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Item 2. Management’s Discussion and Analysis

2024-11-14 compared with 2024-08-13 · 334 added, 315 removed, 357 unchanged (65% of the section changed)

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Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section

27A of the United States Securities Act of 1933, as amended) concerning the Company and other matters.

These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition,

or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management.

Forward-looking statements generally include statements that are predictive in nature and depend

upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar

expressions among others.

This Quarterly Report contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and

Section 27A of the United States Securities Act of 1933, as amended) concerning the Company and other matters.

These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial

condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management.

Forward-looking statements generally include statements that are predictive in nature

and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other

similar expressions among others.

Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance.

Actual results could differ materially from those contained

in any forward-looking statement as a result of various factors, including, without limitation:

Actual results could differ materially from those

contained in any forward-looking statement as a result of various factors, including, without limitation:

the Company’s ability to protect its intellectual property rights;

the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings;

the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its clinical and product candidates, and the risks that raising such additional capital

may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or clinical and product candidates;

the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s

successful implementation of such business plan;

the timing for the Company or its partners to initiate the planned clinical trials for its Versamune® products, including PDS0101, PDS0103, and others, alone or in

combination with PDS01ADC, as well as Infectimune® based clinical candidates and the future success of such trials;

the successful implementation of the Company’s research and development programs and collaborations, including any collaboration trials concerning the Company’s Versamune®, PDS01ADC and Infectimune® based clinical

and product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s clinical and product candidates;

the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current clinical candidates, including statements regarding the timing of initiation, pace of

enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data

capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or clinical and product candidates;

the Company’s limited operating history in the current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful

implementation of such business plan;

the timing for the Company or its partners to initiate the planned clinical trials for its Versamune® products, including Versamune® HPV (formerly

PDS0101) , PDS0103, and others, alone or in combination with PDS01ADC, as well as Infectimune® based clinical candidates and the future success of such trials;

clinical and product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s clinical and product

of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data

reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials;

expectations for the clinical and preclinical development, manufacturing, regulatory approval, and commercialization of the Company’s clinical and product candidates;

any Company statements about its understanding of clinical and product candidates’ mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any

collaboration trials;

any collaboration trials;

the acceptance by the market of the Company’s clinical and product candidates, if approved;

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Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s clinical and product

other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising

from or related to those listed under Part II, Item 1A.

arising from or related to those listed under Part II, Item 1A.

Risk Factors.

Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events or to our future financial performance and involve known and unknown

risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements.

these uncertainties, you should not place undue reliance on these forward-looking statements.

Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events or to our future financial performance and involve known and

unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements.

Given these uncertainties, you should not place undue reliance on these forward-looking statements.

Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, whether as a result of new

information, future events or otherwise.

In this Quarterly Report, unless otherwise stated or the context otherwise indicates, references to “PDS Biotech,” “the Company,” “we,” “us,” “our” and similar references refer to

PDS Biotechnology Corporation, a Delaware corporation.

In this Quarterly Report, unless otherwise stated or the context otherwise indicates, references to “PDS Biotech,” “the Company,” “we,” “us,” “our” and similar references refer

to PDS Biotechnology Corporation, a Delaware corporation.

Company Overview

We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our Versamune® T cell activator and

Versamune® in combination with our interleukin 12 (IL-12) fused anti-body drug conjugate (ADC), PDS01ADC.

We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our Versamune® T cell activator

and Versamune® in combination with our interleukin 12 (IL-12) fused anti-body drug conjugate (ADC), PDS01ADC.

In addition, we are developing the Infectimune® T cell-activator in infectious diseases.

We believe our investigational targeted immunotherapies have the potential to overcome limitations of current immunotherapy approaches through effective conversion of the immune

suppressive tumor to an immunogenic microenvironment in addition to the induction of the right type, potency and quantity of tumor-targeting killer (CD8) T cells.

Our Versamune® immunotherapies and Versamune® in combination with PDS01ADC, are

utilized for treatments in oncology, and Infectimune® is utilized for preventive vaccines against infectious agents.

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 disease-specific CD4 helper and CD8 killer T cells, a specific sub-type of T cell that has shown potential to be more effective

at killing infected or target cells.

We believe our investigational targeted immunotherapies have the potential to overcome limitations of current immunotherapy approaches through effective conversion of the

immune suppressive tumor to an immunogenic microenvironment in addition to the induction of the right type, potency and quantity of tumor-targeting killer (CD8) T cells.

Our Versamune® immunotherapies and Versamune® in combination with PDS01ADC,

are being developed for treatments in oncology, and Infectimune® is being developed for preventive vaccines against infectious agents.

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 disease-specific CD4 helper and CD8 killer T cells, a specific sub-type of T cell that has shown potential to be

more effective at killing infected or target cells.

