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Item 2. Management’s Discussion and Analysis

2025-08-13 compared with 2025-05-14 · 296 added, 264 removed, 326 unchanged (63% of the section changed)

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

The following discussion and analysis of

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

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

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

The following discussion and analysis

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

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

Cautionary Note Regarding Forward-Looking Statements

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equity financings;

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

risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or clinical and product candidates;

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

likelihood of the Company’s successful implementation of such business plan;

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

the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or clinical and product candidates;

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

the likelihood of the Company’s successful implementation of such business plan;

the timing for the Company or its partners to initiate the planned clinical trials for

its Versamune® products, including Versamune® HPV (formerly PDS0101) , Versamune®

MUC1 (formerly PDS0103), and others, alone or in combination with PDS01ADC, as well as Infectimune® based clinical candidates and the future success of such trials;

its Versamune® products, including PDS0101 (Versamune® HPV) , PDS0103 (Versamune® MUC1), and others, alone or in combination with PDS01ADC, as well as Infectimune®

based clinical candidates and the future success of such trials;

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

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th e success, timing and cost of the Company’s ongoing clinical trials and anticipated

clinical trials for the Company’s current clinical candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which

assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or

data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials;

which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results

or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials;

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

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

its clinical development programs and any collaboration trials;

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

from its clinical development programs and any collaboration trials;

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

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Risk Factors.

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

performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by

these forward-looking statements.

Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events or to our future

financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or

implied by these forward-looking statements.

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

Except as required by law, we assume no obligation to update or revise these forward-looking statements for any

reason, whether as a result of new information, future events or otherwise.

Except as required by law, we assume no obligation to update or revise these forward-looking statements

for any reason, whether as a result of new information, future events or otherwise.

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

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We believe that our proprietary combinations of Versamune®

and PDS01ADC together with immune checkpoint inhibitors or other standards of care, may enhance the proliferation, potency and longevity of antigen specific multifunctional CD8 T cells in the tumor microenvironment and work synergistically to inhibit

or treat cancer.

inhibit or treat cancer.

Recent Developments

In February 2023, we announced a successful completion of a

Type B meeting with the FDA for the triple combination of Versamune® HPV and PDS01ADC with an FDA-approved immune checkpoint inhibitor for the treatment of

recurrent/metastatic, ICI resistant head and neck cancer that is positive for the HPV type 16.

In recent interactions with the FDA, we confirmed the required contents of a clinical protocol for the potential registrational trial.

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

Abstract number 6012, Safety and Efficacy of

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

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

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

Working Group on Influenza (ESWI) conference.

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

of the pandemic H1N1 flu virus.

In October 2023, data demonstrating Versamune® HPV in

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

The data from the IMMUNOCERV Phase 2

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

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

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

treatment of recurrent/metastatic head and neck cancer was presented at a key opinion leader roundtable that we sponsored.

In October 2023, interim safety and immune response data was presented for the first-in-human Phase1/2 clinical trial evaluating PDS01ADC

in combination with current SOC chemotherapy, docetaxel, to treat metastatic castration sensitive and castration resistant prostate cancer.

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

Cytokine & Interferon Society.

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

presented at the European Society for Medical Oncology Congress 2023.

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

16-positive cancers.

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

In November 2023, preclinical data from our NCI-led trial including Versamune® HPV , PDS01ADC and an HDAC inhibitor in ICI-resistant HPV-16 positive cancer was presented during a poster presentation at the Society for Immunotherapy of Cancer 38 th Annual Meeting.

In September 2024, we announced updated data from our VERSATILE-002 Phase 2 clinical trial presented during a poster session at the

European Society for Medical Oncology (ESMO) Congress 2024.

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

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

In March 2025, we announced the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating PDS0101 (Versamune® HPV) in

HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.

In July 2025, we announced that the colorectal cancer cohort of a phase 2 clinical trial with PDS01ADC met the pre-defined criteria

for expansion to stage 2 following positive stage 1 results.

Clinical Candidate Pipeline

VERSATILE-003:

Versamune® HPV + pembrolizumab

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

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

PDS0101 (Versamune® HPV) + pembrolizumab

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

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

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

As such, patients

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

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

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

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rate, duration of response and progression free survival.

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

and 18 months following full enrollment, respectively.

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

enrollment and 18 months following full enrollment, respectively.

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

VERSATILE-002:

Versamune® HPV (PDS0101) + Keytruda®

In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune® HPV in combination with Merck’s

anti-PD-1 therapy, Keytruda® (pembrolizumab) which is the FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer commenced.

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

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

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

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

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

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

There are two cohorts in the trial.

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

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

PDS0101 + Keytruda®

In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 in combination with Merck’s anti-PD-1

therapy, Keytruda® (pembrolizumab) which is the FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer commenced.

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

In this trial sponsored by PDS Biotech, patients whose cancer has returned following initial treatment or spread will be treated with

the combination of PDS0101 and Keytruda® to evaluate if the addition of PDS 0101 might improve the efficacy reported in published studies of Keytruda® alone.

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

until disease progression.

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

There are two cohorts

in the trial.

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

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

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

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

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

Data on 34 patients was presented.

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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).

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.

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No Grade 4 or higher TRAEs were observed.

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

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

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

VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune® HPV in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/metastatic head

and neck cancer.

Data on 52 patients was presented.

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In May 2024, at a virtual key opinion leader event, updated interim data was presented based on a November 30, 2023 cut-off from our

and neck cancer.

VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/metastatic head and

Data from 53 patients was presented.

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

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

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

The combination of PDS0101and Keytruda® appeared to be well tolerated with 11% (7/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 2%

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

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

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During the May 2024 event, we also announced an updated clinical strategy with a two-part registrational trial focused on the double

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

combination of Versamune® HPV + pembrolizumab, accompanied by an investigation of the triple combination of PDS0101 + PDS01ADC + pembrolizumab as a first line treatment in HPV16-positive recurrent/metastatic HNSCC.

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

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

Interim data was presented based on a May 17, 2024

The data update was as follows:

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

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

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

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

During the August 2024 update, we

announced our intent to initiate a registrational study in first line treatment in HPV16-positive recurrent/metastatic HNSCC with the double combination of Versamune® HPV + pembrolizumab.

In September 2024, we announced updated data from our VERSATILE-002 Phase 2 clinical trial presented during a poster session at the European

Society for Medical Oncology (ESMO) Congress 2024.

announced our intent to initiate a registrational study in first line treatment in HPV16-positive recurrent/metastatic HNSCC with the double combination of PDS0101 + pembrolizumab.

In September 2024, we announced updated data from our VERSATILE-002 Phase 2 clinical trial presented during a poster session at the

European Society for Medical Oncology (ESMO) Congress 2024.

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

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

In June 2025, we announced publication of an abstract at the American Society of Clinical Oncology (ASCO) Annual Meeting with updated

data from VERSATILE-002.

Main elements of the update were as follows:

Median Overall Survival (mOS) was 30.0 months overall;

39.9 months for patients with CPS≥20;

26.1 months for patients with CPS 1-19.

Median Progression Free Survival (mPFS) was 6.3 months overall;

14.1 months for patients with CPS≥20;

5.1 months for patients with CPS 1-19

Objective Response Rate (ORR) was 35.8% overall;

47.6% for patients with CPS≥20;

28.1% for patients with CPS 1-19

Tumor shrinkage of 90-100% was 20.8% overall;

28.6% for patients with CPS≥20;

15.6% for patients with CPS 1-19

Disease Control Rate (DCR) was 77.4% overall;

81.0% for patients with CPS≥20;

75.0% for patients with CPS 1-19

Median Duration of Response (DoR) was 21.8 months overall;

not yet estimable for patients with CPS≥20;

21.8 months for patients with CPS 1-19

National Cancer Institute:

Versamune® HPV+ PDS01ADC +Bintrafusp Alfa

PDS0101 + PDS01ADC +Bintrafusp Alfa

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

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

In February 2021, the NCI’s

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

patients in this group.

investigator-initiated trial evaluating PDS0101 with PDS01ADC, and M7824 (Bintrafusp alfa), which is owned by EMD Serono (Merck KGaA) in patients with advanced HPV-positive cancers who have failed prior treatment.

In February 2021, the NCI’s Phase 2

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

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

has been closed for enrollment.

The trial has been closed

for enrollment.

Preliminary efficacy assessment of the triple combination in this added group of 29 ICI resistant patients has been completed and evaluation of long-term patient survival is ongoing.

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Doi:10.1136/ jitc-2020-000612) , and indicate

that Versamune® HPV generated both HPV-specific T cells and an associated antitumor

that PDS0101 generated both HPV-specific T cells and an associated antitumor

response when used as a monotherapy.

When Versamune® HPV was combined with the two other novel clinical-stage anti-cancer agents, Bintrafusp Alfa and M9241 (which is now owned by us and referred to as PDS01ADC), the preclinical data suggested that all three therapeutic agents worked synergistically to provide superior tumor T cell responses and subsequent tumor regression when compared to any of the agents alone or the 2-component combinations.

The published preclinical data

demonstrating powerful activity of the triple combination appears to be corroborated in the Phase 2 trial, and this triple combination could form the basis of a unique

platform providing improved cancer treatments across multiple cancers.

In February 2023, we announced the completion of a Type B meeting with the FDA for the combination therapy of Versamune® HPV, PDS01ADC,

and an FDA-approved immune checkpoint inhibitor for the treatment of recurrent/metastatic HPV-positive ICI-resistant head and neck cancer.

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

owned by us and referred to as PDS01ADC), the preclinical data suggested that all three therapeutic agents worked synergistically to provide superior tumor T cell

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

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

In February 2023, we announced the completion of a Type B

meeting with the FDA for the combination therapy of PDS0101 , PDS01ADC, and an FDA-approved immune checkpoint inhibitor for the treatment of recurrent/metastatic

HPV-positive ICI-resistant head and neck cancer.

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

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MD Anderson Cancer Center (IMMUNOCERV):

HPV + Chemoradiotherapy

In October 2020, a Phase 2 Investigator Initiated Trial (IIT)

was initiated with The University of Texas MD Anderson Cancer Center and is actively recruiting patients.

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

We believe that Versamune® has strong

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

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

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

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

Radiation Oncology Annual Meeting which included the following:

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

+ Chemoradiotherapy

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

is actively recruiting patients.

This clinical trial is investigating the safety and anti-tumor efficacy of 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 October 2023, data demonstrating PDS0101 in

The data from the IMMUNOCERV Phase 2

clinical trial was featured in an oral presentation at the American Society for Radiation Oncology Annual Meeting which included the following:

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

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

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100% of patients treated with

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

Versamune® HPV Monotherapy and in combination with Keytruda®

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

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

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

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

PDS0101 had cancer that had spread to the lymph nodes.

PDS0101 ( Versamune® HPV) Monotherapy and in combination with Keytruda®

In February 2022, we initiated an IIT, 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 conducted by the Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers.

believe that this trial allows us to better understand the activity of PDS0101 alone or in combination with Keytruda® in earlier stages of disease.

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

in this setting is referred to as neoadjuvant treatment.

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

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

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

pathologic regression, and decreases in circulating tumor DNA (ctDNA).

Versamune® MUC1 (formerly PDS0103)

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

clinical and preclinical development of Versamune® MUC1.

Versamune® MUC1 is an investigational immune therapy owned by PDS Biotech and designed to treat cancers associated with the mucin-1, or MUC1, oncogenic protein.

These include cancers such as

ovarian, breast, colorectal and lung cancers.

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

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

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

Treatment in this setting is referred to as neoadjuvant treatment.

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

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

The trial will explore whether Versamune®HPV with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor

shrinkage, pathologic regression, and decreases in circulating tumor DNA (ctDNA).

PDS0103 (Versamune® MUC1)

In April 2020, the above mentioned CRADA between PDS Biotech and the NCI was expanded beyond PDS0101 (Versamune® HPV) to include

clinical and preclinical development of PDS0103.

PDS0103 is an investigational immune therapy owned by PDS Biotech and designed to treat cancers associated with the mucin-1, or MUC1, oncogenic protein.

These include cancers such as ovarian, breast,

colorectal and lung cancers.

PDS0103 combines Versamune® with novel highly immunogenic agonist epitopes of MUC1 developed by the NCI and licensed by us.

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

in breast, colorectal, lung and ovarian cancers, for which 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 Versamune® HPV,

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

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

metastatic colorectal cancer.

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

framed protein (TARP) from the NCI.

In preclinical studies, and similarly to PDS0101, PDS0103

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

In March 2025, we announced FDA clearance of our IND application for the combination of PDS0103 and PDS01ADC in treatment of metastatic

colorectal cancer.

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

reading framed protein (TARP) from the NCI.

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

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

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

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

tumor growth rates (NCT00972309).

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

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

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

slowing tumor growth rates (NCT00972309).

IL-12 Oncology Immunocytokine Pipeline

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With the exclusive global license agreement with Merck

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

PDS01ADC has been

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

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

KGaA, Darmstadt, Germany for PDS01ADC, we believe we have simplified our registrational pathway for the NCI-led triple combination by owning both PDS0101 and PDS01ADC and combining these agents with an FDA approved ICI.

PDS01ADC has been designed

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

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

Based on the informative preclinical studies, a number of IIT Phase 2 trials are currently in progress at the NCI, some of which are

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Phase 2 Study Evaluating ICI Naïve and Resistant Patients with HPV-positive malignancies

treated with PDS01ADC, Versamune® HPV and bintrafusp alfa.

treated with PDS01ADC, PDS0101 and bintrafusp alfa.

A Phase 2 Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination with the Immunocytokine PDS01ADC in Localized High and

Intermediate Risk Prostate Cancer Treated with Androgen Deprivation Therapy

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

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

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

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

Our net losses were $8.5 million, and $10.6

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

As of March 31, 2025, we had an accumulated deficit of $190.6 million.

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

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

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

Our net losses were $ 17.9 million, and $18.9 million for the six months ended June 30, 2025 and 2024, respectively.

As of June 30, 2025, we had an accumulated deficit of $200.

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, 2025, we had $31.9 million in cash and cash equivalents.

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

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Infectimune® Development Strategy

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

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

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

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

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

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

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

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

Ted Ross at the University of Georgia to generate broadly protective

anti-influenza immune responses across multiple strains of influenza.

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

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

protective vaccines.

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

However, the induction of T cell responses, in addition to antibody responses, provides more

durable and broad protection against infectious diseases.

Based on the preclinical data with the universal seasonal flu vaccine and the current focus of the NIAID in developing more effective flu

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

However, the induction of T cell responses, in addition to antibody responses,

provides more durable and broad protection against infectious diseases.

Based on the preclinical data with the universal seasonal flu vaccine and the current focus of the NIAID in developing more effective

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

This will involve development of a universal seasonal flu

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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.

Dramatically enhanced CD4 T cell responses

to recombinant influenza proteins compared to leading commercial vaccine adjuvants (Henson TR et al.

Viruses 2023, 15, 538).

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We have not generated any revenues from commercial product sales and do not expect to generate any such revenue in the near future.

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

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

Research and Development Expenses

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

We may never succeed

in achieving marketing approval for our clinical and product candidates.

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

competition, manufacturing capability and commercial viability.

succeed in achieving marketing approval for our clinical and product candidates.

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

trials, competition, manufacturing capability and commercial viability.

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

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Results of Operations

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

The following table summarizes the results of our operations for the three months ended June 30, 2025 and 2024:

Three Months Ended

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Research and Development Expenses

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

The decrease of $0.

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

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

1 million in manufacturing costs .

Research and development (R&D) expenses decreased to

$4.2 million for the three months ended June 30, 2025 from $4.5 million for the three months ended June 30, 2024 .

The decrease of $0.3 million was primarily attributable to a decrease of $0.4 million in manufacturing costs, a decrease of $0.9 million in personnel costs, offset by an increase of $1.0 million in clinical trial costs

General and Administrative Expenses

General and administrative expenses decreased to $3.

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

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

The decrease of $0.

1 million was primarily

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

1 million in professional fees .

4 million for the three months ended June 30, 202 5 from $4.2 million for the three months ended June 30, 202 4 .

The decrease of $0.8 million was primarily attributable to a decrease of $0.4 million in personnel costs and $0.4 million in professional fees.

Benefit from Income Taxes

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

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

Income tax benefit was $0 for the three months ended June 30, 2025 and $0.9 million for the three months ended June 30, 2024.

decrease of $0.9 million was due to the timing of proceeds received from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate

Transfer Net Operating Loss (NOL) Program.

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

The tax benefit of $1.2 million was received in March 2025 and reflected as an income tax benefit for the three months ended March 31, 2025.

Comparison of the Six months June 30, 2025 and 2024

The following table summarizes the results of our operations for the six months ended June 30, 2025 and 2024:

Six Months Ended

Increase (Decrease)

(in thousands)

Operating expenses:

Research and development expenses

General and administrative expenses

Total operating expenses

Loss from operations

Interest income (expense), net

Benefit from income taxes

Net loss and comprehensive loss

Research and Development Expenses

Research and development expenses decreased to $ 10.

0 million for the six months ended June 30, 2025 from $11.2 million for the six months ended

June 30, 2024 .

The decrease of $1.2 million was primarily attributable to a decrease of $0.5 million manufacturing and quality costs, a decrease of $1.1 million

in personnel costs offset by an increase of $0.4 million in clinical trial costs.

General and Administrative Expenses

General and administrative expenses decreased to $6.7 million for the six months ended June 30, 202 5 from $7.6 million for the six months

ended June 30, 202 4 .

The decrease of $0.9 million was primarily attributable to a decrease of $0.5 million in personnel costs and $0.4 million in professional fees.

Benefit from Income Taxes

Income tax benefit was $1.2 million for the six months ended June 30, 2025 and $0.9 million for the six months ended June 30, 2025.

increase of $0.3 million was due to an increase in the amount of New Jersey NOL carryforwards sold when compared to the comparable period.

The New Jersey Economic Development Authority (NJEDA), Technology Business Tax Certificate Transfer (NOL)

program has a lifetime cap of $20 million per business.

We have reached the cap and we will no longer be eligible to participate in the program.

Liquidity and Capital Resources

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

stock, preferred stock, warrants, rights, debt securities, and units, up to an aggregate amount of $150 million, approximately $97 million of which covers the offer, issuance and sale by us of our common stock under the Sales Agreement and the New

Sales Agreement (as discussed below).

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

common stock, preferred stock, warrants, rights, debt securities, and units, up to an aggregate amount of $150 million, approximately $97 million of which covers the offer, issuance and sale by us of our common stock under the Sales Agreement and the

New Sales Agreement (as discussed below).

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

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

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

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

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

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

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

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

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

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

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The New Sales Agreement superseded and replaced the Sales Agreement.

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

For the year ended December 31, 2024, we sold

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

During the three months ended March 31, 2025,

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

the Sales Agreement.

In August 2022, the Company entered into a

venture loan and security agreement, or the Loan and Security Agreement, with Horizon Technology Finance Corporation, as lender and collateral agent for itself and the other lenders.

During the three and six months ended June 30, 2025, we sold 960,511 and 1,165,861 shares, respectively, of our common stock with a net

value of $1.5 million and $1.8 million, respectively, pursuant to the New Sales Agreement.

During the three and six months ended June 30, 2024, we sold 0 and 3,428,681 shares, respectively, of its common stock with a net value of $0 and $19.5

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.

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

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

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

In connection with the Loan and Security Agreement, we issued Horizon Technology Finance Corporation and Powerscourt Investments XXV, LP

warrants to purchase an aggregate total of 381,625 shares of our common stock at an initial exercise price of $3.6685 per share.

Each warrant is classified as equity and is exercisable at any time for a period beginning on the date of grant and

ending on the earlier of (A) 10 years from the date of grant, and (B) the closing of (A) (i) the sale, lease, exchange, conveyance or other disposition of all or substantially all of the our property or business, or (ii) its merger into or

consolidation with any other corporation (other than a wholly-owned subsidiary of the Company), or any transaction (including a merger or other reorganization) or series of related transactions, in which more than 50% of the voting power of the

Company is disposed of, in each case, for cash or for marketable securities meeting certain requirements as described in the applicable warrants.

The key assumptions used in Black-Scholes option pricing model were (i) expected term of 10 years, (ii) a risk-free rate of 3.11% , (iii) expected volatility of 93.8% , and (iv) n o estimated dividend yield.

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

pursuant to its participation in the New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2022.

The Company’s indebtedness under the Loan and Security

Agreement was satisfied in full and retired in full with a portion of the proceeds received from the Securities Purchase Agreement, as discussed below.

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

corporation pursuant to its participation in the New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2022.

In January and February of 2025, we received approximately $1.2 million from the net sale of tax benefits to an unrelated, profitable

New Jersey corporation pursuant our participation in the New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2023.

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

In February 2025, we entered into a securities purchase agreement with certain purchasers, pursuant to which we agreed to sell an

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

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The February 2025 Offering closed on February 28, 2025.

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

party lenders and JGB Collateral LLC , as collateral agent.

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

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

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

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

Company’s indebtedness under the Loan and Security Agreement.

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

On April 30, 2025, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain third party

lenders and JGB Collateral LLC, as collateral agent.

Pursuant to the Securities Purchase Agreement, the we agreed to sell (i) senior secured convertible debentures in an aggregate principal amount of $22,222,222 (collectively, the “Debentures”) and

(ii) warrants to purchase up to 1,000,000 shares of common stock, for an exercise price of $2.52 per share (collectively, the “Warrants”), subject to adjustments as set forth in the Warrants, for a total purchase price of $20,000,000.

Approximately

$19 million of the proceeds from the transactions contemplated by the Securities Purchase Agreement were used to satisfy in full and retire our indebtedness under the Loan and Security Agreement.

The remaining proceeds from the transactions

contemplated by the Securities Purchase Agreement will be used for general corporate purposes and transaction expenses.

Pursuant to the Debentures, we must at all times maintain a cash balance equal to the lesser of (a) $15.0 million and (b) the

then-outstanding principal balance of the Debentures plus $3.0 million, in a deposit account subject to an account control agreement.

In addition, for as long as any portion of the Debentures remain outstanding, we are generally restricted from:

incurring indebtedness;

granting or suffering liens on any of our property or assets;

amending our organizational documents;

repurchasing any of our securities;

paying dividends;

selling, disposing, licensing or leasing our assets other than in the

ordinary course;

and other customary restrictive covenants.

Beginning on August 28, 2025, the holders of the Debentures may require us to redeem a portion of the Debentures in an amount up to $500,000 per calendar month in the aggregate by providing

written notice to us.

In connection with the Securities Purchase Agreement, on April 30, 2025, we also entered into a Security Agreement (the “Security Agreement”), pursuant to which we and our subsidiary granted, for the benefit of the investors, to

secure our obligations under the Securities Purchase Agreement and the Debentures, (i) first priority liens on certain assets, in each case subject to permitted liens described in the Security Agreement.

In addition, on April 30, 2025, we and our

subsidiary entered into a Subsidiary Guarantee, pursuant to which we and our subsidiary guaranteed all of our obligations under the JGB Purchase Agreement and the Debentures.

As of June 30, 2025, we had $31.9 million in cash and cash equivalents.

Our primary uses of cash are to fund operating expenses,

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sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market immunotherapies that we would otherwise prefer to

develop and market ourselves In addition, the Debentures allow for the lenders to call the outstanding balance of the Debentures if we fail to maintain minimum cash balances outlined in the Debentures.

Any of these actions could harm our business,

results of operations and prospects.

develop and market ourselves.

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

Any of these actions could harm our

business, results of operations and prospects.

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

As a result of these uncertainties, we have concluded that substantial doubt exists about our ability to continue as a going concern for a

period of at least 12 months from the date of the issuance of these unaudited Condensed Consolidated Financial Statements.

As a result of these uncertainties, we have concluded that substantial doubt exists about our ability to continue as a going concern for

a period of at least 12 months from the date of the issuance of these unaudited Condensed Consolidated Financial Statements.

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

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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

Net cash used in operating activities

Net cash used in investing activities

Net cash provided by financing activities

Net increase (decrease) in cash and cash equivalents

Net (decrease) increase in cash and cash equivalents

Net Cash Used in Operating Activities

Net cash used in operating activities was $9.0 million and

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

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

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

Net cash used in operating activities was $18.1 million and $18.8 million for the six months ended June 30, 2025 and 2024,

respectively.

The decrease in net cash used in operating activities of $0.7 million was primarily due to a decrease in non-cash stock-based compensation expense of $ 1.7

million offset by a decrease in net loss of $ 1.0 million and changes in the timing of working capital requirements, including changes in prepaid expenses and other

assets, accrued expenses and accounts payable.

Net Cash Used in Investing Activities

Net cash used in investing activities for the six months ended June 30, 2025 and 2024 was $0, respectively.

Net Cash Provided by Financing Activities

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

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

loan repayment.

Net cash provided by financing activities for the six months ended June 30, 2025 and 2024 decreased by $11.7 million primarily due to a

$22.8 million decrease in proceeds due to the repayment of the Loan and Security Agreement, a $17.7 million decrease in proceeds from the issuance of common stock from the Sales Agreement, a $0.5 million decrease in proceeds from the exercise of

stock options, offset by a $19.2 million increase in proceeds from the Securities Purchase Agreement and a $10.2 million increase in proceeds from the issuance of common stock, warrants and pre-funded warrants from the February 2025 Offering.

Operating Capital Requirements

To date, we have not generated any product revenue.

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

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

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

the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any approved products.

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

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

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

additional funding in connection with our continuing operations.

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

expect to generate significant product revenue unless and until we obtain regulatory approval and commercialize one of our current or future product candidates.

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

expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any approved products.

We are subject to all of the risks incident to the development of new

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

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

need substantial additional funding in connection with our continuing operations.

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

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While we intend to finance our cash needs

principally through equity or debt financings, collaborations, strategic alliances, or license agreements with third parties, there is no assurance that new financing will be available to us on commercially acceptable terms or in the amounts required,

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

We have concluded that

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

required, if at all.

In addition, the securities Purchase Agreement allows for the lenders to call the outstanding balance of the term loans if we fail to maintain the minimum cash balances outlined in the Securities Purchase Agreement.

concluded that substantial doubt exists about our ability to continue as a going concern for a period of at least 12 months from the date of the issuance of these unaudited Condensed Consolidated Financial Statements.

We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our

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

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

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

our operations.

Purchase Commitments

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Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which

have been prepared in accordance with U.S.

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements,

which have been prepared in accordance with U.S.

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

As described in Note 2, the preparation of

these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the expenses

incurred during the reporting periods.

Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying

value of assets and liabilities that are not readily apparent from other sources.

As described in Note 2, the

preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as

well as the expenses incurred during the reporting periods.

Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making

judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

Estimates are assessed each period and updated to reflect current information.

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

We believe that the discussion in our management’s discussion and analysis addresses our most critical accounting policies, which are those that are most important to the portrayal of our financial condition and results of operations and require

management’s most difficult, subjective and complex judgments.

There have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2025 from

Actual results may differ from these estimates under

different assumptions or conditions.

results of operations and require management’s most difficult, subjective and complex judgments.

There have been no material changes to our critical accounting policies and estimates during the six months ended June 30, 2025 from

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

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Smaller Reporting Company

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

the JOBS Act.

However, we remain a “smaller reporting company,” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended.

We will cease to be a smaller reporting company if we have a non-affiliate public float in excess of $250

million and annual revenues in excess of $100 million, or a non-affiliate public float in excess of $700 million, determined on an annual basis.

As a smaller reporting company, we are permitted and intend to rely on exemptions from certain disclosure

requirements that are applicable to other public companies that are not smaller reporting companies.

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

We are a “smaller reporting company,” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended.

We will cease to

be a smaller reporting company if we have a non-affiliate public float in excess of $250 million and annual revenues in excess of $100 million, or a non-affiliate public float in excess of $700 million, determined on an annual basis.

reporting company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not smaller reporting companies.

We will continue to take advantage of some or all of the

available exemptions.

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis