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Item 2. Management’s Discussion and Analysis

2025-05-14 compared with 2024-11-14 · 434 added, 535 removed, 156 unchanged (86% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited interim

condensed consolidated financial statements and related notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and with the audited financial statements and notes

thereto of the Company as of and for the year ended December 31, 2023 on Form 10-K, filed with the Securities and Exchange Commission, or SEC, on March 28, 2024.

The following discussion and analysis of

our financial condition and results of operations should be read in conjunction with our unaudited interim condensed consolidated financial

statements and related notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and with the audited financial statements and notes thereto of the Company as of and for the year ended December 31, 2024 on Form

10-K, filed with the Securities and Exchange Commission, or SEC, on March 27, 2025.

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:

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 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;

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

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

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;

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 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) , Versamune®

MUC1 (formerly 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;

th e 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 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 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;

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

the timing of and the Company’s ability to obtain and maintain U.S.

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.

Food and Drug Administration or other regulatory authority approval of, or other action with respect

to, the Company’s clinical and product candidates;

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.

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.

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.

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.

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 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.

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 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 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

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

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

In September 2023, data on our investigational universal flu vaccine, PDS0202, was presented at the 9 th European

Scientific Working Group on Influenza (ESWI) conference.

This data demonstrated broad neutralization across multiple influenza strains in animals and provided protection against infection after challenging animals not previously exposed to flu with

lethal doses of the pandemic H1N1 flu virus.

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

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

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

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

treat metastatic castration sensitive and castration resistant prostate cancer.

The data was featured in an oral presentation at the 11 th Annual Meeting of the

International Cytokine & Interferon Society.

In October 2023, immune response data from a preliminary analysis of a subset of patients in our VERSATILE-002 Phase 2 clinical trial was presented at the European Society for Medical Oncology

Congress 2023.

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

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

Abstract number 6012, Safety and Efficacy of

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

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

In September 2023, data on our investigational universal flu vaccine, PDS0202, was presented at the 9 th European Scientific

Working Group on Influenza (ESWI) conference.

This data demonstrated broad neutralization across multiple influenza strains in animals and provided protection against infection after challenging animals not previously exposed to flu with lethal doses

of the pandemic H1N1 flu virus.

In October 2023, data demonstrating Versamune® HPV in

combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus circulating cell-free DNA (ctHPV-DNA), a potential predictive biomarker of treatment response.

The data from the IMMUNOCERV Phase 2

clinical trial were featured in an oral presentation at the American Society for Radiation Oncology Annual Meeting.

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 treat metastatic castration sensitive and castration resistant prostate cancer.

The data was featured in an oral presentation at the 11 th Annual Meeting of the International

Cytokine & Interferon Society.

In October 2023, immune response data from a preliminary analysis of a subset of patients in our VERSATILE-002 Phase 2 clinical trial was

presented at the European Society for Medical Oncology Congress 2023.

In November 2023, we announced updated survival data from our NCI-led Phase 2 trial investigating the triple combination of Versamune® HPV , PDS01ADC and an investigational immune checkpoint inhibitor (ICI) in two groups of advanced cancer patients with various types of human papillomavirus (HPV)

16-positive cancers.

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

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.

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.

In March 2025, we announced the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating Versamune® HPV in first-line treatment

of recurrent/metastatic head and neck squamous cell carcinoma in HPV16-positive patients.

Clinical Candidate Pipeline

VERSATILE-003:

Versamune® HPV + pembrolizumab

The clinical trial is designed to enroll a total of 351 patients with approximately 234 patients receiving the combination treatment of

Versamune® HPV and pembrolizumab, and approximately 117 patients receiving pembrolizumab alone.

Generally, the patient treatment protocol is identical to that of VERSATILE-002, described below, enrolling only ICI naïve patients.

As such, patients

in the trial will receive a total of 5 cycles of combination therapy, with standard of care pembrolizumab therapy administered every three weeks until disease progression.

The clinical trial’s primary endpoint is median overall survival.

Secondary endpoints are objective response rate, disease control

rate, duration of response and progression free survival.

Furthermore, the clinical trial design includes two interim data readouts estimated at approximately 6 months following full enrollment

and 18 months following full enrollment, respectively.

Final readout from the trial is expected approximately 24 months following full enrollment.

VERSATILE-002:

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 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.

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

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)

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

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

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.

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 (suppl

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 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)

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 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 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.

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

consists of patients who have failed immune checkpoint inhibitor therapy (ICI resistant).

In May 2023, we completed enrollment in the ICI naïve arm.

We filed our amended IND with the FDA in the third quarter of 2023.

In October 2023, we received feedback from the

FDA on the amended IND.

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

Abstract number 6012, Safety and Efficacy of Immune Checkpoint

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

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

and Neck Cancer discussion session.

October 2023, we received feedback from the FDA on the amended IND.

In June 2023, an abstract was presented at the 2023

American Society of Clinical Oncology:

Abstract number 6012, Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of Versamune® HPV and Pembrolizumab in HPV16-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).

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.

3 unchanged sentences

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.

2 unchanged sentences

No Grade 4 or higher TRAEs were observed.

In October 2023, at a key opinion roundtable updated interim data was presented based on an August 2, 2023 cut-off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination of

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

In October 2023, at a key opinion roundtable updated interim data was presented based on an August 2, 2023 cut-off from our VERSATILE-002

Phase 2 clinical trial evaluating the combination of Versamune® HPV in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck

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:

8 unchanged sentences

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

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 stronger

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

and neck cancer.

Data from 53 patients was presented.

from the event based on investigator assessment was as follows:

The data from the event based on investigator assessment was as follows:

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

6 unchanged sentences

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

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

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

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

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

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

investigation of the triple combination of Versamune® HPV + PDS01ADC + pembrolizumab as a first line treatment in HPV16-positive recurrent/metastatic HNSCC.

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 investigation of the triple combination of Versamune® HPV + PDS01ADC + pembrolizumab as a first line treatment in HPV16-positive recurrent/metastatic HNSCC.

In June 2024, we provided a data update from our VERSATILE-002 clinical trial.

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Median Overall Survival of 30 months, consistent with data presented our key opinion leader event in May of 2024, which was based on a data cut as of November 30, 2023.

27 of the censored patients remained alive and were awaiting their next clinical assessment, 6 censored patients had withdrawn consent for further follow-up, and 2 patients had been lost to follow-up, and 18 patients had died.

27 of the censored patients remained alive and were awaiting their next clinical assessment, 6 censored patients had withdrawn consent for further follow-up, and 2

patients had been lost to follow-up, and 18 patients had died.

The lower limit of the 95% confidence interval is 19.7 months, and the upper limit is not yet estimable, as the majority of patients continue to be followed for survival.

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

During the August 2024 update, we announced our intent to initiate a registrational 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.

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.

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

The main elements of the update were as follows:

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National Cancer Institute:

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.

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.

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

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

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

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

The published preclinical data demonstrating powerful activity of the triple combination

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

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

J Clin Oncol 40, 2022 [suppl 16;

abstr 2518]).

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

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 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 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.

In ICI naïve patients 6/8 (75%) were alive at median 17 months of follow up.

Similar OR and survival were seen across all types of HPV16-positive cancers.

Preliminary safety data:

13/30 (43%) of patients experienced Grade 3 treatment-related adverse events (AEs), and 2/30 patients (7%) experienced Grade 4 AEs.

There were no grade 5 treatment-related AEs.

We believe the trial results to date 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:

Survival data:

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

Safety profile:

48% (24/50) patients experienced Grade 3 treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 AEs.

There were no Grade 5 treatment-related AEs.

HPV16-positive ICI naïve patients:

75% (6/8) were alive at a median follow up of 25 months and 38% (3/8) of responders had a complete response.

In December 2022, we presented interim data as follows:

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 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-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 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.

