Item 2. Management’s Discussion and Analysis
ITEM 2.
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, 2025 on Form
10-K, filed with the Securities and Exchange Commission, or SEC, on March 30, 2026.
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report contains forward-looking statements (including within the meaning of Section 21E of the United States Securities
Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning the Company and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events,
results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include
statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,”
“forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual
results could differ materially from those contained in any forward-looking stateme nt as a result of various factors, including, without limitation:
●
the Company’s recent strategic refocus to prioritize the development of PDS0301 and to discontinue the VERSATILE-003 Phase 3 clinical trial of
PDS0101 may not achieve the anticipated benefits and involves significant risks and uncertainties;
●
the Company’s ability to protect its intellectual rights;
●
the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for
future equity financings;
●
the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its clinical and product candidates,
and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or clinical and product candidates;
●
the Company’s limited operating history in the current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan
or the likelihood of the Company’s successful implementation of such business plan;
●
the timing for the Company or its partners to initiate the planned clinical trials for PDS0301 (formerly PDS01ADC) ;
●
the Company’s ability to successfully secure partnership(s) for the further development of its PDS0101 program;
●
the Company may not be able to identify, negotiate, or consummate strategic partnerships or other externally funded opportunities for the continued
development of PDS0101, and any such partnerships may not be on favorable terms;
●
the Company may expend its limited resources to pursue PDS0301 and fail to capitalize on other product candidates or indications that may be more
profitable or for which there is a greater likelihood of success;
●
the discontinuation of the VERSATILE-003 Phase 3 trial and the Company’s limited cash resources may further impact the Company’s ability to continue
as a going concern;
●
the successful implementation of the Company’s research and development programs and collaborations, including any collaboration trials concerning the Company’s
PDS0301,Versamune® and Infectimune® based clinical and product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of
the Company’s clinical and product candidates;
●
th e success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current
clinical candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our
currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily
indicative of the final results of the Company’s ongoing clinical trials;
●
expectations for the clinical and preclinical development, manufacturing, regulatory approval, and commercialization of the Company’s clinical and product
candidates;
●
any Company statements about its understanding of clinical and product candidates’ mechanisms of action and interpretation of preclinical and early clinical
results from its clinical development programs and any collaboration trials; the acceptance by the market of the Company’s clinical and product candidates, if approved;
●
the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with
respect to, the Company’s clinical and product candidates; and
●
other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other
disruptions to normal business operations arising from or related to those listed under Part II, Item 1A. Risk Factors.
Given these uncertainties, you sho uld not place undue reliance on these
forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, whether as a result of new information, future events or otherwise.
In this Quarterly Report, unless otherwise stated or the context otherwise indicates, references to “PDS Biotech,” “the Company,” “we,”
“us,” “our” and similar references refer to PDS Biotechnology Corporation, a Delaware corporation, and subsidiary.
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Company Overview
We are a clinical-stage biotechnology company focused on developing PDS0301, a tumor-targeted IL-12 immunocytokine designed to
modify the tumor microenvironment and enhance the activity and durability of anti-cancer therapies. Our current development strategy prioritizes PDS0301, including its development in colorectal cancer and evaluation in other indications.
We also develop our proprietary Versamune® platform for
treatments in oncology and Infectimune® for treatments in infectious diseases. Our most advanced Versamune® drug candidate, PDS0101, was evaluated in multiple clinical trials and we seek to further the development of PDS0101 through strategic
partnerships.
We believe our investigational 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. PDS0301, Versamune®, and Versamune® in combination with PDS0301 are being developed for
treatments in oncology and Infectimune® is being developed for treatments in infectious disease. PDS0301 is an investigational tumor
targeting IL-12 that we believe may enhance the proliferation, potency and longevity of T cells in the tumor microenvironment.
Recent Developments
In March 2025, we announced the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating PDS0101 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 PDS0301 in combination with Hepatic Artery Infusion Pump
(HAIP) and systemic therapy met the pre-defined criteria for expansion to stage 2 following positive stage 1 results.
In August 2025, we announced final topline survival data from our VERSATILE-002 Phase 2 trial in head and neck cancer.
In October 2025, we announced our intent to seek expedited approval pathway for PDS0101 in
HPV16-positive head and neck cancer based on final VERSATILE-002 trial data showing robust median progression free survival and increased median over all survival of the patients.
In December 2025, we announced the scheduling of a type C meeting with the FDA to discuss a proposed accelerated approval pathway for
PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Patients already enrolled in VERSATILE-003 prior to the amendment remain on the trial and continue to receive treatment.
