for State Fiscal Year 2020.

In June 2021, we sold 6,088,235 shares of common stock at a public offering price of $8.50 per share pursuant to the 2020 Shelf Registration Statement, which includes 794,117

shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price, minus underwriting discounts and commissions.

We received gross proceeds of approximately $51.7 million and net proceeds

of approximately $48.5 million, after deducting underwriting discounts and offering expenses.

In April 2022, we received approximately $1.2 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 State Fiscal Year 2020.

New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2020.

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 Sales Agreement (as discussed below).

The 2022 Shelf Registration Statement was declared effective on September 2, 2022.

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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 also has provided the Agents with customary indemnification and contribution rights.

not obligated to make any sales of our common stock under the Sales Agreement.

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.

For the year ended December 31, 2022, we sold 1,238,491 shares of our common stock for a net value of $9.9 million pursuant to the Sales Agreement.

quarter 2023, we sold 553,293 shares of our common stock for a net value of $4.6 million pursuant to the 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.

During 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.

year ended December 31, 2022, we sold 1,238,491 shares of our common stock for a net value of $9.9 million pursuant to the Sales Agreement.

As of the date of this Annual Report, in the first quarter 2024, we sold 3,428,681 shares of our common

stock for a net value of $19.5 million pursuant to the 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).

(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 F are uncommitted Loans that may be advanced by the lenders upon their discretion prior to July 31, 2023 upon the satisfaction of certain agreed upon conditions precedent.

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.

The principal balance of each Loan bears a floating interest.

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.

In total, we received $24.6 million in net

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 begin 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;

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;

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.

No prepayment premium will be applied to any outstanding balance of any Loan paid on the

stated maturity date.

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.

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.

As of December 31, 2023, we had $56.6 million of cash and cash equivalents.

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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.

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 2023 and beyond

include expenses related to continuing development and clinical studies.

Based on our available cash resources and cash flow projections as of the date the consolidated financial statements were available for issuance, we believe there are

sufficient funds to continue operations and research and development programs into the third quarter of 2024.

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 2024 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.

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development or future commercialization efforts or grant rights to develop and market immunotherapies that we would otherwise prefer to develop and market ourselves.

Any of these actions could harm our business, results of operations and

In addition, the Loan and Security Agreement also 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.

The following table shows a summary of our cash flows for each of the years indicated (in thousands):

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Net cash provided by financing activities

Net increase in cash

Net (decrease) increase in cash and cash equivalents

Net Cash Used in Operating Activities

Net cash used in operating activities was $33.6 million and $25.7 million for the years ended December 31, 2023 and 2022, respectively.

The increase in cash used in operating

activities of $13.2 million is primarily due to the increase in net loss of $23.9 million, reduced by the non-cash stock- based compensation expense of $1.1 and the value of the shares issued for the Merck licensing agreement of $5.0 million,

offset by an increase in prepaid expenses of $1.0 million, and increase in accrued expenses of $5.7 million.

The increase in cash

used in operating activities of $7.9 million is primarily due to the increase in net loss of $2.1 million, reduced by the increase in non-cash stock-based compensation expense of $2.4 million, the value of shares issued from our consulting

agreement of $1.0 million and the value of the shares issued for the Merck licensing agreement of $5.0 million, offset by changes in the timing of working capital requirements, including changes in prepaid expenses and other assets,

accrued expenses and accounts payable.

Net Cash Used in Investing Activities

Net cash used in investing activities for the year ended December 31, 2023 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, 2022 was primarily due to the receipt of net proceeds from the issuance of the note payable of $24.6 and

the issuance of common stock of $9.9 million.

Net cash provided by financing activities for the year ended December 31, 2021 was primarily due to the receipt of net proceeds from the issuance of common stock of $48.5 million.

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.

Net cash provided by financing activities for the year ended December 31, 2022 was primarily due to the receipt of net proceeds from the issuance of the note payable of $24.6

million and the issuance of common stock of $9.9 million.

Operating Capital Requirements

To date, we have not generated any product revenue.

We do not know 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 tablet vaccine candidates, and begin to commercialize any approved vaccine candidates.

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

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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 beyond the filing of this Annual Report.

Our budgeted cash requirements in 2023 and beyond include expenses

related to continuing development and clinical studies.

We believe that our existing cash and cash equivalents as of December

31, 2022 are sufficient to continue operations and research and development programs into the third quarter of 2024.

Until we can generate significant cash from our

operations, we expect to continue to fund our operations with available financial resources.

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

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 2024 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.

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 also 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

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:

funding requirements will depend on many factors, including, but not limited to:

the initiation, progress, timing, costs and results of our planned clinical trials;

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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 tablet vaccines on our own;

the initiation, progress, timing and results of our commercialization of our tablet vaccine candidates, if approved, for commercial sale.

the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize our vaccines on our own;

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.

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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 in the rules and regulations of the SEC.

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

Smaller Reporting Company

As of January 1, 2021, we are no longer an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.

However, we remain 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.

Even though we no longer qualify as an emerging growth company, we may still qualify as a smaller reporting company.

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.

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:

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We are exposed to market risk related changes in interest rates.

As of December 31, 2022, our cash equivalents consisted of bank deposits and money market accounts.

Our primary exposure to market risk is interest

income sensitivity, which is affected by changes in the general level of U.S.

As of December 31, 2023, our cash equivalents consisted of bank

deposits and money market accounts.

Additionally, the principal balance of our Loan and Security agreement with Horizon Technology Finance Corporation bears a floating interest pegged to the prime rate.

Our primary exposure to market risk is

interest income sensitivity, which is affected by changes in the general level of U.S.

interest rates.

However, historical fluctuations in interest income have not been significant for us.

Historically, the net impact of fluctuations in interest rates have not been material to us.

Inflation Risk

Inflation generally affects us by increasing our cost of labor and pricing of contracts.

We do not believe that inflation has had a material effect on our business, financial condition, or results of operations during

the year ended December 31, 2022.

Financial Statements and Supplementary Data

The financial statements required to be filed pursuant to this Item 8 are appended to this report.

An index of those financial statements is found in Item 15.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

As a majority of our outside contracts for services and goods extend over multiple years, we do not

believe that inflation has had a material effect on our business, financial condition, or results of operations during the year ended December 31, 2023.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis