What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-08-14 compared with 2023-05-15 · 250 added, 217 removed, 323 unchanged (59% of the section changed)

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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

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;

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

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;

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

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

Risk Factors.

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We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our Versamune ® , Versamune ® plus PDS0301 and 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.

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

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

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

When paired with an antigen, which

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

CD4 helper and CD8 killer T cells, a specific sub-type of T cell that is more effective at killing infected or target cells.

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

Versamune plus PDS0301 enhances the

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

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.

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 expanded our VERSATILE-002 clinical trial into Europe and in June 2022, 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

American Society of Virology meeting:

Companies with 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 BLA as they are received instead of waiting for the entire BLA submission.

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 BLA.

In July 2022, we announced the presentation of 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.

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

In November 2022, we presented 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-positive malignancies treated with triple combination immunotherapy.

In December 2022, we executed an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor targeting 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

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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.

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

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

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

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

Clinical Candidate Pipeline

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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.

Enrollment in stage 2 of 2 for the ICI naïve arm and the ICI refractory 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 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 ®

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

weeks until disease progression.

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

There are two cohorts in the trial.

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

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 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.

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

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 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 16;

abstr 6041) .

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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.

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

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.

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

We have completed the plan for the Phase 3 clinical program that will support the submission of a BLA for PDS0101 and have submitted to the FDA .

In December 2022, we completed 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 is in progress .

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 and plan to initiate a phase 3 trial for ICI

(VERSATILE-003) in the fourth quarter of 2023.

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

Abstract number 6012, Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and Pembrolizumab in

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

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

in the Head and Neck Cancer discussion session.

The data from the abstract is as follows:

Estimated 12-month overall survival rate was 87.1%.

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

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

Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels*.

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

Confirmed and unconfirmed objective response rate is 41.2% (14/34 patients), which is identical to the preliminary response rate data PDS Biotech previously reported at ASCO 2022 (7/17 patients).

To date these responses have been

confirmed in nine of the 34 patients (26.5%), including one complete response.

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

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

4/48 (8.3%) of patients had a Grade 3 treatment-related adverse event (TRAE).

No Grade 4 or higher TRAEs were observed.

National Cancer Institute:

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

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

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

patients in this group.

In February 2021, the NCI’s Phase 2 clinical trial of

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

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

Preliminary efficacy assessment of the triple combination in this added group of 20 ICI refractory patients has been completed and evaluation of long-term patient survival ongoing.

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

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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 .

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

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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:

In September 2022, we determined, in agreement with the NCI, to select the ICI refractory patients as the preferred treatment group in the on-going PDS0101-based triple combination therapy in advanced HPV-positive cancers and the trial was closed to further enrollment given

the ICI refractory arm had been fully recruited.

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

Survival data:

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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:

In December 2022, we presented 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.

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.

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 refractory patients who received the optimal dose of the triple combination is 63% (5/8).

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

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

Safety data had not changed since October’s update.

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

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

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

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

MD Anderson Cancer Center (IMMUNOCERV):

PDS0101+ Chemoradiotherapy

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

This clinical trial is

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

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:

In October 2020, another PDS0101 Phase 2 IIT was initiated with The University of Texas MD Anderson Cancer Center

and is actively recruiting patients.

This clinical trial is investigating the safety and anti-tumor efficacy of PDS0101 in combination with standard-of-care chemo-radiotherapy, or CRT, and their correlation with critical immunological biomarkers

in patients with locally advanced cervical cancer.

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

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

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

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

advanced cervical cancer (FIGO stage III or IV).

This included 78% (7/9) of

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

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

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

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

residual disease.

One patient who received 3 of the 5 scheduled doses of

PDS0101 showed signs of residual disease.

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

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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.

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

In February 2022, we initiated an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the immune checkpoint inhibitor, KEYTRUDA ® , in patients with HPV-positive oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence.

The trial is being led by Drs.

David Routman, Katharine Price, Kathryn

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

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

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

earlier stages of disease.

David Routman, Katharine Price, Kathryn Van

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

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

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

stages of disease.

This trial is currently open for enrollment.

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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).

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).

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

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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.

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

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

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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.

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 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 allocation

of resources to initiate the pivotal trial for PDS0101.

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 by the end of 2023.

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.

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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.

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

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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 II Study Evaluating ICI Naïve and Refractory Patients with HPV-postive malignancies treated with PDS0301, PDS0101 and bintrafusp alfa.

A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination with the Immunocytokine PDS0301in Localized High and Intermediate Risk Prostate Cancer Treated with Androgen Deprivation

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

Phase I/II of 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.

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

We are working closely with the NCI to 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:

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treatment and preventive options in several infectious disease indications.

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

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.

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

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

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

This will involve development of a universal seasonal flu vaccine and

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

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

American Society of Virology meeting:

Based on the promising data 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, universal flu vaccine preclinical data for PDS0202 at the 41 st American Society of Virology meeting:

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

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

The results for Infectimune based PDS0202 and PDS0203 vaccines were published in two separate articles in the peer reviewed journal Viruses

in February 2023:

The 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.

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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:

Viruses 2023, 15 , 538).

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

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

and 2022, respectively.

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 net losses were $21.2

million, and $14.3 million for the six months June 30, 2023 and 2022, respectively.

As of June 30, 2023, we had an accumulated deficit of $122.8 million.

Substantially all of our net losses have resulted from costs incurred in connection with our

research and development programs and from general and administrative costs associated with these operations.

As of June 30, 2023, we had $60.6 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 oncology and infectious disease clinical trials;

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

the timing and costs of our planned clinical trials;

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

the outcome, timing and costs of seeking regulatory approvals;

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internal manufacturing 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.

probability of successful commercialization of our drug 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 candidates.

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

may never succeed in achieving marketing approval.

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

capability and commercial viability.

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

of our product candidates.

Results of Operations

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

The following table summarizes the results of our operations for the three months ended June 30, 2023 and 2022:

Three Months Ended

(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

Net loss and comprehensive loss

Research and Development Expenses

Research and development (R&D) expenses increased to $8.0 million for the three months ended June 30, 2023 from $3.8 million for the three months ended June 30, 2022 .

The increase of $4.2

million is primarily attributable to an increase of $1.4 million in clinical trials , $0.5 million in personnel costs, including $0.2 million in non-cash

stock-based compensation and $2.3 million in manufacturing expenses .

General and Administrative Expenses

General and administrative expenses increased to $4.7 million for the three months ended June 30, 2023 from $3.3 million for the three months ended June 30, 2022.

The increase of

$1.4 million is primarily attributable to an increase of $0.5 million in personnel costs, including $0.4 million in non-cash stock-based compensation and $0.9 million in professional fees.

Benefit from Income Taxes

Income tax benefit was $1.4 million for the three months ended June 30, 2023 and $1.2 million for the three months ended June 30, 2022.

The increase of $0.2 million

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

Comparison of the Six months June 30, 2023 and 2022

The following table summarizes the results of our operations for the six months June 30, 2023 and 2022:

Six Months Ended

Increase (Decrease)

(in thousands)

Operating expenses:

Research and development expenses

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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 $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 .

Research and development (R&D) expenses increased to $13.8 million for the six months June 30, 2023 from $8.9

million for the six months ended June 30, 2022 .

The increase of $4.9 million was primarily attributable to an increase in personnel costs of $1.4 million,

including $0.7 million in non-cash stock-based compensation, clinical trials of $1.6 million and manufacturing expenses of $1.9 million.

General and Administrative Expenses

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.

General and administrative expenses increased to $8.3 million for the six months June 30, 2023 from $6.6 million for the six months ended June 30, 2022.

The increase of $1.6

million was primarily attributable to an increase in personnel costs of $1.2 million, including $1.0 million in non-cash stock-based compensation and professional and legal costs of $0.4 million.

Benefit from Income Taxes

Income tax benefit was $1.4 million for the six months ended June 30, 2023 and $1.2 million for the six months ended June 30, 2022.

The increase of $0.2 million

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

Liquidity and Capital Resources

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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.

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 have provided the Agents with customary indemnification and contribution rights.

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

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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

agent for itself and the other lenders.

During the three and six

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

In August 2022, we entered into a venture loan and security agreement, or the Loan and Security Agreement, with

Horizon Technology Finance Corporation, as lender and collateral agent for itself and the other lenders.

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 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.

(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 could have been advanced by the lenders upon the Parties agreement prior to July 31, 2023 upon the satisfaction of certain agreed upon conditions.

The Parties are in discussion to extend this option, however, there is no guarantee that such an option

will be extended on terms favorable to the Company or its existing stockholders, or at all.

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

Each Loan matures on the 48-month

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

The principal balance of each Loan bears a floating interest.

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.

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.

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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.

As of June 30, 2023, we had $60.6 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

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 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 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 June 30, 2023 will be sufficient to satisfy our operating cash needs for 12 months following the filing of this Quarterly Report on Form 10-Q .

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

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

Three Months Ended March 31,

Six Months Ended June 30,

Net cash used in operating activities

Net cash provided by financing activities

Net decrease in cash and cash equivalents

Net increase in cash and cash equivalents

Net Cash Used in Operating Activities

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 used in operating activities was $18.0 million and $12.3 million for the six months ended June 30, 2023 and 2022, respectively.

The increase in net cash

used in operating activities of $5.7 million was primarily due to an increase in net loss of $6.9 million, reduced by the increase in the non-cash stock-based compensation expense of $2.0 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 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

Net cash provided by financing activities for the six months ended June 30, 2023 was due to the receipt of net proceeds of $4.8 million due to the sale of common stock under the

Sales Agreement.

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To date, we have not generated any product revenue.

We do not know when, or if, we will generate any product revenue and we do not expect to generate significant product revenue

unless and until we obtain regulatory approval and commercialize one of our current or future product candidates.

We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue

the development of, and seek regulatory approvals for, our tablet vaccine candidates, and begin to commercialize any approved vaccine candidates.

We are 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 vaccine candidates, and begin to commercialize any approved vaccine candidates.

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 2023 and beyond include expenses related to continuing development and clinical studies.

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.

We believe that

our existing cash and cash equivalents as of June 30, 2023 are sufficient to continue operations and research and development programs for 12 months following the

filing of this Quarterly Report on Form 10-Q .

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.

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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, 2023 from those disclosed in our Annual Report on Form 10-K for the

year ended December 31, 2022.

There have been no material changes to our critical accounting policies and estimates during the six months ended June 30, 2023 from those disclosed in our Annual Report on Form 10-K for the year

ended December 31, 2022.

Off-Balance Sheet Arrangements

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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