In February 2026, we announced the adoption of an amended protocol for our VERSATILE-003 Phase 3 trial incorporating progression free survival (PFS) as
a primary endpoint for interim analysis and potential accelerated approval.
In August 2026, we announced a strategic refocus to prioritize PDS0301, our tumor-targeted IL-12 immunocytokine, as our lead
development program. As part of this strategic update, we announced our plan to cease further internal investments in PDS0101, including the discontinuation of the VERSATILE-003 Phase 3 trial, and our intention to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101 .
Clinical Candidate Pipeline
IL-12 Oncology Immunocytokine Pipeline
PDS0301 is a novel investigational IL-12 fused antibody drug conjugate (IgG1), tumor-targeting interleukin 12 (IL-12)
immune-cytokine that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Together with Versamune® based immunotherapies PDS0301 works synergistically to overcome tumor immune suppression and to promote a
targeted T cell attack against cancers. As with Versamune®, PDS0301 is given by a simple subcutaneous injection. Clinical data suggests the addition of PDS0301 to Versamune® based immunotherapies may demonstrate significant disease control in
advanced cancer patients by shrinking tumors and/or prolonging life.
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PDS0301 has been designed to overcome the limitations of cytokine therapy as explained above, and based on extensive preclinical studies performed
at the NCI evaluating PDS0301 as a monotherapy and also in combinations with established standard of care treatments for cancer, we believe that PDS0301 has significant potential as a cytokine therapy. Based on the informative preclinical studies,
a number of ITT Phase 2 trials are currently in progress at the NCI, some of which are outlined below:
●
A Phase 2 trial evaluating PDS0301 in combination with hepatic artery infusion pump (HAIP) and systemic therapy for subjects with metastatic colorectal cancer,
intrahepatic cholangiocarcinoma, or metastatic adrenocortical carcinoma
●
A Phase 2 trial evaluating ICI naïve and resistant patients with HPV-positive malignancies
treated with PDS0301, PDS0101 and bintrafusp alfa
●
A Phase 2 trial evaluating T-cell clonality after stereotactic body radiation therapy alone and in combination with the immunocytokine PDS0301 in localized
high and intermediate risk prostate cancer treated with androgen deprivation therapy
●
A Phase 1/2 trial evaluating PDS0301 in combination with docetaxel in adults with metastatic castration sensitive and castration resistant prostate cancer
●
A Phase 1/2 trial evaluating PDS0301 going forward as a monotherapy in advanced kaposi sarcoma
●
A Phase 1/2 trial evaluating PDS0301 in combination with a histone deacetylase (HDAC) inhibitor in ICI-resistant MUC1-positive colon and bladder cancers among
others
In October 2023, interim safety and immune response data was presented for the first-in-human Phase1/2 clinical trial evaluating PDS0301 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. The data presented included the following:
●
Decrease in PSA levels was seen in all patients at all three tested doses of PDS0301 and 61% of patients had at least a 60% decrease in PSA levels.
●
All doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia.
●
Administration of the combination was associated with decreases in T reg cells and increases in activated natural killer (NK) cells, memory CD8 T cells,
proliferating CD4 and CD8 T cells and cytokines INF-γ and Interleukin 10 (IL-10).
●
The changes in immune responses with the combination were independent of the PDS0301 dose.
In April 2026, we announced the publication of clinical and immunological biomarker
data from Stage 1 of a Phase 2 trial evaluating PDS0301 in the March 10, 2026 issue of Journal of Clinical Oncology (JCO) Oncology Advances . Key findings from stage 1 of the Phase 2 trial are outlined below:
●
Objective response rate by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS0301, the ORR was 35% (7/20)
●
24-month survival rate: Approximately 85%; in the parallel study without PDS0301, the 2-year survival rate was approximately 40%
●
Extrahepatic progression-free survival (PFS): median not reached at minimum follow-up of 13.1 months; in the parallel trial without PDS0301, the PFS was 8.1
months
We are working closely with the NCI to determine the
best pathway forward for the prioritized PDS0301 studies. In January 2025, we submitted an investigational new drug application to the FDA for a Phase 1 trial with PDS0301 and PDS0103 in colorectal cancer. At the time of this Quarterly
Report, we have not initiated this trial.
VERSATILE-003: PDS0101 + pembrolizumab vs pembrolizumab
In March 2025, we initiated our VERSATILE-003 Phase 3 clinical trial evaluating the combination of PDS0101 in combination with the
anti-PD-1 therapy pembrolizumab versus pembrolizumab as a monotherapy. The clinical trial was designed to evaluate the efficacy and safety of this therapeutic
combination as a first line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection.
In this trial, sponsored by us, patients whose cancer has returned following initial treatment or spread (metastasized) were treated with either the combination of PDS0101and pembrolizumab or with pembrolizumab alone, to evaluate if the addition of PDS0101 might improve the efficacy of
pembrolizumab alone. Patients in the trial received a total of 5 cycles of combination therapy in the context of standard of care pembrolizumab therapy administered
every three weeks until disease progression. The primary endpoint of VERSATILE-003 was median overall survival, or mOS, at six months following initiation of
treatment. Following discussions with the FDA in December 2025, we amended the trial’s protocol, among other modifications, to include progression-free survival (PFS) as an interim primary endpoint of the trial. Patients already enrolled prior to the
amendment remain on the trial and continue to receive treatment.
In August 2026, we announced the discontinuation of the trial.
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VERSATILE-002: PDS0101 + Keytruda®
In November 2020, we commenced 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. Enrollment in stage 2 of 2 for the ICI-naïve arm and the ICI-resistant arms are
complete. The clinical trial evaluated the efficacy and safety of this therapeutic combination as a first and second line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection.
In this trial sponsored by us, patients whose cancer had returned following initial treatment or spread were 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 received 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 was the objective
response rate, or ORR, at six months following initiation of treatment. There were two cohorts in the trial. Cohort 1 was for patients who have yet to be treated with
an immune checkpoint inhibitor (ICI naïve) and cohort 2 which consisted of patients who had failed immune checkpoint inhibitor therapy (ICI resistant).
In May 2023, we completed enrollment in the ICI naïve arm. We filed our amended IND with the FDA in the third quarter of 2023. In
October 2023, we received feedback from the FDA on the amended IND.
In June 2023, an abstract was presented at the 2023
American Society of Clinical Oncology: Abstract number 6012, Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of 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. Data on 34 patients was presented. 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 previously
reported by us 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.
In October 2023, at a key opinion roundtable updated interim data was presented based on an August 2, 2023 cut-off from our VERSATILE-002
Phase 2 clinical trial evaluating the combination of PDS0101 in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/ metastatic head and neck cancer. Data
on 52 patients was presented. The data from the roundtable based on investigator assessment was as follows:
Highlights from the ICI naïve cohort include:
●
24-month overall survival (OS) rate is 74%; published 24-month survival rate of less than 30% for approved ICI.
●
12-month OS rate is 80%; published results of 30-50% with approved ICIs.
●
Tumor shrinkage seen in 60% (31/52) of patients.
●
Confirmed overall response rate ORR is 27% (14/52) to date.
●
Median progression-free survival (PFS) is 8.1 months to date; published results of 2-3 months PFS with approved ICIs.
●
13% (8/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 0% (0/62) experienced Grade 4 or 5 TRAE; published results
report 13-17% Grade 3-5 TRAE with approved ICI monotherapy.
●
60% (33/55) of patients have CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (22/55) have CPS score >20 (who
generally have a higher response to Keytruda®).
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Highlights from the ICI refractory cohort include:
●
The 12-month OS rate is 56%. The published median 12-month OS rate is 17% with no salvage chemotherapy following tumor progression on ICI (ICI Resistant).
●
0% (0/21) confirmed ORR suggests that PDS0101’s impact on survival does not appear to be dependent on tumor shrinkage.
●
4% (1/25) of patients experienced Grade 3 TRAE and 0% (0/21) patients experienced Grade 4 and 5 TRAE.
In May 2024, at a virtual key opinion leader event, updated interim data was presented based on a November 30, 2023 cut-off from our
VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck
cancer. Data from 53 patients was presented. The data from the event based on investigator assessment was as follows:
Highlights from the ICI naïve cohort with CPS > 1 included:
●
Median overall survival of 30 months; published results for ICIs are 7-18 months.
●
Confirmed overall response rate ORR of 34% (18/53) to date; published results for comparable patients receiving treatment with ICIs are less than 20%.
●
Confirmed complete responses, partial responses and stable disease according to RECIST v1.1 were seen in 75.5% of patients.
●
Median progression-free survival (PFS) of 6.3 months to date; published results of 2-3 months PFS with approved ICIs.
●
The combination of PDS0101 and Keytruda® appeared to be well tolerated with 11% (7/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 2%
(1/62) experienced Grade 4 or 5 TRAE; published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy.
●
60% (32/53) of patients had CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (21/53) have CPS score >20 (who generally have a higher
response to Keytruda®).
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. The data update was as follows:
●
Median Overall Survival of 30 months, consistent with data presented our key opinion leader event in May of 2024, which was based on a data cut as of November 30, 2023.
