What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2023-05-15 compared with 2022-11-14 · 318 added, 313 removed, 222 unchanged (74% of the section changed)

4 unchanged sentences

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q (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.

results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation:

Actual results could differ materially from those contained

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

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

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

the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its 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 product candidates;

the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its clinical 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 candidates;

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

1 unchanged sentence

the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0103, PDS0203 and other Versamune and

Infectimune based products and the future success of such trials;

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 studies concerning PDS0101, PDS0203 and other Versamune and Infectimune based

products 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 product candidates;

the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product 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 our product candidates;

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

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

clinical 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 candidates;

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

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

data 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 our clinical candidates;

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

collaboration studies;

the acceptance by the market of the Company’s clinical 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 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 COVID-19 and 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 candidates;

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

Risk Factors.

7 unchanged sentences

Company Overview

We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune ® and Infectimune™ T cell activating technology platforms.

Our Versamune based products have demonstrated the potential to overcome the limitations of current

immunotherapies by inducing, in vivo, large quantities of high-quality, potent polyfunctional CD4+ helper and CD8+ killer T cells.

We have developed multiple therapies, based on combinations of Versamune

and disease-specific antigens, designed to train the immune system to recognize diseased cells and effectively attack and destroy them.

We continue to advance our pipeline of candidates to address a wide range of cancers including HPV-positive

cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung prostate and ovarian cancers.

Our Infectimune -based vaccines have demonstrated the potential to induce, not only robust and durable neutralizing antibody

response, but also powerful T cell responses including long-lasting memory T cell responses.

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

In May 2022, we announced that two abstracts had been presented at the 2022 American Society of Clinical Oncology Annual Meeting:

Abstract number 6041, PDS0101 a novel type 1

interferon and CD8+ T cell activating immunotherapy in combination with pembrolizumab in subjects with recurrent/metastatic HPV16-positive squamous cell carcinoma (HNSCC) and Abstract number 2518, Phase II evaluation of the combination of

PDS0101, M9241, and bintrafusp alfa with HPV16+ malignancies.

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

Food and Drug Administration (the “FDA”) had granted

Fast Track designation to our lead candidate PDS010 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).

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

applications that would potentially treat serious or life-threatening conditions.

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

Treatments granted this designation are

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

It also provides the opportunity to submit

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

In addition, Fast Track designated products are eligible for

priority review at the time of NDA or Biologics License Application submission.

We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our Versamune ® , Versamune ® plus PDS0301and Infectimune ™ T cell-activating platforms and PDS0301 tumor targeting immunocytokine.

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

the activation of the right type, quantity and potency of T cells.

Versamune, and Versamune plus PDS0301 for treatments in oncology and Infectimune, for treatments in infectious disease.

When paired with an antigen, which is a disease-related

protein that is recognizable by the immune system, Versamune and Infectimune have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD4 helper and CD8

killer T cells, a specific sub-type of T cell that is more effective at killing infected or target cells.

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

Versamune plus PDS0301 enhances the

proliferation, potency and longevity of T cells in the tumor microenvironment and works synergistically to overcome tumor immune suppression.

Recent Developments

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

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

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

alfa with HPV16 positive malignancies.

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

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

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

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

potentially treat serious or life-threatening conditions.

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

Treatments granted this designation are given the

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

It also provides the opportunity to submit sections of a

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

In addition, Fast Track designated products are eligible for priority

review at the time BLA submission.

In October 2022, we announced the successful end-of-phase 2 meeting with the FDA including guidance on key elements of the clinical program that will support the submission of a

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

1 unchanged sentence

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

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

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

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

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

Our current pipeline of Versamune based targeted immunotherapies and Infectimune based therapies focuses on the use of selected disease-associated antigens that have been

demonstrated to be associated with a variety of solid tumors, as well as specific infectious diseases.

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

for the Society of Immunotherapy of Cancer (SITC):

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

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

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

PDS0301 is a novel investigational tumor-targeting fusion protein of Interleukin 12 that enhances the proliferation, potency, infiltration and longevity of T cells in the tumor microenvironment and is therefore designed to overcome the

limitations of cytokine therapy which today have resulted in high toxicity and limited therapeutic potential.

The proprietary combination of Versamune plus PDS0301 is designed to overcome tumor immune suppression utilizing a different mechanism

from immune checkpoint inhibitors (ICI).

The ownership of both assets we believe will streamline the registrational process and its use.