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

In February 2021, the NCI’s

Phase 2 clinical trial of Versamune® HPV for the treatment of advanced HPV-positive cancers had achieved its preliminary objective response target in patients naïve to check point inhibitors which allowed for full enrollment of approximately 20

patients in this group.

In addition, based on promising results in the ICI naïve arm, the trial was amended to allow enrollment of a separate cohort of IC -resistant patients for assessment of safety and activity of the triple combination.

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) , 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 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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published median OS is 3.4 months

In February 2025, we announced the publication of clinical results in the Journal of the American Medical Association (JAMA) Oncology:

Median Overall Survival (mOS) of 42.4 months in immune checkpoint inhibitor naïve patients;

Historical published result is 7-12 months

Continued survival in the cohort of HPV16-positive immune checkpoint inhibitor naïve patients - mOS not yet reached

Median OS of 17 months in HPV16-positive immune checkpoint inhibitor resistant patients;

Historically published result is 3-4 months

Significant tumor shrinkage with confirmed objective response rate (ORR) of 75% in HPV16-positive immune checkpoint inhibitor naïve patients;

Historically published

result is 11-24%

MD Anderson Cancer Center (IMMUNOCERV):

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:

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).

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 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 following:

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 patients.

This clinical trial is investigating the safety and anti-tumor efficacy of Versamune® HPV in combination with standard-of-care chemo-radiotherapy, or CRT, and their correlation with critical immunological biomarkers in patients with locally advanced cervical cancer.

We believe that Versamune® has strong

T cell induction with the potential to enhance efficacy of the current standard of care CRT treatment in this indication with the FDA at this meeting.

In October 2023, data demonstrating Versamune® HPV in combination with standard-of-care (SOC) chemoradiotherapy was associated with a

rapid decline in human papillomavirus circulating cell-free DNA (ctHPV-DNA), a potential predictive biomarker of treatment response.

The data from the IMMUNOCERV Phase 2 clinical trial was featured in an oral presentation at the American Society for

Radiation Oncology Annual Meeting which included the following:

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.

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 VERSAMUNE® HPV had cancer that had spread to the lymph nodes.

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

This trial is currently open for enrollment.

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 conducted by the Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck

We believe that this trial allows us to better understand the activity of Versamune® HPV alone or in combination with Keytruda® in earlier stages of disease.

In this trial, treatment will be administered before patients proceed to transoral robotic surgery (TORS) with curative intent.

Treatment in this setting is referred to as

neoadjuvant treatment.

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

recurrent/metastatic HPV-positive cancers.

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

decreases in circulating tumor DNA (ctDNA).

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

PDS0102 is designed to treat TARP-associated cancers including, acute myeloid leukemia (AML), prostate and breast cancer.

In our preclinical work, in the administration of PDS0102, the Versamune®+TARP antigen combination led to the induction of large

numbers of tumor targeted killer T cells.

In addition, the TARP tumor antigen alone has already been studied at the NCI in men with prostate cancer and has been shown to be safe, and immunogenic with slowing tumor growth rates (NCT00972309).

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 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

PDS0103 is being developed.

in this setting is referred to as neoadjuvant treatment.

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

studies of patients with advanced recurrent/metastatic HPV-positive cancers.

The 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).

Versamune® MUC1 (formerly PDS0103)

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 Versamune® MUC1.

Versamune® MUC1 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.

Versamune® MUC1 combines Versamune® with novel highly immunogenic agonist epitopes of MUC1 developed by the NCI and licensed by us.

MUC1 is highly expressed in several types of cancer and has been shown to be associated with drug resistance and poor disease prognosis in

breast, colorectal, lung and ovarian cancers, for which Versamune® MUC1 is being developed.

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

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

MUC1-specific CD8 killer T cells.

In 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.

In preclinical studies, and similarly to Versamune® HPV,

Versamune® MUC1 demonstrated the ability to generate powerful MUC1-specific CD8 killer T cells.

In March 2025, we announced FDA clearance of our IND application for the combination of Versamune® MUC1 and PDS01ADC in treatment of

metastatic colorectal cancer.

PDS0102 is an investigational immunotherapy utilizing tumor-associated and immunologically active T cell receptor gamma alternate reading

framed protein (TARP) from the NCI.

PDS0102 is designed to treat TARP-associated cancers including acute myeloid leukemia (AML), prostate and breast cancer.

In our preclinical work, in the administration of PDS0102, the Versamune®+TARP antigen

combination led to the induction of large numbers of tumor targeted killer T cells.

In addition, the TARP tumor antigen alone has already been studied at the NCI in men with prostate cancer and has been shown to be safe, and immunogenic with slowing

tumor growth rates (NCT00972309).

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.

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

With the exclusive global license agreement with Merck KGaA, Darmstadt, Germany for PDS01ADC, we believe we have simplified our registrational pathway for the NCI-led triple combination by owning

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

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

evaluating PDS01ADC as a monotherapy and also in combinations with established standard of care treatments for cancer, we believe that PDS01ADC has significant potential as a cytokine therapy independent of Versamune®.

Based on the informative

preclinical studies, a number of 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

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.

As with Versamune®, PDS01ADC is given by a simple subcutaneous injection.

Clinical data suggests the addition of PDS01ADC to Versamune® based immunotherapies may demonstrate significant disease control in advanced cancer

patients by shrinking tumors and/or prolonging life.

With the exclusive global license agreement with Merck

KGaA, Darmstadt, Germany for PDS01ADC, we believe we have simplified our registrational pathway for the NCI-led triple combination by owning both Versamune® HPV and PDS01ADC and combining these agents with an FDA approved ICI.

PDS01ADC has been

designed to overcome the limitations of cytokine therapy as explained above, and based on extensive preclinical studies performed at the NCI evaluating PDS01ADC as a monotherapy and also in combinations with established standard of care treatments

for cancer, we believe that PDS01ADC has significant potential as a cytokine therapy independent of Versamune®.

Based on the informative preclinical studies, a number of 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 Therapy

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

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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,

to treat metastatic castration sensitive and castration resistant prostate cancer.

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, 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

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All doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia.

Administration of the combination was associated with decreases in T reg cells and increases in activated natural killer (NK) cells, memory CD8 T cells, proliferating CD4 and CD8 T cells and cytokines INF-γ and Interleukin 10 (IL-10).

Administration of the combination was associated with decreases in T reg cells and increases in activated natural killer (NK) cells, memory CD8 T cells, proliferating

CD4 and CD8 T cells and cytokines INF-γ and Interleukin 10 (IL-10).

The changes in immune responses with the combination were independent of the PDS01ADC dose.

We are working closely with the NCI to determine the best pathway forward for the prioritized PDS01ADC studies, as well as evaluating the use of PDS01ADC in combination with other Versamune® based

clinical candidates.

Infectimune® Development Strategy

We believe that the key differentiating attributes of the Infectimune® platform technology are strong induction of CD8 and CD4 T cells as well as antibodies which can be leveraged to improve

treatment and preventive options in several infectious disease indications.

In January 2022, we presented preclinical data on our universal flu program sponsored by the National Institute of Allergy and Infectious Disease (NIAID) demonstrating the

potential of the Infectimune® technology with computationally designed influenza proteins developed by the laboratory of Dr.

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

of influenza.

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

Current preventive and prophylactic vaccine

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

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

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 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®, and PDS01ADC based therapies is as follows:

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.

Current Clinical Pipeline of Versamune®, and PDS01ADC Based Therapies

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

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

30, 2024 and 2023, respectively.

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 net losses were $8.5 million, and $10.6

million for the three months ended March 31, 2025 and 2024, respectively.

As of March 31, 2025, we had an accumulated deficit of $190.6 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 March 31, 2025, we had $40.0 million in cash and cash equivalents.

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

the timing and costs of our planned clinical trials;

the timing and costs of our planned and ongoing clinical trials;

the timing and costs of our planned preclinical studies of our Versamune® platform;

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the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;

the amount and timing of any payments we may be required to make in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other

intellectual property rights;

the amount and timing of any payments we may be required to make in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any

patents or patent applications or other intellectual property rights;

the extent to which we license or acquire other products and technologies.

Infectimune® Development Strategy

We believe that the key differentiating attributes of the Infectimune® platform technology are strong induction of CD8 and CD4 T cells as

well as antibodies which can be leveraged to improve treatment and preventive options in several infectious disease indications.

In January 2022, we presented preclinical data on our universal flu program sponsored by the National Institute of Allergy

and Infectious Disease (NIAID) demonstrating the potential of the Infectimune® technology with computationally designed influenza proteins developed by the laboratory of Dr.

Ted Ross at the University of Georgia to generate broadly protective

anti-influenza immune responses across multiple strains of influenza.

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

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®.

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.

Viruses 2023, 15, 538).

In September 2023, preclinical data on our investigational universal flu vaccine, PDS0202, was presented at the 9th 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.

SELECTED FINANCIAL OPERATIONS OVERVIEW

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 generate revenue in the future from a

combination of research and development payments, license fees and other upfront payments or milestone payments.

generate revenue in the future from a combination of research and development payments, license fees and other upfront payments or milestone payments.

Research and Development Expenses

Research and development expenses include employee-related expenses, costs to acquire license rights to use certain technology in our research and development projects, costs of

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

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

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

Payments for these activities are

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

candidates into and through clinical trials, pursue regulatory approval of our Versamune® and PDS01ADC 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.

Research and development expenses include employee-related

expenses, costs to acquire license rights to use certain technology in our research and development projects, costs of acquiring, developing and manufacturing clinical trial materials, as well as fees paid to consultants and various entities that

perform certain research and testing on our behalf.

Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment,

clinical site activations or information provided by vendors on their actual costs incurred.

Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected

in the 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 candidates into and through clinical trials, pursue regulatory approval of our Versamune® and PDS01ADC product candidates and prepare for a possible commercial launch, all of which will also require a

significant investment in contract research services, manufacturing process validation and inventory related costs.

The process of conducting human clinical trials necessary to obtain regulatory approval is costly and time consuming.

We may never succeed in achieving marketing approval for our

clinical 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.

We may never succeed

in achieving marketing approval for our 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.

Results of Operations

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

The following table summarizes the results of our operations for the three months ended March 31, 2025 and 2024:

Three Months Ended

September 30,

Increase ( Decrease)

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Interest income (expense), net

Net loss and comprehensive loss

Research and Development 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 $ 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.

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)

(in thousands)

Operating expenses:

Research and development expenses

General and administrative expenses

Total operating expenses

Loss from operations

Interest income (expense), net

Benefit from income taxes

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Research and Development Expenses

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.

Research and development (R&D) expenses decreased to $ 5.8 million for the three months ended March 31, 2025 from $6.7 million for the three months ended March 31, 2024 .

The decrease of $0.

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 .

9 million was primarily attributable to a decrease of $ 0.6 million in clinical trial costs, a decrease of $0.

2 million in personnel costs, and a decrease of $0.

1 million in manufacturing costs .

General and Administrative Expenses

General and administrative expenses decreased to $3.

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

3 million for the three months ended March 31, 202 5 from $3.

4 million for the three months ended March 31, 202 4 .

The decrease of $0.

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.

1 million was primarily

attributable to a decrease of $0.2 million in personnel costs offset by a n increase of $0.

1 million in professional fees .

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.

Income tax benefit was $1.2 million for the three months ended March 31, 2025 and $0 million for the three months ended March 31, 2024.

The increase of $1.2 million was due to the timing of proceeds received from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate

Transfer Net Operating Loss (NOL) Program.

The comparable tax benefit of $0.9 million was received in April 2024 and reflected as an income tax benefit for the three months ended June 30, 2024.

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, approximately $97 million of which covers the offer, issuance and sale by us of our common stock under the Sales Agreement and the New

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.

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.

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).

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.

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.

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).

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 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.

The principal balance of each Loan bears a floating interest.

The interest rate is calculated initially and, thereafter, each calendar month as the sum of (a) the per

annum rate of interest from time to time published in The Wall Street Journal as contemplated by the Loan and Security Agreement, or any successor publication thereto, as the “prime rate” then in effect, plus (b) 5.75%;

provided that, in the event

such rate of interest is less than 4.00%, such rate shall be deemed to be 4.00% for purposes of calculating the interest rate.

Interest is payable on a monthly basis based on each Loan principal amount outstanding the preceding month.

We, at our option upon at least ten (10) business days’ written notice

to the lenders, may prepay all (and not less than all) of the outstanding Loan by simultaneously paying to each lender an amount equal to (i) any accrued and unpaid interest on the outstanding principal balance of the Loans;

plus (ii) an amount equal

to (A) if such Loan is prepaid on or before the Loan Amortization Date (as defined in the Loan and Security Agreement) applicable to such Loan, 3% of the then outstanding principal balance of such Loan, (B) if such Loan is prepaid after the Loan

Amortization Date applicable to such Loan, but on or before the date that is 12 months after such Loan Amortization Date, 2% of the then outstanding principal balance of such Loan, or (C) if such Loan is prepaid more than 12 months after the Loan

Amortization Date but prior to the stated maturity date applicable to such Loan, 1% of the then outstanding principal balance of such Loan;

plus (iii) the outstanding principal balance of such Loan;

plus (iv) all other sums, if any, that shall have become due and payable thereunder.

No prepayment premium will be applied to any outstanding balance of any Loan paid on the stated maturity date.

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

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%, and (iv) no estimated dividend yield.

In April 2023, we received approximately $1.4 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant our participation in the New

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

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

For the year ended December 31, 2024, the Company sold

3,428,681 shares of common stock for a net value of $19.5 million pursuant to the Sales Agreement and 1,108,105 shares of common stock for a net value of $3.2 million pursuant to the New Sales Agreement.

During the three months ended March 31, 2025,

the Company sold 205,350 shares of common stock for a net value of $0.3 million pursuant to the New Sales Agreement and during the three months ended March 31, 2024, we sold 3,428,681 shares of common stock for a net value of $19.5 million, pursuant to

the Sales Agreement.

In August 2022, the Company 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.

In total, the Company received $24.6 million in net proceeds under the Loan and Security Agreement.

The Company’s indebtedness under the Loan and Security Agreement was satisfied in full and retired in full with a portion

of the proceeds received from the Securities Purchase Agreement, as discussed below.

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 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% , and (iv) n o estimated dividend yield.

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.

In January and February of 2025, 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 tax year 2023.

In February 2025, we entered into a Securities Purchase Agreement with certain purchasers, pursuant to which the we agreed to sell an

aggregate of 6,396,787 shares of common stock, pre-funded warrants to purchase up to an aggregate of 933,334 shares of common stock, and common stock warrants to purchase up to an aggregate of 7,330,121 shares of common stock at a combined purchase

price of $1.50 per share and warrant (the “February 2025 Offering”).

Two of our directors participated in the February 2025 Offering and purchased 30,121 shares of common stock in the aggregate at an offering price per share of $1.66 and common stock

warrants to purchase 30,121 shares of common stock.

The common stock warrants issued to our directors have an exercise price per share of $1.53, but are otherwise identical to the common stock warrants issued to all other participants in the February

2025 Offering.

Aggregate gross proceeds from the February 2025 Offering were approximately $11 million.

Net proceeds to us from the offering, after deducting the placement agent fees and other estimated offering expenses payable by us, were

approximately $10.05 million.

The February 2025 Offering closed on February 28, 2025.

On April 30, 2025, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with certain third

party lenders and JGB Collateral LLC , as collateral agent.

Pursuant to the Securities Purchase Agreement, the Company agreed to sell (i) senior secured convertible

debentures in an aggregate principal amount of $22,222,222 (collectively, the “Debentures”) and (ii) warrants to purchase up to 1,000,000 shares of common stock, for an exercise price of $2.52 per share (collectively, the “Warrants”), subject to

adjustments as set forth in the Warrants, for a total purchase price of $20,000,000.

Approximately $19 million of the proceeds from the transactions contemplated by the Securities Purchase Agreement were used to satisfy in full and retire the

Company’s indebtedness under the Loan and Security Agreement.

As of March 31, 2025, we had $40.0 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.

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.

We may also enter into government funding programs and consider selectively

partnering for clinical development and commercialization.

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 2025 and beyond include expenses related to continuing development and clinical studies as well as payments on our

We plan to continue to fund our operations and capital

funding needs through existing cash and additional equity and/or debt financing.

However, we cannot be certain that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or our

existing stockholders.

We may also enter into government funding programs and consider selectively partnering for clinical development and commercialization.

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

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

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

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

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

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

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

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

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 we are unable to continue as a going concern.

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 Debentures allow for the lenders to call the outstanding balance of the Debentures if we fail to maintain minimum cash balances outlined in the Debentures.

Any of these actions could harm our business,

results of operations and prospects.

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

As a result of these uncertainties, 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):

Nine Months Ended September 30,

Three Months Ended March 31,

Net cash used in operating activities

Net cash used in investing activities

Net cash provided by financing activities

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Net Cash Used in Operating Activities

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 nine months ended September 30, 2024 and 2023 was $29.0 thousand and $0, respectively.

Net cash used in operating activities was $9.0 million and

$9.9 million for the three months ended March 31, 2025 and 2024, respectively.

The decrease in net cash used in operating activities of $0.9 million was primarily due to a decrease in the non-cash stock-based compensation expense of $0.4

million offset by a decrease in net loss of $2.1 million and changes in the timing of working capital requirements, including changes in prepaid expenses and other assets, accrued expenses and accounts payable.

Net Cash Provided by Financing Activities

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.

Net cash provided by financing activities for the three months ended March 31, 2025 and 2024 decreased by $12.7 million primarily due to a

$19.2 million decrease in proceeds from the issuance of common stock from the Sales Agreement, an increase in proceeds from the issuance of common stock and pre-funded warrants of $10.2 million from the financing agreement, offset by a $3.1 million

loan repayment.

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 product candidates, and begin to commercialize any approved products.

We are subject to all of the risks incident to the development of new products, and may encounter unforeseen expenses,

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

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

with our continuing operations.

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

year after the filing of this Quarterly Report.

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 product candidates, and begin to commercialize any approved products.

We are subject to all of the risks incident to the development of new products, and

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

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

additional funding in connection with our continuing operations.

We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to

continue as a going concern within one year after the filing of this Quarterly Report.

Our budgeted cash requirements in 2025 and beyond include expenses related to continuing development and clinical studies as well as payments on our debt.

Until we can generate significant cash from our

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

can generate significant cash from our operations, we expect to continue to fund our operations with available financial resources.

These financial resources may not be adequate to sustain our operations.

While we intend to finance our cash needs principally through equity or debt

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 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

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:

While we intend to finance our cash needs

principally through equity or debt 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,

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 expect.

Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating

capital requirements.

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

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

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the outcome, timing and cost of meeting regulatory requirements established by the U.S.

Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, and other comparable foreign regulatory

Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, and

other comparable foreign regulatory authorities;

the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

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

Please see the section titled “Risk Factors” elsewhere in the Quarterly Report and Annual Report for additional risks associated with our operations.

Please see the section titled “Risk Factors” elsewhere in the Quarterly Report and Annual Report for additional risks associated with our

Purchase Commitments

We have no material non-cancelable purchase commitments with service providers as we have generally contracted on a cancelable, purchase order basis.

We have no material non-cancelable purchase commitments with service providers as we have generally contracted on a cancelable, purchase

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

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 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

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

liabilities that are not readily apparent from other sources.

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 periods.

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 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

difficult, subjective and complex judgments.

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.

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 three months ended March 31, 2025 from

those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.

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 in the rules

and regulations of the SEC.

Smaller Reporting Company

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.

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.

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

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What changed 10-Q

Item 2. Management’s Discussion and Analysis