PDS Biotechnology Corp

Previous wording

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.

Current wording

The clinical trial is designed to enroll a total of 351 patients with approximately 234 patients receiving the combination treatment of PDS0101 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.

Previous wording

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.

Current wording

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. See above for our October 2025 request to amend the trial’s design.

Previous wording

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

Current wording

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

Previous wording

In this trial, treatment will be administered before patients proceed to transoral robotic surgery (TORS) with curative intent. Treatment in this setting is referred to as neoadjuvant treatment. PDS0101 has been shown to induce 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).

Current wording

In this trial, treatment will be administered before patients proceed to transoral robotic surgery (TORS) with curative intent. Treatment in this setting is referred to as neoadjuvant treatment. PDS0101 has been shown to induce 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 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).

Previous wording

We have never been profitable and have incurred net losses in each year since inception. 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 $200.0 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.

Current wording

We have never been profitable and have incurred net losses in each year since inception. Our net losses were $26.9 million, and $29.7 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $209.0 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.

Previous wording

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

Current wording

As of September 30, 2025, we had $26.2 million in cash and cash equivalents.

Previous wording

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

Current wording

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

Previous wording

Research and development (R&D) expenses decreased to $4.2 millionfor the three months ended June 30, 2025 from $4.5 millionfor 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

Current wording

Research and development (R&D) expenses decreased to $4.6 millionfor the three months ended September 30, 2025 from $6.8 millionfor the three months ended September 30, 2024. The decrease of $2.2 million was primarily attributable to a decrease of $1.9 million in manufacturing costs, a decrease of $0.1 million in personnel costs and a decrease of $0.2 million in clinical trial costs.

Previous wording

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. The 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 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.

Current wording

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

Previous wording

Comparison of the Six months June 30, 2025 and 2024

Current wording

Comparison of the Nine months September 30, 2025 and 2024

Previous wording

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

Current wording

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

Previous wording

Research and development expenses decreased to $10.0 millionfor 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.

Current wording

Research and development expenses decreased to $14.6 millionfor the nine months ended September 30, 2025 from $18.0 millionfor the nine months ended September 30, 2024. The decrease of $3.4 million was primarily attributable to a decrease of $2.4 million in manufacturing and quality costs and a decrease of $1.2 million in personnel costs, partially offset by an increase of $0.2 million in clinical trial costs.

Previous wording

General and administrative expenses decreased to $6.7 million for the six months ended June 30, 2025 from $7.6 million for the six months ended June 30, 2024. 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.

Current wording

General and administrative expenses decreased to $10.2 million for the nine months ended September 30, 2025 from $10.9 million for the nine months ended September 30, 2024. The decrease of $0.7 million was primarily attributable to a decrease of $0.9 million in personnel costs, partially offset by an increase of $0.2 million in professional fees.

Previous wording

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. The 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.

Current wording

Income tax benefit was $1.2 million for the nine months ended September 30, 2025 and $0.9 million for the nine months ended September 30,2024. The increase of $0.3 million was due to an increase in the amount of New Jersey NOL carryforwards sold. 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.

Previous wording

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.

Current wording

During the three and nine months ended September 30, 2025, we sold 1,072,080 and 2,237,941 shares, respectively, of its common stock with a net value of $1.3 million and $3.0 million, respectively, pursuant to the New Sales Agreement. During the three and nine months ended September 30, 2024, we sold 0 and 3,428,681 shares, respectively, of its common stock with a net value of $0 and $19.4 million, respectively, pursuant to the Sales Agreement.

Previous wording

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.

Current wording

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, 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. Effective as of 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. During the three months ended September 30, 2025, we redeemed an aggregate of $1,000,000 of the principal amount of the Debentures. 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.

Previous wording

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, 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.

Current wording

As of September 30, 2025, we had $26.2 million in cash and cash equivalents. Our primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Previous wording

We plan to continue to fund our operations and capital funding needs through existing cash and additional equity and/or debt financing. However, we cannot be certain that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or our existing stockholders. We may also enter into government funding programs and consider selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to our stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market immunotherapies that we would otherwise prefer to develop and market ourselves. In addition, the 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.

Current wording

We plan to continue to fund our operations and capital funding needs through existing cash and additional equity and/or debt financing. However, we cannot be certain that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or our existing stockholders. We may also enter into government funding programs and consider selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to our stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market immunotherapies that we would otherwise prefer to develop and market ourselves. In addition, the Debentures allow for the lenders to call the outstanding balance of the Debentures if we fail to maintain the 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.

Previous wording

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.

Current wording

Net cash used in operating activities was $24.0 million and $26.8 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease in net cash used in operating activities of $2.8 million was primarilydue to a decrease in non-cash stock-based compensation expense of $2.3 million offset by a decrease in the net loss of $2.7 million, an increase in the amortization of debt discount of $0.2 million, an increase in the loss on retirement of debt of $0.8 million and changes in the timing of working capital requirements, including changes in prepaid expenses and other assets, accounts payable and accrued expenses.

Previous wording

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

Current wording

Net cash used in investing activities for the nine months ended September 30, 2025 and 2024 was $0 and $29,000, respectively.

Previous wording

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.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2025 and 2024 decreased by $11.4 million primarily due to a $23.8 million decrease in proceeds due to the repayment of the Loan and Security Agreement, a $16.4 million decrease in proceeds from the issuance of common stock from the Sales Agreement, a $0.6 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.

Previous wording

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.

Current wording

There have been no material changes to our critical accounting policies and estimates during the nine months ended September 30, 2025 from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.