The combination of Versamune® and IL-12 to overcome immune suppression is

patented by PDS Biotech .

In a Phase 2 National Cancer Institute (NCI)-led clinical trial in ICI refractory patients, the combination of PDS0101 and PDS0301 administered

with an investigational bi-functional ICI resulted in a median overall survival of 21 months, which compares favorably to the historical median survival of 3-4 months reported in ICI refractory HPV-positive cancers when treated with ICIs and best

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

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

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

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

for the potential registrational trial.

In April 2023, we announced that an abstract was accepted for a poster discussion at the 2023 American Society of Clinical Oncology:

Abstract Number 6012, Safety

and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and Pembrolizumab in HPV16-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).

In addition, the Abstract was selected to be a featured poster to be reviewed

by an expert panel in the Head and Neck Cancer Discussion Session.

Clinical Candidate Pipeline

VERSATILE-002:

PDS0101 + KEYTRUDA®

In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab) which is the FDA-approved standard of care for first-line treatment of recurrent/ metastatic head and neck cancer commenced and is actively recruiting patients.

clinical trial will evaluate the efficacy and safety of this therapeutic combination as a first-line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection.

In this PDS Biotech-sponsored trial patients whose cancer has returned or spread following initial treatment will be treated with the combination of PDS0101 and KEYTRUDA® to evaluate if the addition of PDS0101 might

improve the efficacy reported in published studies of KEYTRUDA® alone.

Patients in the trial will receive a total of 5 cycles of combination therapy in the context of standard of care KEYTRUDA ® therapy administered every three weeks until disease progression.

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

– or ORR – at six months following initiation of treatment.

In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) which is the FDA-approved

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

Enrollment in stage 2 of 2 for the ICI naïve arm is almost complete, and enrollment in Stage 1 of the ICI refractory arm is complete.

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 PDS Biotech-sponsored trial patients whose cancer has returned following initial treatment or spread will be treated with the combination of PDS0101 and KEYTRUDA® to evaluate if the

addition of PDS0101 might improve the efficacy reported in published studies of KEYTRUDA® alone.

Patients in the trial will receive a total of 5 cycles of combination therapy in the context of standard of care KEYTRUDA® therapy administered every

three weeks until disease progression.

The primary endpoint of VERSATILE-002 is the objective response rate– or ORR – at six months following initiation of treatment.

There are two cohorts in the trial.

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

checkpoint inhibitor therapy (CPI refractory).

In February 2022, we announced we had achieved the preliminary efficacy milestone of at least four or more objective responses of the first 17 patients in the CPI naïve arm which now allows 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 CPI naïve arm.

We continue to enroll patients in

the first stage of the CPI refractory arm.

In May 2022, we announced additional preliminary efficacy and safety data from this trial at the ASCO Annual Meeting.

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

the 19 patients (efficacy).

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 refractory).

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

proceed to full enrollment.

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

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

J Clin Oncol 40, 2022

abstr 6041) .

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

Highlights from the abstract were as follows:

Response rates thus far* (tumor shrinkage greater than 30%) seen in 7/17 (41.2%) patients in comparison to the published results of approximately 19% for approved checkpoint inhibitors, used as monotherapy for

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

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%

8 unchanged sentences

Overall survival (OS) rate was 87.2%

no control or comparative studies have been conducted between checkpoint inhibitors and PDS0101

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

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

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

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

pembrolizumab.

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

attributed to the combination.

The DMC recommended continuing the trial with no modifications.

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

We are currently

evaluating the guidance on the key elements of the clinical program that will support the submission of a Biologics License Application for PDS0101.

We have currently completed development of the Phase 3 clinical program that will

support the submission of a Biologics License Application for PDS0101.

We expect to file the amended IND with the FDA during Q3 2023.

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

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

determine progression to stage 2 enrollment.

National Cancer Institute:

PDS0101+ M9241 +Bintrafusp Alfa

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

NHS-IL12 (M9241), and M7824 (Bintrafusp alfa), both of which are owned by EMD Serono (Merck KGaA) in patients with advanced/refractory HPV-positive cancers who have failed prior treatment.

PDS0101+ M9241 (now PDS0301) +Bintrafusp Alfa

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

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

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

clinical trial of PDS0101 for the treatment of advanced/refractory HPV-positive cancers had achieved its preliminary objective response target in patients naïve to checkpoint inhibitors which allowed for full enrollment of approximately 20

clinical trial of PDS0101 for the treatment of advanced/refractory HPV-positive cancers had achieved its preliminary objective response target in patients naïve to check point inhibitors which allowed for full enrollment of approximately 20

patients in this group.

In addition, based on promising results in the CPI naïve arm, the trial was amended to allow enrollment of a separate cohort of checkpoint inhibitor-refractory patients for assessment of safety and activity of the triple

Preliminary efficacy assessment of the triple combination in this added group of 20 checkpoint inhibitor refractory patients 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 Cancer 2020;8:e000612.

doi:10.1136/ jitc-2020-000612) , indicating that PDS0101 generated both HPV-specific T cells and an

associated antitumor response when used as a monotherapy.

When PDS0101 was combined with two other novel clinical-stage anti-cancer agents, Bintrafusp Alfa and M9241, the preclinical data suggested that all three therapeutic agents worked

synergistically to provide superior tumor T cell responses and subsequent tumor regression when compared to any of the agents alone or the 2-component combinations.

If the published preclinical data demonstrating powerful activity of the triple

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

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

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

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

CPI refractory group 42% (5/12) of patients had an objective response, and 1 subject had achieved a complete response with no evidence of disease.

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

provided in January 2022 showed as of December 31, 2021, that >40 subjects had been recruited into the trial and 30 HPV16-positive patients had been evaluated.

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

The historical survival of CPI naïve and CPI refractory advanced HPV-positive cancers when treated with CPI are 7-11 months and 3-4 months, respectively.

In June 2022, at the 2022 ASCO Annual Meeting, we provided an update to the preliminary data presented at the 2021 meeting.

This included data from 30 patients and highlights were

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

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

Preliminary efficacy assessment of the triple combination in this added group of 20 ICI refractory patients has been completed and evaluation of long-term patient survival 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 PDS0101 generated both HPV-specific T cells and an associated antitumor response when used as a monotherapy.

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

is now owned by us and referred to as PDS0301), the preclinical data suggested that all three therapeutic agents worked synergistically to provide superior tumor T cell responses and subsequent tumor

regression when compared to any of the agents alone or the 2-component combinations.

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

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

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

In the ICI refractory group

42% (5/12) of patients had an objective response, and 1 subject had achieved a complete response with no evidence of disease.

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

An update provided in January 2022

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

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

The historical

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

months in ICI refractory head and neck cancer .

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

Clin Oncol 40, 2022 [suppl 16;

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 checkpoint refractory patients:

M9241 dosing appears to affect response rates, with 5/8 (63%) patients receiving M9241 at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients who received M9241 at 8

With ICI refractory patients:

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

mcg/kg achieving an OR;

4/6 (67%) patients’ responses are ongoing (median 12 months).

Tumor reduction was seen in 45% (10/22) of patients with checkpoint-refractory disease, including patients receiving high or low dose M9241.

In checkpoint refractory patients treated with high or low dose M9241, survival outcomes were similar (p=0.96 by Kaplan Meier analysis).

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

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

At a median of 12 months of follow up 17/22 (77%) of patients were alive.

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

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.

2 unchanged sentences

There were no grade 5 treatment-related AEs.

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

In September 2022, we announced, in agreement with the NCI, that the CPI refractory patients had been selected as the preferred treatment group in the on-going PDS0101-based

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

We and the NCI hope to meet with the FDA in the coming months to discuss the

registrational path forward for the combination therapy as a potential third-line treatment for CPI refractory HPV-positive cancers.

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

In September 2022, we announced, in agreement with the NCI, that the ICI refractory patients had been selected as the preferred treatment group in the on-going PDS0101-based triple

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

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

Survival data:

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

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

Safety profile:

1 unchanged sentence

There were no Grade 3 treatment-related AEs.

HPV16-positive CPI naïve patients:

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 announced expanded interim data as follows:

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

The reported historical median OS in patients with ICI refractory disease is 3-4 months seen with

checkpoint inhibitors and best reported median survival to date with systemic therapy of 8.2 months in ICI refractory head and neck cancer.

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

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

Historically median OS for similar patients with platinum experienced ICI naïve

disease is 7-11 months.

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

In current approaches ORR is reported to be less than 10%.

ORR in ICI naïve patients with the triple combination is 88%.

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

Safety data have not changed since October’s update.

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

compared with approximately 70% of patients receiving the combination of ICIs and chemotherapy reporting Grade 3 and higher treatment-related AEs.