Infectimune® is also designed to promote the induction of disease-specific neutralizing antibodies.

PDS01ADC is an investigational tumor targeting IL-12 that we believe may enhance the proliferation, potency

and longevity of T cells in the tumor microenvironment and reduces the prevalence of immune suppressive cells and components within the tumor.

We believe that our proprietary combinations of Versamune® and PDS01ADC together with immune checkpoint

inhibitors or other standards of care, may enhance the proliferation, potency and longevity of antigen specific multifunctional CD8 T cells in the tumor microenvironment and work synergistically to inhibit or treat cancer.

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 and reduces the prevalence of immune suppressive cells and components within the tumor.

We believe that our proprietary combinations of Versamune® and PDS01ADC together

with immune checkpoint inhibitors or other standards of care, may enhance the proliferation, potency and longevity of antigen specific multifunctional CD8 T cells in the tumor microenvironment and work synergistically to inhibit or treat cancer.

Recent Developments

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

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 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

The proprietary combination of Versamune®HPV 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 VERSAMUNE® HPV and PDS01ADC administered with an investigational

bi-functional ICI resulted in a median overall survival of approximately 20 months.

The historical median survival reported in ICI resistant HPV-positive cancers when treated with ICIs is 3-4 months, and best reported median survival to date with

systemic therapy is 8.2 months in ICI resistant head and neck cancer.

In February 2023, we announced a successful completion of a Type B meeting with the FDA for the triple combination of Versamune®HPV and PDS01ADC with an FDA-approved immune checkpoint inhibitor for the treatment of recurrent/metastatic, ICI resistant head and neck cancer that is positive for the HPV type 16.

In recent interactions with the FDA, we confirmed the

required contents of a clinical protocol for the potential registrational trial.

In June 2023, an abstract was presented at the 2023 American Society of Clinical Oncology:

Abstract number 6012, Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of

PDS0101 and Pembrolizumab in HPV16-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).

Versamune®HPV and Pembrolizumab in HPV16-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).

The abstract was also selected as one of the featured posters reviewed by an expert panel in the Head and Neck Cancer discussion session.

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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

In October 2023, data demonstrating Versamune®HPV in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus circulating cell-free DNA

(ctHPV-DNA), a potential predictive biomarker of treatment response.

The data from the IMMUNOCERV Phase 2 clinical trial were featured in an oral presentation at the American Society for Radiation Oncology Annual Meeting.

In October 2023, updated interim data 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 the FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer was presented at a key opinion leader roundtable that we sponsored.

In October 2023, updated interim data based on an August 2, 2023 cut off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune®HPV in combination with Merck’s

anti-PD-1 therapy, Keytruda® (pembrolizumab) which is the FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer was presented at a key opinion leader roundtable that we sponsored.

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

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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

In November 2023, we announced updated survival data from our NCI-led Phase 2 trial investigating the triple combination of Versamune®HPV, PDS01ADC and an investigational immune checkpoint inhibitor

(ICI) in two groups of advanced cancer patients with various types of human papillomavirus (HPV) 16-positive cancers.

The data showed 75% Survival of ICI naïve patients at 36 months.

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.

In November 2023, preclinical data from our NCI-led trial including Versamune®HPV, PDS01ADC and an HDAC inhibitor in ICI-resistant HPV-16 positive cancer was presented during a poster presentation at

the Society for Immunotherapy of Cancer 38 th Annual Meeting.

In September 2024, we announced updated data from our VERSATILE-002 Phase 2 clinical trial presented during a poster session at the European Society for Medical Oncology (ESMO) Congress 2024.

Clinical Candidate Pipeline

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.

Versamune® HPV (PDS0101) + Keytruda®

In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune® HPV in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is the

FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer commenced.

Enrollment in stage 2 of 2 for the ICI naïve arm and the ICI resistant arms are complete.

The clinical trial will evaluate the efficacy and safety

of this therapeutic combination as a first and second line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection.

In this trial sponsored by 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.

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 Versamune® HPV and Keytruda® to evaluate if the addition of Versamune® HPV might improve the efficacy reported in published studies of Keytruda® alone.

Patients in the trial will receive a total of 5 cycles of

combination therapy in the context of standard of care Keytruda® therapy administered every three weeks until disease progression.

The primary endpoint of VERSATILE-002 is the objective response rate, or

ORR, at six months following initiation of treatment.

There are two cohorts in the trial.

Cohort 1 is for patients who have yet to be treated with an immune checkpoint inhibitor (ICI naïve) and cohort 2 which consists of patients who have failed

immune checkpoint inhibitor therapy (ICI resistant).

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

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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)

Patients had received a median of 4/5 doses of Versamune®HPV (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)

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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 FDA for PDS0101 in combination with Keytruda®.

No control or comparative studies have been conducted between ICIs and Versamune®HPV

In May 2022, we expanded this trial into Europe and in June 2022, as described above, we received Fast Track designation from the FDA for Versamune®HPV 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

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

We also announced the completion of our plan for a potential

Phase 3 clinical program that will support the submission of a BLA for Versamune® HPV and the submission of our plan to the FDA.

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 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.

Inhibitor (ICI) Naïve Cohort from Study of Versamune® HPV and Pembrolizumab in HPV16-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).

The abstract was also selected as one of the featured posters to be reviewed by an expert panel in the Head

and Neck Cancer discussion session.

Data on 34 patients was presented.

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Median progression-free survival was 10.4 months (95% CI 4.2, 15.3).

Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in

patients with similar PD-L1 levels.

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.

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.

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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.

Versamune® HPV in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer.

Data on 52 patients was presented.

The data from the

roundtable based on investigator assessment was as follows:

The data from

the roundtable based on investigator assessment was as follows:

Highlights from the ICI naïve cohort included:

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13% (8/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 0% (0/62) experienced Grade 4 or 5 TRAE;

published results report 13-17%

Grade 3-5 TRAE with approved ICI monotherapy.

60% (33/55) of patients had 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®).

In May 2024, at a virtual key opinion leader event, updated interim data was presented based on a November 30, 2023 cut-off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination

of 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.

published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy.

60% (33/55) of patients had 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®).

In May 2024, at a virtual key opinion leader event, updated interim data was presented based on a November 30, 2023 cut-off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination of

Data from 53 patients was presented.

The data from

the event based on investigator assessment was as follows:

from the event based on investigator assessment was as follows:

Highlights from the ICI naïve cohort with CPS > 1 included:

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

The combination of PDS0101 and Keytruda® appeared to be well tolerated with 11% (7/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and

2% (1/62) experienced Grade 4 or 5 TRAE;

The combination of Versamune® HPV and Keytruda® appeared to be well tolerated with 11% (7/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 2% (1/62) experienced Grade 4 or 5

published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy.

60% (32/53) of patients had CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (21/53) have CPS score >20 (who generally have a

higher response to Keytruda®).

60% (32/53) of patients had CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (21/53) have CPS score >20 (who generally have a higher response to Keytruda®).

During the May 2024 event, we also announced an updated clinical strategy with a two-part registrational trial focused on the double combination of Versamune® HPV + pembrolizumab, accompanied by an

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In August 2024 we provided an update to our clinical strategy following discussions with the FDA.

During the August 2024 update, we announced our intent to initiate a registrational study in first line treatment in

HPV16-positive recurrent/metastatic HNSCC with the double combination of Versamune® HPV + pembrolizumab.

During the August 2024 update, we announced our intent to initiate a registrational study in first

line treatment in HPV16-positive recurrent/metastatic HNSCC with the double combination of Versamune® HPV + pembrolizumab.

In September 2024, we announced updated data from our VERSATILE-002 Phase 2 clinical trial presented during a poster session at the European Society for Medical Oncology (ESMO) Congress 2024.

data presented was based on a May 17, 2024 data cut-off.

The main elements of the update were as follows:

Median Overall Survival (mOS) was 30 months with a lower 95% confidence interval of 19.7 months;

Published mOS for pembrolizumab is 12-18 months

Objective Response Rate (ORR) of 36% (19/53);

Published ORR for pembrolizumab is 19-25%

Disease Control Rate (DCR) is 77% (41/53)

21% (11/53) of patients had deep tumor responses and shrinkage of 90-100%

9% (5/53) of patients had a complete response

Treatment-related adverse events of Grade ≥3 were seen in 9 patients (Grade 3, n=8 and Grade 4, n=1)

National Cancer Institute:

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

Versamune® HPV+ M9241 (now PDS01ADC) +Bintrafusp Alfa

In June 2020, the first patient was dosed under a Cooperative Research and Development Agreement (CRADA), in the NCI led Phase 2 investigator-initiated trial evaluating Versamune® HPV with an IL-12

ADC now PDS01ADC, and M7824 (Bintrafusp alfa), which is owned by EMD Serono (Merck KGaA) in patients with advanced HPV-positive cancers who have failed prior treatment.

In February 2021, the NCI’s Phase 2 clinical trial of Versamune® HPV for the

treatment of advanced HPV-positive cancers had achieved its preliminary objective response target in patients naïve to check point inhibitors which allowed for full enrollment of approximately 20 patients in this group.

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therapeutic vaccine (Journal for ImmunoTherapy of Cancer2020;8:e000612.

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.

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

When Versamune® HPV was combined with the two other novel clinical-stage anti-cancer agents,

Bintrafusp Alfa and M9241 (which is now owned by us and referred to as PDS01ADC), the preclinical data suggested that all three therapeutic agents worked synergistically to provide superior tumor T cell

responses and subsequent tumor regression when compared to any of the agents alone or the 2-component combinations.

The published preclinical data demonstrating powerful activity of the triple combination

appears to be corroborated in the Phase 2 trial, and this triple combination could form the basis of a unique platform providing improved cancer treatments across multiple cancers.

In June 2022, at the 2022 ASCO Annual Meeting, the NCI provided an update to the preliminary data presented at the 2021 meeting (Strauss J et al.

Clin Oncol 40, 2022 [suppl 16;

J Clin Oncol 40, 2022 [suppl 16;

abstr 2518]).

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There were no grade 5 treatment-related AEs.

We believe the trial results to date strongly suggest, in agreement with the published preclinical studies, that all 3 drugs contribute to the clinical outcomes.

In September 2022, we determined, in agreement with the NCI, to select the ICI resistant patients as the preferred treatment group in the on-going 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.

We believe the trial results to date suggest that all 3 drugs contribute to the clinical outcomes, consistent with the published preclinical studies.

In September 2022, we determined, in agreement with the NCI, to select the ICI resistant patients as the preferred treatment group in the on-going Versamune®

HPV -based triple combination therapy in advanced HPV-positive cancers and the trial was closed to further enrollment given the ICI resistant arm had been fully recruited.

In October 2022, we presented additional interim data as follows:

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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 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.

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 completion of a Type B meeting with the FDA for the combination therapy of Versamune® HPV, PDS01ADC, and an FDA-approved immune checkpoint

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

We confirmed the required contents of the trial design for a potential registrational trial of the combination.

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MD Anderson Cancer Center (IMMUNOCERV):

PDS0101+ Chemoradiotherapy

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.

Versamune® HPV + Chemoradiotherapy

In October 2020, a Phase 2 Investigator Initiated Trial (IIT) was initiated with The University of Texas MD Anderson Cancer Center and is actively recruiting

This clinical trial is investigating the safety and anti-tumor efficacy of Versamune® HPV in combination with standard-of-care chemo-radiotherapy, or CRT, and their correlation with critical

immunological biomarkers in patients with locally advanced cervical cancer.

We believe that Versamune® has strong T cell induction with the potential to enhance efficacy of the current standard of care CRT treatment in this indication with the FDA

at this meeting.

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

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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.

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

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

One patient who received

3 of the 5 scheduled doses of Versamune® HPV showed signs of residual disease.

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

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

As previously reported, data confirm PDS0101 treatment activates HPV16-specific CD8 T cells.

This increase was not seen in patients who did not receive PDS0101.

The increase in HPV16-specific T cells generated by

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

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

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

As previously reported, data confirm VERSAMUNE® HPV treatment activates HPV16-specific CD8 T cells.

This increase was not seen in patients who did not receive VERSAMUNE® HPV.

The increase in HPV16-specific T

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

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

Toxicity of VERSAMUNE® HPV remains limited to low-grade local injection site reactions.

In October 2023, data demonstrating Versamune® HPV in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus circulating cell-free DNA

(ctHPV-DNA), a potential predictive biomarker of treatment response.

The data from the IMMUNOCERV Phase 2 clinical trial was featured in an oral presentation at the American Society for Radiation Oncology Annual Meeting which included the

Earlier and greater proportion of ctDNA clearance with PDS0101 plus chemoradiation (CRT) vs.

The data from the IMMUNOCERV Phase 2 clinical trial was featured in an oral presentation at the American Society for Radiation Oncology Annual Meeting which included the following:

Earlier and greater proportion of ctDNA clearance with VERSAMUNE® HPV plus chemoradiation (CRT) vs.

SOC CRT alone (81.3% clearance after 3 weeks vs.

30.3% with SOC (p=0.0018), and 91.7% of clearance at 5 weeks vs.

53.1% with SOC (p=0.0179).

53.1% with SOC

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 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.

100% of patients treated with VERSAMUNE® HPV had cancer that had spread to the lymph nodes.

Versamune® HPV Monotherapy and in combination with Keytruda®

In February 2022, we initiated an IIT, MC200710, for Versamune® HPV alone or in combination with the immune checkpoint inhibitor, Keytruda®, in patients with HPV-positive

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

The trial is being led by Drs.

David Routman, Katharine Price, Kathryn Van Abel, and Ashish Chintakuntlawar at Mayo Clinic, a nationally and internationally recognized

center of excellence for the treatment of head and neck cancers.

We believe that this trial not only broadens our addressable patient population of those affected by the increasing incidence of HPV(+)OPSCC, but also allows us to better understand

the activity of 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 Versamune® HPV alone or in combination with Keytruda® in earlier stages of disease.

This trial is currently open for enrollment.

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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

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

recurrent/metastatic HPV-positive cancers.

This trial will explore whether 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).

This trial will explore whether Versamune® HPV with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic regression, and

decreases in circulating tumor DNA (ctDNA).

PDS0102 is an investigational immunotherapy utilizing tumor-associated and immunologically active T cell receptor gamma alternate reading framed protein (TARP) from the NCI.

is designed to treat TARP-associated cancers including, acute myeloid leukemia (AML), prostate and breast cancer.

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

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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.

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

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 Biotech.

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.

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Expression of MUC1 is often associated with poor disease prognosis, due in part to drug resistance.

In preclinical studies, and similarly to PDS0101, PDS0103 demonstrated the ability to generate powerful MUC1-specific

CD8 killer T cells.

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

However, due to prioritization of our resources, the actual

submission date may be impacted by our decision to pursue initiation of a pivotal trial for Versamune® HPV in combination with pembrolizumab.

In preclinical studies, and similarly to VERSAMUNE® HPV, PDS0103 demonstrated the ability to generate powerful

MUC1-specific CD8 killer T cells.

In the first quarter of 2022, we held a pre-IND meeting with the FDA regarding PDS0103.

Due to prioritization of our resources, the IND submission date may be impacted by our decision to pursue

initiation of a pivotal trial for Versamune® HPV in combination with pembrolizumab.

IL-12 Oncology Immunocytokine Pipeline

PDS01ADC 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.

PDS01ADC 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.

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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.

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

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.

both VERSAMUNE® HPV and PDS01ADC and combining these agents with an FDA approved ICI.

PDS01ADC has been designed to overcome the limitations of cytokine therapy as explained above, and based on extensive preclinical studies performed at the NCI

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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

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

preclinical studies, a number of IIT Phase 2 trials are currently in progress at the NCI, some of which are outlined below:

Phase 2 Study Evaluating ICI Naïve and Resistant Patients with HPV-positive malignancies treated with PDS01ADC, VERSAMUNE® HPV and bintrafusp alfa.

A Phase 2 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

A Phase 1/2 Study of PDS01ADC in Combination with Docetaxel in Adults with Metastatic Castration Sensitive and Castration Resistant Prostate Cancer

Phase 1/2 of PDS01ADC going forward as a Monotherapy in Advanced Kaposi Sarcoma

Phase 1/2 of PDS01ADC in Combination of with a Histone Deacetylase (HDAC) Inhibitor in ICI resistant MUC1-positive colon and bladder cancers among others

In October 2023, interim safety and immune response data was presented for the first-in-human Phase 1/2 clinical trial evaluating PDS01ADC in combination with current SOC chemotherapy, docetaxel,

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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.

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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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.

Ted Ross at the University of Georgia to generate broadly protective anti-influenza immune responses across multiple strains

of influenza.

This data has provided a unique opportunity to highlight Infectimune®’s potentially transformative utility in the development of more broadly effective and longer lasting protective vaccines.

Current preventive and

prophylactic vaccine approaches and technologies predominantly focus on creating strong induction of antibody responses.

However, the induction of T cell responses, in addition to antibody responses, provides more durable and broad protection

against infectious diseases.

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

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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.

This data demonstrated active neutralization across multiple influenza viruses in animals and provided protection against infection and weight loss after challenging with high doses of

H1N1 viruses when they were not previously exposed to flu.

Our current clinical pipeline of Versamune®, and PDS01ADC based therapies is as follows:

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

Our net losses were $18.9 million and $21.2 million for the six months ended June 30, 2024

Our net losses were $29.7 million and $32.0 million for the nine months ended September

30, 2024 and 2023, respectively.

As of June 30, 2024, we had an accumulated deficit of $163.4 million.

Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and

administrative costs associated with these operations.

As of June 30, 2024, we had $57.7 million in cash and cash equivalents.

As of September 30, 2024, we had an accumulated deficit of $174.2 million.

Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from

general and administrative costs associated with these operations.

As of September 30, 2024, we had $49.8 million in cash and cash equivalents.

Our future funding requirements will depend on many factors, including the following:

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acquiring, developing and manufacturing clinical trial materials, as well as fees paid to consultants and various entities that perform certain research and testing on our behalf.

Costs for certain development activities, such as clinical trials,

are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided by vendors on their actual costs incurred.

Payments for these activities

are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the condensed consolidated financial statements as prepaid or accrued expenses.

Costs incurred in connection with

research and development activities are expensed as incurred.

Costs for certain development activities, such as clinical trials, are

recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided by vendors on their actual costs incurred.

Payments for these activities are

based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the Condensed 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 clinical and product

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clinical and product candidates.

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

and commercial viability.

As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our

clinical and product candidates.

commercial viability.

and product candidates.

Results of Operations

The following table summarizes the results of our operations for the three months ended June 30, 2024 and 2023:

The following table summarizes the results of our operations for the three months ended September 30, 2024 and 2023:

Three Months Ended

September 30,

Increase ( Decrease)

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Interest income (expense), net

Benefit from income taxes

Net loss and comprehensive loss

Research and Development Expenses

Research and development expenses decreased to $4.5 million for the three months ended June 30, 2024 from $8.0 million for the three months ended June 30, 2023.

The decrease of $3.5

million was primarily attributable to a decrease of $2.0 million in clinical trials, $0.2 million in personnel costs related to non-cash stock-based compensation and $1.3 million in manufacturing expenses.

Research and development expenses increased to $6.8 million for the three months ended September 30, 2024 from $6.4 million for the three months ended September 30, 2023.

The increase of $0.4 million

was primarily attributable to an increase of $1.6 million in manufacturing expenses, partially offset by a decrease of $0.8 million in clinical costs and a decrease of $0.4 million in personnel costs.

General and Administrative Expenses

General and administrative expenses decreased to $4.2 million for the three months ended June 30, 2024 from $4.7 million for the three months ended June 30, 2023.

General and administrative expenses decreased to $ 3 .

4 million for the three

months ended September 30, 2024 from $ 4 .

1 million for the three months ended September 30, 2023.

The decrease of $0.

$0.5 million was primarily attributable to a decrease of $0.3 million in personnel costs, including $0.1 million in non-cash stock-based compensation, and $0.2 million in professional fees.

Benefit from Income Taxes

Income tax benefit was $0.9 million for the three months ended June 30, 2024 and $1.4 million for the three months ended June 30, 2023.

The decrease of $0.5 million

was due to a decrease in the amount of New Jersey NOL carryforwards sold when compared to the comparable period.

Comparison of the Six months June 30, 2024 and 2023

The following table summarizes the results of our operations for the six months ended June 30, 2024 and 2023:

Six Months Ended

million was primarily attributable to a decrease of $0.

5 million in professional fees and $0.

2 million in personnel

Comparison of the Nine months September 30, 2024 and 2023

The following table summarizes the results of our operations for the nine months ended September 30, 2024 and 2023:

Nine Months Ended

September 30,

Increase (Decrease)

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Research and Development Expenses

Research and development expenses decreased to $ 11.2 million for the six months

ended June 30, 2024 from $13.

8 million for the six months ended June 30, 2023 .

of $2.6 million was primarily attributable to a decrease of $ 0.8 million in clinical studies and medical affairs, a decrease of $0.

million in personnel costs related to non-cash stock-based compensation and $1.4 million in manufacturing and quality costs .

Research and development expenses decreased to $ 18.0 million for the nine months ended September 30, 2024 from $ 20.3 million for the nine months ended September 30, 2023.

The decrease of $2.

3 million was primarily attributable to a decrease of $ 1.6

million in clinical studies and medical affairs, a decrease of $0.

8 million in personnel costs and a decrease in professional fees of $0.1 million,

partially offset by an increase of $0.2 million in manufacturing and quality costs .

General and Administrative Expenses

General and administrative expenses decreased to $7.6 million for the six months ended June 30, 202 4 from $8.3 million for the six months ended June 30, 202 3 .

General and administrative expenses decreased to $ 10 .

9 million for the nine months ended September 30, 202 4 from $ 12 .3 million for the nine months ended September 30, 202 3 .

The decrease of $ 1 .

7 million was primarily attributable to a

decrease of $0.6 million in personnel costs, a decrease in legal fees of $0.3 million, partially offset by a n increase of $0.

2 million in professional fees .

4 million was primarily attributable to a decrease of $0.

8 million in personnel costs, a decrease in professional fees of $0.

4 million and a decrease in facility cost of $0.2 million.

Benefit from Income Taxes

Income tax benefit was $0.9 million for the nine months ended September 30, 2024 and $1.4 million for the nine months ended September 30, 2023.

The decrease of $0.5

million was due to a decrease in the amount of New Jersey NOL carryforwards sold.

Liquidity and Capital Resources

In August 2022, we filed a shelf registration statement, or the 2022 Shelf Registration Statement, with the SEC for the issuance of common stock, preferred stock, warrants, rights,

debt securities, and units, up to an aggregate amount of $150 million, $50 million of which covers the offer, issuance and sale by us of our common stock under the Sales Agreement (as discussed below).

The 2022 Shelf Registration Statement was

declared effective on September 2, 2022.

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, up to an aggregate amount of $150 million, $50 million of which covers the offer, issuance and sale by us of our common stock under the Sales Agreement (as discussed below).

The 2022 Shelf Registration Statement

was declared effective on September 2, 2022.

In August 2022, we entered into an At Market Issuance Sales Agreement, or the Sales Agreement, with B.

Riley Securities, Inc.

and BTIG, LLC, each an Agent and collectively the

Agents, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price of up to $50 million, or the Placement Shares,

through or to the Agents, as sales agents or principals.

Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agents may sell the Placement Shares by any method permitted by law deemed to be an

“at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Capital Market or on any other existing trading market for our common stock.

The Agents will

use commercially reasonable efforts to sell the Placement Shares from time to time, based upon our instructions (including any price, time or size limits or other customary parameters or conditions we may impose).

We will pay the Agents a

commission equal to three percent (3%) of the gross sales proceeds of any Placement Shares sold through the Agents under the Sales Agreement, and we have also provided the Agents with customary indemnification and contribution rights.

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) the termination of the Sales Agreement in accordance with its terms.

For the year ended December 31, 2023, we sold 2,642,269 shares of common stock with a net value of $16.1 million pursuant to the Sales Agreement.

During the three and six

months ended June 30, 2024, we sold 0 shares of our common stock with a net value of $0 million and 3,428,681 shares of our common stock with a net value of $19.5 million, respectively, pursuant to the Sales Agreement.

During the three and six

months ended June 30, 2023, we sold 43,169 shares of our common stock with a net value of $0.2 million and 576,462 share of our common with a net value of $4.8 million, respectively, 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.

BTIG, LLC, each an Agent and collectively the Agents, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price

of up to $50 million, or the Placement Shares, through or to the Agents, as sales agents or principals.

Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agents may sell the Placement

Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Capital Market or on any other

existing trading market for our common stock.

The Agents will use commercially reasonable efforts to sell the Placement Shares from time to time, based upon our instructions (including any price, time or size limits or other customary

parameters or conditions we may impose).

We will pay the Agents a commission equal to three percent (3%) of the gross sales proceeds of any Placement Shares sold through the Agents under the Sales Agreement, and we have also provided the Agents

with customary indemnification and contribution rights.

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

The offering of Placement Shares pursuant to the Sales Agreement will terminate upon the earlier of

(i) the sale of all Placement Shares subject to the Sales Agreement or (ii) the termination of the Sales Agreement in accordance with its terms.

In August 2024, we entered into an Amended and Restated At Market Issuance Sales Agreement, or the New Sales Agreement, with B.

Riley Securities, Inc.

Wainwright & Co., LLC, with terms that are substantially consistent with those included

in the original Sales Agreement.

The New Sales Agreement superseded and replaced the Sales Agreement.

For the year ended December 31, 2023, we sold 2,642,269

shares of common stock with a net value of $16.1 million pursuant to the Sales Agreement.

During the nine months ended September 30, 2024, we sold 3,428,681 shares of its common stock with a net value of $19.

4 million pursuant to the Sales Agreement.

There were no shares of our common stock sold pursuant to the New

Sales Agreement during the three months ended September 30, 2024.

During the three and nine months ended September 30, 2023, we sold 139,575 shares of our common stock with a net value of $0.8 million and 736,037 shares of our common with a net

value of $5.7 million, respectively, 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.

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 by the Company of certain agreed upon conditions.

At this time the option has expired and Loan E and Loan F are no longer available to the Company under

the Loan and Security Agreement.

Loan E and Loan F were

uncommitted Loans that could have been advanced by the Lenders prior to July 31, 2023 upon the satisfaction by us of certain agreed upon conditions.

the option has expired and Loan E and Loan F are no longer available to us 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.

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.

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;

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

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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 our common stock at an initial exercise price of $3.6685 per share.

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 our 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

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Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2021.

In April 2024, we received approximately $0.9 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to its participation in the New

Jersey Technology Business Tax Certificate Transfer of Net Operating Loss (NOL) program for tax year 2022.

As of June 30, 2024, we had $57.7 million in cash and cash equivalents.

Our primary uses of cash are to fund operating expenses, primarily research and development expenditures.

In April 2024, we received approximately $0.9 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to its participation in the

New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2022.

As of September 30, 2024, we had $49.8 million in cash and cash equivalents.

Our primary uses of cash are to fund operating expenses, primarily research and development

expenditures.

Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

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 Quarterly Report on Form 10-Q.

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 Quarterly Report on Form 10-Q.

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.

However, we cannot be certain

that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or our existing stockholders.

However, we cannot be

certain that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or our existing stockholders.

We may also enter into government funding programs and consider selectively

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The sale of additional equity would result in additional dilution to our stockholders.

Incurring debt financing would result in debt service obligations, and the instruments governing

such debt could provide for operating and financing covenants that would restrict our operations.

If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate

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

In addition, the Loan and Security Agreement allows for the lenders

to call the outstanding balance of the term loans if the minimum cash balances outlined in the Loans and Security Agreement are not maintained.

Incurring debt financing would result in debt service obligations, and the instruments governing such

debt could provide for operating and financing covenants that would restrict our operations.

If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our

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

In addition, the Loan and Security Agreement allows for the lenders to

call the outstanding balance of the term loans if the minimum cash balances outlined in the Loans and Security Agreement are not maintained.

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

obtain adequate financing also may adversely affect our ability to operate as a going concern.

As a result of these uncertainties, and as its plans are outside of management’s control, 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 unaudited condensed consolidated financial statements.

The unaudited condensed consolidated financial statements do not include any adjustments to the carrying amounts and

classifications of assets and liabilities that would result if were unable to continue as a going concern.

As a result of these uncertainties, and as its plans are outside of management’s control, 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 unaudited Condensed Consolidated Financial Statements.

The unaudited Condensed Consolidated Financial Statements do not include any adjustments to the carrying amounts and classifications

of assets and liabilities that would result if we are unable to continue as a going concern.

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

Six Months Ended June 30,

Nine Months Ended September 30,

Net cash used in operating activities

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Net Cash Used in Operating Activities

Net cash used in operating activities was $18.8 million and $18.0 million for the six months ended June 30, 2024 and 2023 , respectively.

The increase in net cash used in operating activities of $0.8 million was primarily due to a decrease in

accounts payable and accrued expenses of $2.5 million, partially offset by a decrease in net loss adjusted for non-cash items of $1.4 million.

Net cash used in operating activities was $26.8 million and $25.2 million for the nine months ended September 30, 2024 and 2023, respectively.

The increase in net

cash used in operating activities of $1.6 million was primarily due to accounts payable and accrued expenses of $3.2 million, partially offset by $1.3 million from reduced net loss adjusted for non-cash items.

Net Cash Used in Investing Activities

Net cash used in investing activities for the six months ended June 30, 2024 and 2023 was $0.0 million and $0.0 million, respectively.

Net cash used in investing activities for the nine months ended September 30, 2024 and 2023 was $29.0 thousand and $0, respectively.

Net Cash Provided by Financing Activities

Net cash provided by financing activities for the six months ended June 30, 2024 and 2023 was primarily due to the receipt of net proceeds of $19.4 million and $ 4.8 million,

respectively, from the sale of common stock under the Sales Agreement.

Net cash provided by financing activities for the nine months ended September 30, 2024 and 2023 was primarily due to the receipt of net proceeds of $19.4 million and $5.6

million, respectively, from the sale of common stock under the Sales Agreement.

Operating Capital Requirements

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difficulties, complications, delays and other unknown factors that may harm our business.

We expect to incur additional costs associated with operating as a public company and anticipate that we will need substantial additional funding in

connection with our continuing operations.

We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year

after the filing of this Quarterly Report.

We expect to incur additional costs associated with operating as a public company and anticipate that we will need substantial additional funding in connection

with our continuing operations.

We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one

year after the filing of this Quarterly 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.

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financings, collaborations, strategic alliances, or license agreements with third parties, there is no assurance that new financing will be available to us on commercially acceptable terms or in the amounts required, if at all.

In addition, the

Loan and Security Agreement allows for the lenders to call the outstanding balance of the term loans if the minimum cash balances outlined in the Loans and Security Agreement are not maintained.

We have concluded that substantial doubt exists about

our ability to continue as a going concern for a period of at least 12 months from the date of the issuance of these unaudited Condensed Consolidated financial statements.

In addition, the Loan

and Security Agreement allows for the lenders to call the outstanding balance of the term loans if we fail to maintain the minimum cash balances outlined in the Loans and Security Agreement.

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 unaudited Condensed Consolidated financial statements.

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

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Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S.

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with

Our accounting policies are more fully described in Note 2 to the Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q.

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 expenses incurred during the reporting

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 expenses incurred during the reporting

Our estimates are based on our historical experience and on various other factors 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

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Actual results may differ from these estimates under different assumptions or conditions.

We believe that

the discussion in our management’s discussion and analysis 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

We believe that the

discussion in our management’s discussion and analysis 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.

There have been no material changes to our critical accounting policies and estimates during the six months ended June 30, 2024 from those disclosed in our Annual Report on Form 10-K for the year

ended December 31, 2023.

There have been no material changes to our critical accounting policies and estimates during the nine months ended September 30, 2024 from those disclosed in our Annual Report on Form 10-K for the

year ended December 31, 2023.

Off-Balance Sheet Arrangements

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As of January 1, 2021, we were 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.

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.

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.

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 will continue to take advantage of some or all of the available exemptions.

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-Q

Item 2. Management’s Discussion and Analysis