●
27 of the censored patients remained alive and were awaiting their next clinical assessment, 6 censored patients had withdrawn consent for further follow-up, and 2
patients had been lost to follow-up, and 18 patients had died.
●
The lower limit of the 95% confidence interval is 19.7 months, and the upper limit is not yet estimable, as the majority of patients continue to be followed for survival.
In August 2024, we provided an update to our clinical strategy following discussions with the FDA. During the August 2024 update, we
announced our intent to initiate a registrational trial 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. The main elements of the update were as follows:
●
Median Overall Survival (mOS) was 30 months with a lower 95% confidence interval of 19.7 months; Published mOS for pembrolizumab is 12-18 months
●
Objective Response Rate (ORR) of 36% (19/53); Published ORR for pembrolizumab is 19-25%
●
Disease Control Rate (DCR) is 77% (41/53)
●
21% (11/53) of patients had deep tumor responses and shrinkage of 90-100%
●
9% (5/53) of patients had a complete response
●
Treatment-related adverse events of Grade ≥3 were seen in 9 patients (Grade 3, n=8 and Grade 4, n=1)
In August 2025, we announced final topline survival data from our VERSATILE-002 Phase 2 trial in head and neck cancer.
53 patients were enrolled in the 1L R/M HNSCC arm of the trial:
●
The median overall survival (mOS) is 39.3 months in patients with CPS ≥ 1. The lower limit of the 95% confidence interval is 23.9 months, and the upper limit is not yet
estimable.
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MD Anderson Cancer Center (IMMUNOCERV): PDS0101 +
Chemoradiotherapy
In October 2020, a Phase 2 IIT was initiated with The University of Texas MD Anderson Cancer Center . This clinical trial investigated 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 .
In November 2022, data from this trial was included in a poster presentation at the 2022 SITC Annual Meeting which included the following:
●
9 of the 17 patients had completed a Day 170 post-treatment positron emission tomography, computed tomography (PET CT) scan to assess the status of the cancer. This
included 78% (7/9) of treated patients with advanced cervical cancer (FIGO stage III or IV).
●
100% (9/9) of patients treated with the combination of 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 had a CR died from an event unrelated to either their underlying disease or treatment.
●
1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of PDS0101 and CRT.
●
As previously reported, data confirmed PDS0101 treatment activates HPV16-specific CD8 T cells. This increase was not seen in patients who did not receive PDS0101. The
increase in HPV16-specific T cells generated by the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8 T cells are important mediators of antigen-specific immunity.
●
The data affirms that PDS0101 activates Type 1 interferon pathway in humans, mimicking the mechanism previously demonstrated in preclinical studies in animal models.
●
Toxicity of PDS0101 remains limited to low-grade local injection site reactions.
In October 2023, data demonstrating PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid
decline in human papillomavirus circulating cell-free DNA (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 PDS0101 plus chemoradiation (CRT) vs. SOC CRT alone 81.3% clearance after 3 weeks vs. 30.3% with SOC (p=0.0018),
and 91.7% of clearance at 5 weeks vs. 53.1% with SOC (p=0.0179).
●
Baseline ctDNA levels correlated with the International Federation of Gynecology and Obstetrics (FIGO) stage and lymph node involvement; 100% of patients treated with
PDS0101 had cancer that had spread to the lymph nodes.
In October 2024, we announced updated data from the IMMUNOCERV Phase 2 clinical trial evaluating PDS0101 with chemoradiation to treat
locally advanced cervical cancer presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024 which included the following:
●
All patients received at least 2 doses of PDS0101.
●
Median follow-up was 19 months.
●
36-month overall survival (OS) rate was 84.4%, and 100% for the eight patients who received all five doses of PDS0101. Historical published data show 36-month OS rate
with chemoradiation in this population of approximately 64%.
●
36-month progression free survival (PFS) rate was 74.9%, among all patients and 100% for the eight patients who received all five doses of PDS0101. Historical published
data show 36-month PFS rate with chemoradiation in this population of approximately 61%.
●
Complete metabolic response (CMR) was achieved in 15/17 (88%) patients.
●
PDS0101 appeared to be safe and well-tolerated. The most common treatment-related toxicities were injection site reactions in 12/17 (71%) patients .
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Mayo Clinic: PDS0101 Monotherapy and in combination with pembrolizumab
In February 2022, we initiated an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the immune
checkpoint inhibitor, pembrolizumab, in patients with HPV-positive oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence. The trial was 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.
In this trial, treatment was administered before
patients proceed to transoral robotic surgery (TORS) with curative intent. Treatment in this setting is referred to as neoadjuvant treatment. PDS0101 has been shown to induce killer T cells that target and kill HPV-positive cancers, either alone or
in combination with ICIs in preclinical studies, and in combination in clinical studies of patients with advanced recurrent/metastatic HPV-positive cancers. This trial explored
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).
National Cancer Institute: PDS0101 + PDS0301 + Bintrafusp Alfa
In November 2023, we released updated interim survival data as follows:
●
75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36 months; published median overall survival (OS) in similar patients is 7-11 months
●
12-month survival rate in (ICI) resistant patients of 72%
●
Median OS in ICI-resistant HPV-positive patients is approximately 20 months; published median OS is 3.4 months
PDS0103
In April 2020, an existing Cooperative Research and Development Agreement (“CRADA”) between PDS Biotech and the NCI was expanded beyond
PDS0101 to include clinical and preclinical development of PDS0103. PDS0103 is an investigational immune therapy owned by us 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 PDS0101, PDS0103
demonstrated the ability to generate powerful MUC1-specific CD8 killer T cells.
In January 2025, we submitted an investigational new drug
application to the FDA for a Phase 1 trial with PDS0301 and PDS0103 in colorectal cancer. At the time of this Quarterly Report, we have not initiated this trial.
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Our current clinical pipeline of PDS0301 and Versamune® based therapies:
Infectimune® Development Strategy
We believe that the key differentiating attributes of the Infectimune® platform technology are strong induction of CD8 and CD4 T cells
as well as antibodies which can be leveraged to improve treatment and preventive options in several infectious disease indications. In January 2022, we presented preclinical data on our universal flu program sponsored by the National Institute of
Allergy and Infectious Disease (NIAID) demonstrating the potential of the Infectimune® technology with computationally designed influenza proteins developed by the laboratory of Dr. Ted Ross at the University of Georgia to generate broadly protective
anti-influenza immune responses across multiple strains of influenza. This data has provided a unique opportunity to highlight the potentially transformative
utility of Infectimune® in the development of more broadly effective and longer lasting protective vaccines. Current preventive and prophylactic vaccine approaches
and technologies predominantly focus on creating strong induction of antibody responses. However, the induction of T cell responses, in addition to antibody responses, provides more durable and broad protection against infectious diseases.
Based on the preclinical data with the universal seasonal flu vaccine and the current focus of the NIAID in developing more effective flu
vaccines, we have decided to focus our near-term infectious disease activities to align with the interests of the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) program. This will involve development of a universal seasonal flu
vaccine and the potential development of a universal pandemic influenza vaccine based on similar computationally designed antigens as have shown promise with Infectimune®.
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Clinical Development Strategy
Since our inception we have devoted substantially all our
resources to developing our Versamune® and Infectimune® platforms, and products derived thereof, as well as PDS0301. This includes advancing preclinical programs, conducting clinical trials, manufacturing PDS0101 and PDS0301 for clinical trials,
and providing general and administrative support. We have funded our operations primarily from the issuance of common stock and issuance of debt. We have not generated any product revenue to date.
We have never been profitable and have incurred net losses in each year since inception. Our net losses were $17.1 million, and $17.9
million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $233.7 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, 2026, we had $5.6 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 and ongoing clinical trials;
●
the outcome, timing and costs of seeking regulatory approvals;
●
the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;
●
the amount and timing of any payments we may be required to make in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any
patents or patent applications or other intellectual property rights; and
●
the extent to which we license or acquire other products and technologies.
SELECTED FINANCIAL OPERATIONS OVERVIEW
Revenue
We have not generated any revenues from commercial product sales and do not expect to generate any such revenue in the near future. We may
generate revenue in the future from a combination of research and development payments, license fees and other upfront payments or milestone payments.
Research and Development Expenses
Research and development expenses include employee-related
expenses, costs to acquire license rights to use certain technology in our research and development projects, costs of acquiring, developing and manufacturing clinical trial materials, as well as fees paid to consultants and various entities that
perform certain research and testing on our behalf. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment,
clinical site activations or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected
in the Condensed Consolidated Financial Statements as prepaid or accrued expenses. Costs incurred in connection with research and development activities are expensed as incurred .
We expect that our research and development expenses
will increase significantly over the next several years as we advance our PDS0301 product candidate into and through clinical trials, pursue regulatory approval of our Versamune® and PDS0301 product candidates and prepare for a possible
commercial launch, all of which will also require a significant investment in contract research services, manufacturing process validation and inventory related costs.
The process of conducting human clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed
in achieving marketing approval for our clinical and product candidates. The probability of successful commercialization of our clinical and product candidates may be affected by numerous factors, including clinical data obtained in future trials,
competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the
commercialization and sale of any of our clinical and product candidates.
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Index
Results of Operations
Comparison of the Three months June 30, 2026 and 2025
The following table summarizes the results of our operations for the three months ended June 30, 2026 and 2025:
Three Months Ended
June 30,
Increase ( Decrease)
2026
2025
$ Amount
%
(in thousands)
Operating expenses:
Research and development expenses
$
3,266
$
4,213
$
(947
)
(22
)%
General and administrative expenses
3,231
3,410
(179
)
(5
)%
Total operating expenses
6,497
7,623
(1,126
)
(15
)%
Loss from operations
(6,497
)
(7,623
)
1,126
(15
)%
Interest income (expense), net
(3,254
)
(1,811
)
(1,443
)
80
%
Net loss and comprehensive loss
$
(9,751
)
$
(9,434
)
$
(317
)
3
%
Research and Development Expenses
Research and development (R&D) expenses decreased to $3.3 million for the three months ended June 30, 2026 from $4.2 million for the
three months ended June 30, 2025. The decrease of $0.9 million was primarily attributable to a decrease of $1.0 million in clinical trial costs, a decrease of $0.4 million in manufacturing costs, and a decrease of $0.2 million in personnel costs,
partially offset by an increase of $0.7 million in stock-based compensation expense.
General and Administrative Expenses
General and administrative expenses decreased to $3.2 million for the three months ended June 30, 2026 from $3.4 million for the three months
ended June 30, 2025. The decrease of $0.2 million was primarily attributable to a decrease in professional fees.
Comparison of the Six months June 30, 2026 and 2025
The following table summarizes the results of our operations for the six months ended June 30, 2026 and 2025:
Six Months Ended
June 30,
Increase (Decrease)
2026
2025
$ Amount
%
(in thousands)
Operating expenses:
Research and development expenses
$
6,723
$
10,044
$
(3,321
)
(33
)%
General and administrative expenses
6,295
6,685
(390
)
(6
)%
Total operating expenses
13,018
16,729
(3,711
)
(22
)%
Loss from operations
(13,018
)
(16,729
)
3,711
(22
)%
Interest income (expense), net
(4,082
)
(2,364
)
(1,718
)
73
%
Benefit from income taxes
-
1,170
(1,170
)
(100
)%
Net loss and comprehensive loss
$
(17,100
)
$
(17,923
)
$
823
(5
)%
Research and Development Expenses
Research and development expenses decreased to $ 6.7 million for the six months ended June 30, 2026 from $1 0 . 0 million for the six months ended
June 30, 2025 . The decrease of $ 3 . 3 million was primarily attributable to a decrease of $ 2 .1 million in clinical trial costs, a decrease of $ 1 . 2
million manufacturing and quality costs, a decrease of $0.5 million in personnel costs, partially offset by an increase of $0.5 million in stock-based compensation expense.
28
Index
General and Administrative Expenses
General and administrative expenses decreased to $6. 3 million for the six months ended June 30, 202 6 from $ 6 . 7 million for the six
months ended June 30, 202 5 . The decrease of $0. 4 million was primarily
attributable to a decrease in professional fees.
Benefit from Income Taxes
Income tax benefit was zero for the six months ended June 30, 2026 and $1.2 million for the six months ended June 30, 2025. The decrease of $1.2 million was due to us having met the statutory $20 million lifetime cap on total cumulative value of NOLs sold, which makes us ineligible to continue
participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program.
Liquidity and Capital Resources
In August 2024, we entered into an Amended and Restated At Market Issuance Sales Agreement, or the New Sales Agreement, with B. Riley
Securities, Inc. and H.C. Wainwright & Co., LLC, with terms that are substantially consistent with those included in the original Sales Agreement. During the three and six months ended June 30, 2026, we sold 0 shares and 937,420 shares, respectively, of common stock with a net value of $0 million and $0. 8 million, respectively, pursuant to the New Sales Agreement. During the three and six months
ended June 30, 2025, we sold 960,511 and 1,165,861 shares, respectively, of common stock with a net value of $1.5 and $1.8 million, respectively, pursuant to the New Sales Agreement. The New Sales Agreement was terminated on May 1, 2026.
In June 2026, we entered into a Sales Agreement, or the
June 2026 Sales Agreement with Yorkville Securities, LLC and B. Riley Securities, Inc., with terms that are substantially consistent with those included in the New Sales Agreement. During the three and six months ended June 30, 2026, we
sold 0 shares and 937,420 shares, respectively, of our common stock with a net value of $0 million and $0.8 million, respectively, pursuant to the New Sales Agreement. 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 and $1.8 million, respectively, pursuant to the New Sales Agreement. The New Sales Agreement was
terminated on May 1, 2026.
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. Our 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 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 we agreed to sell an
aggregate of 6,396,787 shares of common stock, pre-funded warrants to purchase up to an aggregate of 933,334 shares of common stock, and common stock warrants to purchase up to an aggregate of 7,330,121 shares of common stock at a combined purchase
price of $1.50 per share and warrant, or the “February 2025 Offering”. Two of our directors participated in the February 2025 Offering and purchased 30,121 shares of common stock in the aggregate at an offering price per share of $1.66 and common stock
warrants to purchase 30,121 shares of common stock. The common stock warrants issued to our directors have an exercise price per share of $1.53 but are otherwise identical to the common stock warrants issued to all other participants in the February
2025 Offering. Aggregate gross proceeds from the February 2025 Offering were approximately $11 million. Net proceeds to us from the February 2025 Offering, after deducting the placement agent fees and other estimated offering expenses payable by us,
were approximately $10.05 million. The February 2025 Offering closed on February 28, 2025.
On April 30, 2025, we entered into a securities purchase agreement, or the “Securities Purchase Agreement” with certain third party
lenders and JGB Collateral LLC, as collateral agent. Pursuant to the Securities Purchase Agreement, 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. On April 30, 2026, the Company delivered a redemption notice
pursuant to which it irrevocably elected to prepay, for cash, all of the outstanding principal amount under each of the Debentures issued pursuant to the Securities Purchase Agreement. On June 15, 2026, the Company paid the applicable redemption
amount, equal to 103% of the principal amount outstanding plus all accrued and unpaid interest and all other amounts payable thereunder, and, upon such payment, each Debenture was redeemed in full and is of no further force or effect.
29
Index
In November 2025, we entered into a securities purchase agreement with certain purchasers, pursuant to which we agreed to sell an
aggregate of 5,741,000 shares of common stock, pre-funded warrants to purchase up to an aggregate of 59,000 shares of common stock, and common stock warrants to purchase up to an aggregate of 5,800,000 shares of common stock (the “November 2025
Offering”). The offering price per share of common stock was $0.91 and the purchase price of each pre-funded warrant was $0.9099. Each common warrant issued in connection with the November 2025 Offering had an exercise price of $1.00 per share, can be
exercised six months after the date of issuance and will expire five years thereafter. Aggregate gross proceeds from the November 2025 Offering were $5.3 million. Net proceeds to the Company from the offering, after deducting the placement agent fees
and other estimated offering expenses payable by the Company, were approximately $4.8 million. In addition, in connection with the November 2025 Offering, we entered into a warrant amendment agreement pursuant to which we agreed, effective upon closing
of the November 2025 Offering, to amend certain existing warrants to purchase up to an aggregate of 5,948,334 shares of common stock at an exercise price of $1.50 per share, so that the amended warrants will have a reduced exercise price of $1.00 per
share effective upon the closing of the November 2025 Offering and will be exercisable beginning on the date that is six (6) months after the closing of the November 2025 Offering. The November 2025 Offering closed on November 12, 2025.
On April 30, 2026, we entered into a securities purchase agreement (the “April 2026 Securities Purchase Agreement”) with YA II PN, LTD., a
Cayman Islands exempt limited company (the “Investor”). Pursuant to the securities purchase agreement, we agreed to issue and sell to the Investor and the Investor agreed to purchase from the Company (i) a promissory note in an aggregate principal
amount of $6,000,000 (the “Promissory Note”) and (ii) a warrant to purchase up to 2,158,274 shares of our Common Stock, par value $0.00033 per share, at an exercise price of $1.1824 per share, subject to adjustments (the “Warrant”). In addition, on
June 15, 2026, in connection with the transactions contemplated by the April 2026 Securities Purchase Agreement, we issued the Promissory Note and the Warrant to the Investor, we and the Investor entered into the Registration Rights Agreement and PDS
Operating Corporation, a Delaware corporation and wholly owned subsidiary of the Company and the Investor entered into a Guaranty Agreement.
On June 15, 2026, we entered into a Sales Agreement (the “June 2026 Sales Agreement”) with Yorkville Securities, LLC, an affiliate of
the Investor (“Yorkville Securities”), and B. Riley Securities, Inc. (“B. Riley Securities,” each of Yorkville Securities and B. Riley Securities individually an “Agent” and collectively, the “Agents”), with respect to an “at-the-market” offering
program pursuant to which we may offer and sell, from time to time at our sole discretion, shares of our Common Stock (the “Placement Shares”) having an aggregate offering price of up to $50,000,000 through or to the Agents, as sales agents or
principals. During the three months ended June 30, 2026, the Company sold 106,153 shares of common stock for a net value of $0.10 million, pursuant to the June 2026 Sales
Agreement.
As of June 30, 2026, we had $5.6 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 beyond the filing of this Quarterly Report on Form 10-Q. Our budgeted cash requirements in 2026 and beyond include expenses related to continuing development and clinical studies as well as payments on our
debt.
We plan to continue to fund our operations and capital funding needs through existing cash and additional equity and/or debt financing.
However, we cannot be certain that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or our existing stockholders. We may also enter into government funding programs and
consider selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to our stockholders. Incurring debt financing would result in debt service obligations, and the
instruments governing such debt could provide for operating and financing covenants that would restrict our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit,
reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market immunotherapies that we would otherwise prefer to develop and market ourselves. Any of these actions could harm our business, results
of operations and prospects.
As a result of these uncertainties, we have concluded that substantial doubt exists about our ability to continue as a going concern for a
period of at least 12 months from the date of the issuance of these unaudited Condensed Consolidated Financial Statements. The unaudited Condensed Consolidated Financial Statements do not include any adjustments to the carrying amounts and
classifications of assets and liabilities that would result if we are unable to continue as a going concern.
30
Index
Cash Flows
The following table shows a summary of our cash flows for each of the periods indicated (in thousands):
Six Months Ended
June 30,
2026
2025
Net cash used in operating activities
$
(7,164
)
$
(18,133
)
Net cash (used)/provided by financing activities
(13,952
)
8,317
Net decrease in cash and cash equivalents
$
(21,116
)
$
(9,816
)
Net Cash Used in Operating Activities
Net cash used in operating activities was $7.2 million and
$18.1 million for the six months ended June 30, 2026 and 2025, respectively. The decrease in net cash used in operating activities of $10.9 million was primarily due to a net increase of $2.0 million in the amortization of debt discount and
loss on retirement of debt, an increase in stock-based compensation expense of $0.6 million, and changes in the timing of working capital. These changes were partially offset by a decrease in net loss of $0.8 million and a decrease in the issuance of
shares in consulting agreement of $0.2 million.
Net Cash Used in Financing Activities
Net cash used in financing activities was $13.9 million for the six months ended June 30, 2026, compared to net cash provided by financing
activities of $8.3 million for the six months ended June 30, 2025. The $22.2 million change was primarily due to a decrease in proceeds from the issuance of common stock of $7.0 million, a decrease in proceeds from the issuance of warrants and
pre-funded warrants of $2.1 million, and a decrease in proceeds from the issuance of debt of $14.9 million, partially offset by a decrease in loan principal payments and loan repayments of $2.6 million and a decrease in net proceeds from the issuance
of common stock under the at-the-market offering program of $0.8 million.
Operating Capital Requirements
To date, we have not generated any product revenue. We do not know when, or if, we will generate any product revenue and we do not expect
to generate significant product revenue unless and until we obtain regulatory approval and commercialize one of our current or future product candidates. We anticipate that we will continue to generate losses for the foreseeable future, and we expect
the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any approved products. We are subject to all of the risks incident to the development of new products, and
may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We expect to incur additional costs associated with operating as a public company and anticipate that we will need substantial
additional funding in connection with our continuing operations.
We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to
continue as a going concern within one year after the filing of this Quarterly Report. Our budgeted cash requirements in 2026 and beyond include expenses related to continuing development and clinical studies as well as payments on our debt. Until we
can generate significant cash from our operations, we expect to continue to fund our operations with available financial resources. These financial resources may not be adequate to sustain our operations. While we intend to finance our cash needs
principally through equity or debt financings, collaborations, strategic alliances, or license agreements with third parties, there is no assurance that new financing will be available to us on commercially acceptable terms or in the amounts
required, if at all.
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.
31
Index
We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our
available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating
capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
●
the initiation, progress, timing, costs and results of our planned clinical trials;
●
the effects of health epidemics, pandemics, or outbreaks of infectious diseases, on our business operations, financial condition, results of operations and cash flows;
●
the outcome, timing and cost of meeting regulatory requirements established by the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, and
other comparable foreign regulatory authorities;
●
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
●
the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us now or in the future;
●
the effect of competing technological and market developments;
●
the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize our products on our own; and
●
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 this Quarterly Report and in our Annual Report on Form 10-K for the year ended
December 31, 2025 for additional risks associated with our operations.
Purchase Commitments
We have no material non-cancelable purchase commitments with service providers as we have generally contracted on a cancelable, purchase
order basis.
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. GAAP. 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. 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 six months ended June 30, 2026 from those
disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules
and regulations of the SEC.
Smaller Reporting Company
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. 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.
32
Index
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.