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

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

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

MD Anderson Cancer Center (IMMUNOCERV):

PDS0101+ Chemoradiotherapy

In October 2020, a third PDS0101 Phase 2 clinical study was initiated with The University of Texas MD Anderson Cancer Center and is actively recruiting patients.

This clinical

trial is investigating the safety and anti-tumor efficacy of PDS0101 in combination with standard-of-care chemo-radiotherapy, or CRT, and their correlation with critical immunological biomarkers in patients with locally advanced cervical cancer.

PDS Biotech believes that Versamune’s strong T cell induction has the potential to meaningfully enhance efficacy of the current standard of care CRT treatment in this indication.

The enrollment rate in this trial has been negatively impacted by

the COVID-19 pandemic and enrollment is on-going.

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

9 of the 17 patients have now completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer.

This includes 78% (7/9) of treated patients with

In October 2020, another PDS0101 Phase 2 IIT was initiated with The University of Texas MD Anderson Cancer Center and is actively recruiting patients.

This clinical trial is

investigating the safety and anti-tumor efficacy of PDS0101 in combination with standard-of-care chemo-radiotherapy, or CRT, and their correlation with critical immunological biomarkers in patients with locally advanced cervical cancer.

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

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

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).

7 unchanged sentences

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

The increase in HPV16-specific T cells generated

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

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

1 unchanged sentence

PDS0101 Monotherapy and in combination with KEYTRUDA ®

In February 2022 we announced the initiation of an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the checkpoint

inhibitor, KEYTRUDA ® , in patients with HPV-positive oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence.

In February 2022, we announced the initiation of an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the immune checkpoint inhibitor, KEYTRUDA ® , in patients with HPV-associated 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 of Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers.

We believe that this upcoming trial not only broadens our

addressable patient population of those affected by the increasing incidence of HPV(+)OPSCC, but also allows us to better understand the activity of PDS0101 alone or in combination with KEYTRUDA ® in earlier stages of disease.

David Routman, Katharine Price, Kathryn

Van Abel, and Ashish Chintakuntlawar at Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers.

We believe that this trial not only broadens our addressable patient population of

those affected by the increasing incidence of HPV(+)OPSCC, but also allows us to better understand the activity of PDS0101 alone or in combination with KEYTRUDA ® in

earlier stages of disease.

This trial is currently open for enrollment.

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

Treatment in this setting is referred to as neoadjuvant treatment.

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

recurrent/metastatic HPV-positive cancers.

This trial will explore whether PDS0101 with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic regression, and decreases

in circulating tumor DNA (ctDNA).

Our clinical development strategy of combining PDS0101 with standard of care treatment is designed to mitigate risk in our proof-of-concept phase 2 trials.

It is also designed to

demonstrate the potential for significantly enhanced clinical benefit to patients over the standard of care, without compounding toxicity.

If we achieve this goal, we believe that we will have a clear path towards commercialization of PDS0101 in

multiple indications.

After initial commercial approval, our strategy of combining PDS0101 with standard of care also positions us for rapid market penetration and expansion.

Other Versamune ® -Based Products in Development:

Treatment in this setting is referred to as

neoadjuvant treatment.

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

recurrent/metastatic HPV-associated cancers.

This trial will explore whether PDS0101 with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic regression, and

decreases in circulating tumor DNA (ctDNA).

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

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

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

numbers of polyfunctional tumor targeted killer T cells.

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

(NCT00972309).

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

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

evaluating the next steps in the clinical development of PDS0102 and are seeking nondilutive financings to move the program into human trials.

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

PDS0103 is an investigational

immunotherapy owned by us and designed to treat cancers associated with the mucin-1, or MUC-1, oncogenic protein.

PDS0103 is an investigational immune therapy owned

by PDS Biotech and designed to treat cancers associated with the mucin-1, or MUC1, oncogenic protein.

These include cancers such as ovarian, breast, colorectal and lung cancers.

PDS0103 combines Versamune with novel highly

immunogenic agonist epitopes of MUC-1 developed by the NCI and licensed by PDS.

PDS0103 is currently in late preclinical development.

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.

PDS0103 combines Versamune with novel highly immunogenic agonist

epitopes of MUC1 developed by the NCI and licensed by PDS.

PDS0103 is currently in the tech transfer and 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.

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

In preclinical studies, and similarly to PDS0101, PDS0103 demonstrated the ability to generate

powerful MUC1-specific CD8 killer T cells.

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

CD8 killer T cells.

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

However, the actual submission date may potentially be

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

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

may delay PDS0103 initiation.

However, the actual submission date may potentially be impacted by the allocation

of resources to initiate the pivotal trial for PDS0101.

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

Our current pipeline of Versamune based therapies is as follows:

IL-12 Oncology Immunocytokine Pipeline

PDS0301 (formerly known as NHS-IL-12 and M9241) is a novel investigational antibody conjugated (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 PDS0301 works synergistically to overcome tumor immune suppression and to promote a targeted T cell attack against

As with Versamune, PDS0301 is given by a simple subcutaneous injection.

Clinical data suggests the addition of PDS0301 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 PDS0301, we believe we have simplified our registrational pathway for the NCI-led triple combination by owning

both PDS0101 and PDS0301 and combining these agents with an FDA approved ICI.

PDS0301 has been designed to overcome the limitations of cytokine therapy as explained above, and based on extensive preclinical studies performed at the NCI

evaluating PDS0301 as a monotherapy and also in combinations with established standard of care treatments for cancer we believe that PDS0301 has significant potential as a cytokine therapy independent of Versamune.

Based on the informative

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

A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination with the Immunocytokine M9241(PDS0301) in Localized High and Intermediate Risk Prostate Cancer Treated with Androgen

Deprivation Therapy

A Phase I/II Study of M9241 (PDS0301) in Combination with Docetaxel in Adults with Metastatic Castration Sensitive and Castration Resistant Prostate Cancer

Phase I/II of 9241 (PDS0301) going forward as a Monotherapy in Advanced Kaposi Sarcoma

Phase I/II of M9241 (PDS0301) in Combination of with a Histone Deacetylase (HDAC) Inhibitor in ICI refractory MUC1-posiive colon and bladder cancers among others

We are working closely with the NCI to determine the determine the best pathway forward for the prioritized PDS0301 studies, as well as evaluating the use of PDS0301 in combination with other

Versamune based clinical candidates.

Our current pipeline of antibody conjugated PDS0301 based therapies is as follows:

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 announced preclinical data on our universal flu program sponsored by the National Institute of Allergy and Infectious Disease

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

Ted Ross at the University of Georgia to generate broadly protective anti-influenza immune

responses across multiple strains of influenza.

This data as well as our COVID-19 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 promising data recently announced with the universal seasonal flu vaccine and the current focus of the NIAID in developing more effective flu vaccines, we have

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

This will involve development of a universal seasonal

flu vaccine and the potential development of a universal pandemic influenza vaccine based on similar computationally designed antigens as have shown promise with Infectimune.

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 announced preclinical data on our universal flu program sponsored by the National Institute of Allergy and Infectious Disease (NIAID) demonstrating the

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

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

of influenza.

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

Current preventive and prophylactic vaccine

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

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

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

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

This will involve development of a universal seasonal flu vaccine and

the potential development of a universal pandemic influenza vaccine based on similar computationally designed antigens as have shown promise with Infectimune.

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

2 unchanged sentences

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

The results for Infectimune based PDS0202 and PDS0203 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).

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

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

Our net losses were $21.7 million, and $10.6 million for the nine months ended September 30,

Our net losses were $9.7 million, and $8.5 million for the three months ended March 31, 2023

and 2022, respectively.

As of September 30, 2022, we had an accumulated deficit of $82.4 million.

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

and administrative costs associated with these operations.

As of September 30, 2022, we had $71.6 million in cash and cash equivalents.

As of March 31, 2023, we had an accumulated deficit of $111.2 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 March 31, 2023, we had $65.2 million in cash and cash equivalents.

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

the timing and costs of our planned clinical trials;

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

the timing and costs of our planned oncology and infectious disease clinical trials;

the timing and costs of our planned preclinical studies of our Immuno-oncology and vaccine clinical candidates;

the outcome, timing and costs of seeking regulatory approvals;

23 unchanged sentences

As a result, we are unable to

determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.

Results of Operations

The following table summarizes the results of our operations for the three months ended September 30, 2022 and 2021:

The following table summarizes the results of our operations for the three months ended March 31, 2023 and 2022:

Three Months Ended

September 30,

(in thousands)

Operating expenses:

Research and development expenses

General and administrative expenses

Total operating expenses

Loss from operations

Interest income (expense), net

Net loss and comprehensive loss

Research and Development Expenses

Research and development (R&D) expenses increased to $4.4 million for the three months ended September 30, 2022 from $3.7 million for the three months ended September 30, 2021.

The increase of $0.7 million in 2022 was primarily attributable to an increase of $0.2 million in clinical study and research costs, $0.3 million in personnel costs and $0.4 million in manufacturing services partially offset by a decrease of $0.2

million in professional fees and facilities.

General and Administrative Expenses

General and administrative expenses decreased to $2.9 million for the three months ended September 30, 2022 from $3.3 million for the three months ended September 30, 2021.

decrease of $0.4 million is primarily attributable to a decrease of $0.5 million in personnel, a decrease of $0.1 million in facilities offset by an increase of $0.2 million in professional fees.

Comparison of the Nine Months Ended September 30, 2022 and 2021

The following table summarizes the results of our operations for the nine months ended September 30, 2022 and 2021:

Nine Months Ended

September 30,

Increase (Decrease)

(in thousands)

Operating expenses:

Research and development expenses

3 unchanged sentences

Interest income (expense), net

Benefit from income taxes

Net loss and comprehensive loss

Research and Development Expenses

Research and development (R&D) expenses increased to $13.3 million for the nine months ended September 30, 2022 from $7.9 million for the same period in 2021.

The increase of $5.4 million was

primarily attributable to an increase in personnel costs of $1.8 million of which $0.5 million was non-cash stock compensation, clinical studies of $1.5 million, manufacturing and quality of $1.9 million, and research and consumables $0.2 million.

Research and development (R&D) expenses increased to $5.8 million for the three months ended March 31, 2023 from $5.2

million for the three months ended March 31, 2023.

The increase of $0.6 million in 2023 was primarily attributable to an increase of $0.2 million in clinical studies and medical affairs , $0.

8 million in personnel costs and $0.

1 million in professional fees offset by a decrease of $0.

5 million manufacturing .

General and Administrative Expenses

General and administrative expenses increased to $9.6 million for the nine months ended September 30, 2022 from $7.3 million for the same period in 2021.

The $2.3 million increase

was primarily attributable to an increase in personnel costs of $1.2 million of which $0.8 million was non-cash stock compensation, and professional and legal costs of $1.1 million.

Benefit from Income Taxes

Income tax benefit was $1.2 million for the nine months ended September 30, 2022 and $4.5 million for the nine months Ended September 30, 2021.

A decrease of $3.3 million was due to

a smaller portion of the accumulated Net Operating Losses (NOL) through 2020 available for sale.

General and administrative expenses increased to $3.6 million for the three months ended March 31, 2023 from $3.3 million for the three months ended March 31, 2022.

The increase of $0.3 million is primarily attributable to a n increase of $0.

8 million in personnel costs offset by a decrease of $0.

5 million in professional fees.

Liquidity and Capital Resources

In July 2020, we filed a shelf registration statement, or the 2020 Shelf Registration Statement, with the SEC, for the issuance of common stock, preferred stock, warrants, rights,

debt securities and units, which we refer to collectively as the Shelf Securities, up to an aggregate amount of $100 million.

The 2020 Shelf Registration Statement was declared effective on July 31, 2020.

The 2020 Registration Statement was

terminated upon effectiveness of the 2022 Registration Statement (as discussed below).

In August 2020, we sold 6,900,000 shares of our common stock at a public offering price of $2.75 per share pursuant to the 2020 Shelf Registration Statement, which includes 900,000

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

We received gross proceeds of approximately $19.0 million and net proceeds of

approximately $17.1 million, after deducting underwriting discounts and offering expenses.

In May 2021, we received approximately $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant our participation in the New Jersey

Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020.

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

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

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

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

In April 2022, we received approximately $1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant our participation in the New

Jersey Technology Business Tax Certificate Transfer NOL program for State Fiscal Year 2020.

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

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

debt securities, and units, which the Company refers to collectively as the Shelf Securities, up to an aggregate amount of $150 million, $50 million of which covers the offer, issuance and sale by the Company of its common stock under the Sales

Agreement (as discussed below).

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

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

The 2022 Shelf Registration Statement was

declared effective on September 2, 2022.

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

5 unchanged sentences

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

We are not obligated to make

any sales of our common stock under the Sales Agreement.

The offering of Placement Shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Placement Shares subject to the Sales Agreement or (ii) termination of

the Sales Agreement in accordance with its terms.

During the quarter ended September 30, 2022, we did not sell any shares of our common stock pursuant to the Sales Agreement.

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

obligated to make any sales of our common stock under the Sales Agreement.

The offering of Placement Shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Placement Shares subject to the Sales Agreement or

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

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

During the quarter ended

March 31, 2023, we sold 553,293 shares of our common stock with a net value of $4.6 million pursuant to the Sales Agreement.

In August 2022, we entered into a venture loan and security agreement, or the Loan and Security Agreement, with Horizon Technology Finance Corporation, as lender and collateral

1 unchanged sentence

The Loan and Security Agreement provides for the following 6 separate and independent term loans:

(a) a term loan in the amount of $7,500,000, or Loan A, (b) a term loan in the amount of $10,000,000, or

Loan B, (c) a term loan in the amount of $3,750,000, or Loan C, (d) a term loan in the amount of $3,750,000, or Loan D, (e) a term loan in the amount of $5,000,000, or Loan E, and (f) a term loan in the amount of $5,000,000, or Loan F, (with each

of Loan A, Loan B, Loan C, Loan D, Loan E, and Loan F, individually a Loan and, collectively, the Loans).

(a) a term loan in the amount of $7,500,000, or Loan A, (b) a term loan in the amount of $10,000,000, or Loan

B, (c) a term loan in the amount of $3,750,000, or Loan C, (d) a term loan in the amount of $3,750,000, or Loan D, (e) a term loan in the amount of $5,000,000, or Loan E, and (f) a term loan in the amount of $5,000,000, or Loan F, (with each of

Loan A, Loan B, Loan C, Loan D, Loan E, and Loan F, individually a Loan and, collectively, the Loans).

Loan A, Loan B, Loan C, and Loan D were delivered to us on August 24, 2022.

Loan E and Loan F are uncommitted Loans that may be advanced

by the lenders upon their discretion prior to July 31, 2023 upon the satisfaction of certain agreed upon conditions precedent.

Loan E and Loan F are uncommitted Loans that may be advanced by the

lenders upon their discretion prior to July 31, 2023 upon the satisfaction of certain agreed upon conditions precedent.

We may only use the proceeds of the Loans for working capital or general corporate purposes.

Each Loan matures on the

48-month anniversary following the applicable funding date unless accelerated pursuant to agreed upon events of default.

Each Loan matures on the 48-month

anniversary following the applicable funding date unless accelerated pursuant to agreed upon events of default.

The principal balance of each Loan bears a floating interest.

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%;

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)

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.

9 unchanged sentences

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

As of September 30, 2022, we had $71.6 million in cash and cash equivalents.

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

expenditures.

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.

As of March 31, 2023, we had $65.2 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.

1 unchanged sentence

after the filing of this Quarterly Report on Form 10-Q.

Based on such evaluation and our current plans, which are subject to change, management believes that our existing cash and cash equivalents as of September 30, 2022 will be sufficient to

satisfy our operating cash needs for at least one year after the filing of this Quarterly Report on Form 10-Q.

Based on such evaluation and our current plans, which are subject to change, management believes that our existing cash and cash equivalents as of March 31, 2023 will be sufficient to satisfy

our operating cash needs into the third quarter of 2024.

We plan to continue to fund our operations and capital funding needs through equity and/or debt financings.

6 unchanged sentences

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

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 clinical development or future

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

1 unchanged sentence

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 provided by financing activities

Net increase in cash and cash equivalents

Net decrease in cash and cash equivalents

Net Cash Used in Operating Activities

Net cash used in operating activities was $18.2 million and $8.0 million for the nine months ended September 30, 2022 and 2021 , respectively.

The increase in net cash used in operating activities of $10.2 million was primarily due to an increase

in net loss of $11.1 million, an increase in prepaid expenses of $1.1 million, and an increase in finance right to use asset of $0.3 million, offset by an increase in stock compensation of $1.4 million, an increase in amortization of debt discount

of $0.1 million, and an increase in accounts payable of $0.7 million.

Net cash used in operating activities was $13.2 million and $6.4 million for the three months ended March 31, 2023 and 2022 , respectively.

The increase in net cash used in operating activities of $6.8 million was primarily due to an

increase in net loss of $1.2 million, reduced by the increase in the non-cash stock-based compensation expense of $1.0 million, offset by changes in the timing of working capital requirements, including changes in prepaid expenses and other assets,

accrued expenses and accounts payable.

Net Cash Provided by Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2022 was primarily due to the receipt of net proceeds of $24.6 million due to a note payable.

Net cash provided by financing activities for the three months ended March 31, 2023 was due to the receipt of net proceeds of $4.6 million due to the sale of common stock under the

Sales Agreement.

Operating Capital Requirements

11 unchanged sentences

Our budgeted cash requirements in 2023 and beyond include expenses related to continuing development and clinical studies.

We believe that our existing cash and cash equivalents as of September 30, 2022

are sufficient to continue operations and research and development programs for at least one year after the date of this Quarterly Report.

Until we can generate significant cash from our operations, we expect to continue to fund our operations with

available financial resources.

We believe that our existing cash and cash equivalents as of March 31, 2023 are

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

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

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

4 unchanged sentences

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

the effects of health epidemics, pandemics, or outbreaks of infectious diseases, including the recent COVID-19 pandemic, on our business operations, financial condition, results of operations and cash flows;

the effects of health epidemics, pandemics, or outbreaks of infectious diseases, on our business operations, financial condition, results of operations and cash flows;

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

4 unchanged sentences

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

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

the initiation, progress, timing and results of our commercialization of our clinical 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.

13 unchanged sentences

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, 2022 from those disclosed in our Annual Report on Form 10-K for the

There have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2023 from those disclosed in our Annual Report on Form 10-K for the

year ended December 31, 2022.

Operations and Liquidity

While the potential economic impact brought by and over the duration of the COVID-19 pandemic may be difficult to assess or predict, the COVID-19 pandemic has resulted

in significant disruption of global financial markets, which could in the future negatively affect our liquidity.

In addition, a recession or market volatility resulting from the COVID-19 pandemic could affect our business.

We have taken

proactive, aggressive action throughout the COVID-19 pandemic to protect the health and safety of our employees and expect to continue to implement these measures until we

determine that the COVID-19 pandemic is adequately contained for purposes of our business.

W e may take further actions as government authorities require or recommend or as we determine to be in the best

interests of our employees.

Given the nature and type of our short-term investments, we do not believe that the COVID-19 pandemic will have a material impact on our current investment liquidity.

Outlook and Impact of COVID-19 on our Business

In December 2019, a novel (new) coronavirus known as SARS-CoV-2 was first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease, known as

COVID-19, that has now spread globally.

On January 30, 2020, the World Health Organization (WHO) declared COVID-19 a public health emergency.

The Secretary of Health and Human Services declared a public health emergency on January 31, 2020, under

section 319 of the Public Health Service Act (42 U.S.C.

247d), in response to the COVID-19 outbreak.

On March 11, 2020, the WHO declared COVID-19 a pandemic and on March 13 the President declared a national emergency in response to the pandemic.

The full impact of the COVID-19 pandemic is unknown and rapidly evolving.

The COVID-19 pandemic has and could continue to negatively affect our liquidity and operations.

To date, two of the three recently initiated PDS0101 clinical trials were

delayed, specifically as a result of the adverse impact the COVID-19 pandemic has had on clinical trial operations for cancer indications in the United States.

The FDA issued and since updated guidance to assist sponsors in assuring the safety of

trial participants, maintaining compliance with Good Clinical Practice (GCP) and minimizing risks to trial integrity.

Clinical trial sites have implemented institution-specific measures securing the safety of patients and staff to ensure the

integrity of the trials in the face of the ongoing pandemic.

All three studies have since been initiated despite the pandemic challenges;

however, the evolving COVID-19 pandemic has impacted the pace of enrollment in clinical trials in general and

we may be negatively affected with our trials.

COVID-19 related travel and other restrictions may also impact the potential for on-site monitoring visiting and audits and inspections by us, third parties, and regulators.

There may be shortages of

site personnel and equipment necessary for the timely completion of our trials.

We are providing support to address these challenges, but these mitigation measures may not overcome the obstacles that the pandemic has wrought which continue to

impede progress of clinical trials.

Although there is uncertainty related to the anticipated impact of the COVID-19 pandemic on our future results, we believe our current cash reserves, leave us well-positioned to

manage our business through this crisis as it continues to unfold.

However, the impacts of the COVID-19 pandemic are broad-reaching and continuing and the financial impacts associated with the COVID-19 pandemic are still uncertain.

Off-Balance Sheet Arrangements

1 unchanged sentence

Smaller Reporting Company

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

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

6 unchanged sentences

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis